Education
About Us
Working with TipRanks
Follow Us
Soleno Therapeutics Inc (SLNO)
NASDAQ:SLNO
Top Page
Soleno Therapeutics
(NASDAQ:SLNO)
Select Model
Select Model
Rating:66Neutral
Price Target:
$44.00
▲(15.52% Upside)
Action:ReiteratedDate:02/26/26
The score is primarily supported by the 2025 financial inflection (new revenue scale, profitability, and positive free cash flow) and very strong balance sheet, reinforced by earnings-call evidence of accelerating commercial launch KPIs and substantial cash. Offsetting factors are weak technical momentum (below key moving averages and negative MACD) and limited valuation support given a negative P/E and no dividend yield.
Positive Factors
Balance Sheet Strength
A very low debt-to-equity profile and a large asset base provide durable financial flexibility. This reduces refinancing risk, funds ongoing U.S. launch and EU/pipeline activities, and creates a multi-quarter cash buffer to absorb launch variability or fund additional indications without urgent capital raises.
2025 Revenue & Profitability Inflection
Achieving material revenue scale and positive net income in 2025 demonstrates that the commercial model can generate sustainable operating cash flow. This validates unit economics, supports reinvestment in growth and R&D, and materially de-risks the commercial program versus prior development-stage losses.
Launch Traction & Payer Coverage
Rapid prescriber additions, tangible patient starts and broad payer coverage reduce access friction and support recurring revenues. Coverage across commercial, Medicare and ~45 state Medicaid programs makes adoption structurally easier and supports durable demand as the company converts coverage into sustained reimbursed claims.
Negative Factors
EU Regulatory Uncertainty
An unresolved EMA decision is a structural gating event for international expansion. A delay or adverse outcome could materially limit addressable market growth, postpone returns on EU investment and concentrate commercial exposure in the U.S., reducing diversification and growth optionality over coming quarters.
Normalization of Cost of Goods
Current low COGS benefited from pre-approval inventory accounting; as on-cost inventory replaces that stock, gross margins and free cash flow could compress. This structural margin normalization risks reducing the profitability cushion demonstrated in 2025 and makes future margin sustainability dependent on pricing and cost control.
Patient Discontinuation / Retention Risk
An expected long-term discontinuation rate of 15%–20% meaningfully lowers lifetime patient value and increases the need for continual new starts. Structurally, higher attrition raises ongoing marketing and provider engagement needs, pressuring sustained top-line growth and requiring steady investment to maintain net patient counts.
Soleno Therapeutics (SLNO) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.10B
Dividend YieldN/A
Average Volume (3M)1.28M
Price to Earnings (P/E)―
Beta (1Y)0.48
Revenue GrowthN/A
EPS Growth44.84%
CountryUS
Employees115
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)0.80
Shares Outstanding53,710,026
10 Day Avg. Volume1,062,922
30 Day Avg. Volume1,275,976
Financial Highlights & Ratios
PEG Ratio-1.08
Price to Book (P/B)5.47
Price to Sales (P/S)12.93
P/FCF Ratio52.69
Enterprise Value/Market Cap0.97
Enterprise Value/Revenue10.67
Enterprise Value/Gross Profit20.97
Enterprise Value/Ebitda215.75
Forecast
1Y Price Target
$105.20Price Target Upside176.19% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering10
EPS Forecast (FY)4.21
Revenue Forecast (FY)$484.92M
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:Feb 25, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 12, 2026
Earnings Call Sentiment Positive
The call communicated a strong commercial launch and material financial progress — meaningful sequential revenue growth (~40% Q/Q), positive operating cash flow and full-year profitability — alongside encouraging commercial metrics (1,250 start forms, 859 active patients, 630 prescribers and coverage of >180M lives). Key near-term risks flagged include EU regulatory uncertainty, anticipated increases in COGS as inventory normalizes, seasonality-driven Q1 gross-to-net effects, elevated SG&A for continued launch investment, and an expected long-term discontinuation range of 15%–20%. On balance, the positive financial and commercial momentum and ample cash runway outweigh the outlined challenges.Q4-2025 Updates
Positive Updates
Strong Revenue Growth and Profitability
Q4 net revenue of $91.7M, representing sequential growth of nearly 40% from $66.0M in Q3; full-year 2025 net revenue of $190.4M (note: <9 months of commercial sales). Achieved profitability with full-year net income of $20.9M and Q4 net income of ~$43.4M compared to a net loss in the prior-year periods.
