Jefferies 2015 Healthcare Conference

Transcription

1 Jefferies 2015 Healthcare Conference Paul J. Hastings Chairman and Chief Executive Officer June 2, 2015

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 Chief Scientific Officer, 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, 2014, filed with the Securities and Exchange Commission (SEC) on March 12, 2015 and our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2015, filed with the SEC on May 7, 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, Inc. Proprietary Discovery Capabilities Targeting critical cancer stem cell and immuno-oncology pathways Pipeline of first-in-class anti-cancer stem cell therapeutics All discovered at OncoMed Deep Clinical Pipeline 6 clinical programs in or advancing to Phase 2 7 th program IND filed 16 active clinical trials: evidence of activity Data from multiple randomized Phase 2 trials by Strong Long-Term Outlook Partnerships with Celgene, Bayer and GSK Ongoing discovery research fueling pipeline Substantial future milestones and cash 3

4 CD44 Tumor Volume (mm3) CD44 Cancer Stem Cells Drive Tumor Growth, Recurrence and Metastasis CSCs Drive Tumor Growth Human colon tumor CSCs Anti-CSC Therapy Blocks Renewal; Forces Differentiation CD166 Self-renewal CSC (7/8) Human colon tumor growth in mouse xenograft Other (0/10) Day post-injection Differentiation FACS analysis of human tumor in mouse CSCs CD166 4

5 Targeting Critical Stem Cell Pathways Notch Pathway Wnt Pathway RSPO/LGR Pathway New Pathways Demcizumab Vantictumab Anti-RSPO3 Immunotherapy Tarextumab Ipafricept Other RSPOs Hippo Brontictuzumab Anti-DLL4/VEGF bispecific Small Molecules Other LGRs Undisclosed 5

6 PRECLINICAL CLINICAL Anti-Cancer Stem Cell Pipeline 6 Clinical Programs, 5+ Research Programs 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 Filed Small Molecules WNT inhibitors Immunotherapy Hippo Pathway Small Molecules (Undisclosed) 6

7 Demcizumab (anti-dll4) Inhibits Tumor Growth by Three 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 Reduced IL-17 production Reduced monocytic myeloid-derived suppressor cells (MDSCs) 7

8 Demcizumab Clinical Program Single agent Combo with chemo Randomized Phase 1b Pancreatic Cancer Phase 2 YOSEMITE Pancreatic Cancer Enrolling Phase 1a Advanced solid tumors Phase 1b Non-Small Cell Lung Phase 2 DENALI NSCLC Enrolling Phase 1b/2 Ovarian Currently In Ph1b Multi-pronged MOA Single agent activity observed partial and minor responses Generally well tolerated Truncated dosing mitigates cardiopulmonary toxicity 8

9 % Change in Tumor Size Demcizumab Phase 1b Pancreatic Cancer Response Rates First-line Pancreatic Cancer (N=29) Demcizumab + Gemcitabine + Abraxane 89% Overall Clinical Benefit Rate Demcizumab + Abraxane + Gemcitabine* (N=29) Abraxane + Gemcitabine** Partial Response 14 (50%) 23% Stable Disease 11 (39%) 27% Hidalgo, et al ASCO 2015 * Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM

10 Probability Probability Demcizumab Phase 1b Pancreatic Cancer Duration of Responses Progression-free Survival Demcizumab + Abraxane + Gemcitabine mpfs (95% CI) = 9.0 months (3.7 NR) Overall Survival Demcizumab + Abraxane + Gemcitabine mos (95% CI) = 10.1 months ( ) Months Months Survival Rates Demcizumab + Abraxane + Gemcitabine* Abraxane + Gemcitabine** Progression-free Survival 9.0 months 5.5 months Overall Survival 10.1 months 8.5 months Hidalgo, et al ASCO 2015 *Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM

11 % Change in Tumor Size Demcizumab Phase 1b NSCLC Response Rates First-Line Advanced NSCLC (N=40) Demcizumab + Pemetrexed + Carboplatin Kotasek, et al ASCO % Overall Clinical Benefit Rate Demcizumab + Pemetrexed + Carboplatin (N=40)* Complete Response 1 (3%) Pemetrexed + Carboplatin** Partial Response 19 (48%) 27% Stable Disease 15 (38%) * Single arm study, unconfirmed responses ** Alimta (pemetrexed) Package insert 11

12 Overall Survival % Alive % Alive NSCLC Overall Survival by Kaplan Meier Phase 1b Exploratory Analysis Continuous Demcizumab Dosing Worst Case Survival Analysis Truncated Demcizumab Dosing mos (95% CI) = 8.1 (5.8-NR) mos mos (95% CI) = 6.3 months (3.2-NR) Months Tumor Biomarker Analysis (%Tils) % %TILs >50% Months Ten of 23 patients (~40%) alive >2 years %TILs 50% %TILs 50% Kotasek, ASCO 2015 Survival days 12

