What changed in this filing

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Item 1. Financial Statements

2025-02-12 compared with 2024-11-12 · 146 added, 114 removed, 524 unchanged (33% of the section changed)

3 unchanged sentences

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

September 30, 2024 March 31, 2024

December 31, 2024 March 31, 2024

Current assets:

5 unchanged sentences

Property, plant and equipment, net 13,616 10,483

Research and development incentives receivable, non-current

Restricted cash 1,700 1,700

Other non-current assets 1,200 —

Right-to-use asset - operating leases 4,120 4,635

16 unchanged sentences

Common stock, $ 0.001 par value;

150,000,000 shares authorized as of September 30, 2024 and March 31, 2024;

68,394,588 and 61,415,105 shares issued and outstanding as of September 30, 2024 and March 31, 2024, respectively

150,000,000 shares authorized as of December 31, 2024 and March 31, 2024;

77,009,058 and 61,415,105 shares issued and outstanding as of December 31, 2024 and March 31, 2024, respectively

Additional paid-in capital 1,350,587 1,070,874

7 unchanged sentences

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

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

Three Months Ended December 31, Nine Months Ended December 31,

2024 2023 2024 2023

9 unchanged sentences

Interest expense on debt obligations ( 1,450 ) ( 1,012 ) ( 4,314 ) ( 3,083 )

Other income (expense) 2,028 ( 1,409 ) 2,433 ( 35 )

Other (expense) income ( 3,281 ) 1,344 ( 850 ) 1,307

Total other income (expense), net 254 5,893 9,707 15,771

8 unchanged sentences

(Amounts in thousands)

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

Three Months Ended December 31, Nine Months Ended December 31,

2024 2023 2024 2023

1 unchanged sentence

Other comprehensive loss:

Foreign currency translation (loss) gain ( 1,905 ) 1,308 ( 2,337 ) 3

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

Foreign currency translation gain (loss) 3,110 ( 1,288 ) 773 ( 1,285 )

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

( 585 ) 534 531 290

28 unchanged sentences

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

Issuance of prefunded warrants to purchase common stock, net of issuance costs — — 48,500 — — 48,500

Issuance of common stock, net of issuance costs and underwriter fees 8,538,377 9 107,516 — — 107,525

Foreign currency translation adjustment — — — — 3,110 3,110

Unrealized loss on short-term investments — — — — ( 585 ) ( 585 )

Exercise of stock options 22,856 — 66 — — 66

Vesting of RSUs 53,237 — — — — —

Stock-based compensation expense — — 8,639 — — 8,639

Net loss — — — ( 66,340 ) — ( 66,340 )

Balances as of December 31, 2024 77,009,058 $ 77 $ 1,350,587 $ ( 874,449 ) $ 6,159 $ 482,374

Balances as of March 31, 2023 56,676,313 $ 57 $ 1,034,994 $ ( 485,488 ) $ 5,729 $ 555,292

14 unchanged sentences

Balances as of September 30, 2023 59,059,343 59 1,054,712 ( 595,087 ) 5,488 465,172

Foreign currency translation adjustment — — — — ( 1,288 ) ( 1,288 )

Unrealized gain on short-term investments — — — — 534 534

Exercise of pre-funded warrants 2,279,967 2 ( 4 ) — — ( 2 )

Vesting of RSUs 48,476 — — — — —

Stock-based compensation expense — — 8,241 — — 8,241

Net loss — — — ( 51,120 ) — ( 51,120 )

Balances as of December 31, 2023 61,387,786 $ 61 $ 1,062,949 $ ( 646,207 ) $ 4,734 $ 421,537

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

2 unchanged sentences

(Amounts in thousands)

Six Months Ended September 30,

Nine Months Ended December 31,

Cash flows from operating activities:

5 unchanged sentences

Noncash interest expense 1,150 786

Unrealized foreign currency transaction (gains) losses ( 2,433 ) 37

Unrealized foreign currency transaction losses (gains) 850 ( 1,307 )

Changes in operating assets and liabilities:

3 unchanged sentences

Finance lease, right-of-use-asset 1,821 1,821

Other non-current assets ( 1,200 ) —

Accounts payable 4,700 ( 1,505 )

