Corporate Presentation January 2020 - s23.q4cdn.com · Corporate Presentation . January 2020. 2....

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NASDAQ: MRTX

Targeting the genetic and immunological drivers of cancer

Corporate Presentation January 2020

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Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the date hereof, are "forward-looking" statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties. Forward looking statements can be identified by the use of forward looking words such as“believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “pro forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future matters such as the development of current or future product candidates, timing of potential development activities and milestones, business plans and strategies, possible changes in legislation and other statements that are not historical. Forward-looking statements are based on current expectations of management and on what management believes to be reasonable assumptions based on information currently available to them, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation potential delays in development timelines, negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks detailed in Mirati's recent filings on Forms 10-K and 10-Q with the U.S. Securities and Exchange Commission. Except as required by law, Mirati undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, orto reflect the occurrence of unanticipated events.

January 27, 2020

Safe Harbor Statement

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Mirati’s Leadership Team Applying Proven Approaches to Oncology Development

Charles M. Baum, M.D., Ph.D.CHIEF EXECUTIVE OFFICERSVP Clinical Research, PfizerLeader of Key Oncology Programs: Ibrance, Xalkori, Sutent, Inlyta, Temodar

James Christensen, Ph.D.CHIEF SCIENTIFIC OFFICERHead of Precision Research, Oncology Research Unit, PfizerDeep experience in precision oncology with Ibrance, Xalkori, Sutent, Inlyta

Ben HickeyCHIEF COMMERCIAL OFFICERCCO at Halozyme Therapeutics, built strong commercial oncology organizations, strategic marketing development and oversight of numerous successful global product launches including Opdivo.

Oncology Experience

Dan FagaCHIEF OPERATING OFFICERCBO at Spark Therapeutics responsibility for corporate strategy, public affairs, portfolio planning & asset management. Managing Director at Centerview Partners. Extensive experience in biopharma growth advisory, business development and M&A.

Isan Chen, M.D.CHIEF MEDICAL OFFICERCMO at Aragon Pharmaceuticals Previously VP at Pfizer with Ibrance, Xalkori, Sutent, Inlyta

http://www.ibrance.com/

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Phase 3

Multiple Near-Term Catalysts Across Portfolio

NSCLC = non-small cell lung cancer; CRC = colorectal cancer; RCC = renal cell cancer; HCC = hepatocellular cancer; OC = ovarian cancer, IND = Investigational New Drug application; Tislelizumab (BeiGene’s anti PD-1)

1) BeiGene is currently running a subset of combination studies of sitravatinib + tislelizumab in Asia for multiple solid tumor indications. BeiGene has Asian commercialization rights (ex-Japan) for sitravatinib as part of our development and commercialization agreement (Jan. 2018). BeiGene is responsible for additional data disclosures.

Preclinical Phase 1/1b Phase 2 Near-Term MilestonesIndication

SitravatinibMulti Kinase

Inhibitor

Sitravatinib+ PD-1

NSCLC

Bladder, RCC, HNSCC Additional data in 2020

Additional data in 2020

SAPPHIRE – 2nd / 3rd Line CPI Refractory

Mirati-run Studies

Interim OS Analysis YE 2021

MRTX849KRAS G12C Inhibitor

MRTX849monotherapy

NSCLC, CRC,Pancreatic

Initiate Q1 2020MRTX849 + PD-1

NSCLC

Initiate P2 NSCLC registration cohort in 1H 2020Duration data 2H 2020KRYSTAL – 2nd Line +

1st Line

G12D Inhibitor Pancreatic, CRC, NSCLC IND enabling studies in 2020KRAS G12D

Inhibitor

Initiate Mid-2020

Initiate Q1 2020CRC

Initiate Mid-2020

MRTX849 + CDK4/6

MRTX849 + cetuximab (EGFR)

MRTX849 + afatinib (pan-EGFR)

2nd Line

2nd Line

2nd Line


- Combinations

Initiate Mid-2020NSCLC, CRCMRTX849 + TNO155 (SHP2) 2nd Line

BeiGene (1)NSCLC, HCC, RCC, OC, Gastric

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Targeted Oncology

MRTX849: KRAS G12C Inhibitor

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KRAS is the Most Frequently Mutated Gene in Human Cancer

