WOBURN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced multiple presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 31-June 4, 2024. The Company has two abstracts selected for oral presentation, including an updated presentation of investigator- assessed 12-month data from the IGNYTE ...

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, 2024 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 ...

Exhibit 99.1 Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update Woburn, MA, May 16, 2024 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2024 and provided a business update. "We have exciting milestones in the coming months, including sharing the investigator-a ...

Core Insights - Replimune Group, Inc. is advancing its lead product candidate RP1 (vusolimogene oderparepvec) for the treatment of anti-PD1 failed melanoma, with a 12-month primary analysis expected in Q2 2024 and a Biologics License Application (BLA) submission anticipated in the second half of 2024 [1][2][4] Clinical Development Updates - The company has successfully completed a Type C meeting with the FDA, confirming alignment on Chemistry, Manufacturing and Controls (CMC) plans for the BLA submission [3][4] - Enrollment of the first patients in the Phase 3 confirmatory trial (IGNYTE-3) for RP1 is expected to begin in the second half of 2024 [1][5] - Positive six-month follow-up data from the IGNYTE clinical trial indicated efficacy and safety of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma [4] Financial Performance - As of March 31, 2024, the company reported cash, cash equivalents, and short-term investments of $420.7 million, down from $583.4 million a year earlier, primarily due to cash utilized in operating activities [9] - Research and development expenses for the fourth quarter were $42.6 million, and $175.0 million for the fiscal year, compared to $37.9 million and $126.5 million, respectively, in the previous year [10] - The net loss for the fourth quarter was $55.1 million, with a total net loss of $215.8 million for the fiscal year, compared to $49.2 million and $174.3 million in the prior year [11] Upcoming Milestones - The company plans to present several abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, including data on RP1 and RP2 in various cancer types [3][4] - The Phase 2 clinical trial of RP2 in hepatocellular carcinoma is expected to initiate in the second half of 2024 [8]

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, 2023 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 inc ...

PART I FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's analysis, market risk, and internal controls [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company reported a **net loss of $109.6 million** for the six months ended September 30, 2023, driven by increased R&D, maintaining **$496.8 million in cash and investments** Condensed Consolidated Balance Sheets (Unaudited) | | September 30, 2023 (Thousands USD) | March 31, 2023 (Thousands USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | **$75,996** | **$146,590** | | Short-term investments | **$420,765** | **$436,796** | | Total current assets | **$508,175** | **$592,603** | | Total assets | **$562,398** | **$646,591** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | **$39,832** | **$33,825** | | Total liabilities | **$97,226** | **$91,299** | | Accumulated deficit | **$(595,087)** | **$(485,488)** | | Total stockholders' equity | **$465,172** | **$555,292** | Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended Sep 30, 2023 (Thousands USD) | Three Months Ended Sep 30, 2022 (Thousands USD) | Six Months Ended Sep 30, 2023 (Thousands USD) | Six Months Ended Sep 30, 2022 (Thousands USD) | | :--- | :--- | :--- | :--- | :--- | | Research and development | **$49,101** | **$28,834** | **$89,538** | **$58,312** | | Selling, general and administrative | **$14,730** | **$12,745** | **$29,941** | **$24,143** | | Loss from operations | **$(63,831)** | **$(41,579)** | **$(119,479)** | **$(82,455)** | | Net loss | **$(60,044)** | **$(43,102)** | **$(109,599)** | **$(85,355)** | | Net loss per common share | **$(0.90)** | **$(0.79)** | **$(1.65)** | **$(1.57)** | Condensed Consolidated Statements of Cash Flows (Unaudited) | | Six Months Ended Sep 30, 2023 (Thousands USD) | Six Months Ended Sep 30, 2022 (Thousands USD) | | :--- | :--- | :--- | | Net cash used in operating activities | **$(92,178)** | **$(66,665)** | | Net cash provided by investing activities | **$20,044** | **$5,351** | | Net cash provided by financing activities | **$1,543** | **$39,945** | | Net (decrease) increase in cash | **$(70,594)** | **$(17,018)** | - The company is a **clinical-stage biotechnology firm** focused on developing **oncolytic immunotherapies** to treat cancer, subject to risks common to **early-stage biotech companies**, including the need for **significant additional capital** and **regulatory approval** for its **product candidates**[24](index=24&type=chunk)[25](index=25&type=chunk) - The company has a **Loan and Security Agreement** with **Hercules Capital, Inc.