Soleno Therapeutics (SLNO) 2025 Conference September 03, 2025 01:00 PM ET Company ParticipantsAnish Bhatnagar - CEO & ChairmanJim Mackaness - CFOConference Call ParticipantsKristen Kluska - Equity Research AnalystKristen KluskaOkay. Hi. Good afternoon everybody. This is Kristen Kluska at Cantor.Very happy to be hosting Cellino Therapeutics. We have Doctor. Nager, the CEO, and Jim McInnes, the CFO. Thank you both so much for being here. Really appreciate it.Anish BhatnagarThank you for having us, Christian.K ...

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]

Financial Data and Key Metrics Changes - The company used $32.8 million in cash for operating activities during Q1 2025, ending the period with $290 million in cash, cash equivalents, and marketable securities, down from $318.6 million as of December 31, 2024 [18] - Research and development expenses for Q1 2025 were $13.5 million, compared to $14.6 million in the same period of 2024 [19] - Selling, general, and administrative expenses for Q1 2025 were $29.3 million, up from $8.5 million in Q1 2024 [19] - The net loss for Q1 2025 was approximately $43.8 million, or $0.95 per share, compared to a net loss of $21.4 million, or $0.59 per share, in Q1 2024 [20] Business Line Data and Key Metrics Changes - The company had not yet commercialized VICAT XR in Q1 2025, resulting in no revenue for the period [19] - As of the end of the reporting period, the company received 268 start forms for VICAT XR in 29 business days since FDA approval [14] Market Data and Key Metrics Changes - The addressable market for VICAT XR in the U.S. is estimated at approximately 10,000 individuals diagnosed with Prader Willi syndrome (PWS) [11] - The company estimates that there are about 9,500 patients with PWS in the EU and the UK, with plans to submit a Marketing Authorization Application (MAA) to the EMA in the first half of the year [22] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for hyperphagia in PWS and is focused on operational excellence and communicating the drug's value proposition [12] - The company is committed to ensuring that VICAT XR is accessible to all eligible patients and has set up a patient services contact point to assist with payer access [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early response from the PWS community to the availability of VICAT XR in the U.S. but cautioned that revenue generation would take time due to the typical lag in commercial launches [24] - The company anticipates modest revenues for Q2 2025 as they navigate the process of converting start forms into actual sales [28] Other Important Information - The company has secured an additional $75 million under a loan agreement to support operations over the next 18 months following the approval of VICAT XR [18] - The company is actively participating in payer outreach to emphasize the complexity of hyperphagia in PWS patients and the need for new therapeutic options [16] Q&A Session Summary Question: How soon can start forms be converted into revenue? - Management indicated that several steps are involved in converting start forms into revenue, and they expect modest revenues for Q2 [28] Question: What percentage of Phase III program patients are reflected in current start forms? - The majority of the 77 patients from the Phase III program have submitted start forms, with 60 of those in the U.S. [33] Question: How does coverage differ on a state-by-state level? - The company is participating in the Medicaid program, with states varying in their timelines for policy decisions [40] Question: What is the competitive landscape for hyperphagia treatments? - The main competitor is ACADIA with Carbitocin, which has faced regulatory challenges, while another competitor is starting a Phase III study [77] Question: How does the company view the European market opportunity? - The company sees significant potential in Europe, with a similar number of PWS patients as in the U.S. and a strong unmet need for treatment [80]