Robust Cash Generation and Balance Sheet
Generated $48.7M of cash from operating activities in Q4 and ended the year with $506.1M of cash, cash equivalents and marketable securities (after a $100M accelerated share repurchase), providing strong capital to support U.S. launch, EU activities and new indications.
Successful Commercial Launch Metrics
Since launch through Dec 31, 2025: 1,250 patient start forms (≈12.5% of the U.S. addressable market) and 859 active patients on treatment (up from 764 at end of Q3, a ~12.4% increase quarter-over-quarter). Added 136 new prescribers in Q4 to reach 630 unique prescribers.
Broad Payer Coverage
Secured coverage across commercial, Medicaid and Medicare channels covering over 180 million lives at the end of Q4, and reimbursed claims from ~45 state Medicaid programs through Q4, supporting rapid access and reauthorization success.
Real-World Safety and Adherence
Real-world safety profile mirrors clinical expectations; launch-to-date discontinuation related to adverse events ~12% and total discontinuation ~15%, consistent with management’s long-term expectation of 15%–20%. High adherence observed as patients settle into optimal doses.
Pipeline Expansion Plans — EU and GSD1
EMA MAA validated; Day 120 questions answered and Day 180 questions expected by end of Feb; decision anticipated mid-2026. Pursuing glycogen storage disease type 1 (GSD1) with orphan designation in U.S. and EU, IND planned in H1 2026 and trial initiation later in 2026.
Negative Updates
EU Regulatory Uncertainty
EMA questions focus on adequacy of efficacy data derived primarily from a randomized withdrawal study; Day 180 questions imminent and decision uncertain — EU approval remains unresolved and could impact near-term international expansion plans.
Seasonal and Gross-to-Net Headwinds in Q1
Potential Q1 seasonality: co-pay resets and plan churn can increase gross-to-net discounts (Soleno ONE reimburses co-pays, increasing discounts) and cause temporary free-drug periods when patients change plans, which may depress reported Q1 revenue despite underlying patient growth.
Rising Commercial Spend and Ongoing Launch Costs
Full-year SG&A increased to $132.1M from $105.9M prior year (+~24.7%) reflecting launch investments; Q4 SG&A $40.9M (includes $8.7M stock comp). Continued commercialization investment will sustain elevated SG&A in the near term.
Cost of Goods Sold to Increase as Inventory Turns
COGS was low ($0.9M in Q4; $2.7M full year) due to pre-approval inventory expensed to R&D at $0 cost; management expects COGS as a % of revenue to rise (anticipate mid-single-digit gross cost levels) as zero-cost inventory is depleted and replaced with at-cost inventory.
Discontinuation and Adherence Uncertainty
Launch-to-date AE-related discontinuation (~12%) and total discontinuation (~15%) are meaningful; management expects long-term 15%–20% discontinuation. While current signals are acceptable, sustained adherence and future discontinuation trends remain a risk to penetration forecasts.
Visibility Changes to KPIs
Company intends to share certain KPIs (patient start forms, unique prescribers, lives covered) through Q1 2026 and then retire these metrics, which could reduce granularity/visibility for investors on ongoing launch performance after that point.
