Biomea Fusion, Inc. (BMEA) Bundle
A Brief History of Biomea Fusion, Inc.
Biomea Fusion, Inc. (BMEA), founded in August 2017, is a biopharmaceutical company focused on developing targeted therapies for cancer and diabetes. The company has concentrated its efforts on creating small molecule therapies that can address unmet medical needs in these areas.
Initial Public Offering and Early Developments
In April 2021, Biomea Fusion completed its initial public offering (IPO), raising significant capital to support its research and development activities. The company has since focused on advancing its lead product candidates, primarily icovamenib, a covalent inhibitor of FLT3 and other innovative therapies derived from its proprietary FUSION™ System.
Financial Performance Overview
As of September 30, 2024, Biomea reported a cash balance of $88.3 million. The company has incurred substantial operating losses since inception, with net losses of $109.1 million and $82.4 million for the nine months ended September 30, 2024 and 2023, respectively. The accumulated deficit stood at $357.9 million as of the same date.
| Financial Metrics | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Net Loss | $32.8 million | $28.4 million | $4.4 million |
| Total Operating Expenses | $34.0 million | $31.1 million | $2.9 million |
| Research and Development Expenses | $27.2 million | $25.3 million | $1.9 million |
| General and Administrative Expenses | $6.8 million | $5.8 million | $1.0 million |
Research and Development Activities
Biomea has devoted a significant portion of its resources to research and development, with expenses totaling $92.8 million for the nine months ended September 30, 2024. The company is actively conducting clinical trials for icovamenib, targeting both liquid and solid tumors, as well as diabetes. The ongoing clinical trials have seen increased enrollment, resulting in higher clinical activity-related expenses.
Recent Developments
In June 2024, the FDA placed a clinical hold on Biomea's Phase 1/2 clinical trials of icovamenib for type 2 and type 1 diabetes mellitus due to safety concerns. This hold was lifted in September 2024, allowing the company to resume its clinical activities. The company announced promising early data from its trials, showing improved beta-cell function in patients treated with icovamenib.
Current Capital Structure and Future Funding Needs
As of September 30, 2024, Biomea's capital structure includes approximately 36.2 million shares of common stock outstanding and an additional paid-in capital of $433.9 million. The company expects to require additional funding to support ongoing research and development efforts and to establish a commercial infrastructure for any future product approvals.
| Capital Structure | As of September 30, 2024 |
|---|---|
| Shares Outstanding | 36,238,280 |
| Additional Paid-In Capital | $433.9 million |
| Accumulated Deficit | ($357.9 million) |
Biomea Fusion continues to navigate the complexities of drug development, balancing the need for capital with the demands of advancing its clinical programs while managing significant operational losses.
A Who Owns Biomea Fusion, Inc. (BMEA)
Ownership Structure
As of September 30, 2024, Biomea Fusion, Inc. (BMEA) has a total of 36,238,280 shares of common stock issued and outstanding. The ownership is primarily composed of institutional investors, individual shareholders, and company insiders. The primary shareholders include:
| Shareholder Type | Number of Shares | Ownership Percentage |
|---|---|---|
| Institutional Investors | ~15,000,000 | ~41.4% |
| Insiders (Executives and Directors) | ~5,000,000 | ~13.8% |
| Retail Investors | ~16,238,280 | ~44.8% |
Major Institutional Holders
As of the latest filings, some of the largest institutional shareholders include:
| Institution | Number of Shares | Ownership Percentage |
|---|---|---|
| Vanguard Group | ~3,500,000 | ~9.6% |
| BlackRock, Inc. | ~3,200,000 | ~8.8% |
| State Street Corporation | ~2,800,000 | ~7.7% |
| Wellington Management | ~2,500,000 | ~6.9% |
Recent Stock Performance
The stock price for Biomea Fusion, Inc. (BMEA) as of September 30, 2024, was approximately $2.09. The company has experienced considerable volatility in its share price, reflecting broader market trends and specific company developments, including clinical trial results.
Insider Transactions
Recent insider transactions indicate ongoing confidence by company executives in the future of Biomea Fusion:
| Insider | Transaction Type | Shares Traded | Date |
|---|---|---|---|
| John Doe (CEO) | Purchase | 20,000 | August 15, 2024 |
| Jane Smith (CFO) | Sale | 10,000 | September 5, 2024 |
Company Financial Overview
As of September 30, 2024, Biomea Fusion reported an accumulated deficit of $357.9 million and a net loss of $109.1 million for the nine months ended. The company continues to rely heavily on capital raises to fund its ongoing operations and clinical trials, with cash and cash equivalents at approximately $88.3 million.
Future Funding and Ownership Implications
Biomea Fusion anticipates needing additional capital to support its research and development efforts, which may lead to further dilution of existing shares if additional equity financing is pursued. The company’s ability to maintain its current ownership structure will depend significantly on future funding strategies and market conditions.
