Form 8-K

8-K — Replimune Group, Inc.

Accession: 0001104659-26-088481

Filed: 2026-07-30

Period: 2026-07-30

CIK: 0001737953

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2621663d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2621663d1_ex99-1.htm)

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8-K — FORM 8-K

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0001737953

2026-07-30

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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): July 30, 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 7.01

Regulation FD Disclosure.

On July 30, 2026, Replimune Group, Inc. (the “Company”)

will attend a meeting with the U.S. Food and Drug Administration's (“FDA”) Cellular, Tissue, and Gene Therapies Advisory Committee

to discuss the Company’s Biologics License Application (“BLA”) resubmission for RP1 (vusolimogene oderparepvec) in combination

with nivolumab for the treatment of advanced melanoma. The Company has made available a copy of the presentation slides to be presented

at the meeting. The presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Company undertakes no obligation

to update, supplement or amend the materials attached hereto.

The information contained in this Item 7.01 and

in the accompanying Exhibit 99.1 shall not be incorporated by reference into any filing of the Company, whether made before or after the

date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such

filing. The information in this Item 7.01 and the accompanying Exhibit 99.1 shall not be deemed to be “filed” for purposes

of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections

11 and 12(a)(2) of the Securities Act of 1933, as amended.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.

Description

99.1

Company

Presentation dated July 30, 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: July 30, 2026

By:

/s/ Sushil Patel

Sushil Patel

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2621663d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

CC-1

Vusolimogene oderparepvec-wtpg (TUDRIQEV )

in Combination with Nivolumab for the Treatment of

Adults with Unresectable Advanced Cutaneous Melanoma

July 30, 2026

United States Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee

CC-2

Introduction

Kari Jeschke, MA

Senior Vice President, Regulatory Affairs, Replimune, Inc.

CC-3

Melanoma Community Support for Urgent Access to RP1

CC-4

TUDRIQEV is indicated in combination with nivolumab

for the treatment of adults with unresectable advanced cutaneous melanoma

who experienced disease progression

with an anti-programmed death receptor-1 (PD-1) based regimen

Proposed Indication Statement

CC-5

Favorable Benefit-Risk for Accelerated Approval

IGNYTE-3 randomized confirmatory trial ongoing with OS data expected in 2030

UNMET NEED: SERIOUS, LIFE-THREATENING DISEASE

EFFICACY

Adequate and

Well-controlled Trial

Supporting

Evidence

IGNYTE ORR: 33.6% (95% CI: 25.8, 42)

DoR: 24.8 months (95% CI: 14.1, NE)

MOA/Biological

Plausibility Preclinical Biomarkers

Well-tolerated

Safety Profile

IGNYTE Mainly Grade 1 and 2

No treatment-related Grade 5 SAFETY

CC-6

Melanoma Approvals Since Initiation of IGNYTE Study

1. NCCN Guidelines Version 2.2026 Melanoma: Cutaneous. MELSYS 2 of 10.

2. Ascierto PA, et al. J Clin Oncol. 2023 May 20;41(15):2724-35.

3. AMTAGVI USPI. 2024 Iovance Biotherapeutics, Inc.

Recent FDA Approvals Year Basis of Approval Relevance to RP1

Relatlimab + Nivolumab

(OPDUALAG) 2022

• Randomized controlled trial

• First-line treatment-naive patients

• Now included in NCCN guidelines1

for second line (ORR 9-12%)2

• Approved post IGNYTE

• >95% selected option for

IGNYTE-3 control arm

Lifileucel (AMTAGVI) +

IL-2 regimen 2024

• Single arm

• Previously treated with anti-PD-1

• ORR (31.5%, n=73);

combination regimen

with 7.5% mortality (n=160)3

• Precedent in similar setting

(PD-1 failed melanoma) with

single arm data

CC-13

Ongoing Collaboration with FDA through 2025

2021 2022 2023 2024 2025

Key alignments with FDA:

• Potential flexibility on single trial, pending compelling evidence (2021)

• Enroll real-world population (2021)

• RECIST 1.1 (2023)

• Analysis of all injected and non-injected lesions (2023)

• Literature to support contribution of effect (2023)

• IGNYTE-3 design (2023)

• SAP and Independent review charter for response assessment (2024)

Key alignments with FDA:

Type B Meeting -

IGNYTE:

Study design

(March)

Type C Meeting -

IGNYTE:

Preliminary

results &

IGNYTE-3 design

(September)

Pre BLA Meeting

(September)

Breakthrough

therapy

designation

(November)

Productive review cycle

>50 information

requests and near final

label (Jan-July)

Priority review

designation

(January)

CC-14

Initial FDA Clinical Review: Basis for Approval

FDA BLA Clinical Review and Evaluation, July 15 2025 (obtained by Replimune through Freedom of Information Act)

“…The reviewers acknowledge that the clinical benefit of VO in combination with

nivolumab is based on results from a single arm trial with inherited biases including

potential patient selection bias, like all single arm trials. However, with over 30

clinical information requests including 27 efficacy related clinical information

requests with over 136 questions, the reviewers did not find any study conduct

or data integrity issues.

