8-K
SOLENO THERAPEUTICS INC (SLNO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): January 12, 2026
SOLENO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36593 | 77-0523891 |
|---|---|---|
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File No.) | (IRS Employer<br>Identification Number) |
100 Marine Parkway, Suite 400
Redwood City, CA 94065
(Address of principal executive offices)
(650) 213-8444
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>symbols | Name of each exchange<br>on which registered |
|---|---|---|
| Common Stock, $0.001 par value | SLNO | NASDAQ |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| ITEM 2.02 | Results of Operations and Financial Conditions |
|---|
On January 12, 2026, Soleno Therapeutics, Inc. (the “Company”) issued a press release to announce certain preliminary financial results and operating metrics for the three months and year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
This information is intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K, “Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| ITEM 9.01 | Financial Statements and Exhibits |
|---|---|
| (d) | Exhibits |
| --- | --- |
| Exhibit<br>No. | Description |
| --- | --- |
| 99.1 | Press release issued by Soleno Therapeutics, Inc. dated January 12, 2026 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SOLENO THERAPEUTICS, INC. | ||
|---|---|---|
| Date: January 12, 2026 | ||
| By: | /s/ Anish Bhatnagar | |
| Anish Bhatnagar | ||
| Chief Executive Officer |
EX-99.1
Exhibit 99.1
Soleno Therapeutics Announces Select Preliminary Fourth Quarter and Full-Year 2025 Results
REDWOOD CITY, Calif., January 12, 2026 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced select preliminary financial and operating results for the fourth quarter and full-year 2025:
| • | Preliminary unaudited full-year 2025 net revenue related to U.S. sales of VYKAT^TM^ XR^^since second quarter launch expected to be in a range of $189 million to $191 million. |
|---|---|
| • | Preliminary unaudited fourth quarter 2025 net revenue expected to be in a range of $90 million to<br>$92 million. |
| --- | --- |
| • | 1,250 total new patient start forms (207 in the fourth quarter) from launch through December 31, 2025, or<br>approximately 12.5% of the total U.S. VYKAT XR addressable market. |
| --- | --- |
| • | Discontinuation rate of VYKAT XR related to adverse events was approximately 12% as of the end of the fourth<br>quarter. |
| --- | --- |
| • | 630 unique prescribers, including 136 new prescribers in the fourth quarter. |
| --- | --- |
| • | Over 185 million lives covered, or approximately 60% of total lives. |
| --- | --- |
| • | Company has responded to Day 120 questions received from the European Medicines Agency. |
| --- | --- |
| • | Company has achieved profitability and positive cash flow. |
| --- | --- |
| • | Year-end 2025 cash, cash equivalents and marketable securities were<br>approximately $500 million, after the $100 million accelerated share repurchase program that the Company announced on November 11, 2025. |
| --- | --- |
“Our strong fourth quarter results cap a truly transformational year for Soleno Therapeutics, driven by the approval and successful launch of VYKAT XR in the U.S.,” said Dr. Anish Bhatnagar, Chief Executive Officer and Chairman of the Board of Soleno Therapeutics. “In less than nine months since launch, we have received patient start forms representing well over 10% of our addressable U.S. Prader-Willi syndrome (PWS) patient population. This reflects the significant unmet medical need that VYKAT XR can address as well as our success in communicating VYKAT XR’s value proposition to payers, providers and caregivers.”
“Looking ahead, as we continue to raise awareness of this first-to-market hyperphagia treatment, we have the opportunity to significantly impact the lives of many more patients and families living with PWS while simultaneously creating sustained value for our company. We are well-funded, our leading indicators are strong, and I am excited for what the future holds in 2026 and beyond,” Dr. Bhatnagar concluded.
The estimates of Soleno’s net revenue, cash, cash equivalents and marketable securities, patient start forms and other metrics above as of December 31, 2025 are preliminary, have not been audited, and do not present all information necessary for an understanding of Soleno’s financial condition as of December 31, 2025. The preliminary select financial information presented in this press release is provided as an approximation in advance of Soleno’s announcement of full fourth quarter and full-year 2025 financial results, which is anticipated to occur in late February 2026.
About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.
About VYKAT XR
VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is commercially available to U.S. patients.
VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
IMPORTANT SAFETY INFORMATION
Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.
Warnings and Precautions
Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.
Risk ofFluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.
Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.
Please see the full Prescribing Information, including Medication Guide**.**
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s first commercial product, VYKAT^™^ XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome and was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025. For more information, please visit www.soleno.life.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company’s prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
Media Contact:
media@soleno.life