Jefferies 2015 Healthcare Conference Paul J. Hastings Chairman and Chief Executive Officer June 2, 2015
Jefferies 2015 Healthcare
Conference
Paul J. HastingsChairman 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, 2015.
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 forward-looking statements for any reason, even if new information becomes available in the future.
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
Strong
Long-Term
Outlook
• 6 clinical programs in or advancing to Phase 2
− 7th program IND filed
• 16 active clinical trials: evidence of activity
• Data from multiple randomized Phase 2 trials by 2016-17
• Partnerships with Celgene, Bayer and GSK
• Ongoing discovery research fueling pipeline
• Substantial future milestones and cash
4
Cancer Stem Cells Drive Tumor Growth,
Recurrence and Metastasis
CSC (7/8)
Other (0/10)
Day post-injection
Tu
mor
Volu
me (
mm
3)
Human
colon tumor
CD
44
CD166
CSCsC
D44
CD166
CSCs
Human
colon tumor growth
in mouse xenograft
FACS analysis of
human tumor in mouse
CSCs Drive Tumor Growth Anti-CSC Therapy Blocks Renewal;
Forces Differentiation
Self-renewal
Differentiation
5
RSPO/LGR
Pathway
Wnt
Pathway
Notch
Pathway
Targeting Critical Stem Cell Pathways
• Demcizumab
• Tarextumab
• Brontictuzumab
• Anti-DLL4/VEGF
bispecific
• Vantictumab
• Ipafricept
• Small
Molecules
• Anti-RSPO3
• Other RSPOs
• Other LGRs
New
Pathways
• Immunotherapy
• Hippo
• Undisclosed
6
Anti-Cancer Stem Cell Pipeline6 Clinical Programs, 5+ Research Programs
Therapeutic Preclinical IND Phase 1a Phase 1b Phase 2
DemcizumabAnti-DLL4; OMP-21M18
TarextumabAnti-Notch2/3; OMP-59R5
Vantictumabanti-Fzd7, OMP-18R5
IpafriceptFzd8-Fc; OMP-54F28
BrontictuzumabAnti-Notch1; OMP-52M51
Anti-DLL4/VEGFOMP-305B83
Anti-RSPO3OMP-131R10
Small MoleculesWNT inhibitors
Immunotherapy
Hippo Pathway
Small Molecules(Undisclosed)
CL
INIC
AL
PR
EC
LIN
ICA
L
Filed
7
Demcizumab (anti-DLL4) Inhibits
Tumor Growth by Three Distinct Mechanisms
Blocks critical DLL4 role in angiogenesis
Angiogenesis Immune ResponseCancer Stem Cells
Promotes differentiation and chemo sensitization
Blocking DLL4 function reduces CSC, inhibits tumor
angiogenesis and relieves immune suppression
Reduced IL-17 production Reduced monocyticmyeloid-derived suppressor cells (MDSCs)
8
Demcizumab Clinical Program
Phase 1a Advanced solid
tumors
Phase 1bPancreatic Cancer
Phase 2YOSEMITE
Pancreatic Cancer
Phase 1bNon-Small Cell
Lung
Phase 2DENALINSCLC
Single agent Combo with chemo Randomized
Enrolling
Currently
In Ph1b
Phase 1b/2Ovarian
Enrolling
• Multi-pronged MOA
• Single agent activity observed – partial and minor responses
• Generally well tolerated
− Truncated dosing mitigates cardiopulmonary toxicity
9
Demcizumab Phase 1b Pancreatic Cancer
Response Rates
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
First-line Pancreatic Cancer (N=29)
Demcizumab + Gemcitabine + Abraxane
**MPACT Phase 3 study; Von Hoff, et al, NEJM 2013
% C
ha
ng
e in
Tu
mo
r S
ize
10
Demcizumab Phase 1b Pancreatic Cancer
Duration of Responses
Hidalgo, et al ASCO 2015
Progression-free Survival
Demcizumab + Abraxane + Gemcitabine
*Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM 2013
Pro
bab
ilit
y
Overall Survival
Demcizumab + Abraxane + Gemcitabine
mOS (95% CI) = 10.1 months (6.5 – 16.2)mPFS (95% CI) = 9.0 months (3.7– NR)
0 5 10 150 5 10 15
Survival Rates
Demcizumab +
Abraxane + Gemcitabine*
Abraxane +
Gemcitabine**
Progression-free Survival 9.0 months 5.5 months
Overall Survival 10.1 months 8.5 months
Months
Pro
bab
ilit
y
Months
11
Demcizumab Phase 1b NSCLC
Response Rates