The IGNYTE trial (RPL-001-16) Phase 2 portion is an adequate and

well-controlled trial which provides substantial evidence of effectiveness…”

CC-15

Initial FDA Clinical Review: Recommended RP1 for Approval

FDA BLA Clinical Review and Evaluation, July 15 2025 (obtained by Replimune through Freedom of Information Act)

“…Based on the IGNYTE trial results, a comprehensive literature review, the life-threatening condition

of the intended patient population, the absence of treatment with proven clinical benefit in the

standard of care setting, and the precedent cases using durable ORR to support drug approvals in this

population, the reviewers conclude that the efficacy and safety results from the IGNYTE trial

have demonstrated substantial evidence of effectiveness of VO. The benefits of VO, used in

combination with nivolumab, outweigh risks, representing an improvement over standard of care. The

benefit over risk profile of VO in combination with nivolumab is superior to lifileucel

treatment which is a multi-component regimen (preconditioning chemotherapy with

cyclophosphamide and fludarabine followed by infusions of lifileucel and up to 6 doses of high dose

IL-2) that is associated with high risks.

Therefore, the reviewers recommend for accelerated approval of VO, used in combinations

with nivolumab, for adult patients with confirmed disease progression on anti-PD-1 based therapy…”

CC-16

Regulatory Topics

CC-17

Relevance of MOA to Response Assessment

LOCAL IMMUNE EFFECT SYSTEMIC IMMUNE EFFECT

• Direct oncolytic virus-mediated tumor lysis attracts antigen-presenting cells

• Antigen-presenting cells internalize tumor antigens, leading to T cell activation

• Activated T cells traffic systemically, driving long-term durable responses in

both injected and non-injected tumors

CC-18

RECIST 1.1: Replimune vs. FDA Response Rate Analysis

*If corrected for denominator = 25% (FDA sensitivity analysis)

FDA ANALYSIS

N=22

N=0

ORR 15.7%*,

n/N=22/140

REPLIMUNE ANALYSIS

N=22

N=25

ORR 33.6%,

n/N=47/140

NON-INJECTED

TARGET LESION

ALL TARGET

LESIONS

INJECTED

Patients with all target lesions injected should be included

CC-19

Replimune Position: Response Assessment

FDA Issues from briefing document

FDA Issue Replimune Position

Application of RECIST 1.1

confounds interpretation

of efficacy results

“RECIST 1.1 specifies that

tumor lesions subjected to

loco-regional therapies are

generally not considered

measurable for response

assessment…”

• IGNYTE study - injected lesions should not be excluded because

the intervention is pre-specified in the protocol

– Protocol details the conditions under which such lesions would

be considered measurable (Eisenhauer 2009)

• RP1 has a dual mechanism of action that stimulates a systemic

T cell response to destroy injected and non-injected lesions

CC-20

Replimune Position: Response Assessment

1. FDA Type C meeting September 2023

FDA Issues from briefing document; BOR, best overall response; IRC, independent review committee

FDA Issue Replimune Position

Other confounding factors:

Patient-by-patient analysis confirms appropriate response assessment

– Per protocol

– Blinded independent review

– Confirmed by initial FDA clinical review team

Retreatment • Aligned with FDA on approach for treatment beyond progression1

• Protocol allows retreatment when in best interest of patients

Surgical procedures

• Majority were biomarker biopsies per protocol; protocol also allows tumor

resections to confirm response

• No evidence biopsies result in any clinically meaningful tumor reduction

Non-evaluable assessments • Limited number of non-evaluable assessments were handled per charter

• Investigator assessment confirms these did not impact BOR

Changes based on pathology • Protocol and RECIST allows determination of response by pathology and histology

• Complete responses were durable

CC-21

Replimune Position: Contribution of Effect

FDA Issues from briefing document

1. NCCN, SITC, Ribas

FDA Issue Replimune Position

“Objective response data from

the single-arm IGNYTE study is

not of sufficient magnitude to

overcome concerns about the

contribution of effect,

particularly in the absence of

a reliable historical control…"

• ORR of 33.6% (CR 16.4%) in IGNYTE is nearly 5x expected response

for nivolumab alone and supports contribution of effect

• FDA previously agreed to the use of literature to provide

historical controls

• Existing literature and expert opinions indicate patients who have

definitively progressed on a prior anti-PD-1 are unlikely to respond

to further anti-PD-1 monotherapy - yielding a 5-7% response rate1

• FDA patient-by-patient analysis (July 2025) concluded prior

anti-PD-1 exhaustion

CC-22

What You Will Hear Today

Dual mechanism of action

Kevin Harrington, MD, PhD, FRCP, FRCR, FRSB

Professor of Biological Cancer Therapies

Institute of Cancer Research

Mechanism

of Action

Michael Wong, MD, PhD, FRCPc

Clinician, IGNYTE Study Advisory Board

Former Physician in Chief, Roswell Park Cancer Center

Unmet

Need

Fills an unmet need

Treats a serious,

life-threatening condition

Kostas Xynos, MD, PhD, MBA

Chief Medical Officer, Replimune, Inc.

