- Biomea is advancing its pipeline in **diabetes and obesity**, with a focus on two key programs: BMF-219 and BMF-650.  **[0001840439_2201363_1]** 
- For diabetes, Biomea plans to initiate two Phase 2 studies for its menin inhibitor, BMF-219, targeting severe insulin-deficient patients and those with uncontrolled HbA1c on GLP-1s, with IND submission expected early **2026**.  **[0001840439_2201363_5]** 
- The company's obesity program, BMF-650 (a small molecule GLP-1 receptor agonist), has received FDA clearance for its Phase 1 SAD/MAD study, with the MAD part scheduled for Q1 **2026** and data readout anticipated in Q1-Q2 **2026**.  **[0001840439_2201363_12]**  Preclinical data showed **12% to 15%** weight reduction in obese monkeys.  **[0001840439_2201363_11]** 
- Biomea projects its current funding will last into **2027**, following significant expense reductions and a strategic focus on its core indications.  **[0001840439_2201363_14]**

Biomea Provides Pipeline and Funding Update, Anticipates Key Clinical Milestones in 2026

- Biomea (BMEA) is focused on two key areas: **diabetes** and **obesity**, with a menin inhibition program for diabetes and an oral GLP-1 receptor agonist for obesity.  **[0001840439_2201650_1]** 
- In diabetes, Biomea's icovamenib showed a **1.5% to 1.8% HbA1c reduction** versus placebo in clinical studies, particularly in severe insulin-deficient patients and those on GLP-1s.  **[0001840439_2201650_1]** **[0001840439_2201650_5]**  Two Phase II studies are planned to start with IND submission early **2026**, with a 26-week primary readout expected by late **2026** or early **2027**.  **[0001840439_2201650_5]** **[0001840439_2201650_6]** 
- For obesity, Biomea's BMF-650, an oral GLP-1 receptor agonist, demonstrated **12% and 15% weight reduction** in obese monkeys over 28 days in preclinical studies and is nearing clinical trials.  **[0001840439_2201650_11]** 
- Biomea has reduced its employee count to **40** and expects current funding to last into **2027**, with a focus on controlling expenses.  **[0001840439_2201650_14]**

Biomea Provides Update on Diabetes and Obesity Programs

- Biomea Fusion announced positive **52-week follow-up results** from its Phase 2 COVALENT-111 study of icovamenib for Type 2 Diabetes (T2D).  **[1840439_2170223:5]** 
- Icovamenib demonstrated **clinically meaningful HbA1c reduction**, with severe insulin-deficient T2D patients in Arm B achieving a mean HbA1c reduction of **1.5%** through Week 52.  **[1840439_2170223:11]** **[1840439_2170223:12]** **[1840439_2170223:14]** 
- The drug also showed **clinically meaningful responses** (HbA1c reduction of **1.3%**) in patients who had not achieved target HbA1c with GLP-1 based therapy.  **[1840439_2170223:12]** **[1840439_2170223:14]** 
- Icovamenib maintained a **favorable safety profile**, with no adverse-event related discontinuations or related serious adverse events.  **[1840439_2170223:9]** **[1840439_2170223:12]** **[1840439_2170223:14]** 
- Future plans include initiating a Food Effect Study (COVALENT-121), a Phase IIb T2D Study (COVALENT-211) for severe insulin-deficient patients, and a Phase II T2D Study (COVALENT-212) in combination with GLP-1 therapy, all expected to initiate or complete by **4Q 2025 or 1H 2026**.  **[1840439_2170223:15]**

Biomea Fusion Announces Positive 52-Week Results for COVALENT-111 Study

- Biomea Fusion announced **positive 52-week results** from its COVALENT-111 study for **acobaminib**, an investigational menin inhibitor for type 2 diabetes.  **[1840439_2170533_1]** **[1840439_2170533_7]** 
- Acobaminib demonstrated clinically meaningful and durable HbA1c reductions, with up to **1.5%** in severe insulin-deficient patients and **1.3%** in GLP-1 treated patients not at goal, alongside a **favorable safety profile**.  **[1840439_2170533_7]** 
- The company plans to initiate larger Phase 2 studies (COVALENT-211 and COVALENT-212) in **Q4 2025** targeting these specific patient populations, with results from a food effect study expected in **December 2025** to optimize dosing.  **[1840439_2170533_7]** **[1840439_2170533_8]** 
- Recent financing has extended Biomea Fusion's cash runway into the **second half of 2027**, supporting the advancement of acobaminib and BMF-650.  **[1840439_2170533_7]**

