Financial Position - Forte Biosciences has approximately $24.5 million in cash and cash equivalents as of June 30, 2024[87]. - The accumulated deficit as of June 30, 2024, was approximately $138.5 million, indicating ongoing financial challenges[104]. - As of June 30, 2024, the company had cash and cash equivalents of approximately $24.5 million, which is expected to fund operations for at least 12 months[104]. - Net cash used in operating activities for the six months ended June 30, 2024, was $12.6 million, compared to $10.7 million for the same period in 2023, reflecting an increase of about 17.7%[111]. - The company has not generated any revenue from product sales or out-licensing, indicating a reliance on external funding for operations[107]. Revenue and Expenses - Forte has no products approved for commercial sale and has not generated any revenue from product sales[92]. - Research and development expenses for the three months ended June 30, 2024, were $5.7 million, a decrease of approximately 19.6% from $7.1 million in the same period in 2023[99]. - General and administrative expenses for the three months ended June 30, 2024, increased to $7.1 million from $1.9 million, reflecting a significant rise of approximately 273.7%[102]. - The net loss for the six months ended June 30, 2024, was approximately $19.9 million, compared to a net loss of $15.6 million for the same period in 2023, representing an increase of about 27.5%[101]. - Other income for the three months ended June 30, 2024, was $307,000, up from $138,000 in the same period in 2023, marking a growth of approximately 122.5%[99]. Research and Development - Forte plans to initiate a patient study in celiac disease in Q3 2024, with top-line results expected by Q2 2025[83]. - Research and development expenses are expected to increase as Forte continues to develop FB102[94]. - The company anticipates an increase in research and development expenses in the future as it continues to develop its lead product candidate, FB102[101]. Market Overview - The estimated prevalence of celiac disease in the U.S. is 1 in 133, equating to approximately 2.5 million people[84]. - The global vitiligo treatment market was valued at $1.2 billion in 2018 and is projected to reach $1.9 billion by 2026[85]. - The global alopecia treatment market was valued at $2.7 billion in 2018, projected to reach $3.9 billion by 2026, with a CAGR of 4.6%[87]. Intellectual Property - Forte owns one U.S. patent related to skin conditions, with an estimated expiration date of 2039, and three pending PCT applications related to FB102, expiring between 2043-2044[90]. Private Placement - The gross proceeds from the Private Placement on July 31, 2023, were approximately $25 million, with issuance costs of $272,000[88]. - The gross proceeds from the private placement on July 31, 2023, were approximately $25 million, which will support ongoing operations and development[105].
Forte Biosciences(FBRX) - 2024 Q2 - Quarterly Report