MRTX849 KRAS G12C Inhibitor

Abnormal KRAS SignalingKRAS Signaling

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MRTX849: Potential Best-in-Class Attributes

Tissue Distribution

Projected Human Volume of Distribution >10 L/Kg

Half Life

Projected Human Half Life >20 hours½

Designed to Fully Suppress Mutant KRAS Signaling

Bioavailability

Projected Human Bioavailability >50%

MRTX849 Designed to Maximize Systemic Exposure

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Phase 1/2 Clinical Trial of MRTX849 in Patients with KRAS G12C+ TumorsPresented at 2019 AACR-NCI-EORTC Conference

Study Population• Solid tumor with KRAS

(p.G12C) mutation based on Sponsor-approved test

• Unresectable or metastatic disease

• No available treatment with curative intent

• No active brain metastases

Study Endpoints• Safety • PK/PD• Clinical Activity

150 mg (QD)N=1

300 mg (QD)N=1

600 mg (QD)N=2

1200 mg QDN=1

SCREENING

ENROLLMENT

Doses Evaluated

Expansion

ClinicalTrials.gov Identifier: NCT03785249

600 mg BIDN=12

Data cut-off date: 11-Oct-2019

9 Median (Min-Max); aN=9; bN=1 (Only 1 patient contributed to the lead-in 96 hours post-dose sampling); Data Source: Interim Pharmacokinetic Data (14 October 2019)

600mg BID Dose Achieved 2X Predicted Exposure for Maximal Response

Clinical Exposure: Steady State

Exposure Required in Most Sensitive Preclinical Models

Exposure Required in Least Sensitive Preclinical Models

600 mg BID GeoMean (CV%)Cmax

(ng/mL)AUC0-24

(ug*h/mL)Cave

(ng/mL)t½ (h)

Steady State (N=10)

3180(50.4)

69.8(58.6)a

2880 (51.4) 24.7b

1200 mg (600 mg BID) exceeded by 2-fold the exposure required for

maximal response in the least sensitive animal models

600 mg QD exceeded the minimum exposure for response in the most

sensitive animal models, but not the least sensitive animal models


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Phase 1/2 Clinical Trial of MRTX849 in Patients with KRAS G12C+ TumorsInitial Data Shows Overall Favorable Tolerability


Patient Incidence of Treatment Related AEs (>10%)

Treatment-Related AEs (N=17) Grade 1n

Grade 2n

Grade 3n

Diarrhea 6 6 0Nausea 8 2 0AST Increased 5 0 0Vomiting 4 1 0Fatigue 2 1 1ALT Increased 3 0 0Creatinine Increased 3 0 0Abdominal Distension 2 0 0Abdominal Pain 2 0 0Alkaline Phosphatase Increased 1 1 0

Treatment-Related AEs (N=17) Grade 1n

Grade 2n

Grade 3n

Anemia 0 2 0Decreased Appetite 2 0 1Dehydration 0 2 0Dry Mouth 2 0 0

Dysgeusia 0 2 0

Dyspnea 0 1 1

QT Prolonged 1 1 0

Hypomagnesemia 2 0 0

Rash 2 0 0

Dose limiting toxicities observed: 1200 QD capsule burden intolerable (12 capsules); 600 mg BID grade 3/4 amylase/lipase increase, isolated enzyme elevation without pancreatitis (only treatment related Grade 4 AE observed)

Data Presented at 2019 AACR-NCI-EORTC Conference

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5%1%

0% -1% -2%-7%

-14%

-21%

-36%

-43%-47%

-62%-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

10%

20%

30%

Max

imum

% C

hang

e fro

m B

asel

ine

CRCNSCLCNSCLCNSCLC CRCAppCRC AppCRC NSCLCEvaluable Patients

at All Doses

NSCLC ORR: 3/6DCR: 6/6

CRC ORR: 1/4DCR: 3/4

Append ORR: 0/2DCR: 2/2

NSCLCNSCLC

ORR: Overall Response RateDCR: Disease Control Rate

(SD+PR at 6 weeks)

