Shares of Replimune Group, Inc. (REPL) have gained 0.7% over the past four weeks to close the last trading session at $7.76, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $12.86 indicates a potential upside of 65.7%.The average comprises seven short-term price targets ranging from a low of $10.00 to a high of $19.00, with a standard deviation of $3.02. While the lowest estimat ...

Company Overview - The company is a clinical-stage biotechnology firm focused on oncolytic immunotherapy, aiming to transform cancer treatment through its proprietary product candidates [117]. Product Development - The RPx platform utilizes an engineered strain of herpes simplex virus 1 (HSV-1) to induce a systemic anti-tumor immune response, with three product candidates (RP1, RP2, RP3) currently in development [119]. - The company is also developing RP2 and RP3, engineered to enhance anti-tumor immune responses for additional tumor types [129]. - The IGNYTE trial for RP1, in combination with nivolumab, includes 140 patients with a confirmed overall response rate (ORR) of 32.9% and a median duration of response of 33.7 months [121]. - An ad hoc analysis from the IGNYTE trial showed an objective response rate of 44% in patients with acral melanoma, with a median duration of response of 11.9 months [120]. - In the non-melanoma skin cancer cohort of the IGNYTE trial, the combination of RP1 and nivolumab achieved an ORR of 30% [126]. - The ARTACUS trial, assessing RP1 in solid organ transplant recipients, reported an ORR of 34.5% and a complete response rate of 21% [127]. - RP2 demonstrated an overall response rate (ORR) of 29.4% in a cohort of metastatic uveal melanoma (mUM) patients, with a median duration of response (DOR) of 11.47 months [130]. - The disease control rate for the mUM cohort was reported at 58.8% [131]. - The REVEAL study aims to enroll approximately 280 patients to evaluate RP2 in combination with nivolumab versus ipilimumab, with primary endpoints including overall survival and progression-free survival [132]. Regulatory and Clinical Trials - The company submitted its first Biologics License Application (BLA) for RP1 in November 2024, which was accepted for priority review with a PDUFA goal date of July 22, 2025 [122]. - The FDA issued a complete response letter for the RP1 BLA, citing the need for a more controlled clinical investigation [122]. - The company plans to conduct an interim overall survival analysis in the I-3 trial in the second half of 2027, with approximately 400 patients expected to be enrolled [124]. Financial Performance - As of December 31, 2025, the company reported net losses of $70.9 million for Q4 2025 and $240.7 million for the nine months ended December 31, 2025 [138]. - The accumulated deficit as of December 31, 2025, was $1,189.3 million, primarily due to research and development and administrative costs [138]. - The company raised approximately $1,112.1 million in net proceeds since its IPO, with $101.2 million from the IPO and $862.0 million from follow-on offerings [137]. - Cash and cash equivalents as of December 31, 2025, were $269.1 million, expected to fund operations for at least 12 months [141]. - Research and development expenses are anticipated to increase as the company continues clinical trials and develops additional product candidates [150]. - The company has not generated any revenue from product sales, as no products have been approved for sale [142]. - Research and development expenses for the three months ended December 31, 2025, were $53.1 million, an increase of $5.1 million from $48.0 million in the same period of 2024 [166]. - Total operating expenses for the nine months ended December 31, 2025, were $246.6 million, up $64.3 million from $182.3 million in the same period of 2024 [170]. - Net loss for the three months ended December 31, 2025, was $70.9 million, compared to a net loss of $66.3 million for the same period in 2024, reflecting an increase of $4.6 million [165]. - Selling, general and administrative expenses for the nine months ended December 31, 2025, were $77.7 million, an increase of approximately $30.9 million from $46.8 million in the same period of 2024 [174]. - For the nine months ended December 31, 2025, net cash used in operating activities was $224.2 million, compared to $138.5 million for the same period in 2024, reflecting a significant increase in operational losses [180][181]. - The company recorded a full valuation allowance against its net deferred tax assets as it is more likely than not that the benefits will not be realized [163]. Funding and Collaborations - The company faces risks related to the need for substantial additional funds to achieve its business objectives, with no committed external sources of funds currently available [191][192]. - The company has entered into collaborations with BMS and Roche for clinical trials, with BMS providing nivolumab at no cost for use in combination with RP1 [194][197]. - The agreement with Roche has been modified to focus solely on the 2L cohort in HCC with RP2, following a re-prioritization of the product development portfolio [197]. Accounting and Taxation - The company participates in a UK tax relief program, allowing reimbursement of up to 16.2% of qualifying research and development expenditures [156]. - The company anticipates an ordinary loss in the United States and the United Kingdom, leading to the exclusion of these jurisdictions from the calculation of the annual effective tax rate [162]. - Stock-based compensation is measured according to ASC 718, with expenses recognized over the requisite service period, typically the vesting period [204]. - The fair value of stock options is estimated using the Black-Scholes option-pricing model, which includes subjective assumptions such as expected stock price volatility and risk-free interest rate [204]. - Recently issued accounting pronouncements that may impact financial position are disclosed in the financial statements [206]. - No quantitative or qualitative disclosures about market risks are applicable [207].