** for a **term loan facility** of up to **$200.0 million**, with an initial **$30.0 million** borrowed in October 2022[39](index=39&type=chunk) - Collaboration agreements are in place with **Bristol-Myers Squibb (BMS)**, **Regeneron**, **Roche**, and **Incyte** for the supply of combination therapies in various clinical trials[83](index=83&type=chunk)[86](index=86&type=chunk)[93](index=93&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's **oncolytic immunotherapy platform**, highlighting increased R&D expenses, higher net loss, and strong liquidity of **$496.8 million** expected to fund operations into late 2025 [Overview](index=25&type=section&id=Overview) This section provides an overview of Replimune's clinical-stage oncolytic immunotherapy platform and lead product candidates - **Replimune** is a **clinical-stage biotechnology company** developing a portfolio of **oncolytic immunotherapies** based on its **proprietary RPx platform**, which uses an engineered strain of **herpes simplex virus 1 (HSV-1)**[113](index=113&type=chunk)[115](index=115&type=chunk) - The lead **product candidate**, **RP1**, is in a registration-directed **Phase 2 trial (CERPASS)** for **cutaneous squamous cell carcinoma (CSCC)**, with a **Biologics License Application (BLA)** submission expected in Q2 2024, assuming positive data[116](index=116&type=chunk) - The **IGNYTE trial** for **anti-PD-1 failed cutaneous melanoma** has completed enrollment of 140 patients, with a **BLA** submission planned for Q3 2024 based on this trial[118](index=118&type=chunk) - The pipeline includes **RP2** and **RP3**, which are being evaluated in various tumor types like **hepatocellular carcinoma (HCC)** and **colorectal cancer (CRC)** in collaboration with partners such as **Roche** and **BMS**[122](index=122&type=chunk)[126](index=126&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20operations) This section details the company's operating results, highlighting changes in research and development and selling, general and administrative expenses Comparison of Operating Results (Three Months Ended Sep 30) | | 2023 (Thousands USD) | 2022 (Thousands USD) | Change (Thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | **$49,101** | **$28,834** | **$20,267** | | Selling, general and administrative | **$14,730** | **$12,745** | **$1,985** | | Loss from operations | **$(63,831)** | **$(41,579)** | **$(22,252)** | | Net loss | **$(60,044)** | **$(43,102)** | **$(16,942)** | - R&D expenses increased by **$20.3 million** for the three months ended Sep 30, 2023, primarily due to increased **clinical trial site and patient enrollment** for **RP1**, higher **manufacturing efforts**, and an **$8.2 million** increase in **personnel-related costs**[157](index=157&type=chunk)[158](index=158&type=chunk)[160](index=160&type=chunk) - SG&A expenses increased by **$2.0 million** for the three months ended Sep 30, 2023, mainly due to a **$1.1 million** increase in **personnel costs** from hiring for **pre-launch planning** and building **commercial infrastructure**, and a **$0.9 million** increase in **sales and marketing costs**[161](index=161&type=chunk) Comparison of Operating Results (Six Months Ended Sep 30) | | 2023 (Thousands USD) | 2022 (Thousands USD) | Change (Thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | **$89,538** | **$58,312** | **$31,226** | | Selling, general and administrative | **$29,941** | **$24,143** | **$5,798** | | Loss from operations | **$(119,479)** | **$(82,455)** | **$(37,024)** | | Net loss | **$(109,599)** | **$(85,355)** | **$(24,244)** | [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20capital%20resources) This section discusses the company's cash position, operating cash flow, and projected liquidity runway - As of September 30, 2023, the company had **cash, cash equivalents, and short-term investments** of **$496.8 million**[173](index=173&type=chunk) - Net cash used in **operating activities** was **$92.2 million** for the six months ended September 30, 2023, compared to **$66.7 million** for the same period in 2022, primarily due to a higher **net loss**[175](index=175&type=chunk)[177](index=177&type=chunk) - Based on the current **operating plan**, existing cash is expected to fund operations and **capital expenditure requirements** into the **second half of 2025**[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable for this reporting period - Not applicable[209](index=209&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting - The **Chief Executive Officer** and **Chief Accounting Officer** concluded that the company's **disclosure controls and procedures** were effective as of September 30, 2023[211](index=211&type=chunk) - There have been no changes in **internal control over financial reporting** for the three months ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, **internal