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Biomea Fusion, Inc.

For the period ended Jun 30, 2026. Filed Aug 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 5, 2026

BMEA$0.57-3.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-11.

0001193125-26-217074

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0001193125-26-335085

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 124 previous paragraphs and 129 current paragraphs.

103 unchanged; 20 reworded; 4 added; 0 removed; 1 previous and 2 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (4)

Current report

Change in fair value of common warrant liability was $3.5 million for the six months ended June 30, 2026 and $0.2 million for the six months ended June 30, 2025, attributable to revaluation of the common warrants issued in connection with the June and October 2025 underwritten public offerings (see Note 5). The common warrants are re-measured at each balance sheet date.

Current report

Gain on sale of property and equipment was $0.0 million for the three months ended June 30, 2026 and June 30, 2025, respectively.

Current report

Interest and other income, net was $0.3 million for the three months ended June 30, 2026 and June 30, 2025, respectively.

Current report

Net cash provided by financing activities was $0.2 million during the six months ended June 30, 2026.
Reworded paragraphs (20)

Previous wording

With our strategic focus to become a diabetes and obesity medicines company, we are concluding our studies exploring icovamenib’s potential in oncology and plan to explore partnerships to further advance our oncology assets (BMF-500, a covalent inhibitor of FLT3, currently in a Phase I trial), while concentrating internal resources on metabolic disorders.

Current wording

With our strategic focus to become a diabetes and obesity medicines company, we discontinued our studies exploring icovamenib’s potential in oncology and plan to explore partnerships to further advance our oncology asset (BMF-500, a covalent inhibitor of FLT3), while concentrating internal resources on metabolic disorders.

Previous wording

In September 2025, we announced that BMF-650, our investigational, next-generation, oral small molecule glucagon-like peptide-1 GLP-1 receptor agonist (GLP-1 RA), received IND-clearance from the FDA. Our Phase I GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers is ongoing, and data is anticipated in the second quarter 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 obesity.

Current wording

In September 2025, we announced that BMF-650, our investigational, next-generation, oral small molecule glucagon-like peptide-1 GLP-1 receptor agonist (GLP-1 RA), received IND-clearance from the FDA. Our Phase I GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers is ongoing, with topline results expected in the third quarter of 2026. With its unique pharmacokinetic profile, enhanced oral bioavailability, and potential for rapid, one-step dose escalation, we believe BMF-650 has the potential to provide a best-in-class therapeutic option for obesity.

Previous wording

As of March 31, 2026, we had an accumulated deficit of $461.5 million. We incurred net losses of $12.4 million and $29.3 million for the three months ended March 31, 2026 and 2025, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of March 31, 2026, 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.

Current wording

As of June 30, 2026, we had an accumulated deficit of $469.8 million. We incurred net losses of $20.7 million and $50.0 million for the six months ended June 30, 2026 and 2025, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of June 30, 2026, without any future financing, will only be sufficient to fund our operations into the second 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 twelve months ended December 31, 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. We did not issue any shares of common stock or receive any proceeds under our 2022 ATM Program during the three months ended March 31, 2026.

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 twelve months ended December 31, 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. We did not issue any shares of common stock or receive any proceeds under our 2022 ATM Program during the six months ended June 30, 2026.

Previous wording

We expect our research and development expenses to increase substantially during the next few years as we seek to initiate and complete clinical trials, pursue regulatory approval of icovamenib and advance BMF-650 and our other programs through preclinical and clinical development. Predicting the timing or the final cost to complete our clinical program or validation of our manufacturing and supply processes is difficult and delays may occur because of many factors. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. To the extent that our product candidates continue to advance into clinical trials, as well as advance into larger and later stage clinical trials, our expenses will increase substantially and may become more variable.

Current wording

We expect our research and development expenses to increase substantially during the next few years as we seek to initiate and complete clinical trials, pursue regulatory approval of icovamenib and advance BMF-650 through preclinical and clinical development. Predicting the timing or the final cost to complete our clinical program or validation of our manufacturing and supply processes is difficult and delays may occur because of many factors. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. To the extent that our product candidates continue to advance into clinical trials, as well as advance into larger and later stage clinical trials, our expenses will increase substantially and may become more variable.

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, 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;

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, enrollment in our Phase I clinical trial for BMF-650, including an additional cohort announced in June 2026, 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

Gain on sale of property and equipment was $0.5 million for the three months ended March 31, 2026 and $0.0 for the three months ended March 31, 2025. The gain in the current period was attributable to proceeds from the sale of laboratory equipment.

Current wording

Gain on sale of property and equipment was $0.0 million and $0.5 million for the three and six months ended June 30, 2026, respectively. No gain on sale of property and equipment was recorded for the three and six months ended June 30, 2025. The gain in the current period was attributable to proceeds from the sale of laboratory equipment.

Previous wording

Comparison of the three months ended March 31, 2026 and 2025

Current wording

Comparison of the three and six months ended June 30, 2026 and 2025

Previous wording

Research and development expenses decreased by $13.8 million during the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The decrease of $7.6 million in external costs was primarily driven by a decrease of $3.8 million related to clinical activities, a decrease of $1.9 million related to preclinical and exploratory programs, and a decrease of $1.9 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $4.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs.

