On February 3, 2022 Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported financial results for the fiscal third quarter ended December 31, 2021 and provided a business update (Press release, Replimune, FEB 3, 2022, View Source [SID1234607671]).
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"We are looking forward to hosting an investor event next month to present on commercial strategy and RP2/3 development plans as well as provide anticipated data updates," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "At the event we intend to present our plans to establish a broad, high value skin cancer franchise with RP1 and provide a thorough overview of our mid-stage development plans for the RP2/3. We will also review other key milestones that we expect to achieve over the next year, including the release of data from registrational studies that we believe will highlight our platform’s potential to become a cornerstone of cancer treatment."
Corporate Updates
Replimune to host an investor event in March 2022. The event will review updated data from completed IGNYTE cohorts in non-melanoma skin cancer (NMSC) and melanoma. In addition, the Company intends to present initial data from the ongoing study in anti-PD1 failed NMSC and from its ARTACUS trial, a Phase 1b/2 trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer. The Company will also provide a detailed overview of its RP2/3 program including the Phase 2 development plan.
Presented updated RP2 data at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting. In November, the Company presented updated interim data from its ongoing Phase 1 trial of RP2 alone and in combination with Opdivo (nivolumab) that demonstrated the potential clinical utility of RP2 in patients with hard-to-treat, anti-PD1 failed cancers, including durability of response, together with biomarker data demonstrating the ability of RP2 to turn immunologically ‘cold’ tumors ‘hot.’
Upcoming Milestones
CERPASS – Registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC)
RP1 in combination with Libtayo (cemiplimab-rwlc) in CSCC: The Company is actively enrolling patients in a registration-directed, global, randomized, controlled, 180-patient Phase 2 clinical trial (CERPASS) evaluating RP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment in mid-year 2022 and the trigger for the primary data analysis to be six months thereafter.
IGNYTE – Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo (nivolumab)
Anti-PD-1 failed melanoma cohort: The Company continues to enroll patients in the 125-patient cohort of the IGNYTE Phase 2 clinical trial in patients with anti-PD1 failed melanoma. The Company expects to release initial directional data from this cohort in late 2022.
Non-melanoma skin cancer (NMSC) cohort: The Company continues to enroll patients with anti-PD-1 failed NMSC. The Company expects to provide initial data from this cohort in the first quarter of 2022.
Anti-PD(L)-1 failed non-small cell lung cancer (NSCLC) cohort: Enrollment is open in a 30-patient cohort of RP1 in combination with Opdivo in anti-PD(L)-1 failed NSCLC patients, with initial data expected to be released in late 2022.
ARTACUS – Phase 1b/2 clinical trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer
Enrollment continues in this 65-patient clinical trial with potential registrational intent, assessing the safety and efficacy of RP1 in organ transplant recipients with skin cancer. The Company expects to present initial data from this clinical trial in the first quarter of 2022.
RP2 and RP3
RP2 alone and in combination with Opdivo in difficult-to-treat cancers: The Company has initiated the expansion of the Phase 1 clinical trial of RP2 in combination with Opdivo, with a focus on patients with liver metastases from various prevalent tumor types including patients with lung, breast and gastrointestinal cancers. The Company expects to release initial expansion patient data in late 2022.
RP3 alone and in combination with Opdivo: The Company is enrolling patients in a Phase 1 clinical trial for RP3, with initial data expected to be released in the first quarter of 2022. The Company expects to start enrolling patients to be treated with RP3 in combination with Opdivo this quarter, including patients with various prevalent tumor types such as lung, breast, head and neck cancer and gastrointestinal cancers. The Company expects to release initial expansion patient data in late 2022.
RP2 and/or RP3 next stage development including in patients with liver metastases from a range of tumor types: The Company remains on track to initiate a broad Phase 2 clinical development program with RP2 and/or RP3, intended to include a range of prevalent tumor types, including in patients with liver metastases, around mid-year 2022. Details of this plan remain on track to be presented in the first quarter of 2022.
Financial Highlights
Cash Position: As of December 31, 2021, cash, cash equivalents and short-term investments were $420.2 million, as compared to $476.3 million as of March 31, 2021. This decrease was primarily related to cash utilized in operating activities in advancing the Company’s expanded clinical development plan.
Based 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 regulatory body.
R&D Expenses: Research and development expenses were $19.4 million for the third quarter ended December 31, 2021, as compared to $14.3 million for the third quarter ended December 31, 2020. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $1.8 million in stock-based compensation expenses for the third quarter ended December 31, 2021.
G&A Expenses: General and administrative expenses were $10.3 million for the third quarter ended December 31, 2021, as compared to $6.0 million for the third quarter ended December 31, 2020. The increase was primarily driven by personnel-related costs, including sales and marketing personnel associated with pre-launch planning and initial build of the Company’s commercial infrastructure. General and administrative expenses included $4.1 million in stock-based compensation expenses for the third quarter ended December 31, 2021.
Net Loss: Net loss was $29.7 million for the third quarter ended December 31, 2021, as compared to a net loss of $21.8 million for the third quarter ended December 31, 2020.
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.