MA Biotech Co. Downgraded to Sell After Second FDA CRL for RP-1 Melanoma BLA
Research Report

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Disclosures for H.C. Wainwright & Co., Replimune Group Inc., April 13, 2026

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility. RETURN ASSESSMENT Market Outperform (Buy): The common stock of the company is expected to outperform a passive index comprised of all the common stock of companies within the same sector. Market Perform (Neutral): The common stock of the company is expected to mimic the performance of a passive index comprised of all the common stock of companies within the same sector. Market Underperform (Sell): The common stock of the company is expected to underperform a passive index comprised of all the common stock of companies within the same sector. Rating and Price Target History for: Replimune Group, Inc. (REPL-US) as of 04-10-2026 25 20 15 10 5 0 Q1 Q2 Q3 2024 Q1 Q2 Q3 2025 Q1 Q2 Q3 2026 Q1 Q2 BUY:$50.00 02/10/23 BUY:$51.00 06/05/23 BUY:$50.00 08/07/23 BUY:$48.00 11/13/23 BUY:$10.00 12/08/23 BUY:$12.00 02/15/24 BUY:$17.00 06/07/24 BUY:$21.00 01/22/25 BUY:$22.00 02/13/25 NEUTRAL:NA 07/23/25 BUY:$12.00 10/27/25 Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months. Distribution of Ratings Table as of April 10, 2026 IB Service/Past 12 Months Ratings Count Percent Count Percent Buy 555 83.08% 159 28.65% Neutral 62 9.28% 10 16.13% Sell 1 0.15% 0 0.00% Under Review 50 7.49% 15 30.00% H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Robert Burns and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Replimune Group, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of March 31, 2026 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Replimune Group, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

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Published April 13, 2026, H.C. Wainwright & Co. analysts Robert Burns and Raghuram Selvaraju, Ph.D. downgraded Replimune Group Inc. (REPL:NASDAQ) to Sell from Buy and removed their price target, citing a second FDA Complete Response Letter (CRL) for the company's lead asset RP-1 that has materially extended — and potentially eliminated — the drug's path to market.

Late last week, Replimune announced that the FDA issued a second CRL in response to the company's resubmitted Biologics License Application (BLA) for RP-1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma patients. The development caught the market off guard, as the FDA had previously characterized the BLA resubmission as a comprehensive response to the first CRL issued in July 2025. The second CRL cited three principal concerns: the inability to isolate RP-1's individual contribution when administered in combination with nivolumab; heterogeneity in the patient population that prevented adequate interpretation of results; and the absence of a well-established historical control limiting response rate comparisons.

The analysts expressed concern that the issues raised — particularly the inability to isolate RP-1's contribution — will likely extend to the ongoing Phase 3 IGNYTE-3 trial evaluating RP-1 plus Opdivo versus the physician's treatment choice, meaning that the trial may ultimately face the same regulatory obstacles. The analysts stated that it "may take until late in this decade" to furnish the agency with the data it appears to be demanding, and cautioned that "there can be no assurance that Replimune would be able to accomplish this."

With no product revenue projected through at least fiscal year 2027, Replimune continues to operate as a pre-commercial entity. The company reported a net loss of US$247.3 million for fiscal year 2025 and is projected to widen its loss to approximately US$307.7 million in fiscal year 2026, before improving modestly to approximately US$250.3 million in fiscal year 2027. Research and development expenses are expected to remain the dominant cost driver, projected at approximately US$219.3 million in fiscal year 2026 and US$187.2 million in fiscal year 2027. On the balance sheet, Replimune held approximately US$269.1 million in cash against US$46.0 million in total debt as of the report date, providing some near-term runway but a limited cushion given the extended development timeline now anticipated.

The analysts withdrew their prior discounted cash flow (DCF)-based valuation, which had incorporated an 85% probability of approval for RP-1, a 12% discount rate, and a 29% effective tax rate. With the price target removed entirely, the firm cited the substantive likelihood that "the FDA remains antipathic to Replimune's attempts to secure RP1 approval" as the basis for suspending formal valuation. REPL shares were trading at US$4.76 at the time of the report, well below the 52-week high of US$13.24, with a 52-week low of US$2.68.

Upside risks identified by the analysts include the possibility of an unexpectedly short timeline for resubmission, FDA willingness to accept incremental clinical data in support of approval, a near-term positive regulatory decision, and favorable data from Replimune's early-stage pipeline of oncolytic virus (OV) candidates.