Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results
- Positive statistically significant top-line data from the randomized withdrawal period of Study C602 provides a strong basis for the potential approval of DCCR for Prader-Willi syndrome, which is a significant milestone for Soleno Therapeutics.
- The gross proceeds of $169.9 million from recent financing activities have significantly bolstered Soleno's financial position, providing ample resources for executing planned corporate strategies.
- The net loss for the three and nine months ended September 30, 2023, was $10.9 million and $27.7 million, respectively, indicating a substantial financial burden on the company.
- The increase in research and development expenses and general and administrative expenses compared to the same periods of 2022 might raise concerns about cost management and efficiency.
REDWOOD CITY, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2023.
Third Quarter 2023 and Recent Corporate Highlights
- Announced positive statistically significant top-line data from 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).
- The study met its primary endpoint, demonstrating a highly statistically significant difference in change from baseline in HQ-CT total score for DCCR compared to placebo (p=0.0022)
- Secondary endpoints of Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) both showed strong trends towards worsening in the placebo group compared to DCCR (p=0.08 and 0.09), respectively.
- DCCR continued to be generally well-tolerated in the randomized withdrawal period with no new or unexpected safety signals, including no serious adverse events or discontinuations due to adverse events occurring in any participants in the treatment group.
- Presented results from the randomized withdrawal phase of Study C602 at the Foundation for Prader-Willi Research (FPWR) 2023 Research Symposium held on October 5-6, 2023 in Denver, Colorado.
- Closed on gross proceeds of approximately
$129 million from an underwritten public offering of common stock and concurrent private placement of common stock and pre-funded warrants in October 2023. - Appointed industry veteran Matthew Pauls, J.D., M.B.A. to the Board of Directors. Mr. Pauls currently serves as Chair of the Board of Directors and Chief Executive Officer of Savara, Inc., a biopharmaceutical company focused on rare respiratory diseases. He is also a member of the Board of Directors at Amplo Biotechnology, a private gene therapy company focused on rare neuromuscular disorders. Previously, he was President and Chief Executive Officer and a member of the Board of Directors at Strongbridge Biopharma plc. In addition, Mr. Pauls has significant experience in global commercial roles, including at Insmed, Shire Pharmaceuticals, Bristol-Myers Squibb and Johnson & Johnson.
- Hired Mike Huang, M.D. as Senior Vice President of Clinical Development. Prior to joining Soleno, Dr. Huang held leadership roles at several biopharmaceutical companies, including AmMax Bio, Spruce Biosciences, Regulus Therapeutics, Auspex Pharmaceuticals and Santarus, where he worked on programs advancing small molecules, biologic agents and oligonucleotide therapies through all phases of clinical development and successful marketing authorizations. Dr. Huang’s therapeutic experience spans an array of indications, including rare/orphan diseases, endocrinology, neurology and oncology.
“The recent announcement of positive results from the randomized withdrawal phase of Study C602 was a significant milestone for us,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We are continuing our ongoing work preparing a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), currently planned for mid-2024. Importantly, following our successfully completed public offering and concurrent private placement, we have initiated commercial readiness activities and are well-capitalized to execute on our planned corporate strategy leading up to and beyond potential approval of DCCR for PWS.”
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.
