Biomea Fusion, Inc. Stock Price, News & Analysis

Biomea Fusion announced that its compensation committee granted stock options to one new employee on December 2, 2024. The grant includes options to purchase 30,000 shares of common stock, which will vest quarterly over four years at a rate of 1/16. The grant was made under Biomea's 2023 Inducement Equity Plan, adopted on November 17, 2023, and serves as an inducement for employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Biomea Fusion presented new analysis from COVALENT-111 trial at ATTD-ASIA 2024, showing promising results for icovamenib in Type 2 Diabetes (T2D) treatment. The study revealed that insulin-deficient patients (approximately 50% of the population) showed a greater mean HbA1c reduction (-1.23% vs -0.48%) compared to insulin-resistant patients at Week 26, following 4 weeks of dosing.

Notable case studies included a 29-year-old patient achieving a 2.5% HbA1c reduction and a 45-year-old patient showing a 1.1% reduction, both with significant improvements in HOMA-B and C-peptide levels. The company expects topline results from the Phase IIb expansion portion, involving over 200 T2D patients, in December.

Biomea Fusion announced that its compensation committee granted stock options to one new employee on November 1, 2024. The grant includes options to purchase 6,500 shares of common stock, which will vest quarterly over four years at a rate of 1/16. The award was made under Biomea's 2023 Inducement Equity Plan and granted as an inducement for employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Biomea Fusion presented preclinical data showing that icovamenib (BMF-219) enhanced the effectiveness of GLP-1-based therapies in diabetes treatment. Ex vivo human islet experiments demonstrated increased insulin secretion when icovamenib was combined with tirzepatide or semaglutide. The company plans to initiate a Phase II study (COVALENT-211) combining icovamenib with GLP-1-based therapy in 2025.

Additionally, Biomea introduced BMF-650, a next-generation oral small-molecule GLP-1 receptor agonist candidate, which showed promising preclinical results including improved glucose-stimulated insulin secretion, better glucose control, and appetite suppression in cynomolgus monkeys.

Biomea Fusion reported Q3 2024 financial results and corporate updates. The FDA lifted clinical holds on COVALENT-111 (Type 2 Diabetes) and COVALENT-112 (Type 1 Diabetes) trials. The company expects topline data from both studies in December 2024. Cash position stood at $88.3 million as of September 30, 2024. Q3 net loss was $32.8 million, with R&D expenses at $27.2 million and G&A expenses at $6.8 million. The company plans to announce its third clinical candidate, BMF-650, an oral GLP-1 receptor agonist for diabetes and obesity treatment.

Biomea Fusion (Nasdaq: BMEA) announced that the World Health Organization (WHO) has approved "icovamenib" as the International Nonproprietary Name (INN) for its lead product candidate BMF-219. The United States Adopted Name Council has also adopted this name as the United States Adopted Name (USAN). Icovamenib is an oral covalent menin inhibitor in clinical development, investigating its impact on insulin-producing beta cells.

The suffix '-menib' denotes a menin inhibitor. INNs and USANs are unique, globally recognized names for pharmaceutical drugs or active ingredients, ensuring safety, consistency, and logic in medication naming. Biomea will use "icovamenib" in future presentations, publications, and public statements as it advances the clinical development of this product candidate.

Biomea Fusion (Nasdaq: BMEA) has announced a conference call and webcast scheduled for Wednesday, October 30th at 4:30 pm ET. The event will focus on two key announcements:

1. Introduction of BMF-650, their lead clinical candidate, described as a next-generation, potent, selective, oral small-molecule GLP-1 receptor agonist (GLP-1 RA).

2. Presentation of preclinical study results examining the synergistic benefits of combining BMF-219 with a GLP-1 RA-based therapy.

The webcast will be accessible to registered attendees through Biomea's investor website. A replay will be available after the event.

Biomea Fusion (Nasdaq: BMEA) will present at the 1st Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) in Singapore, November 18-20, 2024. The company will showcase data from its COVALENT-111 and COVALENT-112 diabetes clinical trials in three presentations.

The presentations will focus on:

• A Phase 2 trial of oral menin inhibitor BMF-219 in Type 2 Diabetes patients (COVALENT-111)
• Case studies of BMF-219 in poorly controlled severe insulin-deficient Type 2 Diabetes
• A Phase 2 trial of BMF-219 in Type 1 Diabetes patients (COVALENT-112)

BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells. Dr. Juan P. Frias will deliver all three presentations, scheduled for November 19-20, 2024.

Biomea Fusion, Inc. (Nasdaq: BMEA) has announced the formation of a Global Scientific Advisory Board (SAB) comprising 22 world-renowned diabetes experts from 11 countries. The SAB will collaborate with Biomea's leadership to advance menin science and beta cell biology, focusing on the development of BMF-219, an investigational covalent menin inhibitor designed to regenerate insulin-producing beta cells.

The SAB, chaired by Dr. Rohit N. Kulkarni, includes prominent figures in diabetes research and therapeutics. They will provide strategic guidance for BMF-219's clinical development and explore its potential as both a monotherapy and in combination with standard care agents. The board's expertise spans various aspects of diabetes management, including beta cell science, clinical trial design, and global diabetes care practices.

This initiative aims to leverage the SAB's collective knowledge to optimize Biomea's clinical development and commercialization strategies for BMF-219, potentially revolutionizing diabetes treatment by addressing beta cell dysfunction, a root cause of the disease.