6 unchanged sentences
Please also see the section titled “Special Note Regarding Forward-Looking Statements.”
−Removed: Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle diseases.
−Removed: We are advancing multiple clinical-stage programs in muscular dystrophies and severe cardiac diseases, as well as a number of preclinical programs.
−Removed: Our muscular dystrophy program includes sevasemten, an orally administered selective, fast myofiber (type II) myosin small molecule inhibitor designed to address contraction-induced muscle injury and is currently being studied in multiple late-stage clinical trials in Becker muscular dystrophy (Becker) and Duchenne muscular dystrophy (Duchenne), including an ongoing pivotal cohort trial in patients with Becker.
−Removed: Our cardiovascular program includes novel, oral, selective cardiac sarcomere modulators EDG-7500 and EDG-15400.
−Removed: EDG-7500 is currently being studied in a multipart Phase 2 trial in both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM).
−Removed: EDG-15400 is currently in a Phase 1 trial of healthy adults with the future disease target of heart failure with preserved ejection fraction (HFpEF) and the Company expects to initiate a Phase 2 trial in HFpEF in the second half of 2026.
−Removed: We are also continuing to advance our preclinical exploration, including novel cardiometabolic targets.
−Removed: The entire team at Edgewise is dedicated to our mission:
−Removed: changing the lives of patients and families affected by serious muscle diseases.
−Removed: As a late-stage clinical biopharmaceutical company, we are focused on the discovery, development and commercialization of innovative treatments for severe muscle diseases for which there is significant unmet medical need.
−Removed: Guided by our holistic drug discovery approach to targeting the muscle as an organ, we have combined our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle focused drug discovery platform.
−Removed: Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases.
−Removed: We have developed and characterized a library of novel sarcomere modulators exhibiting a broad range of pharmacological and pharmacokinetic properties regulating disease-related muscle biology.
+Added: 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.
+Added: 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.
+Added: 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).
+Added: On July 10, 2026, the Sevasemten Sale was completed.
+Added: Following this transaction, Edgewise is positioned as a cardiovascular-focused late-stage clinical biopharmaceutical company advancing therapies for people living with serious cardiovascular diseases.
+Added: 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.
+Added: 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.
+Added: 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.
We have incurred significant losses since the commencement of our operations.
−Removed: Our net losses were $49.0 million and $40.8 million for the three months ended March 31, 2026 and 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.
+Added: 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.
−Removed: As of March 31, 2026, we had an accumulated deficit of $595.4 million.
+Added: 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.
−Removed: From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of March 31, 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.
−Removed: We believe that our existing cash and cash equivalents and
−Removed: marketable securities of $499.6 million will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
+Added: 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.
+Added: 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.
Macroeconomic and Geopolitical Developments
17 unchanged sentences
● expenses related to compliance with regulatory requirements.
−Removed: The majority of these expenses have been incurred to advance our lead product candidates, sevasemten and EDG-7500.
−Removed: We expect that significant additional spending will be required to progress these, EDG-15400, and other potential discoveries through later-stage clinical development phases and potentially registrational activities.
−Removed: These expenses will
−Removed: primarily consist of expenses for the administration of clinical trials as well as manufacturing costs for clinical material supply.
+Added: The majority of these expenses have been incurred to advance our lead product candidate EDG-7500, as well as sevasemten, our previous product candidate sold to Servier in July 2026.
+Added: We expect that significant additional spending will be required to progress EDG-7500, EDG-15400, and other potential discoveries through later-stage clinical development phases and potentially registrational activities.
+Added: These expenses will primarily consist of expenses for the administration of clinical trials as well as manufacturing costs for clinical material supply.
We track our direct research and development expenses on a program-by-program basis once a lead compound has been selected and clinical trials have been initiated.
5 unchanged sentences
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.
−Removed: We are currently conducting three Phase 2 clinical trials with sevasemten for people with muscular dystrophy (LYNX, FOX, and GRAND CANYON, a potentially registrational, or pivotal cohort, in individuals with Becker as part of the CANYON trial), a multipart Phase 2 trial with EDG-7500 for people with HCM (CIRRUS-HCM), and a Phase 1 trial with EDG-15400 of healthy adults with the future disease target of HFpEF.
−Removed: As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance sevasemten, EDG-7500, EDG-15400, and candidates from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates;
+Added: 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.
+Added: 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;
31 unchanged sentences
Results of Operations
−Removed: Comparison of the three months ended March 31, 2026 and 2025
−Removed: The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:
−Removed: Three months ended March 31,
+Added: Comparison of the three months ended June 30, 2026 and 2025
+Added: The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:
+Added: Three months ended June 30,
(in thousands)
3 unchanged sentences
Total operating expenses
+Added: Loss from operations
Interest income
1 unchanged sentence
The following table summarizes our research and development expenses:
−Removed: Three months ended March 31,
+Added: Three months ended June 30,
(in thousands)
6 unchanged sentences
Total research and development expenses
−Removed: Research and development expenses were $42.7 million and $36.8 million for the three months ended March 31, 2026 and 2025, respectively.
