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Replimune Reports Fiscal First Quarter Financial Results and Provides Corporate Update Target enrollment of 180 patients reached in the CERPASS randomized controlled registration-directed clinical trial evaluating RP1 in

Key Takeaway: Fiscal First Quarter Financial Results and Provides Corporate Update of 180 patients reached in the CERPASS randomized controlled registration-directed clinical trial evaluating RP1 in cutaneous squamous cell carcinoma (CSCC); primary analysis data expected to be released in H1

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Fiscal First Quarter Financial Results and Provides Corporate Update
of 180 patients reached in the CERPASS randomized controlled registration-directed clinical trial evaluating RP1 in cutaneous squamous
cell carcinoma (CSCC); primary analysis data expected to be released in H1 2023
enrolled in the IGNYTE clinical trial cohort of RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma; data
snapshot from these patients with six-month follow-up expected to be released in Q4 2022
to be provided by year end, including detailed Phase 2 development plans
Woburn, MA, August 4, 2022
- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel
class of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal first quarter ended
June 30, 2022 and provided a business update.
"Our ambition to establish
a major skin cancer franchise, built off of our lead RP1 program, is progressing to plan. We are pleased to have reached target enrollment
in the CERPASS registration-directed clinical trial in CSCC and expect to complete enrollment in the IGNYTE clinical trial cohort evaluating
RP1 combined with Opdivo in anti-PD1 failed melanoma around the end of year. We look forward to sharing the primary analysis data from
the CERPASS clinical trial in H1 2023 and a data snapshot from the first 75 patients enrolled in the IGNYTE anti-PD1 failed melanoma
cohort in the fourth quarter of 2022. In addition to RP1, we remain excited about the previously reported data with RP2 and look forward
to providing further updates from the RP2/3 program as we move towards initiation of our Phase 2 programs in head and neck cancer, hepatocellular
carcinoma and colorectal cancer. Looking even further ahead, we are well financed as we continue to prepare for the potential commercialization
of our oncolytic immunotherapies and remain on course to achieve our ultimate ambition of establishing our products as a cornerstone
treatment for a variety of solid tumor indications."
Corporate Updates & Upcoming
Financial Highlights
on the current operating plan, Replimune believes that existing cash, cash equivalents and short-term investments will fund operating
expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other
CERPASS is Replimune's registration-directed
randomized, global Phase 2 clinical study to compare the effects of Libtayo (cemiplimab-rwlc) alone versus a combination
of Libtayo and Replimune's investigational oncolytic immunotherapy RP1. The clinical trial comprises approximately 180 evaluable
patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are na ve to anti-PD-1 therapy. The clinical
trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two independent primary efficacy endpoints as
assessed by independent review, as well as secondary endpoints including duration of response, progression-free survival (PFS), and overall
survival (OS). The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial
are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi. Libtayo is a
registered trademark of Regeneron.
IGNYTE is Replimune's multi-cohort
Phase 1/2 trial of RP1 plus Opdivo (nivolumab). There are 4 tumor specific cohorts currently enrolling in this clinical
trial including a 125-patient cohort in anti-PD-1 failed cutaneous 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-PD-1 failed CSCC, in anti-PD1 failed microsatellite
instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under
a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.
RP1 is Replimune's lead product
candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing
potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
RP2 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. 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.
Replimune 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 (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived
antigens and altering of the tumor microenvironment (TME) 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.
Forward Looking Statements
This 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.
Verge Scientific Communications
Replimune Group, Inc.
Condensed Consolidated
Statements of Operations
(Amounts in thousands,
except share and per share amounts)
Three Months Ended June 30,
2022 2021
Operating expenses:
Research and development $ 29,478 $ 18,554
Selling, general and administrative 11,398 8,827
Total operating expenses 40,876 27,381
Loss from operations (40,876 ) (27,381 )
Other income (expense):
Research and development incentives 851 788
Investment income 343 92
Interest expense on finance lease liability (552 ) (558 )
Other (expense) income (2,019 ) (252 )
Total other (expense) income, net (1,377 ) 70
Net loss attributable to common stockholders $ (42,253 ) $ (27,311 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.78 ) $ (0.53 )
Weighted average common shares outstanding, basic and diluted 54,211,446 51,910,331
Replimune Group, Inc.
Condensed Consolidated
(Amounts In thousands,
except share and per share amounts)
June 30, March 31,
2022 2022
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term investments $ 395,082 $ 395,655
Working capital 381,633 383,221
Total assets 459,427 461,192
Total stockholders' equity 410,262 411,229
Last updated: Aug 4, 2022