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]

PART I [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company began generating product revenue from VYKAT XR in Q2 2025, leading to a net loss of $48.5 million for the first six months of 2025 due to commercial launch costs, while total assets slightly increased to $332.3 million [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a slight increase in total assets to $332.3 million as of June 30, 2025, with new current assets from the VYKAT XR commercial launch Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $76,497 | $87,928 | | Marketable securities | $217,346 | $230,720 | | Total current assets | $316,789 | $293,889 | | Total assets | $332,306 | $330,972 | | **Liabilities & Equity** | | | | Total current liabilities | $20,943 | $18,747 | | Long-term debt, net | $49,845 | $49,828 | | Total liabilities | $92,166 | $85,859 | | Total stockholders' equity | $240,140 | $245,113 | - The company reported new current assets of **Accounts Receivable ($24.6 million)** and **Inventory ($2.4 million)** as of June 30, 2025, following the commercial launch of VYKAT XR[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company recorded its first product revenue of $32.7 million in Q2 2025, but increased selling, general, and administrative expenses led to a net loss of $48.5 million for the first six months of 2025 Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $32,657 | $— | $32,657 | $— | | Total operating expenses | $39,182 | $24,868 | $84,925 | $48,343 | | Research and development | $9,147 | $12,342 | $22,664 | $26,944 | | Selling, general and administrative | $28,238 | $10,889 | $57,497 | $19,361 | | Operating loss | $(6,525) | $(24,868) | $(52,268) | $(48,343) | | Net loss | $(4,708) | $(21,854) | $(48,481) | $(43,252) | | Net loss per share, basic and diluted | $(0.09) | $(0.57) | $(1.00) | $(1.16) | - The company began generating product revenue in Q2 2025, recording **$32.7 million** following FDA approval of VYKAT XR, which was accompanied by a significant increase in Selling, General and Administrative expenses to support the commercial launch[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $45.4 million for the first six months of 2025, while investing activities provided cash and financing activities contributed $18.9 million Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(45,360) | $(30,179) | | Net cash provided by (used in) investing activities | $15,022 | $(236,165) | | Net cash provided by financing activities | $18,907 | $153,687 | | **Net decrease in cash and cash equivalents** | **$(11,431)** | **$(112,657)** | - Net cash used in operating activities increased to **$45.4 million** in the first six months of 2025 from **$30.2 million** in the prior year period, primarily due to costs associated with the commercial launch of VYKAT XR[16](index=16&type=chunk) - Financing activities in the first half of 2025 provided **$18.9 million**, mainly from the exercise of stock options and warrants, compared to **$153.7 million** in the same period of 2024 which included proceeds from a common stock sale[16](index=16&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the FDA approval and commercial launch of VYKAT XR, the company's liquidity position, debt agreements, and revenue recognition policies - The company's lead product, **VYKAT XR**, received FDA approval on March 26, 2025, for treating hyperphagia in patients with Prader-Willi syndrome (PWS), with revenue recognition beginning in Q2 2025[18](index=18&type=chunk) - As of June 30, 2025, the company held **$76.5 million** in cash and cash equivalents and **$217.3 million** in marketable securities, which management deems sufficient to meet obligations for at least the next twelve months[19](index=19&type=chunk)[24](index=24&type=chunk) - The company has a loan agreement with Oxford for up to **$200 million**, with **$50 million** outstanding as of June 30, 2025, and an additional **$50 million** available upon FDA approval of VYKAT XR[20](index=20&type=chunk)[66](index=66&type=chunk) - Subsequent to the quarter end, in July 2025, the company closed an underwritten public offering of common stock, raising gross proceeds of **$230.0 million**[23](index=23&type=chunk)[103](index=103&type=chunk) - Product revenue is recognized upon transfer of control to its single specialty pharmacy customer, with net revenue including estimates for variable consideration totaling **$4.3 million** in provisions for the six months ended June 30, 2025[34](index=34&type=chunk)[35](index=35&type=chunk)[38](index=38&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity following VYKAT XR's FDA approval, highlighting initial product revenue of $32.7 million in Q2 2025, increased SG&A expenses for launch, and strengthened liquidity from a recent $230 million public offering [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company's results reflect the commercial launch of VYKAT XR, with new product revenue offset by significantly increased