Post on 05-Jul-2020
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
17 State Street 7TH FLOORNEW YORK NY 10004
NASDAQ TYMEMEDIATYMEINCCOMINVESTORRELATIONSTYMEINCCOM
TYMEINCCOM