Edgewise Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout 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.
Sep 30, 2026 · Filed Nov 4, 2026
EWTX$45.04+15.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001104659-26-091670
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001104659-26-122653
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 81 previous paragraphs and 100 current paragraphs.
49 unchanged; 26 reworded; 22 added; 3 removed; 3 previous and 3 current paragraphs rearranged.
Tables are not compared: 63 previous and 69 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 (22)
Current report
Other income
Current report
Other income includes reimbursements for specified costs incurred in providing transition services to Servier and recognition of consideration allocated to those services at the closing of the Sevasemten Sale. We deferred $7.8 million of the closing consideration and recognize that amount as the related services are provided. Costs incurred in providing transition services are recorded within the applicable operating expense categories. Refer to Note 10 of our financial statements appearing in this Quarterly Report for further information regarding the Sevasemten Sale.
Current report
Gain on the Sevasemten Sale reflects the gain recognized upon the July 10, 2026 sale of the sevasemten program to Servier. The gain represents consideration recognized at closing, less the net carrying value of the assets and liabilities transferred, transaction costs, and other closing-related adjustments. No contingent milestone consideration was recognized as of September 30, 2026.
Current report
Other Income
Current report
Other income for the three months ended September 30, 2026 was $3.1 million, primarily reflecting amounts recognized in connection with transition services provided to Servier following the close of the Sevasemten Sale.
Current report
Gain on the Sevasemten Sale was $1,348.1 million for the three months ended September 30, 2026, following the completion of the sale to Servier on July 10, 2026. Refer to Note 10 of our financial statements appearing in this Quarterly Report for further information regarding the Sevasemten Sale.
Current report
Income Tax
Current report
Income tax expense for the three months ended September 30, 2026 was $155.3 million, primarily due to the gain on sale of the sevasemten program. The related tax expense was partially offset by the utilization of net operating loss carryforwards and the benefit of transferable tax credits purchased at a discount. The effective tax rate for the three months ended September 30, 2026 was 11.8%.
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Current report
General and administrative expenses increased to $40.4 million for the nine months ended September 30, 2026 compared to $27.6 million for the nine months ended September 30, 2025. The increase of $12.8 million was primarily
Current report
Other Income
Current report
Other income for the nine months ended September 30, 2026 was $3.1 million, primarily reflecting amounts recognized in connection with transition services provided to Servier following the close of the Sevasemten Sale on July 10, 2026.
Current report
Gain on the Sevasemten Sale was $1,348.1 million for the nine months ended September 30, 2026, following the completion of the sale to Servier on July 10, 2026. Refer to Note 10 of our financial statements appearing in this Quarterly Report for further information regarding the Sevasemten Sale.
Current report
Income Tax
Current report
Income tax expense for the nine months ended September 30, 2026 was $155.3 million, primarily due to the gain on the Sevasemten Sale. The related tax expense was partially offset by the utilization of net operating loss carryforwards and the benefit of transferable tax credits purchased at a discount. The effective tax rate for the nine months ended September 30, 2026 was 12.8%.
Current report
Cash used in operating activities during the nine months ended September 30, 2026 was $163.3 million, primarily reflecting research and development and general and administrative expenses for the period of $162.2 million. Net income included a $1,348.1 million gain on the Sevasemten Sale, which was deducted in reconciling net income to operating cash flows because the related net cash proceeds are presented within investing activities.
Current report
Cash used in operating activities during the nine months ended September 30, 2025 was $105.2 million, primarily reflecting research and development and general and administrative expenses for the period of $135.4 million, partially offset by interest received.
Current report
On July 10, 2026, we completed the Sevasemten Sale andreceived $1,396.1 million in upfront cash proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million. As a result, cash, cash equivalents, and marketable securities increased to $1,743.9 million as of September 30, 2026 from $530.1 million as of December 31, 2025. For the three and nine months
Current report
We have committed to purchase federal transferable production tax credits. As of September 30, 2026, we have a remaining commitment of $40.0 million through January 2027. Our commitments are contingent upon the satisfaction of certain legal and contractual conditions from the sellers, and the continued availability of the credits under federal tax laws. We expect to utilize these credits in the same quarter in which they are purchased, offsetting federal income tax estimated payments and reducing income tax expense in the associated periods.
