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Replimune Group (NasdaqGS:REPL) FY Conference January 14, 2026 04:30 PM ET Company ParticipantsNone - Company RepresentativeSushil Patel - CEOEmily Hill - CFOConference Call ParticipantsNone - Analyst 1Anupam Rama - Senior Biotech AnalystNone - Analyst 2Anupam RamaAll righty, let's go ahead and get started. Welcome, everyone, to the 44th Annual JPMorgan Healthcare Conference. My name is Anupam Rama. I am one of the Senior Biotech Analysts here at JPMorgan. I'm joined by my squad, Joyce Zhou, Priyanka Grover ...

Click to edit Master title style January 14, 2026 JPM Healthcare Conference Igniting a systemic immune response to cancer with oncolytic immunotherapy © 2026 Replimune Group Inc. JPM 2026 Presentation 1 Click to edit Master text styles Safe harbor © 20256 Replimune Group Inc. Replimune Group Inc. 3 Click to edit Master title style RPx Oncolytic Immunotherapy Overcoming Historical Hurdles ~150 Accounts Ready on Day 1 Go-to market model optimized to enable oncologist/interventional radiologist (IR) coordinati ...

Core Insights - Replimune Group's shares have increased by 131.1% over the last three months due to positive regulatory developments [1] - The FDA has accepted the resubmission of the biologics license application (BLA) for Replimune's lead candidate RP1 in combination with Bristol Myers' Opdivo for advanced melanoma, with a target action date set for April 10, 2026 [1][5] Regulatory Developments - The BLA resubmission follows a complete response letter (CRL) issued in July 2025, which raised concerns about data heterogeneity in the IGNYTE study population [2] - The FDA indicated that the IGNYTE study was not considered adequate for providing substantial evidence of effectiveness [2] - Replimune has engaged with the FDA to address the feedback from the CRL, and the FDA confirmed that the resubmission adequately addresses the previous concerns [3] Clinical Data - The RP1/Opdivo combination achieved a 44% response rate and an 11.9-month median response duration in patients with acral melanoma from the IGNYTE study [5][9] - Replimune is continuing a larger phase III study evaluating the RP1/Opdivo combination against the physician's choice of treatment for melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapies [9] Market Performance - Replimune's shares have declined by 19.6% over the past year, contrasting with the industry's growth of 20.2% [4] - The acceptance of the resubmitted BLA has alleviated investor concerns regarding the RP1/Opdivo combination, leading to increased visibility and confidence in the candidate's approval path [6] Additional Pipeline Information - RP1 is also being evaluated as a monotherapy for solid organ transplant recipients with skin cancers [12] - Replimune has a second oncolytic immunotherapy candidate, RP2, currently in mid-stage to large-stage studies for metastatic uveal melanoma and hepatocellular carcinoma [12]

Core Viewpoint - Replimune Group, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on developing novel oncolytic immunotherapies for cancer treatment [1]. Company Overview - Replimune Group, Inc. was founded in 2015 and is headquartered in Woburn, Massachusetts, with a mission to transform cancer treatment through innovative oncolytic immunotherapies [3]. - The company's proprietary RPx platform utilizes a potent HSV-1 backbone designed to maximize immunogenic cell death and induce a systemic anti-tumor immune response [3]. - The RPx platform aims to achieve local tumor destruction through selective virus-mediated killing, which releases tumor-derived antigens and modifies the tumor microenvironment to activate a robust systemic immune response [3]. - Replimune's product candidates are expected to work synergistically with both established and experimental cancer treatment modalities, allowing for versatile development either alone or in combination with other therapies [3].

Core Insights - The article discusses heavily shorted stocks, highlighting the reasons traders engage in short selling and the potential for short squeezes [1][4][10] Group 1: Reasons for Heavy Shorting - Stocks become heavily shorted when experienced traders and institutional investors believe the company is fundamentally overvalued, anticipating a price decline [2][3] - Short sellers borrow shares, sell them at high prices, and aim to repurchase them at lower prices for profit [3] Group 2: Short Squeeze Dynamics - High short interest can attract bullish traders who see potential for rapid gains through short squeezes, where rising stock prices force short sellers to buy back shares, creating a feedback loop that drives prices higher [4][10] - The volatility associated with short squeezes can lead to returns that significantly exceed typical stock movements in a short time frame [5][10] Group 3: Most Shorted Stocks - As of November 26, the top 10 most shorted stocks include: - The Wendy's Co. (NASDAQ:WEN) - 55.36% - Cambium Networks Corp. (NASDAQ:CMBM) - 50.03% - Lucid Group, Inc. (NASDAQ:LCID) - 48.99% - Wolfspeed, Inc. (NYSE:WOLF) - 48.18% - Hertz Global Holdings, Inc. (NASDAQ:HTZ) - 44.67% - Sable Offshore Corp. (NYSE:SOC) - 38.59% - Replimune Group, Inc. (NASDAQ:REPL) - 38.39% - Hims & Hers Health, Inc. (NYSE:HIMS) - 38.12% - aTyr Pharma, Inc. (NASDAQ:ATYR) - 37.92% - Intellia Therapeutics, Inc. (NASDAQ:NTLA) - 37.85% [6][7]