Clinical

Data

Substantial evidence

of effectiveness

Favorable safety profile

Mohammed Milhem, MBBS

Professor of Internal Medicine

Former Div. Chair and Holden Chair for Experimental Therapeutics

Div. of Hematology and Oncology, University of Iowa

Positive benefit risk

for approval

Clinical

Perspective

CC-23

Additional Experts

RECIST/ itRECIST Greg Goldmacher

Chief Scientific & Medical Officer, Perceptive Inc.

Melanoma Oncologist

Nikhil Khushalani

Vice Chair for the Department of Cutaneous Oncology,

Moffitt Cancer Center

Melanoma Oncologist

Yana Najjar

Associate Professor of Medicine and Director of the Clinical

and Translational Research Center, UPMC Hillman Cancer Center

IGNYTE Response Assessment Steven Soignet

Medical Director, Clario

Senior Biostatistician Martin Roessner

Corporate Vice President Biostatistics, Parexel International

CC-24

RP1 Mechanism of Action and

Biological Plausibility

Kevin Harrington, MD, PhD, FRCP, FRCR, FRSB

Professor of Biological Cancer Therapies

Institute of Cancer Research

CC-25

Dual MOA Drives Local and Systemic Antitumor

Immune Responses

1. Thomas S, et al. J Immunother Cancer. 2019;7(1):214.

RP1 is an HSV-1 based oncolytic viral immunotherapy that expresses

GM-CSF and a fusogenic glycoprotein GALV-GP-R1

1LOCAL IMMUNE EFFECT 2 SYSTEMIC IMMUNE EFFECT

Oncolytic

Immunotherapy Dysregulated host antiviral response allows

robust virus replication and tumor lysis

recruits antigen-presenting cells that migrate

to draining lymph nodes to prime T cells

Healthy tissue Tumor tissue

Local inflammation

Altering of tumor

microenvironment

Tumor cell death and

release of tumor antigens

Release of virus progeny

Infection of more

tumor cells

T cell infiltration and killing of

distant, non-injected tumors

Generating a strong and

durable systemic antitumor

immune response

Enhanced T cell

priming and activation

Dendritic cell

T cell

CC-26

RP1 Combined with Anti-PD-1 Enhances

Systemic Anti-tumor Activity

mRP1=mouse RP1

Thomas et al. JITC 2019

Injected

Tumor

Un-injected

Tumor

Tumor Diameter (mm)

Vehicle Anti-PD1

0/10 regress 0/10 regress

0 5 10 15 20 25 30 35 40

Study Day Study Day

Virus 16 (mRP1)

5 x 106 pfu

Virus 16 (mRP1)

5 x 106 pfu +anti-PD-1

5/10 regress 8/10 regress

6/10 regress 7/10 regress

0 5 10 15 20 25 30 35 40

Study Day Study Day

Anti-PD1-insensitive A20 Lymphoma Mouse Model

CC-27

• Lack of T cell, PD-L1 expression and IFN gamma are known to be the resistance mechanisms

of anti-PD-1 treatment1

• Patients who have drug holiday before progression on anti-PD-1: retreatment may be effective

– Tumor microenvironment may still be immunologically active/sensitive

– Memory CD8+ T cells can be reactivated

• Patients who progress while on anti–PD-1: retreatment is minimally effective

– Tumor microenvironment is immune-suppressive, with low or absent T cell infiltration

and PD-L1 expression

– Low IFN-γ signature

– Low antigen presentation

Mechanisms of Resistance to Anti-PD-1:

Why Further Treatment is Minimally Effective

PMID: 29360728; 1. Nowiciki et al. Cancer J 2018

IGNYTE trial enrolled patients who progressed while on treatment with anti-PD-1

CC-28

RP1+Nivolumab Increases CD8+ T Cells

and PD-L1 Levels in IGNYTE Patients

1. Data on file

Additional analysis confirmed responding lesions exhibit significantly higher

CD8+ and PD-L1 at Day 43 vs. screening (compared to lesions that do not respond)1

1. Data on file

Patient 2 (Responder)

SCREENING

DAY 43

Reversal of immune exclusion

CD8+ T cell (1x) PD-L1 (1x)

Reversal of immune desert

CD8+ T cell PD-L1

Patient 1 (Responder)

CC-29

RP1 + Nivolumab Reprograms the Tumor Microenvironment

(TME) in IGNYTE Melanoma Patients

P Value by Mann-Whitney U Test (Wilcoxon rank-sum test).

