Investor Presentation August 2020 Forward-Looking Statements This - - PowerPoint PPT Presentation

Investor Presentation

August 2020

Science-Based Innovation-Focused ADC Company

Forward-Looking Statements

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This presentation and various remarks we make during this presentation, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding expectations for achieving full FDA approval based on our confirmatory data for TRODELVY and the Company’s development of TRODELVY for additional indications, clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing and approval timelines for BLAs and BLA supplements, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the timing for bringing any product candidate to market, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s reliance on third-party relationships and outsourcing arrangements (for example in connection with manufacturing, logistics and distribution, and sales and marketing) over which it may not always have full control, including the failure of third parties on which the Company is dependent to meet the Company’s business and operational needs for investigational

• r commercial products and, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; the Company’s

ability to meet post-approval compliance obligations; imposition of significant post-approval regulatory requirements on our products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain or obtain full regulatory approval for the Company’s products, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the uncertainties inherent in research and development; safety and efficacy concerns related to the Company’s products and product candidates; uncertainties in the rate and degree of market acceptance of products and product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s products and product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s products and product candidates or limitations by regulators

• n the proposed treatment population for the Company’s products and product candidates; decisions by regulatory authorities regarding labeling and other

matters that could affect the availability or commercial potential of the Company’s products and product candidates; the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop

• ur products and finance our operations; new product development (including clinical trials outcome and regulatory requirements/actions); the risk that we
• r any of our collaborators may be unable to secure regulatory approval of and market our drug candidates; risks relating to the COVID-19 pandemic in the

U.S. and around the world; risks associated with litigation to which the Company is or may become a party, including the cost and potential reputational damage resulting from such litigation; loss of key personnel; competitive risks to marketed products; and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

Seasoned Leadership Team to Drive Growth

Brendan Delaney

CHIEF COMMERCIAL OFFICER

Bryan Ball

CHIEF QUALITY OFFICER

Usama Malik

CHIEF FINANCIAL OFFICER CHIEF BUSINESS OFFICER

Jared Freedberg

GENERAL COUNSEL SECRETARY

Kurt Andrews

CHIEF HUMAN RESOURCES OFFICER

• Dr. Behzad Aghazadeh

EXECUTIVE CHAIRMAN

• Dr. Loretta Itri

CHIEF MEDICAL OFFICER

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John Stubenrauch

SVP, GLOBAL HEAD OF MANUFACTURING

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TRODELVY™ – First ADC Approved Specifically for mTNBC

• Approved on April 22, 2020 in U.S.
• Strong initial launch execution

– Product in channel within one week of approval – NCCN guidelines updated within two weeks of approval

• Rapid adoption in advanced mTNBC

– $20.1M net sales in first two months of commercial launch

TRODELVY’s Launch Strategy is Clear

• 1. Establish TRODELVY as a standard of

care for 3rd-line mTNBC

• Drive rapid awareness & adoption through

product education

• 2. Optimize positive early clinical experience
• Minimize barriers, set clear expectations,

educate on adverse event management

• 3. Become a recognized leader in TNBC
• Build strong scientific and development

partnerships

Goals

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Strategic Imperatives

TRODELVY’s Launch Executed with Strong Sense of Urgency

❑ TRODELVY available in distribution channel within a week of FDA approval ❑ TRODELVY.com with SEO campaign within hours of approval ❑ First Peer-to-Peer speaker program executed in week one of launch ❑ Over 500 attendees for TRODELVY National Broadcasts ❑ First payer coverage policy in place within two weeks of approval

KOL National Broadcasts Trained Speaker Bureau Broad HCP NPP campaign Product Distribution Trodelvy.com Website Patient HUB

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Robust adoption in both the community and academic settings (~67% community accounts)

U.S. Healthcare Professionals Rapidly Gaining Clinical Experience with TRODELVY

7 *IntrinsiQ survey conducted on June 27th, 2020

NCCN Guidelines were updated to include Sacituzumab-Govitecan on May 8, 2020

>80% of top 150 accounts penetrated in first two months of commercial launch >80% HCPs intend to prescribe TRODELVY in third-line mTNBC* >500 accounts ordered TRODELVY in first two months of commercial launch

