Replimune, Inc.

Topline data disclosure from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous squamous cell carcinoma (CSCC) on track for Q3 2023 and Biologics License Application (BLA) submission on track for Q1 2024 Completed enrollment (n=141) of the IGNYTE registration directed cohort of RP1 in anti-PD1 failed melanoma; updated data for the first 75 patients to be presented at ASCO, with data snapshot for all 141 patients expected Q4 2023 RP2 and RP3 Phase 2 programs expected to initiate around mid-year 2023 in third-line (3L) colorectal cancer (CRC), first- and second-line (1L & 2L) hepatocellular carcinoma (HCC) and squamous cell carcinoma of the head and neck (SCCHN); Phase 1 study update expected at year end Strong balance sheet with cash runway into H2 2025 WOBURN, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2023 and provided a business update. “We have multiple value-driving catalysts across our pipeline ahead of us, with a focus on the topline data from our registration-directed CERPASS clinical trial of RP1 combined with Libtayo® in CSCC expected in the next quarter and plan to provide an initial data snapshot from the full IGNYTE anti-PD1 failed melanoma cohort by the year end, by which point all patients will have been followed for at least 6 months,” said Philip Astley-Sparke, CEO of Replimune. “As we prepare for the upcoming data readouts, and intended BLA submission, we continue to ramp up our commercial efforts for a potential launch in late 2024 as we seek to establish a major skin cancer franchise with RP1. We are also looking forward to launching our Phase 2 program with RP2 and RP3 in CRC, HCC and SCCHN in the next few months.” Program Highlights & Milestones: RP1 CERPASS clinical trial of RP1 combined with Libtayo® in cutaneous squamous cell carcinoma (CSCC) The Company remains on track to announce top line data from its registration-directed CERPASS clinical trial in Q3 2023, and assuming positive primary analysis data demonstrating overall clinical benefit, the Company plans to submit a BLA for RP1 in Q1 2024. Completed enrollment in the IGNYTE anti-PD1 failed melanoma cohort The Company enrolled its last patient (n=141) in the registration directed cohort of patients evaluating RP1 combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma in March 2023. In addition to presenting updated data from the first 75 patients at ASCO in June, the Company expects to announce snapshot data for all patients in Q4 2023 by which point all patients will have had at least 6 months follow up, prior to the per protocol primary analysis at 12 months post the last patient enrolled. RP1 combined with Opdivo® in anti-PD1 failed non-melanoma skin cancers Recruitment remains ongoing into the cohort of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, with a data update expected in Q3 2023. RP1 in solid organ transplant recipients with skin cancers The Company continues to enroll patients into its ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers and expects to provide a data update at the American Transplant Congress in June. RP2 and RP3 Phase 2 program RP2 and RP3 in combination with atezolizumab and bevacizumab in 3L CRC Two signal finding cohorts of 30 patients each will be enrolled in collaboration with Roche. The first cohort will enroll patients to be treated with atezolizumab combined with bevacizumab and RP2 and the second cohort with atezolizumab and bevacizumab and RP3. The Company believes that data with both RP2 and RP3 in CRC will allow the comparative efficacy of RP2 and RP3 to be evaluated in a particularly difficult to treat patient population. RP3 in combination with standard of care therapy in SCCHN A two-cohort clinical trial will be conducted, with the first cohort of 100 patients with locally advanced disease being randomized to receive either standard of care (SOC) chemotherapy combined with radiation or RP3 combined with chemotherapy and radiation followed by adjuvant nivolumab therapy. The second, signal finding cohort, will enroll 30 patients with recurrent or metastatic SCCHN with low PDL1 levels (CPS<20) who will be treated with chemotherapy, nivolumab and RP3. RP3 in combination with atezolizumab and bevacizumab in 1L & 2L HCC Two signal finding cohorts of 30 patients each will be enrolled in collaboration with Roche. The first cohort will enroll 1L patients treated with SOC atezolizumab combined with bevacizumab and RP3, and the second cohort will enroll patients who have progressed on 1L immunotherapy (including atezolizumab/bevacizumab), and will be treated with atezolizumab combined with bevacizumab and RP3. The Company expects to initiate the Phase 2 program with RP2 and RP3 around mid-year. Phase 1 program Accrual in the Phase 1 program is expected to materially complete in Q3 2023. Any additional Phase 2 development programs not already announced which are driven by data from the full Phase 1 data and other opportunistic considerations are expected to be disclosed by year end. Corporate Update Replimune has entered into a transition and separation agreement with Jean Franchi, who has informed the company of her intention to leave effective June 2, 2023. Jean will continue to work with the Company as an advisor until December 31, 2023. Andrew Schwendenman, Vice President of Finance, will assume the role of Chief Accounting Officer. Philip Astley-Sparke will serve as interim CFO while the search for a replacement is conducted. “I would like to express my deep gratitude to Jean for all her contributions in leading and strengthening our finance, and general and administrative functions over the last three and a half years,” said Philip Astley-Sparke. “I look forward to continuing to work with her during her transition and we wish her best of luck in her future endeavors.” Financial Highlights Cash Position: As of March 31, 2023, cash, cash equivalents and short-term investments were $583.4 million, as compared to $395.7 million as of fiscal year end March 31, 2022. The increase in cash as of March 31, 2023 reflects net proceeds from equity offerings and the initial debt tranche resulting in approximately $311.4 million of year-to-date financing inflows partially offset by cash utilized in operating activities in advancing the Company’s clinical development plans.Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of March 31, 2023, will enable the Company to fund operations into the second half of calendar year 2025. R&D Expenses: Research and development expenses were $37.9 million for the fourth quarter and $126.5 million for the fiscal year ended March 31, 2023, as compared to $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $2.3 million in stock-based compensation expenses for the fourth quarter and $10.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.S,G&A Expenses: Selling, general and administrative expenses were $15.0 million for the fourth quarter and $50.6 million for the fiscal year ended March 31, 2023, as compared to $10.3 million for the fourth quarter and $38.8 million for the year ended March 31, 2022. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the fourth quarter and $18.1 million in stock-based compensation expenses for the fiscal year ended March 31, 2023.Net Loss: Net loss was $49.2 million for the fourth quarter and $174.3 million for the fiscal year ended March 31, 2023, as compared to a net loss of $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022. About CERPASSCERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical trial to compare the effects of Libtayo® (cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial recently completed enrollment and enrolled 211 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two independent primary efficacy endpoints as assessed by independent review, as well as secondary endpoints including duration of response, progression-free survival (PFS), and overall survival (OS). The clinical trial is being conducted under a clinical trial collaboration agreement with Regeneron and full commercial rights retained by Replimune. Libtayo is a registered trademark of Regeneron. About IGNYTEIGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus nivolumab. The leading IGNYTE cohort is a 125-patient cohort in anti-PD1 failed cutaneous melanoma with registrational intent. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohort is enrolling in non-melanoma skin cancers which includes both naïve and anti-PD1 failed CSCC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb. About RP1RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About RP2 & RP3RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL, but does not express GM-CSF. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic mechanism of action (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment (TME) to ignite a strong and durable systemic response. This MOA is expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. Forward Looking StatementsThis press release contains 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 our expectations about our cash runway, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris BrinzeyICR Westwicke339.970.2843chris.brinzey@westwicke.com Media InquiriesArleen GoldenbergVice President, Corporate Communicationsmedia@replimune.com Replimune Group, Inc.Condensed Consolidated Statements of Operations(Amounts in thousands, except share and per share amounts)(Audited) ​Year Ended March 31,​ 2023 2022 Operating expenses: Research and development$126,527 $79,545 Selling, general and administrative 50,553 38,769 Total operating expenses 177,080 118,314 Loss from operations (177,080) (118,314)Other income (expense): Research and development incentives 2,914 3,170 Investment income 10,006 390 Interest expense on finance lease liability (2,197) (2,223)Interest expense on debt obligations (1,963) - Other (expense) income (5,676) (1,059)Total other income, net 3,084 278 Loss before income taxes (173,996) (118,036)Income tax provision 288 - Net loss$(174,284) $(118,036)Net loss per common share, basic and diluted$(2.99) $(2.26)Weighted average common shares outstanding, basic and diluted 58,213,010 52,212,269 Replimune Group, Inc.Condensed Consolidated Balance Sheets(Amounts In thousands, except share and per share amounts)(Audited) March 31, March 31, 2023 2022 Consolidated Balance Sheet Data: Cash, cash equivalents and short-term investments$583,386 $395,655 Working capital 558,778 383,221 Total assets 646,591 461,192 Total stockholders' equity 555,292 411,229

Dualyx raises €40 million to progress Treg therapies for autoimmune diseases into the clinic Use of proceeds will enable the development of the Company’s lead autoimmune program DT-001, targeting TNFR2, as well as its pipeline of Treg candidatesFinancing co-led by Fountain Healthcare Partners, Forbion and Andera Partners with support from existing investorsBernard Coulie appointed as Independent Chairman with immediate effect May 15 2023, Ghent, Belgium – Dualyx NV, a Ghent based biotech developing next generation immune modulators, today announces that it has completed a €40 million ($44 million) Series A financing. The fundraise has been co-led by Fountain Healthcare Partners, Forbion and Andera Partners, with support from existing investors V-Bio Ventures, BGV, PMV, VIB, HTGF, and GFF. The funds raised will enable Dualyx to progress its lead autoimmune program DT-001, as well as its pipeline of Treg candidates. Ena Prosser, Partner at Fountain Healthcare Partners, Juliette Audet, Partner at Forbion, and Aneta Sottil, Director at Andera Partners will join Dualyx’s Board as non-executive directors. Dualyx’s lead program DT-001 targets the highly attractive TNF receptor 2 (TNFR2), widely regarded as a master control switch in immune modulation. Through state-of-the-art antibody development, Dualyx has developed an agonist to the receptor which shows highly selective activation