Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced its results for the third quarter and provided an update on the company's recent activities.
"We have advanced all of our wholly-owned programs according to our plan for 2019," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "As we approach 2020, we have repositioned Five Prime with a focus on prioritizing our pipeline based on upcoming data readouts, while also extending our cash runway, in order to maximize the long-term potential of the company."
Third Quarter 2019 Business Highlights and Milestones
Clinical Pipeline:
Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b. Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial.
- The company has enrolled approximately 140 patients with newly diagnosed advanced stage gastric cancer into the FIGHT trial, representing approximately 25% of projected total trial enrollment, and has paused pre-screening of patients for enrollment in the trial.
- The prevalence of FGFR2b overexpression in this patient population is approximately 30% based on global pre-screening data.
- The company expects to conduct a planned futility analysis for the FIGHT trial in mid-2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment.
FPA150 (anti-B7-H4) is a first-in-class B7-H4 antibody designed to target tumor cells by enhancing killing of B7-H4 overexpressing tumors through ADCC and by blocking B7-H4 from sending an inhibitory signal to CD8 T cells. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.
- The Phase 1/2 clinical trial continues to progress, with the expected size of the trial increased to 383 patients in July 2019.
Corporate Highlights
Summary of Financial Results and Guidance:
Cash Position: Cash, cash equivalents and marketable securities totaled $186.0 million as of September 30, 2019, compared to $214.1 million as of June 30, 2019. The decrease in cash, cash equivalents and marketable securities was primarily attributable to quarterly operating expenses that exceeded quarterly revenues.
G&A Expenses: General and administrative expenses for the third quarter of 2019 increased by $3.4 million, or 34.7%, to $13.2 million from $9.8 million for the third quarter of 2018. The increase was primarily due to increased compensation costs offset by a reduction in the use of temporary resources.
Net Loss: Net loss for the third quarter of 2019 was $36.1 million, or $1.03 per basic and diluted share, compared to a net loss of $47.2 million, or $1.37 per basic and diluted share, for the third quarter of 2018.
Shares Outstanding: Weighted average shares outstanding for the third quarter of 2019 was 34,996,298 as of September 30, 2019.
Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 million.
Conference Call Information
About Five Prime Therapeutics
Cautionary Note on Forward-looking Statements
Source: Five Prime Therapeutics, Inc.
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