D, day; DAPI, 4′,6-diamidino-2-phenylindole; FOXP3, forkhead box P3; nivo, nivolumab; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; Scr, screening; SOX10, SRY-box transcription factor 10;

TME, tumor microenvironment.

Screening:

Day 43:

SOX10

FOXP3

DAPI

PD-L1

CD8

PD-1

CD68

8 paired biopsies

SCR D43

Cell percentage (%)

Visit

SCR D43

H-score

Visit

300

200

100

SCR D43

H-score

Visit

100

PD-L1 total cells in tumor

SCR D43

H-score

Visit

200

150

100

CD8+ T cells in tumor

PD-L1, CD8+ T cells in tumor PD-L1, CD68+ in tumor

p=0.001 p=0.001

p=0.064 p=0.001

CC-30

Melanoma: Unmet Need and

Treatment Paradigm

Michael Wong, MD, PhD, FRCPc

Clinician, IGNYTE Study Advisory Board

Former Physician in Chief, Roswell Park Cancer Center

CC-31

• In the US, 110,000 new melanoma cases with ~8,500 related deaths

projected in 20261

• 50% of advanced melanoma patients progress in the first 12 months2,3

• Real-world 5-year OS among patients with distant metastatic

disease is only 35%1

Significant Unmet Need Exists for Advanced Melanoma

1. American Cancer Society 2026

2. Tawbi 2022

3. Robert 2015

CC-32

Limited Options Post Immune Checkpoint Inhibitor (ICI)

Progression in Advanced Melanoma

Neoadjuvant/

Adjuvant/

First line • Pembrolizumab (Keytruda)

• Nivolumab (Opdivo)

• Ipilimumab (Yervoy)

• Ipilimumab + Nivolumab

• Relatlimab/Nivolumab (Opdualag)

Monotherapy Combinations

CC-33

Limited Options Post Immune Checkpoint Inhibitor (ICI)

Progression in Advanced Melanoma

Neoadjuvant/

Adjuvant/

First line • Pembrolizumab (Keytruda)

• Nivolumab (Opdivo)

• Ipilimumab (Yervoy)

• Ipilimumab + Nivolumab

• Relatlimab/Nivolumab (Opdualag)

Monotherapy Combinations

Progression on

Anti-PD-1 Based

Regimen Lifileucel (AMTAGVI) + IL-2 is the only “FDA approved” treatment

for anti-PD-1 failed therapy. Other combination treatments per NCCN

Combinations

On progression

CC-34

Lifileucel (AMTAGVI) is the Only FDA Approved Agent

for Anti-PD-1 Failed Melanoma

AMTAGVI (lifileucel) [package insert]; initial approval 2024

Lifileucel (AMTAGVI)

Efficacy (ORR)

• 31.5% (4.1% CR)

• (n=73, primary efficacy data set)

Safety (Gr3+) • 7.5% treatment-related mortality (n=160)

Considerations

• Multi-component approach: involving surgery, chemotherapy

(fludarabine + cyclophosphamide), TIL infusion, high-dose IL-2

• Average time to TIL generation ~34 days (1 month)

CC-35

NCCN Recommendations:

PD-1 Retreatment Unlikely to Show Benefit

“if a patient experienced progression of melanoma during or

shortly after a systemic therapy, rechallenge with the

same therapy or a therapy of the same class is unlikely

to yield a response and is not recommended.”

-NCCN Guidelines Version 2.2026. Melanoma: Cutaneous

CC-36

Options Following Progression on

Monotherapy Anti-PD-1 Progression

1. VanderWalde et al 2023 Nat Med. 2023 Sep;29(9):2278-85;

2. Ascierto et al RELATIVITY-020 trial. J Clin Oncol. 2023 May 20;41(15):2724-35.

On progression

28% ORR1

57% Grade 3+ toxicity

9-12% ORR2

~15% Grade 3+ toxicity

Anti-PD-1

Ipilimumab + Anti-PD-1 OR Relatlimab + Nivolumab

CC-37

Options Following Progression on

Combination Immune Checkpoint Inhibitor (ICI)

1. Ascierto et al RELATIVITY-020 trial. J Clin Oncol. 2023 May 20;41(15):2724-35;

2. Menzies et al 2022 N Engl J Med. 2022;386(17):1668-9

Ipilimumab + Anti-PD-1

Relatlimab + Nivolumab

9-12% ORR1

~15% Grade 3+ toxicity

Relatlimab + Nivolumab

Ipilimumab + Anti-PD-1

11% ORR2

Grade 3+ toxicity not reported

On progression

Clinical Trial

CC-38

• Based on the RELATIVITY-020 study a 9-12% ORR is a reasonable

benchmark for the IGNYTE study data

• Limited existing options have significant toxicity and/or modest

response rates

• Unmet need remains significant for patients who have failed anti-PD-1

based treatments

Summary

CC-39

IGNYTE Study: Anti-PD-1 Failed

Cutaneous Melanoma

Kostas Xynos, MD, PhD, MBA

Chief Medical Officer, Replimune, Inc.

