Biomea Fusion, Inc.

Previous wording

In preclinical studies, the administration of icovamenib has produced a pronounced effect in preclinical models of diabetes, normalizing glucose levels during treatment and even after drug washout. As of March 31, 2025 icovamenib is being evaluated in type 1 and type 2 diabetes across two ongoing clinical trials. With its strategic focus to become a diabetes and obesity medicines company, we plan to conclude our studies exploring icovamenib’s potential in oncology and explore partnerships to further advance our oncology assets (BMF-500, a covalent inhibitor of FLT3, currently in a Phase I study), while concentrating internal resources on metabolic disorders.

Current wording

In preclinical studies, the administration of icovamenib has produced a pronounced effect in preclinical models of diabetes, normalizing glucose levels during treatment and even after drug washout. As of June 30, 2025 icovamenib is being evaluated in type 1 and type 2 diabetes across two ongoing phase II clinical trials. With our strategic focus to become a diabetes and obesity medicines company, we plan to conclude our studies exploring icovamenib’s potential in oncology and explore partnerships to further advance our oncology assets (BMF-500, a covalent inhibitor of FLT3, currently in a Phase I study), while concentrating internal resources on metabolic disorders.

Previous wording

Beyond icovamenib, we are utilizing our novel FUSION™ System to pioneer treatments against other high-value genetic drivers of disease. In October 2024, we announced the nomination of BMF-650 our investigational, next-generation, oral small molecule GLP-1 RA, which is currently advancing through IND-enabling studies. With its unique pharmacokinetic profile and enhanced bioavailability, we believe BMF-650 has the potential to provide a best-in-class therapeutic option for diabetes and obesity. Our goal is to utilize our capabilities and our FUSION™ System platform to become the leader in developing covalent small molecules to maximize the depth and durability of clinical benefit when treating various diseases.

Current wording

Beyond icovamenib, we are utilizing our novel FUSION™ System to pioneer treatments against other high-value genetic drivers of disease. In October 2024, we announced the nomination of BMF-650 our investigational, next-generation, oral small molecule GLP-1 receptor agonist, which is currently advancing through IND-enabling studies. With its unique pharmacokinetic profile and enhanced bioavailability, we believe BMF-650 has the potential to provide a best-in-class therapeutic option for diabetes and obesity. Our goal is to utilize our capabilities and our FUSION™ System platform to become the leader in developing covalent small molecules to maximize the depth and durability of clinical benefit when treating various diseases.

Previous wording

As of March 31, 2025, we had an accumulated deficit of $416.5 million. We incurred net losses of $29.3 million and $39.1 million for the three months ended March 31, 2025 and 2024, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of March 31, 2025, without any future financing, will not be sufficient to fund our operations into the fourth quarter of 2025. We expect to continue to incur significant expenses and operating losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

Current wording

As of June 30, 2025, we had an accumulated deficit of $437.3 million. We incurred net losses of $50.0 million and $76.3 million for the six months ended June 30, 2025 and 2024, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of June 30, 2025, without any future financing, will only be sufficient to fund our operations into the second half of 2026. We expect to continue to incur significant expenses and operating losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

Previous wording

In April 2021, we completed our initial public offering (IPO) and issued an aggregate of 9,000,000 shares of our common stock at a price of $17.00 per share. Subsequent to the close, an additional 823,532 shares were issued in connection with the partial exercise by the underwriters of their option to purchase additional shares of common stock. In addition, immediately prior to the closing of the IPO, all outstanding shares of our convertible preferred stock automatically converted into 7,064,925 shares of common stock. Proceeds from the IPO, net of underwriting discounts and commissions and offering costs were $152.8 million. On April 3, 2023, we issued and sold 5,750,000 shares of common stock, which included 750,000 shares sold pursuant to the exercise of the underwriters’ over-allotment option, at a public offering price of $30.00 per share in an underwritten public offering pursuant to a shelf registration on Form S-3. Our net proceeds from the offering were $161.8 million, after deducting underwriting discounts and commissions and offering costs of $10.7 million. During the three months ended March 31, 2025, we issued 1,261,537 shares of our common stock for aggregate proceeds of $3.3 million, net of commissions and offering costs from our 2022 ATM Program.

Current wording

In April 2021, we completed our initial public offering (IPO) and issued an aggregate of 9,000,000 shares of our common stock at a price of $17.00 per share. Subsequent to the close, an additional 823,532 shares were issued in connection with the partial exercise by the underwriters of their option to purchase additional shares of common stock. In addition, immediately prior to the closing of the IPO, all outstanding shares of our convertible preferred stock automatically converted into 7,064,925 shares of common stock. Proceeds from the IPO, net of underwriting discounts and commissions and offering costs were $152.8 million. On April 3, 2023, we issued and sold 5,750,000 shares of common stock, which included 750,000 shares sold pursuant to the exercise of the underwriters’ over-allotment option, at a public offering price of $30.00 per share in an underwritten public offering pursuant to a shelf registration on Form S-3. Our net proceeds from the offering were $161.8 million, after deducting underwriting discounts and commissions and offering costs of $10.7 million. During the six months ended June 30, 2025, we issued 2,271,122 shares of our common stock for aggregate proceeds of $4.9 million, net of commissions and offering costs from our 2022 ATM Program (as defined below).

