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Soleno Therapeutics (SLNO)
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Soleno Therapeutics (SLNO) AI Stock Analysis

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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
Competitive Advantage
Vykat XR is the first-and-only approved treatment for hyperphagia in Prader-Willi Syndrome, and the FDA label is a best-case scenario.
Market Potential
Soleno's commercial team aims to strategically tap into both the adult and pediatric PWS markets, which together represent approximately 10,000 eligible patients in the US alone.
Regulatory 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.
Negative Factors
Pricing
Management appears prepared to execute on a strong launch with a high price tag and sizable population to itself, and there is optimism that the PWS community's urgency will fuel significant uptake, yet high pricing could be a concern.

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:May 07, 2025
(Q1-2025)
|
% Change Since: 17.39%|
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 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.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.00
Gross Profit0.00-1.96M-2.21M-2.21M-2.19M
EBITDA-173.63M-37.03M-21.86M-28.70M-30.00M
Net Income-175.85M-38.99M-20.32M-29.56M-15.38M
Balance Sheet
Total Assets330.97M180.69M26.50M35.55M64.98M
Cash, Cash Equivalents and Short-Term Investments291.44M169.68M14.60M21.30M49.22M
Total Debt52.83M403.00K155.00K457.00K139.00K
Total Liabilities85.86M23.18M16.15M17.76M19.43M
Stockholders Equity245.11M157.51M10.35M17.79M45.55M
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-225.68M0.00-13.00K-22.00K-7.00K
Financing Cash Flow213.03M180.02M14.09M-128.00K53.72M

Soleno Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price87.64
Price Trends
50DMA
79.24
Positive
100DMA
69.50
Positive
200DMA
59.97
Positive
Market Momentum
MACD
1.80
Positive
RSI
61.35
Neutral
STOCH
55.40
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SLNO, the sentiment is Positive. The current price of 87.64 is above the 20-day moving average (MA) of 83.88, above the 50-day MA of 79.24, and above the 200-day MA of 59.97, indicating a bullish trend. The MACD of 1.80 indicates Positive momentum. The RSI at 61.35 is Neutral, neither overbought nor oversold. The STOCH value of 55.40 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 (46)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
80
Outperform
$4.34B36.1613.90%247.53%118.34%
76
Outperform
$4.29B20.9678.45%62.22%
65
Neutral
$4.10B-58.66%42.77%-51.27%
60
Neutral
$4.13B-27.92%-31.37%
46
Neutral
C$197.02M-3.33-23.14%2.65%20.75%-0.36%
40
Underperform
$4.59B
37
Underperform
$4.51B-105.54%-43.20%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
SLNO
Soleno Therapeutics
87.64
40.68
86.63%
ADMA
ADMA Biologics
17.59
4.23
31.66%
MRUS
Merus
61.44
6.15
11.12%
KRYS
Krystal Biotech
150.15
-53.51
-26.27%
AKRO
Akero Therapeutics
54.33
27.57
103.03%
MTSR
Metsera, Inc.
44.30
16.50
59.35%

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