0001193125-21-151685.txt : 20210505 0001193125-21-151685.hdr.sgml : 20210505 20210505160132 ACCESSION NUMBER: 0001193125-21-151685 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20210505 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210505 DATE AS OF CHANGE: 20210505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SOLENO THERAPEUTICS INC CENTRAL INDEX KEY: 0001484565 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 770523891 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36593 FILM NUMBER: 21893092 BUSINESS ADDRESS: STREET 1: 1235 RADIO ROAD STREET 2: SUITE 110 CITY: REDWOOD CITY STATE: CA ZIP: 94065 BUSINESS PHONE: 650-213-8444 MAIL ADDRESS: STREET 1: 1235 RADIO ROAD STREET 2: SUITE 110 CITY: REDWOOD CITY STATE: CA ZIP: 94065 FORMER COMPANY: FORMER CONFORMED NAME: Capnia, Inc. DATE OF NAME CHANGE: 20100219 8-K 1 d400990d8k.htm 8-K 8-K
SOLENO THERAPEUTICS INC false 0001484565 0001484565 2021-05-05 2021-05-05

 

 

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): May 5, 2021

 

 

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))

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 May 5, 2021, Soleno Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2021. The full text of the press release is attached hereto as Exhibit 99.1 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 No.

  

Description

99.1    Press release issued by Soleno Therapeutics, Inc. dated May 5, 2021
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: May 5, 2020      
    By:  

/s/ Anish Bhatnagar

      Anish Bhatnagar
      Chief Executive Officer
EX-99.1 2 d400990dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2021 Financial Results

REDWOOD CITY, Calif., May 5, 2021 – Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the three months ended March 31, 2021.

“We are continuing our dialogue with the U.S. Food and Drug Administration (FDA) to evaluate the appropriate next steps in our DCCR program for the treatment of Prader-Willi Syndrome (PWS) and work towards obtaining regulatory approval as expeditiously as possible,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “The Soleno team remains committed to the development of DCCR and building an appropriate data set to support its development. To this end, we were excited to recently present behavioral outcomes data from caregiver interviews that summarized individual patient experiences during treatment with DCCR. We were also pleased to speak to the PWS community directly during the recent PWS DCCR Town Hall meeting where we reiterated our continued focus on DCCR and outlined the proposed necessary steps for submitting a marketing application to the FDA in the U.S. More importantly, we were able to listen to the stories about the individual study participants’ experiences during our completed Phase III clinical trial of DCCR, DESTINY PWS, and the ongoing long-term safety extension study.”

Dr. Bhatnagar continued, “We are grateful for the work completed by the Foundation for Prader-Willi Research and Prader-Willi Syndrome Association | USA in collecting the experiences of PWS patients and caregivers treated with DCCR. This petition, which was submitted to the FDA, was signed by more than 26,000 individuals in support of DCCR.”

First Quarter 2021 and Recent Corporate Highlights

 

   

Continued discussions with FDA and currently evaluating appropriate next steps for DCCR program in PWS

 

   

Presented behavioral outcomes data from the Company’s ongoing open-label extension study (C602) of DCCR in PWS at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting (poster available https://investors.soleno.life/events-and-presentations/presentations)

 

     

A majority of patients (83%) reported positive changes in multiple behavioral outcome domains, including food-seeking behaviors, mealtime behaviors and daily life behaviors in a preliminary analysis of data from interviews of caregivers of participants in C602

 

   

Presented assessment of baseline renal function in PWS patients enrolled in clinical study C601 at the Endocrinology Society (ENDO) 2021 Virtual Annual Meeting (poster available https://investors.soleno.life/events-and-presentations/presentations)

 

   

With researchers from the U.S. National Institutes of Health, presented resting energy expenditure data for a limited number of subjects enrolled in clinical studies C601 and


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C602 at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting (poster available https://investors.soleno.life/events-and-presentations/presentations)

 

     

DCCR treated subjects showed progressive increases in resting energy expenditure

 

   

Presented a post-hoc analysis of C601 taking into account data prior to the ‘COVID impact’ (defined as 1 March 2020) at the PES 2021 Virtual Annual Meeting (poster available https://investors.soleno.life/events-and-presentations/presentations)

 

     

The primary endpoint, change in hyperphagia using HQ-CT, and all key secondary endpoints showed significant improvements in DCCR treated subjects compared with placebo

 

     

There were significant improvements in a number of behavioral and cardiometabolic endpoints in DCCR treated subjects compared with placebo

 

   

Participated in PWS DCCR Town Hall

 

     

Highlighted the proposed necessary steps to submit a marketing application for DCCR in the U.S. and reaffirmed the Company’s commitment to this process

 

     

Listened to individual patient and caregiver experiences with DCCR

 

   

Participated in a fireside chat at the 31st Annual Oppenheimer Healthcare Conference

Financial Results

Soleno’s current research and development efforts are primarily focused on advancing its lead product candidate, DCCR, for the treatment of PWS, through late-stage clinical development.