Current report
Accounting for the Sevasemten Sale
Current report
Accounting for the Sevasemten Sale required management to make judgments regarding the measurement and recognition of consideration received or receivable in connection with the transaction, including the treatment of contingent consideration and consideration allocated to transition services. In determining the gain recognized upon closing, we evaluated the terms of the transaction agreements and the relevant facts and circumstances as of the transaction date.
Current report
Potential regulatory and commercial milestone payments of up to $1,100.0 million were not included in the consideration recognized upon closing due to the uncertainties associated with achievement of the underlying milestones. We will reassess the accounting for such contingent consideration at each reporting period based on changes in the relevant facts and circumstances.
Removed paragraphs (3)
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Previous report
Cash used in operating activities during the six months ended June 30, 2026 was $85.0 million primarily driven by our net loss for the period of $106.3 million, and was also impacted by changes in operating assets and liabilities, which decreased net working capital by $3.9 million. Cash used in operating activities was reduced by non-cash charges of $17.4 million relating to stock-based compensation expense of $18.1 million, depreciation of $1.1 million, and amortization of right-of-use asset of $0.1 million, offset by accretion of discounts, net on marketable securities of $1.8 million.
Previous report
Cash used in operating activities during the six months ended June 30, 2025 was $70.4 million primarily driven by our net loss for the period of $76.9 million, and was also impacted by changes in operating assets and liabilities, which increased net working capital by $7.3 million. Cash used in operating activities was reduced by non-cash charges of $13.8 million relating to stock-based compensation expense of $16.8 million, accretion of discounts, net on marketable securities of $4.1 million, depreciation of $1.0 million, and amortization of right-of-use asset of $0.1 million.
Reworded paragraphs (26)
Previous wording
Since our inception in 2017, we have applied our deep expertise in muscle biology and small molecule drug discovery to build a proprietary precision medicine platform. This foundation has generated multiple clinical and preclinical programs across skeletal and cardiac muscle, including sevasemten for muscular dystrophies and our cardiovascular portfolio of novel, oral cardiac sarcomere modulators. In May 2026, we entered into an Asset Purchase Agreement under which Servier Pharmaceuticals LLC and Les Laboratoires Servier (Servier) acquired sevasemten and our muscular dystrophy program for $1,550 million in upfront cash consideration and up to $1,100 million in additional regulatory and commercial milestone payments, for aggregate potential consideration of up to $2,650 million (Sevasemten Sale). On July 10, 2026, the Sevasemten Sale was completed.
Current wording
Since our inception in 2017, we have applied our deep expertise in muscle biology and small molecule drug discovery to build a proprietary precision medicine platform. This foundation has generated multiple clinical and preclinical programs across skeletal and cardiac muscle, including sevasemten for muscular dystrophies and our cardiovascular portfolio of novel, oral cardiac sarcomere modulators. In May 2026, we entered into an Asset Purchase Agreement under which Servier Pharmaceuticals LLC and Les Laboratoires Servier (Servier) acquired sevasemten and our muscular dystrophy program (Sevasemten Sale). The transaction was completed on July 10, 2026, and we received $1,396.1 million in upfront cash proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million. We are also eligible to receive up to $1,100.0 million in additional regulatory and commercial milestone payments, for aggregate potential consideration of up to $2,650.0 million. The resulting gain on the Sevasemten Sale was approximately $1,348.1 million.
Previous wording
Following this transaction, Edgewise is positioned as a cardiovascular-focused late-stage clinical biopharmaceutical company advancing therapies for people living with serious cardiovascular diseases. Our lead cardiovascular program, EDG-7500, is a novel, oral, selective cardiac sarcomere modulator currently being studied in a multipart Phase 2 trial in patients with obstructive and nonobstructive hypertrophic cardiomyopathy, with a Phase 3 program targeted to initiate in the fourth quarter of 2026. EDG-15400, our second cardiovascular product candidate, is currently in a Phase 1 trial in healthy adults, with a future disease target of heart failure with preserved ejection fraction, and we expect to initiate a Phase 2 trial in the second half of 2026. We are also continuing to advance preclinical discovery efforts, including additional cardiovascular and cardiometabolic targets, as we pursue our mission of changing the lives of patients and families affected by serious cardiovascular diseases.
