3 unchanged sentences
(Amounts in thousands, except share and per share amounts)
−Removed: December 31, 2023 March 31, 2023
+Added: June 30, 2024 March 31, 2024
Current assets:
5 unchanged sentences
Property, plant and equipment, net 11,403 10,483
+Added: Research and development incentives receivable, non-current
Restricted cash 1,700 1,700
17 unchanged sentences
Common stock, $ 0.001 par value;
−Removed: 150,000,000 shares authorized as of December 31, 2023 and March 31, 2023;
−Removed: 61,387,786 and 56,676,313 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively
+Added: 150,000,000 shares authorized as of June 30, 2024 and March 31, 2024;
+Added: 68,309,968 and 61,415,105 shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively
Additional paid-in capital 1,177,113 1,070,874
4 unchanged sentences
The accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: Table of Conte nts
REPLIMUNE GROUP, INC.
1 unchanged sentence
(Amounts in thousands, except share and per share amounts)
−Removed: Three Months Ended December 31, Nine Months Ended December 31,
−Removed: 2023 2022 2023 2022
+Added: Three Months Ended June 30,
Operating expenses:
8 unchanged sentences
Interest expense on debt obligations ( 1,426 ) ( 1,115 )
−Removed: Other income (expense) 1,344 147 1,307 ( 4,531 )
+Added: Other income 406 1,374
Total other income (expense), net 3,595 6,294
5 unchanged sentences
The accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: Table of Conte nts
REPLIMUNE GROUP, INC.
1 unchanged sentence
(Amounts in thousands)
−Removed: Three Months Ended December 31, Nine Months Ended December 31,
−Removed: 2023 2022 2023 2022
+Added: Three Months Ended June 30,
Net loss $ ( 53,772 ) $ ( 49,555 )
1 unchanged sentence
Foreign currency translation (loss) gain ( 432 ) ( 1,305 )
−Removed: Net unrealized gain on short-term investments, net of tax of $ 0
+Added: Net unrealized (loss) gain on short-term investments, net of tax of $ 0
( 99 ) ( 458 )
1 unchanged sentence
The accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: Table of Conte nts
REPLIMUNE GROUP, INC.
8 unchanged sentences
Balances as of March 31, 2024 61,415,105 $ 61 $ 1,070,874 $ ( 701,282 ) $ 4,855 $ 374,508
+Added: Issuance of prefunded warrants to purchase common stock, net of issuance costs — — 48,500 — — 48,500
+Added: Issuance of common stock in connection with private placement, net of placement agent fees and offering costs 5,668,937 6 48,198 — — 48,204
Foreign currency translation adjustment — — — — ( 432 ) ( 432 )
6 unchanged sentences
Balances as of June 30, 2024 68,309,968 68 1,177,113 ( 755,054 ) 4,324 426,451
−Removed: Foreign currency translation adjustment — — — — 1,308 1,308
−Removed: Unrealized gain on short-term investments — — — — 214 214
−Removed: Exercise of stock options 67,210 1 549 — — 550
−Removed: Vesting of RSUs 15,808 1 — — — 1
−Removed: Stock-based compensation expense — — 9,114 — — 9,114
−Removed: Net loss — — — ( 60,044 ) — ( 60,044 )
−Removed: Balances as of September 30, 2023 59,059,343 59 1,054,712 ( 595,087 ) 5,488 465,172
−Removed: Foreign currency translation adjustment — — — — ( 1,288 ) ( 1,288 )
−Removed: Unrealized gain on short-term investments — — — — 534 534
−Removed: Exercise of pre-funded warrants 2,279,967 2 ( 4 ) — — ( 2 )
−Removed: Vesting of RSUs 48,476 — — — — —
−Removed: Stock-based compensation expense — — 8,241 — — 8,241
−Removed: Net loss — — — ( 51,120 ) — ( 51,120 )
−Removed: Balances as of December 31, 2023 61,387,786 $ 61 $ 1,062,949 $ ( 646,207 ) $ 4,734 $ 421,537
Balances as of March 31, 2023 56,676,313 $ 57 $ 1,034,994 $ ( 485,488 ) $ 5,729 $ 555,292
−Removed: Issuance of common stock through ATM sales, net of offering costs 1,686,438 2 31,035 — — 31,037
Foreign currency translation adjustment — — — — ( 1,305 ) ( 1,305 )
Unrealized loss on short-term investments — — — — ( 458 ) ( 458 )
+Added: Exercise of pre-funded warrants 1,922,655 — — — — —
Exercise of stock options 96,146 — 1,209 — — 1,209
3 unchanged sentences
Balances as of June 30, 2023 58,976,325 57 1,045,049 ( 535,043 ) 3,966 514,029
−Removed: Issuance of common stock through ATM sales, net of offering costs 340,000 1 6,400 — — 6,401
−Removed: Foreign currency translation adjustment — — — — 2,330 2,330
−Removed: Unrealized gain on short-term investments — — — — 81 81
−Removed: Exercise of stock options 88,252 — 1,108 — — 1,108
−Removed: Vesting of RSUs 12,688 — —
−Removed: Stock-based compensation expense — — 6,992 — — 6,992
−Removed: Net loss — — — ( 43,102 ) — ( 43,102 )
−Removed: Balances as of September 30, 2022 49,739,407 50 777,650 ( 396,559 ) 2,931 384,072
−Removed: Issuance of prefunded warrants to purchase common stock — — 92,778 — — 92,778
−Removed: Issuance of common stock, net of issuance costs and underwriter fees 6,810,658 7 149,847 — — 149,854
−Removed: Foreign currency translation adjustment — — — — 158 158
−Removed: Unrealized gain on short-term investments — — — — 650 650
−Removed: Exercise of stock options 60,921 — 500 — — 500
−Removed: Vesting of RSUs 22,013 — — —
−Removed: Stock-based compensation expense — — 7,023 — — 7,023
−Removed: Net loss — — — ( 39,690 ) — ( 39,690 )
−Removed: Balances as of December 31, 2022 56,632,999 $ 57 $ 1,027,798 $ ( 436,249 ) $ 3,739 $ 595,345
The accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: Table of Conte nts
REPLIMUNE GROUP, INC.