Company Guidance
Management guided to a strong ongoing launch: Q4 net revenue was $91.7M (nearly 40% sequential growth from $66M), full‑year revenue $190.4M (from <9 months of sales), Q4 cash from operations $48.7M, full‑year net income $20.9M, and year‑end cash, cash equivalents and marketable securities of $506.1M (after a $100M accelerated share repurchase). Commercial KPIs through 12/31 included 1,250 patient start forms (~12.5% of the U.S. addressable market), 859 active patients (up from 764 in Q3), 630 unique prescribers (136 added in Q4), coverage for >180 million lives and reimbursed claims from ~45 state Medicaid programs; they expect to capture ~1,000 additional start forms over the next 9–12 months. Safety and retention guidance: launch‑to‑date AE‑related discontinuation ≈12%, total discontinuation ≈15%, and an anticipated long‑term discontinuation rate of 15–20%. Financial and operational notes: Q4 COGS $0.9M (FY $2.7M) with COGS% expected to rise as zero‑cost inventory depletes; Q4 R&D $9.6M (FY $40.6M), Q4 SG&A $40.9M (FY $132.1M); Net income per share Q4 ~$0.82 basic/$0.80 diluted and FY $0.40 basic/$0.39 diluted. Regulatory and pipeline milestones: EMA Day‑180 questions expected end of Feb with a mid‑2026 EU decision window (UK/EU PWS population ~9,500), six Orange Book patents listed (four longest to 2035 with potential extension into the late‑2030s), and GSD‑1 plans (prevalence ~1/100,000 → >7,000 globally, 3–4k in U.S.), with an IND planned in H1 2026 and a clinical program to start later in 2026; the company will share 12‑month KPI updates on the Q1 2026 call and intends to retire those metrics then.Soleno Therapeutics Financial Statement Overview
Summary
2025 marks a sharp inflection with meaningful revenue ($190.4M), profitability (net income $20.9M), and positive operating/free cash flow (~$46.8M/~$46.7M), backed by a very low-debt balance sheet (debt-to-equity ~0.006). The main constraint on the score is limited multi-year proof of sustainability after several years of sizable losses and cash burn.Income Statement
The company shows a major inflection in 2025, with revenue rising to $190.4M and turning profitable (net income $20.9M, ~11.0% net margin; EBITDA margin ~4.9%). This is a sharp improvement versus 2020–2024, when revenue was effectively zero and losses were sizable (e.g., 2024 net loss of $175.9M). Key weakness is limited multi-year evidence of sustainable commercial profitability given the very recent revenue ramp and historically loss-making profile.70
Positive
Balance Sheet
Balance sheet strength is a clear positive: very low leverage in 2025 with total debt of ~$2.7M against ~$450.1M of equity (debt-to-equity ~0.006), and a much larger asset base (~$563.8M). Return on equity turned positive in 2025 (~4.6%) after deeply negative levels in prior years (notably 2024), highlighting improving economics. Main watch-out is the volatility in profitability across years, which can pressure equity over time if losses re-emerge.86
Very Positive
Cash Flow
Cash generation improved meaningfully in 2025 with operating cash flow of ~$46.8M and free cash flow of ~$46.7M, roughly matching reported net income (free cash flow to net income ~1.0), which supports earnings quality. However, cash flow was negative and cash-consuming in 2020–2024, and 2025 free cash flow growth is sharply negative versus the prior period in the dataset, indicating volatility and potential lumpiness as the business transitions.64
Positive
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Mar 2022 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 190.41M | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | -1.96M | 0.00 | 0.00 |
| EBITDA | 9.41M | -173.63M | -37.03M | -22.10M | -30.30M |
| Net Income | 20.89M | -175.85M | -38.99M | -24.07M | -30.91M |
Balance Sheet | |||||
| Total Assets | 563.83M | 330.97M | 180.69M | 26.50M | 35.55M |
| Cash, Cash Equivalents and Short-Term Investments | 305.47M | 291.44M | 169.68M | 14.60M | 21.30M |
| Total Debt | 2.69M | 52.83M | 403.00K | 155.00K | 457.00K |
| Total Liabilities | 113.72M | 85.86M | 23.18M | 16.15M | 17.76M |
| Stockholders Equity | 450.12M | 245.11M | 157.51M | 10.35M | 17.79M |
Cash Flow | |||||
| Free Cash Flow | 46.73M | -69.31M | -24.94M | -20.79M | -27.79M |
| Operating Cash Flow | 46.80M | -69.10M | -24.94M | -20.78M | -27.77M |
| Investing Cash Flow | -201.78M | -225.68M | 0.00 | -13.00K | -22.00K |
| Financing Cash Flow | 137.16M | 213.03M | 180.02M | 14.09M | -128.00K |
Soleno Therapeutics Technical Analysis
Negative
38.09
Price Trends
43.24
Negative
49.73
Negative
62.40
Negative
Market Momentum
-1.19
Negative
41.02
Neutral
69.37
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SLNO, the sentiment is Negative. The current price of 38.09 is below the 20-day moving average (MA) of 39.99, below the 50-day MA of 43.24, and below the 200-day MA of 62.40, indicating a bearish trend. The MACD of -1.19 indicates Negative momentum. The RSI at 41.02 is Neutral, neither overbought nor oversold. The STOCH value of 69.37 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for SLNO.
