Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18...

36
Corporate Presentation June 2020 NASDAQ: TYME

Transcript of Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18...

Page 1: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Corporate Presentation

June 2020

NASDAQ TYME

Safe Harbor StatementIn addition to historical information this presentation contains forward-looking statements under the Private Securities Litigation Reform Act that involvesubstantial risks and uncertainties Such forward-looking statements within this presentation include without limitation statements regarding our drugcandidate SM-88 and its clinical potential and non-toxic safety profiles our drug development plans and strategies ongoing and planned clinical trialspreliminary data results and the therapeutic design and mechanisms of our drug candidates and readers can identify forward-looking statements bysentences or passages involving the use of terms such ldquobelievesrdquo ldquoexpectsrdquo ldquohopesrdquo ldquomayrdquo ldquowillrdquo ldquoplanrdquo ldquointendsrdquo ldquoestimatesrdquo ldquocouldrdquo ldquoshouldrdquo ldquowouldrdquoldquocontinuerdquo ldquoseeksrdquo or ldquoanticipatesrdquo and similar words (including their use in the negative) or by discussions of future matters such as the development andpotential commercialization of our lead drug candidate and of other new products expected releases of interim or final data from our clinical trials possiblecollaborations the timing scope and objectives of our ongoing and planned clinical trials and other statements that are not historical The forward-lookingstatements contained in this presentation are based on managementrsquos current expectations which are subject to uncertainty risks and changes incircumstances that are difficult to predict and many of which are outside of TYMErsquos control These statements involve known and unknown risks uncertaintiesand other factors which may cause the Companyrsquos actual results performance or achievements to be materially different from any historical results and futureresults performances or achievements expressed or implied by the forward-looking statements These risks and uncertainties include but are not limited tothat the information is of a preliminary nature and may be subject to change uncertainties inherent in research and development including the ability toachieve clinical study start and completion dates the possibility of unfavorable study results including unfavorable new clinical data and additional analyses ofexisting data risks associated with early initial data including the risk that the final Phase II data may differ from prior study data or preliminary Phase II datafinal results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development that pastreported data are not necessarily predictive of future patient or clinical data outcomes whether and when any applications or other submissions for SM-88may be filed with regulatory authorities whether and when regulatory authorities may approve any applications or submissions decisions by regulatoryauthorities regarding labeling and other matters that could affect commercial availability of SM-88 the ability of TYME and its collaborators to develop andrealize collaborative synergies competitive developments and the factors described in the section captioned ldquoRisk Factorsrdquo of TYMErsquos Annual Report onForm 10-K filed with the US Securities and Exchange Commission on May 22 2020 as well as subsequent reports we file from time to time with the USSecurities and Exchange Commission (available at wwwsecgov)

The information contained in this presentation is as of this date and TYME assumes no obligation to update forward-looking statements contained in thispresentation as a result of future events or developments

2

TYME Technologies

3

TYME is an emerging biotechnology company focused on exploring novel therapeutic

approaches designed totarget cancerrsquos unique metabolism

TYME is advancing proprietaryCancer Metabolism-Based Therapies (CMBTstrade)

for difficult-to-treat cancers

4

Oral Therapy Advantage Ease of administration amp taken at home offers a key benefit for patients with advanced cancers in todayrsquos environment

Differentiated MOA TYME is exploiting the extensively studied Warburg Effect by developing a first-in-class approach to kill cancer cells through disrupting cancer metabolism through multiple mechanisms of action TYME believes this unique approach can provide broad therapeutic efficacy without unnecessary off-target toxicity

A leader in Cancer Metabolism-Based Therapies (CMBTstrade)Over a decade of experience studying Cancer Metabolism-Based Therapies (CMBTs) with a strong patent portfolio broadly covering compositions methods manufacturing and use extending beyond 2032

Large Growing Markets with Limited Options Targeting metastatic cancers for which there are limited options including pancreatic sarcoma prostate breast cancers and more

