Biomea Fusion, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company focused on the discovery and development of novel oral covalent small molecule drugs to treat patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule drug is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. Leveraging our extensive expertise in covalent binding chemistry and development, we built our proprietary FUSION™ System discovery platform to advance a pipeline of novel covalent small molecule product candidates. Our goal is to utilize our capabilities and FUSIONTM System to become the leader in developing covalent small molecules to maximize the depth and durability of clinical benefit when treating various diseases. To date we have announced two clinical development candidates, icovamenib and BMF-500. We expect to announce preclinical data for a third development candidate, BMF-650, a potent, selective, oral small molecule GLP-1 receptor agonist in the fourth quarter of 2024.

Current wording

We are a clinical-stage diabetes and obesity medicines company focused on the discovery and development of oral small molecule drugs to treat patients with metabolic diseases. A covalent small molecule drug is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. Leveraging our extensive expertise in covalent binding chemistry and development, we built our proprietary FUSION™ System discovery platform to advance a pipeline of novel small molecule product candidates.

Previous wording

As of September 30, 2024, we had an accumulated deficit of $357.9 million. We incurred net losses of $109.1 million and $82.4 million for the nine months ended September 30, 2024 and 2023, respectively. We expect to continue to incur significant expenses and increasing 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 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.

Previous wording

conduct our ongoing preclinical studies and Phase 1 clinical trial of icovamenib in various types of liquid tumors, our planned Phase 1/1b clinical trial of icovamenib in solid tumors with KRAS mutations, our Phase 1/2 clinical trial of icovamenib in type 2 diabetes and our Phase 2 clinical trial of icovamenib in type 1 diabetes;

Current wording

conduct our ongoing preclinical studies and Phase II clinical trial of icovamenib in type 2 diabetes and our Phase II clinical trial of icovamenib in type 1 diabetes;

Previous wording

conduct preclinical studies and initiate and conduct additional clinical trials;

Current wording

conduct preclinical studies and initiate and conduct clinical trials;

Previous wording

expenses incurred under agreements with third-party CMOs, CROs, research and development service providers, academic research institutions and consulting costs; and

Current wording

expenses incurred under agreements with third-party contract manufacturing organizations (CMOs), contract research organizations (CROs), research and development service providers, academic research institutions and consulting costs; and

Previous wording

We expense research and development costs in the periods in which they are incurred. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We track direct costs by stage of program, clinical or preclinical. However, we do not track indirect costs on a program specific or stage of program basis because these costs are deployed across multiple programs and, as such, are not separately classified.

Current wording

We expense research and development costs in the periods in which they are incurred. Non-refundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We track direct costs by stage of program, clinical or preclinical. However, we do not track indirect costs on a program specific or stage of program basis because these costs are deployed across multiple programs and, as such, are not separately classified.

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 BMF-500 and advance 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 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.

Previous wording

the scope, rate of progress, expense and results of our ongoing preclinical development activities and clinical trials of icovamenib and BMF-500 in various types of cancer and metabolic diseases, of 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, 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;

Previous wording

Interest and other income, net consists primarily of interest earned on our investments and non-cash interest income (loss) related to accretion (amortization) of the discount (premium) on marketable securities.

Current wording

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

Previous wording

Comparison of the three and nine months ended September 30, 2024 and 2023

Current wording

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

Previous wording

We track research and development expenses to the extent such spend is attributable to a specific stage of program or type of research and development activity. Many of these expenses are shared among various programs and product candidates and, as such, we do not track expenses by program or indication. The following table summarizes our research and development expenses by stage of program and type of research and development activity incurred during the periods indicated (in thousands):

Current wording

The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):

Previous wording

General and administrative expenses increased by $1.0 million during the three months ended September 30, 2024 compared to the three months ended September 30, 2023. The increase is primarily due to increase in personnel-related expenses, including stock-based compensation of $0.9 million, resulting from an increase in headcount and increase in professional services of $0.2 million related to general external consultants.

Current 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.

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. In April 2021, we completed our initial public offering (IPO), to date, we have used all of the net proceeds from the IPO, and there was no material change in our actual use of the net proceeds from the IPO from that described in the final prospectus for our IPO.

Current 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.

Previous wording

As of September 30, 2024, we had cash, cash equivalents, and restricted cash of $88.3 million and an accumulated deficit of $357.9 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, 2024, will not be sufficient for us to fund our operating expenses and capital expenditure requirements for at least twelve months following the issuance date of the unaudited condensed financial statements. 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 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.

Previous wording

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

Current 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;

Previous wording

the impact of any public health emergencies such as the COVID-19 pandemic and adverse global economic and geopolitical conditions on our business, which may exacerbate the magnitude of the factors discussed above.

Current wording

the impact of any global health emergency and adverse global economic conditions on our business, which may exacerbate the magnitude of the factors discussed above.

Previous wording

If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to third parties rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves.

Current wording

If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves.

Previous wording

Net cash used in operating activities was $73.8 million during the nine months ended September 30, 2023 and consisted of a net loss of $82.4 million, offset by a decrease in net assets of $4.7 million and non-cash adjustments of $13.3 million. The decrease in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $1.4 million, decrease in accounts payable of $1.1 million and decrease in accrued expenses and other current liabilities of $1.5 million and a decrease in operating lease liabilities of $1.8 million. The decrease is offset by an increase in other assets of $1.7 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $10.3 million and operating lease expense of $2.0 million.

Current 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.

Previous 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 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.

Current 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.

Previous 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.

Current 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.

Previous 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, or the ESPP.

Current 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.

Previous wording

Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements, as well as expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Current wording

Our financial statements have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements, as well as expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

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 28, 2024 and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2024, 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 28, 2024.

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 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.