What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-07 · 62 added, 53 removed, 195 unchanged (37% of the section changed)

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Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle diseases.

We are advancing two clinical-stage programs in muscular dystrophies and severe cardiac diseases, as well as a number of preclinical programs.

Our muscular dystrophy program includes sevasemten, an orally administered fast skeletal myosin inhibitor.

Sevasemten is currently being studied in multiple Phase 2 clinical trials, including a pivotal cohort, in patients with either Becker muscular dystrophy (Becker) or Duchenne muscular dystrophy (Duchenne).

Our cardiovascular program includes EDG-7500, a novel, oral, selective cardiac sarcomere modulator.

We are advancing multiple clinical-stage programs in muscular dystrophies and severe cardiac diseases, as well as a number of preclinical programs.

Our muscular dystrophy program includes sevasemten, an orally administered fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage and is currently being studied in multiple Phase 2 clinical trials in Becker muscular dystrophy (Becker) and Duchenne muscular dystrophy (Duchenne), including an ongoing pivotal cohort trial in patients with Becker.

Our cardiovascular program includes novel, oral, selective cardiac sarcomere modulators EDG-7500 and EDG-15400.

EDG-7500 is currently being studied in a multipart Phase 2 trial in both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).

We are also continuing to advance our preclinical exploration, including novel cardiac and cardiometabolic targets.

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).

We are also continuing to advance our preclinical exploration, including novel cardiometabolic targets.

The entire team at Edgewise is dedicated to our mission:

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As a clinical-stage 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.

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.

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.

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.

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We have incurred significant losses since the commencement of our operations.

Our net losses were $36.1 million and $76.9 million for the three and six months ended June 30, 2025, respectively, and $31.5 million and $60.0 million for the three and six months ended June 30, 2024, 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 were $40.7 million and $117.6 million for the three and nine months ended September 30, 2025, respectively, and $34.1 million and $94.2 million for the three and nine months ended September 30, 2024, 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.

As of June 30, 2025, we had an accumulated deficit of $455.5 million.

As of September 30, 2025, we had an accumulated deficit of $496.2 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, 2025, 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.

From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of September 30, 2025, 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 $563.3 million will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.

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We are monitoring macroeconomic and geopolitical developments, such as inflation, instability in the banking and financial services sector, tightening of the credit markets, changes in the U.S.

government administration and policy positions, international conflicts, public health pandemics, cybersecurity, sanctions, and changes in tariffs so that the Company can be prepared to react to new developments as they arise.

government administration and policy positions, the U.S federal government shutdown, international conflicts, public health pandemics, cybersecurity, sanctions, and changes in tariffs so that the Company can be prepared to react to new developments as they arise.

The extent, severity, and duration of the impacts of these events and conditions on our business, operations and research and development timelines and plans cannot be predicted and will depend on numerous factors.

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The majority of these expenses have been incurred to advance our lead product candidates, sevasemten and EDG-7500.

We expect that significant additional spending will be required to progress these and other potential discoveries through the remainder of the clinical development phases.

We expect that significant additional spending will be required to progress these, EDG-15400, and other potential discoveries through the remainder of the clinical development phases.

These expenses will primarily consist of expenses for the administration of clinical trials as well as manufacturing costs for clinical material supply.

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Our direct research and development expenses by program also include costs of laboratory supplies that can be directly attributed to a specific program as well as any fees incurred under license agreements.

We do not allocate employee-related costs,

including stock-based compensation, or facility expenses, including rent, depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified.

We do not allocate employee-related costs, including stock-based compensation, or facility expenses, including rent, depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified.

We use internal resources primarily to conduct our research and discovery activities and to manage our preclinical development, manufacturing and clinical development activities.

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.

We are currently conducting four Phase 2 clinical trials with sevasemten for people with muscular dystrophy (CANYON, LYNX, FOX and DUNE), including a potentially registrational, or pivotal cohort, in individuals with Becker (GRAND CANYON) as part of the CANYON trial, and a multipart Phase 2 trial with EDG-7500 for people with HCM (CIRRUS-HCM).

