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Soleno Therapeutics Inc (SLNO)
NASDAQ:SLNO
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Soleno Therapeutics (SLNO) AI Stock Analysis

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SLNO

Soleno Therapeutics

(NASDAQ:SLNO)

Rating:37Underperform
Price Target:
Soleno Therapeutics shows high risk due to its lack of revenue and reliance on external financing. However, it maintains a solid equity base and is experiencing positive technical momentum, suggesting speculative interest. The valuation is typical for an early-stage biotech, with potential upside reliant on successful R&D outcomes.
Positive Factors
FDA Approval
The FDA's recent approval of Vykat XR for hyperphagia in Prader-Willi Syndrome was an inaugural event for this difficult-to-treat indication.
Market Potential
Assuming an EU approval, peak global Vykat XR sales are modeled at $2.6B, with potential for significant upside due to the urgent unmet need and absence of viable competitors.
Revenue Performance
Soleno reported impressive Vykat XR revenue of $33MM in its first partial quarter, a remarkable beat that speaks to the urgent need for a hyperphagia treatment and Soleno management's commercial prowess.
Negative Factors
Market Competition
The absence of viable competitors in the foreseeable future is crucial for Soleno's market position, yet any new entries could impact this advantage.
Price Strategy
While management appears prepared to execute on a strong launch with a high price tag, the price point could potentially limit broader market adoption.

Soleno Therapeutics (SLNO) vs. SPDR S&P 500 ETF (SPY)

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 Earnings Call Summary

Earnings Call Date:Aug 06, 2025
(Q2-2025)
|
% Change Since: -3.05%|
Next Earnings Date:Nov 05, 2025
Earnings Call Sentiment Positive
The earnings call was overwhelmingly positive, with significant achievements such as the successful launch of Vykat XR, strong financial performance, and broad payer coverage. While there are some concerns about future inventory and revenue normalization, the overall outlook remains strong.
Q2-2025 Updates
Positive Updates
Successful Launch of Vykat XR
The commercial launch of Vykat XR, the first FDA-approved medicine for hyperphagia in PWS, was ahead of schedule and received well by the community. Initial demand and steady growth in patient starts and unique prescribers were noted.
Strong Financial Performance
Total net revenue for the second quarter was $32.7 million, with a significant increase from $0 revenue in the same period in 2024. The company raised an additional $230 million, bringing the total cash balance to over $500 million.
Broad Payer Coverage
Approximately 33% of all insured lives are now covered, representing over 100 million lives in the U.S. This includes major insurers across commercial, Medicaid, and Medicare channels.
Progress in European Expansion
Submission and EMA validation of the marketing authorization application for DCCR in the EU were announced, aiming to expand the commercial market.
Lower Discontinuation Rates
Discontinuation rates for Vykat XR are substantially lower than those observed in clinical trials, indicating strong adherence.
Negative Updates
Potential Inventory and Revenue Challenges
There is potential for fluctuations as the supply chain normalizes and patient start forms stabilize beyond the initial launch phase.
Future Revenue Uncertainty
While Q2 revenue was strong, the company indicated that future trends could normalize, suggesting possible variability in revenue growth.
Company Guidance
In the second quarter of 2025, Soleno Therapeutics reported a successful commercial launch of Vykat XR, the first FDA-approved treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS). The drug was approved on March 26, 2025, and became available on April 14, ahead of schedule. The initial response from the PWS community was positive, with 646 patient start forms received by June 30, 2025, and 295 unique prescribers. The company achieved total net revenue of $32.7 million for the quarter, reflecting the high demand and effective launch efforts. Soleno's efforts to secure payer coverage were successful, with 33% of all insured lives covered across commercial, Medicaid, and Medicare channels. The company also reported a net loss of $4.7 million, with cash, cash equivalents, and marketable securities totaling $293.8 million at the end of the quarter, bolstered by an additional $230 million raised post-quarter through a stock offering. Soleno is actively working towards European market approval for DCCR, marketed as Vykat XR in the U.S., to expand its commercial reach.

Soleno Therapeutics Financial Statement Overview

Summary
Soleno Therapeutics is in its developmental phase, with no revenue generation and substantial net losses. The company shows a strong equity base with minimal debt, but its financial health is heavily reliant on external financing due to the lack of operational cash inflow. This represents a high-risk profile typical for early-stage biotech firms.
Income Statement
10
Very Negative
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.
Balance Sheet
35
Negative
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.
Cash Flow
20
Very Negative
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-494.00K0.00-1.96M-2.21M-2.21M-2.19M
EBITDA-156.82M-173.63M-37.03M-21.86M-28.70M-30.00M
Net Income-198.22M-175.85M-38.99M-20.32M-29.56M-15.38M
Balance Sheet
Total Assets318.09M330.97M180.69M26.50M35.55M64.98M
Cash, Cash Equivalents and Short-Term Investments289.95M291.44M169.68M14.60M21.30M49.22M
Total Debt52.79M52.83M403.00K155.00K457.00K139.00K
Total Liabilities85.83M85.86M23.18M16.15M17.76M19.43M
Stockholders Equity232.26M245.11M157.51M10.35M17.79M45.55M
Cash Flow
Free Cash Flow-89.53M-69.31M-24.94M-20.79M-27.79M-25.23M
Operating Cash Flow-89.32M-69.10M-24.94M-20.78M-27.77M-25.22M
Investing Cash Flow-87.50M-225.68M0.00-13.00K-22.00K-7.00K
Financing Cash Flow215.31M213.03M180.02M14.09M-128.00K53.72M

Soleno Therapeutics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price78.71
Price Trends
50DMA
82.19
Negative
100DMA
75.37
Positive
200DMA
62.49
Positive
Market Momentum
MACD
-0.25
Positive
RSI
37.05
Neutral
STOCH
7.89
Positive
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 78.71 is below the 20-day moving average (MA) of 84.77, below the 50-day MA of 82.19, and above the 200-day MA of 62.49, indicating a neutral trend. The MACD of -0.25 indicates Positive momentum. The RSI at 37.05 is Neutral, neither overbought nor oversold. The STOCH value of 7.89 is Positive, 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 0 New Risks

Soleno Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (65)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
79
Outperform
$4.43B19.7271.23%43.58%491.01%
71
Outperform
$3.98B27.6715.61%247.53%118.34%
65
Neutral
¥342.43B8.69-3.93%2.47%11.18%-19.47%
61
Neutral
$5.02B-48.54%42.77%-51.27%
60
Neutral
$3.95B-27.92%-31.37%
40
Underperform
$3.50B
37
Underperform
$4.31B-69.53%-43.20%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
SLNO
Soleno Therapeutics
78.71
33.63
74.60%
ADMA
ADMA Biologics
16.75
4.56
37.41%
MRUS
Merus
63.39
13.38
26.75%
KRYS
Krystal Biotech
136.10
-44.27
-24.54%
AKRO
Akero Therapeutics
50.45
25.52
102.37%
MTSR
Metsera, Inc.
30.89
3.09
11.12%

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
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

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.Date of analysis: Apr 10, 2025