Biomea Fusion, Inc. (NASDAQ:BMEA) earns a place on our list of the top 10 stocks under $5 that could triple. Analysts Sentiment on Biomea Fusion (BMEA) Remains Strong Amid Strong Diabetes Trial Results As of March 19, 2026, almost 88% of covering analysts keep bullish ratings on the stock. With a consensus price target of $6.00, indicating a potential upside of 415.02%, analyst sentiment remains positive toward Biomea Fusion, Inc. (NASDAQ:BMEA). On March 14, 2026, Biomea Fusion, Inc. (NASDAQ:BMEA) repor ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, Inc. (Exact name of Reg ...

Exhibit 99.1 Biomea Fusion Reports Full Year 2025 Financial Results and Corporate Highlights SAN CARLOS, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the full year ended December 31, 2025 and provided a business update. "The past year was a year of execution for Biomea as we advanced from validating the menin pathway in primarily preclinical ...

Initiated two Phase II trials COVALENT-211 and COVALENT-212 (icovamenib in type 2 diabetes) with 26-week primary endpoint data anticipated in the fourth quarter of 2026Completed 52-week follow-up from Phase II trial COVALENT-112 (icovamenib in type 1 diabetes) with data expected in the second quarter of 2026Initiated Phase I trial enrollment of GLP-131 (BMF-650 in obesity) with initial 28-day weight reduction data expected in the second quarter of 2026Projected cash runway into the first quarter of 2027 SAN ...

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Core Insights - The Phase II COVALENT-111 study results indicate that icovamenib has a favorable safety profile and shows potential in transforming diabetes treatment through significant reductions in HbA1c levels [1][2] Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral covalent small-molecule drugs for metabolic diseases, utilizing its proprietary FUSION System discovery platform [7] - The principal drug candidate, icovamenib, is being investigated for its effects on type 1 and type 2 diabetes, as well as obesity [8] Clinical Study Results - The COVALENT-111 study demonstrated that severe insulin-deficient patients experienced an HbA1c reduction of 1.2% at Week 52, with the most effective dosing regimen achieving a mean reduction of 1.5% [2] - The study maintained a favorable safety profile with no serious treatment-related adverse events reported throughout the 52-week observation period [1] Market Performance - Biomea Fusion shares were up 3.68% at $1.41, indicating positive market sentiment following the study results [11] - The stock is currently trading 2.9% above its 20-day simple moving average and 4.0% above its 100-day simple moving average, suggesting short-term strength [4] Analyst Outlook - The stock carries a Buy Rating, with recent analyst actions including maintaining a target price of $12.00 by D. Boral Capital and a lowered target of $6.00 by Citigroup [11] - The next financial update is expected on March 30, 2026, with an EPS estimate of a loss of 23 cents, improved from a previous estimate of a loss of 81 cents [11]

Core Viewpoint - Biomea Fusion, Inc. announced positive 52-week follow-up results from its Phase II COVALENT-111 study on icovamenib for type 2 diabetes, indicating durable efficacy and safety [1][2]. Study Design and Results - COVALENT-111 was a double-blind, randomized, placebo-controlled trial involving 267 adult patients with type 2 diabetes, focusing on those with inadequate glycemic control despite treatment [3][4]. - The study evaluated three dosing regimens of icovamenib, with a total of 163 patients completing at least 80% of their planned dosing prior to a clinical hold [4]. - Positive results were observed across multiple subgroups, with significant reductions in HbA1c levels, particularly in severe insulin-deficient diabetes patients, achieving a reduction of 1.2% at Week 52 [5][6]. Safety Profile - Icovamenib maintained a favorable safety profile throughout the 52-week observation period, with no treatment-related serious adverse events reported [7]. Future Developments - The company plans to initiate two new Phase II studies targeting patients who showed the best responses in the COVALENT-111 trial [2]. - Initial clinical weight-reduction data from the Phase I GLP-131 study for obesity is anticipated in the second quarter of 2026 [9]. About Icovamenib - Icovamenib is an investigational small molecule targeting menin, which is implicated in beta-cell dysfunction, potentially transforming diabetes treatment by addressing underlying biological mechanisms [10][11]. Market Context - Diabetes affects over 38 million Americans, representing a significant economic burden on the U.S. healthcare system, with severe insulin-deficient diabetes being a high unmet medical need [12]. Company Overview - Biomea Fusion is focused on developing oral small molecule therapies for diabetes and obesity, aiming to deliver transformative treatments for metabolic disorders [13].

