Q3 2018 Financial Update November 6, 2018 NASDAQ:FPRX
2 Forward-Looking Statements Disclaimer Forward-looking statements contained in this presentation include statements regarding (i) the timing of initiation, progress and scope of clinical trials for Five Prime s product candidates; (ii) the potential use of our Five Prime s product candidates, including in combination with other products, to treat certain patients; (iii) the extent of protein overexpression in certain patient populations and the number of potential patients eligible for treatment with our products; (iv) the prevalence and incidence of certain diseases; (iv) the timing of the presentation of data for Five Prime s product candidates; (vi) the date David V. Smith will join Five Prime as Executive Vice President and Chief Financial Officer; (vii) Five Prime s full-year 2018 net cash used in operating activities; and (viii) the amount of Five Prime s cash, cash equivalents and marketable securities at the end of 2018. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during research, preclinical or clinical studies, changes in expected or existing competition, changes in the regulatory, pricing or reimbursement environment, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forwardlooking statements in this press release are discussed in Five Prime s filings with the U.S. Securities and Exchange Commission, including the Risk Factors contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Five Prime Highlights Bemarituzumab (FGFR2b antibody; FPA144) o o Initiated patient dosing in the randomized, controlled Phase 3 FIGHT trial of bemarituzumab with chemotherapy in front-line gastric and GEJ cancer. Present data from the Phase 1 safety lead-in of the FIGHT trial at ASCO GI conference. Cabiralizumab (CSF1R antibody; FPA008) o o o BMS is enrolling patients in a randomized Phase 2 trial evaluating cabiralizumab + OPDIVO as a 2 nd -line treatment in ~160 patients with pancreatic cancer. Stand Up To Cancer and BMS are supporting a randomized Phase 2 front-line maintenance trial (GemCaN) to test if cabiralizumab + OPDIVO can provide prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone. Apexigen and BMS are supporting a Phase 1/1b trial evaluating APX005M (anti-cd40) + cabiralizumab + OPDIVO in patients with melanoma, non-small cell lung cancer or renal cell carcinoma whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor without intervening therapy. FPA150 (B7-H4 antibody) o o o Initiated dosing in an exploratory basket cohort of patients with tumors that overexpress B7-H4 to investigate FPA150 monotherapy at doses that have shown efficacy in preclinical models. Phase 1a dose escalation in solid tumors is ongoing; dosing in seventh of eight expected cohorts. Phase 1b dose expansion in patients whose tumors overexpress B7-H4 (HR+/HER2- and triple negative breast cancers, ovarian cancer and endometrial cancer) will follow completion of Phase 1a. o Anticipate presenting Phase 1 data at a medical conference in 2019. FPT155 (CD80-Fc) o Opened enrollment in the dose escalation portion of a Phase 1a/1b trial in Australia. BMS-986258 (TIM-3 antibody) o BMS Phase 1/2 trial is testing BMS-986258 both as a single agent and in combination with OPDIVO. o BMS to present preclinical poster at SITC conference. 3
4 Oncology-Focused Pipeline with Multiple Clinical Candidates Program Collaborator Bemarituzumab (FPA144) FGFR2b ANTIBODY Cabiralizumab (FPA008) CSF-1R ANTIBODY FIGHT trial (with chemo) in gastric/gej cancer 2L pancreatic cancer trial (with OPDIVO and chemo) Phase 2 1L maintenance Stand Up to Cancer and BMS supported trial (with OPDIVO) Phase 2 Phase 3 Multiple tumor settings (with OPDIVO) Apexigen & BMS supported trial for APX005M (anti-cd40) and cabira and OPDIVO Phase 1 Phase 1 BMS-986258 TIM-3 ANTIBODY Phase 1/2 trial in multiple tumor settings Phase 1 FPA150 B7-H4 ANTIBODY Multiple tumor settings Phase 1a FPT155 CD80-Fc FUSION Multiple tumor settings Phase 1a I-O antibodies Multiple tumor settings Pre-IND Novel I-O biologics Multiple tumor settings Lead Generation
