Biomea Fusion(BMEA) - 2024 Q3 - Quarterly Report

Financial Performance - The company reported an accumulated deficit of $357.9 million as of September 30, 2024, with net losses of$109.1 million and $82.4 million for the nine months ended September 30, 2024, and 2023, respectively[61]. - The total operating expenses for the nine months ended September 30, 2024, were$114.0 million, an increase of $25.2 million compared to$88.8 million for the same period in 2023[68]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $89.9 million, compared to$73.8 million for the same period in 2023[76][78]. - The net loss for the nine months ended September 30, 2024, was $109.1 million, offset by non-cash adjustments of$18.0 million[77]. - Interest and other income, net for the three months ended September 30, 2024, was $1.3 million, a decrease of$1.4 million compared to $2.7 million for the same period in 2023[68]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for a product candidate[61]. - The company has not generated any revenue to date and does not expect to do so in the near future[63]. Research and Development - Icovamenib demonstrated a placebo-adjusted mean percent change of A1c of -1.4$27.2 million, an increase of $1.9 million compared to$25.3 million for the same period in 2023[68]. - General and administrative expenses increased by $1.0 million during the three months ended September 30, 2024, primarily due to personnel-related costs[72]. - The company anticipates significant increases in general and administrative expenses due to staff expansion and compliance costs associated with being a public company[65]. - The company has substantial doubt about its ability to continue as a going concern without obtaining additional financing[73]. - The company anticipates needing to raise substantial additional capital to fund operations and product development, with requirements depending on various factors including clinical trials and regulatory reviews[74]. - The company sold 5,750,000 shares of common stock at a price of$30.00 per share in April 2023, resulting in net proceeds of $161.8 million[73]. - Net cash provided by financing activities was$1.3 million during the nine months ended September 30, 2024, significantly lower than $163.2 million in the same period of 2023[80][81]. Cash Position - As of September 30, 2024, the company had cash, cash equivalents, and restricted cash of$88.3 million and an accumulated deficit of $357.9 million[73]. - As of September 30, 2024, the company held$88.3 million in cash, cash equivalents, and restricted cash[85]. Market Risks - The company is exposed to market risks primarily related to interest rate sensitivities, with no significant foreign currency risk reported[85]. - The company has no material changes in contractual obligations from the previous reporting period[82]. - The company has not reported any off-balance sheet arrangements during the periods presented[82]. - Non-cash adjustments in operating activities included stock-based compensation expense of $14.6 million for the nine months ended September 30, 2024[77]. - The company may seek additional capital through various means, including public or private equity offerings and collaborations[74].