"The second quarter was marked by considerable progress in all of our programs and we continue to advance toward achieving this year's milestones," said
Business Highlights and Recent Developments
•Enrollment Continued in the Phase 1b Clinical Trial of FP-1039/GSK3052230, an FGF Ligand Trap, and Expands into Mesothelioma. GlaxoSmithKline (GSK) continues to actively enroll patients in all three arms of the clinical trial and recently elected to include additional sites globally. Five Prime anticipates preliminary results from the dose escalation portion in patients with FGFR1 gene-amplified squamous non-small cell lung cancer by the end of 2014. Arm C, in which FP-1039 is being combined with front-line chemotherapy for malignant pleural mesothelioma, is open and patients have been enrolled.
•Completed Dosing in the Healthy Volunteer Parts of the Phase 1 Clinical Trial of FPA008, an Anti-CSF1 Receptor Antibody. During the second quarter, Five Prime completed testing of multiple ascending doses of FPA008 in healthy volunteers and expects to report pharmacokinetic, safety and biomarker data in the fourth quarter. By year end, the company plans to begin dosing patients with rheumatoid arthritis and to announce a second indication for FPA008.
•Completed Additional IND-enabling Activities for FPA144, an Anti-FGF Receptor 2b Antibody. Five Prime has made substantial progress in its plan to initiate a global Phase 1 clinical trial of FPA144 in gastric cancer patients by the end of 2014, having now completed GMP manufacturing of the drug substance and substantially all of the 13-week GLP toxicology studies. The company also selected a central lab partner for the molecular diagnostic tests that will be used in the Phase 1 clinical trial. The planned trial will initially enroll unselected patients with solid tumors and will subsequently enroll selected gastric cancer patients with FGFR2b protein overexpression or FGFR2 gene amplification in their tumors.
•Initiating a Therapeutic Antibody Campaign with Adimab for a Cancer Immunotherapy Target. Subsequent to the end of the second quarter, Five Prime selected an undisclosed cancer immunotherapy target for an antibody generation campaign now getting underway with Adimab. Adimab will use its proprietary discovery and optimization platform to identify fully-human antibodies directed to this target.
Cancer Immunotherapy Research:
•Cash Position. Cash, cash equivalents and marketable securities totaled
Summary of Financial Results and Guidance
•Revenue. Collaboration revenue for the second quarter of 2014 increased by
•R&D Expenses. Research and development expenses for the second quarter of 2014 increased by
•G&A Expenses. General and administrative expenses for the second quarter of 2014 increased by
•Net Loss. Net loss for the second quarter of 2014 was
Cash Guidance. Five Prime continues to expect full-year 2014 net cash used in operating activities to be less than
Conference Call Information
Five Prime will host a conference call and live audio webcast today at
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
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 initiation, progress and scope of clinical trials for Five Prime's product candidates; (ii) the reporting of clinical data regarding Five Prime's product candidates; (iii) Five Prime's full-year 2014 net cash used in operating activities; (iv) the amount of Five Prime's cash, cash equivalents and marketable securities at the end of 2014; and (v) 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
|Selected Balance Sheet Data|
|Cash, cash equivalents and marketable securities|
|Current liabilities, excluding short term portion of deferred revenue||8,510||5,910|
|Total deferred revenue||34,608||15,036|
|Total stockholders' equity||100,906||58,026|
|Statements of Operation Data|
|(In Thousands Except Per Share Amounts)|
Three Months Ended ||
Six Months Ended |
|Research and development||11,873||8,585||20,799||16,515|
|General and administrative||3,024||2,386||6,304||4,778|
|Total operating expenses||14,897||10,971||27,103||21,293|
|Loss from operations||(9,916)||(7,422)||(18,576)||(14,769)|
|Interest and other income, net||50||148||66||448|
|Basic and diluted net loss per common share||$(0.46)|
|Shares used to compute basic and diluted net loss per common share||21,465||1,250||20,160||1,240|
Amy Kendall, Corporate Communications 415-365-5776 email@example.com