Soleno Therapeutics Risk Analysis
Soleno Therapeutics disclosed 64 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
UnderperformOutperform
Sector (51)
SLNO
Soleno Therapeutics
39.07
-9.75
-19.97%
ADMA
ADMA Biologics
15.57
-0.82
-5.00%
KRYS
Krystal Biotech
275.64
96.39
53.77%
Soleno Therapeutics Corporate Events
Business Operations and StrategyExecutive/Board Changes
Soleno Therapeutics Announces New Chief Financial Officer Appointment
Positive
Feb 26, 2026
On its February 25, 2026 earnings call, Soleno announced that veteran pharmaceutical finance executive Jennifer Fulk will become chief financial officer on March 2, 2026, succeeding long-time CFO James Mackaness, who plans to retire by the end of March. Fulk’s compensation package includes a $525,000 base salary, performance-based bonus eligibility, and equity grants, underscoring her strategic role as Soleno scales its rare-disease franchise.
Mackaness will remain with the company as an at-will employee until March 31, 2026 and then as a consultant through year-end, providing continuity in financial leadership as Soleno navigates its commercial expansion and ongoing capital markets engagement. The leadership transition pairs Fulk’s extensive experience at Eli Lilly, Talkspace and 120Water with Soleno’s growth trajectory following the U.S. launch of VYKAT XR, aiming to support operational efficiency and long-term value creation for stakeholders.
The most recent analyst rating on (SLNO) stock is a Buy with a $85.00 price target. To see the full list of analyst forecasts on Soleno Therapeutics stock, see the SLNO Stock Forecast page.
Business Operations and StrategyExecutive/Board Changes
Soleno Therapeutics Updates Executive Compensation and Severance Plans
Positive
Jan 23, 2026
On January 21, 2026, Soleno Therapeutics’ board, following a review by its independent compensation consultant and Compensation Committee, approved higher base salaries for fiscal 2026, cash bonuses for fiscal 2025, and new stock option and restricted stock unit grants for its named executive officers, with CEO Anish Bhatnagar, CFO James Mackaness, CCO Meredith Manning and SVP of Regulatory Affairs Patricia Hirano all receiving increased pay and equity awards that vest over time. On the same date, the board also adopted a Key Executive Change in Control and Severance Plan covering vice presidents and above, including the named executive officers, which standardizes severance, bonus eligibility, COBRA coverage and equity-vesting acceleration terms in the event of involuntary termination, particularly around a corporate change in control, aligning Soleno’s executive compensation and severance practices more closely with market norms and potentially strengthening leadership retention and stability during strategic transactions.
The most recent analyst rating on (SLNO) stock is a Buy with a $114.00 price target. To see the full list of analyst forecasts on Soleno Therapeutics stock, see the SLNO Stock Forecast page.
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.