What changed in this filing

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Item 1. Financial Statements

2025-11-06 compared with 2025-08-07 · 177 added, 114 removed, 477 unchanged (38% of the section changed)

3 unchanged sentences

(Amounts in thousands, except share and per share amounts)

June 30, 2025 March 31, 2025

September 30, 2025 March 31, 2025

Current assets:

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Common stock, $ 0.001 par value;

150,000,000 shares authorized as of June 30, 2025 and March 31, 2025;

77,807,174 and 77,085,024 shares issued and outstanding as of June 30, 2025 and March 31, 2025, respectively

150,000,000 shares authorized as of September 30, 2025 and March 31, 2025 ;

78,403,255 and 77,085,024 shares issued and outstanding as of September 30, 2025 and March 31, 2025, respectively

Additional paid-in capital 1,376,507 1,358,897

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(Amounts in thousands, except share and per share amounts)

Three Months Ended June 30,

Three Months Ended September 30, Six Months Ended September 30,

2025 2024 2025 2024

Operating expenses:

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Interest expense on debt obligations ( 1,488 ) ( 1,438 ) ( 2,963 ) ( 2,864 )

Other income (expense) 591 406

Other (expense) income, net

( 876 ) 2,028 ( 284 ) 2,433

Total other income (expense), net 1,191 5,861 4,922 9,456

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(Amounts in thousands)

Three Months Ended June 30,

Three Months Ended September 30, Six Months Ended September 30,

2025 2024 2025 2024

Net loss $ ( 83,100 ) $ ( 53,055 ) $ ( 169,793 ) $ ( 106,827 )

Other comprehensive loss:

Foreign currency translation loss ( 938 ) ( 432 )

Net unrealized loss on short-term investments, net of tax of $ 0

Foreign currency translation gain (loss) 751 ( 1,905 ) ( 187 ) ( 2,337 )

Net unrealized gain (loss) on short-term investments

131 1,215 ( 138 ) 1,116

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Balances as of June 30, 2025 77,807,174 78 1,367,668 ( 1,035,272 ) 4,241 336,715

Foreign currency translation adjustment — — — — 751 751

Unrealized gain on short-term investments — — — — 131 131

Exercise of pre-funded warrants 497,344 — 501 — — 501

Vesting of RSUs 98,737 — — — — —

Stock-based compensation expense — — 8,338 — — 8,338

Net loss — — — ( 83,100 ) — ( 83,100 )

Balances as of September 30, 2025 78,403,255 78 1,376,507 ( 1,118,372 ) 5,123 263,336

Balances as of March 31, 2024 61,415,105 $ 61 $ 1,070,874 $ ( 701,282 ) $ 4,855 $ 374,508

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Balances as of June 30, 2024 68,309,968 68 1,177,113 ( 755,054 ) 4,324 426,451

Foreign currency translation adjustment — — — — ( 1,905 ) ( 1,905 )

Unrealized gain on short-term investments — — — — 1,215 1,215

Exercise of stock options 34,284 — 103 — — 103

Vesting of RSUs 50,336 — — — — —

Stock-based compensation expense — — 8,650 — — 8,650

Net loss — — — ( 53,055 ) — ( 53,055 )

Balances as of September 30, 2024 68,394,588 68 1,185,866 ( 808,109 ) 3,634 381,459

The accompanying notes are an integral part of these condensed consolidated financial statements.

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(Amounts in thousands)

Three Months Ended June 30,

Six Months Ended September 30,

Cash flows from operating activities:

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Noncash interest expense 829 758

Unrealized foreign currency transaction losses (gains) 591 ( 406 )

Unrealized foreign currency transaction (gains)

( 284 ) ( 2,433 )

Changes in operating assets and liabilities:

16 unchanged sentences

Proceeds from exercise of stock options and pre-funded warrants

Net cash (used in) provided by financing activities ( 158 ) 96,637

Net cash provided by financing activities

Effect of exchange rate changes on cash, cash equivalents and restricted cash 26 26

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and Replimune (Ireland) Limited.

The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, third-party intellectual property, compliance with government regulations and the ability to secure additional capital to fund operations.

Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization.

The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, the progress and outcomes of preclinical and clinical development, the requirements and views of regulators, the development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, third-party intellectual property, compliance with government regulations and the ability to secure additional capital to fund operations.

These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance and reporting capabilities.

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Basis of presentation

The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.

The Company has incurred recurring losses since its inception, including net losses of $ 86.7 million and $ 53.8 million for the three months ended June 30, 2025 and 2024, respectively.

In addition, as of June 30, 2025, the Company had an accumulated deficit of $ 1,035.3 million.

The Company expects to continue to generate operating losses for the foreseeable future and to finance its future cash needs through a combination of equity offerings, debt financings, collaborations, strategic partnerships and alliances or licensing arrangements.

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business.

