REPL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• We have been conducting a number of clinical trials of RP1, both as a monotherapy and in combination with anti-PD-1 therapy, with the goal of establishing a major skin cancer treatment franchise.

• The leading tumor specific cohort in the IGNYTE trial is our registration directed Phase 2 expansion cohort in anti-PD-1 failed cutaneous melanoma. The anti-PD-1 failed melanoma cohort from the IGNYTE trial includes 140 patients who received RP1 in combination with nivolumab. On August 6, 2026, we a…

• In November 2024, we announced submission of our first Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or the FDA, for TUDRIQEV in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containi…

• In August 2024, we announced the dosing of the first patient in the IGNYTE-3 trial, or the I-3 trial, a 2-arm randomized Phase 3 clinical trial with physician's choice of treatment as a comparator arm in anti-PD-1 failed melanoma patients. Overall survival is the primary endpoint, and the trial is e…

• In addition to our development of TUDRIQEV for melanoma, we also are studying the product for other indications. In our non-melanoma skin cancer, or NMSC, cohort of the IGNYTE trial, we provided a data update in December 2023 from the first 30 patients with at least 6 months of follow up including p…

相对上期删除的文字 · 来源:10-Q · 2026-02-03

• We are conducting a number of clinical trials of RP1, both as a monotherapy and in combination with anti-PD-1 therapy, with a focus on establishing a major skin cancer franchise, assuming approval of our product candidates by the U.S. Food and Drug Administration, or the FDA, and similar applicable …

• The leading tumor specific cohort in the IGNYTE trial is our registration directed Phase 2 expansion cohort in anti-PD-1 failed cutaneous melanoma. The anti-PD-1 failed melanoma cohort from the IGNYTE trial includes 140 patients who received RP1 in combination with nivolumab. The primary analysis by…

• In November 2024, we announced submission of our first Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or the FDA, for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously receive…

• We are interacting with the FDA during the review of the resubmitted BLA and, if approved, intend to bring RP1 to adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen who otherwise have limited treatment options. Without an approval of RP1 from this resu…

• In August 2024, we announced the dosing of the first patient in the IGNYTE-3 trial, or the I-3 trial, a confirmatory study design concept consisting of a 2-arm randomized Phase 3 clinical trial with physician's choice of treatment as a comparator arm in anti-PD-1 failed melanoma patients. With appro…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• There have been no changes in our internal control over financial reporting for the three months ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2026-02-03

• likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deterio…

• During the audit of our consolidated financial statements as of and for the year ended March 31, 2025, we identified material weaknesses in our internal control over financial reporting whereby we did not design and maintain effective information technology (“IT”) general controls for information sy…

• The material weaknesses identified did not result in any material misstatements in our interim condensed or annual consolidated financial statements or disclosures; however, they could result in misstatements impacting substantially all accounts or disclosures in the annual consolidated or interim c…

• Management, with the oversight of the audit committee of the board of directors, is committed to maintaining a strong internal control environment. Management has expended, and will continue to expend, a substantial amount of effort and resources for the remediation of the previously identified mate…

• •Engaging an external advisor to assist with documenting and testing the design and operating effectiveness of internal control over financial reporting and assist with the remediation efforts, as necessary;

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• On August 6, 2026, a class action complaint alleging violations of the federal securities laws was filed against the Company and its directors and certain officers in the District of Massachusetts. The complaint, captioned Toor v. Replimune Group, Inc. et al., Case No. 1:26-cv-13612, alleges essenti…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• •our ability to successfully commence and achieve commercial sales of TUDRIQEV in the U.S. for its approved indication;

• •our ability to successfully complete one or more confirmatory trials of TUDRIQEV, including our ongoing IGNYTE-3 clinical trial, as well as our other post marketing requirements and commitments;

• Our near-term prospects are wholly dependent on TUDRIQEV. We have no experience with the commercialization of TUDRIQEV, and if we are unable to successfully commercialize TUDRIQEV in the U.S. for its approved indication, our ability to generate meaningful revenue or achieve profitability will be mat…

• In August 2026, we received FDA approval to commercialize TUDRIQEV in combination with nivolumab in the U.S. for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with an anti-PD-1 antibody-based regimen, and we are preparing to initiate a comm…

• TUDRIQEV is our only product approved for marketing by the FDA, and our ability to generate revenue from product sales and achieve profitability is wholly dependent on our ability to successfully commercialize TUDRIQEV in the U.S. for its approved indication. We may not be able to successfully comme…

相对上期删除的文字 · 来源:10-Q · 2026-02-03

• Our product candidates are in various stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable. We have never generated any revenue from product sales and may never be profitable.

• All of our product candidates are in research or development. We have not generated any revenues from the sale of any product. Our lead product candidate, RP1, and any other product candidates will require extensive preclinical and/or clinical testing and regulatory review prior to approval and comm…

• the product has a clinical benefit. Even if accelerated approval is granted, payors, including governmental payors, may be less welling to provide sufficient reimbursement for products approved via accelerated approval;

• We previously submitted a BLA to the FDA for our lead product candidate, RP1. Earlier this year, the FDA accepted our BLA and granted priority review with a PDUFA action date of July 22, 2025. On July 21, 2025 the FDA issued a CRL stating it was not able to approve the BLA for RP1 in its present for…

• Our ability to market, sell, distribute, obtain acceptable reimbursement for, set pricing for, and continue to operate and develop RP1 may be further delayed, adversely affected or prevented altogether. If we discontinue the development of RP1 we may be forced to implement a restructuring plan, whic…

相对上期新增的文字 · 来源:10-Q · 2026-08-14

• None of our directors or officers adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” in each case as defined in Item 408 of Regulation S-K, during the three months ended June 30, 2026.

相对上期删除的文字 · 来源:10-Q · 2026-02-03

• During the three months ended December 31, 2025, the following officer and/or director adopted a “Rule 10b5-1 trading arrangement” (as defined in Item 408 of Regulation S-K) and/or have a Rule 10b5-1 trading arrangement that entered an active trading period that is intended to satisfy the affirmativ…

• Aggregate Number of Shares of Common Stock to be Purchased or Sold Pursuant to Trading Arrangement

• (1) Date of adoption of Rule 10b5-1 trading arrangements is in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations.

• (2) The first trade pursuant to the Rule 10b5-1 trading arrangement will be, in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations, on a date after the date of adoption of the Rule 10b5-1 trading arrangement.

• (3) The Rule 10b5-1 trading arrangement permits transactions through and including the earlier to occur of (a) the completion of all sales or (b) the date listed in the table. The arrangement also provides for automatic expiration in the event of bankruptcy, insolvency, death or mental incapacity of…