TRODELVY Exceeding Payer “Time to Review” Benchmarks

• Majority of national and regional payers have

implemented TRODELVY coverage policies

• Existing TRODELVY coverage policies have limited

restrictions

• Speed and quality of payer coverage resulting in

strong patient access to TRODELVY

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* * Time-to-Review: represents the elapsed time from FDA approval to a

commercial payer implementing a coverage policy for a new product

Important News Flow to Maintain Launch Momentum

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• ASCENT data presentation, publication and regulatory submission
• Expanded clinical experience with TRODELVY in 3rd-line mTNBC
• Branded promotional campaign set to launch in Q3 2020

Robust Sales & Marketing Execution Speed & Quality of Payer Coverage TRODELVY Launch Excellence + =

Upcoming Market Catalysts

Transforming the Treatment Paradigm for Complex Cancers

Company Transformed in Less Than Three Years

FTE doubled in size

Field Base, 67 Office, 317

384

FTE

5 24 27 ~1,000

Pivotal Global Trials Scientific publications & presentations Approved Investigator Initiated Trials Patients on TRODELVY Trials

Global Partnerships

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Commercial

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Manufacturing

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Clinical

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A Powerful Differentiated ADC Platform: Three Key Advantages

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• ADC platform uses SN-38 as

payload of choice

• SN-38 kills cancer cells by

damaging DNA

• 1. Payload – Validated & Well

Tolerated

• Hydrolyzable linker for payload

release

• Allows for intra- and extra-cellular

(bystander effect) killing of tumor cells

• 2. Novel Linker
• hRS7 in TRODELVY targets Trop-2 in multiple solid tumor

indications

• Other pipeline assets: labetuzumab govitecan targets

CEACAM5, IMMU-140 targets HLA-DR

• 3. Antibody – Highly Tumor Specific

Multiple TRODELVY Programs to Address Unmet Needs in Trop-2-Expressing Cancers

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Indication Designation Phase 1 Phase 2 Phase 3 Approval Partner

mTNBC (3L+) mTNBC (3L) ASCENT HR+/HER2‒ mBC TROPiCS-02 mTNBC (3L) (China) mTNBC (1L) / mUC / mNSCLC (+ Tecentriq) MORPHEUS mTNBC / mUC / Ovarian (+ Rubraca) SEASTAR Urothelial (3L) TROPHY U-01 Urothelial (3L) (Pending FDA Discussion) mNSCLC / H&N / Endometrial (Trop-2-enriched) TROPiCS-03

Cohort 1 Enrollment Completed

Met 1o and key 2o endpoints TRODELVYTM

Diverse Registration-Oriented & Signal-Seeking Investigator- Initiated Trials to Explore Effectiveness of TRODELVY

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Indication Designation Phase 1 Phase 2 Phase 3 Sponsor

HER2‒ BC (post-neoadjuvant) SASCIA German Breast Group mTNBC, PD-L1‒ (1L) (+ Keytruda) Dana Farber Cancer Institute HR+/HER2‒ mBC, PD-L1+ (+ Keytruda) Dana Farber Cancer Institute TNBC (neoadjuvant) NeoSTAR Massachusetts General Hospital mTNBC (2L) (+ Talzenna) Massachusetts General Hospital Endometrial Cancer (Persistent or Recurrent) Yale University Metastatic Prostate Cancer (2L) U of Wisconsin & PCCTC Breast Brain Metastasis and Glioblastoma UT Health at San Antonio

Multi-Line Strategy to Establish TRODELVY as SoC in TNBC

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Neo/Adjuvant (24- 26k Pts) 1st Line (10-11k Pts)

2nd Line (9-10k Pts)

3rd Line+ (8-9k Pts)

Stage 3 locally advanced (unresectable), Stage 4 metastatic Stage 1, 2 and 3 (resectable)

Phase 3 ASCENT Phase 1b/2 MORPHEUS Phase 1/2 SEASTAR Phase 3 SASCIA

Highly Differentiated Therapy for mTNBC

Treatment Line

• mTNBC patients with at least 2 prior treatments in the

metastatic setting The Unmet Need

• Low response rates, short response duration and significant

side effects with currently available therapies

• Patients with pre-existing peripheral neuropathy or cardiac

impairment may only have supportive care options Market Size

• U.S. ~8k patients
• EU5, Japan ~14k patients

Status

• FDA granted accelerated approval in 3L-mTNBC
• Confirmatory ASCENT study met 1o and key 2o endpoints