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, a product from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates;

We are currently conducting four Phase 2 clinical trials with sevasemten for people with muscular dystrophy (CANYON, LYNX, FOX and DUNE), including a potentially registrational, or pivotal cohort, in individuals with Becker (GRAND CANYON) 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.

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, product candidates from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates;

continue to develop our proprietary drug discovery platform;

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Results of Operations

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

The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:

Three months ended June 30,

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

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Three months ended September 30,

(in thousands)

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The following table summarizes our research and development expenses:

Three months ended June 30,

Three months ended September 30,

(in thousands)

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EDG-7500 clinical program

EDG-15400 clinical program

Discovery and preclinical

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Total research and development expenses

Research and development expenses were $33.6 million and $30.7 million for the three months ended June 30, 2025 and 2024, respectively.

Research and development expenses were $37.5 million and $32.2 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $5.3 million was attributed to the following:

● an increase of $0.4 million in sevasemten clinical program expenses, which was primarily related to increased clinical activity in the MESA trial due to rollover of substantially all patients from the CANYON, ARCH, and DUNE trials, as well as increased site activation activity related to the rollover of patients from the GRAND CANYON pivotal cohort beginning in April 2025, increased clinical supply manufacturing to support the GRAND CANYON pivotal cohort and MESA trial compared to the same period in 2024, and clinical consulting spend to support sevasemten, which was partially offset by a decrease in clinical activity related to the completion of the ARCH trial in 2024;

● a decrease in EDG-7500 clinical program expenses of $2.0 million primarily related to completion of our Phase 1 trial and a drug interaction study in 2024 for which there was no comparable activity in 2025, which was offset by continued site activation and patient enrollment for Part B and Part C and initiation of Part D of our multipart Phase 2 CIRRUS-HCM trial, for which only Part A was active in the comparable period in 2024;

● an increase in discovery and preclinical expenses of $0.1 million as a result of additional nonclinical costs related to our EDG-003 program and other cardio-metabolic research;

● an increase of $0.5 million in sevasemten clinical program expenses, which was primarily related to increased clinical activity in the MESA trial due to the continued rollover of patients from the GRAND CANYON pivotal cohort beginning in April 2025, offset by decreases in the CANYON, ARCH, and DUNE trials due to rollover of substantially all patients from these trials into MESA.

Additional increases in sevasemten clinical program expenses compared to the same period in 2024 were due to fully enrolling the GRAND CANYON pivotal cohort in February 2025;

● an increase in EDG-7500 clinical program expenses of $0.4 million primarily related to continued patient activity for Part B and Part C and site activation and patient enrollment of Part D of our multipart Phase 2 CIRRUS-HCM trial, for which only Part A was active in the comparable period in 2024, which was offset by completion of our Phase 1 trial in 2024 for which there was no comparable activity in 2025;

● an increase in EDG-15400 clinical program expenses of $3.0 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025.

These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials;

● a decrease in discovery and preclinical expenses of $1.4 million primarily driven by EDG-15400 costs, now shown separately, which were a significant portion of the discovery and preclinical expenses along with other costs from the EDG-003 program during the comparable period in 2024;

● an increase in internal costs of $2.9 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.

General and administrative expenses

General and administrative expenses were $9.1 million and $7.4 million for the three months ended June 30, 2025 and 2024, respectively.

The increase of $1.6 million was primarily due to $1.4 million in increased personnel-related costs, including stock-based compensation, from increased headcount and $0.3 million in increased professional and consulting costs and other administrative costs.

General and administrative expenses were $9.4 million and $8.2 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $1.2 million was primarily due to increased personnel-related costs, including stock-based compensation, from increased headcount.

Interest income

Interest income was $6.5 million and $6.6 million for the three months ended June 30, 2025 and 2024, respectively.