13 Tarextumab: Anti-Notch2/3 Antibody Single agent Combo with chemo Randomized Phase 1a Advanced solid tumors Phase 1b/2 ALPINE Phase Study 1b/2 Pancreatic ALPINE Cancer Pancreatic Phase 1b/2 PINNACLE Study Phase 1b/2 Small Cell PINNACLE Lung Cancer Small Cell Lung Cancer Enrolling Enrolling Reduces CSCs; promotes differentiation Single agent activity On-target, manageable GI toxicities Predictive biomarker program Notch3+ tumor status 13

14 % Change in Tumor Size Tarextumab Phase 1b ALPINE Response Rates First-line Pancreatic Cancer (N=37) Tarextumab + Abraxane + Gemcitabine = Tarextumab + Gemcitabine = Tarextumab + Gemcitabine + Abraxane 30% target tumor reduction 73% Overall Clinical Benefit Rate Tarextumab + Abraxan+ Gemcitabinee* (N=24) Abraxane + Gemcitabine** Partial Response 11 (38%) 23% Stable Disease 10 (35%) 27% PR + SD 21 (73%) 50% O Reilly, et al ASCO GI 2015 *Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM

15 Tarextumab Phase 1b ALPINE Duration and Biomarker Data Tumor Notch3 Level and Timed Endpoints 14.6months O Reilly, et al ASCO GI 2015 Progression-free Survival and Overall Survival Tarextumab + Gemcitabine + Abraxane* mpfs (months) mos (months) All patients (N=24) Notch3 high (50%) (N=12) Gemcitabine + Abraxane** *Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM

16 % Change in Tumor Size Tarextumab Phase 1b PINNACLE Response Rates Extensive-stage SCLC (N=26) Tarextumab + Etoposide + Cisplatin/Carboplatin 100% Overall Clinical Benefit Rate (N=26) Tarextumab + Etoposide + Carboplatin/Cisplatin Cisplatin + Etoposide** Partial Response 20 (77%) 44%-67% Stable Disease 6 (23%) Pietanza, et al ASCO 2015 * Single arm study, unconfirmed responses **SCLC Meta-Analysis; Rossi, et al, JCO

17 Tarextumab Phase 1b PINNACLE Biomarker and Survival Analysis Progression-Free Survival Low Notch3 vs. High Notch3 Overall Survival Low Notch3 vs. High Notch3 Low Notch 3 N=12 High Notch 3 N=13 Low Notch 3 N=12 High Notch 3 N=13 N=13 Months Months Months Months Potentially longer survival noted in Notch3 high patients receiving higher doses of tarextumab ( 12.5mg/kg) + platinum therapy Pietanza, et al ASCO

18 Brontictuzumab: Anti-Notch1 Antibody Dose Escalation Expansion Cohort Phase 1a Advanced solid tumors Phase 1a Biomarker selected Ongoing expansion Phase 1a Hematologic malignancies Phase 1a Biomarker selected Ongoing dose escalation Anti-CSC, anti-angiogenic Single agent activity On-target, manageable GI toxicities Predictive biomarker program IHC assay identifying solid tumors with Notch1 activation 18

19 Brontictuzumab Phase 1a Solid Tumor Trial with Biomarker Assay Partial Response Stable Disease Progressive Disease Total Responses among Evaluable Subjects (N=17) Notch1 High Notch1 Low Notch1? Predictive Biomarker (Notch1) 3 of 4 patients with Notch1 ICD high tumors with clinical benefit 1 of 9 patients with Notch1 ICD low tumors with clinical benefit Phase 1a Expansion Now Enrolling Solid Tumor Types with Notch1 ICD High Prevalence (12%-53%) Colorectal Gastric Esophageal Pancreatic Small cell lung HER2- breast Cholangiocarcinoma Adenoid cystic carcinoma Patnaik, et al EORTC-NCI-AACR

20 Vantictumab (anti-fzd7) WNT Pathway Single agent Phase 1a Advanced solid tumors Combo with chemo Phase 1b Her2- Breast Cancer paclitaxel Phase 1b NSCLC docetaxel Phase 1b Pancreatic Cancer gemcitabine + Abraxane Inhibits Wnt signaling Blocks Frizzled 1, 2, 5, 7, 8 On-target, mild-to-moderate bone-related AEs observed Bone protection strategy Single agent activity 3/3 neuroendocrine tumors 20

21 Ipafricept (Fzd8-FC) WNT Pathway Single agent Combo with chemo Phase 1b Ovarian carboplatin + paclitaxel Phase 1a Advanced solid tumors Phase 1b Hepatocellular sorafenib Phase 1b Pancreatic gemcitabine + Abraxane Inhibits signaling: binds Wnt ligands Distinct from vantictumab On-target, mild-to-moderate bone-related AEs observed Bone protection strategy Single agent activity in diverse tumor types; SD > 112 days in 9 patients 21