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Summary of Biomea Fusion FY Conference Call Company Overview - **Company**: Biomea Fusion (NasdaqGS: BMEA) - **Key Products**: - Icovamenib: An oral small molecule for diabetes - BMF-650: A GLP-1 receptor agonist for weight loss Core Insights and Arguments Icovamenib Development - **Clinical Trials**: - Currently moving into two clinical trials targeting insulin-deficient type 2 diabetes and patients inadequately controlled on GLP-1 therapy [3][11] - **Market Need**: - Diabetes is a significant health issue, with approximately 38 million people in the U.S. affected, and 80% of diabetes patients die from related complications [4][49] - **Efficacy**: - Icovamenib showed a significant reduction in A1C levels over time, with effects lasting up to 9 months post-treatment [5][10] - Mechanism involves the inhibition of menin, which enhances insulin production by increasing beta cell proliferation [6][7] - **Patient Population**: - Focus on patients with A1C levels between 7.5 and 10.5, BMI less than 32, and those who have failed 1-3 prior diabetes medications [25][26] BMF-650 Development - **Clinical Trials**: - Currently in Phase 1 studies, aiming for a favorable pharmacokinetic profile and consistent weight loss response [13][15] - **Weight Loss Efficacy**: - Initial studies in monkeys showed a weight reduction of approximately 12% to 15% over 28 days [14] - **Market Positioning**: - Positioned to address the needs of patients who are overweight or obese and require effective weight management solutions [95][104] Additional Important Points - **Regulatory Strategy**: - The current studies are not registrational but are designed to gather data that could support future Phase 3 trials [75][76] - **Commercial Focus**: - Targeting patients who are uncontrolled on standard therapies, particularly those failing GLP-1 treatments, to prevent progression to insulin dependency [44][49][92] - **Market Size**: - The diabetes market is substantial, with over 10 million insulin-dependent patients in the U.S. alone [44][49] - **Long-term Goals**: - Aim to provide a non-chronic treatment option that can restore beta cell function and reduce the healthcare burden associated with diabetes [61][62] Conclusion - Biomea Fusion is advancing its innovative diabetes treatments, Icovamenib and BMF-650, with a clear focus on addressing unmet needs in the diabetes market. The company is strategically positioning itself to capture a significant share of the market by targeting specific patient populations and demonstrating the efficacy of its therapies through ongoing clinical trials.

Core Insights - Biomea Fusion Inc. is recognized as an overlooked growth stock with a Buy rating and a price target of $8 initiated by Rodman & Renshaw [1][3] Company Strategy - In Q3 2025, Biomea Fusion announced a strategic shift to focus on two primary assets: icovamenib, a menin inhibitor for type 2 diabetes, and BMF-650, an oral GLP-1 receptor agonist for obesity [2][4] - Icovamenib aims to regenerate healthy insulin-producing beta cells by partially inhibiting menin, potentially offering a disease-modifying treatment for diabetes [2] Clinical Data - Biomea Fusion reported durable 52-week data from its Phase II COVALENT-111 study, showing a sustained 1.5% mean reduction in HbA1c nine months after a 12-week course of icovamenib in patients with severe insulin-deficient type 2 diabetes [3] - Patients who previously failed to reach glycemic targets on GLP-1 therapies experienced a 1.3% reduction in HbA1c, indicating a legacy effect of the treatment [3]