1 unchanged sentence
(Amounts in thousands)
−Removed: Nine Months Ended December 31,
+Added: Three Months Ended June 30,
Cash flows from operating activities:
2 unchanged sentences
Stock-based compensation expense 9,475 8,846
−Removed: Depreciation 1,950 1,919
+Added: Depreciation and amortization
Net amortization of premiums and discounts on short-term investments ( 2,788 ) ( 4,091 )
17 unchanged sentences
Cash flows from financing activities:
−Removed: Proceeds from issuance of common stock, net of underwriting fees and discounts — 150,102
−Removed: Proceeds from issuance of prefunded warrants to purchase common stock, net of underwriting fees and discounts — 92,778
−Removed: Proceeds from issuance of common stock through ATM sales, net of offering costs — 37,438
−Removed: Proceeds from long-term debt 15,000 30,000
−Removed: Payment of debt issuance costs — ( 1,846 )
+Added: Proceeds from issuance of common stock in connection with private placement, net of placement agent fees and offering costs 48,204 —
+Added: Proceeds from issuance of prefunded warrants to purchase common stock, net of placement agent fees and offering costs 48,500 —
Principal payment of finance lease obligation ( 134 ) ( 104 )
−Removed: Proceeds from exercise of stock options 1,758 3,170
+Added: Proceeds from exercise of stock options and pre-funded warrants
Net cash provided by financing activities 96,637 1,105
Effect of exchange rate changes on cash, cash equivalents and restricted cash ( 35 ) 13
−Removed: Net (decrease) increase in cash, cash equivalents and restricted cash ( 48,918 ) 100,719
+Added: Net increase (decrease) in cash, cash equivalents and restricted cash
+Added: 77,201 ( 40,109 )
Cash, cash equivalents and restricted cash at beginning of period 76,157 148,226
2 unchanged sentences
Cash paid during the period for interest 1,052 653
−Removed: Cash paid for income taxes
Supplemental disclosure of non-cash investing and financing activities:
−Removed: Common stock issuance costs included in accrued expenses — 249
−Removed: Purchases of property and equipment included in accounts payable 127 19
+Added: Purchases of property and equipment included in accounts payable and accrued expenses
The accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: Table of Conte nts
REPLIMUNE GROUP, INC.
17 unchanged sentences
The Company currently has three RPx product candidates, RP1, RP2 and RP3.
−Removed: RP1 is currently under development in multiple clinical trials, the most advanced being the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.
+Added: RP1 is currently under development in multiple clinical trials, the most advanced being the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial, that, as reported in June 2024, had positive topline primary data analysis by independent central review.
RP2 is currently in clinical development with planning underway for a potentially registration enabling clinical trial in uveal melanoma.
−Removed: As reported in December 2023, our randomized, controlled Phase-2 clinical trial of RP1 with cutaneous squamous cell carcinoma, referred to as CERPASS or the CERPASS trial, did not meet either of the two primary endpoints and development efforts on RP3 have been deprioritized.
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.
−Removed: The Company has incurred recurring losses since its inception, including net losses of $ 51.1 million and $ 39.7 million for the three months ended December 31, 2023 and 2022, respectively, and net losses of $ 160.7 million and $ 125.0 million for the nine months ended December 31, 2023 and 2022, respectively.
−Removed: In addition, as of December 31, 2023, the Company had an accumulated deficit of $ 646.2 million.
+Added: The Company has incurred recurring losses since its inception, including net losses of $ 53.8 million and $ 49.6 million for the three months ended June 30, 2024 and 2023, respectively.
+Added: In addition, as of June 30, 2024, the Company had an accumulated deficit of $ 755.1 million.
The Company expects to continue to generate operating losses for the foreseeable future.
5 unchanged sentences
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.
−Removed: Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the
−Removed: Table of Conte nts
−Removed: accrual for research and development expenses and the valuation of stock-based awards.
−Removed: 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.
+Added: 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.
+Added: The Company bases its estimates on
+Added: 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
−Removed: The accompanying consolidated balance sheet as of December 31, 2023, the consolidated statements of operations, of comprehensive loss and of stockholders’ equity for the three and nine months ended December 31, 2023 and 2022 and the consolidated statements of cash flows for the nine months ended December 31, 2023 and 2022 are unaudited.
−Removed: 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, 2023 and the results of its operations for the three and nine months ended December 31, 2023 and 2022 and its cash flows for the nine months ended December 31, 2023 and 2022.
−Removed: The financial data and other information disclosed in these consolidated notes related to the three and nine months ended December 31, 2023 and 2022 are unaudited.
−Removed: The results for the three and nine months ended December 31, 2023 are not necessarily indicative of results to be expected for the year ending March 31, 2024, any other interim periods or any future year or period.
+Added: The accompanying consolidated balance sheet as of June 30, 2024, the consolidated statements of operations, of comprehensive loss and of stockholders’ equity for the three months ended June 30, 2024 and 2023 and the consolidated statements of cash flows for the three months ended June 30, 2024 and 2023 are unaudited.
+Added: 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 June 30, 2024 and the results of its operations for the three months ended June 30, 2024 and 2023 and its cash flows for the three months ended June 30, 2024 and 2023.
+Added: The financial data and other information disclosed in these consolidated notes related to the three months ended June 30, 2024 and 2023 are unaudited.
+Added: The results for the three months ended June 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 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").
−Removed: During the three and nine months ended December 31, 2023, there have been no changes to the Company’s significant accounting policies as described in the Annual Report.
+Added: During the three months ended June 30, 2024, there have been no changes to the Company’s significant accounting policies as described in the Annual Report.
+Added: Recently Issued Accounting Pronouncements
+Added: In December 2023, the Financial Accounting Standards Board issued Accounting Standards Update ("ASU") No.
+Added: 2023-09, “Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.” This ASU updates income tax disclosure requirements primarily by requiring specific categories and greater disaggregation within the rate reconciliation and disaggregation of income taxes paid by jurisdiction.
+Added: This ASU is effective for annual periods beginning after December 15, 2024 and is applicable to the Company’s fiscal year beginning April 1, 2025, with early application permitted.
+Added: The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
+Added: In November 2023, the FASB issued ASU 2023-07, "Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures".
+Added: The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements.
+Added: This update is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.
+Added: The Company is currently evaluating the potential impact of this adoption on the consolidated financial statements and related disclosures.