1 unchanged sentence

Operating lease liabilities ( 533 ) ( 433 )

Other non-current liabilities 480 320

Net cash used in operating activities ( 138,519 ) ( 139,301 )

3 unchanged sentences

Proceeds from sales and maturities of short-term investments 321,410 459,037

Net cash provided by investing activities 30,224 20,044

Net cash (used in) provided by investing activities ( 16,096 ) 74,000

Cash flows from financing activities:

Proceeds from issuance of common stock in connection with private placement, net of placement agent fees and offering costs 48,204 —

Proceeds from issuance of prefunded warrants to purchase common stock, net of placement agent fees and offering costs 48,500 —

Proceeds from issuance of common stock, net of fees and offering costs 155,729 —

Proceeds from issuance of prefunded warrants to purchase common stock, net of underwriting fees and offering costs 97,000 —

Proceeds from long-term debt — 15,000

Principal payment of finance lease obligation ( 436 ) ( 345 )

34 unchanged sentences

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 $ 53.1 million and $ 60.0 million for the three months ended September 30, 2024 and 2023, and net losses of $ 106.8 million and $ 109.6 million for the six months ended September 30, 2024 and 2023, respectively.

In addition, as of September 30, 2024, the Company had an accumulated deficit of $ 808.1 million.

The Company has incurred recurring losses since its inception, including net losses of $ 66.3 million and $ 51.1 million for the three months ended December 31, 2024 and 2023, and net losses of $ 173.2 million and $ 160.7 million for the nine months ended December 31, 2024 and 2023, respectively.

In addition, as of December 31, 2024, the Company had an accumulated deficit of $ 874.4 million.

The Company expects to continue to generate operating losses for the foreseeable future.

9 unchanged sentences

Unaudited interim financial information

The accompanying consolidated balance sheet as of September 30, 2024, the consolidated statements of operations, of comprehensive loss and of stockholders’ equity for the three and six months ended September 30, 2024 and 2023 and the consolidated statements of cash flows for the six months ended September 30, 2024 and 2023 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 presentation of the Company’s financial position as of September 30, 2024 and the results of its operations for the three and six months ended September 30, 2024 and 2023 and its cash flows for the six months ended September 30, 2024 and 2023.

The financial data and other information disclosed in these consolidated notes related to the three and six months ended September 30, 2024 and 2023 are unaudited.

The results for the three and six months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending March 31, 2025, any other interim periods or any future year or period.

The accompanying condensed consolidated balance sheet as of December 31, 2024, the condensed consolidated statements of operations, condensed consolidated statements of comprehensive loss and consolidated statements of stockholders’ equity for the three and nine months ended December 31, 2024 and 2023 and the condensed consolidated statements of cash flows for the nine months ended December 31, 2024 and 2023 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 presentation of the Company’s financial position as of December 31, 2024 and the results of its operations for the three and nine months ended December 31, 2024 and 2023 and its cash flows for the nine months ended December 31, 2024 and 2023.

The financial data and other information disclosed in these consolidated notes related to the three and nine months ended December 31, 2024 and 2023 are unaudited.

The results for the three and nine months ended December 31, 2024 are not necessarily indicative of results to be expected for the year ending March 31, 2025, 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, 2024, which was filed with the Securities and Exchange Commission on May 16, 2024 (the "Annual Report").

During the three and six months ended September 30, 2024, there have been no changes to the Company’s significant accounting policies as described in the Annual Report.

During the three and nine months ended December 31, 2024, there have been no changes to the Company’s significant accounting policies as described in the Annual Report.

Recently Issued Accounting Pronouncements

9 unchanged sentences

The Company is currently evaluating the potential impact of this adoption on the consolidated financial statements and related disclosures.

In November 2024, the FASB issued an ASU to require more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement.

In November 2024, the FASB issued ASU 2024-03, "Income Statement—Reporting Comprehensive

Income—Expense Disaggregation Disclosures:

The ASU requires more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement.

This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027.

5 unchanged sentences

Fair Value Measurements as of

September 30, 2024 Using:

December 31, 2024 Using:

Level 1 Level 2 Level 3 Total

1 unchanged sentence

Money market funds $ — $ 73,639 $ — $ 73,639

US Government Agency bonds — 9,725 — 9,725

US Treasury bonds — 9,697 — 9,697

Short-term investments

12 unchanged sentences

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

During the three and six months ended September 30, 2024 and 2023, there were no transfers between levels.

