Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update Topline data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo (cemiplimab-rwlc) in cutaneous s

Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update

data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo (cemiplimab-rwlc) in cutaneous

squamous cell carcinoma expected in early Q4 2023 and Biologics License Application submission anticipated in Q1/2 2024

sharing collaboration in cutaneous squamous cell carcinoma in the neoadjuvant setting entered into with Incyte

snapshot for all 141 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma expected Q4 2023

and RP3 Phase 2 programs; third-line colorectal cancer clinical trial initated, first- and second-line hepatocellular carcinoma trials

expected to initiate this quarter; Phase 1 clinical trial update expected at year end

balance sheet with cash runway into H2 2025

MA, August 3, 2023 - Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development

of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal first quarter ended

June 30, 2023 and provided a business update.

was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO. The duration

of responses are particularly impressive with all responding patients in the anti-PD1 failed melanoma 75 patient cohort presented late

last year continuing without progression," said Philip Astley-Sparke, CEO of Replimune. "We now look forward to presenting

the top-line data from our registration-directed CERPASS trial of RP1 in combination with Libtayo in cutaneous squamous cell carcinoma

(CSCC) as well as sharing an initial snapshot from the full patient population in the IGNYTE clinical trial cohort of RP1 combined with

Opdivo in anti-PD1 failed melanoma later in the year. Commercial preparations are progressing, and in line with our ambition of establishing

a major skin cancer franchise, we are pleased to announce that we have entered a cost sharing collaboration with Incyte to conduct a

clinical trial for the neoadjuvant treatment of CSCC with RP1 and the oral PD-L1 inhibitor, INCB99280."

Highlights & Milestones

on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of June 30, 2023,

will enable the Company to fund operations into the second half of calendar year 2025.

is Replimune's registration-directed randomized, global Phase 2 clinical trial to compare the effects of Libtayo

(cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune's investigational oncolytic immunotherapy RP1. The clinical

trial recently completed enrollment and enrolled 211 patients with locally advanced or metastatic cutaneous squamous cell carcinoma who

are na ve to anti-PD-1 therapy. The clinical trial will evaluate complete response rate and overall response rate as its two independent

primary efficacy endpoints as assessed by independent review, as well as secondary endpoints including duration of response, progression-free

survival, and overall survival. The clinical trial is being conducted under a clinical trial collaboration agreement with Regeneron and

full commercial rights retained by Replimune. Libtayo is a registered trademark of Regeneron.

is Replimune's multi-cohort Phase 1/2 trial of RP1 plus nivolumab. There are 3 tumor specific cohorts currently enrolling in this

clinical trial including a 125-patient cohort in anti-PD1 failed melanoma with registrational intent. This cohort was initiated after

completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional

cohorts are in non-melanoma skin cancers which includes both na ve and anti-PD1 failed CSCC, and in anti-PD1 failed microsatellite

instability high, or MSI-H/dMMR tumors. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb.

is Replimune's lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically

armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death, and

the activation of a systemic anti-tumor immune response.

and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule

and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL, but does not express GM-CSF. RP2

and RP3 are 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.

Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development

of novel tumor-directed oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone with

payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a

unique dual local and systemic mechanism of action 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 ignite a strong and durable systemic response. This MOA

is expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile

the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options. For more information,

please visit www.replimune.com.

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 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, 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 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, 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 the coronavirus

as a global pandemic and related public health issues, 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.

Consolidated Statements of Operations

in thousands, except share and per share amounts)

Consolidated Balance Sheets

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