BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells

• Two trial-in-progress oral presentations to feature Phase II study design of oral covalent menin inhibitor BMF-219 in patients with type 2 diabetes (COVALENT-111) and in patients with type 1 diabetes (COVALENT-112)
• One late breaker oral presentation to highlight two case studies assessing BMF-219 in persons with poorly controlled severe insulin-deficient (SIDD) type 2 diabetes

REDWOOD CITY, Calif., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced the attendance at the 1^st Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024), taking place in Singapore, 18-20 November 2024. Data from the company's COVALENT-111 and COVALENT-112 diabetes clinical trials will be featured during a long oral presentation and two short oral presentations.

Biomea will disclose additional information about the presentations in accordance with the ATTD-Asia abstract embargo policies.

Accepted ATTD-Asia 2024 Abstract Titles

• Abstract Title: COVALENT-111: A Phase 2 Trial of the Oral Menin Inhibitor BMF-219 in Patients with Type 2 Diabetes
  Session Name: 0542 - Short Oral Session 06: In-Hospital Glucose Monitoring and Advanced Medical Technologies & Trials in Progress
  Presentation Type: Short Oral Presentation
  Presentation Time: Tue, 11/19/24, 12:55 – 13:00 SGT
  Presenter: Juan P. Frias

• Abstract Title: Assessment of BMF-219 in Persons with Poorly Controlled Severe Insulin-Deficient (SIDD) Type 2 Diabetes (T2D): COVALENT-111 Case Studies
  Session Name: 0542 - Short Oral Session 06: In-Hospital Glucose Monitoring and Advanced Medical Technologies & Trials in Progress
  Presentation Type: Short Oral Late Breaker Presentation
  Presentation Time: Tue, 11/19/24, 13:00 – 13:05 SGT
  Presenter: Juan P. Frias

• Abstract Title: COVALENT-112: A Phase 2 Trial of the Oral Menin Inhibitor BMF-219 in Type 1 Diabetes
  Session Name: 0740 - Oral Presentation Session 08 (ID 54)
  Presentation Type: Long Oral Presentation
  Presentation Time: Wed, 11/20/24, 11:25 - 11:35 SGT
  Presenter: Juan P. Frias

About COVALENT-111
COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy patients were enrolled in single ascending dose cohorts to evaluate safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by standard of care medicines. Once the Escalation Phase of COVALENT-111 was completed, the study advanced into an Expansion Phase consisting of multiple cohorts dosing type 2 diabetes patients up to 12 weeks with either BMF-219 or placebo, followed by a 40-week off treatment period. To date, approximately 200 patients completed their respective dosing period prior to the FDA placing the study on hold. Additional information about this Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

About COVALENT-112
COVALENT-112 is a multi-site, randomized, double-blind, placebo-controlled Phase II study in adults with stage 3 type 1 diabetes. This stage describes the period following clinical diagnosis of type 1 diabetes when symptoms are present due to significant beta cell loss. COVALENT-112 consists of a multi-arm trial comparing two different doses of BMF-219 to placebo to evaluate the efficacy, safety, and durability of BMF-219 in adults with type 1 diabetes. Approximately 150 patients will be enrolled in the trial and will receive either BMF-219 or placebo over 12 weeks, followed by a 40-week off treatment period. This trial also includes an open-label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open-label portion (n=40) is examining the efficacy, safety, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg over a 12-week treatment period followed by a 40-week off treatment period. To date, approximately 20 patients completed 8 weeks of dosing in the open label portion prior to the FDA placing the study on hold. Additional information about the Phase II clinical trial of BMF-219 in type 1 diabetes can be found at ClinicalTrials.gov using the identifier NCT06152042.

About Biomea Fusion
Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.

Visit us at 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 BMF-219, the potential of BMF-219 as a treatment for type 2 and type 1 diabetes, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including COVALENT-111 and COVALENT 112, our plans to address the matters raised in the FDA’s clinical hold letter, our ability to resolve the clinical hold on a timely basis, or at all, the availability of data from our clinical trials 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 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 (the “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:

Investor Relations

Chunyi Zhao, PhD
Associate Director of Investor Relations & Corporate Development
czhao@biomeafusion.com

Media Relations
Neera Chaudhary
nchaudhary@biomeafusion.com