The Company has incurred recurring losses since its inception, including net losses of $ 83.1 million and $ 53.1 million for the three months ended September 30, 2025 and 2024, and net losses of $ 169.8 million and $ 106.8 million for the six months ended September 30, 2025 and 2024, respectively.

In addition, as of September 30, 2025, the Company had an accumulated deficit of $ 1,118.4 million.

The Company expects to continue to generate operating losses for the foreseeable future and will need to finance its future cash needs through any or a combination of equity offerings, debt financings, collaborations, strategic partnerships and alliances or licensing arrangements.

If the Company is unable to obtain funding, the Company would be forced to delay, reduce or eliminate some or all of its research and development programs, preclinical and clinical testing or commercialization efforts, which could adversely affect its business prospects.

The Company expects that its cash and cash equivalents and short-term investments will be sufficient to fund its operations through at least 12 months from the issuance of these consolidated financial statements, which includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

These estimates are based on assumptions that may prove to be wrong, including the assumption that the development of RP1 will remain viable, and the Company could utilize its available capital resources sooner than expected.

The Company expects that its cash and cash equivalents and short-term investments will be sufficient to fund its operations through at least 12 months from the issuance of these condensed consolidated financial statements, which includes the potential commercialization of RP1 in advanced melanoma and for working capital and general corporate purposes and excludes any potential revenue.

These estimates are based on assumptions that may prove to be wrong, including the assumption of a potential commercialization of RP1 in advanced melanoma, that the development of RP1 will even remain viable, and the Company could utilize its available capital resources sooner than expected.

Summary of significant accounting policies

Principles of consolidation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune US, Replimune Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Replimune UK, Replimune US, Replimune Securities Corporation and Replimune (Ireland) Limited after elimination of all intercompany accounts and transactions.

Use of estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods.

Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses and the valuation of stock-based awards.

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods.

Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses and the valuation of stock-based awards.

The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances.

Unaudited interim financial information

The accompanying condensed consolidated balance sheet as of June 30, 2025, the condensed consolidated statements of operations, condensed consolidated statements of comprehensive loss and consolidated statements of stockholders’ equity for the three months ended June 30, 2025 and 2024 and the condensed consolidated statements of cash flows for the three months ended June 30, 2025 and 2024 are unaudited.

The unaudited interim consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2025 and the results of its operations for the three months ended June 30, 2025 and 2024 and its cash flows for the three months ended June 30, 2025 and 2024.

The financial data and other information disclosed in these consolidated notes related to the three months ended June 30, 2025 and 2024 are unaudited.

The results for the three months ended June 30, 2025 are not necessarily indicative of results to be expected for the year ending March 31, 2026, any other interim periods or any future year or period.

The accompanying condensed consolidated balance sheet as of September 30, 2025, the condensed consolidated statements of operations, condensed consolidated statements of comprehensive loss and consolidated statements of stockholders’ equity for the three and six months ended September 30, 2025 and 2024 and the condensed consolidated statements of cash flows for the six months ended September 30, 2025 and 2024 are unaudited.

The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2025 and the results of its operations for the three and six months ended September 30, 2025 and 2024 and its cash flows for the six months ended September 30, 2025 and 2024.

The financial data and other information disclosed in these consolidated notes related to the three and six months ended September 30, 2025 and 2024 are unaudited.

The results for the three and six months ended September 30, 2025 are not necessarily indicative of results to be expected for the year ending March 31, 2026, any other interim periods or any future year or period.

The financial information included herein should be read in conjunction with the financial statements and notes in the Company's Annual Report on Form 10-K for the year ended March 31, 2025, which was filed with the Securities and Exchange Commission on May 22, 2025 (the "Annual Report").

During the three months ended June 30, 2025, there have been no changes to the Company’s significant accounting policies as described in the Annual Report.

During the three and six months ended September 30, 2025, there have been no changes to the Company’s significant accounting policies as described in the Annual Report.

Recently Issued Accounting Pronouncements

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Fair Value Measurements as of

June 30, 2025 Using:

September 30, 2025 Using:

Level 1 Level 2 Level 3 Total

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The underlying securities in the money market funds held by the Company are all government backed securities.

During the three months ended June 30, 2025 and 2024, there were no transfers between levels.

During the three and six months ended September 30, 2025 and 2024, there were no transfers between levels.

Valuation of cash equivalents and short-term investments

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Treasury bonds were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.

Cash equivalents consisted of money market funds at June 30, 2025 and March 31, 2025.

Cash equivalents consisted of money market funds at September 30, 2025 and March 31, 2025.

Short-term investments

As of June 30, 2025 and March 31, 2025, the Company's available-for-sale investments by type consisted of the following:

June 30, 2025

As of September 30, 2025 and March 31, 2025, the Company's available-for-sale investments by type consisted of the following:

September 30, 2025

cost Gross unrealized

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Total $ 372,377 $ 349 $ ( 41 ) $ — $ 372,685

As of June 30, 2025 and March 31, 2025, available-for-sale securities consisted of investments that mature within one year.