During the three and nine months ended December 31, 2024 and 2023, there were no transfers between levels.

Valuation of cash equivalents and short-term investments

2 unchanged sentences

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 September 30, 2024 and money market funds at March 31, 2024.

Cash equivalents consisted of money market funds, U.S.

Government Agency bonds and U.S.

Treasury bonds at December 31, 2024 and money market funds at March 31, 2024.

Short-term investments

As of September 30, 2024 and March 31, 2024, the Company's available-for-sale investments by type consisted of the following:

September 30, 2024

As of December 31, 2024 and March 31, 2024, the Company's available-for-sale investments by type consisted of the following:

December 31, 2024

cost Gross unrealized

9 unchanged sentences

Total $ 346,322 $ 44 $ ( 155 ) $ — $ 346,211

As of September 30, 2024 and March 31, 2024, available-for-sale securities consisted of investments that mature within one year.

As of December 31, 2024 and March 31, 2024, 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:

September 30, 2024 March 31, 2024

December 31, 2024 March 31, 2024

Office equipment $ 1,627 $ 1,464

7 unchanged sentences

Property, plant and equipment, net $ 13,616 $ 10,483

Depreciation and amortization expense was $ 0.9 million and $ 1.7 million for the three and six months ended September 30, 2024 and $ 0.7 million and $ 1.3 million for the three and six months ended September 30, 2023, respectively.

Amortization on capitalized software for the three and six months ended September 30, 2024 was $ 0.1 million and $ 0.1 million, respectively.

Depreciation and amortization expense was $ 1.0 million and $ 2.7 million for the three and nine months ended December 31, 2024 and $ 0.7 million and $ 2.0 million for the three and nine months ended December 31, 2023, respectively.

Amortization on capitalized software for the three and nine months ended December 31, 2024 was $ 0.3 million and $ 0.4 million, respectively.

The Company did not incur any amortization on capitalized software in the prior year.

2 unchanged sentences

Accrued expenses and other current liabilities consisted of the following:

September 30, 2024 March 31, 2024

December 31, 2024 March 31, 2024

Accrued research and development costs $ 17,219 $ 16,376

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.

The impact of this amendment is not a modification, as it does not relate to outstanding debt, but is rather an amendment that provides for a future potential benefit.

The impact of this amendment is not a modification, as it does not relate to

outstanding debt, but is rather an amendment that provides for a future potential benefit.

There is no material impact to the financial statements as a result of the Amendment.

16 unchanged sentences

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 $ 0.8 million as of September 30, 2024 and $ 0.5 million as of March 31, 2024.

The amount accrued for the final payment is $ 0.9 million as of December 31, 2024 and $ 0.5 million as of March 31, 2024.

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

In addition, unamortized deferred financing costs of $ 1.1 million and $ 1.2 million were recorded in other assets as of September 30, 2024 and March 31, 2024, respectively, related to the Company's right to borrow additional amounts from Hercules in the future and amortized to interest expense over the relevant draw period on a straight-line basis.

Interest expense for the three and six months ended September 30, 2024 was $ 1.4 million and $ 2.9 million, respectively, and $ 1.0 million and $ 2.1 million, respectively, for the three and six months ended September 30, 2023.

The summary of obligations under the term loan as of September 30, 2024 and March 31, 2024 consisted of the following (in thousands):

September 30, 2024 March 31, 2024

In addition, unamortized deferred financing costs of $ 1.0 million and $ 1.2 million were recorded in other assets as of December 31, 2024 and March 31, 2024, respectively, related to the Company's right to borrow additional amounts from Hercules in the future and amortized to interest expense over the relevant draw period on a straight-line basis.

Interest expense for the three and nine months ended December 31, 2024 was $ 1.5 million and $ 4.3 million, respectively, and $ 1.0 million and $ 3.1 million, respectively, for the three and nine months ended December 31, 2023.

