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Replimune Group, Inc.
10/28/2026
Good day, and thank you for standing by. Welcome to the Repute Immune's second quarter fiscal 2027 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to your first speaker, Arlene Goldenberg. Head of Investor Relations, please go ahead.
Thank you, Operator, and good morning, everyone. Thank you for joining us for RepliMune's earnings call following the launch of TutraKev. Earlier today, we issued a press release reporting our financial results for the fiscal second quarter ended September 30, 2026. The release accompanying today's webcast is available in the Investors section of our website at RepliMune.com. With me on today's call are Sushil Patel, our Chief Executive Officer, Michelle DiNapoli, our Chief Commercial Officer, and Emily Hill, our Chief Financial Officer. Before we begin, I'd like to remind everyone that today's remarks include forward-looking statements within the meaning of the federal securities laws. Items we discuss today will include forward-looking statements about topics including, but not limited to, our future financial performance, Projections and Assumptions about the Commercial Launch of Tudrakev and Management's Plans and Objectives for Future Operations. Actual results may differ materially from those presented or implied by these forward-looking statements and are subject to risks and uncertainties that could cause actual results to differ. We encourage you to review the risk factors in our most recent Form 10-K and Form 10-Q on file with the Securities and Exchange Commission. Any forward-looking statements that we make on this call are based on our assumptions as of today. Unless required by law, we undertake no obligation to update or revise these statements as a result of new information or future events. With that, I'll turn the call over to Sushil.
Thank you, Arlene, and thank you for joining us today. This is a defining moment for RepRimmune. TutorCav is the first commercial product from our RPX platform. We are excited to now be delivering 2D-CAP to patients, and its availability has been met with excitement from the melanoma community. We are very encouraged by the early traction, and in just the first three weeks since launch, a number of leading melanoma institutions have already ordered, and many others have identified patients to treat. The unmet need and demand are clearly there. Most of our prepared remarks on this call will focus on the commercial launch, including how we will track progress, and our plans to bring Tuja Kev to as many patients as possible. Michelle will provide more detail in a few moments. Importantly, the Tuja Kev broad label reflects how physicians prescribe and they're enthusiastic about it. It allows them to treat a range of patients progressing on PD-1 based therapy with no requirement for prior BRAF targeted therapy. Since approval, we have moved with urgency and focused on the following three priorities. First, and most importantly, meeting the unmet need of patients and the physicians who treat them. There are approximately 10,000 addressable patients in the U.S., and nearly 8,500 patients die of melanoma every year. Once patients fail PD-1-based therapy, treatment options are very limited, and we are seeing real urgency from healthcare providers to gain access to TutorCare. Next, ensuring supply is ready and getting product to patients quickly with next-day delivery. We are ready to meet the demand with more than a year of inventory on hand produced at our in-house manufacturing facility. Finally, we are focused on attracting top talent to rebuild our commercial team. We are now almost fully staffed and right-sized to execute our launch plan. With that, I'll turn it over to our Chief Commercial Officer, Michelle.
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