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 three
months ended March 31, 2021.
“We are continuing our dialogue with the U.S. Food and Drug
Administration (FDA) to evaluate the appropriate next steps in our
DCCR program for the treatment of Prader-Willi Syndrome (PWS) and
work towards obtaining regulatory approval as expeditiously as
possible,” said Anish Bhatnagar, M.D., Chief Executive Officer
of Soleno Therapeutics. “The Soleno team remains committed to
the development of DCCR and building an appropriate data set to
support its development. To this end, we were excited to recently
present behavioral outcomes data from caregiver interviews that
summarized individual patient experiences during treatment with
DCCR. We were also pleased to speak to the PWS community directly
during the recent PWS DCCR Town Hall meeting where we reiterated
our continued focus on DCCR and outlined the proposed necessary
steps for submitting a marketing application to the FDA in the U.S.
More importantly, we were able to listen to the stories about the
individual study participants’ experiences during our completed
Phase III clinical trial of DCCR, DESTINY PWS, and the ongoing
long-term safety extension study.”
Dr. Bhatnagar continued, “We are grateful for the work completed
by the Foundation for Prader-Willi Research and Prader-Willi
Syndrome Association | USA in collecting the experiences of PWS
patients and caregivers treated with DCCR. This petition, which was
submitted to the FDA, was signed by more than 26,000 individuals in
support of DCCR.”
First Quarter 2021 and Recent Corporate
Highlights
- Continued discussions with FDA and currently evaluating
appropriate next steps for DCCR program in PWS
- Presented behavioral outcomes data from the Company’s ongoing
open-label extension study (C602) of DCCR in PWS at the Pediatric
Academic Societies (PAS) 2021 Virtual Annual Meeting (poster
available here)
- A majority of patients (83%) reported positive changes in
multiple behavioral outcome domains, including food-seeking
behaviors, mealtime behaviors and daily life behaviors in a
preliminary analysis of data from interviews of caregivers of
participants in C602
- Presented assessment of baseline renal function in PWS patients
enrolled in clinical study C601 at the Endocrinology Society (ENDO)
2021 Virtual Annual Meeting (poster available here)
- With researchers from the U.S. National Institutes of Health,
presented resting energy expenditure data for a limited number of
subjects enrolled in clinical studies C601 and C602 at the
Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting
(poster available here)
- DCCR treated subjects showed progressive increases in resting
energy expenditure
- Presented a post-hoc analysis of C601 taking into account data
prior to the ‘COVID impact’ (defined as 1 March 2020) at the PES
2021 Virtual Annual Meeting (poster available here)
- The primary endpoint, change in hyperphagia using HQ-CT, and
all key secondary endpoints showed significant improvements in DCCR
treated subjects compared with placebo
- There were significant improvements in a number of behavioral
and cardiometabolic endpoints in DCCR treated subjects compared
with placebo
- Participated in PWS DCCR Town Hall
- Highlighted the proposed necessary steps to submit a marketing
application for DCCR in the U.S. and reaffirmed the Company’s
commitment to this process
- Listened to individual patient and caregiver experiences with
DCCR
- Participated in a fireside chat at the 31st Annual Oppenheimer
Healthcare Conference
Financial ResultsSoleno’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 March 31, 2021 Financial
Results
Research and development expenses were $7.2
million for the quarter ended March 31, 2021, compared
to $6.7 million in the same period of 2020. The increase
was primarily due to increased activities related to the DCCR
development program. General and administrative expense
was $3.0 million for the quarter ended March 31,
2021, compared to $2.0 million in the same period of 2020.
The change in the fair value of contingent consideration results
from Soleno’s obligation to make cash payments
to Essentialis stockholders upon the achievement of
certain future commercial milestones associated with the sale of
DCCR in accordance with the terms of
the Essentialis merger agreement. The fair value was
estimated to be approximately $9.3 million at March
31, 2021, resulting in a decrease in expense of
approximately $1.0 million from the estimate at December
31, 2020.
Total other income was $0.2 million for the quarter ended March
31, 2021, compared to $3.4 million in the same period of 2020, and
consisted primarily of the change in the fair value of our
outstanding warrants.
Net loss for the quarter ended March 31, 2021, was
approximately $9.0 million, or a net loss
of $0.11 per basic and diluted share, compared to a net
loss of approximately $5.9 million, or $0.13 per
basic and diluted share, for the quarter ended March 31,
2020.