selling, general, and administrative expenses Comparison of Three Months Ended June 30, 2025 and 2024 (in thousands) | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $32,657 | $— | $32,657 | 100% | | Research and development | $9,147 | $12,342 | $(3,195) | (26%) | | Selling, general and administrative | $28,238 | $10,889 | $17,349 | 159% | | Net loss | $(4,708) | $(21,854) | $17,146 | (78%) | - For Q2 2025, R&D expenses decreased by **$3.2 million (26%)** YoY due to lower costs for the NDA submission, while SG&A expenses increased by **$17.3 million (159%)** YoY, driven by hiring and program costs for the commercial launch of VYKAT XR[121](index=121&type=chunk)[122](index=122&type=chunk) Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $32,657 | $— | $32,657 | 100% | | Research and development | $22,664 | $26,944 | $(4,280) | (16%) | | Selling, general and administrative | $57,497 | $19,361 | $38,136 | 197% | | Net loss | $(48,481) | $(43,252) | $(5,229) | 12% | - For the first six months of 2025, SG&A expenses increased by **$38.1 million (197%)** YoY, reflecting a **$15.3 million** increase in personnel costs and a **$12.6 million** increase in commercial launch program costs[131](index=131&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a strong liquidity position with substantial cash and marketable securities, further bolstered by available debt and a recent public offering - As of June 30, 2025, the company had **$76.5 million** in cash and cash equivalents and **$217.3 million** in marketable securities, with a working capital of **$295.8 million**[134](index=134&type=chunk) - The company has access to additional capital through its loan agreement with Oxford, with **$50 million** available through September 30, 2025, and further tranches available upon meeting certain milestones[135](index=135&type=chunk) - In July 2025, the company raised gross proceeds of **$230.0 million** from a public offering of common stock, further strengthening its capital position[137](index=137&type=chunk) - Management believes that existing cash, cash equivalents, and marketable securities are sufficient to meet working capital needs for the next twelve months[138](index=138&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there have been no material changes to its exposure to market risk during the six months ended June 30, 2025, as compared to the disclosures in its 2024 Annual Report on Form 10-K - There have been no material changes to the company's market risk exposure during the first six months of 2025[148](index=148&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of June 30, 2025, due to a material weakness in IT general controls, for which a remediation plan is being implemented - Management concluded that disclosure controls were not effective as of June 30, 2025, due to a material weakness in internal control[151](index=151&type=chunk) - The material weakness relates to ineffective design and operation of controls over certain **information technology general controls (ITGCs)**, including segregation of duties, program change management, and user access controls[152](index=152&type=chunk) - The company is implementing a remediation plan that includes hiring additional personnel, enhancing training, and improving oversight of IT controls[154](index=154&type=chunk)[157](index=157&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it may be party to litigation in the ordinary course of business but currently believes these matters will not have a material adverse effect - The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its business[159](index=159&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks primarily from its dependence on the commercial success of VYKAT XR, alongside financial, operational, intellectual property, and regulatory challenges, including potential stock price volatility - The company is highly dependent on the commercial success of its sole FDA-approved product, **VYKAT XR**[164](index=164&type=chunk) - The company has a limited commercialization history, has incurred significant losses since inception, and may need additional funds to support operations[162](index=162&type=chunk)[167](index=167&type=chunk) - Market acceptance of **VYKAT XR** by physicians, patients, and payers is critical for commercial success and is not guaranteed[187](index=187&type=chunk) - The company relies on sole source suppliers for manufacturing and a single specialty pharmacy for initial U.S. distribution, posing supply chain and commercialization risks[236](index=236&type=chunk)[240](index=240&type=chunk) - The company faces risks from potential intellectual property infringement claims and challenges in maintaining and enforcing its own patent rights[245](index=245&type=chunk)[251](index=251&type=chunk) - Ongoing regulatory obligations, healthcare reform measures like the **Inflation Reduction Act**, and compliance with fraud and abuse laws present significant challenges[292](index=292&type=chunk)[307](index=307&type=chunk)[314](index=314&type=chunk)

