SOLENO THERAPEUTICS INC false 0001484565 0001484565 2020-12-10 2020-12-10

 

 

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): December 10, 2020

 

 

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)

203 Redwood Shores Pkwy, Suite 500

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))

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.  ☐

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

 

 

 


Item 8.01

Other Events.

On December 11, 2020, Soleno Therapeutics, Inc. (the “Company”) issued a press release announcing that it was in receipt of minutes from the U.S. Food and Drug Administration (“FDA”) in connection with a meeting the Company had with the FDA on November 12, 2020 to discuss the Company’s New Drug Application (“IND”) for the use of diazoxide choline controlled-release (DCCR) as a treatment for Prader-Willi syndrome (“PWS”). As stated in the minutes, the purpose of the meeting was to discuss the efficacy data obtained from the Company’s recently completed Phase III clinical trial of DCCR (C601), additional data to be obtained from the Company’s long-term extension study of patients treated on C601 (C602) and proposed next steps for developing DCCR as a treatment for PWS. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

ITEM 9.01

Financial Statements and Exhibits

(d)    Exhibits

 

Exhibit

    No.    

  

Description

99.1    Press release issued by Soleno Therapeutics, Inc. dated December 11, 2020
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: December 11, 2020      
    By:  

/s/ Anish Bhatnagar

      Anish Bhatnagar
      Chief Executive Officer