Lead Candidate SM-88 in Pivotal Trials Enrolling patients in pivotal TYME-88-Panc Part 2 trial for third-line pancreatic cancer Enrolling patients in Phase IIIII Precision Promise pivotal trial in second-line pancreatic cancer Enrolling patients in HopES Sarcoma Phase II trial for Ewingrsquos amp high-risk sarcomas Preparing SM-88 for clinical programs in cancers where it has previously shown responses in early clinical trials

including breast prostate and blood cancers

TYME Investment Rationale

Delivering on Key FY2021 Milestones Positions TYME for Long-Term Success

5

Advance enrollment in TYME-88-Panc Pivotal Study

Present andor publish final data from Part 1 of TYME-88-Panc study

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers

Initiate enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

Complete enrollment in TYME-88-Panc pivotal study

Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR

Publish SM-88 Phase II prostate study

Present Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO

Advance plans for TYME-18 IND-enabling program

Advance enrollment in the HopES Sarcoma Phase II Trial

Complete enrollment inHopES Sarcoma study

BrainGliomaNasal

Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE

PHASE I PHASE II PHASE IIIII

Digestively Compromised Patients

6

Pancreatic Third-Line TYME-88-Panc Pivotal Part 2 Enrolling

Prostate Biomarker Recurrent Completed

Metastatic Sarcomas HopES Enrolling

Future Trials Breast and Prostate

Pancreatic Second-Line Monotherapy Precision Promise Enrolling Shortly

Pancreatic First-Line Combo wGA Precision Promise Initiate Following Second-Line

Injectable

SM-88n

SM-88i

Solid TumorsIntra-tumoralTYME-18

Investigator-initiated trial GA = gemcitabineAbraxanereg

Future Trials Hematology

OralSM-88

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 2: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Safe Harbor StatementIn addition to historical information this presentation contains forward-looking statements under the Private Securities Litigation Reform Act that involvesubstantial risks and uncertainties Such forward-looking statements within this presentation include without limitation statements regarding our drugcandidate SM-88 and its clinical potential and non-toxic safety profiles our drug development plans and strategies ongoing and planned clinical trialspreliminary data results and the therapeutic design and mechanisms of our drug candidates and readers can identify forward-looking statements bysentences or passages involving the use of terms such ldquobelievesrdquo ldquoexpectsrdquo ldquohopesrdquo ldquomayrdquo ldquowillrdquo ldquoplanrdquo ldquointendsrdquo ldquoestimatesrdquo ldquocouldrdquo ldquoshouldrdquo ldquowouldrdquoldquocontinuerdquo ldquoseeksrdquo or ldquoanticipatesrdquo and similar words (including their use in the negative) or by discussions of future matters such as the development andpotential commercialization of our lead drug candidate and of other new products expected releases of interim or final data from our clinical trials possiblecollaborations the timing scope and objectives of our ongoing and planned clinical trials and other statements that are not historical The forward-lookingstatements contained in this presentation are based on managementrsquos current expectations which are subject to uncertainty risks and changes incircumstances that are difficult to predict and many of which are outside of TYMErsquos control These statements involve known and unknown risks uncertaintiesand other factors which may cause the Companyrsquos actual results performance or achievements to be materially different from any historical results and futureresults performances or achievements expressed or implied by the forward-looking statements These risks and uncertainties include but are not limited tothat the information is of a preliminary nature and may be subject to change uncertainties inherent in research and development including the ability toachieve clinical study start and completion dates the possibility of unfavorable study results including unfavorable new clinical data and additional analyses ofexisting data risks associated with early initial data including the risk that the final Phase II data may differ from prior study data or preliminary Phase II datafinal results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development that pastreported data are not necessarily predictive of future patient or clinical data outcomes whether and when any applications or other submissions for SM-88may be filed with regulatory authorities whether and when regulatory authorities may approve any applications or submissions decisions by regulatoryauthorities regarding labeling and other matters that could affect commercial availability of SM-88 the ability of TYME and its collaborators to develop andrealize collaborative synergies competitive developments and the factors described in the section captioned ldquoRisk Factorsrdquo of TYMErsquos Annual Report onForm 10-K filed with the US Securities and Exchange Commission on May 22 2020 as well as subsequent reports we file from time to time with the USSecurities and Exchange Commission (available at wwwsecgov)

The information contained in this presentation is as of this date and TYME assumes no obligation to update forward-looking statements contained in thispresentation as a result of future events or developments

2

TYME Technologies

3

TYME is an emerging biotechnology company focused on exploring novel therapeutic

approaches designed totarget cancerrsquos unique metabolism

TYME is advancing proprietaryCancer Metabolism-Based Therapies (CMBTstrade)

for difficult-to-treat cancers

4

Oral Therapy Advantage Ease of administration amp taken at home offers a key benefit for patients with advanced cancers in todayrsquos environment

