Biomea Fusion Presents COVALENT-111 Study Results at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

Rhea-AI Summary

Biomea Fusion (NASDAQ: BMEA) presented COVALENT-111 results at WCIRDC (Dec 3-6, 2025) showing durable glycemic and C‑peptide improvements with icovamenib, a selective menin inhibitor for insulin‑deficient type 2 diabetes. Data reported durable and continuous treatment effect at week 52 (9 months post last dose), exposure‑response for HbA1c, improved long‑term insulin secretion, benefit in prior GLP‑1 “failures,” and generally good tolerability with no related serious adverse events or AE‑related discontinuations. The abstract will appear in Metabolism: Experimental and Clinical and the presentation will be posted on Biomea Fusion’s investor relations site.

Positive

• Durable HbA1c and C‑peptide improvements at week 52 (9 months post last dose)
• Exposure‑response observed: higher icovamenib exposure linked to greater HbA1c reduction
• Improved long‑term insulin secretion in severe insulin‑deficient T2D
• No related serious adverse events and no adverse‑event related discontinuations reported

Negative

• Abstract publication pending in Metabolism: Experimental and Clinical (full peer‑reviewed data not yet available)
• Study population limited to adults diagnosed with T2D within the last 7 years (HbA1c 7.0–10.5%, BMI 25–40)

Key Figures

Q3 2025 net loss $16.4M Net loss reported in Q3 2025 10-Q

Cash balance $47.0M Cash, cash equivalents and restricted cash as of Sep 30, 2025

October 2025 offering proceeds $25.0M Gross proceeds from Oct 6, 2025 public offering

Offering unit price $2.05 Combined public offering price per unit in Oct 7, 2025 424B5

Warrant liability $17.9M Fair value of common warrants issued in June 2025

HbA1c inclusion range 7.0%–10.5% Baseline HbA1c criteria for COVALENT-111 T2D enrollment

BMI inclusion range 25–40 kg/m² Body mass index criteria for COVALENT-111 T2D patients

Icovamenib dosing 100 mg QD 8–12 wks; 100 mg BID 4 wks Three dosing regimens in COVALENT-111 trial arms

Market Reality Check

$1.17 Last Close

Volume Volume 1,404,469 is 15% above 20-day average 1,224,980, indicating elevated interest into the data update. normal

Technical Shares trade below the 200-day MA of 1.89, despite a 11.84% gain ahead of this update.

Peers on Argus 1 Up 1 Down

BMEA gained 11.84% while close biotech peers were mixed: CRBP (-0.19%), PYXS (-3.43%), EQ (-0.61%), KALA (-20.15%), ZNTL (+3.68%). Momentum scanner only flagged KALA and TARA with opposing directions, reinforcing a stock-specific move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 01	Conference presentation	Positive	-7.3%	Announced oral WCIRDC presentation of week 52 icovamenib data in T2D.
Dec 01	Inducement grant	Neutral	-7.3%	Single-employee stock option inducement award under 2023 Inducement Plan.
Nov 24	Investor conferences	Positive	+2.9%	Participation in Piper Sandler and Evercore healthcare conferences with webcasts.
Nov 10	Investor conference	Neutral	+0.0%	Jefferies London Healthcare Conference fireside chat and investor meetings.
Nov 05	Preclinical data	Positive	+6.3%	ObesityWeek data for BMF-650 and icovamenib combo showing metabolic benefits.

Pattern Detected

Recent history shows mixed reactions: preclinical efficacy updates and conference participation often aligned with gains, while recent icovamenib WCIRDC presentation news and an inducement grant coincided with notable downside moves.

Recent Company History

Over the last month, Biomea Fusion has focused on showcasing its diabetes and obesity pipeline. On Nov 5, preclinical data for BMF-650 and icovamenib at ObesityWeek 2025 coincided with a +6.35% move. Multiple conference participations in mid‑November and early December (Jefferies London, Piper Sandler, Evercore) saw flat to modestly positive reactions. However, on Dec 1 an announcement about this WCIRDC oral icovamenib presentation and a small inducement option grant both lined up with a -7.34% move. Today’s detailed COVALENT‑111 results build directly on that WCIRDC disclosure.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-08-05

The company has an active S-3 shelf filed on 2025-08-05, not yet effective, with at least two prospectus supplements (424B5) used on 2025-10-06 and 2025-10-07. This structure enables additional securities offerings in the future, as permitted under the shelf once effective.

Market Pulse Summary

This announcement highlights long‑term COVALENT‑111 data showing durable HbA1c and C‑peptide improvements 9 months after icovamenib dosing in insulin‑deficient type 2 diabetes, with a double‑blind, randomized, placebo‑controlled design and baseline HbA1c of 7.0%–10.5%. Recent filings show a Q3 $16.4M net loss and cash of $47.0M, plus October financings via warrant‑linked offerings under an active S-3. Investors may track further clinical readouts, financing actions, and how beta‑cell restoration data evolve.

