Appointed
Michael Goller
member of the Board
REPL ·
Replimune Group, Inc.
appointed Michael Goller to the Board, effective immediately.
Ready 8-Ks
50
Latest filing
June 29, 2026, 8:11 AM ET
Top materiality
0.95
Event mix
earnings ×16 · other_material ×14 · regulatory ×10
Sentiment
17 pos · 6 neg · 27 neu
Latest earnings
reported 2026-Q3
Executive change
recent →
Recent 8-K filings for REPL
Highest-materiality recent filing
FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back
- FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.
- Without timely accelerated approval, further development of RP1 not viable; company eliminating jobs and scaling back U.S. manufacturing.
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Replimune reports Q4 loss of $73.7M; FDA accepts RP1 BLA resubmission for advanced melanoma
Net loss $73.7M in Q4 FY2026; full-year net loss $313.9M.
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FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; decision by Aug 2
FDA accepted as complete, class 1 response; PDUFA goal date August 2, 2026.
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Replimune to resubmit RP1 BLA for advanced melanoma; FDA agrees to prioritize review
Company will resubmit BLA in coming days after collaborative FDA dialogue aligns on path forward.
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FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back
FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.
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Replimune Q3 net loss $70.9M; cash $269.1M; RP1 BLA PDUFA date April 10, 2026
Cash, cash equivalents, and short-term investments $269.1M as of Dec 31, 2025; cash runway extended late into Q1 2027.
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Replimune files updated corporate presentation for J.P. Morgan; exhibit content not available
Company released updated corporate presentation on January 12, 2026.
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Replimune reports Q2 net loss $83.1M; FDA accepts RP1 BLA resubmission with PDUFA April 10, 2026
Cash, equivalents and investments $323.6M at Sep 30, 2025, down from $483.8M at Mar 31, 2025.
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FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; PDUFA April 10, 2026
FDA accepted resubmission of BLA for RP1 plus nivolumab in advanced melanoma patients who progressed on anti-PD-1 therapy.
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Replimune completes Type A FDA meeting for RP1 BLA in melanoma; path forward uncertain
Completed Type A FDA meeting on Sept 16, 2025 regarding CRL for RP1+nivolumab BLA in advanced melanoma.
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Replimune schedules Type A meeting with FDA to discuss RP1 CRL; program viability at risk
FDA Type A meeting scheduled to discuss CRL for RP1 BLA in advanced melanoma; briefing submitted with additional analysis.
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Replimune reports Q1 FY2026 net loss $86.7M; FDA issues CRL for RP1 BLA
Net loss of $86.7M for quarter ended June 30, 2025, vs $53.8M a year ago.
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Replimune receives FDA Complete Response Letter for RP1 BLA in advanced melanoma
FDA issues CRL for RP1 + nivolumab; IGNYTE trial deemed not adequate/well-controlled.
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Replimune hosts Investor Day on June 24, 2025; updated presentation posted online
Investor Day webcast and updated presentation deck available under Events and Presentations on company website.
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Replimune Q4 net loss $74.1M; RP1 BLA on track for July 22 PDUFA
Net loss Q4 $74.1M, FY $247.3M; cash $483.8M, runway into Q4 2026 excluding revenue.
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Replimune appoints Michael Goller to board; enters registration rights with BBA Funds
Michael Goller appointed to Board on March 5, 2025; board expanded to 10 members.
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Replimune Q3 net loss $66.3M; FDA accepts RP1 BLA with priority review, PDUFA July 22
FDA accepted BLA for RP1+nivolumab in advanced melanoma with Priority Review; PDUFA date July 22, 2025.
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FDA accepted BLA for RP1 (vusolimogene oderparepvec) plus nivolumab for advanced melanoma; granted Priority Review.
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Replimune closes $155.8M public offering of stock and pre-funded warrants
Offering of 6,923,000 common shares at $13.00 and 3,846,184 pre-funded warrants at $12.9999 each, raising ~$155.8M net.
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Replimune prices upsized public offering of ~$140M; 6.9M shares + pre-funded warrants
Offering includes 6,923,000 common shares at $13.00/share and pre-funded warrants for 3,846,184 shares at $12.9999 each.
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Replimune reduces ATM offering capacity from $100M to $89M, suspends sales
Aggregate offering amount cut from $100M to $89M via Amendment No. 2 dated Nov 25, 2024.
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BLA submitted to FDA for RP1 (vusolimogene oderparepvec) + nivolumab in advanced melanoma patients previously treated with anti-PD1.