Differentiated MOA TYME is exploiting the extensively studied Warburg Effect by developing a first-in-class approach to kill cancer cells through disrupting cancer metabolism through multiple mechanisms of action TYME believes this unique approach can provide broad therapeutic efficacy without unnecessary off-target toxicity

A leader in Cancer Metabolism-Based Therapies (CMBTstrade)Over a decade of experience studying Cancer Metabolism-Based Therapies (CMBTs) with a strong patent portfolio broadly covering compositions methods manufacturing and use extending beyond 2032

Large Growing Markets with Limited Options Targeting metastatic cancers for which there are limited options including pancreatic sarcoma prostate breast cancers and more

Lead Candidate SM-88 in Pivotal Trials Enrolling patients in pivotal TYME-88-Panc Part 2 trial for third-line pancreatic cancer Enrolling patients in Phase IIIII Precision Promise pivotal trial in second-line pancreatic cancer Enrolling patients in HopES Sarcoma Phase II trial for Ewingrsquos amp high-risk sarcomas Preparing SM-88 for clinical programs in cancers where it has previously shown responses in early clinical trials

including breast prostate and blood cancers

TYME Investment Rationale

Delivering on Key FY2021 Milestones Positions TYME for Long-Term Success

5

Advance enrollment in TYME-88-Panc Pivotal Study

Present andor publish final data from Part 1 of TYME-88-Panc study

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers

Initiate enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

Complete enrollment in TYME-88-Panc pivotal study

Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR

Publish SM-88 Phase II prostate study

Present Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO

Advance plans for TYME-18 IND-enabling program

Advance enrollment in the HopES Sarcoma Phase II Trial

Complete enrollment inHopES Sarcoma study

BrainGliomaNasal

Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE

PHASE I PHASE II PHASE IIIII

Digestively Compromised Patients

6

Pancreatic Third-Line TYME-88-Panc Pivotal Part 2 Enrolling

Prostate Biomarker Recurrent Completed

Metastatic Sarcomas HopES Enrolling

Future Trials Breast and Prostate

Pancreatic Second-Line Monotherapy Precision Promise Enrolling Shortly

Pancreatic First-Line Combo wGA Precision Promise Initiate Following Second-Line

Injectable

SM-88n

SM-88i

Solid TumorsIntra-tumoralTYME-18

Investigator-initiated trial GA = gemcitabineAbraxanereg

Future Trials Hematology

OralSM-88

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 3: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

TYME Technologies

3

TYME is an emerging biotechnology company focused on exploring novel therapeutic

approaches designed totarget cancerrsquos unique metabolism

TYME is advancing proprietaryCancer Metabolism-Based Therapies (CMBTstrade)

for difficult-to-treat cancers

4

Oral Therapy Advantage Ease of administration amp taken at home offers a key benefit for patients with advanced cancers in todayrsquos environment

Differentiated MOA TYME is exploiting the extensively studied Warburg Effect by developing a first-in-class approach to kill cancer cells through disrupting cancer metabolism through multiple mechanisms of action TYME believes this unique approach can provide broad therapeutic efficacy without unnecessary off-target toxicity

A leader in Cancer Metabolism-Based Therapies (CMBTstrade)Over a decade of experience studying Cancer Metabolism-Based Therapies (CMBTs) with a strong patent portfolio broadly covering compositions methods manufacturing and use extending beyond 2032

Large Growing Markets with Limited Options Targeting metastatic cancers for which there are limited options including pancreatic sarcoma prostate breast cancers and more

Lead Candidate SM-88 in Pivotal Trials Enrolling patients in pivotal TYME-88-Panc Part 2 trial for third-line pancreatic cancer Enrolling patients in Phase IIIII Precision Promise pivotal trial in second-line pancreatic cancer Enrolling patients in HopES Sarcoma Phase II trial for Ewingrsquos amp high-risk sarcomas Preparing SM-88 for clinical programs in cancers where it has previously shown responses in early clinical trials