Current wording
Following this transaction, Edgewise is positioned as a cardiovascular-focused clinical-stage biopharmaceutical company advancing therapies for people living with serious cardiovascular diseases. Our lead cardiovascular program, EDG-7500, is a novel, oral, selective cardiac sarcomere modulator for which we announced positive topline data from the 12-week Part D portion of our multipart Phase 2 trial in patients with obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), with a Phase 3 trial which we plan to initiate in the fourth quarter of 2026. EDG-15400, our second cardiovascular product candidate, is currently in a Phase 2 trial in adults with symptomatic heart failure with
Previous wording
We have incurred significant losses since the commencement of our operations. Our net losses were $57.3 million and $106.3 million for the three and six months ended June 30, 2026, respectively, and $36.1 million and $76.9 million for the three and six months ended June 30, 2025, respectively, and we expect to continue to incur significant losses for the foreseeable future as we advance our product candidates through preclinical development and clinical trials and seek regulatory approval of our product candidates. 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
We have incurred significant losses since the commencement of our operations, except for the three and nine months ended September 30, 2026 where we recognized net income of $1,166.2 million and $1,059.8 million, respectively, primarily due to the gain recognized on the Sevasemten Sale. Our net losses for the three and nine months ended September 30, 2025 were $40.7 million and $117.6 million, respectively. Excluding the gain recognized on the Sevasemten Sale, we expect to continue to incur significant losses for the foreseeable future as we advance our product candidates through preclinical development and clinical trials and seek regulatory approval of our product candidates. 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
As of June 30, 2026, we had an accumulated deficit of $652.7 million. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of June 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under an “at the market offering” program (the ATM Program), and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. We believe that our existing cash and cash equivalents and marketable securities of $460.7 million, together with the $1,550 million in upfront cash proceeds from the Sevasemten Sale received on July 10, 2026, will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
Current wording
As of September 30, 2026, we had retained earnings of $513.4 million. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of September 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under an “at the market offering” program (the ATM Program), and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. We believe that our existing cash and cash equivalents and marketable securities of $1,743.9 million will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
Previous wording
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. In June 2026, we announced positive topline data for our multipart Phase 2 trial with EDG-7500 for people with HCM (CIRRUS-HCM) and are planning to initiate a Phase 3 trial for EDG-7500 in the fourth quarter of 2026 and we have completed dosing in the Phase 1 trial with EDG-15400 of healthy adults with the future disease target of HFpEF and are planning to initiate a Phase 2 trial for EDG-15400 in the second half of 2026. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance EDG-7500, EDG-15400, and candidates from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates; continue to develop our proprietary drug discovery platform; continue to discover and develop additional product candidates; and hire additional personnel.
Current wording
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. In June 2026, we announced positive topline data for our multipart Phase 2 trial with EDG-7500 for people with HCM (CIRRUS-HCM) and are planning to initiate a Phase 3 trial for EDG-7500 in the fourth quarter of 2026. We have completed our Phase 1 trial with EDG-15400 in healthy adults and we have begun dosing patients in our Phase 2 trial with EDG-15400 in adults with symptomatic HFpEF who have an LVEF of at least 50% (EQUINOX-HFpEF). As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance EDG-7500, EDG-15400, and candidates from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates; continue to develop our proprietary drug discovery platform; continue to discover and develop additional product candidates; and hire additional personnel.
Previous wording
The successful development of our product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and extent of expenses necessary to complete the development of our product candidates. We are also unable to predict when, if ever, we will generate revenue from our product candidates to offset these expenses. Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:
Current wording
The successful development of our product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and extent of expenses necessary to complete the development of our product candidates. We are also unable to predict when, if ever, we will generate revenue from our product candidates to offset these expenses. Our expenditures on current and future preclinical and clinical development programs are subject
Previous wording
Research and development expenses were $90.2 million and $70.3 million for the six months ended June 30, 2026 and 2025, respectively. The increase was primarily due to higher EDG-7500, EDG-15400 and internal personnel-related costs, partially offset by lower discovery and preclinical expenses, and was attributed to the following:
Current wording
Research and development expenses were $31.6 million and $37.5 million for the three months ended September 30, 2026 and 2025, respectively. The decrease was primarily due to lower sevasemten costs as a result of the Sevasemten Sale in July 2026, partially offset by higher EDG-7500, discovery and preclinical, and internal personnel-related costs, and was attributed to the following:
Previous wording
General and administrative expenses increased to $14.4 million for the three months ended June 30, 2026 compared to $9.1 million for the three months ended June 30, 2025. The increase of $5.3 million was primarily attributable to $1.7 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth, $1.4 million in increased costs associated with commercial readiness activities for sevasemten, as well as $2.3 million in increased professional and consulting costs, transaction costs related to the Sevasemten Sale, and other administrative costs supporting public company operations and clinical development activities.