Current wording

Research and development expenses decreased by $7.4 million during the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The decrease of $3.2 million in external costs was primarily driven by a decrease of $1.5 million related to preclinical and exploratory programs, a decrease of $1.3 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.0 million of manufacturing costs, offset by an increase of $0.6 million related to clinical activities. Personnel-related expenses decreased by $2.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs.

Previous wording

General and administrative expenses decreased by $3.2 million during the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The decrease was 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 $1.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million.

Current wording

General and administrative expenses decreased by $1.1 million during the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The decrease was primarily driven by a decrease of $0.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.1 million.

Previous wording

Change in fair value of common warrant liability was $0.6 million for the three months ended March 31, 2026 and $0.0 for the three months ended March 31, 2025, attributable to revaluation of the common warrants issued in connection with the June and October 2025 underwritten public offerings (see Note 5). The common warrants are re-measured at each balance sheet date.

Current wording

Change in fair value of common warrant liability was $4.1 million for the three months ended June 30, 2026 and $0.2 million for the three months ended June 30, 2025, attributable to revaluation of the common warrants issued in connection with the June and October 2025 underwritten public offerings (see Note 5). The common warrants are re-measured at each balance sheet date.

Previous wording

Gain on sale of property and equipment was $0.5 million for the three months ended March 31, 2026 and $0.0 for the three months ended March 31, 2025. The gain in the current period was attributable to proceeds from the sale of laboratory equipment.

Current wording

Gain on sale of property and equipment was $0.5 million for the six months ended June 30, 2026 and $0.0 million for the six months ended June 30, 2025. The gain in the current period was attributable to proceeds from the sale of laboratory equipment.

Previous wording

Interest and other income, net was $0.4 million for the three months ended March 31, 2026 compared to $0.5 million for the three months ended March 31, 2025. The decrease of $0.1 million was primarily due to lower interest rates earned on cash and cash equivalents balance.

Current wording

Interest and other income, net was $0.7 million for the six months ended June 30, 2026 compared to $0.8 million for the six months ended June 30, 2025. The decrease of $0.1 million was primarily due to lower interest rates earned on cash and cash equivalents balance.

Previous wording

As of March 31, 2026, we had cash, cash equivalents, and restricted cash of $45.1 million and an accumulated deficit of $461.5 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, 2026, 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.

Current wording

As of June 30, 2026, we had cash, cash equivalents, and restricted cash of $35.2 million and an accumulated deficit of $469.8 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, 2026, will only be sufficient to fund our operations into the second 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

Net cash used in operating activities was $11.7 million during the three months ended March 31, 2026 and consisted of a net loss of $12.4 million offset by increase in net assets of $1.0 million and non-cash adjustments of $1.7 million. The increase in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $1.0 million, a decrease in accrued expenses and other current liabilities of $3.0 million and a decrease in operating lease liabilities of $0.4 million, offset by an increase in accounts payable of $1.4 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $1.6 million, gain on sale of property and equipment of $0.5 million and a non-cash loss on the change in fair value of warrant liability of $0.6 million.

Current wording

Net cash used in operating activities was $21.7 million during the six months ended June 30, 2026 and consisted of a net loss of $20.7 million offset by a decrease in net assets of $0.1 million and non-cash adjustments of $0.8 million. The decrease in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $1.0 million, a decrease in accrued expenses and other current liabilities of $0.1 million and a decrease in operating lease liabilities of $0.7 million, offset by an increase in other assets of $0.4 million and an increase in accounts payable of less than $0.1 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $3.2 million, gain on sale of property and equipment of $0.5 million and a non-cash gain on the change in fair value of warrant liability of $3.5 million.

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 provided by investing activities was $0.6 million during the three months ended March 31, 2026.

Current wording

Net cash provided by investing activities was $0.6 million during the six months ended June 30, 2026.

Previous wording

Net cash provided by financing activities was $0.0 million during the three months ended March 31, 2026.

Current wording

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

Previous wording

Net cash provided by financing activities was $3.3 million during the three months ended March 31, 2025 and relates to proceeds from of issuances of common stock under our 2022 ATM Program.

Current 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 from issuances of common stock and pre-funded warrants under the public offering and our 2022 ATM Program.

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 Estimates” in our Annual Report on Form 10-K filed with the SEC on March 24, 2026 and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the three months ended March 31, 2026, 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 24, 2026.

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 Estimates” in our Annual Report on Form 10-K filed with the SEC on March 24, 2026 and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the six months ended June 30, 2026, 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 24, 2026.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Research and development expenses decreased by $21.2 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decrease of $10.7 million in external costs was primarily driven by a decrease of $3.1 million related to clinical activities, a decrease of $3.4 million related to preclinical and exploratory programs, a decrease of $3.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.0 million of manufacturing costs. Personnel-related expenses decreased by $7.0 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $3.5 million due to a decrease in rent and facilities-related costs.

Current report — wording carried from elsewhere

General and administrative expenses decreased by $4.2 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decrease was primarily driven by a decrease of $2.7 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.3 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

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