CC-40

IGNYTE Phase 2 Study Design:

Anti–PD-1 Failed Cutaneous Melanoma Cohort

CRR, complete response rate; DCR, disease control rate; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death

protein-1; PFS, progression-free survival; PFU, plaque-forming units; Q4W, every 4 weeks; RECIST, Response Evaluation Criteria in Solid Tumors.

a. Nivolumab was given every 2 weeks (Q2W) from Cycle 2-9. b. RP1 can be reinitiated beyond 8 cycles if protocol-specified criteria are met.

Anti–PD-1–failed

cutaneous melanoma

cohort

N=140

• Anti–PD-1–failed advanced

melanoma

• Measurable disease

• Adequate organ function

• No prior oncolytic therapy

• ECOG performance status 0–1

Screening First dose RP1

1×106 pfu/mL

RP1+nivolumaba

1×107 pfu/mL, 240 mg

Nivolumab

240 mg

Nivolumab

480 mg (Q4W)

100-day

safety

follow-up

Cycle 1 Cycles 2–8 Cycle 9 Cycles 10–30b

Tumor response assessment: Radiographic imaging (CT) at baseline and every 8 weeks from first dose

Biopsy assessment: Day 1 and Day 43 biomarker analysis and confirmation of response were allowed

Primary endpoint:

• ORR by Independent Review per RECIST 1.1 (conducted when all patient had potential

for at least 12 months follow up)

Secondary endpoints:

• DOR, CRR, DCR, PFS, and OS

2 Weeks 2 Weeks 2 Weeks

3-year follow-up from last patient enrolled

28 Days

CC-41

Strict Criteria to Ensure Patients who are Enrolled

Definitively Failed Anti–PD-1 Therapy

1. FDA clinical review, July 15, 2025

• Minimum exposure requirement: ≥8 weeks;

96% of patients received ≥12 weeks

• Anti–PD-1 therapy required as the immediate

prior line of treatment

• Confirmed progression while on

anti-PD-1 treatment

• Confirmation based on two assessments ≥4

weeks apart

FDA and Sponsor concurred that patients had sufficient exposure

and exhaustion to prior anti-PD-1 therapy1

Adequate Prior Exposure

to Anti-PD-1 Therapy

Confirmation of

Disease Progression

CC-42

Baseline Clinical Characteristics: A Real-World Population

Data cutoff: October 15, 2024. a Primary resistance: immediate prior anti-PD-1 exposure ≥6 weeks and best response of PD or SD for <6 months. b Secondary resistance: immediate prior anti-PD-1 exposure ≥6 months

and best response of CR, PR, or SD for >6 months .

CTLA-4, cytotoxic T-lymphocyte antigen 4; LDH, lactate dehydrogenase; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; ULN, upper limit of normal.

Patients

N=140

n (%)

Age, median (range), years 62 (21–91)

Sex

Female 45 (32.1)

Male 95 (67.9)

Stage

IIIB/IIIC/IVM1a 72 (51.4)

IVM1b/c/d 68 (48.6)

BRAF status

Wild-type 87 (62.1)

Mutant 53 (37.9)

LDH level

LDH ≤ULN 92 (65.7)

LDH >ULN 47 (33.6)

Unknown 1 (0.7)

Patients

N=140

n (%)

PD-L1 tumor expression

Positive (≥1%) 45 (32.1)

Negative (<1%) 78 (55.7)

Undetermined or missing 17 (12.1)

Prior therapy

Anti–PD-1

Anti–PD-1 only as adjuvant therapy 36 (25.7)

Anti–PD-1 as advanced/metastatic therapy 104 (74.3)

Anti–CTLA-4

Anti–PD-1 combined with anti–CTLA-4 61 (43.6)

Anti–PD-1 treated with anti–CTLA-4 sequentially 4 (2.9)

BRAF/MEK therapy 17 (12.1)

Anti–PD-1 resistance category by SITC

Primary resistancea 100 (71.4)

Secondary resistanceb 40 (28.6)

CC-43

Efficacy

CC-44

Clinically Meaningful Responses Observed

in Anti-PD-1–Refractory Melanoma Population (IGNYTE Study)

Overall Response

Rate (ORR)

Complete Response

(CR)

Partial Response

(PR)

Stable Disease

(SD)

Percent (%)

33.6%

16.4% 17.1%

21.4%

n=47 n=23 n=24 n=30

Data Cutoff: October 15, 2024

Median time to response:

3.9 months

CC-45

Only 5-7% ORR Expected with Further Anti-PD-1 Monotherapy

Following Definitive Progression

Ribas A, et al. Lancet Oncol. 2018;19(5):e219;

Kluger HM, et al. J Immunother Cancer. 2020;8(1):e000398.

