On May 10, 2021 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company reported first quarter 2021 results and provides a general business update on May 10, 2021 (Press release, Tocagen, MAY 10, 2021, View Source [SID1234579578]).

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"Forte has continued to make excellent progress in the fist quarter of 2021. As we have previously highlighted, our randomized clinical trial of FB-401 in atopic dermatitis patients 2 years of age and older, including adolescents and adults, completed enrollment. We expect to report the topline results from that trial in the third quarter of 2021. There is a significant unmet need for safe effective therapies, particularly for children suffering from atopic dermatitis and we are hopeful that FB-401 will address that need," said Paul Wagner, Ph.D., CEO of Forte Biosciences. "In addition to the operational progress, two more patents have now issued, bringing the total number of patents covering FB-401 and our process to eleven as we continue to expand the intellectual property protection."

First Quarter 2021 Results

First Quarter 2021 Business Highlights

In September 2020, Forte initiated a multi-center, placebo-controlled clinical trial of its lead product candidate, FB-401 which was expected to enroll approximately 124 pediatric, adolescent and adult atopic dermatitis subjects aged 2 years of age and older. Enrollment was completed in March 2021 with 154 subjects. Additional information about our Phase 2 trial can be found at ClinicalTrials.gov using the identifier NCT04504279.

Forte ended the first quarter of 2021 with approximately $54.8 million in cash and cash equivalents which Forte believes is sufficient to fund operations for at least the next 12 months. Cash utilization for the first quarter of 2021 was $4.0 million. Forte had approximately 13.5 million shares of common stock outstanding as of March 31, 2021.

First Quarter 2021 Operating Results

Research and development expenses were $3.3 million and $1.4 million for the three months ended March 31, 2021 and 2020, respectively. The increases in 2021 were primarily due to manufacturing, clinical, regulatory and other expenses, including non-cash stock-based compensation, as Forte continues to advance FB-401 through Phase 2 clinical trials.

General and administrative expenses were $1.4 million and $0.7 million for the three months ended March 31, 2021 and 2020, respectively. The increases in 2021 were primarily due to legal, professional, insurance and other expenses as a result of being a public company as well as increases in payroll and related expenses including non-cash stock-based compensation expense as we increased our headcount.

Losses per share were $0.36 and $0.97 for the three months ended March 31, 2021 and 2020, respectively.

Additional detail on our financial results for the first quarter of 2021 can be found in Forte’s Form 10-Q as filed with the SEC on May 10, 2021. You can also find more information in the investor relations section of our website at www.fortebiorx.com.

Conference Call and Webcast Information

Forte management will host a conference call and webcast on Wednesday, May 10th 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: 13719507.