Short answer
Replimune Group, Inc. (REPL) filed its fiscal 2026 10-K annual report with the SEC on Jun 29, 2026.
- Top risk flagged: Regulatory risk FDA Biologics License Application for RP1: two CRLs issued (July 2025, April 2026), with FDA advisory committee meeting scheduled July 2026
FY2026 key financial metrics · XBRL
- Net income
- −$314M
- −26.9% YoY
- EPS (diluted)
- −$3.38
- −10.1% YoY
- ROE
- -188.9%
- −129.5 pp YoY
- Operating cash flow
- −$280M
- −45.8% YoY
Source: XBRL data from the Replimune Group, Inc. (REPL) FY2026 10-K on SEC EDGAR. USD.
Replimune Group, Inc. FY2026 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage biotech focused on oncolytic immunotherapy using engineered HSV-1 platform (RPx) to maximally activate systemic anti-tumor immune response
- FDA issued second Complete Response Letter for RP1 BLA in advanced melanoma; ongoing FDA collaboration and expedited Class 1 resubmission action date August 2, 2026
- Expanded pivotal RP1 development with Phase 3 IGNYTE-3 trial enrolling anti-PD-1 failed melanoma patients; complex FDA feedback on control arms and trial design
- Workforce reduced ~55% in April 2026 restructuring; 465 employees as of March 31, 2026, with 75% in R&D, reflecting operational scale-back risks
- RP2 advanced in metastatic uveal melanoma (mUM) with Phase 2/3 REVEAL trial targeting immune checkpoint inhibitor-naïve patients; additional signal-finding in liver cancers with Roche collaboration
Management Discussion & Analysis
- No product revenue, net loss $313.9M in 2026 vs $247.3M in 2025, operating expenses $319.9M vs $261.6M, loss from operations increased by $58.3M
- R&D expense $221.2M (+17%) driven by $59.8M RP1 and $26.0M RP2 costs; SG&A $98.7M (+37%), personnel costs main driver
- Best segment RP2 with $25.95M costs (up $13.9M); worst RP3 down $2.3M to $2.67M; RP1 increased $12.9M driven by IGNYTE-3 study
- Cash and investments $268.9M as of March 31, 2026; net cash used in operations $280.3M; financing activities provided $66.3M including $35.0M debt; capex approx. $4.2M
- Management expects operating losses into 2027; cash runway into Q1 2027; plans depend on FDA approval outcome for RP1; risks include need for additional financing and potential restructuring
Risk Factors
- Regulatory risk FDA Biologics License Application for RP1: two CRLs issued (July 2025, April 2026), with FDA advisory committee meeting scheduled July 2026
- Geopolitical threat Russia-Ukraine and Israel-Hamas conflicts causing potential supply chain disruptions and inflationary impacts on business
- Operational risk reliance on BMS, Roche for anti-PD-1 therapies (nivolumab, atezolizumab/bevacizumab) critical for combination trials and commercialization
- Competitive risk market competition with Amgen's T-Vec oncolytic immunotherapy and others with greater resources and faster development
- Financial risk net loss $313.9M FY 2026, accumulated deficit $1.26B, cash runway into Q1 2027 without additional financing
Generated from the filing text; verify against the original. How to read a 10-K
Ask about this 10-K
Compare years, dig into a risk factor or check the numbers against insider trades and fund holders.