of regulatory T cells (Tregs). To date, promising results have been observed from pre-clinical research with DT-001 and investigational new drug (IND)-enabling studies have begun. DT-001 holds promise to be a game-changing treatment option for a broad range of autoimmune diseases. The funds will be used to progress Dualyx’s DT-001 program into its early clinical proof-of-concept phase. The company has a pipeline of additional Treg focused programs in early-stage development. Alongside the financing, Bernard Coulie, CEO of Pliant Therapeutics, joins the company as Independent Chairman with immediate effect. Bernard brings with him a wealth of experience in founding and leading successful biotech companies. “It’s clear to me that TNFR2 is a validated and exciting target for autoimmune therapies, and I am confident that Dualyx has all the ingredients for success with its lead program. I’m therefore delighted to join the Board as Chairman while Dualyx heads towards the clinic,” commented Bernard Coulie, Independent Chairman of Dualyx. “I look forward to working closely with Wouter, Luc and the rest of the Dualyx management team over the coming years.” “Attracting the expertise and support of top tier investors to Dualyx highlights the potential of the work to date in our DT-001 program and more importantly, completes our high-quality international investor base. We extend a warm welcome to Bernard as Chairman and I am confident that the combined support of our new board will enable progress with our highly promising TNFR2 program, and ultimately our goal of addressing hard-to-treat autoimmune diseases,” added Wouter Verhoeven, CEO of Dualyx. Dualyx was founded two years ago by CSO Luc Van Rompaey, in a collaborative model with Wurzburg University, Argenx, VIB, Ghent University and KU Leuven. The company has been supported to date by a EUR 7 million seed round from V-Bio Ventures, BGV, PMV, VIB, HTGF, and GFF. *ENDS* Contact UsDualyxWouter Verhoevencontact@dualyx.com Consilium Strategic CommunicationsLucy Featherstone, Kris LamDualyx@consilium-comms.com About DualyxDualyx is a Ghent-based biotech company dedicated to the development of novel Treg based therapies to address the needs of patients with difficult-to-treat autoimmune diseases. The company was founded in 2020 by Luc van Rompaey in a collaborative model with Wurzburg University, Argenx, VIB, Ghent University and KU Leuven. Dualyx has developed a pipeline of highly promising immune modulating programs including DT-001, an antibody agonist program targeting the TNF receptor 2 (TNFR2) which is currently in IND-enabling studies. TNFR2 is widely regarded as a master control switch in for immunosuppression, making it highly attractive for Treg therapies. Dualyx also has a pipeline of additional Treg programs in early development. Dualyx is backed by a group of well-respected investors including: Fountain Healthcare Partners, Forbion, Andera Partners, V-Bio Ventures, BGV, PMV, VIB, HTGF and GFF. About Fountain Healthcare PartnersFountain Healthcare Partners is a European life science focused venture capital fund with over EUR 300 million under management. Within the life science sector, specific areas of interest to Fountain include biotechnology, medical devices, specialty pharma and diagnostics. Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain’s main office is in Dublin, Ireland, with a second office in New York. www.fh-partners.com About ForbionForbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages €3 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 95 companies across 8 funds. Forbion’s record of sourcing, building and guiding life sciences companies has resulted in many breakthrough therapies and valuable exits. Portfolio company successes include NewAmsterdam Pharma (NASDAQ: NAMS), Gyroscope (acquired by Novartis) and Replimune (NASDAQ: REPL). Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. About Andera PartnersCreated over 20 years ago, Andera Partners is a major player in private company investments in France and internationally. Its teams manage over €3.8 billion in investments in life sciences (Andera Life Sciences), growth and buyout capital (Andera MidCap, Andera Expansion, Andera Croissance, Andera Co-Invest), sponsorless transactions (Andera Acto) and ecological transition (Andera Infra). Based in Paris, with offices in Antwerp, Milan, and Munich, Andera Partners is wholly owned by its teams, which count nearly 100 professionals, of which 60 are investment professionals. It is structured as a partnership and managed by a board of 12 partners. Responsible and committed, the management company regularly forms partnerships with non-profit sector entities and takes concrete action in the fight against global warming. Andera’s 15-person life sciences team brings together extensive experience in the life sciences industry, private equity and venture capital. Active since 2000, the team has raised over €1.1 billion through its BioDiscovery family of funds and is currently investing from its new BioDiscovery 6 fund. Since inception, the BioDiscovery funds have invested in more than 75 European and U.S. biotech and medtech companies. Further information: www.anderapartners.com.

WOBURN, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced that members from the Replimune management team will host investor meetings at the Piper Sandler Spring Biopharma Symposium being held from Wednesday, May 17 through Thursday, May 18, 2023 at the Encore Boston Harbor in Boston, MA. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic mechanism of action (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment (TME) to ignite a strong and durable systemic response. This MOA is expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. Investor Inquiries Chris BrinzeyICR Westwicke339.970.2843chris.brinzey@westwicke.com Media InquiriesLissette SteeleVerge Scientific Communications202.930.4762 x 409lsteele@vergescientific.com