Forte Biosciences(FBRX) - 2025 Q2 - Quarterly Report

Financial Position - As of June 30, 2025, the company had approximately $106.1 million in cash and cash equivalents[108]. - The company raised $75.0 million from a public offering on June 25, 2025, with underwriting costs of approximately $5.1 million[133]. - As of June 30, 2025, the company had cash and cash equivalents of approximately $106.1 million, expected to fund operations for at least 12 months[136]. - Net cash used in operating activities for the first half of 2025 was $20.4 million, compared to $12.6 million in the same period of 2024[143]. - The net loss for the first half of 2025 was $26.9 million, compared to a net loss of $19.9 million in the same period of 2024, reflecting ongoing operational challenges[131]. - The company has not generated any revenue from product sales and has incurred operating losses since inception[131]. Clinical Trials and Research - The Phase 1b trial for celiac disease enrolled 32 subjects, showing a statistically significant benefit on the composite histological VCIEL endpoint with a p-value of 0.0099[100]. - FB102 demonstrated a 42% reduction in gluten challenge induced GI symptoms compared to placebo, with 4.0 events per subject in the FB102 group versus 6.9 in the placebo group[102]. - The company initiated a Phase 2 celiac study in July 2025, with topline readout expected in 2026[103]. - FB102 showed significant reductions in NK cell pharmacodynamic markers, with reductions greater than approximately 70% observed in Phase 1 trials[98]. - Research and development expenses for Q2 2025 were $8.6 million, up from $5.7 million in Q2 2024, primarily due to a $3.8 million increase in clinical expenses for Phase 1b trials[123]. - For the first half of 2025, research and development expenses totaled $21.3 million, compared to $10.1 million in the same period of 2024, driven by an $11.7 million increase in manufacturing and clinical expenses[125]. Market Outlook - The global vitiligo treatment market is projected to reach approximately $2.3-2.7 billion by 2032-2034, while the alopecia treatment market could reach $6 billion in the same timeframe[106]. Regulatory and Strategic Considerations - The company has a pending PCT application and multiple pending US applications related to the FB102 program, with estimated expiration dates from 2043 to 2046[112]. - Future capital requirements will depend on various factors, including the progress of clinical trials and potential strategic alliances[137]. - The company is actively monitoring the impacts of global events, including economic uncertainty and geopolitical tensions, on its business operations[114]. Administrative Expenses - General and administrative expenses decreased to $3.0 million in Q2 2025 from $7.1 million in Q2 2024, mainly due to a $4.8 million reduction in professional and legal expenses[127]. - Other income for Q2 2025 increased to $330,000 from $307,000 in Q2 2024, primarily due to higher interest income[122].