The summary of obligations under the term loan as of December 31, 2024 and March 31, 2024 consisted of the following (in thousands):

December 31, 2024 March 31, 2024

Principal loan balance $ 46,276 $ 45,749

2 unchanged sentences

Accumulated end of term fee 893 517

Long term debt, net $ 45,572 $ 44,809

The annual principal payments due under the Loan Agreement as of fiscal September 30, 2024 and March 31, 2024 were as follows:

September 30, 2024 March 31, 2024

Long term debt, net of discount $ 45,960 $ 44,809

The annual principal payments due under the Loan Agreement as of fiscal December 31, 2024 and March 31, 2024 were as follows:

December 31, 2024 March 31, 2024

2027 20,145 20,145

3 unchanged sentences

8 Stockholders’ equity

As of September 30, 2024 and March 31, 2024, 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 December 31, 2024 and March 31, 2024, 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:

September 30, 2024 March 31, 2024

December 31, 2024 March 31, 2024

Stock options, issued and outstanding 10,213,861 8,652,256

6 unchanged sentences

Undesignated preferred stock

As of September 30, 2024, 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, 2024.

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

As of December 31, 2024, 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 December 31, 2024.

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

Under the 2023 Sales Agreement, the Company may sell, from time to time, at its option, up to an aggregate of $ 89.0 million of share of the Company's common stock, $ 0.001 par value shares (the "Shares"), through the Current Agent, as the Company's sales agent.

Any Shares to be offered and sold under the 2023 Sales Agreement will be issued and sold (i) by methods deemed to be an “at the market offering” (“ATM”) as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if authorized by the Company, in negotiated transactions or block trades, and (ii) pursuant to a registration statement on Form S-3 filed by the Company with the Securities and Exchange Commission on August 3, 2023, as amended for

an offering of various securities, including shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one or more public offerings.

Subject to the terms of the 2023 Sales Agreement, the Current Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).

1 unchanged sentence

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

During the three and six months ended September 30, 2024, the Company did not issue or sell any shares under the 2023 Sales Agreement.

During the three and nine months ended December 31, 2024, 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 additional Shares pursuant to the 2023 Sales Agreement.

2 unchanged sentences

The Company received aggregate net proceeds in the Private Placement of approximately $ 96.7 million after deducting placement agent fees and other offering expenses payable by the Company of approximately $ 3.3 million.

On November 25, 2024, the Company completed a public offering of (a) 8,538,377 shares of the Company’s common stock, inclusive of the Underwriters fully exercised 30-day option to purchase up to 1,615,377 additional shares of the Company's common stock at a public offering price of $ 13.00 per share, and (b) pre-funded warrants to purchase 3,846,184 shares of the Company’s common stock at a public offering price of $ 12.9999 per warrant.

The company received aggregate net proceeds of approximately $ 156.0 million after deducting fees and expenses of approximately $ 5.0 million.

9 Pre-funded Warrants

1 unchanged sentence

Unless otherwise modified by a holder of a pre-funded warrant, no holder may exercise a pre-funded warrant if such holder, together with its affiliates, would beneficially own more than 9.99 % of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise.

A holder of the 2024 Pre-funded Warrants may increase or decrease this percentage to any other percentage not in excess of 9.99 %, whereas a holder of the Company's pre-funded warrants issued prior to the 2024 Pre-funded Warrants, may increase or decrease this percentage up to 19.99 %, by providing at least 61 days’ prior notice to the Company.

The 10,211,969 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 outstanding as reported on the consolidated balance sheet, though they are included in the Company's annual pool increase calculation 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 six months ended September 30, 2024, 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.

A holder of the June 2024 Pre-funded Warrants may increase or decrease this percentage to any other percentage not in excess of 9.99 %, whereas a holder of the Company's other Pre-funded Warrants, may increase or decrease this percentage up to 19.99 %, by providing at least 61 days’ prior notice to the Company.

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 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 nine months ended December 31, 2024, 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.

