Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Soleno Therapeutics (NASDAQ: SLNO) reported key developments in Q3 2024, including FDA acceptance of their New Drug Application for DCCR tablets treating Prader-Willi syndrome, with Priority Review and a PDUFA date of December 27, 2024. The company reported a net loss of $76.6 million ($1.83 per share) compared to $10.9 million in Q3 2023. R&D expenses were $30.1 million, while G&A expenses reached $49.2 million. The company maintains a strong balance sheet with $284.7 million in cash and equivalents, preparing for potential commercial launch.
Soleno Therapeutics (NASDAQ: SLNO) ha riportato sviluppi chiave nel terzo trimestre del 2024, inclusa l'accettazione da parte della FDA della loro domanda per un nuovo farmaco relativa ai tablet DCCR per il trattamento della sindrome di Prader-Willi, con Revisione Prioritaria e una data PDUFA fissata per il 27 dicembre 2024. L'azienda ha registrato una perdita netta di 76,6 milioni di dollari (1,83 dollari per azione) rispetto ai 10,9 milioni di dollari del terzo trimestre del 2023. Le spese per ricerca e sviluppo sono state di 30,1 milioni di dollari, mentre le spese generali e amministrative hanno raggiunto 49,2 milioni di dollari. L'azienda mantiene un bilancio forte con 284,7 milioni di dollari in contante e equivalenti, preparandosi per un potenziale lancio commerciale.
Soleno Therapeutics (NASDAQ: SLNO) reportó desarrollos clave en el tercer trimestre de 2024, incluyendo la aceptación por parte de la FDA de su Solicitud de Nuevo Medicamento para tabletas DCCR para tratar el síndrome de Prader-Willi, con Revisión Prioritaria y una fecha PDUFA del 27 de diciembre de 2024. La compañía reportó una pérdida neta de 76.6 millones de dólares (1.83 dólares por acción) en comparación con 10.9 millones de dólares en el tercer trimestre de 2023. Los gastos de I+D fueron de 30.1 millones de dólares, mientras que los gastos generales y administrativos alcanzaron los 49.2 millones de dólares. La empresa mantiene un balance sólido con 284.7 millones de dólares en efectivo y equivalentes, preparándose para un posible lanzamiento comercial.
솔레노 치료제 (NASDAQ: SLNO)는 2024년 3분기에 중요한 발전 사항을 보고했습니다. 여기에는 프라더-윌리 증후군 치료를 위한 DCCR 정제의 새로운 약물 신청서가 FDA에 수락되고 우선 심사로 지정되며 PDUFA 날짜가 2024년 12월 27일로 설정된 것이 포함됩니다. 회사는 2023년 3분기와 비교하여 7,660만 달러 (주당 1.83달러)의 순손실을 보고했습니다. 연구개발비는 3,010만 달러였으며, 일반 관리비는 4,920만 달러에 달했습니다. 회사는 2억 8,470만 달러의 현금 및 현금성 자산을 보유하고 있어 잠재적인 상업적 출시를 준비하고 있습니다.
Soleno Therapeutics (NASDAQ: SLNO) a signalé des développements clés au troisième trimestre de 2024, y compris l'acceptation par la FDA de leur demande de nouveau médicament pour les comprimés DCCR traitant le syndrome de Prader-Willi, avec un examen prioritaire et une date PDUFA fixée au 27 décembre 2024. L'entreprise a enregistré une perte nette de 76,6 millions de dollars (1,83 dollar par action) par rapport à 10,9 millions de dollars au troisième trimestre 2023. Les dépenses de R&D étaient de 30,1 millions de dollars, tandis que les dépenses générales et administratives ont atteint 49,2 millions de dollars. L’entreprise maintient un bilan solide avec 284,7 millions de dollars en liquidités et équivalents, se préparant pour un éventuel lancement commercial.