−Removed: The increase reflects deliberate allocation of capital toward later‑stage clinical programs aligned with near‑ and mid‑term value inflection points, as well as continued investment in internal capabilities required to support clinical execution, and was attributed to the following:
−Removed: ● an increase in EDG-7500 clinical program expenses of $1.6 million primarily related to an increase of $1.1 million from continued patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were enrolling in the comparable period in 2025, and an increase of $0.5 million from pharmacokinetic studies;
+Added: Research and development expenses were $47.5 million and $33.6 million for the three months ended June 30, 2026 and 2025, respectively.
+Added: 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:
+Added: ● an increase in EDG-7500 clinical program expenses of $5.0 million primarily related to an increase of $0.4 million from completion of patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were fully enrolled and Part D was enrolling in the comparable period in 2025, an increase of $2.0 million from pharmacokinetic studies, and a $2.6 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials;
● an increase in EDG-15400 clinical program expenses of $3.4 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025.
1 unchanged sentence
● an increase in internal costs of $5.7 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs;
+Added: ● an increase of $0.2 million in sevasemten clinical program expenses, which was primarily related to a $1.2 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to patient rollover from the GRAND CANYON trial and $0.8 million increase in the GRAND CANYON trial, partially offset by $1.8 million in decreased activity across all other sevasemten trials;
partially offset by:
−Removed: ● a decrease of $0.9 million in sevasemten clinical program expenses, which was primarily related to a $1.3 million decrease in clinical program expenses in GRAND CANYON compared to the same period in 2025 due to patient rollover to the MESA trial.
−Removed: This was offset by a $0.4 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to patient rollover from the GRAND CANYON trial from which no patients had transitioned to the MESA trial in the comparable period in 2025;
● a decrease in discovery and preclinical expenses of $0.3 million, which was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of discovery, preclinical, and nonclinical expenses in the comparable period in 2025.
General and administrative expenses
−Removed: General and administrative expenses increased to $11.5 million for the three months ended March 31, 2026 compared to $9.2 million for the three months ended March 31, 2025.
−Removed: The increase of $2.3 million was primarily attributable to $1.4 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth, as well as increased professional and consulting costs and other administrative costs supporting public company operations and clinical development activities.
+Added: 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.
+Added: 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.
Interest income
−Removed: Interest income was $5.1 million for the three months ended March 31, 2026 compared to $5.2 million for the three months ended March 31, 2025.
−Removed: Interest income reflects returns generated from the disciplined 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.
+Added: 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.
+Added: 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.
+Added: Comparison of the six months ended June 30, 2026 and 2025
+Added: The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
+Added: Six months ended June 30,
+Added: (in thousands)
+Added: Operating expenses:
+Added: Research and development
+Added: General and administrative
+Added: Total operating expenses
+Added: Interest income
+Added: Research and development expenses
+Added: The following table summarizes our research and development expenses:
+Added: Six months ended June 30,
+Added: (in thousands)
+Added: External research and development expenses:
+Added: Sevasemten clinical program
+Added: EDG-7500 clinical program
+Added: EDG-15400 clinical program
+Added: Discovery and preclinical
+Added: Internal costs, including personnel related
+Added: Total research and development expenses
+Added: Research and development expenses were $90.2 million and $70.3 million for the six months ended June 30, 2026 and 2025, respectively.
+Added: 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:
+Added: ● an increase in EDG-7500 clinical program expenses of $6.6 million primarily related to an increase of $1.6 million from completion of patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were completed enrollment and Part D was enrolling in the comparable period in 2025, a $2.3 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials, and an increase of $2.7 million from pharmacokinetic studies;
+Added: ● an increase in EDG-15400 clinical program expenses of $6.5 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025.
+Added: These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials;
+Added: ● an increase in internal costs of $8.6 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs;
+Added: partially offset by:
+Added: ● a decrease of $0.7 million in sevasemten clinical program expenses, which was primarily related to a $1.9 million decrease in spend related to a pharmacokinetic study which was completed in 2025, a $0.6 million decrease in clinical program expenses in CANYON and GRAND CANYON compared to the same period in 2025 due to patient rollover to the MESA trial.
+Added: This was offset by a $1.6 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to continued patient rollover from the GRAND CANYON trial;
+Added: ● a decrease in discovery and preclinical expenses of $1.0 million, which was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of discovery, preclinical, and nonclinical expenses in the comparable period in 2025.
+Added: 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.
+Added: General and administrative expenses
+Added: 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.
+Added: 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.
+Added: Interest income
+Added: 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.
+Added: 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.
Liquidity and Capital Resources
1 unchanged sentence
Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations.
−Removed: To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock.