The decrease in interest income was primarily due to lower average treasury yields during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, partially offset by higher average securities balances during the three months ended June 30, 2025.

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

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:

Six months ended June 30,

Interest income was $6.2 million and $6.3 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $0.1 million was primarily due to lower average treasury yields during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024, partially offset by higher average securities balances during the three months ended September 30, 2025.

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

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Nine months ended September 30,

(in thousands)

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The following table summarizes our research and development expenses:

Six months ended June 30,

Nine months ended September 30,

(in thousands)

2 unchanged sentences

EDG-7500 clinical program

EDG-15400 clinical program

Discovery and preclinical

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Total research and development expenses

Research and development expenses were $70.3 million and $58.4 million for the six months ended June 30, 2025 and 2024, respectively.

Research and development expenses were $107.8 million and $90.6 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $17.2 million was attributed to the following:

● an increase of $2.3 million in sevasemten clinical program expenses, which was primarily related to a net increase in clinical activity in the MESA trial due to rollover of substantially all patients from the CANYON, ARCH, and DUNE trials, as well increased site activation activity related to the rollover of patients from the GRAND CANYON pivotal cohort beginning in April 2025;

● a decrease in EDG-7500 clinical program expenses of $1.8 million primarily related to completion of our Phase 1 trial and a drug interaction study in 2024 for which there was no comparable activity in 2025, which was offset by continued site activation and patient enrollment for Part B and Part C and initiation of Part D of our multipart Phase 2 CIRRUS-HCM trial, for which only Part A was active in the comparable period in 2024;

● an increase in discovery and preclinical expenses of $1.4 million as a result of additional nonclinical costs related to our EDG-003 program and other cardio-metabolic research;

● an increase of $2.7 million in sevasemten clinical program expenses, which was primarily related to a net increase in clinical activity in the MESA trial due to rollover of substantially all patients from the

CANYON, ARCH, and DUNE trials, and patients from the GRAND CANYON pivotal cohort beginning in April 2025.

Additional increases in sevasemten clinical program expenses compared to the same period in 2024 were due to fully enrolling the GRAND CANYON pivotal cohort in February 2025;

● a decrease in EDG-7500 clinical program expenses of $1.4 million primarily related to completion of our Phase 1 trial and a drug interaction study in 2024 for which there was no significant comparable activity in 2025, which was offset by continued patient activity for Part B and Part C and site activation and patient enrollment of Part D of our multipart Phase 2 CIRRUS-HCM trial, for which only Part A was active in the comparable period in 2024;

● an increase in EDG-15400 clinical program expenses of $3.0 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025.

These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials;

● discovery and preclinical expenses were substantially the same between the comparative periods.

This was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of the discovery and preclinical expenses in the comparable period in 2024, offset by additional nonclinical costs related to our EDG-003 cardiometabolic program;

● an increase in internal costs of $13.0 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.

General and administrative expenses

General and administrative expenses were $18.3 million and $14.5 million for the six months ended June 30, 2025 and 2024, respectively.

General and administrative expenses were $27.6 million and $22.7 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $4.9 million was primarily due to $4.2 million in increased personnel-related costs, including stock-based compensation, from increased headcount and $0.7 million in increased professional and consulting costs and other administrative costs.

Interest income

Interest income was $11.7 million and $12.8 million for the six months ended June 30, 2025 and 2024, respectively.

The decrease in interest income was primarily due to lower average treasury yields during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.

Interest income was $17.8 million and $19.1 million for the nine months ended September 30, 2025 and 2024, respectively.

The decrease of $1.3 million was primarily due to lower average treasury yields during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024, partially offset by higher average securities balances during the nine months ended September 30, 2025.

Liquidity and Capital Resources

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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, 2025, 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.

As of June 30, 2025, we had cash, cash equivalents and marketable securities in the amount of $594.0 million.

From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of September 30, 2025, 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.

