Replimune(US:REPL)2026-02-03 13:12Company 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].