RP1 + Nivo

(IGNYTE)

SITC Monotherapy Guidelines

(Kluger 2020)

PD-1 Monotherapy

(Ribas 2018)

Percent (%)

<5%

33.6%

>25% increase

CC-46

RELATIVITY-020 is a Reasonable Benchmark

for Magnitude of Effect

Ascierto PA, et al. J Clin Oncol. 2023;41(15)2724-35.

≤5%

RP1 + Nivolumab

(IGNYTE)

Nivolumab + Relatlimab

(RELATIVITY-020*)

Percent (%)

>20% increase

33.6%

9-12%

Similar study design

• Prospective study with

broadly comparable

resistant-disease populations

• Prior lines of therapy include

anti-PD-1, CTLA-4, and BRAF

• ≥50% of patients received

≥2 prior lines of therapy

• Stage IV disease (~90%

in RELATIVITY-020 and 84%

in IGNYTE non-adjuvant)

• Rare subtypes included

CC-47

RP1+ Nivolumab Delivers Meaningful Responses

Across Clinically Relevant Subgroups

Data cutoff: October 15, 2024

Centrally reviewed RECIST 1.1 responses; all patients have ≥12 months follow-up

All patients 140 33.6 (25.8, 42.0)

Agent Single-agent anti-PD-1 75 40.0 (28.9, 52.0)

Anti–PD-1/CTLA-4 65 26.2 (16.0, 38.5)

Stage Stage IIIb-IVM1a 72 41.7 (30.2, 53.9)

Stage IVM1b-d 68 25.0 (15.3, 37.0)

Resistance Primary resistance 100 34.0 (24.8, 44.2)

Secondary resistance 40 32.5 (18.6, 49.1)

Adjuvant

Status

Anti–PD-1 adjuvant 36 44.4 (27.9, 61.9)

Anti–PD-1 not adjuvant 104 29.8 (21.2, 39.6)

LDH Level

≤ULN 92 37.0 (27.1, 47.7)

>ULN 47 25.5 (13.9, 40.3)

Tumor

Burden

≤10 cm 106 37.7 (28.5, 47.7)

>10 cm 34 20.6 (8.7, 37.9)

0 20 40 60 80

15%

FDA approved statistical analysis plan (SAP) required 95% CI to exclude 15% ORR,

which was achieved for the primary analysis of ORR and for key clinical subgroups

n Confirmed ORR (95% CI)

CC-48

ORR (95% CI) was 33.6% (25.8%, 42.0%), and the median DOR (95% CI) was 24.8 months (14.8, NE)

Durable Response Supports Systemic Benefit

Cutoff: March 8, 2026.

CI, confidence interval; DOR, duration of response; nivo, nivolumab; NE, not estimable; ORR, objective response rate; RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1.

DOR rates, % (95% CI)

1-year 72.3 (56.2, 83.3)

2-year 51.4 (35.0, 65.5)

3-year 44.8 (28.5, 59.8)

RP1 + nivo 47 47 40 35 29 26 25 20 18 17 15 13 10 8 8 8 7 3 3 2

0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

Probability of Ongoing Response

Median (95% Cl), months

24.8 (14.8, NE)

Time (months) Number of patients at risk:

1-year DOR rate

72.3%

2-year DOR rate

51.4% 3-year DOR rate

44.8%

RP1 + nivo

Censored +

Note: Data previously not submitted to FDA

CC-49

3-Year Overall Survival Among All Patients

Data cutoff: March 8, 2026.

CI, confidence interval; nivo, nivolumab; OS, overall survival.

RP1 + nivo

Censored +

Probability of OS

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

Time (months)

0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63 66 69

1-year OS rate

75.3%

2-year OS rate

61.5%

3-year OS rate

47.8%

Median (95% Cl), months

32.9 (25.8, 46.0)

OS rates, % (95% CI)

1-year 75.3 (66.9, 81.9)

2-year 61.5 (52.4, 69.4)

3-year 47.8 (38.6, 56.5)

Number of patients at risk:

RP1 + nivo 140 127 116 104 95 86 83 77 71 66 60 52 49 31 22 18 15 13 11 6 4 2 2 0

Median PFS (95% CI) per RECIST 1.1 by Independent Review was 3.6 months (2.0, 5.0);

34.9 months (22.0, NE) for responders

CC-50

Clinical Safety Data

CC-51

Overview of Safety for RP1 in Combination with Nivolumab

*Includes reports of disease progression=8, death=1, head injury=1, multiple organ disfunction=1, myocardial infarction=1.

