Edgewise Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0001558370-25-006857
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001558370-25-010655
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 69 previous paragraphs and 75 current paragraphs.
46 unchanged; 18 reworded; 4 added; 2 removed; 3 previous and 7 current paragraphs rearranged.
Tables are not compared: 55 previous and 61 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
Comparison of the six months ended June 30, 2025 and 2024
Current report
Research and development expenses
Current report
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:
Current report
General and administrative expenses
Removed paragraphs (2)
Previous report
Interest income
Previous report
Interest income
Reworded paragraphs (18)
Previous wording
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 may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.
Current wording
We have incurred significant losses since the commencement of our operations. 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.
Previous wording
As of March 31, 2025, we had an accumulated deficit of $419.4 million. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception 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. We believe that our existing cash and cash equivalents and marketable securities of $436.4 million will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.
Current wording
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 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.
Previous wording
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.
Current wording
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. 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.
Previous wording
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. These direct costs consist primarily of external costs such as fees paid to outside consultants, CROs, CDMOs, clinical trial sites and central laboratories in connection with our discovery and preclinical activities, process development, manufacturing and clinical development activities. These expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. 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 use
Current wording
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. These direct costs consist primarily of external costs such as fees paid to outside consultants, CROs, CDMOs, clinical trial sites and central laboratories in connection with our discovery and preclinical activities, process development, manufacturing and clinical development activities. These expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. 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,
Previous wording
Research and development expenses were $36.8 million and $27.7 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $9.1 million was attributed to the following:
Current wording
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:
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. To date, we have financed our operations primarily through private placements of 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.
Current wording
Since our inception, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. To date, we have financed our operations primarily through private placements of 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
Previous wording
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 was reduced by non-cash charges of $2.2 million relating to stock-based compensation expense of $4.9 million, accretion of discounts, net on marketable securities of $3.2 million, depreciation of $0.5 million and amortization of right-of-use asset of $0.1 million.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
Cash used in investing activities during the six months ended June 30, 2025 amounted to $118.3 million, due to $385.9 million in purchases of marketable securities and $0.1 million for purchases of equipment, which was partially offset by $229.1 million in maturities of marketable securities and $38.7 million in sales of marketable securities.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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 millionfor the payment of underwriting discounts and commissions and offering costs.
Previous wording
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.
Current wording
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
Previous wording
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. We are subject to all of the risks incident in the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. In addition, we expect to continue to incur additional costs associated with operating as a public company. Our expenses will also increase if, and as, we:
Current wording
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. 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. We are subject to all of the risks incident in the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. In addition, we expect to continue to incur additional costs associated with operating as a public company. Our expenses will also increase if, and as, we:
Previous wording
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. 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
Current wording
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.
Previous wording
Our long-term cash requirements as of March 31, 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.
Current wording
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 June 30, 2025 our total operating lease liability balance is $4.4 million, of which $1.0 million is a current liability.
Previous wording
Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on 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.
Current wording
Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting 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.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses:
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
proceeds from the 2021 ESPP, which was partially offset by $7.9 million for the payment of underwriting commissions and offering costs.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
internal resources primarily to conduct our research and discovery activities and to manage our preclinical development, manufacturing and clinical development activities.
Previous report — wording carried elsewhere
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
Previous report — wording carried elsewhere
only of payments for services provided and expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation.