Strengthened balance sheet raising gross $259 million through an upsized public offering in December, extending cash runway into H2 2025 and increasing operational and strategic flexibility

Topline data from the CERPASS registration-directed clinical trial evaluating RP1 in cutaneous squamous cell carcinoma (CSCC) expected to be announced in Q3 2023 along with updates from ongoing RP1 skin cancer cohorts including anti-PD1 failed non-melanoma skin cancer (CSCC predominant) and the RP1 monotherapy clinical trial in organ transplant recipients with skin cancer

Achieved target enrollment of 125 patients in the IGNYTE clinical trial cohort of RP1 combined with Opdivo®(nivolumab) in anti-PD1 failed melanoma and in December presented positive data from the first 75 patients followed for at least 6 months

Announced collaboration with Roche for signal finding studies in RP2/3 in third-line (3L) colorectal cancer (CRC) and in first- and second-line (1L & 2L) hepatocellular carcinoma (HCC)

WOBURN, Mass., Feb. 09, 2023 (GLOBE NEWSWIRE) -- 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 third quarter ended December 31, 2022 and provided a business update.

“We ended 2022 with a data update from our registration directed IGNYTE cohort of RP1 in anti-PD1 failed melanoma that demonstrated impressive and clinically meaningful activity in a patient population of major unmet need and with limited treatment options,” said Philip Astley-Sparke CEO of Replimune. “As we turn the page to 2023, we believe this data has significantly de-risked our overall skin cancer franchise with RP1, and we look forward to providing additional updates on all of our skin cancer programs, including topline primary analysis data from our registration-directed CERPASS clinical trial evaluating RP1 in CSCC. As we prepare for a potential commercial launch we have made further key appointments to strengthen our commercial team and are well financed to build a commercial capability in the US. With RP2/3 we look forward to commencing our Phase 2 clinical trials and providing further updates from our Phase 1 program this year.”

Corporate Updates

• Entered into clinical collaboration and supply agreement with Roche for the initial development of RP2/3 in third-line (3L) colorectal cancer (CRC) and in first- and second-line (1L & 2L) hepatocellular carcinoma (HCC). Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab in combination with RP3 in 1L & 2L HCC and 3L CRC and supply atezolizumab and bevacizumab for combination with RP2 in 3L CRC. Replimune will have responsibility for operationalizing these clinical trials.
• Announced leadership appointments in preparation for potential 2024 commercial launch of RP1. The Company appointed Christopher Sarchi, former Sanofi U.S. Commercial Oncology Head, as Chief Commercial Officer and Sushil Patel, Ph.D., previously Chief Commercial Officer, to a newly created position of Chief Strategy Officer. These appointments were made to prepare the Company as it begins to ramp up its commercial planning ahead of the potential 2024 commercial launch of RP1.

• Increased operational and strategic flexibility and extended cash runway into H2 2025. In December, the Company closed on an offering of common stock and pre-funded warrants raising approximately $259 million in gross proceeds and received aggregate net proceeds of approximately $243 million after deducting underwriting discounts, commissions, and other offering expenses. This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock. In October, the Company secured a $200 million non-dilutive debt facility of which $30 million gross was funded at closing, the remaining $170 million can largely be drawn at the Company’s option with satisfaction of certain milestones. Excluding any further debt draws the Company expects that its cash, cash equivalents and short-term investments of $616 million as of December 31, 2022 will fund its operating expenses and capital expenditure requirements into H2 2025.

Program Highlights & Milestones:

RP1

• RP1 combined with Libtayo®(cemiplimab-rwlc)in cutaneous squamous cell carcinoma (CSCC)
  • Completed enrollment of 211 patients in the CERPASS registration-directed clinical trial evaluating RP1 combined with Libtayo in patients with CSCC.
  • Topline primary analysis data from this clinical trial is expected to be announced in Q3 2023 updated from H1 2023. This is due to the time being taken and required for responses to be documented and confirmed, including per protocol response confirmation biopsies, and for central reviews to complete.

• RP1 combined with Opdivo in anti-PD1 failed melanoma
  • Presented data evaluating the first 75 patients with at least six-months follow up in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial in December.
  • The data demonstrated an overall response rate (ORR) of 36% and complete response (CR) rate of 20%, with clinically meaningful activity across a broad range of anti-PD1 failed cutaneous melanoma settings observed, including in patients with high tumor burden and visceral disease.
  • Systemic activity was seen in both injected and in un-injected lesions responding, including in un-injected visceral disease, with most responses seen in patients who did not respond to prior anti-PD1 therapy.
  • Safety data with RP1 in combination with nivolumab assessed across all skin cancer patients treated with RP1 combined with nivolumab (all studies, N=187), including the 75 patients reported on in December, continues to demonstrate an attractive safety profile, with predominantly ‘on target’ Grade 1-2 side effects indicative of systemic immune activation.
  • Target enrollment of 125 patients was reached in January with patients in screening at that time continuing to be enrolled. Enrollment is expected to complete this month with a final total study size of approximately 140 patients. The primary analysis is expected in Q1 2024, 12 months after the enrollment of the last patient.

• RP1 combined with Opdivo in anti-PD1 failed non-melanoma skin cancers
  • Recruitment remains ongoing into the cohorts of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, with a data update expected in Q3 2023.

• RP1 in solid organ transplant recipients with skin cancers
  • The Company continues to enroll patients into its ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers and expects to provide a data update in Q3 2023.

• RP1 in other skin cancer indications
  • The Company is currently evaluating all strategic opportunities for RP1 in skin cancers, including the setting for the confirmatory clinical trial in melanoma which is expected to be required to support an accelerated approval of RP1 in anti-PD1 failed melanoma.

RP2 and RP3

• RP2 alone and in combination with Opdivo in difficult-to-treat cancers
  • Completed enrollment (N=17) in the uveal melanoma expansion cohort of the Phase 1 clinical trial evaluating RP2 monotherapy (N=4) and RP2 in combination with Opdivo (N=13) and presented updated data in December further demonstrating the potential to treat a range of intractable tumor types, including those which metastasize to the liver.
  • The Company continues to enroll patients in the expansion cohorts of the Phase 1 clinical trial evaluating RP2 in patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer), with a data update expected in H2 2023.

• RP3 alone and in combination with Opdivo in difficult-to-treat cancers
  • The Company continues to enroll patients in its Phase 1 cohort evaluating RP3 combined with Opdivo with a focus on patients with GI cancers, breast cancer, lung cancer and head and neck cancer and expects to provide an update in H2 2023.
  • In December, the Company presented data from previously enrolled patients with multiple soft tissue sarcomas including in leiomyosarcoma, osteosarcoma, chondrosarcoma, and epithelioid sarcomas who had all failed standard of care.
  • At the data cut-off date, 3 of 5 patients had sufficient follow up for response assessment, and all three were responding to therapy in settings with no viable alternative treatment option, indicating the potential utility of RP3 in treating this difficult tumor type.

Phase 2 Program

• RP3 in combination with standard of care therapy in squamous cell carcinoma of the head and neck (SCCHN)
  • A two-cohort clinical trial will be conducted, with the first cohort of 100 patients with locally advanced disease being randomized to receive either standard of care (SOC) chemotherapy combined with radiation or RP3 combined with chemotherapy and radiation followed by adjuvant nivolumab therapy. The second, signal finding cohort, will enroll 30 patients with recurrent or metastatic SCCHN with low PDL1 levels (CPS