PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) The unaudited financial statements detail Replimune Group, Inc.'s financial position and performance, highlighting increased operating expenses and net losses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | | September 30, 2022 | March 31, 2022 | | :--- | :--- | :--- | | **Total current assets** | $379,390 | $403,977 | | **Total assets** | $436,095 | $461,192 | | **Total current liabilities** | $23,537 | $20,756 | | **Total liabilities** | $52,023 | $49,963 | | **Total stockholders' equity** | $384,072 | $411,229 | *Amounts in thousands* - As of September 30, 2022, the company's cash, cash equivalents, and short-term investments totaled **$371.8 million**, a decrease from **$395.7 million** as of March 31, 2022[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Six Months Ended Sep 30, 2022 | Six Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | **Research and development** | $28,834 | $19,902 | $58,312 | $38,456 | | **Selling, general and administrative** | $12,745 | $9,345 | $24,143 | $18,172 | | **Total operating expenses** | $41,579 | $29,247 | $82,455 | $56,628 | | **Loss from operations** | ($41,579) | ($29,247) | ($82,455) | ($56,628) | | **Net loss** | ($43,102) | ($29,355) | ($85,355) | ($56,666) | | **Net loss per common share** | ($0.79) | ($0.56) | ($1.57) | ($1.09) | *Amounts in thousands, except per share amounts* - Operating expenses increased significantly year-over-year for both the three and six-month periods, driven by higher research and development costs and selling, general, and administrative expenses, leading to a wider net loss[13](index=13&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) | | Three Months Ended Sep 30, 2022 | Six Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | **Net loss** | ($43,102) | ($85,355) | | **Foreign currency translation gain** | $2,330 | $4,067 | | **Comprehensive loss** | ($40,691) | ($81,451) | *Amounts in thousands* [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%20%27%20Equity) - Total stockholders' equity decreased from **$411.2 million** at March 31, 2022, to **$384.1 million** at September 30, 2022. The decrease was primarily due to the net loss of **$85.4 million** for the six-month period, partially offset by proceeds from the issuance of common stock through ATM sales (**$37.4 million**) and stock option exercises[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | | Six Months Ended Sep 30, 2022 | Six Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($66,665) | ($41,275) | | **Net cash provided by investing activities** | $5,351 | $15,940 | | **Net cash provided by financing activities** | $39,945 | $2,270 | | **Net decrease in cash, cash equivalents and restricted cash** | ($17,018) | ($22,549) | *Amounts in thousands* - Cash used in operating activities increased to **$66.7 million** for the six months ended September 30, 2022, from **$41.3 million** in the prior year period, mainly due to a larger net loss. Cash from financing activities was significantly higher at **$39.9 million**, driven by **$37.4 million** in proceeds from ATM stock sales[21](index=21&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biotechnology firm focused on oncolytic immunotherapy. It has incurred recurring losses since inception, with a net loss of **$85.4 million** for the six months ended September 30, 2022, and an accumulated deficit of **$396.6 million**. Management believes current cash, equivalents, and investments are sufficient to fund operations for **at least the next 12 months**[24](index=24&type=chunk)[26](index=26&type=chunk) - During the six months ended September 30, 2022, the company sold **2,026,438 shares** of common stock through its At-The-Market (ATM) programs, raising gross proceeds of **$38.7 million**[47](index=47&type=chunk)[51](index=51&type=chunk) - The company has collaboration agreements with Bristol-Myers Squibb (BMS) for the supply of nivolumab and with Regeneron for the supply of cemiplimab and cost-sharing for the CERPASS trial. A dispute with Regeneron has led the company to stop recording cost-sharing reimbursements since July 2022[75](index=75&type=chunk)[78](index=78&type=chunk)[82](index=82&type=chunk) - Subsequent to the quarter end, on October 6, 2022, the company entered into a Loan and Security Agreement with Hercules Capital for a term loan facility of up to **$200.0 million**, drawing an initial **$30.0 million**[91](index=91&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage oncolytic immunotherapy development, detailing increased operating losses from expanded clinical trials and personnel costs, while maintaining a strong liquidity position [Overview](index=23&type=section&id=Overview) - Replimune is a clinical-stage biotechnology company developing tumor-directed oncolytic immunotherapies from its proprietary RPx platform, with three product candidates: RP1, RP2, and RP3[100](index=100&type=chunk)[102](index=102&type=chunk) - The lead candidate, RP1, is in a registration-directed Phase 2 trial (CERPASS) for cutaneous squamous cell carcinoma (CSCC), with topline data expected in H1 2023. Another registration-directed Phase 2 cohort in the IGNYTE trial is evaluating RP1 in anti-PD-1 failed melanoma, with a data snapshot from the first 75 patients expected in late 2022[102](index=102&type=chunk)[103](index=103&type=chunk)[105](index=105&type=chunk) - RP2 and RP3 are being evaluated in Phase 1 trials, with plans to initiate Phase 2 development in H1 2023 for tumor types such as head and