- Clinical pipeline expected to more than double in 2018
- Global Phase 3 clinical trial of bemarituzumab in gastric cancer anticipated to begin in 2018
- Positive initial data in pancreatic cancer driving cabiralizumab advancement
“2017 was a year of continued progress across our pipeline,” said
2017 Business Highlights and Recent Developments
Cabiralizumab (FPA008): an antibody that inhibits CSF1R and has been shown to block the activation and survival of monocytes and macrophages.
- Completed enrollment of the ongoing Phase 1a/1b trial of cabiralizumab/Opdivo® (nivolumab)and Five Prime continues to treat patients who remain in the study.
- Five Prime completed enrollment in the trial, including patients with pancreatic cancer who were added to the trial after encouraging data were observed in the initial Phase 1b cohort of 31 patients with late-line pancreatic cancer.
Primeand Bristol-Myers Squibb Company(BMS) are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor Opdivo® (nivolumab) in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer.
- BMS initiated randomized Phase 2 clinical trial in patients with locally advanced or metastatic pancreatic cancer.
January 2018,BMS initiated a randomized Phase 2 clinical trial (NCT03336216), evaluating cabiralizumab and Opdivo® (nivolumab) with and without chemotherapy compared to chemotherapy alone in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.
- The advancement of the cabira/ Opdivo® (nivolumab) combination into Phase 2 development triggered a
$25 millionpayment to Five Prime.
- Five Prime and others have previously demonstrated evidence of synergy by combining CSF-1R and PD-1 antibodies with chemotherapy in preclinical models of pancreatic cancer.
- Presented initial Phase 1a/1b data demonstrating early efficacy signal in heavily pre-treated patients with advanced pancreatic cancer with microsatellite stable (MSS) disease.
November 2017,Five Prime and BMS presented initial clinical safety data from all cohorts in the Phase 1a/1b clinical trial of cabiralizumab and Opdivo® (nivolumab), and efficacy data from the Phase 1b pancreatic cancer cohort. In this Phase 1b cohort of heavily pre-treated patients with advanced pancreatic cancer (n=31 evaluable patients), durable clinical benefit was observed in five patients (16%), including confirmed objective responses in four patients with microsatellite stable (MSS) disease (objective response rate of 13%, confirmed by blinded independent review committee), a patient population in which no prior responses to immunotherapy have been demonstrated.
- Preliminary results show that the safety profile of cabiralizumab plus Opdivo® (nivolumab) was generally consistent with that of monotherapy of the two drugs.
- Advanced the ongoing Phase 1/2 trial of cabiralizumab in patients with pigmented villonodular synovitis (PVNS).
- Five Prime reported initial trial data at the ASCO Annual Meeting in
June 2017, showing that cabiralizumab demonstrated clinical benefit in patients with PVNS.
- The company is enrolling up to 30 additional patients in the Phase 2 portion of the trial to refine the dosing schedule to optimize the therapeutic index of cabiralizumab in this chronic disease setting. Data from these additional patients are intended to enable a go/no go decision by the end of 2018 on whether to advance cabiralizumab in PVNS into a pivotal trial.
- Five Prime estimates the combined prevalence of diffuse PVNS is approximately 67,500 patients in the U.S., EU5 and
- Five Prime reported initial trial data at the ASCO Annual Meeting in
Bemarituzumab (FPA144): an isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.
- Initiated Phase 1 portion (NCT03343301) of the FGFR2b Inhibition in Gastric Cancer Treatment (FIGHT) Phase 1/3 clinical trial, a global registrational study.
- The FIGHT trial will evaluate bemarituzumab in combination with the modified FOLFOX6 regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification.
January 2018, Five Prime initiated patient dosing in the Phase 1 portion of the FIGHT trial. This safety lead-in portion of the study is designed to identify a recommended dose of bemarituzumab and to support the Phase 3 portion of the trial.