First Quarter Ended March 31, 2021 Financial Results

Research and development expenses were $7.2 million for the quarter ended March 31, 2021, compared to $6.7 million in the same period of 2020. The increase was primarily due to increased activities related to the DCCR development program. General and administrative expense was $3.0 million for the quarter ended March 31, 2021, compared to $2.0 million in the same period of 2020.

The change in the fair value of contingent consideration results from Soleno’s obligation to make cash payments to Essentialis stockholders upon the achievement of certain future commercial milestones associated with the sale of DCCR in accordance with the terms of the Essentialis merger agreement. The fair value was estimated to be approximately $9.3 million at March 31, 2021, resulting in a decrease in expense of approximately $1.0 million from the estimate at December 31, 2020.

Total other income was $0.2 million for the quarter ended March 31, 2021, compared to $3.4 million in the same period of 2020, and consisted primarily of the change in the fair value of our outstanding warrants.


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Net loss for the quarter ended March 31, 2021, was approximately $9.0 million, or a net loss of $0.11 per basic and diluted share, compared to a net loss of approximately $5.9 million, or $0.13 per basic and diluted share, for the quarter ended March 31, 2020.

As of March 31, 2021, Soleno had cash and cash equivalents of approximately $41.6 million, compared to $49.2 million at December 31, 2020.

About PWS

The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S.

About Soleno Therapeutics, Inc.

Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. 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, including statements regarding timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. 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, as well as risks and uncertainties inherent in Soleno’s business, 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


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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


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Soleno Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands except share and per share data)

 

     March 31,
2021
    December 31,
2020
 

Assets

     (Unaudited)    

Current assets

    

Cash and cash equivalents

   $ 41,607     $ 49,224  

Prepaid expenses and other current assets

     921       1,019  
  

 

 

   

 

 

 

Total current assets

     42,528       50,243  

Long-term assets

    

Property and equipment, net

     20       19  

Operating lease right-of-use assets

     50       124  

Finance lease right-of-use assets

     13       15  

Intangible assets, net

     14,095       14,581  
  

 

 

   

 

 

 

Total assets

   $ 56,706     $ 64,982  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities

    

Accounts payable

   $ 4,669     $ 3,489  

Accrued compensation

     411       1,005  

Accrued clinical trial site costs

     4,140       3,789  

Operating lease liabilities

     57       139  

Other current liabilities

     232       196  
  

 

 

   

 

 

 

Total current liabilities

     9,509       8,618  

Long-term liabilities

    

2018 PIPE Warrant liability

     338       539  

Contingent liability for Essentialis purchase price

     9,291       10,278  
  

 

 

   

 

 

 

Total liabilities

     19,138       19,435  
  

 

 

   

 

 

 

Commitments and contingencies (Note 6)

    

Stockholders’ equity

    

Common stock, $0.001 par value, 250,000,000 shares authorized, 79,723,680 and 79,615,692 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively.

     80       80  

Additional paid-in-capital

     228,887       227,912  

Accumulated deficit

     (191,399     (182,445
  

 

 

   

 

 

 

Total stockholders’ equity

     37,568       45,547  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 56,706     $ 64,982  
  

 

 

   

 

 

 

 


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Soleno Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(In thousands except share and per share data)

 

     Three Months Ended
March 31,
 
     2021     2020  

Operating expenses

    

Research and development

   $ 7,164     $ 6,695  

General and administrative

     2,979       2,003  

Change in fair value of contingent consideration

     (987     584  
  

 

 

   

 

 

 

Total operating expenses

     9,156       9,282  
  

 

 

   

 

 

 

Operating loss

     (9,156     (9,282
  

 

 

   

 

 

 

Other income

    

Change in fair value of warrants liabilities

     201       3,413  

Interest income

     1       11  
  

 

 

   

 

 

 

Total other income

     202       3,424  
  

 

 

   

 

 

 

Net loss

   $ (8,954   $ (5,858
  

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (0.11   $ (0.13
  

 

 

   

 

 

 

Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share

     79,694,781       44,679,858  
  

 

 

   

 

 

 
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Document and Entity Information
May 05, 2021
Cover [Abstract]  
Entity Registrant Name SOLENO THERAPEUTICS INC
Amendment Flag false
Entity Central Index Key 0001484565
Document Type 8-K
Document Period End Date May 05, 2021
Entity Incorporation State Country Code DE
Entity File Number 001-36593
Entity Tax Identification Number 77-0523891
Entity Address, Address Line One 203 Redwood Shores Pkwy
Entity Address, Address Line Two Suite 500
Entity Address, City or Town Redwood City
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94065
City Area Code (650)
Local Phone Number 213-8444
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.001 par value
Trading Symbol SLNO
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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