Soleno used $12.6 million of cash in its operating activities during the three months ended June 30, 2025, and had $293.8 million of cash, cash equivalents and marketable securities as of the end of the quarter. Cash as of the end of the second quarter excludes $230 million of gross proceeds that the company raised in July through an underwritten offering of common stock. Product revenue, net was $32.7 million for the three months ended June 30, 2025. VYKAT XR had not been approved or commercially launched ...

| Date: | Wednesday, August 6, 2025 | | --- | --- | | Time: | 4:30 PM Eastern Time | | United States: | 1-800-717-1738 | | International: | 1-646-307-1865 | | Conference ID: | 96180 | | Webcast: | Link | The conference call will be broadcast live and will be available for replay for 30 days on the Company's website, www.soleno.life. INDICATION REDWOOD CITY, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ("Soleno") (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics ...

Company Overview - Soleno Therapeutics, Inc. (SLNO) currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3][12] - The company has a Zacks Rank of 2 (Buy), suggesting favorable market performance [4][12] Price Performance - SLNO shares have increased by 6.91% over the past week, while the Zacks Medical - Drugs industry has decreased by 0.38% during the same period [6] - Over the past quarter, SLNO shares have risen by 17.34%, and they have gained 87.5% over the last year, outperforming the S&P 500's increases of 16.43% and 18.63%, respectively [7] Trading Volume - The average 20-day trading volume for SLNO is 1,461,273 shares, which is a useful indicator of market interest and price movement [8] Earnings Outlook - In the past two months, three earnings estimates for SLNO have been revised upwards, while none have been revised downwards, leading to an increase in the consensus estimate from -$3.09 to -$2.33 [10] - For the next fiscal year, two estimates have moved upwards with no downward revisions, indicating positive sentiment regarding future earnings [10]

Group 1 - Soleno Therapeutics, Inc. (SLNO) shares have increased by 2.2% over the past four weeks, closing at $86.02, with a mean price target of $114.5 indicating a potential upside of 33.1% [1] - The average price targets from analysts range from a low of $97.00 to a high of $145.00, with a standard deviation of $15.46, suggesting a variability in estimates [2] - Analysts show strong agreement on SLNO's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for SLNO's current year earnings has increased by 25.8% over the past month, with three estimates revised higher and no negative revisions [12] - SLNO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While consensus price targets may not be reliable for predicting the extent of gains, they can provide a directional guide for price movement [14]

Core Viewpoint - Soleno Therapeutics, Inc. has announced a public offering of 2,352,941 shares of common stock priced at $85.00 per share, aiming to raise approximately $200 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 2,352,941 shares, with an additional 30-day option for underwriters to purchase up to 352,941 more shares at the same price [1]. - The offering is expected to close on or about July 11, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds will primarily fund the commercialization of VYKAT XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Additional proceeds will support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3]. Group 3: Underwriters - Goldman Sachs & Co. LLC, Guggenheim Securities, TD Cowen, Cantor, and Oppenheimer & Co. are serving as joint book-running managers for the offering [2]. Group 4: Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product aimed at treating hyperphagia in individuals aged 4 and older with Prader-Willi syndrome [6].

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Item 2.02 Results of Operations and Financial Conditions](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Conditions) Soleno Therapeutics, Inc. announced preliminary Q2 2025 results via a press release, furnished as Exhibit 99.1, not "filed" under Section 18 - The company issued a press release on **July 10, 2025**, announcing preliminary financial results and operating metrics for the **three months ended June 30, 2025**[4](index=4&type=chunk) - Information furnished under Item 2.02, including Exhibit 99.1, is not deemed "filed" for Section 18 of the Exchange Act, nor incorporated by reference unless explicitly stated[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits filed with the Form 8-K, including the press release and interactive data file Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release issued by Soleno Therapeutics, Inc., dated July 10, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=Signatures) The report was officially signed on **July 10, 2025**, by Anish Bhatnagar, Chief Executive Officer - The report was signed on **July 10, 2025**, by **Anish Bhatnagar**, Chief Executive Officer[11](index=11&type=chunk)

Core Viewpoint - Soleno Therapeutics, Inc. plans to offer and sell $200 million of its common stock in an underwritten public offering, with an additional option for underwriters to purchase up to $30 million more [1][2]. Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding the completion or terms of the offering [1]. - Goldman Sachs & Co. LLC and Guggenheim Securities are acting as the joint book-running managers for the offering [2]. - The shares will be offered under a registration statement previously filed with the SEC, and a preliminary prospectus will be made available [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund the commercialization of VYKAT™ XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Proceeds will also support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3][6].