Replimune Group, Inc. filings document regulatory, financing, governance and operating disclosures for a Nasdaq-listed clinical-stage biotechnology company focused on oncolytic immunotherapies. Recent Form 8-K reports cover FDA communications involving the RP1 Biologics License Application, including complete response letters and related Regulation FD disclosures.
The filing record also documents quarterly financial results, corporate presentation materials for RP1 and RP2 programs, amendments to the company’s loan and security agreement, and annual meeting voting results. These disclosures describe Replimune’s development-stage operating profile, capital structure arrangements, stockholder governance matters and material events tied to its cancer immunotherapy pipeline.
Replimune Group, Inc. filed Amendment No. 1 to a shelf registration statement, covering the potential offering of up to $250,000,000 of common stock, preferred stock, debt securities, warrants, and units, to be sold from time to time. The filing also includes a sales agreement prospectus for an at-the-market program of up to $100,000,000 of common stock under a Sales Agreement with Leerink Partners LLC, which is included within the $250,000,000 aggregate. The amendment adds Rule 473(b) language for automatic effectiveness 20 days after filing.
The company states it may use net proceeds to fund continued development of its RPx platform, including indication expansion with RP1 in skin cancer and broadening RP2 development, and for general corporate purposes. Any unsold portion of the $100,000,000 ATM may be offered under the base shelf via prospectus supplement. Replimune’s common stock trades on Nasdaq as REPL; the last reported sale price was $8.58 on November 5, 2025.
Replimune Group, Inc. furnished a current report describing that it issued a news release with its financial results for the second fiscal quarter ended September 30, 2025 and certain corporate updates. The news release is attached as Exhibit 99.1. The company clarifies that this earnings information, including Exhibit 99.1, is being furnished under the securities laws rather than filed, which limits how it is treated for certain liability and incorporation-by-reference purposes.
Replimune Group (REPL) filed its quarterly report, highlighting increased R&D investment and a larger net loss as it advances lead therapy RP1. For the quarter ended September 30, 2025, operating expenses were $84.3 million (R&D $57.9 million; SG&A $26.4 million), resulting in a net loss of $83.1 million, or $0.90 per share. Cash and cash equivalents were $102.3 million and short‑term investments were $221.3 million.
Total assets were $389.5 million and stockholders’ equity was $263.3 million. Net cash used in operating activities for the six months was $158.2 million, offset by $149.2 million provided by investing activities, ending with $104.0 million in cash, cash equivalents and restricted cash. Long‑term debt, net, was $47.2 million under the Hercules facility. The company stated its cash, cash equivalents and short‑term investments are expected to fund operations for at least 12 months from issuance of the statements. The FDA accepted the resubmission of the BLA for RP1 in combination with nivolumab in advanced melanoma, with a PDUFA date of April 10, 2026.
Replimune Group, Inc. (REPL) announced a key regulatory milestone. The FDA accepted the company’s resubmission of its Biologics License Application for RP1 in combination with nivolumab to treat patients with advanced melanoma. The FDA set a PDUFA date of April 10, 2026 based on a Class II resubmission timeline.
The acceptance confirms the application is filed for review and establishes a clear decision date. Replimune furnished a related news release as Exhibit 99.1. Outcomes will depend on the FDA’s review of the RP1 plus nivolumab data package.
Replimune Group, Inc. reported that it completed a Type A meeting with the U.S. Food and Drug Administration on September 16, 2025. The meeting focused on the company’s Biologics License Application for RP1 in combination with nivolumab to treat advanced melanoma.
The company is evaluating the FDA’s feedback from this meeting to determine its next steps for the RP1 program. A news release with additional details was issued on September 18, 2025 and is included as an exhibit to this report.
Replimune Group, Inc. filed an 8-K reporting stockholder voting results and a regulatory update. Stockholders cast tens of millions of votes for multiple director nominees, with each nominee receiving substantially more votes "for" than "withheld," such as Michael Goller with 62,116,691 votes for and 371,431 withheld.
The filing also lists vote counts on additional matters, including one item with 70,375,492 votes for and 142,326 against, and another with 61,212,356 votes for and 1,250,054 against. Separately, the company disclosed that a Type A meeting with the U.S. Food and Drug Administration has been scheduled, as announced in a news release furnished as Exhibit 99.1.
Emily Luisa Hill, Chief Financial Officer of Replimune Group, Inc. (REPL), reported the disposition of common stock on 08/15/2025. The filing shows 9,154 shares were sold at $5.37 per share to satisfy tax withholding associated with partial vesting of restricted stock units. After the sale, the reporting person beneficially owned 134,368 shares. The Form 4 notes the sale was executed under the award agreement's irrevocable "sell to cover" provision and was not a discretionary sale by the reporting person. The form was signed by an attorney-in-fact on 08/19/2025.