As of September 30, 2025, we had cash, cash equivalents and marketable securities in the amount of $563.3 million.

The following table summarizes our sources and uses of cash for each of the periods presented:

Six months ended June 30,

Nine months ended September 30,

(in thousands)

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Operating activities

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 during the nine months ended September 30, 2025 was $105.2 million primarily driven by our net loss for the period of $117.6 million, and was also impacted by changes in operating assets and liabilities, which increased net working capital by $8.0 million.

Cash used in operating activities was reduced by non-cash charges of $20.4 million relating to stock-based compensation expense of $24.9 million, accretion of discounts, net on marketable securities of $6.2 million, depreciation of $1.6 million, and amortization of right-of-use asset of $0.1 million.

Cash used in operating activities during the six months ended June 30, 2024 was $54.7 million primarily driven by our net loss for the period of $60.0 million, and was also impacted by changes in operating assets and liabilities which decreased net working capital by $0.9 million.

Cash used in operating activities during the nine months ended September 30, 2024 was $82.1 million primarily driven by our net loss for the period of $94.2 million, and was also impacted by changes in operating assets and liabilities which decreased net working capital by $3.4 million.

Cash used in operating activities was reduced by non-cash charges of $8.7 million relating to stock-based compensation expense of $17.0 million, amortization of premium and accretion of discounts, net on marketable securities of $9.9 million, depreciation of $1.5 million and amortization of right-of-use asset of $0.2 million.

Investing activities

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.

Cash used in investing activities during the six months ended June 30, 2024 amounted to $230.9 million, which was due to $368.6 million in purchases of marketable securities and $0.5 million for purchases of equipment, which was partially offset by $136.4 million in maturities of marketable securities and $1.8 million in sales of marketable securities.

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.

Cash used in investing activities during the nine months ended September 30, 2024 amounted to $205.6 million, which was due to $413.9 million in purchases of marketable securities and $1.0 million for purchases of equipment, which was partially offset by $196.6 million in maturities of marketable securities and $12.7 million in sales of marketable securities.

Financing activities

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 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 .

Cash provided by financing activities during the six months ended June 30, 2024 was $243.0 million, which was due to cash proceeds of $7.0 million from the ATM Program, $240.0 million from the underwritten registered direct offering, $3.5 million in proceeds from the issuance of common stock upon exercise of stock options, and $0.4 million in

proceeds from the 2021 ESPP, which was partially offset by $7.9 million for the payment of underwriting commissions and offering costs.

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, $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 .

Cash provided by financing activities during the nine months ended September 30, 2024 was $246.4 million, which was due to cash proceeds of $7.0 million from the ATM Program, $240.0 million from the underwritten registered direct offering, $7.1 million in proceeds from the issuance of common stock upon exercise of stock options, and $0.4 million in proceeds from the employee stock purchase plan, which was partially offset by $7.9 million for the payment of underwriting commissions and offering costs and $0.3 million for the payment of deferred offering costs.

Funding requirements

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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.

Our short-term material cash requirements as of June 30, 2025 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.

Our short-term material cash requirements as of September 30, 2025 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.

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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.

Our long-term cash requirements as of June 30, 2025 includes our lease obligations.

Our long-term cash requirements as of September 30, 2025 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, 2025 our total operating lease liability balance is $4.4 million, of which $1.0 million is a current liability.

As of September 30, 2025 our total operating lease liability balance is $4.2 million, of which $1.0 million is a current liability.

Critical Accounting Estimates

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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 March 3, 2025 and the notes to the financial statements appearing elsewhere in this Quarterly Report.

During the three and six months ended June 30, 2025, there were no material changes to our critical accounting estimates from those discussed in our Annual Report on Form 10-K filed on March 3, 2025.

During the three and nine months ended September 30, 2025, there were no material changes to our critical accounting estimates from those discussed in our Annual Report on Form 10-K filed on March 3, 2025.

Recently Issued Accounting Pronouncements

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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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis