Forte Biosciences(US:FBRX)2025-11-14 14:05Financial Position - As of September 30, 2025, the company had approximately $93.4 million in cash and cash equivalents[111]. - Cash and cash equivalents were approximately $93.4 million as of September 30, 2025, expected to fund operations for at least 12 months[139]. - The net loss for the nine months ended September 30, 2025, was $44.6 million, with an accumulated deficit of $198.6 million as of the same date[133]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $34.4 million, compared to $20.7 million for the same period in 2024[145]. - Future capital requirements are uncertain and will depend on various factors, including the progress of clinical trials and potential strategic alliances[140]. Public Offering - The company completed a public offering on June 25, 2025, selling 5,630,450 shares at $12.00 per share, raising gross proceeds of $75.0 million[112]. - The gross proceeds from the public offering on June 25, 2025, were $75.0 million, with underwriting costs of approximately $5.1 million[135]. Research and Development - Research and development expenses for Q3 2025 were $15.2 million, up from $5.9 million in Q3 2024, primarily due to a $9.7 million increase in clinical and manufacturing expenses related to ongoing clinical trials[125]. - For the nine months ended September 30, 2025, research and development expenses totaled $36.5 million, compared to $16.0 million for the same period in 2024, reflecting a $21.6 million increase in manufacturing and clinical expenses[127]. Clinical Trials - The Phase 1 trial of FB102 demonstrated a good safety profile with no dose limiting toxicities and significant reductions in NK cell pharmacodynamic markers (greater than approximately 70%)[101]. - In the Phase 1b celiac disease study, FB102 showed a statistically significant benefit on the composite histological VCIEL endpoint with a mean change of -1.849 for placebo compared to 0.079 for FB102 (p=0.0099)[103]. - The gluten challenge induced GI symptoms showed a 42% benefit for FB102 treated subjects (4.0 events per subject) compared to placebo (6.9 events per subject)[105]. - The company initiated a Phase 2 celiac study in July 2025, with topline readout expected in 2026[106]. Market Potential - The global vitiligo treatment market is projected to reach approximately $2.3-2.7 billion by 2032-2034[109]. - The global alopecia treatment market is valued at around $3-3.5 billion in 2024, with potential to reach $6 billion by 2032-2034[109]. Intellectual Property - The company has one US patent and multiple pending applications related to the FB102 program, with estimated expiration dates from 2043 to 2046[115]. Revenue and Sales - The company has no products approved for commercial sale and has not generated any revenue from product sales[118]. - The company has no products approved for commercial sale and has not generated any revenue from product sales or other sources[133]. Administrative Expenses - General and administrative expenses for Q3 2025 were $3.2 million, an increase from $2.8 million in Q3 2024, mainly due to a $0.6 million rise in personnel-related expenses[129]. - General and administrative expenses for the nine months ended September 30, 2025, decreased to $9.6 million from $13.3 million in 2024, primarily due to a $6.0 million reduction in professional and legal expenses[130]. Regulatory Classification - The company is classified as a smaller reporting company under Rule 12b-2 of the Securities Exchange Act of 1934, thus not required to provide detailed market risk disclosures[153].