As of March 31, 2021, Soleno had cash and cash equivalents
of approximately $41.6 million, compared to $49.2
million at December 31, 2020.
About PWSThe Prader-Willi Syndrome Association
USA estimates that PWS occurs in one in every 15,000 live births in
the U.S. The hallmark symptom of this disorder is hyperphagia, a
chronic feeling of insatiable hunger that severely diminishes the
quality of life for PWS patients 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, 96.5% of respondents
(parent and caregivers) rated hyperphagia as the most important or
a very important symptom to be relieved by a new medicine. There
are currently no approved therapies to treat the
hyperphagia/appetite, metabolic, cognitive function, or behavioral
aspects of the disorder. Diazoxide choline has received Orphan Drug
Designation for the treatment of PWS in the U.S. and EU, 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 Prader-Willi Syndrome (PWS), is currently
being evaluated in a Phase 3 clinical development program. For more
information, please visit www.soleno.life.
Forward-Looking StatementsThis 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 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 RitchieLifeSci
Advisors, LLC212-915-2578
Soleno Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(In thousands except share and per share data)
|
|
March 31,2021 |
|
|
December 31,2020 |
|
Assets |
|
(Unaudited) |
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,607 |
|
|
$ |
49,224 |
|
Prepaid expenses and other current assets |
|
|
921 |
|
|
|
1,019 |
|
Total current assets |
|
|
42,528 |
|
|
|
50,243 |
|
Long-term assets |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
20 |
|
|
|
19 |
|
Operating lease right-of-use assets |
|
|
50 |
|
|
|
124 |
|
Finance lease right-of-use assets |
|
|
13 |
|
|
|
15 |
|
Intangible assets, net |
|
|
14,095 |
|
|
|
14,581 |
|
Total assets |
|
$ |
56,706 |
|
|
$ |
64,982 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,669 |
|
|
$ |
3,489 |
|
Accrued compensation |
|
|
411 |
|
|
|
1,005 |
|
Accrued clinical trial site costs |
|
|
4,140 |
|
|
|
3,789 |
|
Operating lease liabilities |
|
|
57 |
|
|
|
139 |
|
Other current liabilities |
|
|
232 |
|
|
|
196 |
|
Total current liabilities |
|
|
9,509 |
|
|
|
8,618 |
|
Long-term liabilities |
|
|
|
|
|
|
|
|
2018 PIPE Warrant liability |
|
|
338 |
|
|
|
539 |
|
Contingent liability for Essentialis purchase price |
|
|
9,291 |
|
|
|
10,278 |
|
Total liabilities |
|
|
19,138 |
|
|
|
19,435 |
|
Commitments and contingencies
(Note 6) |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value,
250,000,000 shares authorized, 79,723,680 and 79,615,692
shares issued and outstanding at March 31, 2021 and December
31, 2020, respectively. |
|
|
80 |
|
|
|
80 |
|
Additional paid-in-capital |
|
|
228,887 |
|
|
|
227,912 |
|
Accumulated deficit |
|
|
(191,399 |
) |
|
|
(182,445 |
) |
Total stockholders’ equity |
|
|
37,568 |
|
|
|
45,547 |
|
Total liabilities and stockholders’ equity |
|
$ |
56,706 |
|
|
$ |
64,982 |
|
Soleno Therapeutics,
Inc.Condensed Consolidated Statements of
Operations(unaudited)(In thousands except
share and per share data)
|
|
Three Months EndedMarch 31, |
|
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
7,164 |
|
|
$ |
6,695 |
|
General and administrative |
|
|
2,979 |
|
|
|
2,003 |
|
Change in fair value of contingent consideration |
|
|
(987 |
) |
|
|
584 |
|
Total operating expenses |
|
|
9,156 |
|
|
|
9,282 |
|
Operating loss |
|
|
(9,156 |
) |
|
|
(9,282 |
) |
Other income |
|
|
|
|
|
|
|
|
Change in fair value of warrants liabilities |
|
|
201 |
|
|
|
3,413 |
|
Interest income |
|
|
1 |
|
|
|
11 |
|
Total other income |
|
|
202 |
|
|
|
3,424 |
|
Net loss |
|
$ |
(8,954 |
) |
|
$ |
(5,858 |
) |
Net loss per common share, basic
and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.13 |
) |
Weighted-average common shares
outstanding used to calculate basic and diluted net loss per common
share |
|
|
79,694,781 |
|
|
|
44,679,858 |
|
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