including breast prostate and blood cancers

TYME Investment Rationale

Delivering on Key FY2021 Milestones Positions TYME for Long-Term Success

5

Advance enrollment in TYME-88-Panc Pivotal Study

Present andor publish final data from Part 1 of TYME-88-Panc study

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers

Initiate enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

Complete enrollment in TYME-88-Panc pivotal study

Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR

Publish SM-88 Phase II prostate study

Present Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO

Advance plans for TYME-18 IND-enabling program

Advance enrollment in the HopES Sarcoma Phase II Trial

Complete enrollment inHopES Sarcoma study

BrainGliomaNasal

Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE

PHASE I PHASE II PHASE IIIII

Digestively Compromised Patients

6

Pancreatic Third-Line TYME-88-Panc Pivotal Part 2 Enrolling

Prostate Biomarker Recurrent Completed

Metastatic Sarcomas HopES Enrolling

Future Trials Breast and Prostate

Pancreatic Second-Line Monotherapy Precision Promise Enrolling Shortly

Pancreatic First-Line Combo wGA Precision Promise Initiate Following Second-Line

Injectable

SM-88n

SM-88i

Solid TumorsIntra-tumoralTYME-18

Investigator-initiated trial GA = gemcitabineAbraxanereg

Future Trials Hematology

OralSM-88

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 4: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

4

Oral Therapy Advantage Ease of administration amp taken at home offers a key benefit for patients with advanced cancers in todayrsquos environment

Differentiated MOA TYME is exploiting the extensively studied Warburg Effect by developing a first-in-class approach to kill cancer cells through disrupting cancer metabolism through multiple mechanisms of action TYME believes this unique approach can provide broad therapeutic efficacy without unnecessary off-target toxicity

A leader in Cancer Metabolism-Based Therapies (CMBTstrade)Over a decade of experience studying Cancer Metabolism-Based Therapies (CMBTs) with a strong patent portfolio broadly covering compositions methods manufacturing and use extending beyond 2032

Large Growing Markets with Limited Options Targeting metastatic cancers for which there are limited options including pancreatic sarcoma prostate breast cancers and more

Lead Candidate SM-88 in Pivotal Trials Enrolling patients in pivotal TYME-88-Panc Part 2 trial for third-line pancreatic cancer Enrolling patients in Phase IIIII Precision Promise pivotal trial in second-line pancreatic cancer Enrolling patients in HopES Sarcoma Phase II trial for Ewingrsquos amp high-risk sarcomas Preparing SM-88 for clinical programs in cancers where it has previously shown responses in early clinical trials

including breast prostate and blood cancers

TYME Investment Rationale

Delivering on Key FY2021 Milestones Positions TYME for Long-Term Success

5

Advance enrollment in TYME-88-Panc Pivotal Study

Present andor publish final data from Part 1 of TYME-88-Panc study

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers

Initiate enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

Complete enrollment in TYME-88-Panc pivotal study

Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR

Publish SM-88 Phase II prostate study

Present Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO

Advance plans for TYME-18 IND-enabling program

Advance enrollment in the HopES Sarcoma Phase II Trial

Complete enrollment inHopES Sarcoma study

BrainGliomaNasal

Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE

PHASE I PHASE II PHASE IIIII

Digestively Compromised Patients

6

Pancreatic Third-Line TYME-88-Panc Pivotal Part 2 Enrolling

Prostate Biomarker Recurrent Completed

Metastatic Sarcomas HopES Enrolling

Future Trials Breast and Prostate

Pancreatic Second-Line Monotherapy Precision Promise Enrolling Shortly

Pancreatic First-Line Combo wGA Precision Promise Initiate Following Second-Line

Injectable

SM-88n

SM-88i

Solid TumorsIntra-tumoralTYME-18

Investigator-initiated trial GA = gemcitabineAbraxanereg

Future Trials Hematology

OralSM-88

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 5: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Delivering on Key FY2021 Milestones Positions TYME for Long-Term Success

5

Advance enrollment in TYME-88-Panc Pivotal Study

Present andor publish final data from Part 1 of TYME-88-Panc study

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers

Initiate enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

Complete enrollment in TYME-88-Panc pivotal study

Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR

Publish SM-88 Phase II prostate study

Present Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO

Advance plans for TYME-18 IND-enabling program

Advance enrollment in the HopES Sarcoma Phase II Trial

Complete enrollment inHopES Sarcoma study

BrainGliomaNasal

Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE

PHASE I PHASE II PHASE IIIII

Digestively Compromised Patients

6

Pancreatic Third-Line TYME-88-Panc Pivotal Part 2 Enrolling

Prostate Biomarker Recurrent Completed

Metastatic Sarcomas HopES Enrolling

Future Trials Breast and Prostate

Pancreatic Second-Line Monotherapy Precision Promise Enrolling Shortly

Pancreatic First-Line Combo wGA Precision Promise Initiate Following Second-Line

Injectable

SM-88n

SM-88i

Solid TumorsIntra-tumoralTYME-18

Investigator-initiated trial GA = gemcitabineAbraxanereg

Future Trials Hematology

OralSM-88

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 6: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

