Forte Biosciences(FBRX) - 2024 Q3 - Quarterly Report

Financial Performance - Forte Biosciences reported a net loss of $8.39 million for the three months ended September 30, 2024, compared to a net loss of$9.96 million for the same period in 2023, reflecting a decrease of $1.56 million [83]. - The net loss for the nine months ended September 30, 2024, was approximately$28.3 million, compared to a net loss of $25.6 million for the same period in 2023, reflecting an increase of 10.6$20.7 million, compared to $19.7 million for the same period in 2023 [95]. - The net change in cash and cash equivalents for the nine months ended September 30, 2024, was a decrease of$20.8 million, compared to an increase of $5.1 million for the same period in 2023 [94]. Expenses - Research and development expenses for the three months ended September 30, 2024, were$5.87 million, down from $6.37 million in the same period of 2023, a reduction of$0.50 million [83]. - General and administrative expenses decreased to $2.76 million for the three months ended September 30, 2024, from$3.85 million in the same period of 2023, a decrease of $1.09 million [83]. - Research and development expenses for the nine months ended September 30, 2024, were$16.0 million, a decrease of 12.0% from $18.3 million in the same period in 2023 [85]. - General and administrative expenses for the nine months ended September 30, 2024, were$13.3 million, an increase of 70.5% from $7.8 million in the same period in 2023 [86]. Cash Position - As of September 30, 2024, Forte had approximately$16.4 million in cash and cash equivalents [73]. - Cash and cash equivalents as of September 30, 2024, were approximately $16.4 million, with an accumulated deficit of approximately$146.8 million [89]. - The gross proceeds from the Private Placement on July 31, 2023, were $25.0 million, with issuance costs of$272 thousand [89]. Clinical Trials and Product Development - The Phase 1 trial of FB102 demonstrated a good safety profile with no dose-limiting toxicities observed, and significant reductions in NK cell pharmacodynamic markers of over 70% [73]. - Forte initiated a patient-based trial for celiac disease in Q3 2024, with top-line results expected in Q2 2025 [73]. - The company anticipates an increase in research and development expenses in the future as it continues to develop its lead product candidate, FB102 [85]. - The company has not generated any revenue from product sales or out-licensing and expects to incur ongoing losses as it develops FB102, currently in a Phase 1b clinical trial [90]. Market Potential - The global vitiligo treatment market was estimated at $1.2 billion in 2018 and is projected to reach$1.9 billion by 2026, indicating significant market potential for FB102 [73]. - The global alopecia treatment market was valued at $2.7 billion in 2018 and is projected to reach$3.9 billion by 2026, with a CAGR of 4.6% from 2019 to 2026 [73]. Stock Information - Forte's common stock is publicly traded on the Nasdaq Capital Market under the ticker symbol FBRX [73]. Future Outlook - Future capital requirements are difficult to forecast and will depend on various factors, including the initiation and progress of clinical trials and regulatory approvals [90].