controls**[213](index=213&type=chunk) PART II OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, and exhibits related to the company's operations [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any **material legal proceedings**[216](index=216&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including early-stage product development, clinical trial uncertainty, regulatory approval challenges, competition, financial losses, and the need for additional capital [Risks Related to Product Development](index=43&type=section&id=Risks%20related%20to%20product%20development) This section outlines risks associated with early-stage product development, clinical trial outcomes, and platform dependency - All **product candidates** are in early stages of development and may not receive **regulatory approval** or become commercially viable; **preclinical and early clinical trial results** are not predictive of later-stage outcomes[220](index=220&type=chunk)[222](index=222&type=chunk) - Development of **product candidates** in combination with **third-party drugs** (e.g., **anti-PD-1 therapies**) presents challenges, including reliance on supply and the regulatory status of those drugs[229](index=229&type=chunk)[232](index=232&type=chunk) - An underlying problem with the **proprietary RPx platform** could adversely affect the entire pipeline, as all current **product candidates** are based on this platform[234](index=234&type=chunk) [Risks Related to Regulatory Approval](index=47&type=section&id=Risks%20related%20to%20regulatory%20approval) This section addresses risks concerning the lengthy and unpredictable regulatory approval process and potential post-marketing restrictions - The **regulatory approval process** is lengthy, unpredictable, and the company may never obtain approval for its **product candidates**; even if approved, the indications may be limited[237](index=237&type=chunk)[240](index=240&type=chunk) - **Undesirable side effects** could delay or prevent **regulatory approval**, result in a more restrictive label, or lead to post-marketing restrictions[242](index=242&type=chunk) - The company is subject to **ongoing regulatory review** even after approval, which can result in significant expense and limit how products are manufactured and marketed[253](index=253&type=chunk) [Risks Related to Commercialization](index=53&type=section&id=Risks%20related%20to%20commercialization) This section covers risks related to market competition, lack of commercial infrastructure, and challenges in achieving market acceptance and reimbursement - The company faces **significant competition** from other biopharmaceutical companies that may have greater resources and develop products more quickly[268](index=268&type=chunk) - The company currently lacks a **commercial infrastructure** and may be unable to establish effective marketing, sales, and distribution capabilities, which could limit revenue[273](index=273&type=chunk) - Successful commercialization depends on achieving broad **market acceptance** and securing **adequate reimbursement** from government and private payors, which is uncertain[280](index=280&type=chunk)[284](index=284&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=58&type=section&id=Risks%20related%20to%20our%20financial%20position%20and%20need%20for%20additional%20capital) This section highlights risks from the company's limited operating history, continuous net losses, and the necessity for additional financing - The company has a **limited operating history**, has incurred **net losses since inception**, and anticipates substantial and increasing **net losses** for the foreseeable future[291](index=291&type=chunk) - The company will require **additional financing** to achieve its goals, and failure to obtain this capital could force it to **delay, limit, or terminate** its **development programs**[297](index=297&type=chunk) - All **product candidates** are in early stages of development and may never receive **regulatory approval** or become commercially viable; the company has a history of **losses** and expects them to continue[220](index=220&type=chunk)[291](index=291&type=chunk) - The company's ability to commercialize its products depends on successfully transitioning **manufacturing** to its **in-house facility** and maintaining relationships with **third-party suppliers** and **collaborators** like **BMS** and **Regeneron**[218](index=218&type=chunk)[319](index=319&type=chunk) - The company faces risks related to protecting its **intellectual property** and potential **infringement claims** from third parties, such as the recently settled matter with **Amgen** which now requires **royalty payments**[303](index=303&type=chunk)[311](index=311&type=chunk) - The company will require **additional financing** to achieve its goals, and failure to obtain necessary capital could force delays or termination of **product development** or commercialization