First Quarter 2020 and Recent Corporate Highlights
- Completed enrollment for Phase III DESTINY PWS study evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader Willi Syndrome (PWS) in the first quarter 2020 and reconfirming top-line data anticipated before the end of the current quarter
° A total of 127 subjects were randomized at 29 sites in the
U.S.and the UK.
° Subjects who have completed DESTINY PWS continue to be treated in the open-label extension study (C602), the duration of which has been increased from 12 months to up to 36 months.
° No new safety signals associated with DCCR have been identified to date and no serious, unexpected adverse events related to DCCR have been reported.
- Published paper authored by Soleno’s researchers, entitled “The Potential Role of Activating the ATP-Sensitive Potassium Channel in the Treatment of Hyperphagic Obesity,” in the peer-reviewed journal, Genes
° The article was included in the journal’s special supplement on the genetics of PWS and can be accessed at: https://www.mdpi.com/2073-4425/11/4/450/htm.
“Following the completion of enrollment in our ongoing DESTINY PWS study earlier this year, we remain on track to announce top-line data during the current quarter,” 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.
First Quarter Ended
Research and development expenses were $6.7 million for the quarter ended March 31, 2020, compared to $2.8 million in the same period of 2019. The increase was primarily due to increased activities related to the DCCR development program.
General and administrative expense was $2.0 million for the quarter ended March 31, 2020, essentially flat as compared to the same period of 2019.
The change in the fair value of contingent consideration results from Soleno’s obligation to make cash payments to
Total Other income was income of $3.4 million and expense of
Net loss for the quarter ended March 31, 2020, was approximately $5.9 million, or a net loss of
As of March 31, 2020, Soleno had cash and cash equivalents of approximately $15.1 million, compared to $20.7 million at December 31, 2019.
In conformance with local public health orders, Soleno has instituted a work from home policy for all employees to protect their health and well-being. While there has been no meaningful impact on the anticipated timeline for the availability of top-line data from the Phase III DCCR program, there have been certain changes in the conduct of Soleno’s clinical trials, depending on institution-, state- and country-specific restrictions, such as stay at home requirements. The changes align with the guidance provided by the
About DESTINY PWS
DESTINY PWS is a randomized, double-blind, placebo-controlled study of once-daily oral administration of DCCR versus placebo in 127 randomized subjects. Patients who complete DESTINY PWS have the option to enroll into an open-label extension study (C602) and continue treatment with DCCR.
For further information about DESTINY PWS (NCT03440814), please visit: www.clinicaltrials.gov.
About Diazoxide Choline Controlled-Release (DCCR) Tablet
Diazoxide Choline Controlled-Release tablet is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which 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 I clinical studies in healthy volunteers and three completed Phase II clinical studies, one of which was in PWS patients. In the PWS Phase II 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 abnormal lipid profiles.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, Diazoxide Choline Controlled-Release (DCCR) tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase III 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 Company’s expectations concerning, among other things, our ability to receive top-line data in the first half of 2020 from Phase III DESTINY PWS and the impact of the COVID-19 pandemic on our operations and clinical trial. 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||$||15,070||$||20,733|
|Prepaid expenses and other current assets||572||411|
|Total current assets||15,642||21,144|
|Property and equipment, net||19||22|
|Operating lease right-of-use assets||332||398|
|Finance lease right-of-use assets||22||24|
|Intangible assets, net||16,039||16,525|
|Other long-term assets||59||59|
|Liabilities and stockholders’ equity|
|Accrued clinical trial site costs||2,846||1,999|
|Operating lease liabilities||315||305|
|Other current liabilities||308||382|
|Total current liabilities||7,287||4,964|
|2017 PIPE Warrant liability||7,656||10,822|
|2018 PIPE Warrant liability||1,107||1,354|
|Contingent liability for
|Other long-term liabilities||60||147|
|Commitments and contingencies (Note 6)|
44,686,811 and 44,658,054 shares issued and outstanding at
|Total stockholders’ equity||9,481||14,947|
|Total liabilities and stockholders’ equity||$||32,113||$||38,172|
Condensed Consolidated Statements of Operations
(In thousands except share and per share data)
|Three Months Ended
|Research and development||$||6,695||$||2,760|
|General and administrative||2,003||2,012|
|Change in fair value of contingent consideration||584||206|
|Total operating expenses||9,282||4,978|
|Other income (expense)|
|Change in fair value of warrants liabilities||3,413||(1,919||)|
|Loss from minority interest investment||—||(190||)|
|Total other income (expense)||3,424||(2,052||)|
|Net loss per common share, basic and diluted||$||(0.13||)||$||(0.22||)|
|Weighted-average common shares outstanding used to calculate basic and
diluted net loss per common share
Source: Soleno Therapeutics