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SOUTH SAN FRANCISCO, Calif., Aug. 6, 2015 (GLOBE NEWSWIRE) -- Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the second quarter ending June 30, 2015.
"Five Prime is actively building a comprehensive and complementary portfolio of immuno-oncology candidates and programs that target macrophages, immune check points, T cell agonist pathways and regulatory T cells in the tumor microenvironment," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "Regarding our clinical programs, we recently received IND clearance for our Phase 1a/1b clinical trial to evaluate the combination of our CSF1 receptor antibody, FPA008, and Bristol-Myers Squibb's nivolumab, and plan to initiate dosing this month. In July, we began dosing patients in our Phase 1/2 clinical trial of FPA008 in PVNS, a tumor driven by the CSF1 pathway. On the research side, we added a T cell agonist to our early pipeline with the in-licensing of Inhibrx's antibodies to GITR, a pathway we identified in our protein library and proprietary in vivo screens as one of the most potent inhibitors of tumor growth. We also licensed to bluebird bio our novel human antibodies to an undisclosed target to develop CAR T cell therapies for hematologic malignancies and solid tumors."
"Looking ahead, we expect data from two of our clinical programs before year end. GSK intends to present initial data from the Phase 1b clinical trial of FP-1039 in squamous non-small cell lung cancer and mesothelioma patients at the World Conference on Lung Cancer in September, and we plan to report preliminary data from the open label portion of our Phase 1 study of FPA008 in rheumatoid arthritis patients by year end."
Business Highlights and Recent Developments
Summary of Financial Results and Guidance:
Updated 2015 Cash Guidance. Five Prime expects full-year 2015 net cash used in operating activities to be between $65 and $70 million and estimates ending 2015 with between $158 and $163 million in cash, cash equivalents and marketable securities. With the addition of the GITR program to the pipeline in July 2015, Five Prime expects to have cash to fund operations through 2017, without entering into any additional collaboration or license agreements or receiving any future milestone payments. This provides sufficient runway to move Five Prime's three clinical programs beyond efficacy data readouts and to move one or more new immuno-oncology candidates into clinical trials.
Conference Call Information
Five Prime will host a conference call and live audio webcast today at 5 p.m. (ET) / 2 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 97608881. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime's website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime's website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.
About Five Prime
Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
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 at the end of 2015; and (vi) the period during which FivePrime expects to be able to fund operations. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Five Prime's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Five Prime's 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" sections 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|
|June 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and marketable securities||$207.4||$149.1|
|Total current liabilities (excluding deferred revenue)||8.5||7.9|
|Deferred revenue (in total, including short term portion)||59.4||60.6|
|Total stockholders' equity||145.9||85.2|
|Five Prime Therapeutics, Inc.|
|Condensed Statements of Operations Data|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration and license revenue||$6.3||$5.0||$10.6||$8.5|
|Research and development||13.3||11.9||24.5||20.8|
|General and administrative||4.6||3.0||8.8||6.3|
|Total operating expenses||17.9||14.9||33.3||27.1|
|Net loss||$ (11.5)||$ (9.9)||$ (22.5)||$ (18.5)|
|Basic and diluted net loss per common share||$ (0.45)||$ (0.46)||$ (0.89)||$ (0.92)|
CONTACT: Amy Kendall, Corporate Communications 415-365-5776 email@example.comNEXT ARTICLE
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