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% in the 200 mg cohort after 26 weeks, with 36% of participants achieving a durable glycemic response[49]. - The FDA lifted the clinical hold on the COVALENT-111 and COVALENT-112 trials in September 2024, allowing the company to continue its clinical investigations[52]. - The company expects to announce preclinical data for a third development candidate, BMF-650, in Q4 2024[43]. - The Phase 1/2 clinical trial COVALENT-111 for type 2 diabetes includes approximately 270 participants, with dosing durations up to 12 weeks[47]. - Icovamenib is being investigated in oncology through ongoing Phase 1 trials COVALENT-101 and COVALENT-102, focusing on liquid tumors and KRAS solid tumors, respectively[54]. - The company initiated dosing in the Phase 1 clinical trial COVALENT-101 in January 2022, targeting relapsed/refractory AML and ALL[55]. - BMF-500, a third-generation oral covalent small molecule inhibitor, was nominated in May 2022 and is currently in a Phase 1 study (COVALENT-103) for relapsed or refractory acute leukemia[61]. - The company anticipates completing dose escalation for COVALENT-101 and COVALENT-102 by the end of 2024[60]. - The company expects research and development expenses to increase substantially in the coming years as it seeks to initiate and complete clinical trials[63]. Expenses and Financial Outlook - Research and development expenses for the three months ended September 30, 2024, were $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].

Exhibit 99.1 Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights • U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT112 (Type 1 Diabetes) trials • COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024 • COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024 • On track to announce our third clinical candidate, BMF-650, for the treatment o ...

Core Insights - The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Biomea Fusion's COVALENT-111 and COVALENT-112 trials for Type 2 and Type 1 diabetes, respectively [1][3] - The company is on track to announce topline data for COVALENT-111 and COVALENT-112 in December 2024, with approximately 200 and 20 patients involved [1][4] - Biomea Fusion is advancing its third clinical candidate, BMF-650, a next-generation oral small-molecule GLP-1 receptor agonist, with preclinical data expected to be shared on October 30, 2024 [1][2] Clinical Trials - COVALENT-111 and COVALENT-112 trials have resumed following FDA approval, focusing on icovamenib for Type 2 and Type 1 diabetes [3] - The company has formed a Global Scientific Advisory Board consisting of 22 experts in diabetes therapeutics [3] - Upcoming presentations at the 1st Asian Conference on Innovative Therapies for Diabetes Management will feature ongoing trial designs and case studies [3] Financial Performance - As of September 30, 2024, the company reported cash, cash equivalents, and restricted cash of $88.3 million, down from $177.2 million at the end of 2023 [6][14] - The net loss for Q3 2024 was $32.8 million, compared to a net loss of $28.4 million in Q3 2023 [6][12] - Research and Development (R&D) expenses increased to $27.2 million in Q3 2024 from $25.3 million in Q3 2023, primarily due to clinical activities and personnel-related expenses [6][12] Anticipated Milestones - Topline data readouts for COVALENT-111 and COVALENT-112 are expected in December 2024 [4] - Preclinical data on BMF-650 and the combination of icovamenib with GLP-1 RA-based therapies will be shared on October 30, 2024 [4] - The company aims to deliver a fourth IND candidate in 2025 based on its FUSION™ Platform technology [5]

Core Insights - Biomea Fusion, Inc. has received approval from the World Health Organization (WHO) for "icovamenib" as the International Nonproprietary Name (INN) for its lead product candidate BMF-219, which has also been adopted as the United States Adopted Name (USAN) [1][2] Company Overview - Biomea Fusion is a clinical-stage biopharmaceutical company focused on developing oral covalent small molecules aimed at treating diabetes, obesity, and genetically defined cancers [3] - The company utilizes its proprietary FUSION™ System to discover and develop next-generation covalent-binding small molecule medicines, which are designed to provide greater target selectivity and lower drug exposure compared to conventional non-covalent drugs [3] Product Development - The suffix '-menib' in "icovamenib" indicates that it is a menin inhibitor, which is relevant to its therapeutic applications [1] - Biomea plans to use "icovamenib" in future presentations and publications as it advances the clinical development of this product candidate [2]

Core Insights - Biomea Fusion, Inc. is developing BMF-219, an investigational oral covalent menin inhibitor aimed at regenerating insulin-producing beta cells for diabetes treatment [1][6] - The company will present data from its Phase II clinical trials, COVALENT-111 and COVALENT-112, at the ATTD-ASIA 2024 conference in Singapore [1][3] Group 1: Clinical Trials - COVALENT-111 is a Phase I/II study focusing on type 2 diabetes, involving approximately 200 patients who completed their dosing period before the FDA placed the study on hold [4] - COVALENT-112 is a Phase II study for adults with stage 3 type 1 diabetes, enrolling around 150 patients, with an open-label portion for adults diagnosed up to 15 years [5] Group 2: Presentation Details - The presentations will include a long oral presentation on COVALENT-112 and two short oral presentations on COVALENT-111, scheduled for November 19-20, 2024 [3] - The late breaker presentation will focus on case studies assessing BMF-219 in patients with poorly controlled severe insulin-deficient type 2 diabetes [1][3] Group 3: Company Overview - Biomea Fusion specializes in discovering and developing oral covalent small molecules for treating metabolic diseases and genetically defined cancers [6] - The company utilizes its proprietary FUSION™ System to enhance the development of next-generation covalent-binding small molecule medicines [7]

