OncoMed Pharmaceuticals Jefferies Healthcare Conference. Sunil Patel, Chief Financial Officer, SVP, Corp. Development & Finance June 9, 2016

Transcription

1 OncoMed Pharmaceuticals Jefferies Healthcare Conference Sunil Patel, Chief Financial Officer, SVP, Corp. Development & Finance June 9, 2016

2 Safe Harbor Statement These slides and accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides and accompanying oral presentation are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as may, could, will, would, should, expect, plan, anticipate, believe, estimate, intend, predict, seek, contemplate, potential or continue or the negative of these terms or other comparable terminology. Forward-looking statements in these slides and accompanying oral presentation include, but are not limited to, statements about: the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our ability to advance product candidates into, and successfully complete, clinical trials; the tolerability of our product candidates at efficacious doses; our collaborators exercise of their license options; the commercialization of our product candidates; the implementation of our business model, strategic plans for our business, product candidates and technology; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; estimates of our expenses, future revenues, capital requirements and our needs for additional financing; the timing or likelihood of regulatory filings and approvals; our ability to maintain and establish collaborations or obtain additional government grant funding; our financial performance; and developments relating to our competitors and our industry. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; our dependence on our collaboration partners, including Celgene, GlaxoSmithKline and Bayer, for the funding of our partnered programs; our ability to raise additional capital to support the development of our unpartnered programs; our dependence on the development and marketing efforts of our partners for the commercial success of our partnered product candidates; our reliance on third parties to conduct certain preclinical studies and all of our clinical trials; our reliance on single source third-party contract manufacturing organizations to manufacture and supply our product candidates; our ability to validate, develop and obtain regulatory approval for companion diagnostics; our ability to achieve market acceptance and commercial success of our product candidates once regulatory approval is achieved; our ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; our dependence on our Chairman and Chief Executive Officer, our Executive Vice President, Research and Development, our Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate our patents or proprietary rights; and the ability of our proprietary rights to protect our technologies and product candidates. Other factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Risk Factors or otherwise described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed with the Securities and Exchange Commission (SEC) on March 10, 2016, and our other periodic reports filed with the SEC. Any forward-looking statement you see or hear during this presentation reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forwardlooking statements for any reason, even if new information becomes available in the future. 2

3 OncoMed Pharmaceuticals Proprietary Discovery Capabilities Critical cancer stem cell & immuno-oncology targets Strong cancer biology and antibody capabilities Entire pipeline discovered at OncoMed Deep Clinical Pipeline 7 clinical programs in 14 active clinical trials 2 immuno-oncology INDs in Data from multiple randomized Phase 2 trials in Strong Long-Term Outlook Partnerships with Celgene, Bayer and GSK Q1 cash of $194M; YE projected cash of >$100M Substantial future milestones, cash and value 3

4 Targeting Fundamental Drivers of Cancers Self Renewal & Differentiation Cancer stem cells (CSCs) drive tumor initiation, metastases Focusing on key CSC pathways Notch Wnt R-spondin Immune Evasion Required to avoid immune surveillance Tackling key IO challenges MDSC and myeloid suppression Getting leukocytes into the tumor Novel checkpoint agents Tumor-antigen dilemma Self-renewal Differentiation Tumor Lysis 4

5 OncoMed s Pipeline 7 Clinical Programs, 5+ Research Programs CLINICAL PRECLINICAL Therapeutic Preclinical IND Phase 1a Phase 1b Phase 2 Demcizumab Anti-DLL4; OMP-21M18 Tarextumab Anti-Notch2/3; OMP-59R5 Vantictumab Anti-Fzd7, OMP-18R5 Ipafricept Fzd8-Fc; OMP-54F28 Brontictuzumab Anti-Notch1; OMP-52M51 Anti-DLL4/VEGF OMP-305B83 Anti-RSPO3 OMP-131R10 GITRL-Fc IO#2 IO#3 Undisclosed Small Molecules WNT inhibitors 5

6 Demcizumab (anti-dll4) Randomized Data in 2017 Single agent Combination Randomized Phase 1b Pancreatic Cancer Phase 2 YOSEMITE Pancreatic Cancer Data in 2017 Phase 1a Advanced solid tumors Phase 1b Non-Small Cell Lung Phase 2 DENALI NSCLC Data in 2017/2018 Phase 1b + anti-pd1 Data in 2017 Single-agent activity: partial response and stable disease Primary toxicity = hypertension, bleeding reversible cardio-pulmonary events Truncated dosing successful mitigates cardiopulmonary toxicities >300 patients treated Potential partner opt-in in

7 Anti-DLL4 Inhibits Tumor Growth by 3 Distinct Mechanisms Blocking DLL4 function reduces CSC, inhibits tumor angiogenesis and relieves immune suppression Cancer Stem Cells Angiogenesis Immune Response Promotes differentiation and chemo sensitization Blocks critical DLL4 role in angiogenesis Reduces IL-17 production Reduces monocytic myeloid-derived suppressor cells (MDSCs) 7