Fair value of financial assets and liabilities
1 unchanged sentence
Fair Value Measurements as of
−Removed: December 31, 2023 Using:
+Added: June 30, 2024 Using:
Level 1 Level 2 Level 3 Total
15 unchanged sentences
The underlying securities in the money market funds held by the Company are all government backed securities.
−Removed: During the three and nine months ended December 31, 2023 and 2022, there were no transfers between levels.
+Added: During the three months ended June 30, 2024 and 2023, there were no transfers between levels.
Valuation of cash equivalents and short-term investments
−Removed: Table of Conte nts
Money market funds, U.S.
1 unchanged sentence
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.
−Removed: Cash equivalents consisted of money market funds at December 31, 2023 and money market funds at March 31, 2023.
+Added: Cash equivalents consisted of money market funds at June 30, 2024 and money market funds at March 31, 2024.
Short-term investments
−Removed: As of December 31, 2023 and March 31, 2023, the Company's available-for-sale investments by type consisted of the following:
−Removed: December 31, 2023
+Added: As of June 30, 2024 and March 31, 2024, the Company's available-for-sale investments by type consisted of the following:
+Added: June 30, 2024
cost Gross unrealized
9 unchanged sentences
Total $ 346,322 $ 44 $ ( 155 ) $ — $ 346,211
−Removed: As of December 31, 2023, available-for-sale securities consisted of investments that mature within one year.
−Removed: As of March 31, 2023, available-for-sale securities consisted of investments that mature within one year, with the exception of certain U.S.
−Removed: Government agency bonds and U.S.
−Removed: Treasury bonds which had maturities between one and two years and an aggregate fair value of $ 15.1 million.
+Added: As of June 30, 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:
−Removed: December 31, 2023 March 31, 2023
+Added: June 30, 2024 March 31, 2024
Office equipment $ 1,487 $ 1,464
7 unchanged sentences
Property, plant and equipment, net $ 11,403 $ 10,483
−Removed: Depreciation expense was $ 0.7 million and $ 2.0 million for the three and nine months ended December 31, 2023 and $ 0.7 million and $ 1.9 million for the three and nine months ended December 31, 2022, respectively.
+Added: Depreciation expense was $ 0.7 million and $ 0.6 million for the three months ended June 30, 2024 and 2023, respectively.
Depreciation 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:
−Removed: Table of Conte nts
−Removed: December 31, 2023 March 31, 2023
+Added: June 30, 2024 March 31, 2024
Accrued research and development costs $ 16,166 $ 16,376
9 unchanged sentences
The Loan Agreement was subsequently amended (the "Amendment") on June 28, 2023 pursuant to which the Company agreed to draw an initial term loan advance in an aggregate principal amount not less than $ 30.0 million, provided that the aggregate amount of the term loan advances made under tranche 1 do not exceed $ 30.0 million, which reflects a decrease of $ 30 million from the $ 60.0 million in the original Loan Agreement for tranche 1.
−Removed: The total amount of the Loan Agreement, as well as the outstanding balance of the loan, is unchanged, but the option to borrow an additional $ 30.0 million moved from tranche 1 to tranche 2.
−Removed: Therefore, the Amendment provides that the Company can draw down an additional $ 45.0 million on or prior to December 31, 2023, which includes the $ 30.0 million that was moved from tranche 1 to tranche 2, and the $ 15.0 million in the original Loan Agreement for tranche 2.
+Added: 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.
There is no material impact to the financial statements as a result of the Amendment.
−Removed: A second amendment was made to the Loan Agreement (the "Second Amendment") on December 22, 2023 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, which reflects a decrease of $ 30.0 million from the $ 45.0 million per the Amendment noted above.
−Removed: In addition, the third loan tranche advance under the Second Amendment was increased from $ 25.0 million to $ 30.0 million and the availability of the tranche was extended until March 31, 2025, the fourth tranche advance was increased from $ 35.0 million to $ 50.0 million and the availability of the tranche was extended until March 31, 2026, and the fifth tranche advance was increased from $ 40.0 million to $ 50.0 million and the availability of the tranche was extended until September 15, 2026, subject to the terms and conditions of the Loan Agreement.
−Removed: The total aggregate maximum principal amount to be drawn under the Loan Agreement remains as up to $ 200.0 million.
−Removed: The Company evaluated the Second Amendment as a modification under appropriate accounting guidance, and based on our analysis and the immaterial change in cash flows on current outstanding debt, it was determined that there was no material accounting impact.
+Added: A second amendment was made to the Loan Agreement (the "Second Amendment") on December 22, 2023 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.
+Added: The Second Amendment re-allocated the total future consideration of the Loan Agreement to the future
+Added: tranches extending through September 2026, subject to the terms and conditions of the Loan Agreement.
+Added: 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.
+Added: The Company evaluated the Second Amendment as a modification under relevant accounting guidance, and based on that analysis and the immaterial change in cash flows on current outstanding debt, it was determined that there was no material accounting impact.
Upon closing of the Second Amendment, the Company drew down the tranche 2 amount of $ 15.0 million.
6 unchanged sentences
At the Company's option, the Company may prepay all or a portion of the outstanding borrowings, subject to a prepayment fee of 3.0 % of the principal amount if prepayment had occurred during the 12 months following the closing date, 2.0 % after 12 months following the closing date but prior to 36 months following the closing date, and 1.0 % thereafter.
−Removed: Table of Conte nts
−Removed: The Loan Agreement contains customary facility fees, events of default and representations, warranties and affirmative and negative covenants, including a financial covenant requiring the Company to maintain unrestricted cash in an amount not less than 35 % of the aggregate outstanding secured obligations under the Loan Agreement in accounts subject to a control agreement in favor of the Agent (the “Unrestricted Cash”) at all times commencing on January 1, 2024.
+Added: The Loan Agreement contains customary facility fees, events of default and representations, warranties and affirmative and negative covenants, including a financial covenant requiring the Company to maintain unrestricted cash in an amount not less than 35 % of the aggregate outstanding secured obligations under the Loan Agreement in accounts subject to a control agreement in favor of the Agent (the “Unrestricted Cash”) at all times which commenced on January 1, 2024.