As of September 30, 2025 and March 31, 2025, available-for-sale securities consisted of investments that mature within one year.

Property, plant and equipment, net

Property, plant and equipment, net consisted of the following:

June 30, 2025 March 31, 2025

September 30, 2025 March 31, 2025

Office equipment $ 1,897 $ 1,812

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Property, plant and equipment, net $ 14,711 $ 13,739

Depreciation and amortization expense was $ 0.9 million for the three months ended June 30, 2025 and $ 0.7 million for the three months ended June 30, 2024.

Amortization on capitalized software for the three months ended June 30, 2025 was $ 0.3 million.

Amortization of capitalized software for the three months ended June 30, 2024 was immaterial .

Depreciation and amortization expense was $ 0.8 million and $ 1.7 million for the three and six months ended September 30, 2025 and $ 0.9 million and $ 1.7 million for the three and six months ended September 30, 2024.

Amortization on capitalized software for the three and six months ended September 30, 2025 was $ 0.3 million and $ 0.6 million, respectively.

Amortization of capitalized software for the three and six months ended September 30, 2024 was immaterial .

Depreciation and amortization expense is recorded within research and development and selling, general and administrative expenses in the consolidated statement of operations.

1 unchanged sentence

Accrued expenses and other current liabilities consisted of the following:

June 30, 2025 March 31, 2025

September 30, 2025 March 31, 2025

Accrued research and development costs $ 23,436 $ 19,606

10 unchanged sentences

The total amount of the Loan Agreement, as well as the outstanding balance of the loan, is unchanged, but the option to borrow additional funds were redistributed from tranche 1 to tranche 2.

A second amendment was made to the Loan Agreement (the "Second Amendment") on December 22, 2023 (the "closing date") pursuant to which the Company agreed to draw a term loan advance in an aggregate principal amount not less than $ 15.0 million, provided that the aggregate amount of the term loan advances made under tranche 2 do not exceed $ 15.0 million on or prior to December 31, 2023.

The Second Amendment re-allocated the total future consideration of the

Loan Agreement to the future tranches extending through September 2026, subject to the terms and conditions of the Loan Agreement.

$ 15.0 million on or prior to December 31, 2023.

The Second Amendment re-allocated the total future consideration of the Loan Agreement to the future tranches extending through September 2026, subject to the terms and conditions of the Loan Agreement.

The Second Amendment did not change the total aggregate maximum principal amount to be drawn under the Loan Agreement, which remains as up to $ 200.0 million.

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(1) achieve a minimum amount of trailing three-month net product revenue tested on a monthly basis, (2) maintain a market capitalization in excess of $ 1.2 billion and Unrestricted Cash in an amount no less than 50 % of the outstanding amount under the Term Loan Facility, or (3) maintain Unrestricted Cash in an amount no less than 85 % of the outstanding amount under the Term Loan Facility.

During the three months ended September 30, 2025, the unrestricted cash amount, in accounts subject to a control agreement, fell below the 35 % threshold for the Company, as defined in the Loan Agreement, for one monthly reporting period.

The unrestricted cash amount was immediately rectified in the following month as a result of a cash transfer between accounts.

The Company has obtained a waiver for the debt covenant violation that occurred on that date.

The Company paid a $ 0.5 million facility charge and incurred debt issuance costs of $ 1.5 million upon closing of the Loan Agreement.

The Loan Agreement also provides for a final payment, payable upon maturity or the repayment of the obligations in full or in part (on a pro rata basis), equal to 4.95 % of the aggregate principal amount of Term Loans advanced to the Company and repaid on such date, which is being accrued on the Company's consolidated balance sheet.

The amount accrued for the final payment is $ 1.2 million as of June 30, 2025 and $ 1.0 million as of March 31, 2025.

The amount accrued for the final payment is $ 1.3 million as of September 30, 2025 and $ 1.0 million as of March 31, 2025.

Unamortized debt issuance costs and deferred financing costs are recorded as a reduction of the carrying amount on the term loan and amortized as interest expense using the effective-interest method.

Unamortized debt issuance costs and deferred financing costs of $ 1.0 million and $ 1.1 million were recorded in other assets as of June 30, 2025 and March 31, 2025, respectively.

Interest expense for the three months ended June 30, 2025 was $ 1.5 million, and $ 1.4 million for the three months ended June 30, 2024.

The summary of obligations under the term loan as of June 30, 2025 and March 31, 2025 consisted of the following (in thousands):

June 30, 2025 March 31, 2025

Unamortized debt issuance costs and deferred financing costs of $ 0.9 million and $ 1.1 million were recorded in other assets as of September 30, 2025 and March 31, 2025, respectively.

Interest expense for the three and six months ended September 30, 2025 was $ 1.5 million and $ 3.0 million, and $ 1.4 million and $ 2.9 million for the three and six months ended September 30, 2024.