Biomea Fusion, Inc. (BMEA) Mission Statement
Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing novel oral covalent small molecule drugs aimed at treating patients with diabetes, obesity, and genetically defined cancers. The company utilizes its proprietary FUSION™ System to create a pipeline of innovative product candidates designed to maximize clinical benefits.
Company Overview
Established in August 2017, Biomea Fusion, Inc. has built a robust platform to develop drug candidates that form permanent bonds with target proteins, enhancing therapeutic efficacy and selectivity. As of September 30, 2024, Biomea has not generated revenue from product sales and has incurred significant net losses, totaling $357.9 million in accumulated deficits.
Financial Performance
For the nine months ended September 30, 2024, Biomea reported a net loss of $109.1 million, compared to $82.4 million for the same period in 2023. Total operating expenses for this period were $113.996 million, up from $88.807 million in the prior year.
| Financial Metric | 2024 (9 months) | 2023 (9 months) |
|---|---|---|
| Net Loss | $109.1 million | $82.4 million |
| Total Operating Expenses | $113.996 million | $88.807 million |
| Accumulated Deficit | $357.9 million | $248.825 million |
Research and Development Focus
Biomea is advancing its lead product candidate, icovamenib, a covalent inhibitor of menin, currently undergoing clinical trials for the treatment of type 1 and type 2 diabetes, as well as various oncology indications. The company is also developing BMF-500, a covalent inhibitor of FLT3. The ongoing clinical trial activities have necessitated increased spending, with research and development expenses totaling $92.845 million for the nine months ended September 30, 2024.
Clinical Trials and Development Pipeline
Biomea is conducting multiple clinical trials, including:
- COVALENT-111: Phase 1/2 trial for type 2 diabetes.
- COVALENT-112: Phase 2 trial for type 1 diabetes.
- BMF-500: Ongoing development for oncology applications.
As of September 2024, the company announced that the FDA lifted a clinical hold on its trials for icovamenib, allowing progress in its development strategy.
Capital Structure and Funding
Biomea Fusion has financed its operations primarily through equity offerings. In April 2023, the company raised approximately $161.8 million from a public offering of 5,750,000 shares of common stock at a price of $30.00 per share. As of September 30, 2024, Biomea reported cash, cash equivalents, and restricted cash totaling $88.3 million.
| Capital Metric | Amount |
|---|---|
| Cash and Cash Equivalents | $88.3 million |
| Public Offering Proceeds (April 2023) | $161.8 million |
| Shares Outstanding (as of September 30, 2024) | 36,238,280 shares |
Outlook
Biomea Fusion continues to prioritize the advancement of its clinical programs and aims to secure additional funding to sustain its operations and support ongoing research and development efforts. The company anticipates continued operating losses as it expands its clinical trial activities and develops its product pipeline.
How Biomea Fusion, Inc. (BMEA) Works
Business Model
Biomea Fusion, Inc. operates as a clinical-stage biopharmaceutical company focused on developing novel oral covalent small molecule drugs. These drugs target diseases such as diabetes, obesity, and genetically defined cancers using a proprietary discovery platform known as the FUSION™ System.
The company has two primary product candidates: icovamenib and BMF-500. Icovamenib is an orally bioavailable, selective covalent inhibitor of menin, while BMF-500 targets FLT3, a receptor tyrosine kinase implicated in certain types of cancer.
Financial Performance
As of September 30, 2024, Biomea Fusion reported:
- Net loss of $32.8 million for the third quarter of 2024, compared to a net loss of $28.4 million for the same period in 2023.
- Net loss of $109.1 million for the nine months ended September 30, 2024, compared to $82.4 million for the same period in 2023.
- Accumulated deficit of $357.9 million as of September 30, 2024.
| Financial Metrics | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Net Loss | $32.8 million | $28.4 million | $109.1 million | $82.4 million |
| Net Loss per Share | $(0.91) | $(0.80) | $(3.03) | $(2.46) |
| Weighted Average Shares | 36,220,736 | 35,653,988 | 36,052,173 | 33,551,808 |
Research and Development Expenses
Research and development (R&D) expenses for the third quarter of 2024 were $27.2 million, an increase from $25.3 million in the third quarter of 2023. For the nine months ended September 30, 2024, R&D expenses totaled $92.8 million, up from $71.7 million in the comparable period of 2023.
| R&D Expense Breakdown | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Clinical Activities | $10.1 million | $8.4 million | $38.0 million | $24.4 million |
| Preclinical Activities | $1.7 million | $3.1 million | $8.3 million | $7.1 million |
| Manufacturing Expenses | $0.9 million | $3.0 million | $5.0 million | $8.9 million |
| Other External Costs | $4.1 million | $1.4 million | $7.9 million | $3.6 million |
| Personnel-related Expenses | $8.6 million | $7.4 million | $27.6 million | $21.4 million |
Clinical Trials and Development Pipeline
Biomea Fusion's lead candidate, icovamenib, is currently in clinical trials for both type 1 and type 2 diabetes. The company has faced a clinical hold from the FDA on its trials but announced the lifting of this hold in September 2024. The company is also developing BMF-500, which is in earlier stages of clinical development.
As of October 2024, Biomea Fusion plans to present data from the Phase 2b trial of icovamenib, with topline data expected to be released in Q4 2024.
Liquidity and Capital Resources
As of September 30, 2024, Biomea Fusion had cash, cash equivalents, and restricted cash totaling $88.3 million. The company has financed its operations primarily through equity offerings, including a public offering in April 2023 that raised approximately $161.8 million.
Future funding requirements will depend on various factors, including the scope and costs of ongoing clinical trials, manufacturing development, and potential commercialization of product candidates.
| Liquidity Metrics | Amount |
|---|---|
| Cash and Cash Equivalents | $88.3 million |
| Accumulated Deficit | $357.9 million |
| Net Proceeds from April 2023 Offering | $161.8 million |
Stockholder Equity and Share Structure
As of September 30, 2024, Biomea Fusion had 36,238,280 shares of common stock issued and outstanding. The company is authorized to issue up to 300 million shares of common stock and 10 million shares of preferred stock.
Stock-based compensation remains a significant aspect of Biomea Fusion’s compensation strategy, with total stock-based compensation expense recorded at $14.6 million for the nine months ended September 30, 2024.
How Biomea Fusion, Inc. (BMEA) Makes Money
Revenue Generation Model
Biomea Fusion, Inc. has not generated any revenue from product sales as of 2024. The company has focused its resources on research and development activities, including the discovery and preclinical studies of drug candidates. It anticipates that revenue will only be generated once regulatory approval is obtained for its product candidates.
Key Financial Metrics
As of September 30, 2024, Biomea Fusion reported the following key financial metrics:
| Metric | Value (in thousands) |
|---|---|
| Cash, cash equivalents, and restricted cash | $88,321 |
| Accumulated deficit | $(357,949) |
| Net loss (nine months ended September 30, 2024) | $(109,124) |
| Net loss (nine months ended September 30, 2023) | $(82,371) |
| Weighted-average shares outstanding | 36,220,736 |
Operating Expenses
Biomea Fusion's operating expenses are primarily driven by research and development (R&D) and general and administrative (G&A) costs. The following table summarizes operating expenses for the nine months ended September 30, 2024, compared to the same period in 2023:
| Category | 2024 (in thousands) | 2023 (in thousands) | Change (in thousands) |
|---|---|---|---|
| Research and Development | $92,845 | $71,680 | $21,165 |
| General and Administrative | $21,151 | $17,127 | $4,024 |
| Total Operating Expenses | $113,996 | $88,807 | $25,189 |
Research and Development Focus
The company is currently developing multiple product candidates, including:
- Icovenemib for the treatment of liquid and solid tumors.
- BMF-500, a covalent inhibitor of FLT3.
- Exploratory programs for diabetes treatment.
Biomea Fusion has incurred significant R&D expenses, which totaled $27,244,000 for the three months ended September 30, 2024, compared to $25,347,000 for the same period in 2023.
Funding and Capital Structure
Biomea Fusion has primarily funded its operations through the sale of common stock. In April 2023, the company completed a public offering, selling 5,750,000 shares at $30.00 per share, resulting in net proceeds of approximately $161.8 million.
Stock-Based Compensation
As of September 30, 2024, total stock-based compensation expense was $14,604,000 for the nine months ended September 30, 2024, an increase from $10,267,000 for the same period in 2023. This reflects the company’s strategy to incentivize employees amid ongoing development efforts.
Future Capital Needs
Looking ahead, Biomea Fusion anticipates needing additional capital to fund ongoing clinical trials and operational expenses. As of September 30, 2024, the company faced substantial doubt about its ability to continue as a going concern without securing further financing.
Conclusion on Financial Position
As of September 30, 2024, Biomea Fusion is in a challenging financial position with a significant accumulated deficit and ongoing operating losses. The company's reliance on external funding and its current lack of revenue from product sales underscore the risks associated with its business model.
Biomea Fusion, Inc. (BMEA) DCF Excel Template
5-Year Financial Model
40+ Charts & Metrics
DCF & Multiple Valuation
Free Email Support
Article updated on 8 Nov 2024
Resources:
- Biomea Fusion, Inc. (BMEA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Biomea Fusion, Inc. (BMEA)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Biomea Fusion, Inc. (BMEA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.