Financial Performance - As of December 31, 2025, the company's cash, cash equivalents, and short-term investments totaled $269.1 million, down from $483.8 million as of March 31, 2025, reflecting cash burn related to clinical development activities [7]. - The net loss for the fiscal third quarter ended December 31, 2025, was $70.9 million, compared to a net loss of $66.3 million for the same period in 2024 [11]. - Selling, general and administrative expenses for the fiscal third quarter were $18.7 million, compared to $18.0 million in the same quarter of 2024 [11]. - The total operating expenses for the fiscal third quarter were $71.9 million, up from $66.0 million in the same quarter of 2024 [11]. - The company expects its existing cash resources to fund operations into the first quarter of calendar 2027, including potential commercialization of RP1 [7]. Research and Development - Research and development expenses for the fiscal third quarter were $53.1 million, an increase from $48.0 million in the same quarter of 2024, primarily due to costs associated with the RP1 confirmatory study [11]. - The ongoing IGNYTE-3 Phase 3 trial is expected to enroll approximately 400 patients, assessing RP1 in combination with nivolumab versus physician's choice [5]. - RP1 combined with nivolumab showed an objective response rate (ORR) of 44% in patients with acral melanoma, with a median duration of response of 11.9 months [5]. Regulatory and Funding - The company has a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026, for the resubmission of the Biologics License Application (BLA) for RP1 in advanced melanoma [3]. - The company amended its loan agreement with Hercules Capital, allowing for an initial drawdown of $35 million and potential additional funding of $120 million upon post-approval milestones [4].

Core Insights - Replimune Group, Inc. announced financial results for the fiscal third quarter ended December 31, 2025, and provided a business update, highlighting the upcoming FDA action date for RP1 in advanced melanoma on April 10, 2026 [1][2]. Financial Performance - As of December 31, 2025, the company's cash, cash equivalents, and short-term investments totaled $269.1 million, down from $483.8 million as of March 31, 2025, primarily due to cash burn related to clinical development activities [8][19]. - Research and development expenses for the fiscal third quarter were $53.1 million, an increase from $48.0 million in the same quarter of 2024, driven by costs associated with the RP1 and RP2 studies [12]. - Selling, general and administrative expenses were $18.7 million for the fiscal third quarter, compared to $18.0 million in the prior year [12]. - The net loss for the fiscal third quarter was $70.9 million, compared to a net loss of $66.3 million for the same period in 2024 [12]. Product Development and Clinical Trials - The FDA accepted the resubmission of the Biologics License Application (BLA) for RP1 in October 2025, with a target action date set for April 10, 2026, and commercial readiness activities are in progress [2][4]. - The REVEAL Study for RP2 in metastatic uveal melanoma is actively enrolling approximately 280 patients, evaluating RP2 in combination with nivolumab versus ipilimumab [5]. - The IGNYTE-3 Confirmatory Study is assessing RP1 in combination with nivolumab in advanced melanoma patients who have progressed on prior therapies, with a primary endpoint of overall survival [6]. - Recent data presented at ESMO Congress 2025 showed an objective response rate (ORR) of 44% for RP1 plus nivolumab in acral melanoma patients [6]. - The ARTACUS Study demonstrated RP1 monotherapy's robust anti-tumor activity in cutaneous squamous cell carcinoma patients, with an ORR of 34.6% [6]. Strategic Financial Moves - The company amended its loan agreement with Hercules Capital, Inc., allowing for a drawdown of $35 million and the potential for an additional $120 million upon achieving post-approval milestones, while delaying debt repayment from 2026 to 2027 [3].

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Replimune Group FY Conference Summary Company Overview - **Company**: Replimune Group (NasdaqGS:REPL) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 14, 2026 Key Industry Insights - **Oncolytic Immunotherapy**: Replimune is focused on delivering oncolytic immunotherapy, particularly through its assets RP1 and RP2, which are designed to enhance systemic immune activation against various cancers [11][13][41]. Core Points and Arguments 1. **Commercial Launch Plans**: Replimune is prepared for a commercial launch, with plans to work closely with oncology and interventional radiology stakeholders. The logistics have been simplified for next-day delivery and room temperature stability of their product [11][22]. 2. **Expanded Treatment Scope**: The company has successfully conducted over 1,000 deep injections, expanding the treatment potential beyond superficial lesions to include deeper tumors in organs like the lung and liver [12][35]. 3. **Clinical Trial Data**: The IGNITE trial demonstrated a 34% response rate in primary resistant melanoma patients, indicating the efficacy of RP1 in difficult-to-treat populations [17][18]. The trial's design ensures that patients have definitively failed prior PD-1 treatments, providing a robust assessment of RP1's contribution [15][19]. 4. **Durability of Responses**: Analysis shows that responses to RP1 are durable, with significant improvements in time to progression compared to prior treatments [20][21]. 5. **Patient Population**: Approximately 10,000 melanoma patients are addressable, with 80% eligible for RP1 treatment. The regimen is designed to be practical and broadly applicable across various patient subtypes [22][23]. 6. **Safety Profile**: The safety profile of RP1 is reported to be tolerable, making it a viable option for a wide range of patients [23][41]. Additional Important Insights - **Regulatory Engagement**: The FDA has been responsive, and the company is optimistic about the upcoming PDUFA date on April 10, 2026, for their class two resubmission [42][43]. - **Enrollment in Trials**: Enrollment in the IGNITE-3 trial is progressing well, with over 60 patients already enrolled, and expansion into Europe is planned [49][51]. - **Compassionate Use Requests**: There has been a notable increase in compassionate use requests, indicating a strong demand for RP1 among physicians and patients [50][53]. - **Future Directions**: Replimune is exploring the use of RP1 in other cancer types beyond melanoma, including liver and biliary tract cancers, and is preparing for additional trials [40][41]. Conclusion Replimune Group is positioned to make significant advancements in the field of oncolytic immunotherapy, with a strong focus on expanding treatment options for patients with difficult-to-treat cancers. The company is ready for commercial launch and is actively engaging with regulatory bodies to ensure timely approval and access to their therapies.

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].