600 mg (BID)150 mg (QD) 300 mg (QD) 600 mg (QD)Dose:

PR

PR

PR

PR

SDSD

SDSDSDSD

SDSD

‡

†

†

§

* Based on local radiographic scans every 6 weeks using RECIST 1.1 criteria

Patient on study (off study patients: 1 progressive disease, 1 global deterioration of health, 1 patient withdrawal of consent)

Response yet to be confirmed (on study but only 1 scan)†Confirmed response (1st scan: -37%, 2nd scan: -47%);‡Patient had confirmed PR post data cut-off (1st scan: -33%, 2nd scan: -43%)§


Initial MRTX849 Data Show Activity Across Multiple G12C+ Tumor TypesInitial Data Also Demonstrate Clinical Efficacy and Tolerability


All Evaluable Patients: Best Tumor Response* (N=12)


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Phase 1/2 Clinical Trial of MRTX849 in Patients with KRAS G12C+ TumorsInitial Data at 600mg BID Demonstrate Clinical Efficacy and Tolerability

Evaluable Patients at 600mg BID




BID: Twice a Day DosingORR: Overall Response RateDCR: Disease Control Rate

(SD+PR at 6 weeks)


* Based on local radiographic scans every 6 weeks using RECIST 1.1 criteria

Patient on study (off study patient: 1 patient withdrawal of consent [travel constraints])

Response yet to be confirmed (on study but only 1 scan);†Confirmed response (1st scan: -37%, 2nd scan: -47%);‡Patient had confirmed PR post data cut-off (1st scan: -33%, 2nd scan: -43%)§

0% -1%

1%

-47%

-2%

-21%

-36%

-43%

-62%-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

10%

20%

30%

Max

imum

% C

hang

e fro

m B

asel

ine

Appendiceal(N=2)

CRC(N=2)

NSCLC (N=5)

600 mg (BID)Dose:

PR ‡ PR

PR

PR

SD

SDSD

SDSD

†

†

§

600mg BID Dose Patients: Best Tumor Response* (N=9)


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Early MRTX849 Duration Data Encouraging in KRAS G12C+ TumorsEv

alua

ble

Patie

nts

(N=1

2)

0 5 10 15 20 25 30 35 40 45

Duration of Treatment (Weeks) CRC AppendicealTumor Type: NSCLC

SD

SD

SD

SD

SD

SD

SD

SD

PR

PR

PR

PR

On StudyFirst Response

Disease ProgressionBest Response

Duration on Treatment (as of 11-Oct-2019)NSCLC (N=6): 6.7 - 38.6 weeksCRC (N=4): 9.9 - 30.1 weeksAppendiceal (N=2): 10.7 - 20.7 weeks

a

b

c

Dose: a. 150 mg QD; b. 300 mg QD; c. 600 mg QD; all other patients received 600 mg BID Data cut-off date: 11-Oct-2019

All Evaluable Patients: Duration of Treatment (N=12)

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Case Study #1: NSCLC Patient

Presented at the AACR-NCI-EORTC Meeting in October 2019 Data cut-off date: 11-Oct-2019

Demographics

45 year old female with metastatic adenocarcinoma, former smoker

Molecular Characteristics KRAS G12C mutation (c.34G>T) KEAP1 (K97M) STK11 (E223*)

Treatment History Carboplatin/pemetrexed/pembrolizumab Docetaxel Investigational treatment with binimetinib plus palbociclib Best response on prior regimens was SD

Best Response

Deepening of response over time.

Marked clinical improvement within 2 weeks, including complete resolution of baseline cough and oxygen dependency.

This patient had confirmed PR post data cut-off (1st scan: -33%, 2nd scan: -43%)§

Base

line

Post

cyc

le 2

-33%

-43%§

Post

cyc

le 4

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Case Study #2: CRC PatientBa

selin

ePo

st c

ycle

2Po

st c

ycle

4

TL2

-37%

-47%

Demographics

47 year old KRAS (p.G12C) female with adenocarcinoma of the left colon with extensive metastases involving the liver, peritoneum, ovaries and lymph nodes, never smoked

Treatment History FOLFOX/bevacizumab, partial response Capecitabine monotherapy, no response FOLFIRI/bevacizumab, no response Investigational antibody drug conjugate, no response

Best Response

PR: 37% reduction at first scan, confirmed PR with 47% reduction at second scan. The patient remained on study as of the cut-off date.

