Biomea Fusion (NASDAQ:BMEA) outlined several near-term clinical milestones and development priorities during a JPMorgan conference call, with executives emphasizing upcoming Phase I data for its oral GLP-1 receptor agonist candidate BMF-650 and continued advancement of icovamenib in diabetes.
BMF-650: Phase I readout expected in Q2
JPMorgan biotech analyst Anupam Rama said Phase I data for BMF-650, an oral GLP-1 receptor agonist built on the orforglipron scaffold, is expected in the second quarter. Biomea Co-Founder, President and COO Ramses Erdtmann said the company’s goal is to deliver an oral agent with “better pharmacokinetics, which could lead to better tolerability,” and noted the Phase I program is designed to test that premise.
Kirschberg also described a design choice related to potency and tolerability during early dosing. He said the company “took a little bit the potency out” so that initial exposure during titration may be easier for patients, while still aiming to reach “a pharmacologically relevant dose” quickly.
Trial design: SAD completed, MAD ongoing
Kirschberg summarized the Phase I program as consisting of a single-ascending dose (SAD) portion and a multiple-ascending dose (MAD) portion. The SAD portion, which he said has concluded, included five cohorts escalating from 10 mg to 200 mg single doses. The goal there is to establish safety, tolerability, and pharmacokinetics.
The ongoing MAD portion includes four cohorts of 10 individuals each, with an 8-to-2 active-to-placebo split per cohort, in “healthy individuals that are overweight or obese, so non-diabetic,” Kirschberg said. The dosing plan spans six weeks of once-daily dosing, consisting of a two-week up-titration followed by a four-week hold at target dose levels of 100 mg, 200 mg, 300 mg, and 400 mg.
Kirschberg said the structure is intended to provide multiple views of performance, including the tolerability and dynamics of titration as well as weight loss over four weeks at a fixed target dose.
What Biomea considers a “win” for oral GLP-1 Phase I
Asked what would constitute a favorable outcome in the upcoming Phase I update, Kirschberg said weight loss should be evaluated alongside tolerability and the speed of dose escalation. “Those three things need to be looked at then in weighted balance,” he said, citing weight loss magnitude, GI side effects during up-titration, and how quickly the compound can be titrated.
As a reference point, Kirschberg pointed to earlier publicly reported results for orforglipron over a four-week up-titration and weight-loss assessment. He noted that in that report, “the placebo group lost essentially 2 kilograms” while “the highest dose lost five,” and said the field’s expectations for small-molecule GLP-1 agents often center around “the 5 kg, 5% weight loss mark.” Interim CEO and Director Mick Hitchcock added that comparisons can be complicated because heavier patients tend to lose more weight and because the referenced orforglipron data were reported in kilograms rather than percentages.
Looking ahead, Hitchcock said the company expects to move into longer-term studies if Phase I results are supportive. He also said Biomea wants to explore not only weight loss but also maintenance strategies, including approaches to “back titrate in a way that keeps people at the weight they wanna be, rather than taking them off drug and seeing them jump back to where they were in the first place.”
Icovamenib: positioning as a non-chronic approach in diabetes
Biomea also discussed icovamenib, which the company is developing for diabetes. Erdtmann argued that many existing diabetes therapies are chronic and focused on managing high blood glucose rather than addressing underlying dysfunction. He said a key misperception is underappreciation of how many patients progress to insulin dependency, describing it as “about a third of all patients.”
Erdtmann positioned icovamenib as intended for patients who are failing standard therapies, with the goal of improving beta-cell function and helping patients avoid insulin. He emphasized icovamenib as “a non-chronic agent,” adding, “We restore the healthy or the functioning pool within 12 weeks.” He said some patients may require re-dosing over time, but described the program as designed for restoration of beta-cell function.
He also said the company is running studies with a 26-week primary endpoint and a 52-week secondary endpoint, and that Biomea is planning to request an end-of-Phase II meeting with the FDA after that dataset, with an intent to enter Phase III “next year.”
Upcoming data and operational update
Joyce Zhou, a biotech research analyst at JPMorgan, asked about upcoming icovamenib data from the COVALENT-112 study in type 1 diabetes, with 52-week follow-up expected in the second quarter. Erdtmann described COVALENT-112 as a proof-of-concept study with two cohorts—patients zero to three years since diagnosis and patients three to 15 years since diagnosis—totaling about 20 patients. He noted that the subsets most likely to show responses could represent only “a handful of patients,” but said the update will include the full 20-patient dataset.
Zhou also asked about enrollment for two Phase II studies in type 2 diabetes, COVALENT-211 and COVALENT-212, including a cohort of type 2 patients not controlled on a GLP-1. Erdtmann reiterated guidance for data from both studies in the fourth quarter and said Biomea had “engaged with about 20-plus sites,” with site initiation activities underway and plans to begin enrolling in Q2 and finish enrollment in Q2 to support a year-end readout.
Discussing what would constitute success for those Phase II readouts, Erdtmann said HbA1c reduction is the typical endpoint and cited 0.5% as an FDA benchmark for approval in prior settings. “If we hit anything above 0.5, we’re good,” he said, adding that clearing 0.5% would be meaningful given the company’s view that icovamenib is non-chronic and could help keep patients off insulin. Hitchcock also said the company is focused on durability, noting prior observations of larger reductions at 52 weeks than at 26 weeks and stating that a key question is “how long that persists for.”
On safety enabling longer dosing, Erdtmann said the company has reported longer-term toxicology in two species and said it does not see concerning signals. However, he said Biomea’s current Phase II approach is not limited by tox, and that longer dosing may be considered for certain future populations, including potentially type 1 diabetes.
Finally, Erdtmann reviewed Biomea’s cash position, stating the company ended last year with $56 million in cash and expects it to last into 2027, while also noting that, based on the company’s spending plan, it would run out of cash “somewhere in Q1.” He said the existing cash is intended to support multiple anticipated milestones, including the type 1 diabetes update, the BMF-650 update, and the two Phase II type 2 diabetes readouts by year-end. Erdtmann said the company has reduced spending and is now “running lean at 40 people,” focused on clinical development, quality, and CMC, and said future financing timing “depends” on how data develop.
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.