Core Insights - Heavily shorted stocks attract traders due to the potential for profit from a decline in value or a short squeeze [1][4] - A stock is considered heavily shorted when a significant number of traders believe it is overvalued and its price will fall [2][3] Short Selling Mechanics - Short sellers borrow shares, sell them at a high price, and aim to repurchase them at a lower price for profit [3] - High short interest indicates strong conviction among traders that a company faces serious risks [3] Short Squeeze Dynamics - A short squeeze occurs when a stock's price unexpectedly rises, forcing short sellers to buy back shares, which further drives up the price [4] - The volatility associated with short squeezes can lead to returns that exceed typical stock movements in a short time frame [5] Most Shorted Stocks - The top 10 most shorted stocks as of November 26 include: - The Wendy's Co. (NASDAQ:WEN) - 55.36% - Cambium Networks Corp. (NASDAQ:CMBM) - 50.03% - Lucid Group, Inc. (NASDAQ:LCID) - 48.99% - Wolfspeed, Inc. (NYSE:WOLF) - 48.18% - Hertz Global Holdings, Inc. (NASDAQ:HTZ) - 44.67% - Sable Offshore Corp. (NYSE:SOC) - 38.59% - Replimune Group, Inc. (NASDAQ:REPL) - 38.39% - Hims & Hers Health, Inc. (NYSE:HIMS) - 38.12% - aTyr Pharma, Inc. (NASDAQ:ATYR) - 37.92% - Intellia Therapeutics, Inc. (NASDAQ:NTLA) - 37.85% [6][7] Market Implications - Highly shorted stocks represent a battleground between negative fundamentals and speculative trading [10] - Monitoring short interest can help identify potential short squeeze opportunities, though timing remains challenging [10]

Core Insights - Replimune Group, Inc. presented biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab at the SITC 2025 meeting, indicating potential to reverse resistance mechanisms to PD-1 blockade in advanced melanoma patients who previously failed anti-PD-1 therapy [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, with its lead product candidate RP1 based on a proprietary strain of herpes simplex virus [4][6] - The company aims to transform cancer treatment by maximizing tumor killing potency and activating systemic anti-tumor immune responses through its RPx platform [6] Clinical Trial Insights - The IGNYTE phase 2 cohort included 140 patients with stage IIIB-IV cutaneous melanoma who had confirmed progression on anti-PD-1 therapy for over 8 weeks [3] - RP1 was administered intratumorally every two weeks for up to 8 doses, combined with intravenous nivolumab, which was then given alone for up to 2 years [3] Efficacy and Response Rates - The combination of RP1 and nivolumab demonstrated a clinically meaningful overall response rate (ORR) of 33.6% and a median duration of response of 24.8 months, with consistent results across different tumor types [5] - The treatment showed comparable efficacy in BRAF-mutant and BRAF-wild-type advanced melanoma, with greater activity observed in BRAF-naïve patients [5] Mechanism of Action - RP1 plus nivolumab was shown to upregulate gene signatures associated with responsiveness to PD-1 blockade, reversing multiple resistance mechanisms that were not addressed during prior anti-PD-1 therapy [5]

Financial Performance - As of September 30, 2025, cash, cash equivalents, and short-term investments were $323.6 million, down from $483.8 million as of March 31, 2025, indicating a cash burn related to clinical development activities [7]. - Research and development expenses for the fiscal second quarter were $57.9 million, compared to $43.4 million for the same period in 2024, primarily due to increased costs associated with the RP1 and RP2 studies [11]. - Selling, general, and administrative expenses rose to $26.4 million for the fiscal second quarter, up from $15.5 million in the prior year, reflecting increased personnel-related costs [11]. - The net loss for the fiscal second quarter was $83.1 million, compared to a net loss of $53.1 million for the same period in 2024 [11]. - The company expects existing cash to fund operations into late Q4 2026, including potential commercialization of RP1 [7]. Clinical Trials and Developments - The ongoing global Phase 3 trial IGNYTE-3 is expected to enroll approximately 400 patients, evaluating RP1 in combination with nivolumab versus a control arm in advanced melanoma patients [5]. - RP1 plus nivolumab demonstrated an objective response rate (ORR) of 44% in acral melanoma patients, with a median duration of response of 11.9 months [5]. - The registration-directed Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling approximately 280 patients [5]. - The FDA has accepted the BLA resubmission of RP1 for advanced melanoma, with a target action date set for April 10, 2026 [2]. - The IGNYTE clinical trial cohort in non-melanoma skin cancer (NMSC) is ongoing, with promising response rates across multiple tumor types [5].