Marked clinical improvement within 3 weeks and a visible decrease in size of her umbilical Sister Mary Joseph’s nodule.

Presented at the AACR-NCI-EORTC Meeting in October 2019 Data cut-off date: 11-Oct-2019

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MRTX849 Monotherapy Development Plan Existing Phase 1/2 Protocol Potentially Supports Monotherapy Registrations

NSCLCEnrolling

Expansion Cohort

Q1 2020 FDAMeeting

Potential for Single Arm Accelerated Approval Pathway

CRCConfirm

Monotherapy Activity

Potential for Single Arm Accelerated Approval Pathway

Enrolling Expansion

Cohort

Pancreatic and OthersConfirm

Monotherapy Activity

Potential for Tumor Agnostic Approval Pathway

Enrolling Expansion

Cohort

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MRTX849 Combination Development Strategy: Opportunities to Expand Clinical Benefit to Patients

MRTX849: KRAS G12C Inhibitor – Combinations

NSCLC

• Preclinical data demonstrate durable complete responses

• KRAS G12C+ tumors have responded to checkpoint inhibitor therapy in clinical trials

• Potential rapid path to 1st Line

PD-1 CombinationMRTX849 + pembrolizumab

• Synergistic preclinical data• Positive results from EGFR combination

with bRAF/MEK is supportive of approach

EGFR CombinationMRTX849 + cetuximab

CRC

Priority Combinations

Additional CombinationOpportunities

• Synergistic preclinical data

SHP2 Combination in NSCLC and CRCMRTX849 + TNO115 (Novartis)

EGFR CombinationMRTX849 + pan-EGFR inhibitor

CDK 4/6 CombinationMRTX849 + CDK 4/6 inhibitor

• SHP2 shifts KRAS into GDP state which enhances MRTX849 activity

• Synergistic preclinical data in EGFR and CDK 4/6 combinations in CRC with MRTX849

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PD-1 Combinations: Result in Durable Complete Regressions with MRTX849 in vivo

KRAS G12C NSCLC tumors have elevated levels of TMB and PD-L1 expression.

MRTX849 treatment stimulated anti-tumor immunity by recruiting CD4+ & CD8+ T cells in KRAS G12C positive mutant tumors.

MRTX849 combined with a PD-1 inhibitor may optimize efficacy in first line treatment.

1. Preliminary results from MRTX849 testing in CT26 Clone E3 G12C syngeneic mouse model

KRAS G12C Inhibition Combined with Checkpoint Inhibitor Therapy Demonstrates Durable Complete

Regressions In-Vivo1

MRTX849 100mg/kg

Vehicle

PD-1 10mg/kg IP

MRTX849 + PD-1


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EGFR and SHP2 Combinations with MRTX849 Optimized to Combat RAS Pathway Reactivation

1. KYSE-410 xenograft model (MRTX849 100mg/kg; RMC-4550 30mg/kg); 2. LU11692 xenograft model (MRTX849 100mg/kg; afatinib 12.5mg/kg)


VehicleDosing Stopped

MRTX849 and SHP2 Inhibitor1

MRTX849 + RMC-4550 (SHP2)

MRTX849RMC-4550 (SHP2)

MRTX849 and EGFR Inhibitor2Tu

mor

Vol

ume

(mm

3 )

Treatment (Days)

MRTX849

Vehicle

afatinib (pan-EGFR)


20

1. Mirati frequency estimates based upon the following sources and underlying databases: Zehir A et al, Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nat Med. 2017;23(6):703-713.; Campbell et al, Nature Genetics 2016 “Distinct patterns of somatic genome alterations in lung adenocarcinomas”; Bailey P et al, Nature 2016 “Genomic analyses identify molecular subtypes of pancreatic cancer”; MSKCC Cancer Hot Spots database; NIH TCGA: The Cancer Genome Atlas

2. Mirati estimates based on epidemiology data reported in Globocan 2022 (accessed January 2019) and frequencies by mutation. Rounded to the nearest 100.

