Soleno Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
Second Quarter 2023 and Recent Corporate Highlights
- Completed enrollment in the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS).
- Top-line data expected around the end of third quarter 2023.
$10 millionin connection with closing of December 2022Securities Purchase Agreement (SPA) for up to $60 millionwith Nantahala Capital Management, Abingworth and Vivo Capital, triggered by announcement of enrollment completion.
“We are eagerly awaiting top-line results from the fully-enrolled randomized withdrawal period of Study C602, which remain on track for the third quarter of 2023,” said
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.
Second Quarter 2023 Financial Results
Research and development expenses for the three and six months ended
General and administrative expenses for the three and six months ended
Soleno is obligated to make cash payments of up to a maximum of
Total other income was
Net loss for the three and six months ended
About DCCR (Diazoxide Choline) Extended-Release Tablets
DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in PWS patients. In the PWS Phase 3 study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.
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.
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 the closing of the warrant financing under the Securities Purchase Agreement, the receipt of top-line data from the randomized withdrawal period, and the 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
Condensed Consolidated Balance Sheets
(In thousands except share and per share data)
|Cash and cash equivalents||$||19,368||$||14,602|
|Prepaid expenses and other current assets||1,130||1,045|
|Total current assets||20,498||15,647|
|Property and equipment, net||19||26|
|Operating lease right-of-use assets||541||131|
|Intangible assets, net||9,721||10,693|
|Other long-term assets||165||-|
|Liabilities and stockholders’ equity|
|Accrued clinical trial site costs||3,466||3,222|
|Operating lease liabilities - current||212||155|
|Other current liabilities||513||484|
|Total current liabilities||8,798||7,313|
|2018 PIPE Warrant liability||-||1|
|Operating lease liabilities - noncurrent||273||-|
|Contingent liability for Essentialis purchase price||9,447||8,835|
|Commitments and contingencies (Note 6)|
9,141,185 and 8,159,382 shares issued and outstanding at
|Accumulated other comprehensive income||-||-|
|Total stockholders’ equity||12,426||10,348|
|Total liabilities and stockholders’ equity||$||30,944||$||26,497|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development||$||5,141||$||3,696||$||10,457||$||7,684|
|General and administrative||3,169||2,467||6,023||5,110|
|Change in fair value of contingent consideration||313||616||612||(242||)|
|Total operating expenses||8,623||6,779||17,092||12,552|
|Change in fair value of warrants liabilities||1||2||1||29|
|Total other income||148||54||261||103|
|Other comprehensive income (loss)|
|Foreign currency translation adjustment||(16||)||1||-||(1||)|
|Total comprehensive loss||$||(8,491||)||$||(6,724||)||$||(16,831||)||$||(12,450||)|
|Net loss per common share, basic and diluted||$||(0.81||)||$||(0.72||)||$||(1.69||)||$||(1.69||)|
|Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share||10,423,598||9,339,254||9,938,171||7,348,045|
Source: Soleno Therapeutics