Biomea Fusion (NASDAQ:BMEA) highlighted two clinical-stage programs focused on diabetes and obesity during a presentation at the 44th Annual JPMorgan Healthcare Conference, with CEO Mick Hitchcock outlining recent data, planned studies, and key milestones for 2026 and beyond.
Company focus and pipeline overview
Hitchcock, who said he joined the company in March, described Biomea Fusion’s “new focus” on diabetes and obesity. The company is advancing two oral small-molecule assets:
- Icovamenib, a selective and partial menin inhibitor being developed for diabetes, with data discussed from the COVALENT-111 study and plans for follow-on trials.
- BMF-650, an oral GLP-1 receptor agonist being developed for weight loss, currently in a phase 1 study called GLP-131.
Icovamenib: durable A1C reduction and insulin secretion signals
In discussing COVALENT-111, Hitchcock emphasized that patients were dosed orally once daily at 100 mg for three months, followed by longer-term follow-up. He highlighted that HbA1c decreased during the 12-week dosing period and, importantly, continued to decline after dosing stopped. He said the company previously reported 26-week follow-up data and later observed continued improvement at 52 weeks, with an overall placebo-adjusted HbA1c reduction of about 1.5. He acknowledged that the subset shown contained a limited number of patients and said the company is addressing that with new studies.
As a potential mechanistic correlate, Hitchcock pointed to increases in C-peptide, which he described as a measure of insulin secretion because it remains after insulin is used. He said C-peptide increased over time and continued to rise even after treatment ended, which the company interprets as improved beta cell number and productivity. He also reviewed preclinical work in rats showing increased beta cell number with icovamenib and described studies in isolated human islets from two donors in which insulin production appeared greater following icovamenib treatment versus solvent control.
Activity in GLP-1 “failures” and safety observations
Hitchcock also discussed a subgroup within COVALENT-111 consisting of 12 patients who entered the trial while on a GLP-1 agent but had HbA1c at 7.5% or above, which he characterized as failing to reach target. These patients remained on their GLP-1 therapy while receiving three months of icovamenib or placebo. He said this subgroup showed a placebo-adjusted HbA1c reduction of about 1.2 at 52 weeks, with continued improvement after dosing stopped.
On safety, Hitchcock said adverse event rates were “pretty similar” between placebo and icovamenib across the overall study population (267 patients total: 66 placebo and 201 across icovamenib arms). He noted observed increases in ALT and AST (liver enzymes) while on therapy, but said they resolved without interruption of study treatment, describing resolution as 100%.
He added that higher icovamenib exposure was associated with improved responses, based on a segmentation of patients by HbA1c reduction. To address exposure variability, he said the company completed a food-effect study (referred to as “121”) and found that dosing with food produced about twice the exposure compared with dosing without food, regardless of meal fat content or whether dosing occurred 30 minutes or one hour after a meal. Future studies will include dosing instructions to take the drug with food, he said.
Next steps: two phase 2 studies planned to start in 1Q
Biomea Fusion plans to run two parallel studies intended to replicate outcomes seen in COVALENT-111:
- COVALENT-211 in insulin-deficient T2D patients with HbA1c 7.5% to 10.5% and BMI under 32, focused on patients previously treated with one to three antidiabetic medications. The trial is designed with 40 patients on treatment and 20 on placebo, with a primary endpoint at week 26 and a secondary endpoint at week 52.
- COVALENT-212 in patients on GLP-1-based therapy (restricted to semaglutide, Hitchcock said) who are not meeting target (HbA1c >7.5%), with BMI 25 to 40. The trial similarly plans 40 patients on treatment and 20 on placebo, with week 26 and week 52 assessments.
In the Q&A, Hitchcock said protocols are approved, contract research organizations are in place, and the remaining steps to start dosing involve final site selection and shipping drug supply. He described a “win” scenario for both studies as data similar to COVALENT-111, noting that anything above a 0.5 HbA1c reduction at week 26 is generally considered approvable, while the company would prefer a more competitive outcome. If phase 2 results support moving forward, he said Biomea would pursue FDA discussions on a phase 3 program, adding that earlier FDA feedback suggested a three-month dosing regimen could mean icovamenib would not be considered a chronic agent, potentially reducing the scale of long-term requirements.
BMF-650: phase 1 progressing, early weight-loss benchmark discussed
For BMF-650, Hitchcock presented preclinical monkey data, describing a 28-day dosing study with five monkeys per group. He said the top dose produced about a 15% reduction in body weight and the lower dose produced about a 12% reduction, which he associated with reduced food intake.
He said Biomea’s chemotype is similar to Chugai’s oral GLP-1 agent orforglipron, and he contrasted that with another chemotype that has shown liver function test (LFT) abnormalities leading to discontinuations. Hitchcock said Biomea has not seen LFT signals in cynomolgus monkey studies lasting up to six weeks or to date in the ongoing first-in-human study, including no ALT/AST elevations.
The GLP-131 phase 1 study includes a single ascending dose (SAD) portion followed by a multiple ascending dose (MAD) portion in overweight or obese participants (BMI 30 to 45). Hitchcock said the company was still escalating SAD cohorts and expected to start the first MAD cohort within “the next week or two,” with 8 participants on active drug and 2 on placebo. He said the FDA allowed a six-week in-human MAD duration based on six-week toxicology work.
Asked what would constitute a successful early efficacy outcome, Hitchcock said a general benchmark in the field is 5% weight loss after 28 days. He added that if weight loss is lower, tolerability and the ability to up-titrate faster than current GLP-1 regimens would be important considerations.
Biomea Fusion’s stated milestones include first patient enrollment in both COVALENT-211 and COVALENT-212 in the first quarter, 26-week readouts for both studies expected in the fourth quarter of the year, and 28-day weight-loss results from the BMF-650 MAD portion expected in the second quarter of 2026.
On financing, Hitchcock said the company had about $70 million in cash at the end of the third quarter after adding a $27 million raise, with quarterly spending of roughly $12 million plus or minus a couple million, which he said supports runway into early 2027.
About Biomea Fusion (NASDAQ:BMEA)
Biomea Fusion, Inc (NASDAQ:BMEA) is a clinical‐stage biopharmaceutical company headquartered in Carlsbad, California. The company is dedicated to the discovery and development of small molecule therapies that target epigenetic regulators implicated in cancer. By leveraging a proprietary chemistry and drug discovery platform, Biomea Fusion aims to design precision medicines that modulate gene expression pathways involved in the initiation and progression of hematological malignancies and solid tumors.
The company’s lead clinical asset, BMF-219, is an orally bioavailable inhibitor of the menin–mixed‐lineage leukemia (MLL) protein–protein interaction.
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