Current wording
General and administrative expenses increased to $14.6 million for the three months ended September 30, 2026 compared to $9.4 million for the three months ended September 30, 2025. The increase of $5.2 million was primarily attributable to $1.5 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth and $3.7 million in increased professional and consulting costs, and other administrative costs supporting public company operations and clinical development activities.
Previous wording
Interest income was $4.6 million for the three months ended June 30, 2026 compared to $6.5 million for the three months ended June 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.
Current wording
Interest income was $16.5 million for the three months ended September 30, 2026 compared to $6.2 million for the three months ended September 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:
Previous wording
Research and development expenses were $47.5 million and $33.6 million for the three months ended June 30, 2026 and 2025, respectively. The increase was primarily due to higher EDG-7500, EDG-15400 and internal personnel-related costs, partially offset by lower discovery and preclinical expenses, and was attributed to the following:
Current wording
Research and development expenses were $121.8 million and $107.8 million for the nine months ended September 30, 2026 and 2025, respectively. The increase was primarily due to higher EDG-7500, EDG-15400, discovery and preclinical expenses, and internal personnel-related costs, partially offset by lower sevasemten expenses, and was attributed to the following:
Previous wording
Following completion of the Sevasemten Sale on July 10, 2026, we do not expect direct external clinical program costs associated with sevasemten to continue, except for retained obligations and transition-services activities performed under the Transition Services Agreement.
Current wording
Following completion of the Sevasemten Sale on July 10, 2026, direct external clinical program costs associated with sevasemten will not continue, except for retained obligations and transition-services activities performed under the TSA.
Previous wording
Interest income was $9.7 million for the six months ended June 30, 2026 compared to $11.7 million for the six months ended June 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.
Current wording
Interest income was $26.2 million for the nine months ended September 30, 2026 compared to $17.8 million for the nine months ended September 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.
Previous wording
convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of June 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under the ATM Program, and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. Additionally, pursuant to the Sevasemten Purchase Agreement, we completed the sale of sevasemten and our muscular dystrophy program to Servier on July 10, 2026 and received upfront cash consideration of $1,550 million. As of June 30, 2026, we had cash, cash equivalents and marketable securities in the amount of $460.7 million.
Current wording
Since our inception, we have not generated any product revenue and have incurred significant operating losses and negative cash flows from our operations. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of September 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under the ATM Program, and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. Additionally, pursuant to the Sevasemten Purchase Agreement, we completed the sale of sevasemten and our muscular dystrophy program to Servier on July 10, 2026 and we received $1,396.1 million in upfront cash proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million. As of September 30, 2026, we had cash, cash equivalents and marketable securities in the amount of $1,743.9 million.
Previous wording
Cash provided by investing activities during the six months ended June 30, 2026 amounted to $80.9 million, due to $217.7 million in maturities of marketable securities and $26.8 million in sales of marketable securities, which were partially offset by $163.2 million in purchases of marketable securities and $0.3 million for purchases of equipment.
Current wording
Cash provided by investing activities during the nine months ended September 30, 2026 amounted to $140.6 million, primarily due to the approximately $1,348.9 million in cash proceeds from the Sevasemten Sale completed on July 10, 2026, net of $47.2 million in transaction related costs paid. Additional increases were due to $314.3 million in maturities of marketable securities and $45.3 million in sales of marketable securities, which were partially offset by $1,567.5 million in purchases of marketable securities and $0.3 million for purchases of equipment.
Previous wording
Cash used in investing activities during the six months ended June 30, 2025 amounted to $118.3 million, due to $385.9 million in purchases of marketable securities and $0.1 million for purchases of equipment, which was partially offset by $229.1 million in maturities of marketable securities and $38.7 million in sales of marketable securities.
Current wording
Cash used in investing activities during the nine months ended September 30, 2025 amounted to $82.6 million, due to $452.9 million in purchases of marketable securities and $0.2 million for purchases of equipment, which was partially offset by $319.1 million in maturities of marketable securities and $51.5 million in sales of marketable securities.
Previous wording
Cash provided by financing activities during the six months ended June 30, 2026 was $15.3 million due to cash proceeds of $14.5 million from the issuance of common stock upon exercise of stock options and$0.8 million in proceeds from the Company’s 2021 Employee Stock Purchase Plan (2021 ESPP).