In addition, the Loan Agreement also contains a financial covenant that beginning on the later of (i) July 1, 2024 and (ii) the date on which the aggregate outstanding principal amount of the Term Loan Facility is equal to or greater than $ 100.0 million, the Company is required to satisfy one of the following requirements:
2 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.
−Removed: The amount accrued for the final payment is $ 0.4 million as of December 31, 2023 and $ 0.2 million as of March 31, 2023.
+Added: The amount accrued for the final payment is $ 0.6 million as of June 30, 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.
−Removed: In addition, unamortized deferred financing costs related to the Company's right to borrow additional amounts from Hercules in the future were recorded in other assets and amortized to interest expense over the relevant draw period on a straight-line basis.
−Removed: As a result of the Amendment, the Company recorded $ 0.1 million of the remaining unamortized deferred financing costs related to the Tranche 1 delayed draw to interest expense as of December 31, 2023.
−Removed: Interest expense for the three months and nine months ended December 31, 2023 was $ 1.0 million and $ 3.1 million.
−Removed: The summary of obligations under the term loan as of December 31, 2023 and March 31, 2023 consisted of the following (in thousands):
−Removed: December 31, 2023 March 31, 2023
+Added: In addition, unamortized deferred financing costs of $ 1.1 million and $ 1.2 million were recorded in other assets as of June 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.
+Added: Interest expense for the three months ended June 30, 2024 was $ 1.4 million.
+Added: The summary of obligations under the term loan as of June 30, 2024 and March 31, 2024 consisted of the following (in thousands):
+Added: June 30, 2024 March 31, 2024
Principal loan balance $ 45,923 $ 45,749
3 unchanged sentences
Long term debt, net $ 45,192 $ 44,809
−Removed: The annual principal payments due under the Loan Agreement as of December 31, 2023 and March 31, 2023 were as follows:
−Removed: December 31, 2023 March 31, 2023
+Added: The annual principal payments due under the Loan Agreement as of June 30, 2024 and March 31, 2024 were as follows:
+Added: June 30, 2024 March 31, 2024
2027 20,145 20,145
3 unchanged sentences
8 Stockholders’ equity
−Removed: As of December 31, 2023 and March 31, 2023, 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.
−Removed: Table of Conte nts
+Added: As of June 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.
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:
−Removed: December 31, 2023 March 31, 2023
+Added: June 30, 2024 March 31, 2024
Stock options, issued and outstanding 10,157,054 8,652,256
−Removed: Restricted stock units 2,040,997 1,351,280
+Added: Restricted and performance stock units 3,370,183 2,397,890
Stock options and restricted stock units, future issuance 1,988,217 2,284,141
4 unchanged sentences
Undesignated preferred stock
−Removed: As of December 31, 2023, 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.
−Removed: There were no undesignated preferred shares issued or outstanding as of December 31, 2023.
−Removed: On August 11, 2020, the Company and the SVB Leerink LLC (the "Agent") entered into a sales agreement, which was subsequently amended on October 21, 2020 (as amended, the “2020 Sales Agreement”), pursuant to which the Company could sell, from time to time, at its option, up to an aggregate of $ 62.5 million of shares of the Company’s common stock, $ 0.001 par value per share, through the Agent, as the Company’s sales agent.
−Removed: During the three months ended June 30, 2022 the Company settled transactions that occurred pursuant to the 2020 Sales Agreement, whereby the Company issued and sold an aggregate of 1,686,438 shares of its common stock, resulting in gross proceeds of $ 32.0 million, before deducting fees of $ 1.0 million.
−Removed: On June 23, 2022, the 2020 Sales Agreement was terminated by the execution by the Company and the Agent of a new sales agreement (the “2022 Sales Agreement”).
−Removed: Under the 2022 Sales Agreement, the Company could sell, from time to time, at its option, up to an aggregate of $ 100.0 million of shares of the Company’s common stock, $ 0.001 par value per share, through the Agent, as the Company’s sales agent.
−Removed: During the three and nine months ended December 31, 2022, pursuant to the 2022 Sales Agreement, the Company issued and sold an aggregate of 340,000 shares of its common stock, resulting in gross proceeds of $ 6.7 million, before deducting fees of $ 0.3 million.
−Removed: On August 3, 2023, the 2022 Sales Agreement was terminated by the execution by the Company and Leerink Partners LLC (formerly known as SVB Securities LLC) (the "Current Agent") of a new sales agreement (the "2023 Sales Agreement").
+Added: As of June 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.
+Added: There were no undesignated preferred shares issued or outstanding as of June 30, 2024.
+Added: 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").
Under the 2023 Sales Agreement, the Company may sell, from time to time, at its option, up to an aggregate of $ 100.0 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.
−Removed: 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 an automatically effective registration statement on Form S-3 filed by the Company with the Securities and Exchange Commission on August 3, 2023 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.
−Removed: 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).
+Added: 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.
+Added: 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
+Added: conditions the Company may impose).
The Company will pay the Current Agent a commission of up to 3.0 % of the gross proceeds from the sale of the Shares.
The Company has also agreed to provide the Current Agent with customary indemnification rights.
−Removed: Table of Conte nts
−Removed: During the three and nine months ended December 31, 2023, the Company did not issue or sell any shares under the 2023 Sales Agreement.
+Added: During the three months ended June 30, 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.
Equity offerings
−Removed: In December 2022, the Company completed a public offering of (a) 6,810,658 shares of the Company’s common stock, inclusive of the underwriters 30-day option to purchase up to an additional 1,436,172 shares of the Company’s common stock, at a public offering price of $ 23.50 per share and (b) pre-funded warrants to purchase 4,200,000 shares of the Company’s common stock at a public offering price of $ 23.4999 per warrant.
−Removed: The Company received aggregate net proceeds of approximately $ 242.6 million after deducting underwriting discounts, commissions and other offering expenses payable by the Company of approximately $ 16.1 million.
+Added: On June 14, 2024, the Company completed a private placement transaction (the "Private Placement") pursuant to which the Company sold (a) 5,668,937 shares of the Company's common stock, at an offering price of $ 8.82 , and (b) in lieu of common stock to certain investors, pre-funded warrants to purchase 5,669,578 shares of the Company's common stock at an offering price of $ 8.819 per warrant (the "2024 Pre-funded Warrants").
+Added: 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.
