Soleno Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results
Second Quarter 2024 and Recent Corporate Highlights
- Submitted New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for Diazoxide Choline Extended-Release (DCCR) for the treatment of Prader-Willi Syndrome (PWS) in individuals four years and older who have hyperphagia. - Closed on an approximately
$158.7 million underwritten public offering of 3,450,000 shares of common stock at a public offering price of$46.00 per share, which includes the exercise in full by the underwriters of their overallotment option to purchase additional shares. - Granted Breakthrough Therapy Designation by the FDA for DCCR for the treatment of adults and children ages four years and older with genetically confirmed PWS who have hyperphagia.
- Presented data from the randomized withdrawal period of Study C602 of DCCR in PWS in an oral presentation at the Annual Meeting of the
Endocrine Society (ENDO 2024), heldJune 1-4, 2024 inBoston, Massachusetts . - Joined the broad-market Russell 3000® Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective
July 1, 2024 .
“The second quarter of 2024 saw substantial progress for Soleno, highlighted by submission of an NDA to the FDA for DCCR. We look forward to continuing to work with the FDA,” said
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.
Second Quarter Ended
As of
Research and development expense was
General and administrative expense was
Soleno is obligated to make cash payments of up to a maximum of
Total other income, net, was
Net loss was approximately
About PWS
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 for the therapeutic use of diazoxide, diazoxide choline 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 patients with PWS. In the PWS Phase 3 clinical development program, 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. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company recently submitted an NDA to the FDA, supported by its Phase 3 development program, for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS). 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 the timing of any regulatory process, filing of an NDA, 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 the projected timeline of our NDA submission, whether FDA will agree with our interpretation of the data or the adequacy of data to support an NDA, the FDA’s review of our NDA, 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
Corporate Contact:
212-915-2578
Condensed Consolidated Balance Sheets (In thousands except share and per share data) |
|||||||
2024 |
2023 |
||||||
Assets | (Unaudited) | ||||||
Current assets | |||||||
Cash and cash equivalents | $ | 57,024 | $ | 169,681 | |||
Marketable securities | 209,099 | — | |||||
Prepaid expenses and other current assets | 1,379 | 1,677 | |||||
Total current assets | 267,502 | 171,358 | |||||
Long-term assets | |||||||
Property and equipment, net | 19 | 12 | |||||
Operating lease right-of-use assets | 268 | 407 | |||||
Intangible assets, net | 7,777 | 8,749 | |||||
Long-term marketable securities | 28,482 | - | |||||
Other long-term assets | 83 | 165 | |||||
Total assets | $ | 304,131 | $ | 180,691 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities | |||||||
Accounts payable | $ | 3,716 | $ | 3,149 | |||
Accrued compensation | 2,149 | 3,135 | |||||
Accrued clinical trial site costs | 1,863 | 3,393 | |||||
Operating lease liabilities | 296 | 273 | |||||
Other current liabilities | 1,126 | 1,555 | |||||
Total current liabilities | 9,150 | 11,505 | |||||
Long-term liabilities | |||||||
Contingent liability for Essentialis purchase price | 13,587 | 11,549 | |||||
Common stock purchase liability | 637 | — | |||||
Long-term lease liabilities | — | 130 | |||||
Total liabilities | 23,374 | 23,184 | |||||
Commitments and contingencies (Note 6) | |||||||
Stockholders’ equity | |||||||
Preferred stock, |
— | — | |||||
Common stock, 38,386,779 and 31,678,159 shares issued and outstanding at |
38 | 32 | |||||
Additional paid-in-capital | 600,534 | 433,885 | |||||
Accumulated other comprehensive loss | (153 | ) | - | ||||
Accumulated deficit | (319,662 | ) | (276,410 | ) | |||
Total stockholders’ equity | 280,757 | 157,507 | |||||
Total liabilities and stockholders’ equity | $ | 304,131 | $ | 180,691 | |||
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands except share and per share data) |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Operating expenses | |||||||||||||||
Research and development | $ | 12,342 | $ | 5,141 | $ | 26,944 | $ | 10,457 | |||||||
General and administrative | 10,889 | 3,169 | 19,361 | 6,023 | |||||||||||
Change in fair value of contingent consideration | 1,637 | 313 | 2,038 | 612 | |||||||||||
Total operating expenses | 24,868 | 8,623 | 48,343 | 17,092 | |||||||||||
Operating loss | (24,868 | ) | (8,623 | ) | (48,343 | ) | (17,092 | ) | |||||||
Other income, net | |||||||||||||||
Change in fair value of warrants liabilities | — | 1 | — | 1 | |||||||||||
Interest income, net | 3,014 | 147 | 5,091 | 260 | |||||||||||
Total other income, net | 3,014 | 148 | 5,091 | 261 | |||||||||||
Net loss | $ | (21,854 | ) | $ | (8,475 | ) | $ | (43,252 | ) | $ | (16,831 | ) | |||
Other comprehensive income (loss) | |||||||||||||||
Net unrealized loss on marketable securities | (46 | ) | — | (151 | ) | — | |||||||||
Foreign currency translation adjustment | (1 | ) | (16 | ) | (2 | ) | — | ||||||||
Total comprehensive loss | $ | (21,901 | ) | $ | (8,491 | ) | $ | (43,405 | ) | $ | (16,831 | ) | |||
Net loss per common share, basic and diluted | $ | (0.57 | ) | $ | (0.81 | ) | $ | (1.16 | ) | $ | (1.69 | ) | |||
Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share | 38,631,565 | 10,423,598 | 37,419,968 | 9,938,171 | |||||||||||
Stock-based Compensation Expense (In thousands) |
|||||||||||
Three Months Ended |
Six Months Ended |
||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||
Research and development | $ | 2,705 | $ | 470 | $ | 5,166 | $ | 652 | |||
General and administrative | 4,455 | 734 | 8,439 | 1,183 | |||||||
Total | $ | 7,160 | $ | 1,204 | $ | 13,605 | $ | 1,835 |
![](https://ml.globenewswire.com/media/NDVhYTY2YmItYzY1OC00OTQ1LWE2YzEtNTAyYzQ2YTYyYjBlLTUwMDA3Mjk5OQ==/tiny/Soleno-Therapeutics.png)
Source: Soleno Therapeutics