8 Demcizumab Phase 1b Pancreatic Cancer Response Rates First-line Pancreatic Cancer (N=29) Demcizumab + Gemcitabine + Abraxane % Change in Tumor Size 50% Objective Response Rate Published Rates D+A+G* (N=28) A+G** Partial Response 14 (50%) 23% Stable Disease 11 (39%) 27% * Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM 2013 Hidalgo, et al Gastrointestinal Cancers Symposium 8

9 Demcizumab Phase 1b Pancreatic Cancer Duration of Benefit Demcizumab + Abraxane + Gemcitabine Progression-free Survival Overall Survival 1.0 mpfs (95% CI) = 7.1 months 1.0 mos (95% CI) = 12.7 months Probability Probability Months Months Survival Rates D+A+G* Published Rates A+G** Progression-free Survival 7.1 months 5.5 months Overall Survival 12.7 months 8.5 months *Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM 2013 Hidalgo, et al Gastrointestinal Cancers Symposium 9

10 Demcizumab Phase 1b NSCLC Response Rates First-Line Advanced NSCLC (N=40) Demcizumab + Pemetrexed + Carboplatin % Change in Tumor Size 50% Objective Response Rate Published Rates D+P+C (N=40)* P+C** Complete Response 1 (3%) Partial Response 19 (48%) 27% Stable Disease 15 (38%) McKeage, et al - ASCO 2016 * Single arm study, unconfirmed responses ** Alimta (pemetrexed) package insert 10

11 NSCLC Overall Survival by Kaplan Meier Continuous Demcizumab Dosing Survival Analysis (N=23) mos 7.1 months* Truncated Demcizumab Dosing Survival Analysis (N=23) mos 11.5 months % Alive % Alive Months 10 of 23 patients (~40%) alive >2 years Months 8 of 23 patients (~35%) alive between 18 and 37 months *This is a worst case analysis; mos could be underestimated McKeage, et al - ASCO

12 Demcizumab + anti-pd1 Preclinical Evidence of Synergy Anti-DLL4 Combination Activity with Anti-PD1 Phase 1b Combination Study Trial Design Tumor volume (mm 3 ) CT26 Tumor Model Days Data in 1H

13 Tarextumab: Anti-Notch2/3 Antibody Single agent Combo with SoC Randomized Phase 1a Advanced solid tumors Single-agent activity On-target, manageable GI toxicities Phase 1b/2 Phase 1b/2 ALPINE Study PINNACLE Pancreatic Cancer Small Cell Lung Cancer Phase 1b/2 Phase 1b/2 PINNACLE Study ALPINE Small Cell Lung Cancer Pancreatic Cancer Tarextumab MOA suggests potential differences in activity in SCLC vs. pancreatic cancer ALPINE discontinued following interim read-out by DSMB PINNACLE continues following review of unblinded data by DSMB and FDA >350 patients treated Data in 1H 2017 Discontinued Potential $25M partner opt-in in

14 Tarextumab Phase 1b Response Rates Extensive-stage SCLC (N=26) Tarextumab + Etoposide + Cisplatin/Carboplatin Low Dose High Dose 77% Objective Response Rate (N=26) Published Rates T+E+C* E+C** Partial Response 20 (77%) 44%-67% Stable Disease 6 (23%) * Single arm study, unconfirmed responses **SCLC Meta-Analysis; Rossi, et al, JCO 2012 Chiang, et al - ASCO

15 Tarextumab Phase 1b Kaplan-Meier Analysis of PFS and OS Higher tarextumab dose ( 12.5mg/kg Q3W) appears superior to lower doses Low dose mpfs = 4.29 mos High does mpfs = 5.2 mos Low dose mos = 7.59 mos High does mos = mos Months Months High Notch target genes (HES1, HES6, HEY2, HEY1) + higher tarextumab dose trending to longer PFS and OS >=12.5 mg/kg dose <=10mg/kg dose Chiang, et al - ASCO 2016 >=12.5 mg/kg dose <=10mg/kg dose 15

16 Vantictumab (anti-fzd) WNT Pathway Single agent Combo with SoC Phase 1a Advanced solid tumors Phase 1b Her2- Breast Cancer paclitaxel Phase 1b Pancreatic Cancer gemcitabine + Abraxane Phase 1b Expansion Blocks Frizzled 1, 2, 5, 7, 8 On-target, mild-to-moderate bone-related AEs observed Bone protection strategy appears to mitigate bone toxicities Preclinical synergy observed with taxanes Predictive biomarkers identified and assays being used in breast and pancreatic cancer trials Potential $25M partner opt-in in