Core Viewpoint - Biomea Fusion's shares rose by 9.1% following the FDA's decision to lift the clinical hold on its studies for BMF-219, a candidate for treating type 1 and type 2 diabetes, indicating positive regulatory progress for the company [1]. Regulatory Updates - In June 2024, the FDA had placed a full clinical hold on Biomea's phase I/II studies (COVALENT-111 and COVALENT-112) for BMF-219 due to concerns over potential drug-induced liver toxicity [2]. - The FDA's review revealed issues related to elevated liver enzymes during the Dose Escalation phase of COVALENT-111, which were possibly influenced by high doses of BMF-219 and other factors [3]. Clinical Study Insights - Biomea reported that BMF-219 has been generally well tolerated in clinical studies, with most adverse events being mild to moderate, and no serious adverse reactions identified in either COVALENT-111 or COVALENT-112 [4]. - The FDA's safety review indicated that concerning safety signals from the phase IIa portion of COVALENT-111 did not carry over to the ongoing phase IIb expansion, with no confirmed serious liver injury reported [5]. Future Expectations - The company anticipates reporting top-line 26-week data from the phase IIb portion of COVALENT-111, involving approximately 200 patients, and top-line data from the phase IIa portion of COVALENT-112, involving around 20 patients, both expected in the fourth quarter of 2024 [7]. - Biomea plans to announce a new development candidate, a selective oral small molecule GLP-1 receptor agonist, by the end of this year [7]. Pipeline Overview - In addition to diabetes, Biomea is developing BMF-219 for oncology indications, with ongoing studies (COVALENT-101 and COVALENT-102) evaluating the candidate in patients with liquid tumors and KRAS solid tumors [8]. - Biomea also has another investigational candidate, BMF-500, in development for relapsed or refractory acute leukemia, currently in an early-stage study (COVALENT-103) [9].

Core Insights - The U.S. FDA has lifted the clinical hold on Biomea Fusion's Phase I/II trials for the investigational covalent menin inhibitor BMF-219, which targets type 1 and type 2 diabetes [1][2] Company Overview - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral covalent small molecules for metabolic diseases and genetically defined cancers [7] - The company utilizes its proprietary FUSION™ System to design and develop next-generation covalent-binding small molecule medicines [8] Clinical Trials - The ongoing trials include COVALENT-111 for type 2 diabetes and COVALENT-112 for type 1 diabetes, with the latter involving approximately 150 patients [4][5] - COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study, while COVALENT-112 is a Phase II study comparing two doses of BMF-219 to placebo [4][5] - The Phase IIb Expansion Study of COVALENT-111 has shown no concerning safety signals translating from the earlier Phase 2a Escalation Study [2] Upcoming Milestones - The company plans to announce a third development candidate, a GLP-1 receptor agonist, and expects topline data readouts for both COVALENT-111 and COVALENT-112 in Q4 2024 [4]

Core Viewpoint - Biomea Fusion, Inc. (BMEA) shows significant upside potential with a mean price target of $23.86, indicating a 317.9% increase from the current trading price of $5.71 [1] Price Targets and Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $20.63, where the lowest estimate is $5 (12.4% decline) and the highest is $60 (950.8% increase) [2] - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [7] Analyst Sentiment - Analysts have shown increasing optimism about BMEA's earnings prospects, as indicated by a trend of higher EPS estimates, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has risen by 0.8% over the past month, with two estimates increasing and one decreasing [10] Zacks Rank - BMEA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential for upside in the near term [11]

Core Insights - Biomea Fusion, Inc. is a clinical stage biopharmaceutical company focused on developing covalent small molecules for genetically defined cancers and metabolic diseases [3][4] - The company granted non-qualified stock options for 25,000 shares to a new employee, with vesting occurring quarterly over four years [1] - The stock option award was made under Biomea's 2023 Inducement Equity Plan, which was adopted on November 17, 2023 [2] Company Overview - Biomea Fusion specializes in the discovery and development of oral covalent small molecules, which form permanent bonds to target proteins, offering advantages such as greater selectivity and lower drug exposure [3] - The company utilizes its proprietary FUSION™ System to develop a pipeline of next-generation covalent-binding small molecule medicines aimed at maximizing clinical benefits for patients with various cancers and metabolic diseases [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value BMEA The Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commissio ...