neck, hepatocellular, and colorectal cancers. An update on these programs is expected by year-end 2022[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) | | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | **Research and development** | $28,834 | $19,902 | $8,932 | | **General and administrative** | $12,745 | $9,345 | $3,400 | | **Total operating expenses** | $41,579 | $29,247 | $12,332 | | **Net loss** | ($43,102) | ($29,355) | ($13,747) | *Amounts in thousands* | | Six Months Ended Sep 30, 2022 | Six Months Ended Sep 30, 2021 | Change | | :--- | :--- | :--- | :--- | | **Research and development** | $58,312 | $38,456 | $19,856 | | **General and administrative** | $24,143 | $18,172 | $5,971 | | **Total operating expenses** | $82,455 | $56,628 | $25,827 | | **Net loss** | ($85,355) | ($56,666) | ($28,689) | *Amounts in thousands* - R&D expenses for the six months ended Sep 30, 2022 increased by **$19.9 million** YoY to **$58.3 million**. This was driven by a **$7.6 million** increase in RP1 program costs due to trial site expansion and reduced cost-sharing from Regeneron, a **$6.9 million** increase in the RP3 program, and a **$6.8 million** increase in personnel-related costs[147](index=147&type=chunk)[148](index=148&type=chunk) - SG&A expenses for the six months ended Sep 30, 2022 increased by **$6.0 million** YoY to **$24.1 million**, primarily due to a **$2.5 million** increase in personnel-related costs from hiring, including for pre-launch commercial planning[149](index=149&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2022, the company had **$371.8 million** in cash, cash equivalents, and short-term investments[153](index=153&type=chunk) - Net cash used in operating activities for the six months ended September 30, 2022, was **$66.7 million**, an increase from **$41.3 million** in the prior-year period, primarily due to a higher net loss[156](index=156&type=chunk) - In October 2022, the company secured a **$200 million** non-dilutive debt financing agreement with Hercules Capital. Management believes existing cash plus available funds from this facility will fund operations into **calendar 2025**[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company indicates this section is not applicable for the reporting period - This section is not applicable[185](index=185&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2022, with no material changes in internal controls - Based on an evaluation as of September 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[186](index=186&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[188](index=188&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports it is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[191](index=191&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including early-stage product development, clinical trial failures, reliance on collaborations, manufacturing challenges, competition, and the need for additional financing - All product candidates are in early development stages and may never receive regulatory approval or become commercially viable. A fundamental problem with the underlying RPx platform could force discontinuation of all pipeline candidates[195](index=195&type=chunk)[196](index=196&type=chunk) - The company's product candidates are designed for use in combination with third-party drugs like nivolumab (BMS) and cemiplimab (Regeneron). The company has limited control over the supply and regulatory status of these drugs, and any issues could delay development[204](index=204&type=chunk)[207](index=207&type=chunk) - The company has a history of net losses (**$396.6 million** accumulated deficit as of Sep 30, 2022) and will require substantial additional financing to achieve its goals. Failure to obtain capital could force delays or termination of programs[261](index=261&type=chunk)[267](index=267&type=chunk) - The company faces intellectual property risks and may become involved in litigation. On November 2, 2022, the company filed a petition for inter partes review with the USPTO to invalidate certain claims of a patent held by Amgen Inc[278](index=278&type=chunk) - The transition of manufacturing to the new in-house facility in Framingham, MA, presents risks. Delays or issues with process transfer, comparability analysis, and regulatory approval could disrupt the supply of product candidates for clinical trials[310](index=310&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[377](index=377&type=chunk) [Item 6. Exhibits](index=88&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Loan and Security Agreement and CEO/CFO certifications - Lists exhibits filed with the report, including required CEO/CFO certifications and the new Loan and Security Agreement with Hercules Capital, Inc[382](index=382&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpo ...

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) Delaware 82-2082553 (State or other ...

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Safe Harbor Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements r ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of in ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpo ...

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) Delaware 82-2082553 (State or other jurisdiction of ( ...

NEXT GENERATION ONCOLYTIC IMMUNOTHERAPY NEXT-GENERATION ONCOLYTIC IMMUNOTHERAPY JP Morgan January 2021 Safe harbor 2 Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the advancement of our clinical trials, patient enrollments in our existing and planned clinical ...