Key Terms

glp-1 medical

"Treatment effect in GLP-1 “failures” continued to improve with durable and clinically significant improvements in HbA1c"

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

double-blind medical

"COVALENT-111 is a double-blind, randomized, placebo-controlled trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"COVALENT-111 is a double-blind, randomized, placebo-controlled trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. Not financial advice.

Durable Glycemic and C-Peptide Improvements with Icovamenib in Insulin-Deficient Type 2 Diabetes

SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data showed durable glycemic and c-peptide improvements with icovamenib, a menin inhibitor targeting beta-cell restoration in insulin deficient type 2 diabetes.

“I am very pleased that our data was selected for an oral presentation at the WCIRDC meeting this year. Over the past 24 months, our clinical studies have shown that selective inhibition of menin can meaningfully influence the clinical response of patients with insulin deficient diabetes. The results we presented at this meeting highlight the lasting and continuous benefits observed in in our study, with durable glycemic and C-peptide improvements 9 months after the last dose,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “Targeting menin offers promise for people living with diabetes, with the potential to support the natural insulin producing capacity of the pancreatic beta cells. Icovamenib, as a selective menin inhibitor, represents a first in class approach in this area of research.”

Key Highlights from WCIRDC showing HbA1c and C-peptide responses at week 52 – 9 months post the last dose:

• Icovamenib demonstrated durable and continuous treatment effect in severe insulin-deficient type 2 diabetes (T2D)
• Higher HbA1c reduction was associated with higher icovamenib exposure
• Icovamenib improved long-term insulin secretion in severe insulin-deficient T2D
• Treatment effect in GLP-1 “failures” continued to improve with durable and clinically significant improvements in HbA1c
• Icovamenib was generally well-tolerated, with no adverse-event related discontinuations and no related serious adverse events
  

The abstract will be published in the peer-reviewed Metabolism: Experimental and Clinical. The presentation will be available on Biomea Fusion's Investor Relations Page under the Events. Please find a link here to our website where the poster will be available.

COVALENT-111 Study Design
COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last 7 years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications. The study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks.

About Icovamenib
Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The proposed mechanism of action for icovamenib in diabetes is selective and partial inhibition of menin, a regulator of beta cell quantity and function, thereby enabling the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the first non-chronic therapy for T2D, icovamenib could become an important addition to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies.

About Biomea Fusion  
Biomea Fusion is a clinical-stage biopharmaceutical company advancing oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.

Visit us at www.biomeafusion.com and follow us on LinkedIn, X and Facebook. 

Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib and the potential of icovamenib as a treatment for T1D and T2D, and our expectations regarding the optimal dose and target patient population; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Food Effect Study (COVALENT-121), the initiation of our Phase IIb trial (COVALENT-211) in severe insulin-deficient type 2 diabetes patients, to initiate in fourth quarter of 2025 and the initiation of our Phase II trial with GLP-1 therapy (COVALENT-212) in type 2 diabetes patients, in the fourth quarter of 2025; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
ir@biomeafusion.com

FAQ

What did Biomea Fusion (BMEA) report from the COVALENT-111 trial on Dec 5, 2025?

Biomea reported durable HbA1c and C‑peptide improvements with icovamenib at week 52 (9 months post last dose) and an exposure‑response for HbA1c.

How safe was icovamenib in the COVALENT-111 results presented by BMEA?

Icovamenib was described as generally well tolerated with no related serious adverse events and no AE‑related discontinuations.

When and where will Biomea Fusion (BMEA) publish the COVALENT-111 abstract and presentation?

The abstract will be published in Metabolism: Experimental and Clinical and the presentation will be posted on Biomea Fusion’s investor relations page.

Which patients were included in the COVALENT-111 trial (BMEA)?

Adults with T2D diagnosed within the last 7 years, baseline HbA1c 7.0%–10.5%, and BMI 25–40 kg/m² who had inadequate glycemic control on up to three antidiabetic medications.

Did icovamenib show benefit for patients who failed GLP‑1 therapy in COVALENT-111?

Yes; treatment effect in prior GLP‑1 “failures” continued to improve with durable and clinically significant HbA1c improvements.

How was icovamenib dosed in the COVALENT-111 study reported by BMEA?

The trial tested three regimens: Arm A 100 mg QD for 8 weeks; Arm B 100 mg QD for 12 weeks; Arm C 100 mg QD for 8 weeks then 100 mg BID for 4 weeks.