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, 2022.
First Quarter 2022 and Recent Corporate
Highlights
- Continuing dialogue with the U.S. Food and Drug Administration
(FDA) to obtain alignment on the design of a study to provide
additional clinical data to support the potential filing of a New
Drug Application for diazoxide choline extended-release (DCCR) for
the treatment of Prader-Willi Syndrome (PWS)
- Presented posters highlighting long-term results from the
Company’s studies evaluating DCCR tablets for the treatment of
patients with PWS who received DCCR for 52 weeks and compared to a
matched cohort from the PATH for PWS natural history study
(C601/C602) at the Pediatric Academic Societies (PAS) 2022 Virtual
Annual Meeting and Pediatric Endocrinology Society (PES) 2022
Virtual Annual Meeting
- Closed $15 million public offering on March 31,
2022
“We look forward to reaching alignment with the FDA
on generating additional controlled clinical data,” said Anish
Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics.
“Achieving regulatory approval as expeditiously as possible for
DCCR continues to be the Soleno team’s core priority. Our recent
data presentations at the PAS and PES annual meetings highlight the
significant potential of DCCR to improve behavioral and metabolic
outcomes for people with PWS who have no current therapeutic
options. Our recently closed public offering has strengthened our
balance sheet, providing us with financial flexibility as we
continue to advance our strategic clinical and operational
plans.”
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,
2022 Financial Results
Research and development expenses were $4.0
million for the quarter ended March 31, 2022, compared
to $7.2 million in the same period of 2021. Soleno’s
research and development spending continues to fluctuate depending
upon the state of its clinical programs and the timing of CMC costs
and other projects necessary to support the submission of an
NDA.
General and administrative expense was $2.6
million for the quarter ended March 31, 2022, compared
to $3.0 million in the same period of 2021. The decrease
was primarily due to a reduction in stock-based compensation.
The change in fair value of contingent
consideration is a result of Soleno remeasuring at the end of each
reporting period its obligation to make cash payments to
Essentialis stockholders upon the achievement of certain future
commercial milestones associated with the acquisition of DCCR in
accordance with the terms of the Essentialis merger agreement. The
fair value was estimated to be approximately $8.7 million as
of March 31, 2022, a $0.9 million decrease from the estimate as of
December 31, 2021.
Total other income was $0.05 million for
the quarter ended March 31, 2022, compared to $0.2
million in the same period of 2021, and consisted of the
change in the fair value of Soleno’s outstanding warrants and
interest income.
Net loss for the quarter ended March 31, 2022,
was approximately $5.7 million, or a net loss
of $0.07 per basic and diluted share, compared to a net
loss of approximately $9.0 million, or $0.11 per
basic and diluted share, for the quarter ended March 31,
2021.
As of March 31, 2022, Soleno had cash and cash
equivalents of approximately $29.0 million, compared
to $21.3 million as of December 31, 2021.
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, a once-daily oral
tablet for the treatment of Prader-Willi syndrome (PWS), is
currently being evaluated in an ongoing Phase 3 clinical
development program. For more information, please visit
www.soleno.life.
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 and 92.9 % body
composition 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 DCCR (Diazoxide Choline)
Extended-Release TabletsDCCR 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 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 PWS patients. In the PWS Phase 3
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 other metabolic
parameters. Soleno has been in ongoing discussions with the FDA
regarding additional data needed to support the submission of an
NDA.
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 31,2022 |
|
|
December 31,2021 |
|
Assets |
(Unaudited) |
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
28,974 |
|
|
$ |
21,304 |
|
Prepaid expenses and other current assets |
|
1,004 |
|
|
|
1,118 |
|
Total current assets |
|
29,978 |
|
|
|
22,422 |
|
Long-term assets |
|
|
|
|
|
|
|
Property and equipment, net |
|
27 |
|
|
|
33 |
|
Operating lease right-of-use assets |
|
350 |
|
|
|
421 |
|
Intangible assets, net |
|
12,151 |
|
|
|
12,637 |
|
Other long-term assets |
|
40 |
|
|
|
40 |
|
Total assets |
$ |
42,546 |
|
|
$ |
35,553 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
2,411 |
|
|
$ |
3,254 |
|
Accrued compensation |
|
598 |
|
|
|
728 |
|
Accrued clinical trial site costs |
|
3,521 |
|
|
|
3,420 |
|
Operating lease liabilities |
|
344 |
|
|
|
282 |
|
Other current liabilities |
|
439 |
|
|
|
323 |
|
Total current liabilities |
|
7,313 |
|
|
|
8,007 |
|
Long-term liabilities |
|
|
|
|
|
|
|
2018 PIPE Warrant liability |
|
4 |
|
|
|
31 |
|
Contingent liability for Essentialis purchase price |
|
8,689 |
|
|
|
9,547 |
|
Long-term lease liabilities |
|
79 |
|
|
|
175 |
|
Total liabilities |
|
16,085 |
|
|
|
17,760 |
|
Commitments and contingencies
(Note 6) |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Common stock, $0.001 par value,
250,000,000 shares authorized, 120,088,816 and 79,864,310 shares
issued and outstanding at March 31, 2022 and December 31, 2021,
respectively. |
|
120 |
|
|
|
80 |
|
Additional paid-in-capital |
|
245,422 |
|
|
|
231,068 |
|
Accumulated deficit |
|
(219,079 |
) |
|
|
(213,355 |
) |
Accumulated other comprehensive
loss |
|
(2 |
) |
|
|
— |
|
Total stockholders’ equity |
|
26,461 |
|
|
|
17,793 |
|
Total liabilities and stockholders’ equity |
$ |
42,546 |
|
|
$ |
35,553 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soleno Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(unaudited) (In thousands except
share and per share data)
|
|
|
|
Three Months EndedMarch 31, |
|
|
2022 |
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
$ |
3,988 |
|
|
$ |
7,164 |
|
General and administrative |
|
2,643 |
|
|
|
2,979 |
|
Change in fair value of contingent consideration |
|
(858 |
) |
|
|
(987 |
) |
Total operating expenses |
|
5,773 |
|
|
|
9,156 |
|
Operating loss |
|
(5,773 |
) |
|
|
(9,156 |
) |
Other income |
|
|
|
|
|
|
|
Change in fair value of warrants liabilities |
|
27 |
|
|
|
201 |
|
Interest income |
|
22 |
|
|
|
1 |
|
Total other income |
|
49 |
|
|
|
202 |
|
Net loss |
$ |
(5,724 |
) |
|
$ |
(8,954 |
) |
|
|
|
|
|
|
|
|
Other comprehensive loss |
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(2 |
) |
|
|
— |
|
Total comprehensive loss |
$ |
(5,726 |
) |
|
$ |
(8,954 |
) |
|
|
|
|
|
|
|
|
Net loss per common share, basic
and diluted |
$ |
(0.07 |
) |
|
$ |
(0.11 |
) |
Weighted-average common shares
outstanding used to calculate basic and diluted net loss per common
share |
|
80,020,677 |
|
|
|
79,694,781 |
|
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