22 Anti-DLL4/VEGF Bispecific (OMP-305B83) Single agent Anti- VEGF Heavy chain Anti-DLL4 Heavy chain Phase 1a Advanced solid tumors Dual inhibitor DLL4 & VEGF Multi-pronged MOA Preclinical data: improved efficacy and safety Phase 1a initiated December 2014 Dose escalation, expansion Advanced, refractory solid tumors Yen AACR

23 New R&D Candidates Anti-RSPO3 (OMP-131R10) IND filed April 2015 Multiple therapeutic opportunities Strong predictive biomarker strategy Broad, issued claims cover therapeutic antibodies that disrupt RSPO-LGR signaling RSPO LGR Immuno-oncology Two novel immuno-oncology programs Hippo pathway (Celgene) GITR Ligand-Fc (OMED wholly owned) Discovery of missing checkpoint receptor to PD-L2 OMED wholly owned GITRL-Fc Other Anti-RSPO candidates RSPO 1, 2, 4; LGR 4, 5, 6 Gurney AACR

24 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% *Celgene: $155M cash, $22.25 equity; GSK: $17.5M cash, $17.5M equity Note: equity % stake per most recent SEC filing 24

25 Program Financial Milestone Snapshot Program Potential Future Milestones/Payments Demcizumab ~$790M Tarextumab $319.5M Vantictumab $357.5M Ipafricept $347.5M Brontictuzumab $330.5M Anti-DLL4/VEGF bispecific ~$505M Anti-RSPO3 ~$440M RSPO/undisclosed pathway ~$440M each, up to 3 Bayer small molecules $110M Celgene small molecules >$100M Total Potential Milestones >$4 Billion Over $378M* received to date from Celgene, Bayer, GSK *Includes $5M receivable 25

26 Potential Collaborative Revenue Milestone/Payments Partner Amount Timing Brontictuzumab Phase 1 expansion Demcizumab Phase 2 safety analysis $5M 1H 2015 $70M Q4 2015/2016 Vantictumab opt-in $25M 2H 2015/2016 Ipafricept opt-in $15M 2H 2015/2016 Brontictuzumab opt-in $18.75M 2H 2015/2016 Payment increases to $25M if GSK chooses to wait to opt in at Phase 2 Tarextumab opt-in $25M 2016 Total Potential Milestones >$150M Through 1H 2016* * Additional milestones could be achieved in 2015/2016 related to preclinical and small molecule programs 26

27 OMED Financial Guidance Cash*: $213M as of March 31, Financial Guidance: $100 - $110M cash operating expenses, excluding non-cash expenses YE cash of over $120M before potential milestone payments $150M+ in potential 2015/16 payments from existing partnerships Existing cash plus future milestones may fund operations through commercialization without need for future financing * Cash, equivalents, and short-term investments; unaudited 27

28 2015 Pipeline Progress 1H 2015 Anti-DLL4/VEGF Phase 1a FPI ASCO GI - Tarextumab Final Phase 1b pancreatic; biomarker Phase1a Brontictuzumab expansion Demcizumab NSCLC Phase 2 FPI Demcizumab Pancreatic Phase 2 FPI ELCC - Demcizumab Updated Phase 1b NSCLC data AACR 7 abstracts accepted for presentation R&D Investor Day April 29 in NYC File anti-rspo3 IND ASCO - Tarextumab Phase 1b SCLC ASCO - Demcizumab Phase 1b Pancreatic & NSCLC Financial/Corporate* 2H 2015 Complete Demcizumab Phase 1b Ovarian Anti-RSPO3 Phase 1a FPI Complete Tarextumab Phase 2 enrollment in pancreatic cancer Present Phase 1a Brontictuzumab data Biomarker-selected expansion cohort Present Ipafricept data Present Vantictumab data Present opt-in package to Bayer Vantictumab & ipafricept Demcizumab Phase 2 safety analysis * Select financial milestones Data 2015 / 2016 Clinical 28

29 OncoMed Pharmaceuticals, Inc. Proprietary Discovery Capabilities Targeting critical cancer stem cell and immuno-oncology pathways Pipeline of first-in-class anti-cancer stem cell therapeutics All discovered at OncoMed Deep Clinical Pipeline 6 clinical programs in or advancing to Phase 2 7 th program IND filed 16 active clinical trials: evidence of activity Data from multiple randomized Phase 2 trials by Strong Long-Term Outlook Partnerships with Celgene, Bayer and GSK Ongoing discovery research fueling pipeline Substantial future milestones and cash 29

30 Thank you