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Phase 3 ASCENT Study Confirmed Compelling Safety and Efficacy Profile of TRODELVY

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02574455 17

Continue treatment until progression

N = 529

mTNBC

≥2 prior treatments OR 1 therapy for advanced disease who also progressed within 12 months of (neo)adjuvant therapy Primary Endpoint

• PFS (brain mets-neg)

Secondary Endpoint

• OS, ORR, DoR

Indication Endpoint

TRODELVY 10 mg/kg IV day 1 & 8, every 21 days Traditional chemotherapy treatment of physicians’ choice*

Twin Arm Study

* Eribulin, gemcitabine, capecitabine & vinorelbine

Study Met Primary and Key Secondary Endpoints

Brian mets+ capped at 15%

TRODELVY – First ADC Shown to Improve Clinical Outcomes in Late-Line mTNBC

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TPC2 TRODELVY 1.7 Months 5.6 Months

ASCENT P3 Topline

mPFS HR=0.41, p<0.00011

1: mPFS: median progression free survival; primary endpoint in brain met negative patients 2: Treatment of physician’s choice: eribulin, capecitabine, gemcitabine, and vinorelbine

• ASCENT met key secondary endpoints,
• incl. OS and ORR3
• Safety profile consistent with FDA-approved

label and no new safety signals

• Full data will be submitted to ESMO as late-

breaking abstract

• sBLA submission for full approval expected

in Q4’20, EU submission targeted for H1’21

Other Key Takeaways from ASCENT

3: OS: Overall Survival; ORR: Overall Response Rate by RECIST1.1

Drug Phase N Population ORR (%) Median PFS (months) Median OS (months)

Carboplatin1 3 188 1st line 31 3.1 12.4 Docetaxol1 3 188 1st line 36 4.5 12.3 Cisplatin or Carboplatin2 2 86 1st line (80.2%) 25.6 2.9 11.0 Atezolizumab + nab-paclitaxel3 3 451 1st line (untreated) 56.0 7.2 21.3 Nab-paclitaxel3 3 451 1st line (untreated) 45.9 5.5 17.6

* Includes breast cancer drugs with data from Phase 2/3 studies with minimum mTNBC sample size > 60; ORR and PFS data. Source of data: 1) Tutt A, SABCS 2014; 2) Isakoff SJ, J Clin Oncol 2015; 3) Schmid P, et al. N Engl J Med. 2018;379:2108-2121

Room for Improvement with Existing First-Line TNBC Agents*

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Metastatic Urothelial Cancer – Targeting our 2nd High Unmet Need Indication

The Unmet Need

• Current therapies for metastatic disease post chemotherapy

and immune checkpoint inhibitors offer low response rate, short response duration and high toxicity Market Size

• 3rd line mUC – U.S. ~8k patients
• 3rd line mUC – EU5, Japan ~10k patients

Status

• May obtain accelerated approval based on results of Ph 2

TROPHY U-01 trial

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21

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(N=45)

14 8.6 8.9

Docetaxel in 2nd line Phase 33 Docetaxel in 2nd line Phase 22 Vinflunine in 2nd line1 TRODELVY in ≥3rd line4 Docetaxel in 2nd line Phase 33 Docetaxel in 2nd line Phase 22 Vinflunine in 2nd line1 TRODELVY in ≥3rd line4

ORR

(%)

PFS

(months) 3.0 7.3

(N=45)

2.8 2.8

TRODELVY Achieved Strong ORR and PFS Compared to SoC in

Phase 1/2 Single-Arm Basket Study*

* Information is based on comparative results from independent studies Source of data: 1) Bellmunt J, JCO 2009; 2) Petrylak D, JCO 2016; 3) Petrylak D, Lancet 2017; 4) Tagawa S, ASCO-GU 2019

Pivotal TROPHY U-01 Study of TRODELVY Designed to Support Accelerated Approval

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT03547973 22

• First patient dosed in August 2018 in U.S.
• Interim cohort 1 results presented at ESMO 2019
• Full cohort 1 enrollment reached in October 2019
• Cohort 3 added to evaluate TRODELVY +

pembrolizumab in CPI-naïve patients

Continue treatment until progression

mUC

Cohort 1: Post platinum- and CPI-based therapies (N = 100) Cohort 2: 2nd line post CPI for cisplatin-ineligible patients (N = 40) Cohort 3: 2nd line post pt- based therapy for CPI-naïve patients (N = ~60) Primary Endpoint