- The Phase 3 portion of the FIGHT trial is expected to begin in 2018 and will include sites in the U.S.,
Europeand Asia, including China, South Koreaand Japan, where the incidence of gastric cancer is high.
- Five Prime will use immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with gastric cancer who would be eligible for the trial.
- Entered into strategic development collaboration and exclusive license agreement in
Greater Chinafor bemarituzumab with Zai Labin December 2017. Five Prime’s collaboration with Zai Labwill increase the speed of the FIGHT trial and lower Five Prime’s global development costs for the FIGHT trial. Five Prime earned a $5 million upfront payment and is eligible to receive up to $39 million in development and regulatory milestone payments. Five Prime is also eligible to receive from Zai Lab a royalty percentage on net sales of bemarituzumab in Greater China ranging from the high teens to the low twenties.
December 2017, Five Prime filed a clinical trial application (CTA) for bemarituzumab in China. With its collaborators at Zai Lab, Five Prime is aiming to initiate clinical trial sites in Chinafor the FIGHT trial by the end of 2018.
- Enrolling patients in Phase 1 safety trial of bemarituzumab monotherapy in unselected patients with gastric cancer in Japan, where the incidence of gastric cancer is high. Completion of this Phase 1 trial is intended to enable the inclusion of Japanese patients in the Phase 3 portion of the FIGHT trial.
- Advanced the Phase 1 monotherapy cohort testing bemarituzumab in patients with metastatic bladder cancer. The company continues to enroll patients in the Phase 1 clinical trial cohort testing bemarituzumab as a treatment for patients with metastatic bladder cancer whose tumors overexpress FGFR2b.
FPA150 (anti-B7-H4): An antibody designed for two mechanisms of action: to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4-expressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.
- Investigational New Drug (IND) application submitted
- Five Prime anticipates initiating the Phase 1 trial in the first half of 2018.
- Data featured in an oral poster discussion during the ESMO 2017 Congress.
- Data presented suggest that FPA150, which possesses T cell checkpoint and ADCC activity, has the potential to be an effective therapeutic by improving anti-tumor immune responses in patients with cancer.
BMS TIM-3 Antibody: Achieved a
January 2018, BMS filed an IND for the first clinical candidate from the immuno-oncology research collaboration with Five Prime. The candidate is a fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.
December 2017, BMS extended the research term an additional year to March 2019. This is the second extension to the original research term under the agreement that was established in March 2014.
Preclinical Research and Development:
FPT155 (CD80-Fc): A CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment and (ii) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism.
- Preclinical data on FPT155 were featured in a poster presentation at the 2017
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeuticsin October. Work done in preclinical models with FPT155 suggests that it has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity, and it may have a synergistic effect when combined with anti-PD1 therapy.
- Five Prime anticipates filing an IND application or a foreign equivalent in mid-2018.
August 2017, GSK exercised its right to license exclusively a drug target discovered by Five Prime in the respiratory disease collaboration between the companies. This resulted in a $500,000payment to Five Prime.
- This is the second respiratory target that GSK exclusively licensed from Five Prime under the respiratory disease collaboration.
Summary of Financial Results and Guidance:
- Cash Position. Cash, cash equivalents and marketable securities totaled
$292.7 millionon December 31, 2017compared to $421.7 millionon December 31, 2016. The decrease in year-end cash in 2017 was primarily attributable to net cash used in operations to advance the company's clinical and preclinical pipeline. On January 29, 2018, Five Prime completed a public offering resulting in estimated net proceeds of approximately $108 million.
- Revenue. Collaboration and license revenue for the fourth quarter of 2017 increased by
$4.9 million, or 59%, to $13.2 millionfrom $8.3 millionfor the fourth quarter of 2016. Five Prime earned a $5 millionmilestone payment from BMS in the fourth quarter of 2017 for the first IND application by BMS for a therapeutic candidate under the immune checkpoint pathway discovery collaboration. Collaboration and license revenue for the full year 2017 increased by $8.8 million, or 29%, to $39.5 millionfrom $30.7 millionfor the full year 2016. This difference was primarily from increases in revenue from the cabiralizumab collaboration agreement with BMS and the immune checkpoint pathway discovery collaboration with BMS.
