Financial Data and Key Metrics Changes - Total net revenue for Q2 2025 was $32.7 million, reflecting strong demand for VICAT XR, compared to no revenue in Q2 2024 [20][21] - The company used $12.6 million in cash for operating activities during the quarter and had cash, cash equivalents, and marketable securities of approximately $293.8 million at the end of the quarter [20][21] - The net loss for Q2 2025 was approximately $4.7 million, or $0.09 per share, compared to a net loss of $21.9 million, or $0.57 per share, in Q2 2024 [22] Business Line Data and Key Metrics Changes - VICAT XR was launched in March 2025, becoming the first FDA-approved treatment for hyperphagia in patients with Prader-Willi syndrome (PWS) [7][8] - The company received 646 patient start forms from launch through June 30, 2025, with a majority of patients aged between 4 and 26 years [14][15] - The number of unique prescribers reached 295, with over a third of the top 300 prescribers actively writing prescriptions [15][18] Market Data and Key Metrics Changes - Approximately 33% of all insured lives in the U.S. are now covered for VICAT XR, representing over 100 million lives [18] - The company is actively engaging with payers to establish broad reimbursement coverage, which is a high priority moving forward [9][18] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for PWS-related hyperphagia and is focused on expanding its market presence in Europe [24][10] - Plans for potential approval of DCCR in Europe are underway, with a marketing authorization application submitted to the EMA [10][12] - The company is considering both standalone and partnership approaches for commercialization in Europe, leveraging its strong cash position of over $500 million [20][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for VICAT XR and its potential to become a long-term therapy for PWS patients [27][28] - The company is optimistic about the trajectory of patient starts and prescriber engagement, indicating a strong launch momentum [24][44] - Management acknowledged the need for ongoing monitoring of safety data in the post-marketing setting, with no new safety signals reported so far [41][42] Other Important Information - The cost of goods sold for Q2 2025 was $700,000, with research and development expenses at $9.1 million, reflecting a decrease from the previous year [21][22] - Selling, general, and administrative expenses for the quarter were $28.2 million, indicating increased investment in personnel and programs to support the VICAT XR launch [22] Q&A Session Summary Question: How do you see monthly scripts in July compared to earlier months? - Management refrained from discussing data post-quarter end but expressed confidence in VICAT XR becoming the standard of care for PWS [27] Question: Are there any emerging pain points during the patient start form process? - Management noted a strong start with 646 patient starts and indicated that the next couple of quarters will be educational regarding potential pain points [33] Question: What are the early compliance trends tracking? - Early data suggests discontinuation rates are lower than those seen in clinical trials, indicating strong compliance [36] Question: Can you comment on safety based on real-world evidence? - No new safety signals have been observed in the post-marketing setting, and discontinuation rates remain low [41][42] Question: What is the breakdown of revenue trends for the rest of the year? - Management indicated that while the start was strong, normalization may occur in the coming quarters [44] Question: Are there any patterns in patient severity for those receiving VICAT XR? - Management does not actively collect severity data but suspects a mix of motivated families and physician referrals are driving early prescriptions [61] Question: What are the plans for expanding the portfolio beyond VICAT XR? - The company is currently focused on the launch of VICAT XR but may consider diversification in the long term [81]

Financial Data and Key Metrics Changes - Total net revenue for Q2 2025 was $32.7 million, reflecting strong demand for VICAT XR, compared to no revenue in Q2 2024 [19][20] - The company used $12.6 million in cash for operating activities during the quarter and had cash, cash equivalents, and marketable securities of approximately $293.8 million at the end of the quarter [19][20] - The net loss for Q2 2025 was approximately $4.7 million, or $0.09 per share, compared to a net loss of $21.9 million, or $0.57 per share, in Q2 2024 [21][22] Business Line Data and Key Metrics Changes - The commercial launch of VICAT XR for treating hyperphagia in Prader Willi syndrome (PWS) began on April 14, 2025, following FDA approval on March 26, 2025 [6][7] - The company received 646 patient start forms from launch through June 30, 2025, with a majority of patients aged between 4 and 26 years [14][15] - There were 295 unique prescribers for VICAT XR, with over a third of the top 300 prescribers already writing prescriptions [15][16] Market Data and Key Metrics Changes - Approximately 33% of all insured lives in the U.S. are now covered for VICAT XR, representing over 100 million lives [17][18] - The company is actively engaging with payers to establish broad reimbursement for VICAT XR, which is a high priority moving forward [8][17] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for PWS-related hyperphagia and is focused on expanding its market presence in Europe [22][10] - Plans for potential approval of DCCR in Europe are underway, with a marketing authorization application submitted to the EMA [10][12] - The company is considering both standalone and partnership approaches for commercialization in Europe, leveraging its strong cash position of over $500 million [19][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for VICAT XR and its potential to become the standard therapy for PWS [25][22] - The company is optimistic about the trajectory of patient starts and prescriber engagement, indicating a strong launch momentum [22][19] - Management acknowledged the need for continued monitoring of safety data in the post-marketing setting, with no new safety signals reported so far [37][38] Other Important Information - The company raised an additional $230 million through an underwritten offering of common stock after the quarter ended, enhancing its financial position [19] - Research and development expenses for Q2 2025 were $9.1 million, down from $12.3 million in the same period of 2024, reflecting a shift in focus towards commercialization [20][21] Q&A Session Summary Question: How do you see monthly scripts in July compared to earlier months? - Management refrained from discussing data post-quarter end but expressed confidence in VICAT XR becoming the standard of care for PWS [25] Question: Are there any emerging pain points during the patient start form process? - Management noted a strong start with 646 patient starts and indicated that the next couple of quarters will provide more insights into potential pain points [30] Question: What are the early compliance trends tracking? - Early data suggests discontinuation rates are lower than in clinical trials, indicating strong compliance among patients [32] Question: Can you comment on safety based on real-world evidence? - Management reported no new safety signals in the post-marketing setting, consistent with clinical trial data [38] Question: What is the breakdown of revenue trends for the rest of the year? - Management indicated that while Q2 was strong, normalization may occur in the coming quarters [39] Question: Are there any concerns regarding prescribers deploying VICAT XR in patients with diabetes? - Management stated that controlled diabetes should not deter prescribers from using VICAT XR, but uncontrolled diabetes may raise concerns [78] Question: Is the company considering expanding its portfolio beyond VICAT XR? - Management confirmed a focus on VICAT XR for now but acknowledged the need for future diversification [79]

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]