KRAS G12C Mutations Occur Frequently in Multiple Tumor TypesPrevalent in Tumors with High Unmet Need

KRAS G12C Mutational Frequencies1

NSCLCadenocarcinoma

14% 44,400

Total US/EU Pts (2)


4%

2%

19,600

4,000

Large Patient PopulationUS and EU Patients2

010,00020,00030,00040,00050,00060,00070,00080,000

KRASG12C

ALK RET TRK

NSCLC CRC Pancreatic

US

and

EU P

atie

nts 68,000

Colorectal

Pancreatic

21

Large Patient Population: KRAS G12C incidence is ~24,500 in the U.S. alone (1)

Large Commercial Opportunity: Patient population is 3X larger than the $1.8B ALK market (2)

MRTX849 Summary: A Potential Best-in-Class KRAS G12C Inhibitor

Long half life: projected >20-hour human half life maintains full inhibition of KRAS G12C

Volume of Distribution: Projected Human Volume of Distribution >10 L/Kg

Monotherapy: Phase 2 registration trial starting in 1H 2020

Combinations: EGFR, PD-1, SHP2 and CDK 4/6 combination trials will start in 1H 2020


Initial Clinical Data Demonstrate Clinical Efficacy and Tolerability

Significant Commercial Potential Potential Registration Pathways

1. Mirati estimates based on epidemiology data reported in Globocan 2022 (accessed January 2019) and frequencies by mutation2. ALK market: 2018 worldwide sales

Clinical Attributes of MRTX849

Evaluable Patients at 600mg BID




22

Targeted Oncology

KRAS G12D Program

22

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1. Sources: Zehir, Ahmet et al. Nature Med 23 2017 “Mutational Landscape of Metastatic Cancer”; Krakstad et al. PLoS One 2012, “High-Throughput Mutation Profiling of Primary and Metastatic Endometrial Cancers”; NIH TCGA: The Cancer Genome Atlas; cbioportal.org.

2. Mirati estimates based on epidemiology data reported in Globocan 2022 (accessed November 2019) and frequencies by mutation; RET estimate does not include thyroid cancer. Rounded to the nearest 100.3. Estimate includes both adenocarcinoma and large cell carcinoma pts. Frequency of KRAS G12C mutations in adenocarcinomas and large cell carcinomas are approximately equivalent, per https://www.cbioportal.org/.

KRAS G12D: Significant Patient Population with High Unmet Need

Large Patient PopulationUS and EU Patients2

0

50,000

100,000

150,000

200,000

KRASG12D

KRASG12C

ALK RET TRK

Pancreatic CRC Endometrial NSCLC

US

and

EU P

atie

nts

ALK RET TRKKRASG12D

Prevalent in Tumors with High Unmet NeedKRAS G12D Mutational Frequencies1

KRASG12C

Endometrial

36%

NSCLCadenocarcinoma

Pancreatic

6%

12%Colorectal

4%

68,000

70,500

81,000

15,000

12,500 (3)

Total US/EU Pts (2)

179,000

KRAS G12D Inhibitor

https://www.cbioportal.org/

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Sitravatinib + Checkpoint Inhibitors

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25

Sitravatinib in the Tumor Microenvironment Aims to Restore Immune Responses Through Inhibition of Immunosuppressive Signaling


Sitravatinib has low peak to trough variability with higher relative activity versus TAM and compared to VEGF

26


SAPPHIRE: Phase 3 Trial in 2nd / 3rd Line NSCLCPotential to establish sitravatinib + nivolumab as new standard of care after checkpoint inhibitor failure

Sitravatinib + Nivolumab

N=266

DocetaxelN=266

CheckpointRefractory

NSCLC2nd / 3rd Line Patients

after Checkpoint Inhibitor Therapy

DocumentedTumor

Progression

* This trial is being amended to include both 2nd and 3rd line patients who have progressed following checkpoint inhibitor therapy and to add OS as an interim analysis endpointORR = Overall Response Rate; DOR = Duration of Response; OS = Overall Survival; PFS = Progression-Free Survival; NSCLC = non-small cell lung cancer