BrainGliomaNasal

Advancing Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

PROGRAM FORMULATION CANCER INDICATION DEVELOPMENTSTAGE

PHASE I PHASE II PHASE IIIII

Digestively Compromised Patients

6

Pancreatic Third-Line TYME-88-Panc Pivotal Part 2 Enrolling

Prostate Biomarker Recurrent Completed

Metastatic Sarcomas HopES Enrolling

Future Trials Breast and Prostate

Pancreatic Second-Line Monotherapy Precision Promise Enrolling Shortly

Pancreatic First-Line Combo wGA Precision Promise Initiate Following Second-Line

Injectable

SM-88n

SM-88i

Solid TumorsIntra-tumoralTYME-18

Investigator-initiated trial GA = gemcitabineAbraxanereg

Future Trials Hematology

OralSM-88

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 7: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Expanding Opportunities for Cancer Metabolism-Based Therapies to Transform Treatment of Metastatic Cancers

7source IQVIA global oncology market trends 2019 American Cancer Societyrsquos cancer facts amp figures 2019 wwwncbinlmnihgov drugscom ajmccom boneandjointburdenorg

PANCREAS(Third-line)

10K$09B

INCIDENCE

MARKETOPPORTUNITY

PANCREAS(First Second and Third-line)

57K$51B

INCIDENCE

MARKETOPPORTUNITY

SARCOMA

12K$11B

INCIDENCE

MARKETOPPORTUNITY

PROSTATE

450K$144B

PREVALENCE

MARKETOPPORTUNITY

BREAST(Metastatic)

150K$194B

INCIDENCE

MARKETOPPORTUNITY

HEMATOLOGY(DLBC RR AML)

48K$84B

INCIDENCE

MARKETOPPORTUNITY

(Recurrent)

(Ewingrsquos amp High-Risk)

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 8: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

UNIQUE SCIENTIFIC APPROACH

8

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 9: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

SM-88 SM-8

8

SM-88

3 Decreased cellular defenses

Free Radicals

(ROS)

2 Protein synthesis fails1 Induce uptake of TYMErsquos

modified dysfunctional Tyrosine

4 Cell death from oxidative stress

Exploiting Warburg Effect Through Modified Dysfunctional Amino Acids Targeting Cancerrsquos Unique Metabolism

9

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 10: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Expanding Breadth and Depth of Strong Patent Portfolio

10

Patents broadly cover compositions methods manufacturing and use of the Companyrsquos pipeline to 2032 and beyond2032

GLOBAL 194 Patent Applications Granted andor Pending

US

EU

APAC

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 11: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

CLINICAL TRIALSMETASTATIC CANCER

11

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 12: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

SM-88 Achieved Confirmed Clinical Responses Across 15 Tumor Types

12

NCIorg statistics for 2018

Success in pancreatic cancer may offer a path for SM-88 development into many of the 15 advanced cancers

where imaging responses were demonstrated

Cancers with Demonstrated Responses to SM-88

Pancreatic Breast Ovarian

Prostate Colon GliomaGlioblastoma

Ewingrsquos Sarcoma Renal Appendix

Soft-Tissue Sarcoma Thyroid Hodgkinrsquos Lymphoma

Lung Head amp Neck Non-Hodgkinrsquos Lymphoma

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 13: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Overall Survival (months)RECIST Designation1

Median OS of 298 Months

First Human Study in Metastatic CancerSM-88 has been evaluated in more than 200 patients

Acirc Phase 1 with 30 patients who had actively progressing metastatic cancer and received only SM-88 used with M2PS2