The summary of obligations under the term loan as of September 30, 2025 and March 31, 2025 consisted of the following (in thousands):

September 30, 2025 March 31, 2025

Principal loan balance $ 46,805 $ 46,450

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Long term debt, net of discount $ 47,206 $ 46,377

The annual principal payments due under the Loan Agreement as of fiscal June 30, 2025 and March 31, 2025 were as follows:

June 30, 2025 March 31, 2025

The annual principal payments due under the Loan Agreement as of fiscal September 30, 2025 and March 31, 2025 were as follows:

September 30, 2025 March 31, 2025

2027 20,145 20,145

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8 Stockholders’ equity

As of June 30, 2025 and March 31, 2025, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 150,000,000 shares of common stock, par value $ 0.001 per share.

As of September 30, 2025 and March 31, 2025, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 150,000,000 shares of common stock, par value $ 0.001 per share.

The Company had reserved for common stock for the exercise of outstanding stock options and the vesting of restricted stock units, the number of shares remaining available for grant under the Company’s 2018 Omnibus Incentive Compensation Plan and the Company’s Employee Stock Purchase Plan (see Note 10) and the exercise of the outstanding warrants to purchase shares of common stock as follows:

June 30, 2025 March 31, 2025

September 30, 2025 March 31, 2025

Stock options, issued and outstanding 12,232,757 10,214,878

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Undesignated preferred stock

As of June 30, 2025, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $ 0.001 per share.

There were no undesignated preferred shares issued or outstanding as of June 30, 2025.

As of September 30, 2025, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $ 0.001 per share.

There were no undesignated preferred shares issued or outstanding as of September 30, 2025.

On August 3, 2023, the Company and Leerink Partners LLC (the "Agent") entered into a sales agreement, which was subsequently amended on May 16, 2024, November 25, 2024 and May 22, 2025 (as so amended, the "2023 Sales Agreement").

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The Company has also agreed to provide the Agent with customary indemnification rights.

During the three months ended June 30, 2025, the Company did not issue or sell any shares under the 2023 Sales Agreement.

During the three and six months ended September 30, 2025, the Company did not issue or sell any shares under the 2023 Sales Agreement.

The Company cannot provide any assurances that it will issue any Shares pursuant to the 2023 Sales Agreement.

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The 14,058,153 shares of the Company's common stock underlying the pre-funded warrants issued by the Company are not included in the number of issued and outstanding shares of the Company’s common stock as reported on the consolidated balance sheet, though they are included in the Company's annual pool increase calculation as described in Note 10, as well as the weighted average outstanding common stock in the calculation of basic and diluted net loss per share, as described below in Note 11.

During the three months ended June 30, 2025, there were no exercises of pre-funded warrants.

During the year ended March 31, 2025, a holder of the Company's pre-funded warrants exercised 739,225 of its pre-funded warrants for an exercise price of $ 0.001 per pre-funded warrant and the Company issued 739,225 shares of Common Stock in exchange thereof.

During the three and six months ended September 30, 2025, one pre-IPO warrant holder exercised 248,672 of the Company's pre-funded warrants for an exercise price of $ 1.01 per pre-funded warrant.

In addition, a second holder of the Company's pre-IPO warrants exercised 248,672 of the Company's pre-funded warrants for an exercise price of $ 1.01 per pre-funded warrant.

As a result of the exercises, the Company issued 497,344 shares of Common Stock in exchange thereof.

10 Stock-based compensation

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Three Months Ended

September 30, Six Months Ended

September 30,

2025 2024 2025 2024

Research and development $ 4,379 $ 4,078 $ 9,068 $ 8,304

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$ 8,338 $ 8,650 $ 17,100 $ 18,125

The following table summarizes stock-based compensation expense by award type for the three months ended June 30, 2025 and 2024:

The following table summarizes stock-based compensation expense by award type for the three and six months ended September 30, 2025 and 2024:

Three Months Ended

September 30, Six Months Ended September 30,

2025 2024 2025 2024

Stock options $ 4,161 $ 4,894 $ 8,298 $ 10,627

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4,177 3,756 8,802 7,498

$ 8,338 $ 8,650 $ 17,100 $ 18,125

2018 Omnibus Incentive Compensation Plan

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If any options or stock appreciation rights, including outstanding options and stock appreciation rights granted under the 2017 Plan (up to 2,520,247 shares), terminate, expire, or are canceled, forfeited, exchanged, or surrendered without having been exercised, or if any stock awards, stock units or other stock-based awards, including outstanding awards granted under the 2017 Plan, are forfeited, terminated, or otherwise not paid in full in shares of common stock, the shares of the Company’s common stock subject to such grants will be available for purposes of the 2018 Plan.

