Enrollment in the CERPASS clinical trial with RP1 in cutaneous squamous cell carcinoma (CSCC) expected to be completed in mid-year 2022; top line data expected Q1 2023
Directional data from the first 75 patents with 6 months follow up from the IGNYTE clinical trial with RP1 in anti-PD1 failed melanoma expected in late 2022
Phase 2 development plan for RP2/RP3 in HCC, CRC and SCCHN announced
WOBURN, Mass., May 19, 2022 (GLOBE NEWSWIRE) — 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 fourth quarter and year ended March 31, 2022 and provided a business update.
“We have ended the fiscal year in a very strong position from which to execute on our vision to establish our products as a cornerstone of immuno-oncology regimens and we look forward with these firm foundations in place to a potentially transformative 12-month period ahead,” said Philip Astley-Sparke CEO of Replimune. “Updated data in anti-PD1 naïve cutaneous squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma continue to support our two registration-directed clinical trials in these settings. We are maintaining guidance that we expect to complete enrollment into our registration directed CERPASS clinical trial in CSCC mid-year and to release top line data in early 2023. Further, we expect to release initial directional data from our registration directed IGNYTE clinical trial in anti-PD1 failed melanoma in late 2022. Launch scale manufacturing has been established and commercial planning to establish a major skin cancer franchise is advancing. With RP2/3 we have announced an exciting mid stage program in colorectal cancer (CRC), hepatocellular carcinoma (HCC) and head and neck cancer (SCCHN) where an expedited path to potential approval in some settings may be feasible. Finally, we have a strong cash position to drive value through multiple major data catalysts.”
Corporate Updates
Upcoming Milestones
CERPASS – Registration-directed Phase 2 clinical trial in CSCC
IGNYTE – Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo
RP2 and RP3
Financial Highlights
Based on the current operating plan, Replimune believes that existing cash and 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 regulatory body.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo®. alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. 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.
About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo®. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. 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 naïve 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.
About RP1
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.
About RP2 & RP3
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.
About Replimune
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.
Investor Inquiries
Chris Brinzey
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Lissette Steele
Verge Scientific Communications
202.930.4762 x 409
lsteele@vergescientific.com
Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Audited) |
||||||||
| Year Ended March 31, | |||||||
| 2022 | 2021 | ||||||
Operating expenses: | ||||||||
Research and development | $ | 79,545 | $ | 56,754 | ||||
Selling, general and administrative | 38,769 | 23,201 | ||||||
Total operating expenses | 118,314 | 79,955 | ||||||
Loss from operations | (118,314 | ) | (79,955 | ) | ||||
Other income (expense): | ||||||||
Research and development incentives | 3,170 | 2,807 | ||||||
Investment income | 390 | 916 | ||||||
Interest expense on finance lease liability | (2,223 | ) | (2,242 | ) | ||||
Interest expense on debt obligations | – | (818 | ) | |||||
Loss on extinguishment of debt | – | (913 | ) | |||||
Other (expense) income | (1,059 | ) | (665 | ) | ||||
Total other income (expense), net | 278 | (915 | ) | |||||
Net loss attributable to common stockholders | $ | (118,036 | ) | $ | (80,870 | ) | ||
Net loss per common share, basic and diluted | $ | (2.26 | ) | $ | (1.75 | ) | ||
Weighted average common shares outstanding, basic and diluted | 52,212,269 | 46,248,969 | ||||||
Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Audited) |
||||||||
March 31, | March 31, | |||||||
2022 | 2021 | |||||||
Consolidated Balance Sheet Data: | ||||||||
Cash, cash equivalents and short-term investments | $ | 395,655 | $ | 476,302 | ||||
Working capital | 383,221 | 469,200 | ||||||
Total assets | 461,192 | 543,098 | ||||||
Total stockholders’ equity | 411,229 | 498,728 |
Charlotte, North Carolina--(Newsfile Corp. - December 23, 2024) - cbdMD, Inc. (NYSE American: YCBD) (NYSE…
AUSTIN, TEXAS / ACCESSWIRE / December 23, 2024 / Interactive Strength Inc. (Nasdaq:TRNR) ("TRNR" or…
Originally published in Quest Diagnostics' 2023 Corporate Responsibility ReportNORTHAMPTON, MA / ACCESSWIRE / December 23,…
Marlborough, Massachusetts--(Newsfile Corp. - December 23, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage…
WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotech company developing the world’s most…
WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotech company developing the world’s most…