Biomea Fusion(US:BMEA)2022-07-31 16:00Financial Performance - As of June 30, 2022, the company had an accumulated deficit of $83.4 million and incurred net losses of $17.3 million and $33.6 million for the three and six months ended June 30, 2022, respectively[97]. - The net loss for the three months ended June 30, 2022, was $17.3 million, compared to a net loss of $8.4 million for the same period in 2021, representing an increase of $8.9 million (106%) in losses[107]. - Net cash used in operating activities was $25.4 million for the six months ended June 30, 2022, compared to $10.6 million for the same period in 2021[116]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the near future[100]. Research and Development - The company plans to initiate a Phase 1/2 clinical trial of BMF-219 in diabetes within the second half of 2022, subject to IND submission and clearance[97]. - BMF-219 demonstrated over 99% cell lethality in multiple myeloma (MM) cell lines with RAS mutations and showed pronounced anti-cancer activity in vitro across various KRAS mutant cell lines[95]. - The company expects research and development expenses to increase substantially as it seeks to initiate and complete clinical trials and pursue regulatory approval for BMF-219 and advance BMF-500[101]. - Research and development expenses increased by $7.4 million (141%) to $12.6 million for the three months ended June 30, 2022, compared to $5.2 million for the same period in 2021[107]. - The company has devoted substantially all efforts and financial resources to research and development activities since its establishment in 2017[96]. - The company plans to develop covalent treatments against other high-value oncogenic drivers of cancer using its FUSION™ System discovery platform[97]. Operating Expenses - General and administrative expenses rose by $1.7 million (52%) to $4.9 million for the three months ended June 30, 2022, compared to $3.2 million for the same period in 2021[109]. - Total operating expenses increased by $9.0 million (107%) to $17.5 million for the three months ended June 30, 2022, compared to $8.4 million for the same period in 2021[107]. - The company anticipates a substantial increase in general and administrative expenses due to staff expansion and compliance costs associated with being a public company[104]. Capital and Funding - Proceeds from the IPO in April 2021 were $152.8 million after underwriting discounts and commissions[99]. - The company may need to raise additional capital in the future to fund operations and clinical trials for product candidates[97]. - The company expects to require additional capital to develop product candidates and fund operations in the foreseeable future[113]. - The company raised $152.8 million from its IPO in April 2021, issuing 9,000,000 shares at $17.00 per share[112]. Cash and Investments - As of June 30, 2022, the company had cash, cash equivalents, restricted cash, and investments totaling $150.2 million[112]. - As of June 30, 2022, the company held $150.2 million in cash, cash equivalents, restricted cash, and investments[124]. - Cash equivalents and investments included money market funds, corporate debt securities, commercial paper, and asset-backed securities[124]. - The company had no interest-bearing liabilities as of June 30, 2022[124]. Risk Factors - There was no material foreign currency risk for the quarter ended June 30, 2022[124]. - Historical fluctuations in interest rates have not been significant for the company[124]. - An immediate 10% relative change in interest rates would not have a material effect on the fair market value of cash equivalents and investments due to their short-term maturities[124]. - The company has not experienced delays in discovery and development activities due to the COVID-19 pandemic but continues to monitor its impact[99].