• ORR (BICR)

Secondary Endpoint

• DoR, PFS & OS

Indication Endpoint

Cohort 1 & 2: TRODELVY 10 mg/kg IV day 1 & 8, every 21 days Cohort 3: TRODELVY + pembrolizumab 200 mg day 1, every 21 days

Single-Arm Study

Interim Results Confirm Clinical Activity in mUC

Endpoint Cohort 1 (N=35) Median follow-up, mon 4.1 Patients continuing treatment, n (%) 20 (57) ORR, n (%) [95% CI] 10 (29) [15, 46] CR, n (%) 2 (6) PR, n (%) 6 (17) uPR pending confirmation,a n (%) 2 (6) Median time to onset of response, mon (range) 1.5 (1.2, 2.8)

CI, confidence interval; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ORR, objective response rate; PR, partial response; uPR, unconfirmed partial response.

Category Subgroup ORR, % (n/N) Overall N/A 29 (10/35) Age <75 29 (8/28) ≥75 29 (2/7) ECOG PS 33 (5/15) 1 25 (5/20)

• No. prior anticancer

regimens 2 18 (2/11) ≥3 33 (8/24) Visceral involvement at study entry Yes 23 (5/22) Liver 25 (2/8) No 39 (5/13) Bellmunt risk factors 0-1 35 (10/29) 2-3 0 (0/6)

ORR in Patient Subgroups Response Outcomes

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New Therapeutic Options Needed for HR+/HER2– mBC

The Unmet Need

• The most common form of breast cancer in U.S.
• Initial treatments, endocrine and CDK4/6 therapy, eventually

fail and cancer relapses, requiring chemotherapy treatment

• Prognosis for patients with visceral metastases is poor

Market Size

• 3rd line HR+/HER2‒ mBC – U.S. ~25k patients
• 3rd line HR+/HER2‒ mBC – EU5, Japan ~35k patients

Status

• Potential accelerated approval submission from ORR analysis
• n pre-specified number of patients in registrational Phase 3

TROPiCS-02 study

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25

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(N=54)

13 11.0

Vinorelbine in 2nd line chemo mBC1 TRODELVY in ≥3rd line chemo3

ORR

(%)

PFS

(months) 3 6.8

(N=54)

3.1 2.5

TRODELVY Achieved Impressive ORR and PFS Compared to SoC

in Late-Line HR+/HER2– mBC*

* Information is based on comparative results from independent studies Source of data: 1) Jones S, JCO 1995; 2) Kaufman PA, JCO 2015; 3) Kazmi S, ESMO 2019 Abstract 366P; 4) Kalinsky K, SABCS 2018

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TRODELVY in ≥3rd line chemo4 Eribulin in 3rd line chemo mBC2 Eribulin in 3rd line chemo mBC3 Capecitabine in 3rd line chemo mBC3 Capecitabine in 3rd line chemo mBC2 Vinorelbine in 2nd line chemo mBC1

Phase 3 TROPiCS-02 Study in Late-Line HR+/HER2– mBC Designed to Support Accelerated Approval

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Continue treatment until progression

N = 400

HR+/HER2‒ mBC

• Prior hormonal and

CDK4/6 treatments

• ≥2 prior chemotherapies

Protocol Allows ORR Analysis for Potential Accelerated Approval Submission Based

• n Pre-determined Number of Patients

Primary Endpoint

• PFS, ORR

Secondary Endpoint

• OS, DoR, Safety & QoL

Indication Endpoint

TRODELVY 10 mg/kg IV day 1 & 8, every 21 days Traditional chemotherapy treatment of physicians’ choice

Twin Arm Study

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCTNCT03901339

* Eribulin, gemcitabine, capecitabine & vinorelbine

Adverse Event mTNBC (N=108)1 mUC (N=35)2 HR+/HER2‒ mBC (N=50)3 Grade 3 (%) Grade 4 (%) Grade 3 (%) Grade 4 (%) Grade 3 or 4 (%) Blood and lymphatic system