Attractive Commercial Opportunity for Bemarituzumab in Front-Line Treatment of FGFR2b+ Gastric and GEJ Cancer 5 Estimated Addressable Metastatic Gastric and GEJ Adenocarcinoma Patients 1 US EU Japan/Korea China 1 st line patients 28,400 153,100 134,300 474,000 Treatment eligible (10% FGFR2b+) Patients treated with systemic therapy 2,840 15,300 13,430 47,400 2,050 11,020 9,670 34,130 Global pricing for recently launched biologics range ~$6,500 to >$14,000/month 1 Median PFS of FOLFOX alone in front-line gastric cancer treatment: 6-7 months 2 Median OS of FOLFOX alone in front-line gastric cancer treatment: 10-11 months 2 Unmet need: FGFR2b+ patients have significantly reduced survival 3 1) Internal estimates based on population, published incidence and recurrence rates and estimated treatment rates, CancerMPact Kantar Health, Accessed October 2018. 2) Yoon et al. J Clin Oncol 2014. Shah et al. JAMA Oncol 2017. Al-Batran SE et al. J Clin Oncol 2008. 3) Jung et al. 2009. Hattori et al. 1996.
Attractive Market Opportunity for Cabira: Unresectable or Metastatic Pancreatic Cancer in Major Markets 6 Incidence (2016) 1 US EU5* Japan First-line 45,950 52,130 32,240 Second-line 22,827 26,049 15,618 Sources: 1 - Decision Resources Group; Pancreatic Cancer Epidemiology Overview, August 2017. * - EU5 = France, Germany, Italy, Spain, UK
FPA150: Opportunity to Address Large Patient Populations with High Unmet Medical Need 7 Late-line Treatment Estimated Eligible Population 1 US EU5 Japan TNBC 3L+ 5,170 5,230 2,000 HR+/HER2- Breast Hormone-refractory and 3L chemo+ Ovarian 2L+ platinum-resistant Endometrial 2L+ Estimated Addressable Patients and Unmet Need 45,800 49,560 14,200 10,740 10,970 3,730 Late-line data not available Historical mpfs 2 < 4 months Potential to expand to earlier lines of therapy in combination with standard of care (e.g., PD-(L)1 therapy, chemotherapy, PARP inhibitors) 1 Decision Resources Group 2018, 2 Twelves C, Breast Cancer: Basic and Clinical Research 2016, 3 Mutch DG, J Clin Oncol 2007, 4 Aghajanian C, J Clin Oncol 2011, 5 Powels T, Lancet 2018
Bemarituzumab (FPA144) Was Designed to Recruit Tumor-Killing NK Cells into the Tumor Microenvironment and Block Growth Factor Ligands 8 Natural Killer Cell Enhanced ADCC to increase NK cell recruitment Bema FGFR2b FGF7, 10, 22 Specific to FGFR2b splice variant; blocks growth factor ligands Tumor Cell
FIGHT Phase 3 Trial of Bemarituzumab in Front-Line FGFR2b+ Gastric and GEJ Cancer 9 Randomized Phase 3 ~550 patients Initiated September 2018 Bema + mfolfox6 vs Placebo + mfolfox6 Study Endpoints OS PFS ORR FGFR2b overexpression and FGFR2 gene amplification associated with worse prognosis ~10% of gastric and GEJ cancer patients expected to be biomarker-positive Select patients by IHC (tumor sample) or ctdna (blood-based) tests
Cabiralizumab, a Product of the Five Prime Platform, Blocks Survival of Macrophages 10 Cabiralizumab (FPA008) is an antibody to CSF-1R CSF-1 IL-34 Five Prime discovered IL-34, one of the two ligands for CSF-1R that cabiralizumab (FPA008) blocks
Durable Responses Observed Without Chemo in Late-Line Pancreatic Cancer* Percent change in tumor burden (SLD) from baseline 11 Best change in tumor burden over time in efficacy-evaluable patients treated with cabiralizumab 4 mg/kg + nivolumab 3 mg/kg (n=31) Progressive disease Treated beyond progressive disease Partial response Day Efficacy & Safety: Durable clinical benefit observed Confirmed ORR = 13% DCR = 16% Disease control: 5 to 9+ months Heavily pretreated population (average 3 prior therapies) All responders had microsatellite stable tumors (do not respond to PD1/L1 therapy) No new or additive safety signals identified Whole exome sequencing analysis demonstrated that nearly all patients had low TMB Days * SITC, November 2017 Wainberg Z, et al.
