Biomea Fusion, Inc.

Previous wording

Our lead clinical program’s drug candidate, icovamenib, is currently being developed as an orally bioavailable, and selective covalent inhibitor of menin in two clinical and multiple preclinical studies, investigating icovamenib’s potential in type 1 and type 2 diabetes, as well as its impact in obesity. Menin serves as a checkpoint to prevent beta cell proliferation. Thus, we believe inhibiting menin via icovamenib has the potential to enable the proliferation, preservation, and reactivation of healthy, function beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 1 and type 2 diabetes. Menin is also an important transcriptional regulator known to play a direct role in oncogenic signaling in multiple cancers and in beta cell homeostasis.

Current wording

Our lead clinical program’s drug candidate, icovamenib, is currently being developed as an orally bioavailable, and selective covalent inhibitor of menin in two clinical and multiple preclinical studies, investigating icovamenib’s potential in type 1 and type 2 diabetes, as well as its impact in obesity. Menin serves as a checkpoint to prevent beta cell proliferation. Thus, we believe inhibiting menin via icovamenib has the potential to enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 1 and type 2 diabetes. Menin is also an important transcriptional regulator known to play a direct role in oncogenic signaling in multiple cancers and in beta cell homeostasis.

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 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.

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 September 30, 2025 icovamenib is being evaluated in type 1 and type 2 diabetes across two ongoing phase II clinical trials. In October 2025, we reported 52-week results from our Phase II COVALENT-111 trial of icovamenib in type 2 diabetes. With our strategic focus to become a diabetes and obesity medicines company, we are concluding 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 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.

Current wording

Beyond icovamenib, we are utilizing our novel FUSION™ System to pioneer treatments against other high-value genetic drivers of disease. In September 2025, we announced that BMF-650, our investigational, next-generation, oral small molecule GLP-1 receptor agonist (RA), received IND-clearance from the FDA. Initiation of our Phase I trial (GLP-131) for BMF-650 in obese, otherwise healthy volunteers is ongoing, and data is anticipated in the first half of 2026 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 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.

Current wording

As of September 30, 2025, we had an accumulated deficit of $453.7 million. We incurred net losses of $66.4 million and $109.1 million for the nine months ended September 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 September 30, 2025, without any future financing, will only be sufficient to fund our operations into the first quarter of 2027. 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 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).

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 nine months ended September 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.

Previous wording

In June 2025, we issued and sold 19,450,000 shares of common stock at an offering price of $2.00 per share and, to a certain investor in lieu of common stock, pre-funded warrants to purchase up to 550,000 shares of common stock at an offering price of $1.9999 per share, and accompanying common warrants to purchase up to 23,000,000 shares of common stock at a per share exercise price of $2.50. In July 2025, in connection with the completed underwritten public offering, the underwriters partially exercised their over-allotment option to purchase an additional 1,381,262 shares of common stock. The aggregate gross proceeds from the offering were approximately $42.8 million, before deducting underwriting discounts and commissions and offering costs.

Current wording

In June 2025, we issued and sold 19,450,000 shares of common stock at an offering price of $2.00 per share and, to a certain investor in lieu of common stock, pre-funded warrants to purchase up to 550,000 shares of common stock at an offering price of $1.9999 per share, and accompanying common warrants to purchase up to 23,000,000 shares of common stock at a per share exercise price of $2.50. In July 2025, in connection with the June 2025 underwritten public offering, the underwriters partially exercised their over-allotment option to purchase an additional 1,381,262 shares of common stock at an offering price of $2.00 per share. The aggregate gross proceeds from the offering, including the proceeds from the underwriters' over-allotment option, were approximately $42.8 million, before deducting underwriting discounts and commissions and offering costs.

Previous wording

the scope, rate of progress, expense and results of our ongoing clinical trials, including our ongoing Phase II clinical trial of icovamenib in type 2 diabetes and Phase II clinical trial of icovamenib in type 1 diabetes, our preclinical development activities for BMF-650, as well as any future preclinical development and clinical trials of our product candidates, and other research and development activities we may conduct;

Current wording

the scope, rate of progress, expense and results of our ongoing clinical trials, including our ongoing Phase II clinical trial of icovamenib in type 2 diabetes and Phase II clinical trial of icovamenib in type 1 diabetes, enrollment in our Phase I clinical trial for BMF-650, as well as any future preclinical development and clinical trials of our product candidates, and other research and development activities we may conduct;

Previous wording

maintaining a continued acceptable safety profile of our product candidates following approval, if any, of any of our product candidates;

Current wording

our ability to maintain a continued acceptable safety profile of our product candidates following approval, if any, of any of our product candidates;

Previous wording

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

Current wording

Comparison of the three and nine months ended September 30, 2025 and 2024

Previous 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.

Current wording

Research and development expenses decreased by $12.8 million during the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease of $7.4 million in external costs was primarily driven by a decrease of $4.7 million related to clinical activities, a decrease of $2.6 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $0.5 million related to preclinical and exploratory programs. This decrease in external costs was partially offset by an increase of $0.5 million in manufacturing costs. Personnel-related expenses decreased by $4.8 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $0.7 million due to a decrease in rent and facilities-related costs.

Previous wording

Research and development expenses decreased by $15.3 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease of $11.4 million in external costs was primarily driven by a decrease of $9.1 million related to clinical activities, a decrease of $2.0 million related to preclinical and exploratory programs, a decrease of $0.1 million of manufacturing costs and a decrease of $0.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $3.8 million, including stock-based compensation, due to a decrease in headcount.

Current wording

Research and development expenses decreased by $39.0 million during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease of $28.0 million in external costs was primarily driven by a decrease of $21.1 million related to clinical activities, a decrease of $3.6 million related to preclinical and exploratory programs, a decrease of $2.0 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.3 million in manufacturing costs. Personnel-related expenses decreased by $10.2 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $0.7 million due to a decrease in rent and facilities-related costs.