Soleno Therapeutics (NASDAQ: SLNO) berichtete über wichtige Entwicklungen im dritten Quartal 2024, einschließlich der Zulassung durch die FDA für ihren Antrag auf ein neues Medikament für DCCR-Tabletten zur Behandlung des Prader-Willi-Syndroms, mit priorisierter Prüfung und einem PDUFA-Datum am 27. Dezember 2024. Das Unternehmen meldete einen Nettoverlust von 76,6 Millionen US-Dollar (1,83 US-Dollar pro Aktie) im Vergleich zu 10,9 Millionen US-Dollar im dritten Quartal 2023. Die F&E-Ausgaben betrugen 30,1 Millionen US-Dollar, während die allgemeinen Verwaltungs- und Vertriebskosten 49,2 Millionen US-Dollar erreichten. Das Unternehmen verfügt über eine starke Bilanz mit 284,7 Millionen US-Dollar an Bargeld und Barmitteln und bereitet sich auf einen möglichen kommerziellen Start vor.
- FDA granted Priority Review for DCCR with PDUFA date set
- Strong cash position of $284.7 million
- Higher interest income from cash investments
- Net loss increased to $76.6 million from $10.9 million YoY
- R&D expenses increased to $30.1 million from $6.0 million YoY
- G&A expenses rose to $49.2 million from $3.3 million YoY
- Potential liability of up to $21.2 million in commercial milestone payments
Insights
The Q3 2024 results reveal significant financial developments for Soleno Therapeutics. The company maintains a strong cash position of
The substantial increase in expenses primarily reflects preparation for DCCR's potential commercial launch and FDA submission activities. The net loss widened to
The FDA's acceptance of DCCR's NDA with Priority Review status for Prader-Willi syndrome treatment marks a important regulatory milestone. The PDUFA date of December 27, 2024, indicates potential market entry in early 2025. The FDA's current stance on not requiring an advisory committee meeting suggests confidence in the submission package, though this could change during the review process.
The company's investment in commercial preparation, including supply chain activities and medical affairs, demonstrates readiness for potential market launch. If approved, DCCR would address a significant unmet need in PWS treatment, a rare genetic disorder with therapeutic options.
REDWOOD CITY, Calif., Nov. 06, 2024 (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, 2024.
Third Quarter 2024 and Recent Corporate Highlights
- New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) accepted by the U.S. Food and Drug Administration (FDA) and granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.
- The FDA Review Division determined that there does not appear to be a need for an advisory committee meeting at this time. However, the Division’s review team will continue to consider the potential need for an advisory committee meeting during their ongoing review.
- Announced updates to its Board of Directors:
- Appointed Dawn Carter Bir, a seasoned biotechnology executive with over 30 years of industry executive leadership and strategic experience, to Soleno’s Board of Directors.
- Current Board member Matthew Pauls, J.D., M.B.A assumed the role of Lead Independent Director.
- Soleno mourned the passing of former Chairman of the Board Ernest Mario, Ph.D. Dr. Mario served as Soleno’s (formerly Capnia’s) Chairman from 2007 through August 2024.
“In the third quarter of 2024, we achieved a major milestone with FDA acceptance of our NDA seeking approval of DCCR for the treatment of PWS,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Our dialogue with the FDA has been productive to date, and we look forward to continued collaboration as the review process advances. As we look towards potential approval of DCCR, our commercial team continues to prepare for our planned U.S. market launch. Our strong balance sheet supports successful execution of a launch and the delivery of a transformative therapy to people living with PWS, if approved.”
