Replimune Group (REPL) 2025 Conference Summary Company Overview - **Company**: Replimune Group (REPL) - **Event**: Jefferies 2025 Healthcare Global Conference - **Date**: June 5, 2025 Key Updates and Core Points 1. **Regulatory Progress**: The company is on track for a PDUFA date on July 22, having completed late cycle meetings and manufacturing inspections, with label negotiations forthcoming [11][61][63] 2. **ASCO Data Highlights**: At the ASCO meeting, Replimune presented data showing RP1's systemic activity in visceral lesions, with increased response rates in deep lesions compared to superficial ones, supporting the hypothesis of enhanced patient outcomes [12][14][19] 3. **Safety Profile**: The safety profile of RP1 was emphasized, with no increased bleeding rates from liver injections and manageable pneumothorax from lung injections, which is crucial for physician confidence [13][14] 4. **Commercialization Strategy**: The company is focusing on logistics and biosafety for RP1, indicating that standard cleaning procedures are sufficient for handling the product, which is not classified as an airborne virus [15][16] 5. **Physician Engagement**: Key opinion leaders (KOLs) are shifting their focus to incorporating RP1 into their practices, with a significant portion of patients having deeper lesions that require image guidance for treatment [19][20] 6. **Market Targeting**: Replimune plans to target approximately 350 accounts in the U.S. that treat over half of melanoma patients, with an initial focus on 150 high-volume accounts for rapid adoption [24][46] 7. **Payer Engagement**: The reimbursement model is favorable, with existing procedural codes supporting the use of RP1, and payers recognizing the unmet need in the disease setting [32][33] 8. **Commercial Infrastructure**: The company has established a commercial team of about 60 people, including sales representatives and interventional radiology coordinators, to support the launch and ensure effective communication with healthcare providers [71][72] 9. **Future Expansion Plans**: Replimune is exploring additional indications for RP1, including non-melanoma skin cancers and earlier disease settings, with ongoing trials in uveal melanoma [80][82] Additional Important Insights 1. **Clinical Trial Insights**: The IGNITE study showed a consistent efficacy response across various patient subgroups, reinforcing the potential for a broad label upon approval [66][68] 2. **Interventional Radiology Role**: Interventional radiologists are expected to play a critical role in the treatment process, with a growing interest in active treatment options like RP1 [53][55] 3. **Operational Efficiency**: The company has managed to keep operational expenses (OpEx) in check, with favorable cost of goods sold (COGS) due to in-house manufacturing capabilities [76][78] 4. **Patient-Centric Approach**: The treatment plan allows flexibility in lesion selection and injection sequence, emphasizing a practical approach to patient care [21][29] This summary encapsulates the key points discussed during the Replimune Group conference, highlighting the company's strategic direction, regulatory progress, and market engagement efforts.

Soleno Therapeutics (SLNO) Conference February 06, 2025 02:00 PM ET Company Participants Debjit Chattopadhyay - Managing DirectorAnish Bhatnagar - CEO Debjit Chattopadhyay Alright. Good afternoon, and, thank you for joining Guggenheim's second SMITCAP conference. I'm Devjit, one of the therapeutic analysts here. And on stage with me today is doctor Anish Vatnagar, CEO of Cellino Therapeutics. Anish, thank you for your time, and maybe we can get started very quickly on the regulatory front. Anish Bhatnagar T ...