17 Vantictumab + Paclitaxel Phase 1b in Her2- Breast Cancer Partial Response Stable Disease 1 st -line (n=9) 33% Overall Response (N=27) 2 nd -line (n=7) 3 rd -line (n=11) Hormone Receptor + (n=12) Triple Negative (n=15) Total (n=27) 4 (44%) 1 (14%) 4 (36%) 3 (25%) 6 (40%) 9 (33%) 2 (22%) 3 (43%) 2 (18%) 4 (33%) 3 (20%) 7 (26%) 6-Gene Biomarker and PFS/OS Mita, et al - ASCO

18 Ipafricept (Fzd8-Fc) WNT Pathway Single agent Phase 1a Advanced solid tumors Combo with SoC Phase 1b Ovarian carboplatin + paclitaxel Phase 1b Pancreatic gemcitabine + Abraxane Phase 1b Expansion Binds Wnt ligands On-target, mild-to-moderate bone-related AEs observed Bone protection strategy appears to mitigate bone toxicities Single-agent activity in diverse tumor types SD > 112 days in 9 of 26 patients Potential $15M partner opt-in in

19 Ipafricept Phase 1b Ovarian Cancer Response Rates Platinum-Sensitive Ovarian Cancer (N=19) Ipafricept +Carboplatin and Paclitaxel 84% Objective Response Rate Published Rates I+C+P (N=19)* C+P** Complete Response 8 (42%) 18% Partial Response 8 (42%) 41% ORR 16 (84%) 59% * Single arm study, unconfirmed responses **Coleman, et al, SGO 2015 O Cearbhaill, et al - ASCO

20 Advancing Toward Opt-ins Brontictuzumab (anti-notch1) Dose Escalation Phase 1a Advanced solid tumors Biomarker selected patients Combo with SoC Phase 1b Colorectal Cancer Planned for 2H 2016 (with GSK) Anti-RSPO3 Anti-DLL4/VEGF Bispecific Single agent Phase 1a Advanced Solid Tumors Data in 2H 2016 Dose Escalation Phase 1a Advanced solid tumors Data in 2H 2016 Expansion Cohort Phase 1a Expansion Biomarker Selected Combo with SoC Phase 1b Planned for 2H 2016 Combo with SOC Phase 1b Colorectal FOLFIRI 20

21 GITRL-Fc: Differentiated Strategy for Activating TNF Receptors Fully Human Single-gene Ligand-Fc Fusion Protein GITRL-Fc Impact on Tumor Volume Single-gene trimer approach enables bispecific formats RENCA (RCC) Tumor Model GITRL-Fc and IO#2 on track for INDs late16/1h 17 21

22 3 Significant Partnerships Provide Funding and Value Partner Year Upfront Comments 2013 $177M* 2010 $40M 2007, 2011 $35M* Up to 6 biologics + small molecules Co-development/commercialization on 5 of 6 biologics Demcizumab end of Phase 2 opt-in Anti-DLL4/VEGF, RSPO3, Others Phase 1 opt-in 1/3 OMED 2/3 CELG development cost share US profit share Ex-US royalties Celgene equity stake ~5% Up to 3 biologic & 2 small molecule programs Opt-in through end of Phase 1b for vantictumab, ipafricept Mid-single digit to high teens royalties on biologics 2 biologics programs Opt-in at end of Phase 2 for tarextumab Opt-in at end of Phase 1 or Phase 2 for brontictuzumab Low double-digit to high teens royalties GSK equity stake ~8.8% Over $450M received to date from Celgene, Bayer, GSK Up to $5B in potential future milestones/payments 22

23 Collaboration Payments Partner Potential Payments Description $168M+ $60M $43M+ Demcizumab opt-in Anti-DLL4/VEGF opt-in Anti-RSPO3 opt-in Potential new research programs Vantictumab opt-in Ipafricept opt-in Small molecule milestones Tarextumab opt-in Brontictuzumab opt-in >$270M in potential payments from existing collaborations 23

24 Financial Discipline Cash*: $193.5M as of 3/31/16 $70M demcizumab safety milestone received from Celgene December Guidance Anticipated operating costs $110-$120 Year-end cash of >$100M Cash through ~Q before potential milestone payments * Cash, equivalents, short-term investments, and receivables; unaudited 24

25 Achievements Recent Events Coming up in 2H - ASCO presentations for 4 clinical candidates - IO, biomarker and PDX data at AACR - Initiated Phase 1b demcizumab + pembro study - $70M safety milestone for demcizumab - Complete Phase 2 enrollment for PINNACLE and YOSEMITE trials - Present first clinical data for bispecfic and anti-rspo3 - Initiate Phase 1b trials for brontictuzumab and bispecific YE 16/1H 17 Catalysts - GITRL-Fc/IO#2 IND filing(s) - Randomized Phase 2 clinical trial data from PINNACLE and YOSEMITE - Potential for partner opt-ins 25

26 Thank you