RAN

DO

MIZ

ATIO

N 1

:1

Key Inclusion/Exclusion Criteria: Advanced, Non-Squamous NSCLC

2nd / 3rd Line: progression on or following PD-(L)1 inhibitor in combination or following chemotherapy

Patients must have remained on prior PD-(L)1 therapy for at least 4 months

Excludes known driver mutations

Endpoints: Primary: OS

Secondary: PFS, duration of response, safety, tolerability

Interim Analysis: OS

Final AnalysisOverall Survival

Interim AnalysisOverall Survival

YE 2021

N=5321:1 randomization

27

• Encouraging Preliminary OS Data from Phase 2 Trial– MRTX-500: Sitravatinib + nivolumab in checkpoint refractory NSCLC

– Kaplan-Meier estimated median survival: 15.1 months

• Historical OS for Docetaxel in 2nd Line: 8.5 – 9.6 months– Opportunity for sitravatinib + nivolumab to potentially demonstrate

OS advantage at interim analysis

• Protocol Amendments to Phase 3 Sapphire Trial– Adding OS as endpoint for interim analysis: potential for full approval

based upon interim OS analysis (242 events)

– Enrolling both 2nd and 3rd line NSCLC patients, following chemotherapy and PD-(L)1 therapy, in combination or sequentially

– Interim analysis of OS planned for YE 2021

SAPPHIRE: Phase 3 Trial in 2nd / 3rd Line NSCLCPotential to establish sitravatinib + nivolumab as new standard of care after checkpoint inhibitor failure

Trial Compound Pts OS, Mo. (Range)

CheckMate 057[1]

nivolumab n=292 12.2 (9.7-15.0)

docetaxel n=290 9.4 (8.1-10.7)

OAK[2]atezolizumab n=425 13.8 (11.8-15.7)

docetaxel n=425 9.6 (8.6-11.2)

KEYNOTE 010[3]

pembrolizumab n=345 10.4 (9.4-11.9)

docetaxel n=343 8.5 (7.5-9.8)

MRTX-500[4] sitravatinib +nivolumab n=56 15.1*

Advanced NSCLC2nd Line or Subsequent Therapy

1. Borghaei H, et al. N Engl J Med. 2015;373:1627-1639. 2. Rittmeyer A, et al. Lancet. 2017;389:255-265. 3. Herbst RS, et al. Lancet. 2016;387:1540-1550. 4. MRTX-500 Phase 2 trial, Prior Benefit cohort, data cut-off 27-Aug-2018

OS: Overall Survival* Preliminary Kaplan-Meier Estimate

(N=64, 25 events, 42 censored patients)

Data presented are from separate studies and does not reflect results that might have been obtained from head-to-head studies. Results from Mirati’s on-going Phase 3 trial comparing sitravatinib + nivolumab to

docetaxel may differ materially from prior studies presented.


28 POC = proof of concept; NSCLC = non-small cell lung cancer; RCC = renal cell cancer; HCC = hepatocellular carcinoma


Sitravatinib Has Potential Across Multiple Tumor Types

Bladder

Phase 3Phase 1/1b Phase 2

HCC, RCC and Ovarian

BeiGene

Additional Data 2020Bladder

NSCLC 2nd / 3rd line NSCLC (SAPPHIRE) checkpoint refractorysitravatinib + nivolumab vs. docetaxel

1st line HCC checkpoint naïve sitravatinib + tislelizumab; Sitravatinib alone

1st / 2nd line RCC checkpoint naïve & refractorysitravatinib + tislelizumab

Ovarian cancer following platinumsitravatinib + tislelizumab

2nd / 3rd line Gastric following chemotherapysitravatinib + tislelizumab

2nd / 3rd line Bladder checkpoint refractorysitravatinib + nivolumab

Additional Data 2020

Interim Analysis YE 2021

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Positive Preliminary Phase 2 Efficacy Data in Checkpoint Refractory NSCLC1


Sitravatinib Summary: Registration Trial Focus on NSCLC with Potential in Expanded Indications

1. Data presented at ESMO 2018 Congress; Data cut-off: 27-Aug-2018; Response data per investigator assessment, response confirmations updated after data cut-off.2. Clinical Benefit defined as Stable Disease (SD), Partial Response (PR) or Complete Response (CR)