efforts[297](index=297&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=77&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[407](index=407&type=chunk) [Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company has indicated that this section is not applicable - Not applicable[408](index=408&type=chunk) [Mine Safety Disclosure](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) The company has indicated that this section is not applicable - Not applicable[409](index=409&type=chunk) [Other Information](index=77&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this period - None[410](index=410&type=chunk) [Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including employment agreements and CEO/CFO certifications - Exhibits filed include **employment agreements**, **stock option agreements**, and **CEO/CFO certifications** required under **Sections 302 and 906** of the **Sarbanes-Oxley Act**[412](index=412&type=chunk)

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the quarter ended June 30, 2023 [Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, reporting a net loss of $49.6 million for the quarter ended June 30, 2023 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets to $603.9 million from $646.6 million at the end of the previous quarter, primarily due to a reduction in cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | March 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $106,481 | $146,590 | | Short-term investments | $432,619 | $436,796 | | **Total Assets** | **$603,891** | **$646,591** | | Total current liabilities | $32,242 | $33,825 | | **Total Liabilities** | **$89,862** | **$91,299** | | Accumulated deficit | $(535,043) | $(485,488) | | **Total Stockholders' Equity** | **$514,029** | **$555,292** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2023, the company reported a net loss of $49.6 million, or ($0.75) per share, compared to a net loss of $42.3 million, or ($0.78) per share, for the same period in 2022 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :--- | :--- | :--- | | Research and development | $40,437 | $29,478 | | Selling, general and administrative | $15,211 | $11,398 | | **Total operating expenses** | **$55,648** | **$40,876** | | Loss from operations | $(55,648) | $(40,876) | | Investment income | $6,186 | $343 | | **Net loss** | **$(49,555)** | **$(42,253)** | | Net loss per common share | $(0.75) | $(0.78) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $48.6 million for the three months ended June 30, 2023, a significant increase from $33.5 million in the prior-year period, primarily due to a higher net loss Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(48,588) | $(33,455) | | Net cash provided by investing activities | $7,361 | $5,315 | | Net cash provided by financing activities | $1,105 | $32,522 | | **Net (decrease) increase in cash** | **$(40,109)** | **$6,297** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's clinical-stage biotechnology business, its liquidity assessment, and significant collaboration and loan agreements - The company is a clinical-stage biotechnology firm focused on tumor-directed oncolytic immunotherapies, acknowledging risks like the need for **additional capital** and **regulatory approval**[23](index=23&type=chunk)[24](index=24&type=chunk) - Despite recurring losses and an accumulated deficit of **$535.0 million**, the company expects existing cash to fund operations for at least **12 months** from the issuance date[25](index=25&type=chunk) - In October 2022, the company secured a Loan Agreement with Hercules Capital for up to **$200.0 million**, with an initial draw of **$30.0 million**, and an amendment in June 2023[38](index=38&type=chunk)[39](index=39&type=chunk) - Collaboration agreements include receiving nivolumab from BMS for RP1 and RP2 trials, and a cost-sharing agreement with Regeneron for the Phase 2 CERPASS trial, with reimbursements completed in June 2022[84](index=84&type=chunk)[86](index=86&type=chunk)[94](index=94&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical program advancements for RP1, RP2, and RP3, increased operating expenses, and liquidity, projecting cash to fund operations into the second half of 2025 [Overview](index=24&type=section&id=Overview) Replimune, a clinical-stage biotech, is advancing its oncolytic immunotherapy candidates RP1, RP2, and RP3, with key RP1 data readouts anticipated in Q4 2023 and new Phase 2 collaborations initiated - Topline data for the registration-directed CERPASS trial (RP1 in CSCC) is now expected in **early Q4 2023**, a revision from Q3 2023 due to slower independent review read rates[113](index=113&type=chunk) - Snapshot data for all **141 patients** in the IGNYTE trial (RP1 in anti-PD-1 failed melanoma) is on track for **Q4 2023**, with evaluation for potential dual launch with CERPASS[115](index=115&type=chunk) - Phase 2 development for RP2 and/or RP3 is progressing with signal-finding studies in collaboration with **Roche** (for CRC and HCC) and **BMS** (for