Acirc 298 month median overall survival

Acirc 13 months of progression free survival (PFS) without additional therapy

Acirc 33 (1030) achieved RECIST CRPR with mean time to best response of 33m3

Acirc 57 (1730) achieved RECIST stable disease with a median duration of 11m

13

1 Five year analysis as of September 20172 SM-88 = DL-alpha-metyrosine SM-88 used with M2PS is DL-alpha-metyrosine used with low dose

methoxsalen melanin phenytoin and sirolimus3 Response based on RECIST 11 criteria CR = complete response

PR = partial response SD = stable disease PD = progressive disease OS = overall survival ORR = Objective response rate

A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer Invest New Drugs 2019 Mar 30 doi 101007s10637-019-00758-8

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 14: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

CLINICAL TRIALSPANCREATIC CANCER

14

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 15: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

US Pancreatic Treatment Paradigm

15

gt 10000Receive 3rd Line

gt 20000Receive 2nd Line

Acirc Onivydereg +5FULV (GA-failed)Acirc GA (5FU-failed)Acirc Single agent (ECOG 2)

gt 41000Receive 1st Line

Acirc Gemzarreg Abraxanereg (ldquoGArdquo) orAcirc FOLFIRINOXAcirc Single agent (ECOG 2)

8-11 months

4-6 months

2-3 months

~30

~10

~0

Diagnosed (US)

ASCO Guidelines (Metastatic)

Metastatic at Diagnosis

of Patients

55400

~80

Localized ~20

ldquoNo data are available to recommend third-line (or greater)

therapy with a cytotoxic agentrdquo

Historical Trial Medians

Source 2018 American Cancer Society patient statistics Metastatic Pancreatic Cancer ASCO Clinical Practice Guidelines Abrams et al 2017 Bachet et al 2009

ORR Survival

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 16: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Acirc Focus on 3rd line patients

Acirc Trial design reflects FDA protocol evaluation

Acirc Randomized with overall survival as primary endpoint

16

SM-88 Monotherapy in Patients with Radiographically Progressing Metastatic Pancreatic Cancer (Phase IIIII)

Structure Part 1 single-arm ~25 sites across the US Part 2 randomized 10 ndash 15 sites planned

Primary Endpoint for Part 2 Overall Survival CRO IQVIA Biotech

Dosing Part 1

Acirc Randomized to 920 mg or 460 mg dose tyrosine

Acirc Completed enrollment ahead of expectations by Sep 2018

Acirc Measuring multiple indicators of efficacy and safety

Initial data analysis presentedat ASCO GI 2019

Completed FDA discussions on 3rd line pivotal trial design

TYME-88-Panc Overview

Pivotal Part 2

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 17: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Promising Overall Survival Data From TYME-88-Panc Study (Part 1)

Acirc Third-line PDAC has no established therapy

Acirc Previously reported survival for third line PDAC patients is approximately 20 ndash 25 months (Manax et al ASCO GI Poster 2019)

Acirc The preliminary median Kaplan-Meier (KM) derived overall survival of the evaluable population is currently 64 months

17

Data cutoff as of 42519

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 18: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

SM-88 Impacts Circulating Tumor Cells (CTCs) Reducing Risk of Death

18

HR 04 95CI (011 ndash 15)p = 018

Best CTC Response by Reduction (n=24) Acirc Emerging biomarker in pancreatic cancer

Acirc Patients who had at least an 80 CTC reduction trended towards greater survival

Acirc These patients demonstrated a 60 decrease in risk of death

Data cutoff as of 42519

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 19: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Reported Strong Clinical Benefit Rate in Patient Population with Poor Prognosis

19

HR 008 (95 CI 001 ndash 063)p = 002

Acirc 60 (1220) PERCIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved as least SD by first assessment demonstrated greater survival than PD patients

Acirc Patients who achieved at least PERCIST SD had a 72 reduction in risk of death

RECIST Disease Control

Data cutoff as of 42519

HR 028 (95 CI 005 mdash 148)p = 011

PERCIST Disease Control

Data cutoff as of 42519

Acirc 44 (1125) RECIST Clinical Benefit Rate (SD or PR)

Acirc Patients who achieved at least SD by first assessment demonstrated statistically significant greater survival than PD patients

Acirc Patients who achieved at least RECIST SD had a 92 reduction in risk of death

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 20: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Acirc SM-88 has demonstrated well tolerated safety profile with only 4 of patients reporting serious adverse events (SAEs) across multiple clinical trials

Acirc SM-88 has demonstrated a favorable safety profile in 15 different tumor types including solid tumors and hematologic malignancies across four separate studies