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Replimune reports Q2 FY2025 net loss $53.1M; BLA for RP1 in melanoma on track before year-end
Completed pre-BLA meeting with FDA; BLA submission for RP1+nivolumab in anti-PD1 failed melanoma via accelerated approval path on track by end of 2024.
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Replimune shareholders elect three Class III directors and ratify auditor at annual meeting
Class III directors elected: Sushil Patel (54.6M for), Dieter Weinand (46.9M for), Madhavan Balachandran (54.6M for).
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Replimune Q1 FY2025: $53.8M net loss, $469.1M cash; RP1 BLA on track for 2H 2024
Net loss $53.8M for Q1 ended June 30, 2024, up from $49.6M YoY; R&D expenses $43.0M versus $40.4M.
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Replimune raises $100M in PIPE to fund RP1 commercialization; BLA filing on track for 2H 2024
Issued 5.67M shares at $8.82/share and 5.67M pre-funded warrants at $8.819/warrant.
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Primary analysis shows ORR 33.6% (modified RECIST 1.1) and 32.9% (RECIST 1.1) by independent central review; all responses >6 months, median DOR >35 months.
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Replimune presents positive RP1/RP2 data at ASCO: 32.7% ORR in melanoma, BLA on track for 2H 2024
RP1+nivolumab in anti-PD-1 failed melanoma (n=156) showed 32.7% ORR by investigator; median duration of response >36 months.
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Replimune posts Q4 net loss $55.1M; RP1 melanoma BLA on track for 2H 2024
Net loss of $55.1M for Q4 FY2024; full-year net loss $215.8M vs $174.3M prior year.
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Replimune names Sushil Patel CEO effective April 1; Astley-Sparke becomes Executive Chairman
Dr. Sushil Patel appointed CEO effective April 1, 2024; previously Chief Strategy Officer.
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Replimune reports Q3 FY2024 net loss $51.1M; cash $466.4M; RP1 BLA plan for 2H 2024
Net loss of $51.1M for Q3 FY2024, up from $39.7M in prior year; R&D expenses $42.8M vs $30.3M.
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Replimune reports ~$466M cash, runway into 2H 2026; updates RP1/RP2 clinical data
Preliminary cash and equivalents of ~$466M as of Dec 31, 2023; funds operations into second half of 2026.
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Replimune amends Hercules loan: extends revenue milestone to 2026, adjusts tranches up to $50M
Second tranche cut from $45M to $15M (funded Dec 22, 2023); third tranche raised to $30M, extended to Mar 2025.
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Replimune CERPASS trial misses primary endpoints; BLA for RP1 in melanoma planned 2H 2024
CERPASS trial of RP1+cemiplimab in CSCC did not meet primary endpoints; CRR 38.1% vs 25% (p=0.040 just below threshold).
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Replimune Q2 FY2024 net loss $60M; cash $496.8M; RP1 data and new CFO announced
Net loss of $60.0M for Q2 ended Sep 30, 2023, compared to $43.1M loss a year ago.
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Replimune names Emily Hill as CFO; previously CFO of PTC Therapeutics
Appointed Emily Hill as CFO effective Sept 18, 2023; she was previously CFO of PTC Therapeutics.
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Replimune stockholders elect two Class II directors, ratify PwC as auditor
Paolo Pucci elected with 25,146,894 votes for and 21,307,605 withheld; 5,424,721 broker non-votes.
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Replimune Q1 net loss $49.6M; CERPASS data delayed to early Q4; inks Incyte CSCC trial
Net loss $49.6M in fiscal Q1 vs $42.3M a year ago; cash $539.1M provides runway into H2 2025.
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Replimune enters $250M at-the-market equity agreement with Leerink, cancels prior $100M ATM
New Sales Agreement with Leerink Partners allows sale of up to $250M of common stock via ATM or negotiated transactions.
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Sander Slootweg to leave Replimune board at 2023 annual meeting
Sander Slootweg, founder/managing partner at Forbion, will not stand for reelection at the upcoming annual meeting.
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Replimune appoints Veleka Peeples-Dyer to Board of Directors, effective June 1, 2023
Veleka Peeples-Dyer appointed to Board as tenth member, filling vacancy from Board size increase.
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Replimune reports Q4 FY2023 net loss $49.2M, CFO Franchi resigns, cash $583.4M into H2 2025
Q4 net loss $49.2M, FY net loss $174.3M vs $118.0M prior year; R&D spend $126.5M up 59% YoY.
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Replimune provides FDA update on CERPASS trial; no changes to protocol or endpoints
FDA agreed no changes to CERPASS clinical trial protocol or data analysis plan after meeting.
