Five Prime Therapeutics Reports Third Quarter 2015 Results and Provides Business Update
Established license and collaboration agreement with Bristol-Myers Squibb for FPA008:
$1.74 billionin upfront and milestone payments, double-digit royalties, and ability to continue development in PVNS and with Five Prime oncology candidates
- Expanded Immuno-Oncology Pipeline with New GITR Agonist Antibody Program
"Our accomplishments since the second quarter have been transformational for Five Prime in many ways— highlighting our ability to discover and develop candidates and combinations to drive future immuno-oncology therapies, expanding our clinical programs and immuno-oncology pipeline, and strengthening our financial base going forward to augment and accelerate all of these activities," said
Business Highlights and Recent Developments
FPA008: FPA008 is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R) and has been shown to block the activation and survival of monocytes and macrophages in vivo. In particular, inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment.
Established Exclusive Worldwide License and Collaboration Agreement with Bristol-Myers Squibb (BMS) for FPA008. In October, Five Prime and BMS entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of FPA008. In addition to the
$350 millionupfront payment, Five Prime will be eligible to receive development and regulatory milestone payments for each anti-CSF1R antibody product as follows: up to $1.05 billionfor combinations with OPDIVO® (nivolumab) and other BMS or Five Prime oncology products and up to $340 millionfor therapeutic uses in pigmented villonodular synovitis (PVNS) and non-oncology indications. BMS will be responsible for manufacturing and global commercialization. FivePrime will be eligible to receive tiered royalty percentages ranging from the high teens to the low twenties on future worldwide net sales of FPA008 and other anti-CSF1R antibody products developed by BMS, and retains a U.S. co-promotion option for an additional low single-digit royalty. Importantly, Five Prime will lead and execute the three trials that are currently underway and has the ability to continue development of FPA008 in PVNS, in combination with its own oncology pipeline, and in non-oncology indications. The agreement is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act (HSR) and will become effective once clearance is received.
Initiated Phase 1a/1b FPA008/OPDIVO Combination Trial. In
September 2015, Five Prime initiated patient dosing in the Phase 1a/1b clinical trial evaluating the immunotherapy combination of FPA008 with OPDIVO, Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor, in eight tumor settings. The trial is exploring the safety, tolerability and preliminary efficacy of the combination in patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma and now includes two arms of anti-PD-1 resistant patients. The trial also was featured in a trial-in-progress poster at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference in September. Five Prime will continue to conduct the trial under the license agreement with BMS and expects to complete Phase 1a dose escalation and expand into Phase 1b with the selected dose of FPA008 in early 2016.
- Initiated Phase 1/2 Clinical Trial of FPA008 in Pigmented Villonodular Synovitis (PVNS). In July, Five Prime initiated patient dosing in its Phase 1/2 clinical trial of FPA008 in PVNS, a CSF1R-driven tumor and an orphan indication. During the Phase 1 dose escalation portion of the trial, Five Prime is assessing safety and pharmacodynamics of selected doses of FPA008 to determine the dose for expansion. During the Phase 2 expansion, the company will evaluate tumor response rate and duration, as well as measures of pain and joint function, in approximately 30 patients. Five Prime is entitled to continue independent development in PVNS under the BMS license agreement and expects to complete dose escalation and move into dose expansion in early 2016.
Continued Dosing Rheumatoid Arthritis (RA) Patients in Open-Label Portion of Phase 1 Clinical Trial of FPA008. During the quarter, Five Prime continued to dose FPA008 in RA patients with active disease who are on methotrexate in its Phase 1 clinical trial. The company is scheduled to present preliminary open-label data from RA patients on
November 10, 2015, at the American College of RheumatologyAnnual Meeting. Five Prime plans to complete the open-label portion of the trial but does not intend to proceed with a randomized cohort or to conduct additional RA trials at this time in order to focus development of FPA008 in immuno-oncology and PVNS.
- Established Exclusive Worldwide License and Collaboration Agreement with Bristol-Myers Squibb (BMS) for FPA008. In October, Five Prime and BMS entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of FPA008. In addition to the
- Continued Enrollment in the Phase 1 Clinical Trial of FPA144. Five Prime continued to enroll the Phase 1a/1b clinical trial of FPA144, a selective ADCC-enhanced antibody in development as a targeted therapy for tumors that over-express FGFR2b. By the end of 2015, the company expects to complete Phase 1a dose escalation in patients with solid tumors, including gastric cancer, and to begin the Phase 1b expansion at a selected dose in gastric cancer patients whose tumors over-express FGFR2b.
Initial Data from Phase 1b Clinical Trial of FP-1039/GSK3052230 Presented at
World Conference on Lung Cancer. Initial safety and efficacy data from GlaxoSmithKline's ongoing Phase 1b clinical trial of FP-1039/GSK3052230, an FGF ligand trap, were featured in an oral presentation during the World Conference on Lung Cancerin September 2015. The three-arm study is still underway in patients with newly-diagnosed or recurrent FGFR1 gene-amplified squamous non-small cell lung cancer and malignant pleural mesothelioma.