The number of shares reserved for issuance under the 2018 Plan will increase automatically on the first day of each April equal to 4.0 % of the total number of shares of common stock outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the 14,058,153 shares issuable upon exercise of those pre-funded warrants as of March 31, 2025, as described in Note 9 to these consolidated financial statements, or such lesser amount as determined by the Board.

The number of shares reserved for issuance under the 2018 Plan will increase automatically on the first day of each April equal to 4.0 % of the total number of shares of common stock outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the 14,058,153 shares issuable upon exercise of those pre-funded warrants as of March 31, 2025, as described in Note 9 to these condensed consolidated financial statements, or such lesser amount as determined by the Board.

On April 1, 2025, the number of shares reserved for issuance under the 2018 Plan automatically increased by 3,645,727 shares pursuant to the terms of the 2018 Plan and based on total number of shares of common stock outstanding on March 31, 2025.

As of June 30, 2025, 1,733,799 shares remained available for future grants under the 2018 Plan.

As of September 30, 2025, 1,897,696 shares remained available for future grants under the 2018 Plan.

The 2018 Plan is administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors.

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The RSUs typically vest over four approximately equal annual installments with the first such installment occurring on a designated vesting date that is approximately on the one-year anniversary of the date of grant and the subsequent installments occurring on the subsequent three annual anniversaries of the designated vesting date.

In 2024 the Board of Directors approved the award of performance stock units ("PSUs"), under the 2018 Plan in addition to the aforementioned stock option awards and RSUs available as part of the Company’s equity incentive for employees, officers, advisors and consultants of the Company.

In 2024 the Board of Directors approved the award of performance stock units ("PSUs"), under the

2018 Plan in addition to the aforementioned stock option awards and RSUs available as part of the Company’s equity incentive for employees, officers, advisors and consultants of the Company.

The PSUs will become vested, if at all, upon the achievement of the approval of the Company's first Biologics License Application ("BLA") for RP1 by the Food and Drug Administration ("FDA") no later than June 30, 2026, and the expense recognized for these awards is based on the grant date fair value of the Company's common stock multiplied by the number of units granted.

The timing of recognition of this stock-based compensation expense is subject to our judgment as to when the performance conditions are considered probable of being achieved.

The Company granted 246,110 PSUs under the 2018 Plan during the three months ended June 30, 2024.

As more fully described in Note 18, the Company has received a CRL from the FDA with respect to the Company's first BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma.

If the Company does not achieve the approval of the Company's first BLA for RP1 before June 30, 2026 then no PSU will be earned or vested.

The Company did no t grant any PSUs under the 2018 Plan during the six months ended September 30, 2025 and the Company granted 246,110 PSUs under the 2018 Plan during the six months ended September 30, 2024.

As more fully described within this Quarterly Report on Form 10-Q, the FDA has accepted the resubmission of the BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma.

If the Company does not receive FDA approval of the Company's first BLA for RP1 on or before June 30, 2026 then no PSU will be earned or vested.

Employee Stock Purchase Plan

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The total shares of common stock initially reserved for issuance under the ESPP is 348,612 shares.

In addition, as of the first trading day of each fiscal year during the term of the ESPP (excluding any extensions), an additional number of shares of the Company’s common stock equal to 1 % of the total number of shares outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the 14,058,153 shares issuable upon exercise of those pre-funded warrants described in Note 9 to these consolidated financial statements, or 697,224 shares, whichever is less (or such lesser amount as determined by the Company’s board of directors) will be added to the number of shares authorized under the ESPP.

In addition, as of the first trading day of each fiscal year during the term of the ESPP (excluding any extensions), an additional number of shares of the Company’s common stock equal to 1 % of the total number of shares outstanding on the last trading day in the immediately preceding fiscal year, which includes for these purposes, the 14,058,153 shares issuable upon exercise of those pre-funded warrants described in Note 9 to these condensed consolidated financial statements, or 697,224 shares, whichever is less (or such lesser amount as determined by the Company’s board of directors) will be added to the number of shares authorized under the ESPP.

In accordance with the terms of the ESPP, on April 1, 2025, the number of shares reserved for issuance under the ESPP automatically increased by 697,224 , for a total of 4,102,399 shares reserved for the ESPP.

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The inducement grants are included in the stock option and RSU award tables below.

During the three months ended June 30, 2025 and 2024, the Company granted 156,895 and 75,000 nonqualified stock options to purchase shares of the Company's common stock, and 240,960 and 50,000 restricted stock units under employment inducement grants.

During the six months ended September 30, 2025 and 2024, the Company granted 202,945 and 75,000 nonqualified stock options to purchase shares of the Company's common stock, and 333,130 and 50,000 restricted stock units under employment inducement grants.