Patients with:

N=140

n (%)

Any TEAE 137 (97.9)

Any SAE 50 (35.7)

Any TEAE with outcome of death* 12 (8.6)

Any TEAE of CTCAE Grade 3 or higher 44 (31.4)

Any TEAE leading to dose interruption of RP1 or nivolumab 32 (22.9)

Any TEAE leading to discontinuation of RP1 11 (7.9)

CC-52

Adverse Events Occurring in >10% of Patients (Excluding

Laboratory-Related Adverse Events) – IGNYTE Study (N=140)

* A composite that includes multiple related terms

Data cutoff: October 15, 2024

None of the common

adverse events were

Grade 4 or 5

0.7

1.4

2.1

1.4

11.4

12.1

12.9

15.7

16.4

17.1

17.9

18.6

20.0

26.4

28.6

29.3

30.7

32.1

38.6

45.0

Dyspnea*

Skin/superficial infection*

Dizziness

Decreased appetite

Constipation

Arthralgia*

Rash*

Pruritus

Vomiting

Cough*

Headache

Asthenia*

Influenza like illness*

Injection site reaction*

Nausea

Diarrhea*

Musculoskeletal pain*

Chills

Pyrexia*

Fatigue

All Grades

Grade 3

CC-53

Fatal Events Considered Possibly Related by FDA:

Pooled Safety Analysis (N=335)

Data cutoff: October 15, 2024

MCC, Merkel cell carcinoma; CSCC, cutaneous squamous cell carcinoma; NMSC, non-melanoma skin cancer

Related to

RP1/Nivolumab

Patient

ID Age/Sex Cohort (Malignancy) Preferred Term Investigator Sponsor

1 70/M Anti-PD-1 Failed

Cutaneous Melanoma Myocardial infarction (G5) N/N N/N

2 44/M Anti-PD-1 Failed

Cutaneous Melanoma Multiple organ dysfunction syndrome (G5) N/N N/N

3 78/M Anti-PD-1 Failed NMSC

(MCC) Capillary leak syndrome (G5) Y/Y N/N

4 87/M Anti-PD-1 Naive NMSC

(CSCC) Immune-mediated myocarditis (G5) N/Y N/Y

5 90/M Anti-PD-1 Failed NMSC

(CSCC) Pneumonia (G5) N/N N/N

6 75/M Anti-PD-1 Failed NMSC

(NMSC)

Tumor hemorrhage (G3)

Disease progression (G5) N/N N/N

7 72/M Anti-PD-1 Naive NMSC

(CSCC)

Pulmonary sepsis (G3)

Malignant neoplasm progression (G5) N/N N/N

CC-54

Assessment of Topics of Interest

• Contribution of Effect

• Response Assessment

CC-55

Patients Serving as Their Own Control Analysis

Supports the Contribution of Effect (IGNYTE Study)

Replimune data on file. ORR analysis includes non-adjuvant patients only (cannot assess prior response to adjuvant treatment) n=104 for all patients and n=31 for responders.

Patient Population

Time on Prior

Treatment Months

(Range)

ORR on Prior PD-1

Based Therapy

% (n; 95% CI)

ORR

During IGNYTE

% (n; 95% CI)

All Patients (N=104)

Non-adjuvant

5.6

(2.1, 60.0)

11.5%

(12; 6.1-19.3)

29.8%

(31; 21.2-39.6)

Responders Only (N=31)

Non-adjuvant

5.6

(3.5, 46.9)

12.9%

(4; 3.6-29.8)

100%

(31; 88.8-100)

Contribution of Effects

CC-56

Durability Supports Systemic Impact

in IGNYTE Study

*If corrected for denominator = 25% (FDA sensitivity analysis)

NE, not evaluable

NR, not reached

Responder

(n/N)

ORR

(95% CI)

DOR, months

(95% CI)

Patients who

had all target

lesions

injected

25/51 49.0

(34.8, 63.4)

(25.6, NE)

FDA

ANALYSIS

N=22

N=0

ORR 15.7%*,

n/N=22/140

REPLIMUNE

ANALYSIS

N=22

N=25

ORR 33.6%,

n/N=47/140

NON-INJECTED

TARGET LESION

ALL TARGET

LESIONS

INJECTED

Response Assessment

CC-57

Patient Example With Injected Only Disease

Baseline

NOV 2021 MAR 2022 FEB 2024

Liver

INJECTED

Response Assessment

Disease Background:

• 68 yo M, Stage IVM1c

Prior line of therapy:

• Pembrolizumab

(adjuvant)

Confirmed BOR per

RECIST 1.1 by IRC = PR

DOR = 45.7mo

Injected

CC-58

Response in All Lesions Measured is Consistent

with RECIST 1.1 ORR 33.6%

*Only target lesions

Best Response Category

Response Based on Injected

Measured Lesions Only

n (%)

Response Based on Non-injected

Measured Lesions Only

n (%)

CR 16 (14.8) 13 (12.0)

PR 18 (16.7) 18 (16.7)

SD 33 (30.6) 28 (25.9)

PD 32 (29.6) 35 (32.4)

