Replimune(REPL) - 2025 Q3 - Quarterly Report

Clinical Efficacy - The overall response rate (ORR) for RP1 combined with nivolumab in the anti-PD-1 failed melanoma cohort was 33.6% by modified RECIST 1.1 criteria, with 85% of responses lasting more than 12 months[117]. - The median duration of response from baseline for RP1 was 27.6 months, and the median duration of response from treatment initiation was 21.6 months[117]. - In the non-melanoma skin cancer cohort, RP1 combined with nivolumab achieved an ORR of 30%, with 60% of patients demonstrating clinical benefit[119]. - The Phase 1b/2 ARTACUS trial of RP1 in solid organ transplant recipients reported an ORR of 34.5% and a complete response rate of 21%[120]. - RP2 demonstrated an ORR of 29.4% in a cohort of metastatic uveal melanoma patients, with a median duration of response of 11.47 months[124]. - The FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab for advanced melanoma, with a BLA submission accepted and priority review granted[117]. - The IGNYTE-3 trial, a confirmatory study for RP1, is planned to have over 100 sites globally and is currently enrolling patients[118]. Financial Performance - The company has raised approximately $1,101.8 million in net proceeds since its IPO, with$862.0 million from four follow-on offerings[128]. - The net losses for the three months ended December 31, 2024, were $66.3 million, compared to$51.1 million for the same period in 2023[129]. - As of December 31, 2024, the accumulated deficit stood at $874.4 million, primarily due to research and development costs[129]. - Total operating expenses for the three months ended December 31, 2024, were$66.0 million, an increase of $9.5 million compared to$56.5 million for the same period in 2023[156]. - Research and development expenses for the three months ended December 31, 2024, were $48.0 million, up from$42.8 million in the same period in 2023, reflecting an increase of $5.2 million[157]. - The company reported a net loss of$66.3 million for the three months ended December 31, 2024, compared to a net loss of $51.1 million for the same period in 2023, representing an increase in loss of$15.2 million[156]. - Selling, general and administrative expenses increased to $46.8 million for the nine months ended December 31, 2024, up from$43.6 million in the same period of 2023, reflecting a rise of approximately 7.3%[166]. - Research and development expenses for the nine months ended December 31, 2024, were $135.5 million, compared to$132.4 million for the same period in 2023, marking an increase of about 2.3%[163]. - Total operating expenses for the nine months ended December 31, 2024, were $182.3 million, up from$176.0 million in 2023, representing a rise of approximately 3.6%[162]. - The company incurred a net loss of $173.2 million for the nine months ended December 31, 2024, compared to a net loss of$160.7 million for the same period in 2023, reflecting an increase in loss of approximately 7.8%[162]. - Investment income decreased by approximately $2.7 million year over year, attributed to a lower cash and investment balance due to normal cash burn[167]. - The company raised$252.5 million in net cash from financing activities during the nine months ended December 31, 2024, compared to $16.4 million in the same period of 2023, indicating a significant increase in financing[176][177]. Research and Development - Direct research and development costs for the RP1 program decreased by$1.9 million to $10.6 million due to reduced enrollment in ongoing studies[158]. - Personnel-related costs within research and development increased by$3.7 million, contributing to the overall rise in unallocated expenses[157]. - The company anticipates continued increases in selling, general, and administrative expenses as it prepares for potential commercialization of product candidates[148]. - Research and development incentives from the UK government reimburse up to 14.5% of qualifying expenditures, contributing to other income[149]. - The company has not generated any revenue from product sales to date, as it lacks approved products[134]. - Future profitability remains uncertain due to risks associated with pharmaceutical product development and the need for additional capital[132]. - The company is unable to estimate the timing and amounts of increased capital outlays and operating expenses for the development of RP1 and other product candidates due to numerous risks and uncertainties[180]. - Future capital requirements will include conducting clinical trials for RP1, RP2, and RP3, further preclinical development of the RPx platform, and maintaining the in-house manufacturing facility[180]. - The company does not currently have any committed external source of funds, and raising additional capital may dilute shareholders' interests[182]. - If additional funds are not raised, the company may need to delay or terminate product development programs or commercialization efforts[183]. Collaborations and Agreements - The company entered into a Clinical Trial Collaboration and Supply Agreement with BMS, which provides nivolumab for use in combination with RP1 at no cost[185]. - A Master Clinical Trial Collaboration and Supply Agreement with Regeneron involves conducting clinical trials with cemiplimab, with costs split equally between the parties[189]. - The company announced a collaboration with Roche for RP2 and RP3 programs in colorectal cancer and hepatocellular carcinoma, sharing costs and retaining commercialization rights[192]. - A Clinical Trial Collaboration and Supply Agreement with Incyte was initiated, but was terminated after Incyte discontinued development of its oral PD-L1 inhibitor[193]. - The company has not recorded any cost-sharing reimbursements from Regeneron related to the initial study plan, as reimbursements have completed[190]. Accounting and Financial Reporting - The company’s financial statements are prepared in accordance with generally accepted accounting principles, requiring estimates and assumptions that may affect reported amounts[195].