9 Pre-funded Warrants
−Removed: The pre-funded warrants described above are exercisable at any time after the date of issuance.
+Added: The Company's pre-funded warrants are exercisable at any time after the date of issuance.
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.
−Removed: A holder of a pre-funded warrant may increase or decrease this percentage up to 19.99 % by providing at least 61 days’ prior notice to the Company.
−Removed: The 5,281,616 shares of the Company's common stock underlying the above-described pre-funded warrants 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.
−Removed: During the nine months ended December 31, 2023, a holder of the Company's pre-funded warrants exercised 4,202,622 of its pre-funded warrants and the Company issued 4,202,622 shares of common stock in exchange thereof.
+Added: 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.
+Added: 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.
+Added: During the three months ended June 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.
10 Stock-based compensation
2 unchanged sentences
Three Months Ended
−Removed: December 31, Nine Months Ended
−Removed: 2023 2022 2023 2022
Research and development $ 4,226 $ 3,298
1 unchanged sentence
$ 9,475 $ 8,846
−Removed: The following table summarizes stock-based compensation expense by award type for the three and nine months ended December 31, 2023 and 2022:
+Added: The following table summarizes stock-based compensation expense by award type for the three months ended June 30, 2024 and 2023:
Three Months Ended
−Removed: December 31, Nine Months Ended December 31,
−Removed: 2023 2022 2023 2022
Stock options $ 5,733 $ 5,614
−Removed: Restricted stock units 2,996 2,212 9,655 6,394
+Added: Restricted and performance stock units
$ 9,475 $ 8,846
1 unchanged sentence
The 2015 Enterprise Management Incentive Share Option Plan of Replimune UK (the “2015 Plan”) provided for Replimune UK to grant incentive stock options, non-statutory stock options, stock awards, stock units, stock appreciation rights and other stock-based awards.
−Removed: Incentive stock options were granted under the 2015 Plan only to the Company’s employees,
−Removed: Table of Conte nts
−Removed: including officers and directors who were also employees.
+Added: Incentive stock options were granted under the 2015 Plan only to the Company’s employees, including officers and directors who were also employees.
Non-statutory stock options were granted under the 2015 Plan to employees, members of the board of directors, outside advisors and consultants of the Company.
6 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.
−Removed: 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, 2023.
+Added: 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 June 30, 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.
7 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.
−Removed: As of December 31, 2023, 2,487,540 shares remained available for future grants under the 2018 Plan.
+Added: As of June 30, 2024, 1,988,217 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.
5 unchanged sentences
In 2021 the board of directors initiated the award of restricted stock units ("RSUs"), under the 2018 Plan in addition to stock option awards available as part of the Company's equity incentive for employees, officers, advisors and consultants of the Company.
−Removed: The RSUs typically vest over four approximately equal annual installments with the first such installment occurring on a designated vesting date that is
−Removed: Table of Conte nts
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: The PSUs will become vested 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.
+Added: 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.
+Added: The Company granted 246,110 PSUs under the 2018 Plan during the three months ended June, 2024.
+Added: 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.
Employee Stock Purchase Plan
6 unchanged sentences
Out-of-Plan Inducement Grants
−Removed: In May 2021, the Company granted an equity award to a newly hired executive as a material inducement to enter into employment with the Company.
−Removed: The grant constitutes an "employment inducement grant" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of the other stock incentive plans described above.
−Removed: The inducement grant included a nonqualified stock option to purchase up to 125,000 shares of the Company's common stock, as well as a restricted stock unit grant representing 88,333 shares of the Company's common stock.
−Removed: These stock option and restricted stock unit inducement grants have terms and conditions consistent with those set forth under the 2018 Plan and vest under the same respective vesting schedules as stock option and restricted stock unit awards granted under the 2018 Plan.
−Removed: The inducement grant is included in the stock option and RSU award tables below.
−Removed: In December 2022, the Company granted an equity award to a newly hired executive as a material inducement to enter into employment with the Company.
−Removed: The grant constitutes an "employment inducement grant" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of the other stock incentive plans described above.
−Removed: The inducement grant included a nonqualified stock option to purchase up to 82,500 shares of the Company's common stock, as well as a restricted stock unit grant representing 55,000 shares of the Company's common stock.
−Removed: These stock option and restricted stock unit inducement grants have terms and conditions consistent with those set forth under the 2018 Plan and vest under the same respective vesting schedules as stock option and restricted stock unit awards granted under the 2018 Plan.
−Removed: The inducement grant is included in the stock option and RSU award tables below.
−Removed: In September 2023, the Company granted an equity award to a newly hired executive as a material inducement to enter into employment with the Company.
−Removed: The grant constitutes an "employment inducement grant" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of the other stock incentive plans described above.
−Removed: The inducement grant included a nonqualified stock option to purchase up to 125,000 shares of the Company's common stock, as well as a restricted stock unit grant representing 83,330 shares of the Company's common stock.
+Added: From time to time, the Company grants equity awards to newly hired executives as a material inducement to enter into employment with the Company.
+Added: The grants constitute "employment inducement grants" in accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules and was issued outside of the 2018 Plan and each of the other stock incentive plans described above.
+Added: The inducement grants typically include nonqualified stock options to purchase shares of the Company's common stock, as well as restricted stock unit grants representing shares of the Company's common stock.
These stock option and restricted stock unit inducement grants have terms and conditions consistent with those set forth under the 2018 Plan and vest under the same respective vesting schedules as stock option and restricted stock unit awards granted under the 2018 Plan.
−Removed: The inducement grant is included in the stock option and RSU award tables below.
+Added: The inducement grants are included in the stock option and RSU award tables below.
+Added: During the three months ended June 30, 2024, the Company granted 75,000 nonqualified stock options to purchase shares of the Company's common stock and 50,000 restricted stock units under employment inducement grants, and in the same period in 2023, the Company did no t grant any employment inducement grants.
Stock option valuation
5 unchanged sentences
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.
−Removed: Table of Conte nts
−Removed: 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.
+Added: 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.