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 Ended September 30, 2024 Financial Results
Soleno used
Research and development expense was
General and administrative expense was
We are obligated to make cash payments of up to a maximum of
Total other income, net, was
Net loss was approximately
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 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 U.S. and E.U., and Fast Track and Breakthrough Designations 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. An NDA for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS) is currently under review by the FDA and was granted Priority Review. 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 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 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, 2024 | December 31, 2023 | ||||||
| Assets | (unaudited) | ||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 48,413 | $ | 169,681 | |||
| Marketable securities | 208,363 | — | |||||
| Prepaid expenses and other current assets | 1,423 | 1,677 | |||||
| Total current assets | 258,199 | 171,358 | |||||
| Long-term assets | |||||||
| Property and equipment, net | 196 | 12 | |||||
| Operating lease right-of-use assets | 2,992 | 407 | |||||
| Intangible assets, net | 7,291 | 8,749 | |||||
| Long-term marketable securities | 27,945 | - | |||||
| Other long-term assets | 83 | 165 | |||||
| Total assets | $ | 296,706 | $ | 180,691 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 6,243 | $ | 3,149 | |||
| Accrued compensation | 3,408 | 3,135 | |||||
| Accrued clinical trial site costs | 1,762 | 3,393 | |||||
| Operating lease liabilities | 448 | 273 | |||||
| Other current liabilities | 3,101 | 1,555 | |||||
| Total current liabilities | 14,962 | 11,505 | |||||
| Long-term liabilities | |||||||
| Contingent liability for Essentialis purchase price | 14,464 | 11,549 | |||||
| Long-term lease liabilities | 2,581 | 130 | |||||
| Total liabilities | 32,007 | 23,184 | |||||
| Commitments and contingencies (Note 6) | |||||||
| Stockholders’ equity | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 41 | 32 | |||||
| Additional paid-in-capital | 660,041 | 433,885 | |||||
| Accumulated other comprehensive gain | 895 | - | |||||
| Accumulated deficit | (396,278 | ) | (276,410 | ) | |||
| Total stockholders’ equity | 264,699 | 157,507 | |||||
| Total liabilities and stockholders’ equity | $ | 296,706 | $ | 180,691 | |||
| 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, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 30,138 | $ | 6,043 | $ | 57,082 | $ | 16,500 | |||||||
| General and administrative | 49,197 | 3,318 | 68,558 | 9,341 | |||||||||||
| Change in fair value of contingent consideration | 877 | 1,021 | 2,915 | 1,633 | |||||||||||
| Total operating expenses | 80,212 | 10,382 | 128,555 | 27,474 | |||||||||||
| Operating loss | (80,212 | ) | (10,382 | ) | (128,555 | ) | (27,474 | ) | |||||||
| Other income (expense), net | |||||||||||||||
| Change in fair value of warrants liabilities | — | (653 | ) | — | (652 | ) | |||||||||
| Interest income, net | 3,596 | 174 | 8,687 | 434 | |||||||||||
| Total other income (expense), net | 3,596 | (479 | ) | 8,687 | (218 | ) | |||||||||
| Net loss | $ | (76,616 | ) | $ | (10,861 | ) | $ | (119,868 | ) | $ | (27,692 | ) | |||
| Other comprehensive income (loss) | |||||||||||||||
| Net unrealized gain on marketable securities | 1,049 | — | 898 | — | |||||||||||
| Foreign currency translation adjustment | (1 | ) | (1 | ) | (3 | ) | (1 | ) | |||||||
| Total comprehensive loss | $ | (75,568 | ) | $ | (10,862 | ) | $ | (118,973 | ) | $ | (27,693 | ) | |||
| Net loss per common share, basic and diluted | $ | (1.83 | ) | $ | (0.95 | ) | $ | (3.08 | ) | $ | (2.65 | ) | |||
| Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share | 41,879,025 | 11,436,748 | 38,917,169 | 10,443,186 | |||||||||||
| Soleno Therapeutics, Inc. Stock-based Compensation Expense (In thousands) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Research and development | $ | 18,516 | $ | 935 | $ | 23,682 | $ | 1,587 | |||||||
| General and administrative | 38,082 | 1,266 | 46,521 | 2,449 | |||||||||||
| Total | $ | 56,598 | $ | 2,201 | $ | 70,203 | $ | 4,036 | |||||||
FAQ
What is the PDUFA date for Soleno's (SLNO) DCCR drug application?
How much cash does Soleno (SLNO) have as of Q3 2024?
What was Soleno's (SLNO) net loss in Q3 2024?