Previous wording

Interest and other income, net consists primarily of interest earned on our investments.

Current wording

Interest and other income, net consists primarily of interest income earned on our cash and cash equivalents and revaluation of the common warrants issued in connection with the June 2025 underwritten public offering (see Note 5). The common warrants are re-measured at each balance sheet date.

Previous wording

Comparison of the three months ended March 31, 2025 and 2024

Current wording

Comparison of the three and six months ended June 30, 2025 and 2024

Previous wording

Research and development expenses decreased by $10.9 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease of $9.2 million in external costs was primarily driven by a decrease of $7.3 million related to clinical activities, a decrease of $1.8 million related to manufacturing costs and decrease of $1.0 million related to preclinical activities and exploratory programs. This decrease in external costs was partially offset by an increase of $0.9 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $1.7 million, including stock-based compensation, due to a decrease in headcount.

Current wording

Research and development expenses decreased by $26.1 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease of $20.6 million in external costs was primarily driven by a decrease of $16.4 million related to clinical activities, a decrease of $3.0 million related to preclinical and exploratory programs and a decrease of $1.9 million of manufacturing costs. This decrease in external costs was partially offset by an increase of $0.7 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $5.5 million, including stock-based compensation, due to a decrease in headcount.

Previous wording

General and administrative expenses decreased by $0.5 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease is primarily due to a decrease in personnel-related expenses, including stock-based compensation of $0.9 million, due to a decrease in headcount. The decrease is partially offset by an increase in professional and legal services of $0.4 million.

Current wording

General and administrative expenses decreased by $2.4 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease is primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.4 million related to professional and legal services.

Previous wording

We have funded our operations primarily through the sale and issuance of shares of our common and convertible preferred stock and the issuance of unsecured promissory notes from inception through December 2020, issuance of our common stock through our IPO in April 2021, our secondary public offering in March 2023 and through sales under our 2022 ATM Program.

Current wording

We have funded our operations primarily through the sale and issuance of shares of our common and convertible preferred stock, pre-funded and common warrants and the issuance of unsecured promissory notes from inception through December 2020, issuance of our common stock through our IPO in April 2021, our secondary public offerings in March 2023 and June 2025 secondary public offerings and through sales under our 2022 ATM Program.

Previous wording

On October 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf Registration Statement) with the SEC relating to the registration of up to an aggregate of $350.0 million in shares of our common stock, preferred stock, debt securities, warrants and units or any combination thereof. The Shelf Registration Statement was declared effective by the SEC on October 24, 2022. In April 2023, pursuant to the Shelf Registration Statement, we sold an aggregate of 5,750,000 shares of common stock at a price of $30.00 per share in an underwritten public offering for gross proceeds of $172.5 million, resulting in net proceeds of $161.8 million after deducting underwriting discounts, commissions, and offering costs.

Current wording

On October 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf Registration Statement) with the SEC relating to the registration of up to an aggregate of $350.0 million in shares of our common stock, preferred stock, debt securities, warrants and units or any combination thereof. The Shelf Registration Statement was declared effective by the SEC on October 24, 2022. In April 2023, pursuant to the Shelf Registration Statement, we sold an aggregate of 5,750,000 shares of common stock at a price of $30.00 per share in an underwritten public offering for gross proceeds of $172.5 million, resulting in net proceeds of $161.8 million after deducting underwriting discounts and commissions, and offering costs.

Previous wording

Additionally, we are party to an equity distribution agreement, dated November 25, 2022, with Piper Sandler & Co. (Piper Sandler) with respect to an ATM offering program (the 2022 ATM Program), under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (which is included in the $350.0 million originally registered under the Shelf Registration Statement) through Piper Sandler as the sales agent. Through March 31, 2025, we have received aggregate proceeds from our 2022 ATM Program of $3.3 million, net of commissions and offering costs, pursuant to the issuance of 1,261,537 shares. As of March 31, 2025, we have $96.7 million available under the 2022 ATM Program.

Current wording

Additionally, we are party to an equity distribution agreement, dated November 25, 2022, with Piper Sandler & Co. (Piper Sandler) with respect to an ATM offering program (the 2022 ATM Program), under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (which is included in the $350.0 million originally registered under the Shelf Registration Statement) through Piper Sandler as the sales agent. Through June 30, 2025, we have received aggregate proceeds from our 2022 ATM Program of $4.9 million, net of commissions and offering costs, pursuant to the issuance of 2,271,122 shares. As of June 30, 2025, we have $94.8 million available under the 2022 ATM Program.