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
−Removed: December 31, Nine Months Ended
−Removed: 2023 2022 2023 2022
Risk-free interest rate 4.43 % 3.60 %
11 unchanged sentences
Cancelled ( 216,743 ) $ 17.82
−Removed: Outstanding as of December 31, 2023 8,833,069 $ 17.23 6.67 $ 6,040
−Removed: Options exercisable as of December 31, 2023 5,521,235 $ 15.46 5.42 $ 6,039
−Removed: Options vested and expected to vest as of December 31, 2023 8,833,069 $ 17.23 6.67 $ 6,040
−Removed: As of December 31, 2023, there was $ 38.6 million of unrecognized compensation cost related to unvested common stock options, which is expected to be recognized over a weighted average period of 2.5 years.
−Removed: The weighted average grant-date fair value of stock options granted during the nine months ended December 31, 2023 and 2022 was $ 12.08 and $ 12.64 , respectively.
−Removed: The aggregate intrinsic value of stock options exercised during the nine months ended December 31, 2023 was $ 1.3 million.
−Removed: Restricted stock units
−Removed: A summary of the changes in the Company's RSUs during the nine months ended December 31, 2023 is as follows:
+Added: Outstanding as of June 30, 2024 10,157,054 $ 15.37 6.84 $ 8,837
+Added: Options exercisable as of June 30, 2024 6,152,459 $ 16.16 5.40 $ 6,541
+Added: Options vested and expected to vest as of June 30, 2024 10,157,054 $ 15.37 6.84 $ 8,837
+Added: As of June 30, 2024, there was $ 35.7 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.
+Added: The weighted average grant-date fair value of stock options granted during the three months ended June 30, 2024 and 2023 was $ 5.37 and $ 12.09 , respectively.
+Added: The aggregate intrinsic value of stock options exercised during the three months ended June 30, 2024 was $ 0.1 million.
+Added: Restricted and performance stock units
+Added: In January 2024, the Board approved a one-time PSU award under the 2018 Plan for all employees at the vice president level and below as of January 31, 2024, subject to non-market performance and service conditions.
+Added: The grants will become vested 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.
+Added: 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.
+Added: 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.
+Added: The Company reassesses the probability of achieving the performance condition at each reporting period.
+Added: As of June 30, 2024, the Company has not recognized any expense related to PSUs.
+Added: A summary of the changes in the Company's RSUs and PSUs during the three months ended June 30, 2024 is as follows:
Number of Restricted Shares Weighted
4 unchanged sentences
Cancelled ( 124,393 ) 15.23
−Removed: Outstanding as of December 31, 2023 2,040,997 20.57
−Removed: As of December 31, 2023, there was $ 33.9 million of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of 2.8 years.
−Removed: Table of Conte nts
+Added: Outstanding as of June 30, 2024 3,370,183 $ 12.77
+Added: As of June 30, 2024, there was $ 34.5 million of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of 2.8 years.
+Added: Of the $ 34.5 million of total unrecognized compensation cost, performance based awards tied to the achievement of a company milestone account for approximately $ 4.8 million.
+Added: The performance based awards will vest upon achievement of the performance milestone.
+Added: The remaining unrecognized compensation cost is related to restricted stock units which vest over time.
11 Net loss per share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
−Removed: Three Months Ended December 31, Nine Months Ended December 31,
−Removed: 2023 2022 2023 2022
+Added: Three Months Ended June 30,
Net loss $ ( 53,772 ) $ ( 49,555 )
2 unchanged sentences
The 10,211,969 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.
−Removed: The Company’s potentially dilutive securities, which include stock options 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.
+Added: 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:
−Removed: Three and Nine Months Ended December 31,
+Added: Three Months Ended June 30,
Options to purchase common stock 10,157,054 9,067,305
−Removed: Unvested restricted stock units 2,040,997 1,353,745
+Added: Unvested restricted and performance stock units
+Added: 3,370,183 2,069,415
Warrants to purchase common stock 497,344 497,344
10 unchanged sentences
Upon termination, the licenses granted to the Company to use BMS’s compound in the clinical trial will terminate.
−Removed: Table of Conte nts
In April 2019, the Company entered into a separate agreement with BMS on terms similar to the terms set forth in the agreement described above, pursuant to which BMS will provide to the Company, at no cost, nivolumab for use in the Company’s Phase 1 clinical trial of RP2 in combination with nivolumab.
2 unchanged sentences
(“Regeneron”).
−Removed: The Company and Regeneron are each independently developing compounds for the treatment of certain tumor types.
−Removed: Pursuant to the agreement, the Company agreed to undertake one or more clinical trials with Regeneron for the administration of our product candidates in combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types.
−Removed: The first of which, agreed in June 2018, is our ongoing Phase 2 clinical trial testing RP1 in combination with cemiplimab versus cemiplimab alone in patients with CSCC.
+Added: Pursuant to the agreement the Company agreed to undertake one or more clinical trials with Regeneron for the administration of the Company's product candidates in combination with cemiplimab, an anti-PD-1 therapy developed by Regeneron, across multiple solid tumor types.
+Added: The first of which, agreed in June 2018, is the Company's ongoing clinical trial testing RP1 in combination with cemiplimab versus cemiplimab alone in patients with CSCC.
Each clinical trial will be conducted pursuant to an agreed study plan which, among other things, will identify the name of the sponsor and which party will manage the particular study, and include the protocol, the budget and a schedule of clinical obligations.
−Removed: The first study plan related to Phase 2 clinical trial in CSCC has been agreed.
−Removed: Pursuant to the terms of the agreement, each party granted the other party a non-exclusive license under its respective intellectual property and agreed to contribute the necessary resources needed to fulfill its respective obligations, in each case, under the terms of the agreed-upon or to-be agreed upon study plans.
−Removed: Development costs of a particular clinical trial will be split equally.
+Added: Pursuant to the terms of the agreement, each party granted the other party a non-exclusive license of their respective intellectual property and agreed to contribute the necessary resources needed to fulfill their respective obligations, in each case, under the terms of agreed study plans.
+Added: The Company does not expect any further reimbursements from Regeneron related to the initial study plan of June 2018 and the CERPASS trial.
The agreement contains representations, warranties, undertakings and indemnities customary for a transaction of this nature.
−Removed: The agreement also contains certain time-based covenants that restrict us from entering into a third-party arrangement with respect to the use of our product candidates in combination with an anti-PD-1 therapy and that restrict Regeneron from entering into a third-party arrangement with respect to the use of cemiplimab in combination with an HSV-1 virus, in each case, for the treatment of a tumor type that is the subject of a clinical trial to which the covenants apply.