Previous 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.

Current wording

General and administrative expenses decreased by $2.6 million during the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was primarily driven by a decrease of $2.5 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.1 million related to facilities-related costs.

Previous wording

General and administrative expenses decreased by $2.8 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease is primarily driven by a decrease of $2.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. The decrease is partially offset by an increase in facilities-related costs of $0.1 million.

Current wording

General and administrative expenses decreased by $5.4 million during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily driven by a decrease of $5.4 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount.

Previous 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.

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, June 2025 and October 2025 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 and commissions, and offering costs.

Current wording

On October 14, 2022, we filed the 2022 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 2022 Registration Statement was declared effective by the SEC on October 24, 2022. In April 2023, pursuant to the 2022 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. On August 5, 2025, we filed the 2025 Registration Statement with the SEC relating to the registration of up to an aggregate of $300.0 million in shares of our common stock, preferred stock, debt securities, warrants and units or any combination thereof to replace the 2022 Registration Statement. The 2025 Registration Statement was declared effective by the SEC on August 15, 2025.

Previous wording

In June 2025, we completed an underwritten public offering, in which we issued and sold 19,450,000 shares of common stock at an offering price of $2.00 per share and to a certain investor in lieu of common stock, pre-funded warrants to purchase up to 550,000 shares of common stock at an offering price of $1.9999 per share, and accompanying common warrants to purchase up to 23,000,000 shares of common stock at a per share exercise price of $2.50. Our net proceeds from the offering were approximately $37.2 million, after deducting underwriting discounts and commissions and offering costs of approximately $2.8 million.

Current wording

In June 2025, we completed an underwritten public offering, in which we issued and sold 19,450,000 shares of common stock at an offering price of $2.00 per share and to a certain investor in lieu of common stock, pre-funded warrants to purchase up to 550,000 shares of common stock at an offering price of $1.9999 per share, and accompanying common warrants to purchase up to 23,000,000 shares of common stock at a per share exercise price of $2.50. Our net proceeds from the offering were approximately $37.2 million, after deducting underwriting discounts and commissions and offering costs of approximately $2.8 million. In July 2025, in connection with the June 2025 underwritten public offering, the underwriters partially exercised their over-allotment option to purchase an additional 1,381,262 shares of common stock at an offering price of $2.00 per share. The net proceeds from the offering pursuant to the over-allotment option were approximately $2.6 million, after deducting underwriting discounts and commissions and offering costs of approximately $0.2 million.

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 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.

Current wording

Additionally, we are party to an equity distribution agreement, dated November 25, 2022, with Piper Sandler with respect to 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 was included in the $350.0 million originally registered under the 2022 Registration Statement and is now included in the $300.0 million originally registered under the 2025 Registration Statement) through Piper Sandler as the sales agent. Through September 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 September 30, 2025, we have $94.8 million available under the 2022 ATM Program.

Previous 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.

Current wording

As of September 30, 2025, we had cash, cash equivalents, and restricted cash of $47.0 million and an accumulated deficit of $453.7 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 September 30, 2025, will only be sufficient to fund our operations into the first quarter of 2027. 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

the scope, timing, progress, duration, costs and results of our drug discovery, preclinical development activities, laboratory testing and clinical trials for our product candidates;

Current wording

the scope, timing, progress, duration, costs and results of our clinical trials, drug discovery, preclinical development activities and laboratory testing for our product candidates;

Previous 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.

Current wording

Net cash used in operating activities was $56.4 million during the nine months ended September 30, 2025 and consisted of a net loss of $66.4 million offset by a decrease in net assets of $1.2 million and non-cash adjustments of $8.8 million. The decrease in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $7.3 million, a decrease in other assets of $0.6 million, a decrease in accounts payable of $6.5 million and a decrease in operating lease liabilities of $1.9 million, offset by an increase in accrued expenses and other current liabilities of $1.7 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $7.7 million, operating lease expense of $1.7 million, depreciation expense of $1.4 million, impairment of property and equipment of $2.2 million and a non-cash gain on the change in fair value of warrant liability of $4.1 million.

Previous 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.

Current wording

Net cash used in operating activities was $89.9 million during the nine months ended September 30, 2024 and consisted of a net loss of $109.1 million offset by an increase in net assets of $1.3 million and non-cash adjustments of $18.0 million. The increase in net assets consisted primarily of an increase in prepaid expenses and other current assets of $3.3 million, a decrease in other assets of $0.9 million, an increase in accounts payable of $2.1 million, an increase in accrued expenses and other current liabilities of $2.4 million and a decrease in operating lease liabilities of $0.7 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $14.6 million, operating lease expense of $2.1 million and depreciation expense of $1.3 million.

Previous wording

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

Current wording

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

Previous 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.

Current wording

Net cash used in investing activities was $0.3 million during the nine months ended September 30, 2024 and was primarily related to the purchase of property and equipment.

Previous wording

Net cash provided by financing activities was $42.8 million during the six months ended June 30, 2025 and primarily relates to net proceeds of $42.8 million from issuances of common stock and pre-funded warrants under the public offering and the 2022 ATM Program.

Current wording

Net cash provided by financing activities was $44.8 million during the nine months ended September 30, 2025 and primarily relates to net proceeds of $44.7 million from issuances of common stock and pre-funded warrants under the public offering and the 2022 ATM Program, and $0.1 million of proceeds from stock option exercises and purchases under the employee stock purchase plan.

Previous 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.

Current wording

Net cash provided by financing activities was $1.3 million during the nine months ended September 30, 2024 and relates to proceeds received from stock option exercises and purchases under the 2021 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 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.

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 nine months ended September 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.