20

Data cutoff as of 42519

Targeted Mechanism of Action Delivering Favorable Safety Profile Compared With Other Cancer Treatments

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 21: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

ENDPOINT(S)DESIGN

Enrolling Patients in TYME-88-Panc Pivotal Trial for Third-line Treatment

21

PIVOTAL SM-88 used with MPS in Patients with Metastatic Adenocarcinoma of the Pancreas Whose Disease Has Progressed or Reoccurred Study Identifier NCT03512756

Histologically confirmed pancreatic adenocarcinoma

Received 2 lines of prior systemic therapy

Adequate organ function

KEY ELIGIBILITY CRITERIA

SM-88(N=~125)

Investigator-chosen Therapy(N=~125)

R11

Treatment untilunacceptabletoxicity diseaseprogression or any treatment discontinuation criteria are met

SCR

EENIN

G

Primary OSSecondary PFS CBR and QoL Key Exploratory Endpoints Biomarker analysis including CTCs

Other secondary and exploratory endpoints will also be captured

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 22: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Experience Delivering Disease-Altering Innovative Cancer Medicines to Orphan Patient Population

22

Acirc Blockbuster Oral IMiD Therapy

Acirc All Stages of Multiple Myeloma

Acirc Myelodysplastic Syndrome del 5q

Acirc Mantle Cell Lymphoma

Acirc Global Markets

Acirc Potential Blockbuster CAR-T Therapy

Acirc Non-Hodgkin Lymphoma

Acirc US Launch

Acirc Blockbuster Oral IMiD Therapy

Acirc RelapsedRefractory Multiple Myeloma

Acirc Global Markets

Acirc Blockbuster Nanotechnology Cancer Therapy

Acirc Metastatic Pancreatic Cancer

Acirc Metastatic Breast Cancer

Acirc Advanced Non-Small Cell Lung Cancer

Acirc Global Markets

Acirc HDAC Inhibitor Therapy

Acirc Cutaneous T- Cell Lymphoma

Acirc Peripheral T- Cell Lymphoma

Acirc US Launch

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 23: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

CLINICAL TRIALSPRECISION PROMISESM

PANCREATIC CANCER

23

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 24: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

PanCAN Precision PromiseSM

Clinical Trial Consortium Sites

PanCAN Worldrsquos Largest Advocate Committed to Curing Pancreatic Cancer

Precision Promise is the first response-adaptive randomized clinical trial platform for pancreatic cancer patients in the world and the Pancreatic Cancer Action Networkrsquos groundbreaking initiative to dramatically improve outcomes for pancreatic cancer patients and advance the organizationrsquos goal to double survival

ldquo

rdquondash Pancreatic Cancer Action Network

24

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 25: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

CLINICAL TRIALSSARCOMAS

25

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 26: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Acirc Ewingrsquos accounts for 30 of bone cancers in children

Acirc Tumor of the bone or soft tissue most often in the pelvis thigh lower leg upper arm and chest wall

Acirc 30 5-year survival rate for metastatic disease

Acirc All sarcomas represent 12000 new cases annually in US alone

Acirc TYME Dr Sant Chawla and The Joseph Ahmed Foundation (JAF) are addressing unmet need in ultra-rare metastatic sarcoma

Acirc JAF is funding the trial and is using its nationwide network to assist potential patients and their families

Acirc Based on compassionate use results in two metastatic Ewingrsquos sarcoma patients who achieved CR or PR with no drug-related SAEs

Acirc If proof-of-concept is demonstrated a multi-site confirmatory study will be evaluated

Ewingrsquos and High-risk Sarcoma

JAF HopES Trial Enrolling Patients with Ultra-Rare Metastatic Sarcoma

26

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 27: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

ENDPOINT(S)DESIGN

SM-88 for Advanced Ewings Sarcoma and Salvage Therapy for Sarcoma Patients (HopES)

27

Phase 2 SM-88 Used With MPS in Patients With High-Risk Ewingrsquos and Other Sarcoma Types Study Identifier NCT03778996

Bx proven previously treated Sarcoma

High Risk for PD ie gt 2 prior lines of systemic treatments

Ewingrsquos patients may be treated in SD immediately following 1st or 2nd line therapy