−Removed: Unless otherwise mutually agreed in a future study plan, these covenants are only applicable to our ongoing Phase 2 clinical trial in CSCC.
+Added: The agreement also contains certain time-based covenants that restrict the Company from entering into a third-party arrangement with respect to the use of its product candidates in combination with an anti-PD-1 therapy and that restrict Regeneron from entering into a third-party arrangement with respect to the use of cemiplimab in combination with an HSV-1 virus, in each case, for the treatment of a tumor type that is the subject of a clinical trial to which the covenants apply.
+Added: Unless otherwise mutually agreed in a future study plan, these covenants are only applicable to the Company's ongoing Phase 2 clinical trial in CSCC.
The agreement may be terminated by either party if (i) there is no active study plan for which a final study report has not been completed and the parties have not entered into a study plan for an additional clinical trial within a period of time after the delivery of the most recent final study report or (ii) in the event of a material breach
−Removed: The agreement with Regeneron is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and each party pays its own compound costs and shares equally in development costs in accordance with and up to the amount in the agreed upon first study plan.
−Removed: The Company will account for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations.
−Removed: The Company will recognize any amounts received from Regeneron in connection with this agreement as an offset to research and development expense within the consolidated statement of operations.
+Added: The agreement with Regeneron is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and each party pays its own compound costs and share equally in development costs.
+Added: The Company accounts for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations.
+Added: The Company recognizes any amounts received from Regeneron in connection with this agreement as an offset to research and development expense within the consolidated statement of operations.
In July 2022, Regeneron informed the Company that the costs of the study have reached the initial budget for the initial study plan of June 2018 and that Regeneron's reimbursement of CERPASS study costs to the Company have completed in the period ending June 30, 2022 in relation to the initial study budget.
−Removed: As a result of this notice from, and the ongoing communications with, Regeneron, we have not recorded any cost-sharing reimbursements from Regeneron in prepaid expenses and other current assets in the consolidated balance sheet or as an offset to research and development expense within the consolidated statement of operations since Regeneron informed us that Regeneron’s reimbursement of CERPASS study costs have completed.
+Added: As a result of this notice from, and the ongoing communications with, Regeneron, the Company has not recorded any cost-sharing reimbursements from Regeneron in prepaid expenses and other current assets in the consolidated balance sheet or as an offset to research and development expense within the consolidated statement of operations since Regeneron informed it that Regeneron’s reimbursement of CERPASS study costs have completed.
The Company does not expect any further reimbursements from Regeneron related to the initial study plan of June 2018.
−Removed: The Company did no t record any costs as an offset to research and development expenses during the nine months ended December 31, 2023, and recorded $ 1.1 million during the nine months ended December 31, 2022.
−Removed: During the nine months ended December 31, 2023 and 2022, the Company received payments under the terms of the agreement from Regeneron of $ 0.0 million and $ 3.1 million, respectively.
−Removed: No receivables from Regeneron were booked in connection with this agreement as of December 31, 2023 or March 31, 2023.
13 Collaboration and other arrangements
−Removed: Table of Conte nts
−Removed: In December 2022, the Company announced that it had entered into a Master Clinical Trial Collaboration and Supply Agreement with Roche in relation to its RP2 and RP3 programs in colorectal cancer, or CRC, and hepatocellular carcinoma, or HCC.
−Removed: Under the agreement, the companies will collaborate in two 30 patient cohort signal finding studies in third-line, or 3L, CRC and two 15 patient cohort signal finding studies in second-line, or 2L, HCC.
−Removed: Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab for 2L HCC and 3L CRC combined with RP3.
−Removed: Roche will also supply atezolizumab and bevacizumab for 2L HCC and 3L CRC combined with RP2.
−Removed: The Company has retained the responsibility of operating the clinical trials as well as retaining all the rights to the development and commercialization of the Company's product candidates.
+Added: In December 2022, the Company entered into a Master Clinical Trial Collaboration and Supply Agreement with Roche in relation to the Company's RP2 and RP3 programs in colorectal cancer, or CRC, and hepatocellular carcinoma, or HCC.
+Added: Under the agreement, the companies intended to collaborate in 30 patient cohort signal finding studies in third-line, or 3L, CRC and in first- and second-line, or 1L and 2L, respectively, HCC.
+Added: Following the Company's re-prioritization of its product development portfolio in December 2023, the Company has agreed with Roche to terminate the CRC collaboration and pursue the 2L cohort in HCC with RP2 only.
+Added: Roche has expressed its intent to continue to supply its currently approved drugs, atezolizumab and bevacizumab for the 2L cohort in HCC but is unlikely to share costs following the Company's re-prioritization.
+Added: The Company is in discussions with Roche about revising these agreements following the Company's changes to its RP2 and RP3 development plans.
+Added: Under the terms of the initial agreement the Company retained the responsibility of operating the clinical trials as well as retaining all the rights to the development and commercialization of its product candidates.
The agreement may be terminated by either party upon sixty days prior written notice to the other party.
−Removed: The agreement with Roche is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and each party pays its own compound costs and shares equally in development costs in accordance with and up to the amount in the agreed upon first study plan.
−Removed: The Company will account for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations.
+Added: The agreement with Roche is accounted for under ASC 808, Collaborative Arrangements (“ASC 808”), as both parties are active participants and each party pays its own compound costs.
+Added: The Company accounts for costs incurred as part of the study, including costs to supply compounds for use in the study, as research and development expenses within the consolidated statement of operations.
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.
−Removed: During the three and nine months ended December 31, 2023 and 2022, the Company did not make any payments to Roche under the terms of the agreement.
−Removed: 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.
−Removed: 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, 2022.
−Removed: During the nine months ended December 31, 2023 and 2022, the Company received payments under the terms of the agreement from Roche of $ 1.7 million and $ 0.0 million , respectively.
−Removed: As of December 31, 2023 and March 31, 2023, the Company recorded $ 1.8 million and $ 0.9 million as receivables from Roche in connection with this agreement, respectively.
+Added: During the three months ended June 30, 2024 and 2023, the Company did not make any payments to Roche under the terms of the agreement.
+Added: The Company recorded $ 0.0 million and $ 0.7 million as an offset to research and development expenses during the three months ended June 30, 2024, and 2023, respectively.
