On August 15, 2022 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases, reported second quarter 2022 results and provided a business update (Press release, Tocagen, AUG 15, 2022, View Source [SID1234618355]).

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!

"Forte is excited to continue down our new path as we develop novel compounds for the treatment of autoimmune diseases, including potentially graft versus host disease (GvHD), vitiligo and alopecia areata which represent combined markets of over $6 billion." said Paul Wagner, Ph.D., President and Chief Executive Officer of Forte Biosciences. "We expect FB-102, our lead molecule, to be in the clinic late 2023 or early 2024. We believe that our innovative approach to treating autoimmune disease has the potential to drive significant value for Forte shareholders. Beyond FB-102 we will continue to strategically evaluate opportunities to create value for shareholders."

Second Quarter 2022 Business Highlights

In May 2022, Forte appointed Steve Doberstein, Ph.D. to its board of directors, which further strengthened Forte’s board of directors. Dr. Doberstein previously served at the Chief Research and Development Officer at Nektar Therapeutics and has led research efforts at Xencor, FivePrime, Exelixis and Xoma.

In June 2022, Forte announced that Dr. Hubert Chen, M.D., joined the company as Chief Scientific Officer and President. Dr. Chen previously served as Chief Medical Officer at Metacrine, a clinical-stage company focused on the treatment of liver and gastrointestinal diseases. Prior, he was the Chief Scientific and Medical Officer of Pfenex, vice president of clinical development at Aileron Therapeutics, vice president of translational medicine at Regulus Therapeutics, and senior director of clinical research at Amylin Pharmaceuticals.

"Forte is tremendously fortunate that Steve and Hubert have agreed to join Forte. They are both thought leaders in the industry and will add significant experience and perspective to our pre-clinical and clinical development efforts." said Dr. Wagner.

Forte ended the second quarter of 2022 with approximately $38.5 million in cash and cash equivalents. Forte had approximately 14.8 million shares of common stock outstanding as of June 30, 2022. Subsequent to the June quarter-end, Forte issued an additional 5.6 million shares of common stock between July 1 and August 10, 2022 for gross proceeds of approximately $7.0 million under its At-the-Market (ATM) financing facility further strengthening its balance sheet.

Second Quarter 2022 Operating Results

Research and development expenses were $1.0 million and $3.5 million for the three months ended June 30, 2022 and 2021, respectively. Research and development expenses were $1.7 million and $6.8 million for the six months ended June 30, 2022 and 2021, respectively. The decreases in 2022 were primarily due to the wind down of our FB-401 program as the Company began the shift in development activities to autoimmune indications with FB-102.

General and administrative expenses were $2.0 million and $2.2 million for the three months ended June 30, 2022 and 2021, respectively. The decrease in 2022 was primarily due to a decrease in legal and professional expenses partially offset by an increase in stock-based compensation and other expenses. General and administrative expenses were $3.8 million and $3.6 million for the six months ended June 30, 2022 and 2021, respectively. The increase in 2022 was primarily due to an increase in stock-based compensation expense partially offset by a decrease in legal and professional expenses.

Net loss per share were ($0.21) and ($0.43) for the three months ended June 30, 2022 and 2021, and ($0.38) and ($0.79) for the six months ended June 30, 2022 and 2021, respectively.