Potential Registration Path for 2nd / 3rd Line NSCLC: Phase 3 Randomized Trial (SAPPHIRE)

Checkpoint Refractory Bladder Cancer:Initial Phase 2 data presented at SITC 2019

21/22 (95%) CR+PR+SD

8/22 (36%) Tumor Regression >30%

6/22 (27%) Confirmed Response (CR+PR)

Preliminary Kaplan-Meier estimated Median OS

Phase 2 Clinical Trials in Other Indications 2

Sitravatinib + nivolumab vs. docetaxel in 2nd / 3rd line checkpoint refractory NSCLC

Interim Analysis (OS) to support NDA submission seeking accelerated approval expected by YE 2021

Primary Analysis (OS) to support NDA submission seeking full approval

Median DoR:9.2 months

Median PFS:6.8 months

Median OS:15.1 months

BeiGene Phase 2 Trials: Initial data in ovarian at ESMO

IO in Q4 2019 (of 17 platinum-resistant efficacy-evaluable

patients, 7 PRs (4 confirmed), 8 SD, 2 PD); additional data in,

HCC, RCC, Ovarian and Gastric expected in 2020

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Phase 3

Multiple Near-Term Catalysts Across Portfolio

NSCLC = non-small cell lung cancer; CRC = colorectal cancer; RCC = renal cell cancer; HCC = hepatocellular cancer; OC = ovarian cancer, IND = Investigational New Drug application; Tislelizumab (BeiGene’s anti PD-1)

1) BeiGene is currently running a subset of combination studies of sitravatinib + tislelizumab in Asia for multiple solid tumor indications. BeiGene has Asian commercialization rights (ex-Japan) for sitravatinib as part of our development and commercialization agreement (Jan. 2018). BeiGene is responsible for additional data disclosures.

Preclinical Phase 1/1b Phase 2 Near-Term MilestonesIndication

SitravatinibMulti Kinase

Inhibitor

Sitravatinib+ PD-1

NSCLC

Bladder, RCC, HNSCC Additional data in 2020

Additional data in 2020

SAPPHIRE – 2nd / 3rd Line CPI Refractory

Mirati-run Studies

Interim OS Analysis YE 2021


MRTX849monotherapy

NSCLC, CRC,Pancreatic

Initiate Q1 2020MRTX849 + PD-1

NSCLC

Initiate P2 NSCLC registration cohort in 1H 2020Duration data 2H 2020KRYSTAL – 2nd Line +

1st Line

G12D Inhibitor Pancreatic, CRC, NSCLC IND enabling studies in 2020KRAS G12D

Inhibitor

Initiate Mid-2020

Initiate Q1 2020CRC

Initiate Mid-2020

MRTX849 + CDK4/6

MRTX849 + cetuximab (EGFR)


2nd Line

2nd Line

2nd Line


- Combinations

Initiate Mid-2020NSCLC, CRCMRTX849 + TNO155 (SHP2) 2nd Line

BeiGene (1)NSCLC, HCC, RCC, OC, Gastric

31

Select Company Financials

* This amount is preliminary, has not been audited and is subject to change upon completion of the audit of our consolidated financial statements as of and for the year ended December 31, 2019.** Shares outstanding as of September 30, 2019 information, which includes 39.4 million shares of common stock outstanding as of September 30, 2019, and pre-funded warrants to purchase a total of 9.7

million shares of common stock, outstanding as of September 30, 2019. The pre-funded warrants have a per share exercise price of $0.001. *** Includes 3.1 million shares offered by Mirati and 0.4 million shares granted to underwriters as an option to purchase in connection with the January 2020 public offering.

NASDAQ

Cash as of 12/31/19*

Shares issued January 2020 public offering***

MRTX

$415.2M

Net proceeds from January 2020 public offering $324.1M

Shares outstanding as of September 30, 2019**

3.5M

49.1M

32

NASDAQ: MRTX

Targeting the genetic and immunological drivers of cancer

Corporate Presentation January 2020

Corporate Presentation January 2020 - s23.q4cdn.com · Corporate Presentation . January 2020. 2....

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