Stock option valuation

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Three Months Ended

September 30, Six Months Ended

September 30,

2025 2024 2025 2024

Risk-free interest rate 4.00 % 3.72 % 3.97 % 4.37 %

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Cancelled ( 131,464 ) $ 13.45

Outstanding as of June 30, 2025 12,273,997 $ 14.05 6.61 $ 11,170

Options exercisable as of June 30, 2025 7,574,723 $ 16.17 5.13 $ 7,511

Options vested and expected to vest as of June 30, 2025 12,273,997 $ 14.05 6.61 $ 11,170

As of June 30, 2025, there was $ 31.7 million of unrecognized compensation cost related to unvested common stock options, which is expected to be recognized over a weighted average period of 2.8 years.

The weighted average grant-date fair value of stock options granted during the three months ended June 30, 2025 and 2024 was $ 5.80 and $ 5.37 , respectively.

The aggregate intrinsic value of stock options exercised during the three months ended June 30, 2025 was immaterial .

The aggregate intrinsic value of stock options exercised during the three months ended June 30, 2024 was $ 0.1 million.

Outstanding as of September 30, 2025 12,232,757 $ 14.04 6.34 $ 1,116

Options exercisable as of September 30, 2025 7,892,224 $ 16.05 4.98 $ 1,116

Options vested and expected to vest as of September 30, 2025 12,232,757 $ 14.04 6.34 $ 1,116

As of September 30, 2025, there was $ 27.6 million of unrecognized compensation cost related to unvested common stock options, which is expected to be recognized over a weighted average period of 2.6 years.

The weighted average grant-date fair value of stock options granted during the six months ended September 30, 2025 and 2024 was $ 5.81 and $ 5.51 , respectively.

The aggregate intrinsic value of stock options exercised during the six months ended September 30, 2025 was immaterial .

The aggregate intrinsic value of stock options exercised during the six months ended September 30, 2024 was $ 0.3 million.

Restricted and performance stock units

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The grants will become vested, if at all, upon the achievement of the approval of the Company’s first BLA for RP1 by the FDA no later than June 30, 2026.

As more fully described in Note 18, the Company has received a CRL from the FDA with respect to the Company’s first BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma.

If the Company does not achieve the approval of the Company's first BLA for RP1 before June 30, 2026 then no PSU will be earned or vested.

As more fully described within this Quarterly Report on Form 10-Q, the FDA has accepted the resubmission of the BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma.

If the Company does not receive approval from the FDA of the Company's first BLA for RP1 on or before June 30, 2026 then no PSU will be earned or vested.

The grant date fair value for the PSUs is determined based on the market price of the Company's common stock on the grant date and is recognized over the requisite service period if and when the achievement of such performance condition is determined to be probable by the Company.

The Company reassesses the probability of achieving the performance condition at each reporting period.

As of June 30, 2025, the Company has not recognized any expense related to PSUs.

A summary of the changes in the Company's RSUs and PSUs during the three months ended June 30, 2025 is as follows:

As of September 30, 2025, the Company has not recognized any expense related to PSUs.

A summary of the changes in the Company's RSUs and PSUs during the six months ended September 30, 2025 is as follows:

Number of Restricted Shares Weighted

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Cancelled ( 176,245 ) 9.95

Outstanding as of June 30, 2025 5,231,911 $ 10.07

As of June 30, 2025, there was $ 43.3 million of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of 2.9 years.

Outstanding as of September 30, 2025 5,107,447 $ 9.96

As of September 30, 2025, there was $ 38.8 million of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of 2.63 years.

In addition, unrecognized compensation costs related to performance based awards tied to the achievement of a company milestone account for approximately $ 4.3 million.

2 unchanged sentences

Basic and diluted net loss per share attributable to common stockholders was calculated as follows:

Three Months Ended June 30,

Three Months Ended September 30, Six Months Ended September 30,

2025 2024 2025 2024

Net loss $ ( 83,100 ) $ ( 53,055 ) $ ( 169,793 ) $ ( 106,827 )

1 unchanged sentence

Net loss per share, basic and diluted $ ( 0.90 ) $ ( 0.68 ) $ ( 1.85 ) $ ( 1.45 )

The 14,058,153 shares of the Company's common stock issuable upon exercise of pre-funded warrants described in Note 9 to these consolidated financial statements are included as outstanding common stock in the calculation of basic and diluted net loss per share.

The 14,058,153 shares of the Company's common stock issuable upon exercise of pre-funded warrants described in Note 9 to these condensed consolidated financial statements are included as outstanding common stock in the calculation of basic and diluted net loss per share.

The Company’s potentially dilutive securities, which include stock options, unvested restricted and performance stock units and warrants to purchase shares of common stock that resulted from the conversion of warrants to purchase shares of series seed preferred stock existing before the Company's IPO, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.

Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same.

The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:

Three Months Ended June 30,

The Company excluded the following

potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:

Three and Six Months Ended September 30,

Options to purchase common stock 12,232,757 10,232,085

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The Company will recognize any amounts received from Roche in connection with this agreement as an offset to research and development expense within the consolidated statement of operations.

During the three months ended June 30, 2025 and 2024, the Company did not make any payments to Roche under the terms of the agreement.