Current wording
Cash provided by financing activities during the nine months ended September 30, 2026 was $30.2 million due to cash proceeds of $29.4 million from the issuance of common stock upon exercise of stock options and$0.8 million in proceeds from the Company’s 2021 Employee Stock Purchase Plan (2021 ESPP).
Previous wording
issuance of common stock upon exercise of stock options, $0.6 million in proceeds from the Company’s 2021 Employee Stock Purchase Plan (2021 ESPP), which was partially offset by $12.6 million for the payment of underwriting discounts and commissions and offering costs.
Current wording
Cash provided by financing activities during the nine months ended September 30, 2025 was $192.1 million, due to cash proceeds of $200.0 million from the April 2025 underwritten registered direct offering, $4.2 million in proceeds from the issuance of common stock upon exercise of stock options, and $0.6 million in proceeds from the Company’s 2021 Employee Stock Purchase Plan (2021 ESPP), which was partially offset by $12.6 million for the payment of underwriting discounts and commissions and offering costs.
Previous wording
On July 10, 2026, we completed the Sevasemten Sale and received $1,550 million in upfront cash proceeds. As a result, our available liquidity increased materially after June 30, 2026. In the quarter ending September 30, 2026, we expect to recognize a gain on the sale within other income, subject to final closing-date carrying values of the assets transferred and liabilities assumed, transaction costs, and the related income tax effects. We also expect our future operating expenses to be affected by the elimination of direct sevasemten program costs that will not continue following the sale, partially offset by costs and reimbursements associated with the Transition Services Agreement. Any contingent milestone payments will be recognized only if and when the applicable recognition criteria are met.
Current wording
ended September 30, 2026, we recognized a gain of $1,348.1 million on the Sevasemten Sale. Research and development expenses for the three months ended September 30, 2026 decreased, primarily due to the elimination of direct sevasemten program costs that have not continued following the sale, partially offset by costs associated with the TSA. Any contingent milestone payments will be recognized only if and when the applicable recognition criteria are met.
Previous wording
We may continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future. On May 10, 2024, we filed an automatic shelf registration statement on Form S-3ASR that allows us to undertake various equity and debt offerings and entered into the Leerink Sales Agreement under which we may offer and sell shares of common stock, having aggregate sales proceeds of up to $175.0 million from time to time, through the Leerink ATM.
Current wording
Based on our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report. Drug development and commercialization are capital intensive, and we may seek additional capital in the future to expand our development programs, prepare for commercialization or pursue strategic opportunities. On May 10, 2024, we filed an automatic shelf registration statement on Form S-3ASR that allows us to undertake various equity and debt offerings and entered into the Leerink Sales Agreement under which we may offer and sell shares of common stock, having aggregate sales proceeds of up to $175.0 million from time to time, through the Leerink ATM.
Previous wording
On May 31, 2026, the Company entered into the Sevasemten Purchase Agreement, pursuant to which Servier acquired sevasemten and certain other related assets collectively constituting the Company’s muscular dystrophy program and assumed certain related liabilities for aggregate potential consideration of up to $2,650 million. On July 10, 2026, the Company completed the Sevasemten Sale receiving $1,550 million in upfront cash proceeds and is eligible to receive up to $1,100 million in potential future milestone payments, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for Becker muscular dystrophy in the amount of (i) $200 million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $100 million in cash, payable in the event of an approved labelling including only specified adult populations (if (i) has not previously been achieved); (b) a potential milestone payment of $600 million in cash, payable upon the achievement of U.S. marketing approval for sevasemten for Duchenne muscular dystrophy; and (c) a potential milestone payment of $300 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $550 million.
Current wording
On May 31, 2026, we entered into the Sevasemten Purchase Agreement, pursuant to which Servier acquired sevasemten and certain other related assets collectively constituting our muscular dystrophy program and assumed certain related liabilities for aggregate potential consideration of up to $2,650.0 million. The transaction was completed on July 10, 2026, and we received $1,396.1 million in upfront cash proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million. The Company is eligible to receive up to $1,100.0 million in potential future milestone payments, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for Becker muscular dystrophy in the amount of (i) $200.0 million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $100.0 million in cash, payable in the event of an approved labelling including only specified adult populations (if (i) has not previously been achieved); (b) a potential milestone payment of $600.0 million in cash, payable upon the achievement of U.S. marketing approval for sevasemten for Duchenne muscular dystrophy; and (c) a potential milestone payment of $300.0 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $550.0 million. Achievement of these milestones depends on regulatory and commercial outcomes controlled by Servier, and we may not receive any milestone payments. On November 3, 2026, Servier announced that the pivotal GRAND CANYON study of sevasemten in Becker muscular dystrophy did not meet its primary or secondary endpoints. Servier is conducting further analysis of the study results and relevant prior clinical data.