10 Stock-based compensation

2 unchanged sentences

Three Months Ended

September 30, Six Months Ended

September 30,

December 31, Nine Months Ended

2024 2023 2024 2023

2 unchanged sentences

$ 8,639 $ 8,241 $ 26,764 $ 26,201

The following table summarizes stock-based compensation expense by award type for the three and six months ended September 30, 2024 and 2023:

The following table summarizes stock-based compensation expense by award type for the three and nine months ended December 31, 2024 and 2023:

Three Months Ended

September 30, Six Months Ended September 30,

December 31, Nine Months Ended December 31,

2024 2023 2024 2023

14 unchanged sentences

Restricted stock awards and non-statutory stock options were granted under the 2017 Plan to employees, officers, members of the board of directors, advisors and consultants of the Company.

The maximum number of common shares that may be issued under the 2017 Plan was 2,659,885 , of which no ne remained available for future grants as of September 30, 2024.

The maximum number of common shares that may be issued under the 2017 Plan was 2,659,885 , of which no ne remained available for future grants as of December 31, 2024.

Shares with respect to which awards have expired, terminated, surrendered or cancelled under the 2017 Plan without having been fully exercised will be available for future awards under the 2018 Plan referenced below.

2 unchanged sentences

On July 9, 2018, the Company’s board of directors adopted, and the Company’s stockholders approved the 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”), which became effective immediately prior to the effectiveness of the registration statement filed in connection with the Company’s initial public offering.

The 2018 Plan provides for the issuance of incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards.

The 2018 Plan provides for the issuance of incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based

The number of shares of common stock initially reserved for issuance under the 2018 Plan is 3,617,968 shares.

2 unchanged sentences

On April 1, 2024, the number of shares reserved for issuance under the 2018 Plan automatically increased by 2,667,868 shares pursuant to the terms of the 2018 Plan and based on total number of shares of common stock outstanding on March 31, 2024.

As of September 30, 2024, 1,841,705 shares remained available for future grants under the 2018 Plan.

As of December 31, 2024, 1,921,800 shares remained available for future grants under the 2018 Plan.

The 2015 Plan, the 2017 Plan and the 2018 Plan are administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors.

9 unchanged sentences

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 six months ended September 30, 2024.

The Company granted 246,110 PSUs under the 2018 Plan during the nine months ended December 31, 2024.

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

12 unchanged sentences

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

During the six months ended September 30, 2024 and 2023, the Company granted 75,000 and 125,000 nonqualified stock options to purchase shares of the Company's common stock, and 50,000 and 83,330 restricted stock units under employment inducement grants.

During the nine months ended December 31, 2024 and 2023, the Company granted 124,065 and 125,000 nonqualified stock options to purchase shares of the Company's common stock, and 148,190 and 83,330 restricted stock units under employment inducement grants.

Stock option valuation

The fair value of stock option grants is estimated using the Black-Scholes option-pricing model.

As the Company has limited company-specific historical and implied volatility information, the expected stock volatility is based on a combination of Replimune volatility and the historical volatility of a publicly traded set of peer companies.

For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.

The fair value of stock option grants is estimated using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions including the expected stock price volatility, the expected term of the option, the risk-free interest rate determined by reference to the U.S Treasury yield curve in effect at the time of grant of the award for a period that approximates the expected term of the option, and our expected dividend yield.

The expected term of stock options granted to non-employees is equal to the contractual term of the option award.

The risk-free interest rate is determined by reference to the U.S.

Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.

Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

Forfeitures are accounted for as they occur.

The fair value of each RSU and PSU is estimated on the date of grant based on the fair value of our common stock on that same date

The following table presents, on a weighted-average basis, the assumptions that the Company used to determine the grant-date fair value of stock options granted to employees and directors:

Three Months Ended

September 30, Six Months Ended

September 30,

December 31, Nine Months Ended

2024 2023 2024 2023

12 unchanged sentences

Cancelled ( 342,536 ) $ 18.20

Outstanding as of September 30, 2024 10,232,085 $ 15.27 6.64 $ 16,026

Options exercisable as of September 30, 2024 6,355,335 $ 16.46 5.29 $ 9,711

Options vested and expected to vest as of September 30, 2024 10,232,085 $ 15.27 6.64 $ 16,026

As of September 30, 2024, 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 2.6 years.

The weighted average grant-date fair value of stock options granted during the six months ended September 30, 2024 and 2023 was $ 5.51 and $ 12.19 , respectively.