The Company did no t record any costs as an offset to research and development expenses during the three months ended June 30, 2025 and 2024.

During the three months ended June 30, 2025 and 2024, the Company received payments under the terms of the agreement from Roche of $ 0.0 million and $ 1.8 million, respectively.

As of June 30, 2025 and March 31, 2025, no receivables were recorded from Roche in connection with this agreement.

During the three and six months ended September 30, 2025 and 2024, the Company did not make any payments to Roche under the terms of the agreement.

The Company did no t record any costs as an offset to research and development

expenses during the three and six months ended September 30, 2025 and 2024.

During the six months ended September 30, 2025 and 2024, the Company received payments under the terms of the agreement from Roche of $ 0.0 million and $ 1.8 million, respectively.

As of September 30, 2025 and March 31, 2025, no receivables were recorded from Roche in connection with this agreement.

In August 2023 the Company entered into a Settlement Agreement with Amgen and mutually agreed to terminate the Company's challenges to Amgen's patents.

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14 Commitments and contingencies

The table below presents the lease-related costs which are included in the consolidated statements of operations for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30,

The table below presents the lease-related costs which are included in the consolidated statements of operations for the three and six months ended September 30, 2025 and 2024:

Three Months Ended September 30, Six Months Ended September 30,

2025 2024 2025 2024

Finance lease costs:

3 unchanged sentences

Total lease cost $ 1,415 $ 1,423 $ 2,830 $ 2,845

The following table summarizes the classification of lease costs in the consolidated statement of operations for the three months ended June 30, 2025 and 2024 as follows:

Three Months Ended June 30,

The following table summarizes the classification of lease costs in the consolidated statement of operations for the three and six months ended September 30, 2025 and 2024 as follows:

Three Months Ended September 30, Six Months Ended September 30,

2025 2024 2025 2024

Finance Lease Costs

Research and development $ 607 $ 607 $ 1,214 $ 1,214

Other income (expense) 521 534

Other expenses (income)

518 531 1,039 1,065

Operating Lease Costs

2 unchanged sentences

Total lease cost $ 1,415 $ 1,423 $ 2,830 $ 2,845

The following table summarizes the maturity of the Company's lease liabilities on an undiscounted cash flow basis by fiscal year and a reconciliation to the operating and financing lease liabilities recognized on its balance sheet as of June 30, 2025:

June 30, 2025

September 30, 2025

Operating leases Financing lease Total

2026 (remaining nine months) $ 915 $ 2,111 $ 3,026

2026 (remaining six months) $ 604 $ 1,417 $ 2,021

2027 1,169 2,883 4,052

6 unchanged sentences

Total lease liabilities $ 3,933 $ 25,185 $ 29,118

The following table provides lease disclosure as of June 30, 2025 and March 31, 2025:

June 30, 2025 March 31, 2025

The following table provides lease disclosure as of September 30, 2025 and March 31, 2025:

September 30, 2025 March 31, 2025

Right-of-use operating lease asset $ 3,692 $ 3,998

6 unchanged sentences

Total lease liabilities $ 29,118 $ 29,788

The following table provides lease disclosure for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30,

The following table provides lease disclosure for the six months ended September 30, 2025 and 2024:

Six Months Ended September 30,

Other information

8 unchanged sentences

Weighted-average discount rate - financing leases 8.3 % 8.3 %

The variable lease costs and short-term lease costs were insignificant for the three months ended June 30, 2025 and 2024.

The variable lease costs and short-term lease costs were insignificant for the three and six months ended September 30, 2025 and 2024.

Manufacturing commitments

The Company has entered into an agreement with a contract manufacturing organization to provide clinical trial products.

As of June 30, 2025 and March 31, 2025, the Company had committed to minimum payments under these arrangements totaling $ 0.8 million and $ 0.8 million, respectively.

As of September 30, 2025 and March 31, 2025, the Company had committed to minimum payments under these arrangements totaling $ 0.8 million and $ 0.8 million, respectively.

Indemnification agreements

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To date, the Company has not incurred any material costs as a result of such indemnifications.

The Company is not aware of any claims under indemnification arrangements, and therefore it has not accrued any liabilities related to such obligations in its consolidated financial statements as of June 30, 2025 or March 31, 2025.

The Company is not aware of any claims under indemnification arrangements, and therefore it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2025 or March 31, 2025.

Legal proceedings

On July 24, 2025 a class action complaint alleging violations of the federal securities laws was filed against the Company in the United States District Court for the District of Massachusetts.

The complaint was filed shortly after the Company announced it received a complete response letter from the FDA for its RP1 BLA for the treatment of advanced melanoma on July 22, 2025.

The Company denies any wrongdoing and will vigorously defend this action.

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.

The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated.

Significant judgment is required to determine both probability and the estimated amount.

On July 24, 2025 a class action complaint alleging violations of the federal securities laws was filed against the Company and its directors and certain officers in the United States District Court for the District of Massachusetts, or the District of Massachusetts.

The complaint, captioned Jboor v.

Replimune Group, Inc.

1:25-cv-12085-JEK, was filed shortly after the Company announced it received a complete response letter from the FDA for its RP1 BLA for the treatment of advanced melanoma on July 22, 2025 and the subsequent decline in the trading price of the Company's common stock.

The Court is in the process of appointing a lead plaintiff.

The Company and the other defendants deny any wrongdoing and will vigorously defend this action.

Following the class action complaint, three shareholders filed separate derivative actions on behalf of the Company in the District of Massachusetts captioned Chea v.

1:25-cv-12316-JEK, Wright v.

1:25-cv-12401-WGY, and Vochten v.

1:25-cv-12484-JEK.

The plaintiffs allege substantially similar facts as the class action complaint and assert that the Company’s directors and officers breached their fiduciary duties.

The parties are in the process of consolidating the derivative actions and negotiating a stay pending further developments in the class action.

On September 10, 2025, the Company received a letter from a shareholder demanding that the Board of Directors take action to address alleged wrongdoing by certain directors and officers.

The demand letter alleged substantially similar facts as the class action and derivative action complaints.

The Board determined to defer action on the demand pending further developments in the class action.

On September 29, 2025, the U.S.

Securities and Exchange Commission, or the SEC, informed the Company that it is conducting an investigation and requested that the Company produce certain documents and communications connected with the RP1 BLA.

The investigation is reviewing essentially the same subject matter raised in the litigation following the CRL.

The Company intends to cooperate with the SEC’s investigation and provide the requested materials.

As the matters noted above are preliminary, the Company is unable to determine whether any loss will ultimately occur and cannot reasonably estimate the range of expected exposure.

Therefore, the Company has not recorded any liability in the condensed consolidated financial statements as of and for the three and six months ended September 30, 2025.

15 Income taxes

The Company did no t record an income tax provision for the three months ended June 30, 2025 or 2024 as a result of a forecasted United States and United Kingdom losses for the respective years.

The Company did no t record an income tax provision for the three and six months ended September 30, 2025 or 2024 as a result of forecasted United States and United Kingdom losses for the respective years.

The Company has evaluated the positive and negative evidence bearing upon its ability to realize its deferred tax assets both in the United States and United Kingdom, which primarily consist of net operating loss carryforwards.

The Company has considered its history of cumulative net losses, future reversals of existing taxable temporary differences, estimated future taxable income and prudent feasible tax planning strategies and has concluded that it is more likely than not that the Company will not realize the benefits of its deferred tax assets.

As a result, as of June 30, 2025 and March 31, 2025, the Company has recorded a full valuation allowance against its net deferred tax assets.

On July 4, 2025, the One Big Beautiful Bill (OBBB) Act, which includes a broad range of tax reform provisions, was signed into law in the United States.

The Company is currently evaluating the impact of the new legislation but does not expect it to have a material impact on the results of operations.

As a result, as of September 30, 2025 and March 31, 2025, the Company has recorded a full valuation allowance against its net deferred tax assets.

On July 4, 2025, the One Big Beautiful Bill Act ("OBBBA") was signed into law.

The OBBBA introduced multiple U.S.

federal income tax changes, including the deductibility of domestic research and development expenses, deductibility of certain property additions and limitations on interest expense deduction.

The Company has evaluated the enactment of the OBBBA and continues to assess the detailed impacts of its provision.

Based on its current analysis, the Company does not expect the legislation to have a material impact on the Company’s consolidated financial statements while the Company maintains a full valuation allowance on all domestic net deferred tax assets.

16 Geographic information

2 unchanged sentences

Information about the Company’s long-lived assets held in different geographic regions is presented in the table below:

June 30, 2025 March 31, 2025

September 30, 2025 March 31, 2025

United States $ 13,694 $ 12,820

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The CODM reviews consolidated operating results, and uses the Company's loss from operations and consolidated net income (loss), in order to monitor actual results as compared to the budget, and to determine how best to allocate the Company's operating and capital resources, specifically as it relates to the Company's development programs.

The following table presents selected financial information with respect to the Company's single operating segment, including significant segment expenses by program, for the three months ended June 30, 2025 and 2024:

Three Months Ended

September 30, Six Months Ended

September 30,

2025 2024 2025 2024

Operating expenses:

18 unchanged sentences

18 Subsequent Events

On July 22, 2025, the Company announced that the FDA issued a Complete Response Letter ("CRL") regarding the BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

The FDA stated in the CRL that it is unable to approve the application in its present form and that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness, including contribution of components.

Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population.

The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components.

No safety issues were raised.

On October 20, 2025, the Company announced that the FDA had accepted the resubmission of the BLA for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on anti-PD-1 containing regimen.

The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.

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 1. Financial Statements