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Soleno Therapeutics Inc (SLNO)
NASDAQ:SLNO
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Soleno Therapeutics
(NASDAQ:SLNO)
Rating:37Underperform
Price Target:―
Positive Factors
FDA Approval
The FDA approval of VYKAT XR for treating hyperphagia in Prader-Willi syndrome is a significant milestone for Soleno Therapeutics.
Financial Resources
Soleno had $290M in cash and cash equivalents, with years of cash left greater than 4.0, supporting its operational sustainability.
Market Launch
The commercial launch of Vykat XR began ahead of internal forecasts with 268 patient start forms and 131 unique prescribers since approval.
Negative Factors
Financial Performance
Soleno reported a net loss of $43.8M in Q1 2025, compared to a net loss of $21.4M in 2024.
Market Risks
Risks to Soleno's success include slower-than-expected U.S. market uptake due to market access or reimbursement issues and potential long-term dilution risks.
Pricing Strategy
The disclosed annualized pricing of $466,200 represents moderate upside to the original DCCR $400K per patient annualized pricing assumption.
Soleno Therapeutics (SLNO) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$3.78B
Dividend YieldN/A
Average Volume (3M)1.06M
Price to Earnings (P/E)―
Beta (1Y)-0.51
Revenue GrowthN/A
EPS Growth-43.20%
CountryUS
Employees115
SectorHealthcare
Sector Strength44
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.95
Shares Outstanding50,393,932
10 Day Avg. Volume852,756
30 Day Avg. Volume1,061,497
Financial Highlights & Ratios
PEG Ratio0.64
Price to Book (P/B)12.90
Price to Sales (P/S)0.00
P/FCF Ratio-47.63
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$107.67Price Target Upside46.89% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering9
Soleno Therapeutics Business Overview & Revenue Model
Company DescriptionSoleno Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of novel therapeutics for the treatment of rare diseases. Its lead candidate is Diazoxide Choline Controlled-Release, a once-daily oral tablet for the treatment of Prader-Willi Syndrome, which is being evaluated in an ongoing Phase III clinical development program. The company was formerly known as Capnia, Inc. and changed its name to Soleno Therapeutics, Inc. in May 2017. Soleno Therapeutics, Inc. was incorporated in 1999 and is based in Redwood City, California.
How the Company Makes MoneySoleno Therapeutics primarily makes money through the development and potential commercialization of its core product, DCCR tablets. The company aims to generate revenue by obtaining regulatory approval for DCCR and subsequently marketing it to healthcare providers and patients. Revenue streams are anticipated to include product sales, licensing agreements, and potential partnerships with pharmaceutical companies for distribution and commercialization. Soleno's financial performance is heavily dependent on the successful clinical development, regulatory approval, and market acceptance of its therapeutic products.
Soleno Therapeutics Financial Statement Overview
Summary
Soleno Therapeutics shows typical early-stage biotech financials with no revenue and significant net losses. The balance sheet is supported by strong equity, but the reliance on external funding and negative cash flows highlight financial risks.Income Statement
Soleno Therapeutics has reported zero revenue consistently, indicating the company is yet in developmental stages with no commercialized products. The net losses have been substantial over the years, with no gross or net profit margins to evaluate, reflecting ongoing operational expenses without revenue generation. This indicates a high-risk profile typical for early-stage biotech firms.10
Very Negative
Balance Sheet
The balance sheet shows a relatively high stockholders' equity compared to total assets, indicating a solid equity base. However, the total debt is minimal, which is positive, but the lack of revenue raises concerns about sustainability. The equity ratio is strong, but the absence of revenue impacts overall financial health adversely.35
Negative
Cash Flow
Operating cash flow is negative, which is expected for a company in the biotechnology sector still in R&D phases. Free cash flow trends are also negative, highlighting ongoing cash burn without revenue inflow. Financing activities have supplemented cash flows significantly, hinting at reliance on external funding to support operations.20
Very Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| 0.00 | -1.96M | -2.21M | -2.21M | -2.19M | EBIT |
| 0.00 | -41.38M | -24.40M | -31.53M | -36.29M | EBITDA |
| 0.00 | -37.03M | -21.86M | -28.70M | -30.00M | Net Income Common Stockholders |
| -175.85M | -38.99M | -20.32M | -29.56M | -15.38M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 291.44M | 169.68M | 14.60M | 21.30M | 49.22M | Total Assets |
| 330.97M | 180.69M | 26.50M | 35.55M | 64.98M | Total Debt |
| 3.00M | 403.00K | 155.00K | 457.00K | 139.00K | Net Debt |
| -84.93M | -169.28M | -14.45M | -20.85M | -49.09M | Total Liabilities |
| 85.86M | 23.18M | 16.15M | 17.76M | 19.43M | Stockholders Equity |
| 245.11M | 157.51M | 10.35M | 17.79M | 45.55M |
| Cash Flow | Free Cash Flow | |||
| -69.31M | -24.94M | -20.79M | -27.79M | -25.23M | Operating Cash Flow |
| -69.10M | -24.94M | -20.78M | -27.77M | -25.22M | Investing Cash Flow |
| -225.68M | 0.00 | -13.00K | -22.00K | -7.00K | Financing Cash Flow |
| 213.03M | 180.02M | 14.09M | -128.00K | 53.72M |
Soleno Therapeutics Technical Analysis
Neutral
73.30
Price Trends
66.91
Positive
56.98
Positive
53.95
Positive
Market Momentum
2.01
Positive
52.63
Neutral
36.91
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SLNO, the sentiment is Neutral. The current price of 73.3 is below the 20-day moving average (MA) of 74.90, above the 50-day MA of 66.91, and above the 200-day MA of 53.95, indicating a neutral trend. The MACD of 2.01 indicates Positive momentum. The RSI at 52.63 is Neutral, neither overbought nor oversold. The STOCH value of 36.91 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for SLNO.
