Replimune(US:REPL)2025-11-06 13:07Clinical Trials and Research - The company is conducting the IGNYTE trial, which includes 140 patients with anti-PD-1 failed cutaneous melanoma, showing a confirmed overall response rate (ORR) of 32.9% and a median duration of response of 33.7 months[114]. - The company plans to enroll up to 400 patients in the confirmatory IGNYTE-3 trial, assessing RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD-1 and anti-CTLA-4 therapies[117]. - In the non-melanoma skin cancer cohort of the IGNYTE trial, the combination of RP1 and nivolumab led to an ORR of 30%, with 60% of patients demonstrating clinical benefit[119]. - The ARTACUS trial is open for enrollment, assessing RP1 monotherapy in solid organ transplant recipients with skin cancers, showing an ORR of 34.5% and a complete response rate of 21% in initial data[120]. - 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[123]. - The disease control rate for the mUM cohort was reported at 58.8%[123]. - The REVEAL study aims to enroll approximately 280 patients to evaluate RP2 in combination with nivolumab versus ipilimumab in mUM patients who are immune checkpoint inhibitor-naïve[124]. - The company plans to release preliminary data for the HCC trial by the end of 2026, with ongoing enrollment in the signal finding trial[125]. Regulatory and Development Status - The FDA accepted the biologics license application (BLA) for RP1 in combination with nivolumab, with a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2025, but issued a complete response letter (CRL) on July 21, 2025, indicating the trial was not adequately controlled[115]. - The company has received Breakthrough Therapy designation from the FDA for RP1 in combination with nivolumab for advanced melanoma[115]. - The company is evaluating feedback from the FDA regarding the CRL to determine next steps for the RP1 development program[116]. - The company plans to close enrollment in the non-melanoma skin cancer cohort in the fourth quarter of 2025[119]. Financial Performance - The company has raised approximately $1,101.8 million in net proceeds since its IPO on July 20, 2018, with $101.2 million from the IPO and $862.0 million from four follow-on offerings[129]. - Net losses for the three months ended September 30, 2025, were $83.1 million, compared to $53.1 million for the same period in 2024[130]. - As of September 30, 2025, the accumulated deficit stood at $1,118.4 million, primarily due to research and development costs[130]. - Cash and cash equivalents and short-term investments totaled $323.6 million as of September 30, 2025, expected to fund operations for at least 12 months[133]. - For the three months ended September 30, 2025, total operating expenses were $84.3 million, an increase of $25.4 million from $58.9 million in the same period in 2024[157]. - Research and development expenses for the three months ended September 30, 2025, were $57.9 million, up from $43.4 million in 2024, reflecting a $14.4 million increase[158]. - Selling, general and administrative expenses rose to $26.4 million for the three months ended September 30, 2025, compared to $15.5 million in 2024, marking a $10.9 million increase[160]. - For the six months ended September 30, 2025, total operating expenses were $174.7 million, an increase of $58.4 million from $116.3 million in 2024[163]. - Research and development expenses for the six months ended September 30, 2025, were $115.7 million, compared to $86.4 million in 2024, reflecting a $29.3 million increase[164]. - Selling, general and administrative expenses for the six months ended September 30, 2025, were $59.0 million, up from $29.9 million in 2024, indicating a $29.1 million increase[166]. - The company has not generated any revenue from product sales to date, as no products have been approved for sale[134]. - The company has not generated any revenue from product sales and has incurred significant operating losses and negative cash flows from operations[168]. Cash Flow and Financing - For the six months ended September 30, 2025, net cash used in operating activities was $158.2 million, compared to $87.8 million for the same period in 2024, reflecting an 80% increase in cash outflow[171][172]. - Net cash provided by investing activities for the six months ended September 30, 2025, was $149.2 million, significantly higher than $30.2 million in 2024, indicating a substantial increase in cash inflows from investments[173][174]. - Net cash provided by financing activities was only $0.2 million for the six months ended September 30, 2025, a sharp decline from $96.6 million in 2024, primarily due to reduced financing activities[175][176]. - As of September 30, 2025, the company had cash and cash equivalents and short-term investments totaling $323.6 million, which is expected to fund operations into the fourth quarter of 2026[179]. - The company has financed its operations primarily through the sale of equity securities, receiving net proceeds of $1,101.8 million through various offerings[169]. Risks and Uncertainties - The company acknowledges the risks and uncertainties associated with the development of its product candidates, which may impact future capital requirements and operational expenses[180]. - The company may determine that the continued development of RP1 is not viable, which could lead to uncertainty in future plans and expenses[178]. - The company has no committed external source of funds and may face dilution of shareholder interest if additional capital is raised through equity or convertible debt securities[181]. - Recently issued accounting pronouncements may impact the company's financial position and results of operations[196]. Collaborations and Partnerships - The collaboration with BMS involves the provision of nivolumab for clinical trials at no cost, with the company retaining rights to the study data related to RP1[185][186]. - The agreement with Roche has been modified to focus solely on the 2L cohort in HCC, with Roche continuing to supply approved drugs but not sharing costs[188]. Operational Activities - The company collaborates with CROs for research activities and clinical trials[197]. - The company engages CMOs for the production of preclinical and clinical trial materials[197]. - Investigative sites and service providers are utilized for conducting clinical trials[197]. - Vendors are involved in preclinical and clinical development activities[197]. - Vendors are also related to product manufacturing and distribution of clinical supplies[197].