Bioma Fusion is a clinical-stage biotechnology company specializing in covalent small molecule drugs for metabolic diseases like diabetes and obesity, with a focus on innovative drug discovery platforms and pipeline candidates in clinical development.

# Company Overview: Biomea Fusion, Inc.

## Business Focus
- **Industry:** Biotechnology / Pharmaceuticals
- **Stage:** Clinical-stage company
- **Core Mission:** Focused on discovering and developing oral covalent small molecule drugs to treat metabolic diseases, primarily diabetes and obesity, with the goal of providing therapies that could potentially cure these conditions.

## Technology and Approach
- **Type of Drugs:** Covalent small molecules that form permanent bonds with target proteins.
- **Advantages of Covalent Drugs:** Greater selectivity, lower systemic exposure, deeper and more durable responses.
- **Discovery Platform:** Proprietary **FUSION™ System** utilizing artificial intelligence (AI), virtual reality (VR), and custom synthesis to identify and develop covalent inhibitors against disease-driving proteins, especially in metabolic disorders.

## Key Product Candidates
- **Icovamenib:** 
  - Developed as a selective covalent inhibitor of menin.
  - Intended to induce beta cell proliferation and enhance insulin secretion in diabetes (both type 1 and type 2).
  - Significant clinical data: A Phase II study (COVALENT-111) showed a statistically significant HbA1c reduction of 0.84%, with durable effects extending beyond active treatment.
  - Currently in ongoing clinical trials, including Phase IIb.

- **BMF-650:**
  - Next-generation oral GLP-1 receptor agonist.
  - Showed promising preclinical results such as improved glucose-stimulated insulin secretion, weight loss (11.5%), and appetite suppression.
  - IND-enabling studies underway; IND submission planned for 2H 2025.

- **BMF-500:**
  - Covalent inhibitor of FLT3, in clinical development for relapsed or refractory acute leukemia.
  - First patient dosed in October 2023.

- **Strategic Shift:** 
  - Discontinued oncology programs in early 2025 to focus on metabolic disorders.
  - Leading efforts in diabetes and obesity, aiming to develop therapies that modify disease progression.

## Company Size and Financials (as of December 31, 2024)
- **Employees:** Approximately 80 employees.
- **Market Capitalization:** Approximate market value of $124.1 million, based on the closing share price on June 30, 2024.
- **Shares Outstanding:** 37,572,250 shares as of March 24, 2025.
- **Revenue:** $0 (no products approved and no revenue generated).
- **Net Income:** Loss of approximately $138.4 million for the year ended December 31, 2024.
- **Total Assets / Cash:** 
  - Cash, cash equivalents, and restricted cash as of December 31, 2024: approx. $58.6 million.
- **Stockholders' Equity:** Significant accumulated deficit of $387.3 million.

## Business Strategy
- Develop targeted covalent therapies with potential first-in-class or best-in-class status.
- Prioritize icovamenib for diabetes and metabolic diseases, especially in insulin-deficient populations.
- Advance pipeline with BMF-650 in obesity and type 2 diabetes, with IND planned.
- Seek collaborations to accelerate development and gain market reach.
- Build internal capabilities for commercialization, including sales and marketing, if approved.

## Summary
- **Bioma Fusion** is a biotechnology company specializing in covalent small molecule drugs for metabolic diseases, aiming to create durable disease-modifying therapies. It has a small but growing team, significant R&D resources, and a pipeline that includes clinical-stage candidates targeting diabetes, obesity, and leukemia. The company has not yet generated revenue or gone through regulatory commercialization, but operates with a focused strategy on innovative covalent drug platforms.

Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing covalent small molecule drugs for metabolic diseases and genetically defined cancers.

# Company Overview

**Company Name: Biomea Fusion, Inc.**

## General Business Description
Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company founded in August 2017. The company is dedicated to the discovery and development of oral covalent small molecule drugs specifically targeting metabolic diseases and genetically defined cancers. Covalent small molecule drugs create permanent bonds with their target proteins, potentially offering advantages such as greater target selectivity, lower systemic exposure, and enhanced therapeutic responses compared to conventional non-covalent drugs.

## Key Technologies and Product Candidates
- **FUSION™ System**: A proprietary discovery platform that enables the development of novel covalent small molecules.
- **Lead Product Candidate – BMF-219**: 
  - An orally available, potent, and selective covalent inhibitor of menin.
  - Target indications include type 1 diabetes, type 2 diabetes, and various liquid and solid tumors.
  - Currently undergoing Phase 2 clinical trials in type 1 (COVALENT-112) and type 2 diabetes (COVALENT-111).
  
- **Second Product Candidate – BMF-500**: 
  - A covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3).
  - Recently started clinical trials in relapsed or refractory acute leukemia (COVALENT-103).

## Employee and Financial Information
- **Employees**: As of December 31, 2023, Biomea has approximately **103 full-time employees**, with **78 engaged in research and development** activities.
- **Revenue**: Biomea Fusion, Inc. has **not generated any revenue** to date as it continues to focus on clinical trials.
- **Losses**: The company has incurred significant net losses, reporting **$117.3 million** for the year ended December 31, 2023, and an **accumulated deficit of $248.8 million** as of the same date.
- **Clinical Trials**: Biomea is actively conducting clinical trials for both BMF-219 and BMF-500, including:
  - COVALENT-111 (Type 2 Diabetes)
  - COVALENT-112 (Type 1 Diabetes)
  - COVALENT-101 (Liquid tumors)
  - COVALENT-102 (Solid tumors)
  - COVALENT-103 (Relapsed or refractory acute leukemia)

## Strategic Focus
Biomea's strategic focus is on leveraging its FUSION™ System to become a leader in developing covalent small molecules, maximizing clinical efficacy, and addressing substantial unmet medical needs in oncology and metabolic disease management.

## Conclusion
Biomea Fusion, Inc. is positioned at the forefront of biopharmaceutical innovation, capitalizing on expertise in covalent drug development, with ongoing clinical trials and a robust pipeline aimed at improving patient outcomes in complex diseases.

Biomea Fusion, Inc.

10-K / March 31, 2025

10-K / March 28, 2024

10-K / March 31, 2025

Company Overview: Biomea Fusion, Inc.

Business Focus

Technology and Approach

Key Product Candidates

Company Size and Financials (as of December 31, 2024)

Business Strategy

Summary