NE 9 (8.3) 14 (13.0)

ORR 34 (31.5) 31 (28.7)

95% CI 22.9, 41.1 20.4, 38.2

All measured lesion analysis more comprehensive than RECIST 1.1*

Response in Patients Who Had Both Injected and Non-injected Measured Lesions (N=108)

Response Assessment

CC-59

Patient Level Analysis Supports Systemic Effect

(Responders, All Measured Lesions)

Data cutoff: October 15, 2024

a. Patient had a CR as a radical resection of all 3 lesions on the skin of the left foot confirmed full regression; b. The sum of diameters of 4 target lesions met the criteria for a PR

Injected Non-Injected

Patients

-100

-80

-60

-40

-30

Best Percentage Change from Baseline

-20

Response Assessment

53 non-injected lesions were visceral (30 were lung lesions,14 were liver lesions)

66.0% (35/53) had a reduction of >30%

CC-60

Deep Responses Across Tumor Burden Spectrum

Cutoff: 8 March 2024

All Measured Lesions

Baseline (mm)

Patients with Adjuvant Therapy: +

Combined Sum of Diameter

-100

-80

-60

-40

-20

300

200

220

240

260

280

180

100

120

140

160

Patients

+ +

+ + + +

+ +

Tumor Burden at Baseline (mm) Best Percentage Change

from Baseline (%) + Indicates adjuvant patients

10 cm

>30%

reduction

Response Assessment

CC-61

Summary

CC-62

Favorable Benefit-Risk for Accelerated Approval

IGNYTE-3 randomized confirmatory trial ongoing with OS data expected in 2030

UNMET NEED: SERIOUS, LIFE-THREATENING DISEASE

EFFICACY

Adequate and

Well-controlled Trial

Supporting

Evidence

IGNYTE ORR: 33.6% (95% CI: 25.8, 42)

DoR: 24.8 months (95% CI: 14.1, NE)

MOA/Biological

Plausibility Preclinical Biomarkers

Well-tolerated

Safety Profile

IGNYTE Mainly Grade 1 and 2

No treatment-related Grade 5 SAFETY

CC-63

Mohammed Milhem, MBBS

Professor of Internal Medicine

Former Division Chair and Holden Chair for Experimental Therapeutics

Division of Hematology and Oncology, University of Iowa

Clinical Perspective

and Case Studies

CC-64

• Patients whose disease progresses after PD-1 therapy have:

– Limited treatment options

– Modest response rates

– TILs treatment present logistical and safety challenges

• What we need:

– New treatment options that can benefit patients whose disease

has progressed on prior PD-1 therapy

– Injection of tumors in different locations overcomes resistance mechanisms

– Durable responses that will likely translate into survival

– Manageable safety profile

Clinical Reality Today

CC-65

• Three patient examples

– Adjuvant Failed

– Failed Multiple Lines

– Non-injected Visceral Responses

RP1+Nivolumab Provides an Important Option

for Difficult to Treat Patients

CC-66

Patient Example: Adjuvant Failed

Left Posterolateral Back

NON-INJECTED

Left Axillary

Lymph Node

INJECTED

Left Axilla

NON-INJECTED

BASELINE

6 MONTHS

(PR)

29 MONTHS

(CR)

Disease Background:

• 50 yo F, Stage IIIC

Prior lines of therapy:

• Pembrolizumab

• Elevated LDH at

baseline

Confirmed BOR

per IRC = CR

Injected Non-injected

CC-67

Patient Example: Failed Multiple Lines

Multiple sites of disease at baseline including chest, abdomen, and pelvis

BASELINE

9 MONTHS

BASELINE

9 MONTHS

Disease Background:

• 74 yo F, Stage IVM1b

Prior lines of therapy:

• Atezolizumab+

cobimetinib

• Atezolizumab

• Ipilimumab

• SX682 (CXCR-inhibitor)+

pembrolizumab

• Ipilimumab+

nivolumab

• Carboplatin+paclitaxel+

pembrolizumab

Confirmed BOR per

IRC = PR

Injected Non-injected

CC-68

Patient Example: Non-injected Visceral Responses

BASELINE

9 MONTHS

Disease Background:

• 62 yo F, Stage IVM1c

Prior lines of therapy:

• Nivolumab (adjuvant)

• Pembrolizumab

(adv/met)

• Elevated LDH

at baseline

Confirmed BOR per

by IRC = PR

Injected Non-injected

CC-69

• Urgent unmet need remains

• RP1 has a positive clinical benefit risk

– Compelling efficacy

– Favorable safety profile

• Innovative modalities require creative and pragmatic approaches

to advance the field

RP1 Needed for Patients Now

CC-70

Vusolimogene oderparepvec-wtpg (TUDRIQEV )

in combination with nivolumab for the treatment of

adults with unresectable advanced cutaneous melanoma

July 30, 2026

United States Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee

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