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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): July 10, 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 2.02. | Results of Operations and Financial Conditions |
On July 10, 2025, Soleno Therapeutics, Inc. (the “Company”) issued a press release to announce certain preliminary financial results and operating metrics for the three months ended June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
The information furnished pursuant to Item 2.02 (including Exhibit 99.1) on this Form 8-K, 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 it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. |
Description |
|
| 99.1 | Press Release issued by Soleno Therapeutics, Inc., dated July 10, 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| SOLENO THERAPEUTICS, INC. | ||||||
| Date: July 10, 2025 | By: | /s/ Anish Bhatnagar |
||||
| Anish Bhatnagar | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
SOLENO THERAPEUTICS ANNOUNCES PRELIMINARY FINANCIAL AND OPERATIONAL RESULTS FOR THE SECOND QUARTER ENDED JUNE 30, 2025
REDWOOD CITY, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (Nasdaq:SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today certain preliminary unaudited financial and operational results for the three months ended June 30, 2025:
| • | Soleno expects its net revenue from the sales of VYKATTM XR, for the three months ended June 30, 2025 to be between $31.0 million and $33.0 million. Soleno has determined net revenue for VYKATTM XR with specific assumptions for Medicare/Medicaid rebates, chargebacks, copay assistance, returns reserve and prompt pay discounts. |
| • | Soleno had approximately $293.8 million in cash, cash equivalents and marketable securities as of June 30, 2025. |
| • | Soleno received approximately 646 patient start forms from approximately 295 unique prescribers between March 26, 2025, the date of approval of its lead product candidate, VYKAT™ XR, and June 30, 2025. |
| • | Soleno continued to have approximately $50.0 million of debt outstanding under its loan and security agreement with Oxford Financing LLC and its affiliates as of June 30, 2025. |
Soleno has not yet completed its financial close and review processes for the three months ended June 30, 2025. The review of Soleno’s financial statements for the three months ended June 30, 2025 is ongoing and could result in changes to the financial results estimated above. The estimates of Soleno’s net revenue, cash, cash equivalents and marketable securities, patient start forms, and unique prescribers, as of June 30, 2025 are preliminary, have not been audited, do not present all information necessary for an understanding of Soleno’s financial condition as of June 30, 2025, and are subject to change upon completion of Soleno’s financial statement closing procedures. The preliminary financial data included in the above has been prepared by, and is the responsibility of, Soleno’s management. Soleno’s independent registered public accounting firm has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data.
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, VYKATTM 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.
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, including statements about Soleno’s expectations for its preliminary financial and operating results for the three months ended June 30, 2025, and all other statements that are not statements of historical facts. 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 the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, as well as risks and uncertainties inherent in Soleno’s business, including those described in Soleno’s Annual Report on Form 10-K for the year ended December 31, 2024, Soleno’s Quarterly Report on Form 10-Q for the three month period ended March 31, 2025, prior press releases and in other filings and reports filed with the SEC. The events and circumstances reflected in Soleno’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, Soleno 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
