Financial Performance - As of June 30, 2025, the company had an accumulated deficit of $437.3 million and incurred net losses of $50.0 million for the six months ended June 30, 2025, compared to $76.3 million for the same period in 2024, reflecting a decrease of $26.3 million [77]. - Total operating expenses for the six months ended June 30, 2025, were $50.988 million, down from $79.957 million in 2024, a reduction of $28.969 million [93]. - The company expects to continue incurring significant losses for the foreseeable future, with expenses anticipated to increase as clinical trials and research activities progress [78]. - Net cash used in operating activities was $44.9 million for the six months ended June 30, 2025, compared to $64.7 million for the same period in 2024 [111]. - The company has incurred substantial operating losses and will require additional financing to continue operations beyond the second half of 2026 [104]. Research and Development - Research and development expenses for the six months ended June 30, 2025, were $39.463 million, a decrease of $26.138 million from $65.601 million in 2024 [93]. - Research and development expenses decreased by $15.3 million to $16.6 million for the three months ended June 30, 2025, compared to $31.8 million for the same period in 2024 [94]. - Total research and development expenses decreased by $26.1 million to $39.5 million for the six months ended June 30, 2025, compared to $65.6 million for the same period in 2024 [96]. - The company is currently evaluating icovamenib in two ongoing Phase II clinical trials for type 1 and type 2 diabetes, with a strategic focus on diabetes and obesity medicines [74]. - The company plans to advance BMF-650, a next-generation oral small molecule GLP-1 receptor agonist, through IND-enabling studies, aiming to provide a best-in-class therapeutic option for diabetes and obesity [75]. Capital and Financing - In June 2025, the company issued 19,450,000 shares of common stock at an offering price of $2.00 per share, generating approximately $42.8 million in gross proceeds [82]. - The company will need to raise additional capital in the future to fund operations and complete clinical trials for product candidates [79]. - The company anticipates needing to raise substantial additional capital to fund operations and develop product candidates [106]. - The company completed a public offering in June 2025, issuing 19,450,000 shares at $2.00 per share, resulting in net proceeds of approximately $37.2 million [102]. - The company has $94.8 million available under the 2022 ATM Program as of June 30, 2025 [103]. Cash and Liquidity - As of June 30, 2025, the company had cash, cash equivalents, and restricted cash of $56.6 million and an accumulated deficit of $437.3 million [104]. - The company held $56.6 million in cash, cash equivalents, and restricted cash as of June 30, 2025 [120]. - Cash equivalents consisted of money market funds, while restricted cash included two stand-by letters of credit related to lab leases [120]. - Net cash provided by financing activities was $42.8 million during the six months ended June 30, 2025, primarily from issuances of common stock and pre-funded warrants [114]. Risk Management - The company is exposed to market risks primarily related to interest rate sensitivities [120]. - There was no material foreign currency risk for the quarter ended June 30, 2025 [120]. - Historical fluctuations in interest rates have not been significant for the company [120]. - An immediate 10% relative change in interest rates would not have a material effect on the fair market value of cash equivalents due to their short-term maturities [120]. - The primary objectives of the company's investment activities are to ensure liquidity and preserve capital [120]. Accounting Policies - There were no material changes to critical accounting policies from those discussed in the Annual Report on Form 10-K filed on March 31, 2025 [119]. - The company had no interest-bearing liabilities as of June 30, 2025 [120]. - The company’s estimates and assumptions affect the reported amounts of assets and liabilities, which are based on historical experience and other reasonable factors [118].
Biomea Fusion(BMEA) - 2025 Q2 - Quarterly Report