Soleno Therapeutics Risk Analysis
Soleno Therapeutics disclosed 74 risk factors in its most recent earnings report. Soleno Therapeutics reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 3 New Risks
1.
In the future we may identify additional material weaknesses, fail to remediate our current material weakness or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our financial statements or cause us to fail to meet our periodic reporting obligations. Q4, 2024
2.
If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operation could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock. Q4, 2024
3.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which would harm our business. Q4, 2024
Soleno Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
66 Neutral | $3.64B | 142.49 | 5.88% | ― | 2.78% | -54.72% | |
60 Neutral | $3.79B | ― | -27.92% | ― | ― | -31.37% | |
53 Neutral | $5.24B | 3.07 | -43.58% | 2.80% | 16.87% | -0.11% | |
52 Neutral | $4.06B | ― | -418.97% | ― | 48.88% | 39.30% | |
50 Neutral | $3.39B | ― | -19.71% | ― | -86.13% | -67.29% | |
45 Neutral | $2.55B | ― | -74.17% | ― | ― | -43.10% | |
37 Underperform | $3.78B | ― | -105.54% | ― | ― | -43.20% |
* Healthcare Sector Average
Performance Comparison
SLNO
Soleno Therapeutics
73.30
32.13
78.04%
CRSP
Crispr Therapeutics AG
36.99
-18.74
-33.63%
RYTM
Rhythm Pharmaceuticals
62.41
25.04
67.01%
AKRO
Akero Therapeutics
48.35
29.44
155.68%
IMVT
Immunovant
14.41
-13.98
-49.24%
SHC
Sotera Health
12.34
1.15
10.28%
Soleno Therapeutics Earnings Call Summary
Earnings Call Date:May 07, 2025
(Q1-2025)
| % Change Since: -1.82%|
Next Earnings Date:Aug 06, 2025
Earnings Call Sentiment Positive
The earnings call was overall optimistic with a strong focus on the successful approval and launch of VYKAT XR, which has been met with significant interest from both patients and prescribers. The financial outlook is stable with adequate reserves, though the company reported no revenue for Q1 2025 and an increased net loss.Q1-2025 Updates
Positive Updates
FDA Approval and Launch of VYKAT XR
FDA approved VYKAT XR for hyperphagia in Prader-Willi syndrome, and the commercial launch followed swiftly with patients receiving treatment ahead of schedule.
Strong Initial Launch Metrics
268 patient start forms received within 29 business days and 131 unique prescribers engaged, indicating strong initial interest and awareness.
Sufficient Financial Reserves
The company ended the quarter with $290 million in cash and believes it has sufficient funds to reach cash flow breakeven, with an additional $75 million available through a loan agreement.
Positive Payer and Market Feedback
Positive feedback from payers regarding the VYKAT XR value proposition, and anticipation of broad payer coverage in the U.S.
Negative Updates
No Revenue in Q1 2025
The company generated no revenue for the first quarter ended March 31, 2025, as VYKAT XR was not yet commercialized.
Increased Net Loss
Net loss for Q1 2025 was $43.8 million, compared to $21.4 million in the same period of 2024, primarily due to increased SG&A expenses.
Company Guidance
During the Soleno Therapeutics first quarter 2025 earnings call, the company provided significant updates, notably the FDA approval and commercial launch of VYKAT XR for treating hyperphagia in individuals aged four and older with Prader-Willi syndrome (PWS). The company reported the receipt of 268 patient start forms within 29 business days post-approval and identified 131 unique prescribers, indicating strong early adoption. Soleno anticipates modest revenue initially, as patient scheduling and payer coverage policies develop. Financially, the company ended the quarter with $290 million in cash, cash equivalents, and marketable securities, down from $318.6 million at the end of 2024. Research and development expenses were $13.5 million, while selling, general, and administrative expenses rose to $29.3 million, reflecting pre-launch preparations. Soleno plans to submit a marketing authorization application to the European Medicines Agency in the first half of 2025, aiming to expand VYKAT XR's availability internationally.Soleno Therapeutics Corporate Events
Executive/Board ChangesBusiness Operations and Strategy
Soleno Therapeutics Enhances Executive Compensation Structure
Neutral
Jan 24, 2025
On January 21, 2025, Soleno Therapeutics’ Board of Directors approved increases to the base salaries for fiscal year 2025 and the payment of cash bonuses for fiscal year 2024 for its named executive officers, along with certain equity awards. This decision reflects the company’s ongoing efforts to enhance its executive compensation structure, which may impact its strategic operations and stakeholder expectations.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.