−Removed: From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of March 31, 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.
−Removed: As of March 31, 2026, we had cash, cash equivalents and marketable securities in the amount of $499.6 million.
+Added: To date, we have financed our operations primarily through private placements of
+Added: convertible preferred stock and public offerings of our common stock.
+Added: 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.
+Added: 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.
+Added: As of June 30, 2026, we had cash, cash equivalents and marketable securities in the amount of $460.7 million.
The following table summarizes our sources and uses of cash for each of the periods presented:
−Removed: Three months ended March 31,
+Added: Six months ended June 30,
(in thousands)
Net cash used in operating activities
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
Net cash provided by financing activities
−Removed: Net (decrease) increase in cash and cash equivalents
+Added: Net increase in cash and cash equivalents
Operating activities
−Removed: Cash used in operating activities during the three months ended March 31, 2026 was $42.5 million primarily driven by our net loss for the period of $49.0 million, and was also impacted by changes in operating assets and liabilities, which increased net working capital by $1.8 million.
+Added: 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.
−Removed: Cash used in operating activities during the three months ended March 31, 2025 was $37.9 million primarily driven by our net loss for the period of $40.8 million, and was also impacted by changes in operating assets and liabilities, which increased net working capital by $4.8 million.
−Removed: Cash used in operating activities was reduced by non-cash charges of $7.7 million relating to stock-based compensation expense of $9.1 million and depreciation of $0.5 million, offset by accretion of discounts, net on marketable securities of $1.9 million.
+Added: 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.
+Added: 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.
Investing activities
−Removed: Cash provided by investing activities during the three months ended March 31, 2026 amounted to $2.4 million, due to $108.9 million in maturities of marketable securities and $4.0 million in sales of marketable securities, which were partially offset by $110.2 million in purchases of marketable securities and $0.3 million for purchases of equipment.
−Removed: Cash provided by investing activities during the three months ended March 31, 2025 amounted to $43.9 million, due to $151.1 million in maturities of marketable securities and $15.0 million in sales of marketable securities, which was partially offset by $122.2 million in purchases of marketable securities.
+Added: 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.
+Added: 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.
Financing activities
−Removed: Cash provided by financing activities during the three months ended March 31, 2026 was $12.2 million due to cash proceeds from the issuance of common stock upon exercise of stock options.
−Removed: Cash provided by financing activities during the three months ended March 31, 2025 was $2.2 million, due to cash proceeds of $2.3 million from the issuance of common stock upon exercise of stock options, which was partially offset by the payment of $38,000 in deferred offering costs.
+Added: 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) .
+Added: 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
+Added: 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.
+Added: Impact of the Sevasemten Sale
+Added: On July 10, 2026, we completed the Sevasemten Sale and received $1,550 million in upfront cash proceeds.
+Added: As a result, our available liquidity increased materially after June 30, 2026.
+Added: 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.
+Added: 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.
+Added: Any contingent milestone payments will be recognized only if and when the applicable recognition criteria are met.
Funding requirements
−Removed: We will continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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);
+Added: (b) a potential milestone payment of $600 million in cash, payable upon the achievement of U.S.
+Added: marketing approval for sevasemten for Duchenne muscular dystrophy;
+Added: and (c) a potential milestone payment of $300 million in cash, payable upon the achievement of annual U.S.
+Added: net sales of sevasemten products exceeding $550 million.
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the development of and seek regulatory approvals for our product candidates and begin to commercialize any approved products.
12 unchanged sentences
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.
−Removed: In order to complete the process of obtaining regulatory approval for our product candidates and to build the
−Removed: sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding.
+Added: 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.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect.
26 unchanged sentences
We expect that our existing cash and cash equivalents and marketable securities, will be sufficient to enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
−Removed: Our short-term material cash requirements as of March 31, 2026 are to fund our operations, which consist primarily of research and development expenses related to our programs, and to a lesser extent, general and administrative expenses.
+Added: Our short-term material cash requirements as of June 30, 2026 are to fund our operations, which consist primarily of research and development expenses related to our programs, and to a lesser extent, general and administrative expenses.
We have entered into contracts in the normal course of business with CROs, CDMOs and other third parties for preclinical research studies and testing, clinical trials and manufacturing services.
1 unchanged sentence
Payments due upon cancellation consist only of payments for services provided and expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation.
−Removed: Our long-term cash requirements as of March 31, 2026 includes our lease obligations.
+Added: 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.
−Removed: As of March 31, 2026, our total operating lease liability balance is $3.8 million, of which $1.0 million is a current liability.
+Added: As of June 30, 2026, our total operating lease liability balance is $3.6 million, of which $1.0 million is a current liability.
Critical Accounting Estimates
4 unchanged sentences
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.
−Removed: During the three months ended March 31, 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.
+Added: 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.
Recently Issued Accounting Pronouncements
1 unchanged sentence
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.