On November 9, 2020 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, reported third quarter 2020 financial results and provided a general business update (Press release, Tocagen, NOV 9, 2020, View Source [SID1234570456]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This was an eventful quarter for Forte with significant progress in advancing FB-401 for the treatment of atopic dermatitis." said Paul Wagner, Ph.D., CEO of Forte Biosciences "The initiation of our randomized trial in atopic dermatitis patients, including adults and children 2 years of age and older, was a pivotal event and the achievement of this important milestone was the result of a fantastic effort by the Forte team. There is a significant need for safe and effective atopic dermatitis therapies, particularly for children, and we were pleased by the FDA’s recognition of this unmet need with the granting of Fast Track designation to FB-401 for the treatment of atopic dermatitis."
Third Quarter 2020 Results
Business Highlights
In September 2020, Forte initiated a multi-center, placebo controlled clinical trial of our lead product candidate, FB-401 which is expected to enroll pediatric, adolescent and adult atopic dermatitis ("AD") subjects aged 2 years of age and older. For additional information about the trial, see ClinicalTrials.gov using the identifier NCT04504279.
In October 2020, the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis.
Forte Biosciences ended the quarter with approximately $20.2 million in cash which the company believes is sufficient to fund operations for at least the next 12 months. Approximately $2.4 million of the cash utilization in the quarter was due to merger related costs. Forte had 11.2 million shares of common stock outstanding as of September 30, 2020. Following the close of the quarter, Forte raised $46.0 million in gross proceeds from a public offering on November 2nd.
Operating Results
Research and development expenses were $3.7 million and $7.0 million for the three and nine months ended September 30, 2020, respectively, compared to $0.4 million and $1.5 million for the comparable periods in 2019. The increases in 2020 were primarily due to manufacturing costs and clinical development costs as we continue to advance FB-401.
General and administrative expenses were $1.3 million and $2.8 million for the three and nine months ended September 30, 2020, respectively, compared to $0.3 million and $1.0 million for the comparable periods in 2019. The increases in 2020 were primarily due to professional fees for legal, auditing, tax and business consulting services, and personnel expenses as we transitioned to being a public company.
In 2Q 2020, we recognized a charge of $32.1 million for acquired in-process research and development related to the reverse merger with Tocagen which closed on June 15th.
Conference Call and Webcast Information
The Forte management will host a conference call and webcast today at 4:30 PM Eastern Time. Participants may access the call by dialing 877-705-6003 (Domestic) or 201-493-6725 (International), the conference ID number is: 13712591. The call will also be webcast and can be accessed from the investor relations section of Forte’s website at View Source or View Source A replay of the call will also be available through November 16th.