89% Overall Clinical Benefit Rate
Demcizumab + Pemetrexed
+ Carboplatin (N=40)*
Pemetrexed +
Carboplatin**
Complete Response 1 (3%)
Partial Response 19 (48%) 27%
Stable Disease 15 (38%)
* Single arm study, unconfirmed responses ** Alimta® (pemetrexed) Package insert
First-Line Advanced NSCLC (N=40)
Demcizumab + Pemetrexed + Carboplatin
Kotasek, et al ASCO 2015
% C
ha
ng
e in
Tu
mo
r S
ize
12
NSCLC Overall Survival by Kaplan MeierPhase 1b Exploratory Analysis
% A
live
mOS (95% CI) = 6.3 months (3.2-NR)
Truncated Demcizumab Dosing
% A
live
mOS (95% CI) = 8.1 (5.8-NR) mos
Kotasek, ASCO 2015
Continuous Demcizumab Dosing
“Worst Case” Survival Analysis
Ten of 23 patients (~40%)
alive >2 years
0 10 20 30 40 50
Months
Months 0 5 10 15 20 25
Tumor Biomarker Analysis (%Tils)
%TILs ≤50%Ove
rall
Su
rviv
al
Survival days
% TILs >50%%TILs >50%
%TILs ≤50%
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Tarextumab: Anti-Notch2/3 Antibody
Phase 1b/2
ALPINE StudyPancreatic Cancer
Phase 1b/2
PINNACLE StudySmall Cell Lung Cancer
Single agent Combo with chemo Randomized
Phase 1a Advanced solid tumors
Phase 1b/2
ALPINEPancreatic
Phase 1b/2
PINNACLESmall Cell Lung Cancer
Enrolling
Enrolling
• Reduces CSCs; promotes differentiation
• Single agent activity
On-target, manageable GI toxicities
• Predictive biomarker program
− Notch3+ tumor status
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Tarextumab Phase 1b ALPINE
Response Rates
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
First-line Pancreatic Cancer (N=37)
Tarextumab + Abraxane + Gemcitabine
30% target tumor reduction
% C
ha
ng
e in
Tu
mo
r S
ize
= Tarextumab + Gemcitabine
= Tarextumab + Gemcitabine + Abraxane
*Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM 2013
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Tarextumab Phase 1b ALPINE
Duration and Biomarker Data
O’Reilly, et al ASCO GI 2015
Tumor Notch3 Level and Timed Endpoints
Progression-free Survival and Overall Survival
Tarextumab + Gemcitabine +
Abraxane*mPFS (months) mOS (months)
All patients (N=24) 5.6 11.6
Notch3 high (50%) (N=12) 6.6 14.6
Gemcitabine + Abraxane** 5.5 8.5
14.6months
*Single arm study, unconfirmed responses **MPACT Phase 3 study; Von Hoff, et al, NEJM 2013
16
Tarextumab Phase 1b PINNACLE
Response Rates
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 **SCLC Meta-Analysis; Rossi, et al, JCO 2012* Single arm study, unconfirmed responses
Extensive-stage SCLC (N=26)
Tarextumab + Etoposide + Cisplatin/Carboplatin
% C
ha
ng
e in
Tu
mo
r S
ize
17
Tarextumab Phase 1b PINNACLEBiomarker and Survival Analysis
Pietanza, et al ASCO 2015
Progression-Free Survival
Low Notch3 vs. High Notch3
Potentially longer survival noted in Notch3 high patients receiving higher
doses of tarextumab (≥12.5mg/kg) + platinum therapy
N=13Low Notch 3
N=12
Overall Survival
Low Notch3 vs. High Notch3
Low Notch 3
N=12
High Notch 3
N=13
High Notch 3
N=13
Months MonthsMonths Months
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Brontictuzumab: Anti-Notch1 Antibody
Dose Escalation Expansion Cohort
Phase 1aAdvanced solid tumors
Phase 1aBiomarker selected
Phase 1aHematologic malignancies
Phase 1aBiomarker selected
Ongoing
dose escalation
Ongoing
expansion
• Anti-CSC, anti-angiogenic
• Single agent activity
On-target, manageable GI toxicities
• Predictive biomarker program
− IHC assay identifying solid tumors with Notch1 activation
19
Brontictuzumab Phase 1a
Solid Tumor Trial with Biomarker Assay
Patnaik, et al EORTC-NCI-AACR 2014
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
Notch1 High Notch1 Low Notch1 ?
