What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-07 compared with 2025-05-08 · 72 added, 41 removed, 176 unchanged (39% of the section changed)

20 unchanged sentences

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

Our net losses were $40.8 million and $28.5 million for the three months ended March 31, 2025 and 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 $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 may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

As of March 31, 2025, we had an accumulated deficit of $419.4 million.

As of June 30, 2025, we had an accumulated deficit of $455.5 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 through March 31, 2025, these private placements have provided gross proceeds of $160.7 million, and the initial public offering, follow-on public offering, issuance of our common stock under an “at the market offering” program (the ATM Program), and underwritten registered direct offering have generated net proceeds of $606.6 million.

In addition, on April 3, 2025, we closed an underwritten registered direct offering of 9,935,419 shares of our common stock at an offering price of $20.13 per share (April 2025 Offering).

The net proceeds from the April 2025 Offering after deducting underwriting discounts and commissions but before offering expenses were $188.0 million.

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.

We believe that our existing cash and cash equivalents and marketable securities of $594.0 million will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.

1 unchanged sentence

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 and sanctions so that the Company can be prepared to react to new developments as they arise.

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.

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.

For more information regarding the risks related to macroeconomic and geopolitical developments, see the section titled “Risk Factors” found elsewhere in this Quarterly Report.

Components of Our Results of Operations

18 unchanged sentences

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.

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

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.

31 unchanged sentences

Results of Operations

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

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:

Three months ended March 31,

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,

(in thousands)

7 unchanged sentences

The following table summarizes our research and development expenses:

Three months ended March 31,

Three months ended June 30,

(in thousands)

5 unchanged sentences

Total research and development expenses

Research and development expenses were $36.8 million and $27.7 million for the three months ended March 31, 2025 and 2024, respectively.

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

The increase of $2.9 million was attributed to the following:

● an increase of $1.9 million in sevasemten clinical program expenses, which was primarily due to increased clinical trial activity from completion of patient enrollment of the GRAND CANYON pivotal cohort of the CANYON trial and continued activity in the MESA and FOX trials that were in early enrollment phases during the comparable period in 2024, as well as general clinical and outreach costs incurred in connection with all sevasemten trials.

● an increase in EDG-7500 clinical program expenses of $0.2 million primarily related to increased costs from site activation and patient enrollment for Part B and Part C of our multipart Phase 2 CIRRUS-HCM trial, for which Part A was in the start-up phase in the comparable period in 2024;

which was offset by the decreased activity in our Phase 1 trial, which was still underway in the comparable period in 2024.

● 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 in internal costs of $5.7 million, primarily related to personnel costs and stock-based compensation resulting from increased employee headcount to support the growth of our research and development programs.

● an increase in internal costs of $4.4 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 $9.2 million and $7.1 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $2.1 million was primarily due to $1.6 million in increased personnel-related costs from increased headcount and stock-based compensation and $0.5 million in increased professional and consulting costs and other administrative costs.

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.

Interest income

Interest income was $5.2 million and $6.2 million for the three months ended March 31, 2025 and 2024, respectively.

The decrease in interest income was primarily due to lower balances of marketable securities during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.

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,

(in thousands)

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Interest income

Research and development expenses

The following table summarizes our research and development expenses:

Six months ended June 30,

(in thousands)

External research and development expenses:

Sevasemten clinical program

EDG-7500 clinical program

Discovery and preclinical

Internal costs, including personnel related

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.

The increase of $11.9 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 in internal costs of $10.1 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.

The increase of $3.8 million was primarily due to $3.0 million in increased personnel-related costs, including stock-based compensation, from increased headcount and $0.8 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.

Liquidity and Capital Resources

2 unchanged sentences

To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock.

From inception through March 31, 2025, these private placements have provided gross proceeds of $160.7 million, and the initial public offering, follow-on public offering, issuance of our common stock under the ATM Program, and underwritten registered direct offerings have generated net proceeds of $606.6 million.

In addition, the net proceeds from the April 2025 Offering , after deducting underwriting discounts and commissions but before offering expenses, were $188.0 million.

As of March 31, 2025, we had cash, cash equivalents and marketable securities in the amount of $436.4 million.

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.

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

Three months ended March 31,

Six months ended June 30,

(in thousands)

Net cash used in operating activities

Net cash provided by (used in) investing activities

Net cash used in investing activities

Net cash provided by financing activities

1 unchanged sentence

Operating activities

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.

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, accretion of discounts, net on marketable securities of $1.9 million, and depreciation of $0.5 million.

Cash used in operating activities during the three months ended March 31, 2024 was $28.6 million primarily driven by our net loss for the period of $28.5 million, and was also impacted by changes in operating assets and liabilities which increased net working capital by $2.3 million.

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.

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 was reduced by non-cash charges of $4.5 million relating to stock-based compensation expense of $10.1 million, amortization of premium and accretion of discounts, net on marketable securities of $6.7 million, depreciation of $1.0 million and amortization of right-of-use asset of $0.1 million.

Investing activities

Cash provided by investing activities during the three months ended March 31, 2025 amounted to $43.9 million, due to $122.2 million in purchases of marketable securities, which was partially offset by $151.1 million in maturities of marketable securities and $15.0 million in sales of marketable securities.

Cash provided by investing activities during the three months ended March 31, 2024 amounted to $268.3 million, which was due to $327.6 million in purchases of marketable securities and $0.1 million for purchases of equipment, which was partially offset by $58.7 million in maturities of marketable securities and $0.9 million in sales of marketable securities.

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.

Financing activities

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 in proceeds 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.

Cash provided by financing activities during the three months ended March 31, 2024 was $241.1 million, which was due to cash proceeds of $7.0 million from the ATM Program, $240.0 million from the underwritten registered direct offering, and $1.9 million in proceeds from the issuance of common stock upon exercise of stock options, which was partially offset by $7.8 million for the payment of underwriting commissions and offering costs.

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.

Funding requirements

We will 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.

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.

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.

41 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.

Our short-term material cash requirements as of March 31, 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 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.

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.

These contracts do not contain any minimum purchase commitments and are cancelable by us upon prior notice.

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 March 31, 2025 includes our lease obligations.

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.

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 March 31, 2025 our total operating lease liability balance is $4.6 million, of which $1.0 million is a current liability.

As of June 30, 2025 our total operating lease liability balance is $4.4 million, of which $1.0 million is a current liability.

Critical Accounting Estimates

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

During the three months ended March 31, 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 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.

Recently Issued Accounting Pronouncements

7 unchanged sentences

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