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

Outstanding as of December 31, 2024 10,213,861 $ 15.28 6.42 $ 20,715

Options exercisable as of December 31, 2024 6,559,867 $ 16.73 5.14 $ 11,982

Options vested and expected to vest as of December 31, 2024 10,213,861 $ 15.28 6.42 $ 20,715

As of December 31, 2024, there was $ 27.0 million of unrecognized compensation cost related to unvested common stock options, which is expected to be recognized over a weighted average period of 2.4 years.

The weighted average grant-date fair value of stock options granted during the nine months ended December 31, 2024 and 2023 was $ 5.60 and $ 12.08 , respectively.

The aggregate intrinsic value of stock options exercised during the nine months ended December 31, 2024 was $ 0.5 million.

Restricted and performance stock units

4 unchanged sentences

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

As of September 30, 2024, 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, 2024 is as follows:

As of December 31, 2024, the Company has not recognized any expense related to PSUs.

A summary of the changes in the Company's RSUs and PSUs during the nine months ended December 31, 2024 is as follows:

Number of Restricted Shares Weighted

4 unchanged sentences

Cancelled ( 236,538 ) 13.26

Outstanding as of September 30, 2024 3,496,654 $ 12.51

As of September 30, 2024, there was $ 32.6 million of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of 2.7 years.

Outstanding as of December 31, 2024 3,491,335 $ 12.36

As of December 31, 2024, there was $ 29.5 million of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of 2.5 years.

Of the $ 29.5 million of total unrecognized compensation cost, performance based awards tied to the achievement of a company milestone account for approximately $ 4.8 million.

3 unchanged sentences

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

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

Three Months Ended December 31, Nine Months Ended December 31,

2024 2023 2024 2023

3 unchanged sentences

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 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.

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 and Six Months Ended September 30,

Three and Nine Months Ended December 31,

Options to purchase common stock 10,213,861 8,833,069

43 unchanged sentences

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 and six months ended September 30, 2024 and 2023, 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, 2024.

The Company recorded $ 1.0 million and $ 1.7 million as an offset to research and development expenses during the three and six months ended September 30, 2023, respectively.

During the six months ended September 30, 2024 and 2023, the Company received payments under the terms of the agreement from Roche of $ 1.8 million and $ 0.9 million, respectively.

As of September 30, 2024 and March 31, 2024, the Company recorded $ 0.0 million and $ 1.8 million as receivables from Roche in connection with this agreement, respectively.

During the three and nine months ended December 31, 2024 and 2023, 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 nine months ended December 31, 2024.

The Company recorded $ 0.8 million and $ 2.6 million as an offset to research and development expenses during the three and nine months ended December 31, 2023, respectively.

During the nine months ended December 31, 2024 and 2023, the Company received payments under the terms of the agreement from Roche of $ 1.8 million and $ 1.7 million, respectively.

As of December 31, 2024 no receivables were recorded from Roche in connection with this agreement.

As of March 31, 2024, the Company recorded $ 1.8 million as receivables from Roche in connection with this agreement.

In July 2023, the Company entered into a Clinical Trial Collaboration and Supply Agreement with Incyte Corporation, or Incyte.

1 unchanged sentence

Under the terms of the agreement, the Company will supply Incyte with RP1 for the study and share costs of the study equally with Incyte.

The agreement may be terminated by either party upon (i) a material breach not reasonably cured within thirty ( 30 ) days;

The agreement may be terminated by either party upon (i) a material breach not

reasonably cured within thirty ( 30 ) days;

(ii) the discontinuation of development of its clinical drug candidate;

3 unchanged sentences

On July 30, 2024, Incyte announced it has discontinued further development of its oral small molecule PD-L1 inhibitor, which was the intended study drug in the Company's planned collaboration with Incyte.

On August 1, 2024, the Company received notice of termination of the Clinical Trial Collaboration and Supply Agreement from

On August 1, 2024, the Company received notice of termination of the Clinical Trial Collaboration and Supply Agreement from Incyte.

During the year ended March 31, 2024, the Company did not make any payments to, or receive any payments from, Inctye under the terms of the agreement.

Additionally, no costs were recorded to research and development expenses during the three and six months ended September 30, 2024 related to this agreement.