Partial Response1 - -
Stable Disease2 1
Progressive
Disease 1 8 4
Total4 9 4
Responses among Evaluable Subjects (N=17)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
20
Vantictumab (anti-Fzd7) WNT Pathway
Single agent
Phase 1aAdvanced solid tumors
Phase 1bHer2- Breast Cancer
paclitaxel
Phase 1bNSCLCdocetaxel
Phase 1bPancreatic Cancergemcitabine + Abraxane
Combo with chemo
• 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
21
Ipafricept (Fzd8-FC) WNT Pathway
Single agent
Phase 1aAdvanced solid tumors
Phase 1bOvarian
carboplatin + paclitaxel
Phase 1bHepatocellular
sorafenib
Phase 1bPancreatic
gemcitabine + Abraxane
Combo with chemo
• 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
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• 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
Anti-DLL4/VEGF Bispecific (OMP-305B83)
Single agent
Phase 1aAdvanced solid tumors
Yen AACR 2014
Anti-DLL4
Heavy chain
Anti- VEGF
Heavy chain
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
Other Anti-RSPO candidates
• RSPO 1, 2, 4; LGR 4, 5, 6
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
Gurney AACR 2014
RSPO
LGR
GITRL-Fc
24
3 Significant Partnerships Provide
Funding and Value
Partner Year Upfront Comments
2013 $177M*
• 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
– 50-50 US profit share
– Ex-US royalties
• Celgene equity stake ~5%
2010 $40M
• 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
2007,
2011$35M*
• 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
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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
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Potential Collaborative Revenue 2015-16
Milestone/Payments Partner Amount Timing
Brontictuzumab Phase 1
expansion$5M 1H 2015
Demcizumab Phase 2 safety
analysis$70M Q4 2015/2016
Vantictumab opt-in $25M 2H 2015/2016
Ipafricept opt-in $15M 2H 2015/2016
Brontictuzumab opt-in $18.75M2H 2015/2016Payment 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
27
OMED Financial Guidance
• Cash*: $213M as of March 31, 2015
• 2015 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
28
2015 Pipeline Progress
1H 2015
ClinicalDataFinancial/Corporate*
2H 2015
Anti-DLL4/VEGF Phase 1a FPI
ASCO GI - TarextumabFinal Phase 1b pancreatic; biomarker
Demcizumab NSCLC Phase 2 FPI
Demcizumab Pancreatic Phase 2 FPI
Phase1a Brontictuzumab expansion
File anti-RSPO3 IND
ASCO - DemcizumabPhase 1b Pancreatic & NSCLC
ELCC - DemcizumabUpdated Phase 1b NSCLC data
ASCO - TarextumabPhase 1b SCLC
Present opt-in package to BayerVantictumab & ipafricept
Present Phase 1a Brontictuzumab dataBiomarker-selected expansion cohort
Present Ipafricept data
Complete Demcizumab Phase 1bOvarian
Demcizumab Phase 2 safety analysis
Present Vantictumab data
Complete Tarextumab Phase 2
enrollment in pancreatic cancer
* Select financial milestones
Anti-RSPO3 Phase 1a FPI
2015 /
2016
AACR7 abstracts accepted for presentation
R&D Investor DayApril 29 in NYC
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
Strong
Long-Term
Outlook
• 6 clinical programs in or advancing to Phase 2
− 7th program IND filed
• 16 active clinical trials: evidence of activity
• Data from multiple randomized Phase 2 trials by 2016-17
• Partnerships with Celgene, Bayer and GSK
• Ongoing discovery research fueling pipeline
• Substantial future milestones and cash
Thank you