KEY ELIGIBILITY CRITERIA

SM-88 in Ewingrsquos(N=12) Treat until

Progressive disease or unacceptable toxicity

Primary Response RateSecondary PFS CBR

Other secondary and exploratory endpoints will also be captured

SM-88 in Other Sarcomas (N=12)

SCR

EENIN

G

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 28: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

CLINICAL TRIALSPROSTATE CANCER

28

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 29: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

SM-88 Demonstrated Potential To Postpone Hormone Therapy in Recurrent Prostate Cancer

29

At 6 months 100 (2323) of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

After 3 months 78 (1823) of patients demonstrated a median 65 decrease in median CTCs from baseline

52 (1223) of patients showed improvement in median PSA doubling time

No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Benjamin Gartrell1 Mack Roach2 Giuseppe Del Priore3 Avi Retter4 Wen-Tien Chen5 Gerald H Sokol6 Alexander Vandell3 Howard I Scher7

1)Albert Einstein College of MedicineMontefiore Medical Center 2)University of California San Francisco 3)TYME Inc 4)ECCCNY Cancer and Blood Specialists 5)LineaRx 6)Florida Cancer Specialist 7)Memorial Sloan-Kettering Cancer Center

Data cutoff as of September 2019

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 30: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Clinical Trial Demonstrates Potential To Postpone Hormone Therapy Based on Encouraging Clinical Data

30

bull At 6 months 100 of patients were free of metastatic progression and 87 of patients remained free of radiographic progression

bull After 3 months 78 of patients demonstrated a median 65 decrease in median CTCs from baseline

bull 52 of patients showed improvement in median PSA doubling time

bull No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 31: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Leadership Role in Advancing Clinical Research of CTCs in Prostate Cancer

31

Progression included regional radiographic PD and PCWG3 PSA progression

Data cutoff as of September 2019

Achieving CTCs of lt10 cells4mL correlated with improved progression-free survival

Reductions in CTC number may be a more informative indicator of benefit than changes in PSA

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 32: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

METASTATIC BREAST CANCER

32

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 33: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Compelling SM-88 Data in PatientsWith Metastatic Breast Cancer

Acirc SM-88 demonstrated clinical benefit in metastatic breast cancer (mBC) with a favorable safety and quality of life profile There was no indication of cross-resistance based on hormone receptor profile prior treatments or metastatic siteAcirc A total of 25 mBC patients were treated with SM-88 between 2012ndash2017Acirc All subjects had previously treated progressing mBC Acirc Subjects had a median of 3 prior therapies (range of 1 ndash 8)

Acirc Overall response rate was 44 (1125) Acirc 16 (425) Experienced a Complete ResponseAcirc 79 Improved ECOG Performance Status Acirc 57 Pain Reduction (NRS-11)

Acirc There were no unanticipated or drug-related adverse events

33

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 34: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

KEY MILESTONES FOR FISCAL YEAR 2021

34

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 35: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

Milestone Timing

Clinical Trial Milestones

Advance enrollment in TYME-88-Panc Pivotal Study FY2021

Advance enrollment in the HopES Sarcoma Phase II Trial FY2021

Advance enrollment in PanCANrsquos Precision PromiseSM adaptive randomized Phase IIIII trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy

FY2021

Publish SM-88 Phase II prostate study 1HFY2021

Advance SM-88 clinical programs into other tumor types potentially including metastatic breast recurrent prostate andor hematological cancers 2HFY2021

Present andor publish final data from Part 1 of TYME-88-Panc study Late 2020

Complete enrollment in TYME-88-Panc pivotal study Late 2020 ndashEarly 2021

Complete enrollment in HopES Sarcoma study 1HFY2022

Preclinical amp Clinical Data Milestones Abstracts to be presented on preclinical data for SM-88 amp TYME-18 at AACR 1HFY2021

OtherPresent Health Economic Outcomes study on total cost of care for pancreatic cancer patients at ISPOR amp ASCO 1HFY2021

Advance plans for TYME-18 IND-enabling program 2HFY2021

35

FY2021 Creates Pivotal Inflection Point with Multiple Value Drivers

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM

Page 36: Corporate Presentation › 265040820 › files › doc... · HR: 0.4 95%CI (0.11 – 1.5) p = 0.18 Best CTC Response by % Reduction (n=24) Â Emerging biomarker in pancreatic cancer

17 State Street 7TH FLOORNEW YORK NY 10004

NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM

TYMEINCCOM