Previous wording

As of March 31, 2025, we had cash, cash equivalents, and restricted cash of $36.2 million and an accumulated deficit of $416.5 million. We have incurred substantial operating losses and have used cash in our operating activities since inception. Without any future financing, the current operating plan under the existing cash and cash equivalents, and restricted cash as of March 31, 2025, will only be sufficient to fund our operations into the fourth quarter of 2025. Our ability to continue as a going concern will require us to obtain additional financing to fund our operations and there can be no assurance that additional financing will be available to us or that such financing, if available, will be available on terms acceptable to us. Accordingly, there is substantial doubt about our ability to continue as a going concern.

Current wording

As of June 30, 2025, we had cash, cash equivalents, and restricted cash of $56.6 million and an accumulated deficit of $437.3 million. We have incurred substantial operating losses and have used cash in our operating activities since inception. Without any future financing, the current operating plan under the existing cash and cash equivalents, and restricted cash as of June 30, 2025, will only be sufficient to fund our operations into the second half of 2026. Our ability to continue as a going concern will require us to obtain additional financing to fund our operations and there can be no assurance that additional financing will be available to us or that such financing, if available, will be available on terms acceptable to us. Accordingly, there is substantial doubt about our ability to continue as a going concern.

Previous wording

Net cash used in operating activities was $25.7 million during the three months ended March 31, 2025 and consisted of a net loss of $29.3 million offset by a decrease in net assets of $0.8 million and non-cash adjustments of $4.4 million. The decrease in net assets consisted primarily of an increase in accrued expenses and other current liabilities of $4.0 million, offset by a decrease in accounts payable of $5.2 million, decrease in prepaid expenses of $1.2 million and a decrease in operating lease liabilities of $0.8 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $3.2 million, operating lease expense of 0.8 million and depreciation expense of $0.5 million.

Current wording

Net cash used in operating activities was $44.9 million during the six months ended June 30, 2025 and consisted of a net loss of $50.0 million offset by a decrease in net assets of $2.9 million and non-cash adjustments of $8.0 million. The decrease in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $1.6 million, a decrease in other assets of $0.6 million, a decrease in accounts payable of $4.7 million and a decrease in operating lease liabilities of $1.7 million, offset by an increase in accrued expenses and other current liabilities of $1.3 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $5.7 million, operating lease expense of $1.6 million, depreciation expense of $0.9 million and a non-cash loss on the change in fair value of warrant liability of $0.2 million.

Previous wording

Net cash used in operating activities was $32.0 million during the three months ended March 31, 2024 and consisted of a net loss of $39.1 million, offset by an increase in net assets of $0.6 million and non-cash adjustments of $6.4 million. The increase in net assets consisted primarily of an increase in prepaid expenses and other current assets of $0.3 million, an increase in other assets of $1.2 million, a decrease in accounts payable of $2.2 million offset by an increase in accrued expenses and other current liabilities of $3.8 million, and an increase in operating lease liabilities of $0.5 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $5.0 million and operating lease expense of $1.0 million.

Current wording

Net cash used in operating activities was $64.7 million during the six months ended June 30, 2024 and consisted of a net loss of $76.3 million and decrease in net assets of $0.4 million, offset by non-cash adjustments of $12.1 million. The decrease in net assets consisted primarily of an increase in prepaid expenses and other current assets of $0.7 million, an increase in other assets of $1.2 million, a decrease in accounts payable of $1.1 million offset by an increase in accrued expenses and other current liabilities of $2.5 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $9.9 million, operating lease expense of $1.4 million and depreciation expense of $0.8 million.

Previous wording

Net cash used in investing activities was $0.0 million during the three months ended March 31, 2025,

Current wording

Net cash used in investing activities was $0.0 million during the six months ended June 30, 2025.

Previous wording

Net cash used in investing activities was $0.03 million during the three months ended March 31, 2024 and was primarily related to the purchase of property and equipment.

Current wording

Net cash used in investing activities was $0.1 million during the six months ended June 30, 2024 and was related to the purchase of property and equipment.

Previous wording

Net cash provided by financing activities was $0.1 million during the three months ended March 31, 2024 and relates to proceeds received from stock option exercises.

Current wording

Net cash provided by financing activities was $1.2 million during the six months ended June 30, 2024 and relates to proceeds received from stock option exercises and purchases under the employee stock purchase plan.

Previous wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K filed with the SEC on March 31, 2025 and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the three months ended March 31, 2025, except as described in Note 2 to the unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, there were no material changes to our critical accounting policies from those discussed in our Annual Report on Form 10-K filed with the SEC on March 31, 2025.

Current wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K filed with the SEC on March 31, 2025 and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the six months ended June 30, 2025, except as described in Note 2 to the unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, there were no material changes to our critical accounting policies from those discussed in our Annual Report on Form 10-K filed with the SEC on March 31, 2025.