Financial Performance - The net loss for Q1 2025 was $15.7 million, compared to a net loss of $7.4 million in Q1 2024, representing an increase in loss of $8.2 million[112]. - The net loss for Q1 2025 was $15.7 million, with an accumulated deficit of $169.7 million as of March 31, 2025[118]. - Total operating expenses for Q1 2025 were $16.1 million, compared to $7.8 million in Q1 2024, reflecting an increase of $8.3 million[112]. - General and administrative expenses decreased to $3.4 million for Q1 2025 from $3.5 million in Q1 2024, primarily due to a $1.0 million reduction in legal and professional expenses[115]. - Net cash used in operating activities for Q1 2025 was $10.4 million, compared to $6.7 million in Q1 2024[127]. - The company has not generated any revenue from product sales or out-licensing and has never been profitable[118]. Cash Position - The company had approximately $45.9 million in cash and cash equivalents as of March 31, 2025[99]. - Cash and cash equivalents were approximately $45.9 million as of March 31, 2025, expected to fund operations for at least 12 months[122]. - The gross proceeds from the 2024 Private Placement were $53.0 million, with issuance costs of $3.4 million[120]. Research and Development - Research and development expenses increased to $12.7 million for Q1 2025, up from $4.4 million in Q1 2024, primarily due to an $8.9 million rise in manufacturing expenses for clinical trials[113]. - FB102, the current lead product candidate, is in Phase 1 clinical development, targeting autoimmune-related indications[123]. - A Phase 1 trial of FB102 demonstrated a good safety profile, with significant reductions in NK cell pharmacodynamic markers of over 70%[94]. - The company initiated a patient-based trial for celiac disease in Q3 2024, with top-line results expected in Q2 2025[94]. - The company expects to incur ongoing losses as it develops FB102, with future capital requirements difficult to forecast[123]. Market Potential - The global vitiligo treatment market is projected to reach $1.9 billion by 2026, indicating significant market potential for FB102[96]. - 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%[97]. Securities and Financing - Forte filed a new shelf registration statement for the issuance of up to $300 million in securities, effective April 2025[100]. - The company filed a shelf registration statement to register the issuance of up to $300 million in securities in March 2025[119]. - Net cash provided by investing activities for Q1 2025 was primarily due to proceeds from the redemption of U.S. treasury bills[130].
Forte Biosciences(FBRX) - 2025 Q1 - Quarterly Report