MA Biotech Reports Positive Meeting with FDA
Research Report

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Disclosures for Roth MKM, Replimune Group Inc., September 9, 2024

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Disclosures: ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report 

Roth MKM analyst Dr. Benjamin Paluch, in a research report published on September 9, 2024, provided an update on Replimune Group Inc. (REPL:NASDAQ) following the company's announcement of a successful pre-Biologics License Application (BLA) meeting with the FDA. The analyst maintained a Buy rating and a 12-month price target of US$17.00 on the stock.

Replimune announced that the pre-BLA meeting sets up a BLA submission for RP1 in the second half of 2024 for accelerated approval.

Paluch stated, "We are incrementally positive on Replimune's announcement of a positive Pre-BLA Meeting with the FDA this morning. We continue to believe RP1 will get accelerated approval and have a successful launch in anti-PD1 failed melanoma in late 2025."

The analyst believes there is significant unmet need in anti-PD1 failed melanoma despite the recent accelerated approval of Iovance's Lifileucel. "Lifileucel is geared towards younger, fitter patients that can tolerate lymphodepletion, TIL infusion and IL-2. We believe this leaves open the opportunity for RP1 to address older, less fit anti-PD1 failed melanoma patients," Paluch noted.

Replimune's strategic focus includes advancing RP1 for various indications, including anti-PD1 failed melanoma, first-line cutaneous squamous cell carcinoma, and solid organ transplant recipients with skin cancer. The company is also developing RP2 for second-line metastatic uveal melanoma and anti-PD1/PD-L1 progressed hepatocellular carcinoma.

Roth MKM's valuation methodology for Replimune is based on a sum-of-the-parts approach. "Our US$17 price target is based on sum-of-the-parts valuation using 3x sales multiple on risk-adjusted peak sales and 9% WACC, consistent with industry norms," Paluch explained. The valuation includes specific allocations for various indications and pipeline assets.

With a Buy rating and a price target of US$17.00, representing a potential return of approximately 64% from the price at the time of the report of US$10.37, Roth MKM sees significant upside potential for Replimune.

Paluch concluded, "We continue to believe RP1 will have a successful launch in late 2025 for anti-PD1 failure melanoma combined with nivolumab."