Third Quarter 2023 Financial Results
As of September 30, 2023, Soleno had cash and cash equivalents of approximately
Research and development expenses for the three and nine months ended September 30, 2023, were
General and administrative expenses for the three and nine months ended September 30, 2023, were
Soleno is obligated to make cash payments of up to a maximum of
Total other expense was
Net loss for the three and nine months ended September 30, 2023, was
The following table summarizes the Soleno’s outstanding common stock and common stock warrants as of October 31, 2023:
| As of October 31, 2023 | ||||||||
| Number of Common Shares | Weighted Average Exercise Price per Shares | |||||||
| Common stock outstanding | 30,499,352 | $ | - | |||||
| Common stock warrants | 7,904 | $ | 388.94 | |||||
| 2018 PIPE warrants | 34,241 | $ | 30.00 | |||||
| March 2022 common warrants | 2,122,924 | $ | 4.50 | |||||
| March 2022 Pre-funded warrants | 0 | $ | 0.15 | |||||
| May 2023 Tranche A warrants | 0 | $ | 1.75 | |||||
| May 2023 Tranche A Pre-funded warrants | 3,058,837 | $ | 0.01 | |||||
| May 2023 Tranche B warrants | 7,000,000 | $ | 2.50 | |||||
| May 2023 Tranche B Pre-funded warrants | 451,632 | $ | 0.01 | |||||
| Oct 2023 Pre-funded warrants | 1,125,019 | $ | 0.01 | |||||
| Total | 44,299,909 | |||||||
About PWS
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, food pre-occupation, extreme drive to food seek and consume food that severely diminish the quality of life for patients with PWS 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,
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, 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 U.S. and E.U., 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 PWS, recently completed its Phase 3 development program to support a planned NDA submission. 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 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 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
Soleno Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands except share and per share data)
| September 30, 2023 | December 31, 2022 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 52,437 | $ | 14,602 | ||||
| Prepaid expenses and other current assets | 1,222 | 1,045 | ||||||
| Total current assets | 53,659 | 15,647 | ||||||
| Long-term assets | ||||||||
| Property and equipment, net | 15 | 26 | ||||||
| Operating lease right-of-use assets | 474 | 131 | ||||||
| Intangible assets, net | 9,235 | 10,693 | ||||||
| Other long-term assets | 165 | - | ||||||
| Total assets | $ | 63,548 | $ | 26,497 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,216 | $ | 1,777 | ||||
| Accrued compensation | 1,498 | 1,675 | ||||||
| Accrued clinical trial site costs | 3,237 | 3,222 | ||||||
| Common stock purchase liability | 19,938 | - | ||||||
| Operating lease liabilities - current | 256 | 155 | ||||||
| Other current liabilities | 848 | 484 | ||||||
| Total current liabilities | 28,993 | 7,313 | ||||||
| Long-term liabilities | ||||||||
| 2018 PIPE Warrant liability | 653 | 1 | ||||||
| Operating lease liabilities - noncurrent | 214 | - | ||||||
| Contingent liability for Essentialis purchase price | 10,468 | 8,835 | ||||||
| Total liabilities | 40,328 | 16,149 | ||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 15 | 8 | ||||||
| Additional paid-in-capital | 288,320 | 247,762 | ||||||
| Accumulated deficit | (265,114 | ) | (237,422 | ) | ||||
| Accumulated other comprehensive loss | (1 | ) | - | |||||
| Total stockholders’ equity | 23,220 | 10,348 | ||||||
| Total liabilities and stockholders’ equity | $ | 63,548 | $ | 26,497 | ||||
Soleno Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(In thousands except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 6,043 | $ | 3,771 | $ | 16,500 | $ | 11,455 | ||||||||
| General and administrative | 3,318 | 2,332 | 9,341 | 7,442 | ||||||||||||
| Change in fair value of contingent consideration | 1,021 | 132 | 1,633 | (110 | ) | |||||||||||
| Total operating expenses | 10,382 | 6,235 | 27,474 | 18,787 | ||||||||||||
| Operating loss | (10,382 | ) | (6,235 | ) | (27,474 | ) | (18,787 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Change in fair value of warrants liabilities | (653 | ) | 2 | (652 | ) | 31 | ||||||||||
| Interest income | 174 | 101 | 434 | 175 | ||||||||||||
| Total other income (expense), net | (479 | ) | 103 | (218 | ) | 206 | ||||||||||
| Net loss | $ | (10,861 | ) | $ | (6,132 | ) | $ | (27,692 | ) | $ | (18,581 | ) | ||||
| Other comprehensive loss | ||||||||||||||||
| Foreign currency translation adjustment | (1 | ) | (1 | ) | (1 | ) | (2 | ) | ||||||||
| Total comprehensive loss | $ | (10,862 | ) | $ | (6,133 | ) | $ | (27,693 | ) | $ | (18,583 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.95 | ) | $ | (0.65 | ) | $ | (2.65 | ) | $ | (2.31 | ) | ||||
| Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share | 11,436,748 | 9,417,705 | 10,443,186 | 8,045,513 | ||||||||||||
FAQ
What is the significance of the positive top-line data from the randomized withdrawal period of Study C602 for Soleno Therapeutics (NASDAQ: SLNO)?
How much cash and cash equivalents did Soleno Therapeutics have as of September 30, 2023?
What were the gross proceeds from Soleno Therapeutics' recent financing activities?
What was Soleno Therapeutics' net loss for the three and nine months ended September 30, 2023?