Neutropenia 26 16 29 26 42 Anemia 11 17 6

General and administration-site

Fatigue and asthenia 8 6 2

Gastrointestinal

Diarrhea 8 6 3 4 Nausea 6 2 Vomiting 6 4

Manageable and Predictable Safety Profile Allows for Repeated Dosing & Combination Use

27 Source of data: 1) Bardia A, et al. N Engl J Med. 2019; 380:741-51; 2) Tagawa, S, et al. ESMO 2019; 3) Bardia, A, et al. ASCO 2018

No >grade 2 neuropathy or rash and no treatment-related deaths or interstitial lung disease, low discontinuation rates due to AEs

Grades 3 and 4 Adverse Events Occurring in >5% of Patients

TRODELVY has Potential to Change Treatment Landscape

• f Breast and Urothelial Cancers

Cancer Type ORR (%) PFS (months) Other Agents TRODELVY Other Agents TRODELVY mTNBC

11 – 15 (single chemo) 33 1.7* (erib, gem, cap or vin) 5.6*

mUC

9 – 14 (single chemo) 31** 29*** ~2.8 – 3 (single chemo) 7.3** TBD***

HR+/HER2‒ mBC

11 – 13 (single chemo) 31 ~2.5 – 3.1 (cap, gem or erib) 6.8

* From ASCENT topline; ** From IMMU-132-01 (full mUC Cohort); ** From TROPHY-U-01 interim

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Non-Small Cell Lung Cancer – Large Population with High Unmet Need

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The Unmet Need

• NSCLC accounts for about 85% of all lung cancers
• Following initial treatment with checkpoint inhibitors and

chemotherapy, therapeutic 2nd line options for advanced disease are limited Market Size

• Trop-2-enriched* 3rd line mNSCLC – U.S. ~10k patients
• Trop-2-enriched* 3rd line mNSCLC – EU5, Japan ~15k patients

Status

• Trop-2 biomarker-selected study (TROPiCS-03) launched to

evaluate TRODELVY in NSCLC

* Initially targeting highest 25% Trop-2 expressors with potential increase of this percentage allowed under the study protocol

Trop-2-Enriched Multi-Cohort Study (TROPiCS-03) to Unlock Full Potential of TRODELVY

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Continue treatment until progression

NSCLC & H&N

• 3rd line post CPI- and

chemotherapy

Endometrial

• 2nd line post platinum-

based chemotherapy

Primary Endpoint

• ORR

Secondary Endpoint

• DoR, PFS & Safety

Indication Endpoint

TRODELVY 10 mg/kg IV day 1 & 8, every 21 days

Simon Two-Stage Design

Exploratory

• Biomarker, QoL

Stage 1: 40 Patients per Indication Stage 2: 60 Additional Patients per Indication

National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT03964727

• Study initiated in July 2019 in U.S.
• First NSCLC patient dosed in October 2019

Significant U.S. Markets for TRODELVY – Large Opportunity in Rest of World

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mTNBC (8k-9k) mUC (8k-15k) HR+/HER2‒ mBC (25k/28k)

Cancer Indication (# U.S. Patients 3rd/2nd Line)

mNSCLC (40k/60k)

Well Capitalized to Pursue Strategic Priorities

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Balance Sheet June 30, 2020

Cash, cash equivalents, and marketable securities $975.5 million* Basic shares outstanding (fully diluted) 231million (242 million)

Projected financial resources adequate to support planned operations into 2021, including:

• Commercial launch of TRODELVY in the United States in mTNBC
• Continue to expand clinical development programs for TRODELVY
• Invest in broader clinical development of ADC platform (including IMMU-130 and IMMU-140)
• Ongoing scale-up of global supply-chain to meet significant future commercial/clinical demand
• General working capital requirements

* Includes a $60 million milestone payment from Everest Medicines for TRODELVY approval in the U.S.

A Transformed Company At Inflection Point

Strong Foundation

• Validated ADC science & Trop-2 target
• Long patent life & unencumbered asset

Significant Market Opportunity

• Multiple tumor types & treatment lines
• Large indications

At Inflection Point

• Accelerated approval granted
• Multiple clinical, regulatory &

commercial catalysts

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Partner of Choice

• Clinical: Roche, Clovis, MGH, DFCI, GBG,

Wisconsin, MSK, Yale, Fred Hutch …

• Manufacturing: Samsung, JMPS, BSP …
• Commercial: Royalty Pharma, Janssen,

Everest …