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.

Summary of Soleno Therapeutics (SLNO) Conference Call - February 06, 2025 Company Overview - **Company**: Soleno Therapeutics (SLNO) - **Participants**: Anish Bhatnagar (CEO), Debjit Chattopadhyay (Managing Director) Key Points Regulatory Updates - The PDUFA date has been delayed from December 27 to March 27, 2025, primarily due to the volume of information provided in response to FDA inquiries [2][4] - No major new questions have been raised by the FDA, and inspections have occurred without any Form 483s issued [5][4] - The company is not expecting any earlier decisions than the March 27 PDUFA date [9][10] Market and Product Launch - Soleno is prepared to launch the drug shortly after the PDUFA date, with expectations to have the product in channels by May 2025 [10][11] - Consensus estimates for first-year sales have not fully adjusted for the PDUFA delay, indicating potential underestimation of market entry timing [11] - The target market size is estimated to be between 7,000 to 12,000 patients, with Soleno projecting around 10,000 patients likely to be on label [12][13] Patient Demographics and Targeting - Approximately 300 healthcare providers are expected to influence prescriptions for about 4,000 patients, representing 40% of the total addressable market (TAM) [15] - The company plans to utilize a combination of field sales, targeted outreach to group homes, and digital marketing to reach patients effectively [16][17] Pricing Strategy - While specific pricing details are not disclosed, the expected range is between $300,000 to $400,000, with weight-based dosing likely influencing final pricing [19][20] - The company is conducting extensive research on pricing analogs and market dynamics [19] Compliance and Patient Management - Compliance is expected to be manageable due to the nature of the patient population, particularly in group home settings where staff can assist with medication adherence [24][25] - An estimated 10% of the target patient population resides in group homes [26] European Market Strategy - Soleno plans to submit for approval in Europe in the first half of 2025, with potential for direct commercial infrastructure in the EU due to favorable market conditions [29][30] - The company is exploring partnerships for ex-US commercialization but has not made definitive decisions yet [31] Intellectual Property and Competition - The company anticipates a minimum of seven years of patent protection, with potential extensions available [36] - The competitive landscape includes Acadia's drug, which has faced regulatory challenges, suggesting limited immediate competition for Soleno [37][38] Future Directions - Soleno is evaluating additional indications for its drug DCCR, focusing on diseases associated with hyperphagia and hypoglycemia [39][40] - The current strategy remains focused on DCCR, with potential for licensing new molecules in the future [42] Additional Insights - The company is optimistic about the demand for its product, driven by advocacy from families and caregivers [17] - The CEO emphasized the importance of successfully launching DCCR before considering further licensing opportunities [42]