Biomea Fusion (NASDAQ:BMEA) executives outlined the company’s strategy in diabetes and obesity during a fireside chat at the H.C. Wainwright 4th Annual BioConnect Investor Conference, highlighting ongoing Phase 2 work with its menin inhibitor icovamenib and upcoming Phase 1 data for its obesity candidate BMF-650.
The discussion featured Ramses Erdtmann, chief operating officer of Biomea Fusion, and Steve Morris, chief development officer. The moderator disclosed at the start of the session that H.C. Wainwright covers Biomea with a buy rating.
Biomea Focuses on Beta Cell Restoration in Diabetes
“We’re addressing the reason why they have diabetes, which is the depleted pool of beta cells,” Erdtmann said. He described the company’s work around menin, a protein that Biomea believes plays a role in regulating beta cell growth and function. According to Erdtmann, pregnancy and obesity are two natural conditions in which the body increases insulin-producing capacity, and Biomea has sought to replicate aspects of that mechanism pharmacologically.
Erdtmann said Biomea initially tested the mechanism in animal models and human cells before moving into human studies. He said the company observed that the mechanism appeared to be self-regulating and tied to glucose toxicity, meaning insulin production was not increased when not needed.
Type 2 Diabetes Plans Center on Insulin-Deficient Patients
The company discussed its work in Type 2 diabetes, including patients categorized by academia as having severe insulin-deficient diabetes, or SIDD. Erdtmann noted that regulators prefer companies define trial populations through inclusion and exclusion criteria rather than new disease labels.
Biomea is now enrolling patients in Phase 2 studies using those criteria, he said. Erdtmann described the target population as patients whose A1C remains elevated despite therapies such as metformin and SGLT2 inhibitors, before they progress to insulin use.
“Give me that patient before he goes on insulin,” Erdtmann said. “I’m gonna help him restore his function, so he doesn’t have to go on insulin.”
He said the company is working with regulators as it designs studies, including COVALENT-211 and COVALENT-212, with the goal of supporting a potential registration path if results are positive.
Company Sees Potential in GLP-1 Non-Responders
Morris also discussed a subset of Type 2 diabetes patients in Biomea’s initial study who were taking GLP-1 receptor agonists but had not achieved glycemic targets, defined as A1C of 7% or below. He said adding icovamenib to GLP-1 therapy in that group was associated with an A1C reduction of about 1.5%.
Morris said the company believes the response may be driven partly by increasing the beta cell pool. He also said Biomea and independent academic researchers have shown that menin inhibition may modulate expression of the GLP-1 receptor, GLP-1, and GLP-1 itself.
“You add icovamenib, you increase the receptor expression, you increase GLP-1, you convert a type 2 patient who is failing a GLP-1 receptor agonist now to a responder,” Morris said.
Type 1 Diabetes Study Plans Advance
In Type 1 diabetes, Morris highlighted exploratory data from the open-label COVALENT-112 trial, saying icovamenib was associated with a 52% increase from baseline in C-peptide levels after 12 weeks of dosing in patients within three years of diagnosis. C-peptide is a marker of endogenous insulin production.
Morris contrasted Biomea’s approach with other Type 1 diabetes therapies under investigation, which he said generally aim to slow autoimmune destruction of beta cells rather than increase beta cell number or function.
“We’re not just protecting the beta cells that are there. We’re adding to the pool,” Morris said.
Erdtmann said Biomea is planning a Phase 2 study in Type 1 diabetes that would dose patients for six months, then evaluate whether beta cell responses are maintained and whether autoimmune activity is triggered. He said one arm may continue dosing for another six months, while another would stop treatment to assess durability. The company also plans to evaluate whether immunomodulation could add benefit, while first collecting six months of safety and activity data without it.
Erdtmann said investigators from major diabetes centers have expressed interest in the protocol, including representatives associated with the Barbara Davis Center, Joslin Diabetes Center, Miami and San Antonio.
BMF-650 Obesity Data Expected This Summer
Biomea also discussed BMF-650, its obesity candidate. Erdtmann said the company expects Phase 1 data “sometime this summer” and is seeking to differentiate the oral GLP-1 receptor agonist by improving tolerability, titration and pharmacokinetic characteristics compared with other oral GLP-1 agents.
He specifically referenced orforglipron as a leading oral GLP-1 compound and said Biomea’s goal is to build on that type of scaffold by extending half-life and improving bioavailability. He said the company hopes to show a safety benefit while maintaining similar efficacy, though he acknowledged that some differentiation may be difficult to demonstrate in Phase 1.
Erdtmann said tolerability remains a key issue across the GLP-1 market, citing patient discontinuation as a challenge. He also said Biomea has observed signals in animal models suggesting icovamenib combined with a GLP-1 may increase weight loss, but added that the company needs human data and does not currently have funding for all potential studies.
Looking ahead, Erdtmann said Biomea expects readouts from its two ongoing Phase 2 studies around year-end or the first quarter, followed by potential discussions with the FDA. He also said updates on Type 1 diabetes enrollment and BMF-650 are expected as those programs progress.
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.