Research Programs and Collaborations:
Established New GITR Antibody Program. Five Prime established a research collaboration and license agreement for Inhibrx's novel multivalent glucocorticoid-induced tumor necrosis factor receptor (GITR) antibodies. The program is currently at lead selection stage and the company is targeting an IND for 2017. Using its comprehensive protein library and proprietary in vivo screening technologies, Five Prime identified the GITR pathway as one of the most potent inhibitors of tumor growth and these agonist antibodies have the potential to be additive or synergistic with other immuno-oncology therapies and candidates in Five Prime's portfolio. Five Prime paid an upfront fee of
$10 millionto Inhibrx in July 2015.
GlaxoSmithKline (GSK) and UCB Pharma (UCB) Reserved Targets Discovered by Five Prime. In September, GSK exercised its option to reserve specific targets discovered by Five Prime under the respiratory diseases research collaboration between the companies, triggering a
$300,000payment. In September, UCB exercised its option to reserve certain targets discovered by Five Prime under its discovery collaboration with Five Prime in the area of fibrosis-related inflammatory diseases, triggering $140,000in payments.
- Expanded Antibody Capabilities with License to Human Antibody Generation Platforms. The company continues to expand its antibody capabilities and internal expertise to capitalize on immuno-oncology targets identified using Five Prime's discovery platform and to move candidates rapidly toward INDs. During October, Five Prime secured a license from Open Monoclonal Technology (OMT) to access mono- and bi-specific antibody platforms and antibody repertoire sequencing technology for the generation of novel therapeutic candidates. These platforms are designed to deliver human antibodies with high affinity, specificity, expression, solubility and stability and current OMT partners include leading pharmaceutical and biotech companies.
Summary of Financial Results and Guidance:
Cash Position. Cash, cash equivalents and marketable securities totaled
$183.4 millionon September 30, 2015compared with $149.1 millionon December 31, 2014. The increase was primarily attributable to Five Prime's January 2015public offering of common stock, offset by cash used in operations. This does not include the $350 millionupfront payment from BMS the company expects to receive under the FPA008 license and collaboration agreement.
Revenue. Collaboration and license revenue for the third quarter of 2015 decreased by
$0.2 millionto $5.9 millionfrom $6.1 millionin the third quarter of 2014.
R&D Expenses. Research and development expenses for the third quarter of 2015 increased by
$14.9 million, or 152%, to $24.7 millionfrom $9.8 millionin the third quarter of 2014. This increase was primarily related to in-licensing GITR antibodies, advancing the FPA008 development program into additional indications and expanding the company's internal immuno-oncology research and preclinical activities.
G&A Expenses. General and administrative expenses for the third quarter of 2015 increased by
$1.8 million, or 53%, to $5.2 millionfrom $3.4 millionin the third quarter of 2014. This increase was primarily due to increases in personnel related expenses, including stock-based compensation, and facility costs.
Net Loss. Net loss for the third quarter of 2015 was
$24.0 million, or $0.93per basic and diluted share, compared with a net loss of $7.1 million, or $0.33per basic and diluted share, for the third quarter of 2014. This increase in net loss was primarily related to in-licensing GITR antibodies, advancing the FPA008 development program into additional indications and expanding internal immuno-oncology research and preclinical activities.
Updated 2015 Guidance. Five Prime expects to have in excess of
Conference Call Information
Five Prime will host a conference call and live audio webcast today at
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 about (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
reporting of clinical data regarding Five Prime's product candidates; (iv) Five Prime's full-year 2015 net cash used in operating activities; (v) the amount of Five Prime's cash, cash equivalents and marketable securities; (vi) the effectiveness of the license and collaboration agreement with BMS; and (v) the
|Selected Balance Sheets Data|
|Balance Sheet Data:|
|Cash, cash equivalents and marketable securities||
|Total current liabilities (excluding deferred revenue)||10.6||7.9|
|Deferred revenue (in total, including short term portion)||57.3||60.6|
|Total stockholders' equity||125.6||85.2|
|Condensed Statements of Operations Data|
|Three Months Ended||Six Months Ended|
|Collaboration and license revenue||
|Research and development||24.7||9.8||49.3||30.6|
|General and administrative||5.2||3.4||14.0||9.7|
|Total operating expenses||29.9||13.2||63.3||40.3|
|Net loss||$ (24.0)||$ (7.1)||$ (46.5)||$ (25.6)|
|Basic and diluted net loss per common share||$ (0.93)||$ (0.33)||
Amy Kendall, Corporate Communications 415-365-5776 firstname.lastname@example.org
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