BMS-Sponsored Randomized, Open-Label Phase 2 Trial of Cabiralizumab/OPDIVO in 2 nd -Line Pancreatic Cancer (NCT03336216) 12 Prior Line: Gemcitabine-Based Chemotherapy Trial Arms (2 nd -Line) Arm A: Chemotherapy alone Gemcitabine/Abraxane or 5-FU/leucovorin/Onivyde Arm B: Cabiralizumab + OPDIVO N ~160 patients Study Objectives Progression free survival (primary) Objective response rate and duration Prior Line: 5-Fluorouracil-Based Chemotherapy Arm C: Cabiralizumab + OPDIVO combined with gemcitabine + Abraxane Arm D: Cabiralizumab + OPDIVO combined with oxaliplatin/5-fu/leucovorin Overall survival rate Safety PK First patient dosed January 2018 Study will generate data that could support a front-line or second-line pivotal study
13 FPA150 Has Two Mechanisms: Block the Checkpoint and Enhance ADCC Enhanced NK-mediated cell killing (ADCC) FPA150 B7-H4 T Cell B7-H4 Tumor Cell B7-H4 FPA150 Blocks B7-H4 checkpoint activity
B7-H4 is Expressed in Multiple Solid Tumors Not Well Served by Checkpoint Inhibitors 14 Expression Levels N e g a t i v e M o d e r a t e - H i ( ~ 6 0 % ) N e g a t i v e M o d e r a t e - H i ( ~ 5 0 % ) N e g a t i v e M o d e r a t e - H i ( ~ 5 0 % ) L o w L o w L o w Breast cancer T N B C Ovarian O v a r i a n cancerc a n c e r Endometrial E n d o m e t r i a l c a cancer n c e r Very little expression on normal cells/tissue
FPA150: Phase 1a/1b Clinical Trial to Look for Monotherapy Activity Against B7-H4 Overexpressing Tumors 15 PHASE 1a Dose escalation Any Solid Tumor Initiated March 2018 Exploratory cohort Basket B7-H4+ Tumors Initiated Oct. 2018 PHASE 1b Expansion; B7-H4+ tumors HR+/HER2- Breast Cancer Triple Negative Breast Cancer Ovarian Cancer Study Objectives Safety Objective response rate and duration Survival Baseline and on-treatment biopsies Endometrial Cancer IHC assay to select patients with B7-H4 expressing tumors in exploratory cohort and Phase 1b Evaluating I-O and chemo combination strategies Additional Cohorts TBD
FPT155: First-In-Class CD80-Fc Fusion Protein Engineered for Monotherapy Efficacy by Activating T Cells Through Multiple Pathways 16 Normal T cell activation via CD80 Antigen presenting cell MHC TCR T cell (+) signal FPT155 uses the binding interactions of soluble CD80 to: Directly engage CD28 to enhance its co-stimulatory activity (without super agonism) Block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation CD80 CD28 CD80 extracellular domain CD80 is a co-stimulatory molecule expressed on antigen presenting cells Human IgG1 Fc