Previous wording
We do not currently have any long-term material capital requirements other than what will be required to fund operations for the foreseeable future and the amounts disclosed on the contractual obligations and commitments section below. In order to complete the process of obtaining regulatory approval for our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we may require substantial additional funding.
Current wording
We do not currently have any long-term material capital requirements other than those disclosed below under contractual obligations and commitments. Obtaining regulatory approval for our product candidates and building the sales, marketing and distribution infrastructure necessary to commercialize them, if approved, will require significant resources, and we may seek additional funding to support those activities.
Previous wording
If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts. We may also be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Current wording
If we need to raise additional funds in the future and are unable to do so on acceptable terms, we may be required to delay, limit or reduce the scope of our development or commercialization plans, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
Our long-term cash requirements as of June 30, 2026 includes our lease obligations. In January 2022, we entered into a lease agreement for approximately 18,614 square feet of office and laboratory space in Boulder, Colorado which includes escalating rent payments and an 8.2 year term, plus our share of operating expenses. In February 2023, the lease was modified to occupy an additional 9,624 square feet of office space, with aggregate payments of approximately $1.5 million over the initial 7.3 year term, plus our share of operating expenses. As of June 30, 2026, our total operating lease liability balance is $3.6 million, of which $1.0 million is a current liability.
Current wording
Our long-term cash requirements as of September 30, 2026 include our lease obligations. In January 2022, we entered into a lease agreement for approximately 18,614 square feet of office and laboratory space in Boulder, Colorado which includes escalating rent payments and an 8.2 year term, plus our share of operating expenses. In February 2023, the lease was modified to occupy an additional 9,624 square feet of office space, with aggregate payments of approximately $1.5 million over the initial 7.3 year term, plus our share of operating expenses. As of September 30, 2026, our total operating lease liability balance is $3.4 million, of which $1.0 million is a current liability.
Previous wording
Our financial statements are prepared in accordance with generally accepted accounting principles in the United States and requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, costs, expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on a periodic basis. Our actual results may differ from these estimates.
Current wording
Our financial statements are prepared in accordance with generally accepted accounting principles in the United States and require management to make estimates and judgments that affect the reported amounts of assets, liabilities, costs, expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, and evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these 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 Estimates” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2026 and the notes to the financial statements appearing elsewhere in this Quarterly Report. During the three and six months ended June 30, 2026, there were no material changes to our critical accounting estimates from those discussed in our Annual Report on Form 10-K filed on February 26, 2026.
Current wording
Our critical accounting estimates 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 Securities and Exchange Commission on February 26, 2026 and the notes to the financial statements appearing elsewhere in this Quarterly Report. During the three and nine months ended September 30, 2026, the completion of the Sevasemten Sale resulted in significant judgments related to the accounting for the transaction, including contingent consideration, as described below. Except for this matter, there were no material changes to our critical accounting estimates from those discussed in our Annual Report on Form 10-K filed on February 26, 2026.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) of at least 50%. We are also continuing to advance preclinical discovery efforts, including additional cardiovascular and cardiometabolic targets, as we pursue our mission of changing the lives of patients and families affected by serious cardiovascular diseases.
Current report — wording carried from elsewhere
to numerous uncertainties in timing and cost to completion. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:
Current report — wording carried from elsewhere
attributable to $4.6 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth and $8.2 million in increased professional and consulting costs, and other administrative costs supporting public company operations and clinical development activities.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
General and administrative expenses increased to $25.9 million for the six months ended June 30, 2026 compared to $18.3 million for the six months ended June 30, 2025. The increase of $7.6 million was primarily attributable to $3.0 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth, $2.1 million in increased costs associated with commercial readiness activities for sevasemten, as well as $2.5 million in increased professional and consulting costs, transaction costs related to the Sevasemten Sale, and other administrative costs supporting public company operations and clinical development activities.
Previous report — wording carried elsewhere
Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. To date, we have financed our operations primarily through private placements of
Previous report — wording carried elsewhere
Cash provided by financing activities during the six months ended June 30, 2025 was $190.5 million, due to cash proceeds of $200.0 million from the April 2025 underwritten registered direct offering, $2.5 million in proceeds from the