Replimune Group, Inc. (REPL)
Replimune Group (Nasdaq: REPL) is a clinical-stage biotech focusing on a library of oncolytic immunotherapies leveraging a proprietary HSV-1 platform. Its lead product, RP1, is in Priority Review with the FDA, with a PDUFA target of July 22, 2025, for accelerated approval in anti-PD-1-failed mela...
Replimune Group, Inc. (REPL) Annual 10-K Review and Analysis
In a Nutshell
Replimune Group, Inc. (Nasdaq: REPL) is a clinical-stage biotech company focused on developing a platform of “armed” oncolytic immunotherapies. Its lead candidate, RP1, is a modified herpes simplex virus designed to kill tumors directly and spark systemic anti-tumor immune responses. Replimune has advanced RP1 into pivotal studies in anti-PD-1-failed melanoma and non-melanoma skin cancers and has filed a BLA for accelerated approval in the anti-PD-1-failed melanoma setting, with a PDUFA target of July 22, 2025.
Warren.AI 💰 1 / 10
The company reported a widening net loss of $247 million for FY 2025, up 15% year-over-year, reflecting higher R&D and SG&A costs as it ramps trials, builds its commercial readiness, and operates its in-house manufacturing facility. Cash, cash equivalents, and short-term investments totaled $484 million at March 31, 2025—enough to fund operations into Q4 2026 under current burn projections.
Investment Score: 6.7/10
Replimune’s oncolytic platform is differentiated and synergizes with PD-1 blockers, but it remains in a high-risk clinical stage. Near-term catalysts include the July 2025 PDUFA for RP1 in anti-PD-1-failed melanoma and Phase 3 confirmatory trial starts. The balance sheet is solid for another ~18 months of operations, but additional funding will be needed to complete pivotal studies and prepare commercial launch.
Key Financial Metrics (FY 2025 vs. FY 2024)
| Metric | FY 2025 | FY 2024 | Change |
|---|---|---|---|
| R&D Expenses | $189.4 M | $175.0 M | +8% |
| SG&A Expenses | $72.2 M | $59.8 M | +21% |
| Net Loss | $(247.3) M | $(215.8) M | –15% |
| Cash & Short-Term Investments | $483.8 M | $545.2 M | –11% |
| Working Capital | $456.5 M | $517.6 M | –12% |
| Runway (est.) | Q4 2026 | — | — |
R&D Expenses (+8%)
• Headcount and personnel costs increased to staff ongoing registration-directed and signal-finding programs, including RP1 pivotal cohorts, RP2 uveal melanoma, HCC, and RP3 research.
• In-house manufacturing facility costs kicked in, adding facility depreciation, quality, and supply chain expenses.
• Continued preclinical and protocol development for next-generation candidates.
SG&A Expenses (+21%)
• Pre-commercial readiness: headcount growth in finance, legal, commercial planning and corporate functions.
• Public company costs: audit, tax, investor relations, corporate governance and insurance.
• Business development and partner management spend to support BMS, Roche, Regeneron, and potential future collaborations.
Other Income, Net (–24%)
• Investment income fell 10% on lower yields despite higher average deployed balances.
• Interest expense on the $210 M term loan under the Hercules facility rose 28% as draws increased.
• U.K. R&D tax credit receipts dipped as a percentage of R&D spend.
Net Loss (–15%)
• Net loss widened to $247 M, or $3.21 per share, reflecting the above expense trends partially offset by other income.
Liquidity & Capital Resources
• Cash Position: $111.8 M in cash & equivalents; $372.0 M in short-term investments.
• Working Capital: ~$456.5 M as of 3/31/2025.
• Runway: Management guidance indicates funding into Q4 2026 under existing plan.
• Debt: $210 M in term loans (Hercules), bearing interest at ~10%, with principal payments beginning in October 2026.
• Recent Financing: $96.7 M raised via a July 2024 private placement; ~$42 M raised in ATM sales to date.
Use of Funds
• RP1 BLA submission and priority review ($~20 M)
• Phase 3 confirmatory programs in melanoma (~$100 M)
• RP2 registrational studies (uveal melanoma, HCC) (~$80 M)
• In-house manufacturing operations and scale-up (~$25 M)
• Corporate overhead & pre-commercial launch build (~$40 M)
Capital Need
• Additional financing likely required in late 2026 to fund trial readouts, potential commercial build, and working capital.
Clinical & Regulatory Milestones
RP1 (Vusolimogene Oderparepvec)
• BLA Filed (11/2024) in anti-PD-1 failed melanoma under accelerated approval; accepted with Priority Review; PDUFA July 22, 2025.
• Breakthrough Therapy Designation from FDA.
• Data Highlights (Ignyte): 33.6% ORR, median DOR >21.6 months; efficacy in prior PD-1 and CTLA-4 failures.
• Phase 3 (I-3): Randomized, physician’s choice comparator in anti-PD-1/CTLA-4 failed melanoma; >100 sites, 400 patients; first patient dosed 8/2024; enrollment ongoing.
• Skin Cancer Cohorts: NMSC cohort (CSCC, MCC, BCC) ~30% ORR; transplant recipient monotherapy trial (ARTACUS) ~35% ORR; no graft rejections.
RP2
• Mechanism: Anti-CTLA-4 expression + HSV-1 + fusogen.
• Phase 1/2 (mUM): 29.4% ORR in metastatic uveal melanoma with monotherapy/PD-1 combo; 12- to 21-month DOR.
• Phase 2/3 (Reveal): Checkpoint inhibitor–naïve mUM vs. ipilimumab/nivolumab; enrollment underway.
• Phase 2 (HCC): 2L trial with atezo/bev in collaboration with Roche; underway.
RP3
• Additional co-stimulatory ligands (CD40L, 4-1BBL) plus anti-CTLA-4 and fusogen.
• Development de-prioritized; opportunity for later re-launch.
Key Risks & Considerations
- Clinical & Regulatory: Success depends on pivotal trial readouts and FDA decisions. PDUFA in July 2025 is a key near-term catalyst.
- Funding: Runway into Q4 2026; additional financing needed to complete registrational programs and launch preparations.
- Manufacturing: In-house facility mitigates CMO risk, but commercial-scale validation, cGMP compliance and cost efficiency must be proven.
- Competition: Other oncolytic and immuno-oncology platforms, including viral therapies and checkpoint blockers, intensifying.
- Commercial Execution: If approved, Replimune must build or partner for sales, reimbursement, and clinician adoption.
- Intellectual Property: Patents granted in U.S., EU, Japan; ongoing challenges against IP remain a risk.
- Valuation: Shares trade at ~2.5x cash; a premium on potential value but sensitive to clinical and regulatory outcomes.
Final Thoughts
Replimune’s novel oncolytic immunotherapy platform is a compelling complement to the checkpoint inhibitor era. RP1’s strong durability signals in anti-PD-1 failures and the compelling Phase 3 design make it a high-impact near-term opportunity. Balanced against the capital-intensive nature of pivotal trials, commercial scale-up and the need for further data, we assign Replimune a 6.7/10 investment score. Near-term execution against the July 2025 PDUFA, Phase 3 enrollment, and efficient capital allocation will be critical to realizing value.