Full Press Release Details
Fiscal Second Quarter Financial Results and Provides Corporate Update
Completed enrollment in the CERPASS registration-directed
clinical trial evaluating RP1 in cutaneous squamous cell carcinoma (CSCC); primary analysis data expected to be released in H1 2023
Six-month follow-up data from the first 75 patients
enrolled in the IGNYTE clinical trial cohort of RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma expected
An update on the RP2/3 development program remains
on track to be provided by year end
Completed $200 million term-loan that extended
cash runway into 2025
Woburn, MA, November 3, 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 second quarter ended September 30, 2022 and provided a business update.
"We continue working towards establishing our oncolytic immunotherapies
as the cornerstone treatment for a variety of solid tumor indications," said Philip Astley-Sparke CEO of Replimune. "We plan
to establish a major skin cancer franchise with our lead program, RP1 and are on track to announce primary data from the CERPASS clinical
trial in CSCC in the first half of 2023. Additionally, we look forward to announcing initial data from the IGNYTE clinical trial cohort
evaluating RP1 combined with Opdivo in anti-PD1 failed melanoma later this year. As we continue advancing the rest of our pipeline, we
are pleased to report that we also remain on track to provide an update on the RP2/3 program, targeted at treating a number of difficult-to-treat
cancers, later this year. With a strong financial position enhanced by our recently announced term loan, we have extended our cash runway
into 2025 to fund key value-driving catalysts, including the costs of funding commercial infrastructure and running a confirmatory clinical
trial to support potentially filing for FDA approval in anti-PD1 failed melanoma under the accelerated approval pathway."
Program Highlights & Milestones:
Financial Highlights
Based on the current
operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of September 30, 2022, together
with unrestricted proceeds available to be drawn under the Hercules debt facility, will enable us to fund our operations into calendar
2025, inclusive of the costs of funding commercial infrastructure and running a confirmatory clinical trial to support a potential filing
for FDA approval in anti-PD1 failed melanoma under the accelerated approval pathway.
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 recently completed enrollment and
enrolled 211 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 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
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
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 28,834 | $ | 19,902 | $ | 58,312 | $ | 38,456 | ||||||||
| General and administrative | 12,745 | 9,345 | 24,143 | 18,172 | ||||||||||||
| Total operating expenses | 41,579 | 29,247 | 82,455 | 56,628 | ||||||||||||
| Loss from operations | (41,579 | ) | (29,247 | ) | (82,455 | ) | (56,628 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 574 | 725 | 1,425 | 1,513 | ||||||||||||
| Investment income | 1,112 | 80 | 1,455 | 172 | ||||||||||||
| Interest expense on finance lease liability | (550 | ) | (557 | ) | (1,102 | ) | (1,115 | ) | ||||||||
| Other (expense) income | (2,659 | ) | (356 | ) | (4,678 | ) | (608 | ) | ||||||||
| Total other (expense) income, net | (1,523 | ) | (108 | ) | (2,900 | ) | (38 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (43,102 | ) | $ | (29,355 | ) | $ | (85,355 | ) | $ | (56,666 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.79 | ) | $ | (0.56 | ) | $ | (1.57 | ) | $ | (1.09 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 54,770,291 | 52,081,325 | 54,492,395 | 51,962,795 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| September 30, | March 31, | |||||||
| 2022 | 2022 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 371,820 | $ | 395,655 | ||||
| Working capital | 355,853 | 383,221 | ||||||
| Total assets | 436,095 | 461,192 | ||||||
| Total stockholders' equity | 384,072 | 411,229 |