November 27, 2014 7:36 PM ET

Biotechnology

Company Overview of Five Prime Therapeutics, Inc.

Company Overview

Five Prime Therapeutics, Inc., a clinical-stage biotechnology company, focuses on the discovery and development of protein therapeutics that block cancer and inflammatory disease processes. The company’s product candidates include FP-1039/GSK3052230, a protein therapeutic, which is in Phase 1b clinical trials for trapping and neutralizing cancer-promoting fibroblast growth factors (FGFs) involved in cancer cell proliferation and new blood vessel formation; FPA008, a Phase 1 clinical trial stage antibody that inhibits colony stimulating factor-1 receptor; and FPA144 is an antibody for inhibiting FGF receptor 2b, as well as to treat patients with gastric cancer and potentially other solid tumo...

Two Corporate Drive

South San Francisco, CA 94080

United States

Founded in 2001

105 Employees

Phone:

415-365-5600

Fax:

415-365-5601

Key Executives for Five Prime Therapeutics, Inc.

Founder
Age: 65
Total Annual Compensation: $525.0K
Chief Business Officer
Age: 45
Total Annual Compensation: $362.8K
Chief Medical Officer and Senior Vice President
Age: 56
Total Annual Compensation: $350.0K
Senior Vice President
Age: 43
Total Annual Compensation: $311.9K
Compensation as of Fiscal Year 2013.

Five Prime Therapeutics, Inc. Key Developments

Bristol-Myers Squibb Company, Five Prime Therapeutics to Evaluate Investigational Immunotherapies in Six Tumor Types

Bristol-Myers Squibb Company and Five Prime Therapeutics said they have agreed to evaluate Bristol's Opdivo in combination with Five Prime's FPA008 in five different tumor types. Under the terms of the agreement, Bristol-Myers Squibb will make a one-time payment of $30 million to Five Prime Therapeutics, and will be responsible for study costs. Five Prime will conduct the clinical trial, which is expected to begin in 2015. The clinical collaboration with evaluate the safety tolerability and preliminary efficacy of combining Opdivo (nivolumab), an investigational PD-1 (programmed death-1) immune checkpoint inhibitor, with FPA008, a monoclonal antibody that inhibits colony stimulating factor-1 receptor. The combination will be evaluated in patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.

Five Prime Therapeutics to Present Data From Healthy Volunteer Cohorts in Phase 1 Trial of FPA008 at the 2014 ACR/ARHP Annual Scientific Meeting

Five Prime Therapeutics, Inc. announced that it will present results from the healthy volunteer cohorts in its Phase 1 clinical trial of FPA008, a monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF-1R). The results will be featured in a poster presentation titled "A Phase 1 Study of FPA008, an Anti-Colony Stimulating Factor 1 Receptor (anti-CSF-1R) Antibody in Healthy Volunteers and Subjects with Rheumatoid Arthritis (RA): Preliminary Results" at the 2014 American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP) Annual Scientific Meeting. The Phase 1 clinical trial of FPA008 is a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study of FPA008 being conducting in three parts. In Part 1, eight healthy volunteers per dose cohort were randomized (3:1) to receive a single intravenous infusion of FPA008 (at dose levels of 0.2, 1, 3, or 10 mg/kg) or placebo. In Part 2, an additional eight healthy volunteers per dose cohort were randomized (3:1) to receive two doses of FPA008 or placebo administered 14 days apart, at 1 or 3 mg/kg. Dose escalation decisions were based on the incidence of dose limiting toxicities (DLTs) plus attributed adverse events (AEs) beyond the DLT period. Pharmacokinetic (PK), CD16+ monocytes, bone turnover markers, and serum concentrations of the CSF-1R ligands CSF1 and IL34 were assessed. Part 3 consists of an open-label evaluation of 3 dose levels in RA patients whose disease is not responding to methotrexate therapy. The primary endpoint of the trial is safety, with secondary endpoints including PK, pharmacodynamics (PD) and disease activity as measured by ACR scores and joint MRI. Preliminary results from the healthy volunteer portion of the trial found that FPA008 is well tolerated in doses up to 3 mg/kg. Additionally, at all dose levels tested, Five Prime observed PD effects of suppression of non-classical CD16+ monocytes and a decrease of bone turnover biomarkers (CTx, Trap5), all of which may indicate the potential for clinical benefit in RA patients. The most common FPA008 treatment-related toxicities were pruritus, eyelid edema along with facial swelling, fatigue, and headache. These events were mild (Grade 1 or 2) and self-limited. Some dose-dependent elevations of CK, LDH, AST were observed but were not associated with clinical signs/symptoms, were reversible, and were expected due to FPA008-mediated inhibition of Kupffer cells responsible for removing these enzymes. Five Prime expects to begin enrolling RA patients in Part 3 of the study by year end. The Company also recently announced that it is expanding development of FPA008 into solid tumors and anticipates initiating a clinical trial in 2015.

Five Prime Therapeutics, Inc. Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Provides Net Cash Used in Operating Activities Guidance for 2014

Five Prime Therapeutics, Inc. reported earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported collaboration revenue increased by $2.6 million, or 74.0%, to $6.1 million from $3.5 million in the third quarter of 2013. This increase of $2.6 million was primarily due to GSK's payment of a $1.5 million option exercise fee to license an undisclosed muscle disease target and revenue from new collaborations that it established in the last two years. Loss from operations was $7.1 million against $7.3 million last year. Net loss for the third quarter of 2014 was $7.1 million, or $0.33 per basic and diluted share, compared to net loss of $7.2 million, or $2.74 per basic and diluted share, for the third quarter of 2013. For the nine months, the company reported collaboration revenue of $14.6 million against $10.0 million last year. Loss from operations was $25.7 million against $22.1 million last year. Net loss was $25.6 million, or $1.24 per basic and diluted share, compared to net loss of $21.6 million, or $12.60 per basic and diluted share last year. The company expects full year of 2014 net cash used in operating activities to be less than $30 million.

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