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Replimune Q3 net loss $39.7M; cash $616M; RP1 melanoma achieves 36% ORR in IGNYTE cohort
Net loss $39.7M for fiscal Q3 ended Dec 31, 2022 vs $29.7M YoY; R&D expenses rose to $30.3M.
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Chris Sarchi, former Sanofi U.S. Commercial Oncology Head, named Chief Commercial Officer.
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Replimune prices $225M public offering of common stock and pre-funded warrants
Offering of 5.37M shares at $23.50/share and pre-funded warrants for 4.20M shares at $23.4999/warrant.
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Replimune reports 36% ORR in anti-PD1 failed melanoma; enters Roche collaboration for RP2/3
Collaboration with Roche to develop RP3 with atezolizumab/bevacizumab in 3L CRC and 1L/2L HCC; cost sharing; Phase 2 start H1 2023.
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Replimune Q2 net loss $43.1M; CERPASS enrollment complete, cash runway extended into 2025
Net loss of $43.1M for Q2 FY2022 (vs $29.4M in Q2 FY2021); R&D expenses $28.8M.
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Replimune secures $200M non-dilutive debt facility from Hercules Capital
$200M term loan; $30M funded at closing, $30M available by Sep 30, 2023.
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Replimune holds annual meeting; elects directors, ratifies PwC as auditor
Philip Astley-Sparke elected with 31,308,902 votes for, 5,731,814 withheld, 7,702,397 broker non-votes.
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Replimune Q1 net loss $42.3M; CERPASS trial hits 180-patient enrollment target
Cash & short-term investments $395.1M as of June 30, 2022, vs $395.7M at March 31, 2022.
Executive changes
Role change
Paul Bullock
chief manufacturing officer
REPL ·
Replimune Group, Inc.
Paul Bullock, the Company’s current senior vice president, operations and Framingham site head, is being promoted to the Company’s chief manufacturing officer effective April 1, 2024
Role change
Dr. Sushil Patel
chief executive officer
REPL ·
Replimune Group, Inc.
Dr. Sushil Patel, the Company’s current chief strategy officer, has been appointed as the Company’s chief executive officer, effective as of April 1, 2024
Role change
Dieter Weinand
lead independent director of the Board
REPL ·
Replimune Group, Inc.
Dieter Weinand, the Company’s current chair of the Board, will transition into the newly created role of the lead independent director of the Board
Role change
Tanya Lewis
advisor
REPL ·
Replimune Group, Inc.
Tanya Lewis, the Company’s current chief development operations officer, will leave their executive positions and plan to continue to lend their functional expertise in an advisory capacity
Role change
Philip Astley-Sparke
executive chairman of the Board
REPL ·
Replimune Group, Inc.
Philip Astley-Sparke, the Company’s current chief executive officer, will transition to the role of executive chairman of the Board
Departed
Dr. Colin Love
chief operating officer
REPL ·
Replimune Group, Inc.
Dr. Colin Love, the Company’s current chief operating officer, will retire from the Company, effective May 31, 2024
Appointed
Emily Hill
Chief Financial Officer
REPL ·
Replimune Group, Inc.
On September 19, 2023, Replimune Group, Inc. (“Replimune”) announced the appointment of Emily Hill as its Chief Financial Officer.
Departed
Sander Slootweg
Director
REPL ·
Replimune Group, Inc.
On July 14, 2023, Sander Slootweg, a member of the Board of Directors (the “Board”) of Replimune Group, Inc. (the “Company”), notified the Board that he will not stand for reelection at the Company’s 2023 annual meeting of stockholders (the “Annual Meeting”), and therefore his service as a director of the Company will end at the conclusion of the Annual Meeting.
Appointed
Veleka Peeples-Dyer
Director
REPL ·
Replimune Group, Inc.
On June 1, 2023, based on the recommendation of the Nominating and Corporate Governance Committee of the Board of Directors (the "Board") of Replimune Group, Inc. (the "Company"), the Board appointed Veleka Peeples-Dyer to serve as a member of the Board, effective immediately.
Departed
Jean Franchi
Chief Financial Officer
REPL ·
Replimune Group, Inc.
Jean Franchi has resigned from her position as the Company’s Chief Financial Officer, effective as of June 2, 2023
Appointed
Andrew Schwendenman
Chief Accounting Officer
REPL ·
Replimune Group, Inc.
the Board of Directors of the Company designated Andrew Schwendenman, the Company’s former Vice President of Finance, to serve as the Company’s Chief Accounting Officer effective as of May 18, 2023
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.95 · Median 0.70 · Most common event earnings