Biomea Fusion Reports Positive 52-Week COVALENT-111 Study Results for Acobaminib

- Biomea Fusion, Inc. has priced its public offering, which includes **11,195,121 shares** of common stock with accompanying warrants, and up to **1,000,000 pre-funded warrants** with accompanying warrants.  **[1840439_7e2ee2b8ba1847e9aa4f74ee1106a6ca_0]** 
- The combined offering price for each share of common stock and accompanying warrant is **$2.05**, while for each pre-funded warrant and accompanying warrant it is **$2.0499**.  **[1840439_7e2ee2b8ba1847e9aa4f74ee1106a6ca_0]** 
- The accompanying warrants have an exercise price of **$2.50** per share and will be exercisable for three years from issuance.  **[1840439_7e2ee2b8ba1847e9aa4f74ee1106a6ca_0]** 
- The offering is expected to generate approximately **$25.0 million** in gross proceeds for Biomea, before deductions, and is anticipated to close on **October 8, 2025**.  **[1840439_7e2ee2b8ba1847e9aa4f74ee1106a6ca_0]** 
- **Jefferies** is serving as the sole book-running manager, with **H.C. Wainwright & Co.** acting as the lead manager for the offering.  **[1840439_7e2ee2b8ba1847e9aa4f74ee1106a6ca_0]** **[1840439_7e2ee2b8ba1847e9aa4f74ee1106a6ca_1]**

Biomea Fusion Prices Public Offering of Securities

- Biomea Fusion, Inc. reported **positive 52-week results** from its Phase II COVALENT-111 study for icovamenib in Type 2 diabetes on **October 6, 2025**.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]** 
- The study demonstrated a **durable HbA1c reduction of 1.2% (p=0.01)** sustained through Week 52 in severe insulin-deficient patients who received 12 weeks of treatment, with the strongest arm achieving a **1.5% reduction (p=0.01)**.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]** 
- Icovamenib also showed a **1.3% reduction in HbA1c (p=0.05)** in patients receiving GLP-1-based therapy, while maintaining a **favorable safety profile** with no treatment-related serious adverse events.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]** 
- The company plans to initiate a Phase IIb trial (COVALENT-211) and a Phase II trial (COVALENT-212) in Type 2 diabetes patients in the **fourth quarter of 2025**.  **[1840439_0001193125-25-231903_d79150d8k.htm:1]**

Biomea Fusion Reports Positive 52-Week Results from COVALENT-111 Study

- Biomea Fusion announced **positive 52-week results** from its Phase II COVALENT-111 study evaluating **icovamenib** in patients with Type 2 Diabetes (T2D).  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_1]** 
- Icovamenib demonstrated a **sustained treatment benefit** at Week 52 in severe insulin-deficient diabetes patients, showing a **1.8% placebo adjusted mean reduction in HbA1c**.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** 
- Type 2 diabetes patients on GLP-1-based therapy who were failing to achieve their target HbA1c also showed a **clinically meaningful response**, with a **1.8% mean placebo adjusted HbA1c reduction** at Week 52 after only 12 weeks of treatment.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** 
- Icovamenib was **generally well tolerated** and maintained a **favorable safety and tolerability profile** throughout the 52-week observation period.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_2]** 
- **Phase II trials** (COVALENT-211 and COVALENT-212) for icovamenib in these patient populations are expected to begin in the **fourth quarter of 2025**.  **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_0]** **[1840439_d5b3734eb55947a8a76bd0b4a8f72bf2_2]**

Biomea Fusion (BMEA)