SCCHN)[124](index=124&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company's net loss increased to $49.6 million for the quarter ended June 30, 2023, from $42.3 million in the prior-year period Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $40,437 | $29,478 | $10,959 | | Selling, general and administrative | $15,211 | $11,398 | $3,813 | | **Total operating expenses** | **$55,648** | **$40,876** | **$14,772** | - Increased RP1 program costs resulted from more clinical trial sites, higher patient enrollment, increased data management, and reduced cost-sharing from Regeneron[162](index=162&type=chunk) - SG&A expenses rose due to a **$2.8 million** increase in personnel costs and a **$1.3 million** increase in other variable costs, including pre-launch sales and marketing programs[165](index=165&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had $539.1 million in cash, cash equivalents, and short-term investments, with management believing these funds are sufficient to support operations into the second half of 2025 - As of June 30, 2023, the company held **$539.1 million** in cash, cash equivalents, and short-term investments[170](index=170&type=chunk) - Net cash used in operating activities increased to **$48.6 million** for the quarter, up from **$33.5 million** in the prior-year period, primarily due to a higher net loss[172](index=172&type=chunk)[173](index=173&type=chunk) - Based on the current operating plan, existing cash resources are expected to fund operations into the **second half of 2025**[179](index=179&type=chunk)[294](index=294&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that this section is not applicable to its business at this time - The company has determined this item is **not applicable**[203](index=203&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer and Chief Accounting Officer, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2023 - As of June 30, 2023, the CEO and Chief Accounting Officer concluded that the company's disclosure controls and procedures were **effective**[204](index=204&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter[206](index=206&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers other required disclosures, including legal proceedings, risk factors, and exhibits [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any **material legal proceedings**[209](index=209&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including uncertainties in clinical development, regulatory approval, reliance on third parties, capital needs, competition, and intellectual property challenges - The company's product candidates are in early development and may never receive **regulatory approval** or become commercially viable[213](index=213&type=chunk) - The company has a history of net losses, anticipates increasing future losses, and will require **additional financing** to achieve its objectives[284](index=284&type=chunk) - Development and commercialization depend on successful collaborations with partners like **BMS** and **Regeneron** for checkpoint blockade therapy supply[222](index=222&type=chunk)[312](index=312&type=chunk) - Risks exist in transferring manufacturing to the new in-house facility, including potential delays, higher expenses, and failure to achieve anticipated efficiencies[334](index=334&type=chunk) - The company is involved in an inter partes review petition with the USPTO challenging an **Amgen Inc. patent**, which could impact its freedom to operate[304](index=304&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=75&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 covered by the report - The company reports **None** for this item[400](index=400&type=chunk) [Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - The company reports **Not applicable** for this item[401](index=401&type=chunk) [Mine Safety Disclosure](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) The company reports that this item is not applicable - The company reports **Not applicable** for this item[402](index=402&type=chunk) [Other Information](index=75&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed in this section - The company reports **None** for this item[403](index=403&type=chunk) [Exhibits](index=76&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the 10-Q, including the First Amendment to the Loan and Security Agreement with Hercules Capital and a Separation Agreement with former CFO Jean Franchi - Exhibit 10.1 is the **First Amendment to the Loan and Security Agreement** with Hercules Capital, dated June 28, 2023[405](index=405&type=chunk) - Exhibits 10.2 and 10.3 are the **Separation Agreement** and **Consulting Agreement** with former CFO Jean Franchi, dated May 18, 2023[405](index=405&type=chunk)

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, 2023 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, 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) Delaware 82-2082553 (State or other ...

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)