+Added: During the three months ended June 30, 2024 and 2023, the Company received payments under the terms of the agreement from Roche of $ 1.8 million and $ 0.2 million, respectively.
+Added: As of June 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.
In July 2023, the Company entered into a Clinical Trial Collaboration and Supply Agreement with Incyte Corporation, or Incyte.
6 unchanged sentences
In addition, the Company may terminate the agreement upon the inappropriate or unsafe use of the RP1 product candidate.
−Removed: During the three and nine months ended December 31, 2023, the Company did not make any payments to, or receive any payments from, Inctye under the terms of the agreement.
−Removed: Additionally, no costs were recorded to research and development expenses during the three and nine months ended December 31, 2023 related to this agreement.
+Added: 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.
+Added: On August 1, 2024, the Company received notice of termination of the Clinical Trial Collaboration and Supply Agreement from Incyte.
+Added: During the year ended March 31, 2024, the Company did not make any payments to, or receive any payments from,
+Added: Inctye under the terms of the agreement.
+Added: Additionally, no costs were recorded to research and development expenses during the three months ended June 30, 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
−Removed: The table below presents the lease-related costs which are included in the consolidated statements of operations for the three and nine months ended December 31, 2023 and 2022:
−Removed: Table of Conte nts
−Removed: Three Months Ended December 31, Nine Months Ended December 31,
−Removed: 2023 2022 2023 2022
+Added: The table below presents the lease-related costs which are included in the consolidated statements of operations for the three months ended June 30, 2024 and 2023:
+Added: Three Months Ended June 30,
Finance lease costs:
3 unchanged sentences
Total lease cost $ 1,422 $ 1,431
−Removed: The following table summarizes the classification of lease costs in the consolidated statement of operations for the three and nine months ended December 31, 2023 and 2022 as follows:
−Removed: Three Months Ended December 31, Nine Months Ended December 31,
−Removed: 2023 2022 2023 2022
+Added: The following table summarizes the classification of lease costs in the consolidated statement of operations for the three months ended June 30, 2024 and 2023 as follows:
+Added: Three Months Ended June 30,
Finance Lease Costs
Research and development $ 607 $ 607
−Removed: Selling, general and administrative — 89 — 268
Other income (expense) 534 544
3 unchanged sentences
Total lease cost $ 1,422 $ 1,431
−Removed: The following table summarizes the maturity of the Company's lease liabilities on an undiscounted cash flow basis and a reconciliation to the operating and financing lease liabilities recognized on its balance sheet as of December 31, 2023:
−Removed: December 31, 2023
+Added: The following table summarizes the maturity of the Company's lease liabilities on an undiscounted cash flow basis and a reconciliation to the operating and financing lease liabilities recognized on its balance sheet as of June 30, 2024:
+Added: June 30, 2024
Operating leases Financing lease Total
−Removed: 2024 (remaining three months) $ 289 $ 668 $ 957
+Added: 2025 (remaining nine months) $ 872 $ 2,050 $ 2,922
2026 1,171 2,799 3,970
6 unchanged sentences
Total lease liabilities $ 4,764 $ 25,994 $ 30,758
−Removed: The following table provides lease disclosure as of December 31, 2023 and March 31, 2023:
−Removed: Table of Conte nts
−Removed: December 31, 2023 March 31, 2023
+Added: The following table provides lease disclosure as of June 30, 2024 and March 31, 2024:
+Added: June 30, 2024 March 31, 2024
Right-to-use operating lease asset $ 4,475 $ 4,635
6 unchanged sentences
Total lease liabilities $ 30,758 $ 31,060
−Removed: The following table provides lease disclosure for the nine months ended December 31, 2023 and 2022:
−Removed: Nine Months Ended December 31,
+Added: The following table provides lease disclosure for the three months ended June 30, 2024 and 2023:
+Added: Three Months Ended June 30,
Other information
8 unchanged sentences
Weighted-average discount rate - financing leases 8.3 % 8.3 %
−Removed: The variable lease costs and short-term lease costs were insignificant for the three and nine months ended December 31, 2023 and 2022.
+Added: The variable lease costs and short-term lease costs were insignificant for the three months ended June 30, 2024 and 2023.
Manufacturing commitments
The Company has entered into an agreement with a contract manufacturing organization to provide clinical trial products.
−Removed: As of December 31, 2023 and March 31, 2023, the Company had committed to minimum payments under these arrangements totaling $ 0.9 million and $ 1.0 million, respectively.
+Added: As of June 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.
Indemnification agreements
3 unchanged sentences
To date, the Company has not incurred any material costs as a result of such indemnifications.
−Removed: 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 December 31, 2023 or March 31, 2023.
+Added: 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, 2024 or March 31, 2024.
Legal proceedings
−Removed: Table of Conte nts
The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities.
15 Income taxes
−Removed: 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.
−Removed: The Company’s income tax provision and effective tax rate for the three months ended December 31, 2022 was $ 0.0 million and 0.0 %, respectively.
−Removed: The income tax provision and effective tax rate for the three months ended December 31, 2023 is primarily due to forecasted U.S.
−Removed: taxable income for the year that is not fully offset by available net operating loss carryforward s .
−Removed: 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.
−Removed: The Company’s income tax provision and effective tax rate for the nine months ended December 31, 2022 was $ 0.0 million and 0.0 %, respectively.
−Removed: The income tax provision and effective tax rate for the nine months ended December 31, 2023 is primarily due to forecasted U.S.
−Removed: taxable income for the year that is not fully offset by available net operating loss carryforwards.
−Removed: 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.
−Removed: 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.
−Removed: As a result, as of December 31, 2023 and March 31, 2023, the Company has recorded a full valuation allowance against its net deferred tax assets.
+Added: 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.
+Added: 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.
+Added: Changes in deferred tax assets and liabilities are recorded in the provision for income taxes.
+Added: 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.
+Added: Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
+Added: 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.
+Added: First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities.
+Added: 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.
+Added: 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.
+Added: 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.
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:
−Removed: December 31, 2023 March 31, 2023
+Added: June 30, 2024 March 31, 2024
United States $ 10,006 $ 8,992
1 unchanged sentence
$ 11,403 $ 10,483
−Removed: Table of Conte nts
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.