- R&D Expenses. Research and development expenses for the fourth quarter of 2017 increased by
$3.6 million, or 12%, to $32.7 millionfrom $29.1 millionin the fourth quarter of 2016. Full year 2017 research and development expenses increased by $56.8 million, or 60%, to $150.9 millionfrom $94.1 millionin 2016. These increases were primarily related to advancing the bemarituzumab program in a Phase 1 clinical trial, advancing the cabiralizumab program in immuno-oncology and PVNS, advancing the FPA150program to an IND application, and advancing our internal immuno-oncology preclinical and research activities.
- G&A Expenses. General and administrative expenses for both the fourth quarters of 2017 and 2016 was
$10.5 million. Full year 2017 general and administrative expenses were $40.0 million, an increase of $4.2 million, or 12%, from $35.8 millionin 2016. This increase was primarily due to greater facilities expenses related to our new corporate office and personnel related expenses, including stock-based compensation.
- Net Income (Loss). Net loss for the fourth quarter of 2017 was
$29.2 million, or $1.04per basic share and diluted share, compared to a net loss of $20.1 million, or $0.73per basic and diluted share, for the fourth quarter of 2016. Full year 2017 net loss was $150.2 million, or $5.38per basic share and diluted share, compared to a net loss of $65.7 million, or $2.44per basic share and diluted share for the full year 2016. These increases in net loss were primarily related to advancing the clinical pipeline and preclinical research and development.
Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than
Conference Call Information
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About Five Prime
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding (i) the timing of IND filings; (ii) the timing of initiation, progress and scope of clinical trials for Five Prime’s product candidates; (iii) the extent of gene amplification and protein overexpression in certain patient populations; (iv) the prevalence and incidence of certain diseases; ; (v) Five Prime’s potential receipt of milestone payments and royalties; (vi) Five Prime’s full-year 2018 net cash used in operating activities; and (vii) 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 forward-looking 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 Therapeutics, Inc.|
|Selected Balance Sheets Data|
|December 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and marketable securities||$||292,690||$||421,748|
|Total current liabilities (excluding deferred revenue)||38,268||24,591|
|Deferred revenue (in total, including short term portion)||22,936||32,006|
|Total stockholders’ equity||265,202||391,575|
|Five Prime Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except per share amounts)|
|For The Three Months Ended
|For The Year Ended
|Collaboration and license revenue||$||13,218||$||8,262||$||39,508||$||30,691|
|Research and development||32,671||29,149||150,908||94,072|
|General and administrative||10,479||10,522||40,002||35,831|
|Total operating expenses||43,150||39,671||190,910||129,903|
|Operating income (loss)||(29,932||)||(31,409||)||(151,402||)||(99,212||)|
|Interest income and other expense||721||646||2,884||2,467|
|Income (loss) before income tax||(29,211||)||(30,763||)||(148,518||)||(96,745||)|
|Income tax benefit (provision)||—||10,657||(1,704||)||31,048|
|Net income (loss)||$||(29,211||)||$||(20,106||)||$||(150,222||)||$||(65,697||)|
|Basic net income (loss) per common share||$||(1.04||)||$||(0.73||)||$||(5.38||)||$||(2.44||)|
|Diluted net income (loss) per common share||$||(1.04||)||$||(0.73||)||$||(5.38||)||$||(2.44||)|
|Shares used to compute basic net income (loss) per common share||28,129||27,436||27,945||26,955|
|Shares used to compute diluted net income (loss) per common share||28,129||27,436||27,945||26,955|
Five Prime Therapeutics, Inc.
Heather Rowe, 415-365-5737
Senior Director, Investor Relations and Corporate Communications