T u m o r V o lu m e (M e a n m m 3 S D ) 17 Single Agent mfpt155 Can Induce Tumor Regressions at Low Doses CT26 Tumor Growth Ig G 2 a 0.9 m g /k g 2 4 0 0 m F P T 1 5 5 0.1 m g /k g (s in g l m F P T 1 5 5 0.3 m g /k g (s in g l 2 0 0 0 m F P T 1 5 5 0.6 m g /k g (s in g l 1 6 0 0 1 2 0 0 8 0 0 migg2 control m F P T 1 5 5 0.9 m g /k g (s in g l 0.1 mg/kg mmfpt155 F P T 1 5 5 0.1 One m g /k g (3 d o s 0.2 mg/kg mfpt155 administration 0.6 mg/kg m mfpt155 F P T 1 5 5 0.2 m g /k g (3 d o s 0.9 mg/kg mmfpt155 F P T 1 5 5 0.3 m g /k g (3 d o s 0.1 mg/kg mfpt155 Three 0.2 mg/kg mfpt155 administrations 0.3 mg/kg mfpt155 4 0 0 0 0 5 1 0 1 5 2 0 2 5 3 0 D a y s p o s t-in o c u la tio n Murine FPT155 (mfpt155) demonstrates monotherapy anti-tumor activity in MC38, EMT6, 4T1, and B16-F10 models
mfpt155 Has Synergistic Activity in Combination with anti-pd1 in Large Tumors that are Insensitive to Anti-PD1 18 migg2a CT26 Tumor Growth mfpt155 5/15 rejections anti-pd1 Combination 9/15 rejections
19 IND Engine: Unique Platform Generating Novel Therapeutics Comprehensive Libraries of Extracellular Proteins Proprietary Screens Protein Therapeutics Secreted Factors In Clinical Development bemarituzumab (anti-fgfr2b ) Cell-based Screens Antibodies cabiralizumab (anti-csf-1r) Cell Surface Receptors/Ligands In Vivo Screens Soluble Receptors Ligand Traps FPA150 (anti-b7h4) BMS-986258 (anti-tim-3) Soluble Extracellular Domains Receptor-Ligand Matching FPT155 (CD80-Fc Fusion)
20 Cash and Shares Outstanding Cash, cash equivalents & marketable securities Shares outstanding Estimated cash, cash equivalents & marketable securities, EOY 2018 FY 2018 estimated net cash used in operating activities $321.6 million as of Sept. 30, 2018 34.5 million as of Sept. 30, 2018 ~ $265 million < $135 million
Summary of Financial Results (In Millions Except Per Share Amounts) 21 3Q18 3Q17 Revenue $5.8 $8.3 R&D Expenses $44.7 $42.7 G&A Expenses $9.8 $9.7 Net Loss ($47.2) ($43.3) EPS Basic & Diluted ($1.37) ($1.54)
Five Prime News Flow and Milestones Bemarituzumab (FPA144) GASTRIC/GEJ CANCER Cleared Phase 1 safety lead-in to FIGHT chemo combo trial Initiated randomized, global Phase 3 FIGHT trial Present Phase 1 FIGHT trial safety lead-in data at the ASCO GI conference FPA150 (B7-H4 Antibody) Initiated exploratory cohort of FPA150 monotherapy in patients with tumors that overexpress B7-H4 Complete Phase 1a dose escalation, select a dose and initiate Phase 1b expansion Present Phase 1 data at medical conference in 2019 Cabiralizumab PANCREATIC CANCER BMS completes enrollment in randomized Phase 2 trial (2 nd -line pancreatic) combo with OPDIVO + chemo Stand Up To Cancer & BMS initiated randomized Ph 2 front-line maintenance pancreatic trial (GemCaN) FPT155 (CD80-Fc Fusion Protein) Opened enrollment in Phase 1a dose escalation portion of Phase 1 trial in Australia BMS-986258 (TIM-3 Antibody) BMS advances trial to Phase 2 BMS presents preclinical poster at SITC 22
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