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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): October 13, 2025
SOLENO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36593 | 77-0523891 | ||
| (State or other jurisdiction of incorporation) |
(Commission File No.) |
(IRS Employer 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)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading symbols |
Name of each exchange 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 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On October 13, 2025, the Board of Directors (the “Board”) of Soleno Therapeutics, Inc. (the “Company”) increased the size of its Board and the Audit Committee of its Board (the “Audit Committee”) by one member and appointed Mark W. Hahn to the Board and to the Audit Committee. Mr. Hahn will serve as a Class II director with a term expiring at the annual meeting of stockholders to be held in 2028.
Mr. Hahn recently served as Chief Financial Officer of Verona Pharma PLC from March 2020, through the phase 3 program and launch of its first approved product, and until its acquisition by Merck & Co., Inc. for approximately $10 billion in October 2025. From January 2018 until its acquisition by Swedish Orphan Biovitrum (Sobi) for up to $915 million in November 2019, Mr. Hahn served as CFO of Dova Pharmaceuticals, where he was instrumental in raising capital and in the launch of Dova’s first commercial rare disease product. From 2010 until its acquisition by Melinta Therapeutics in 2017, Mr. Hahn was CFO of Cempra, Inc. where he led the company’s IPO and several subsequent follow-on offerings. Prior to Cempra, Mr. Hahn was the CFO of several other public and private companies. Mr. Hahn began his career at Ernst & Young. Mr. Hahn also serves as a Board member and Audit Committee Chair for Opterion Health AG. He received a Bachelor of Business Administration degree in Accounting and Finance from the University of Wisconsin-Milwaukee and is a certified public accountant in Maryland and North Carolina.
The Company believes Mr. Hahn can make valuable contributions to the Board and Audit Committee due to his nearly 30 years of CFO-level experience and key roles in numerous successful product launches, financings and strategic transactions within the life sciences sector.
In connection with the appointment of Mr. Hahn to the Board and in accordance with the Company’s Outside Director Compensation Policy, he received a grant of 10,046 restricted stock units (“RSUs”). One-third the RSUs vest on October 13, 2026 and each annual anniversary thereafter, subject to Mr. Hahn continuing as a service provider through each such date. The RSU award is subject to the terms and conditions of the Company’s Amended and Restated 2014 Equity Incentive Plan and its related grant agreement. As a director, Mr. Hahn will participate in the compensation program applicable to all non-employee directors, which is described under the heading “Non-Employee Director Compensation” in the Company’s Definitive Proxy Statement relating to the Annual Meeting of Stockholders filed with the Securities and Exchange Commission on April 22, 2025.
Mr. Hahn also executed the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.1 to the Company’s Registration Statement on Form S-1/A (File No. 333-196635) filed with the Securities and Exchange Commission on June 10, 2014.
There are no arrangements or understandings between Mr. Hahn and any other persons pursuant to which Mr. Hahn was appointed as a director.
| ITEM 8.01 | Other Events |
On October 13, 2025, the Company issued a press release (the “Press Release”) announcing Mr. Hahn’s appointment to the Board and Audit Committee. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 8.01 (including Exhibit 99.1) is being furnished pursuant to Item 8.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
| ITEM 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued by Soleno Therapeutics, Inc. dated October 13, 2025 | |
| 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: October 14, 2025 | ||||||
| By: | /s/ Anish Bhatnagar |
|||||
| Anish Bhatnagar | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
Soleno Therapeutics Appoints Biopharmaceutical Executive Mark W. Hahn to its Board of Directors
Appointment adds three decades of financial and operational leadership to Soleno’s Board
REDWOOD CITY, Calif., October 13, 2025 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the appointment of biopharmaceutical finance veteran Mark W. Hahn as an independent director to its Board of Directors and a member of its Audit Committee. Mr. Hahn brings to Soleno’s Board nearly 30 years of CFO-level experience and has played a key role in numerous successful product launches, financings, and M&A transactions within the life sciences sector. With the addition of Mr. Hahn, the Soleno Board increases to seven seats.
“I am very pleased to welcome Mark to the Soleno Board as we continue to execute a strong commercial launch of VYKAT™ XR,” said Dr. Anish Bhatnagar, Chief Executive Officer and Chairman of the Board of Soleno Therapeutics. “With his broad and diverse financial leadership experience, including as CFO of commercial-stage companies developing therapeutics for rare and serious diseases, I believe Mark’s background perfectly aligns with our current needs, and I look forward to his contributions.”
“Having seen first-hand the positive impact that innovation can have on the lives of people living with rare diseases, I could not be more excited to join the Soleno Board at this stage in the Company’s evolution as a commercial organization,” added Mr. Hahn. “I look forward to working with Anish, my fellow Board members, and the Soleno leadership team to maximize the reach of VYKAT™ XR and offer new hope to the PWS community, including patients, their physicians and caregivers.”
Prior to joining the Soleno Board, Mr. Hahn served as Chief Financial Officer of Verona Pharma PLC, through the phase 3 program and launch of its first approved product, from March 2020 until its acquisition by Merck & Co., Inc. for approximately $10 billion in October 2025. From January 2018 until its acquisition by Swedish Orphan Biovitrum (Sobi) for up to $915 million in November 2019, Mr. Hahn served as CFO of Dova Pharmaceuticals, where he was instrumental in raising capital and in the launch of Dova’s first commercial rare disease product. From 2010 until its acquisition by Melinta Therapeutics in 2017, Mr. Hahn was CFO of Cempra, Inc. where he led the company’s IPO and several subsequent follow-on offerings. Prior to Cempra, Mr. Hahn was the CFO of several other public and private companies. Mr. Hahn began his career at Ernst & Young.
Mr. Hahn also serves as a Board member and Audit Committee Chair for Opterion Health AG.
He received a Bachelor of Business Administration degree in Accounting and Finance from the University of Wisconsin-Milwaukee and is a certified public accountant in Maryland and North Carolina.
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 now 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 of Fluid 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