Additionally, no costs were recorded to research and development expenses during the three and nine months ended December 31, 2024 related to 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.

1 unchanged sentence

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 September 30, 2024 and 2023:

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

The table below presents the lease-related costs which are included in the consolidated statements of operations for the three months ended December 31, 2024 and 2023:

Three Months Ended December 31, Nine Months Ended December 31,

2024 2023 2024 2023

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Total lease cost $ 1,418 $ 1,426 $ 4,264 $ 4,287

The following table summarizes the classification of lease costs in the consolidated statement of operations for the three months ended September 30, 2024 and 2023 as follows:

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

The following table summarizes the classification of lease costs in the consolidated statement of operations for the three months ended December 31, 2024 and 2023 as follows:

Three Months Ended December 31, Nine Months Ended December 31,

2024 2023 2024 2023

6 unchanged sentences

Total lease cost $ 1,418 $ 1,426 $ 4,264 $ 4,287

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 September 30, 2024:

September 30, 2024

December 31, 2024

Operating leases Financing lease Total

2025 (remaining six months) $ 599 $ 1,376 $ 1,975

2025 (remaining three months) $ 289 $ 689 $ 978

2026 1,167 2,799 3,966

6 unchanged sentences

Total lease liabilities $ 4,389 $ 25,692 $ 30,081

The following table provides lease disclosure as of September 30, 2024 and March 31, 2024:

September 30, 2024 March 31, 2024

The following table provides lease disclosure as of December 31, 2024 and March 31, 2024:

December 31, 2024 March 31, 2024

Right-to-use operating lease asset $ 4,120 $ 4,635

6 unchanged sentences

Total lease liabilities $ 30,081 $ 31,060

The following table provides lease disclosure for the three months ended September 30, 2024 and 2023:

Six Months Ended September 30,

The following table provides lease disclosure for the three months ended December 31, 2024 and 2023:

Nine Months Ended December 31,

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 and six months ended September 30, 2024 and 2023.

The variable lease costs and short-term lease costs were insignificant for the three and nine months ended December 31, 2024 and 2023.

Manufacturing commitments

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

As of September 30, 2024 and March 31, 2024, the Company had committed to minimum payments under these arrangements totaling $ 0.9 million and $ 0.9 million, respectively.

As of December 31, 2024 and March 31, 2024, the Company had committed to minimum payments under these arrangements totaling $ 0.8 million and $ 0.9 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 September 30, 2024 or March 31, 2024.

Legal proceedings

1 unchanged sentence

15 Income taxes

The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company's tax returns.

Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.

Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.

The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense.

Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.

The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized.

First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities.

If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements.

The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement.

The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.

The Company’s income tax provision and effective tax rate for the three months ended December 31, 2024 was $ 0.6 million and 0.9 %, respectively.

The Company’s income tax provision and effective tax rate for the three months ended December 31, 2023 was $ 0.5 million and 0.9 %, respectively.

The income tax provision and effective tax rate for the three months ended December 31, 2024 is primarily due to forecasted U.S.

taxable income for the year that is not fully offset by available net operating loss and tax credit carryforwards as well as a provision to return adjustment.

The income tax provision and effective tax rate for the three months ended December 31, 2023 is primarily due to forecasted U.S.

taxable income for the year that is not fully offset by available net operating loss carryforwards.

The Company's income tax provision and effective tax rate for the nine months ended December 31, 2024 was $ 0.6 million and 0.3 %, respectively.

The Company’s income tax provision and effective tax rate for the nine months ended December 31, 2023 was $ 0.5 million and 0.3 %, respectively.

The income tax provision and effective tax rate for the nine months ended December 31, 2024 is primarily due to forecasted U.S.

taxable income for the year that is not fully offset by available net operating loss and tax credit carryforwards as well as a provision to return adjustment.

The income tax provision and effective tax rate for the nine months ended December 31, 2023 is primarily due to forecasted U.S.

taxable income for the year that is not fully offset by available net operating loss carryforwards.

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 December 31, 2024 and March 31, 2024, the Company has recorded a full valuation allowance against its 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 tables below:

September 30, 2024 March 31, 2024

December 31, 2024 March 31, 2024

United States $ 13,058 $ 8,992

2 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 1. Financial Statements