UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 3, 2026
REPLIMUNE GROUP, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38596 | 82-2082553 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
500 Unicorn Park Drive
Suite 303
Woburn, MA 01801
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (781) 222-9600
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | REPL | The Nasdaq Stock Market LLC (Nasdaq Global Select Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 1.01 | Entry into a Material Definitive Agreement. |
On January 29, 2026 (the “Third Amendment Closing Date”), Replimune Group, Inc. (the “Company”) and certain subsidiaries of the Company (collectively, the “Borrowers”) entered into a Third Amendment to Loan and Security Agreement (the “Amendment”) with Hercules Capital, Inc. (“Hercules”), in its capacity as administrative agent and collateral agent (the “Agent”), and certain other financial institutions that from time to time may become parties to the Loan Agreement as lenders (collectively, the “Lenders”), pursuant to which the Company, Hercules, and the Lenders agreed to amend the Loan and Security Agreement dated October 6, 2022 (as amended by that First Amendment to Loan and Security Agreement dated as of June 28, 2023, and that Second Amendment to Loan and Security Agreement dated as of December 22, 2023, collectively the “Loan Agreement”) to, among other things, extend the revenue milestone date thereunder to September 30, 2027.
Pursuant to the Amendment, (i) the third loan tranche advance under the Loan Agreement was increased from $30 million to $35 million and the availability of the tranche was extended until June 15, 2026, (ii) the fourth tranche advance under the Loan Agreement was decreased from $50 million to $30 million and the availability of the tranche was extended until September 30, 2026 or sixty (60) days following the achievement of the approval milestone, (iii) the availability of the fifth tranche advance under the Loan Agreement of $50 million was extended until December 31, 2027 or sixty (60) days following the achievement of the revenue milestone, and (iv) the sixth tranche advance under the Loan Agreement was increased from $25 million to $40 million, each subject to the terms and conditions thereof. In addition, the interest rate was amended to be equal to the greater of either (i) 8.50% and (ii) the Prime Rate (as defined in the Loan Agreement) plus 1.75%, and the amortization date was extended from October 1, 2026 to October 1, 2027. The third loan tranche advance of $35 million was funded on the Third Amendment Closing Date.
The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2025.
| Item 2.02 | Results of Operations and Financial Condition. |
On February 3, 2026, the Company issued a news release announcing its financial results for the third fiscal quarter ended December 31, 2025 and certain corporate updates. A copy of the news release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly stated by specific reference in such filing.
| Item 2.03 | Creation of a Direct Financial Obligation or an Obligation Under an Off-Balance Sheet Arrangement of a Registrant. |
The foregoing description in Item 1.01 above with respect to the Amendment is incorporated into this Item 2.03 by reference. This description is qualified in its entirety by reference to the full text of the Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2025.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | News Release dated February 3, 2026. | |
| 104 | Cover page interactive data file (formatted as Inline XBRL). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| REPLIMUNE GROUP, INC. | ||
| Date: February 3, 2026 | By: | /s/ Sushil Patel |
| Sushil Patel | ||
| Chief Executive Officer | ||
Exhibit 99.1
Replimune Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update
April 10, 2026 Target Action Date for RP1 in Advanced Melanoma
Woburn, MA, February 3, 2026 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2025 and provided a business update.
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. Commercial readiness activities are well underway to support a potential launch, if approved.
The Company has amended its existing loan agreement with Hercules Capital, Inc. The amendment included the draw down of $35 million upon closing and the potential to draw another $120 million at post approval milestones. The amendment also delays the repayment of debt from 2026 to 2027. The Company has extended its cash runway late into the first quarter of 2027.
“We have been engaged with the FDA in the review of the BLA resubmission for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. “Advanced melanoma patients can progress quickly and are in urgent need of safe and effective treatment options. Our team remains ready to launch RP1 with commercial supply produced and the commercial organization prepared to engage with our target accounts rapidly, assuming FDA approval.”
Program Highlights & Milestones
RP1 (vusolimogene oderparepvec)
| • | IGNYTE-3 Confirmatory Study: The global Phase 3 trial will enroll approximately 400 patients and is assessing RP1 in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate. |
| • | Acral Melanoma: Recent data for RP1 plus nivolumab was recently presented at the ESMO Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events. |
| • | Advanced Non-melanoma Skin Cancer (NMSC) Studies: Additionally, a poster from ESMO featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing, however, enrollment was stopped in Q4 2025. |
| • | ARTACUS Study: Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22nd International Congress. RP1 monotherapy showed robust anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate was 23.1%) and 2-year duration of response of 61.0%. RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers. |
RP2
| • | REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027, with PFS analysis potentially supporting accelerated approval. |
| • | Liver-focused Studies: The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol was amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also has enrolled its first patients in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab. |
Financial Highlights
| • | Cash Position: As of December 31, 2025, cash, cash equivalents and short-term investments were $269.1 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans. |
| Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations late into the first quarter of calendar 2027. This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue. |
| • | R&D Expenses: Research and development expenses were $53.1 million for the fiscal third quarter and $48.0 million for the fiscal third quarter ended December 31, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025. |
| • | S,G&A Expenses: Selling, general and administrative expenses were $18.7 million for the fiscal third quarter ended December 31, 2025, as compared to $18.0 million for the fiscal third quarter ended December 31, 2024. Selling, general and administrative expenses included $3.4 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025. | |
| • | Net Loss: Net loss was $70.9 million for the fiscal third quarter ended December 31, 2025 and $66.3 million for the fiscal third quarter ended December 31, 2024. |
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About RP2
RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 53,140 | $ | 48,004 | $ | 168,860 | $ | 135,472 | ||||||||
| Selling, general and administrative | 18,728 | 18,015 | 77,721 | 46,827 | ||||||||||||
| Total operating expenses | 71,868 | 66,019 | 246,581 | 182,299 | ||||||||||||
| Loss from operations | (71,868 | ) | (66,019 | ) | (246,581 | ) | (182,299 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 341 | 376 | 1,138 | 1,222 | ||||||||||||
| Investment income | 2,846 | 5,137 | 11,256 | 15,243 | ||||||||||||
| Interest expense on finance lease liability | (514 | ) | (528 | ) | (1,553 | ) | (1,594 | ) | ||||||||
| Interest expense on debt obligations | (1,466 | ) | (1,450 | ) | (4,429 | ) | (4,314 | ) | ||||||||
| Other (expense) income, net | (580 | ) | (3,281 | ) | (865 | ) | (850 | ) | ||||||||
| Total other income (expense), net | 627 | 254 | 5,547 | 9,707 | ||||||||||||
| Loss before income taxes | $ | (71,241 | ) | $ | (65,765 | ) | $ | (241,034 | ) | $ | (172,592 | ) | ||||
| Income tax (benefit) provision | $ | (311 | ) | $ | 575 | $ | (311 | ) | $ | 575 | ||||||
| Net loss | $ | (70,930 | ) | $ | (66,340 | ) | $ | (240,723 | ) | $ | (173,167 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.77 | ) | $ | (0.79 | ) | $ | (2.62 | ) | $ | (2.25 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 92,187,581 | 83,498,892 | 91,874,481 | 77,113,695 | ||||||||||||
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
(Unaudited)
| December 31, 2025 |
March 31, 2025 |
|||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 269,137 | $ | 483,804 | ||||
| Working capital | 230,267 | 433,518 | ||||||
| Total assets | 333,590 | 551,328 | ||||||
| Total stockholders' equity | 210,539 | 415,843 | ||||||