Replimune Group, Inc. (REPL) SEC Filings & Earnings Calls

Commercialization risk

“We may not be able to successfully commercialize TUDRIQEV for a number of reasons, including: we may not be able to establish or demonstrate in the medical community the safety and efficacy of TUDRIQEV” · word for word

Accelerated approval withdrawal risk

“If we fail to complete IGNYTE-3 or any other required post-approval study with due diligence, if any such study fails to verify and describe the predicted clinical benefit of TUDRIQEV or if other evidence demonstrates that TUDRIQEV is not shown to be safe or effective under the conditions of use, the FDA may withdraw approval of TUDRIQEV” · word for word

Dependence on third-party drug supply

“We have entered into agreements with BMS for the supply of nivolumab... If we are unable to source a supply of an acceptable alternative anti-PD-1 therapy, or are unable to do so on commercially reasonable terms, our business... may be materially harmed.”

Financial risk

“We will be required to obtain additional funds to complete clinical trials and prepare for possible commercialization of our product candidates.” · word for word

Confirmatory trial risk; accelerated approval may be withdrawn if clinical benefit not verified.

“Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).” · word for word

Dilution risk from equity offering; share count increases significantly.

“Issuance of 9,701,490 shares and pre-funded warrants for 2,736,340 shares.”

Continued approval contingent on confirmatory trial verification

“Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)” · word for word

BLA resubmission still subject to FDA final decision; advisory committee vote is non-binding

“Advisory Committee vote is advisory; FDA final decision pending”

Regulatory risk: FDA advisory committee meeting outcome uncertain; potential for non-approval or delayed approval.

“Advisory committee meeting scheduled; FDA review recommended approval but final decision pending.”

FDA regulatory risk for lead product candidate

“On June 30, 2026, the Compensation Committee discussed the series of complete response letters (CRLs) issued by the Food and Drug Administration (FDA) in connection with the Company’s Biologics License Application (BLA) for RP1” · word for word

Dilution risk from authorized share increase

“to approve an amendment to the Third Amended and Restated Certificate of Incorporation of the Company to increase the number of authorized shares of common stock, par value $0.001 per share, from 150,000,000 shares to 300,000,000 shares” · word for word

Pre-commercial stage with significant net losses

“Net Income (in millions) $ -313.9 for FY2026”

Cash burn and no revenue; depends on regulatory approval and commercial launch.

“Cash runway into Q1 2027; net loss widened to $313.9M.”

Clinical and regulatory risk; BLA decision and advisory committee meeting pending.

“FDA advisory committee meeting expected in late July 2026.”

Regulatory approval risk for RP1

“On April 10, 2026, the FDA issued a second CRL in connection with our BLA for RP1 for the treatment of advanced melanoma.” · word for word

Cash runway and going concern risk

“Without a near-term accelerated approval of our BLA for RP1 plus nivolumab for the treatment of advanced melanoma, we may be required to initiate a further reduction in our workforce.” · word for word

Dependence on single product candidate

“Our lead product candidate, RP1, and any other product candidates require extensive preclinical and/or clinical testing and regulatory review from the FDA prior to approval and commercial use.” · word for word

Pricing and reimbursement pressure

“Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy.” · word for word

Regulatory risk: FDA may not approve RP1; advisory committee outcome uncertain

“The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.” · word for word

Clinical trial risk: reliance on IGNYTE trial data for accelerated approval

“The resubmission seeks accelerated approval of RP1 in advanced melanoma based on data from the IGNYTE clinical trial” · word for word

Regulatory risk remains as BLA resubmission still requires FDA approval; no guarantee of success.

“Forward-looking statements caution about FDA review outcomes.”

FDA regulatory setback with second CRL for lead product candidate RP1

“FDA has issued a second Complete Response Letter regarding the BLA for RP1” · word for word

Company viability risk as development of RP1 will not be viable without accelerated approval

“Without timely accelerated approval, the development of RP1 will not be viable” · word for word

Workforce reduction and manufacturing scale-back

“We have no choice but to eliminate jobs, including substantially scaling back our U.S. based manufacturing operations” · word for word

Regulatory risk: RP1 BLA under FDA review with PDUFA date of April 10, 2026; no guarantee of approval

“The Company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026.” · word for word

Regulatory approval risk for RP1

“On July 21, 2025 the FDA issued a CRL stating it was not able to approve the BLA for RP1 in its present form.” · word for word

No revenue from product sales

“We have never generated any revenue from product sales and may never be profitable.” · word for word

Dependence on third-party drug supply

“Our ability to develop and ultimately commercialize our product candidates used in combination with nivolumab, cemiplimab, atezolizumab, bevacizumab or any other checkpoint blockade therapy will depend on our ability to access such drugs on commercially reasonable terms.” · word for word

Forward-looking statements; no specific risk signals in excerpt

“Boilerplate safe harbor language.”

Clinical and regulatory risk; cash runway only into late Q4 2026

“Cash runway into late Q4 2026; no approved products; net loss $83.1M”

Regulatory approval failure for lead candidate RP1

“On July 21, 2025 the FDA issued a CRL stating it was not able to approve the BLA for RP1 in its present form.” · word for word

Dependence on third-party drug supply for combination trials

“Our ability to develop and ultimately commercialize our product candidates used in combination with nivolumab, cemiplimab, atezolizumab, bevacizumab or any other checkpoint blockade therapy will depend on our ability to access such drugs on commercially reasonable terms for the clinical trials and their availability for use with the commercialized product, i” · word for word

History of losses and need for additional financing

“We have never generated any revenue from product sales and may never be profitable.” · word for word