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 first quarter ended March 31,
2023.
First Quarter 2023 and Recent Corporate
Highlights
- Completed enrollment in the
randomized withdrawal period of Study C602, a long-term treatment
study of Diazoxide Choline (DCCR) Extended-Release tablets for the
treatment of Prader-Willi syndrome (PWS).
- The U.S. Food and Drug
Administration previously acknowledged that data from the study has
the potential to support a New Drug Application (NDA) submission
for DCCR.
- Top-line data continue to be
expected in the third quarter 2023.
- Received $10 million in connection
with closing of December 2022 Securities Purchase Agreement with
Nantahala Capital Management, Abingworth and Vivo Capital,
triggered by announcement of enrollment completion.
“We are very pleased to have recently completed enrollment in
the randomized withdrawal phase of Study C602 and would like to
thank the participants, their families and the study sites for
helping us reach this important milestone,” said Anish Bhatnagar,
M.D., Chief Executive Officer of Soleno Therapeutics. “We continue
to be on track for the availability of top-line data in the third
quarter of 2023. Furthermore, completing enrollment satisfied the
closing condition on our December 2022 Securities Purchase
Agreement, enabling us to receive $10 million that will support
clinical operations through top-line data leading to a potential
NDA filing and approval of DCCR.”
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.
First Quarter 2023 Financial Results
As of March 31, 2023, Soleno had cash and cash equivalents of
approximately $7.9 million. This amount does not include the $10
million recently received following enrollment completion in the
randomized withdrawal period of Study C602 and the satisfaction of
the closing conditions related to the Company’s December 2022
Securities Purchase Agreement. Soleno continues to believe that, in
aggregate, these funds are sufficient to fund operations through
top-line data, which is anticipated in the third quarter of
2023.
Research and development expenses for the three months ended
March 31, 2023, were $5.3 million, compared to $4.0 million for the
same period of 2022. The cadence of Soleno’s research and
development expenditures fluctuates depending upon the state of its
clinical programs and the timing of CMC and other projects
necessary to support the submission of an NDA.
General and administrative expenses for the three months ended
March 31, 2023, were $2.9 million, compared to $2.6 million for the
same period of 2022. The increase was primarily attributable to an
increase in professional services expense.
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 of up to $21.2 million to former
Essentialis stockholders upon 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 of the liability payable was estimated to be $9.1
million as of March 31, 2023, a $0.3 million increase from the
estimate as of December 31, 2022. During the three months ended
March 31, 2022, the estimate decreased by $0.8 million from the
$9.5 million estimate as of December 31, 2021.
Total other income was approximately $113,000 in the three
months ended March 31, 2023, compared to $49,000 during the three
months ended March 31, 2022. The increase was primarily due to an
increase in interest income.
Net loss for the three months ended March 31, 2023, was $8.4
million, or $0.88 per basic and diluted share, compared to a net
loss of $5.7 million, or $1.07 per basic and diluted share, in the
same period of 2022.
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% rated body composition as either 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
E.U., 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.
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 the closing of the warrant financing under the
Securities Purchase Agreement, the receipt of top-line data from
the randomized withdrawal period, and 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 RitchieLifeSci
Advisors, LLC212-915-2578
Soleno Therapeutics, Inc. |
Condensed Consolidated Balance Sheets |
(In thousands except share and per share data) |
|
|
|
March 31,2023 |
|
|
December 31,2022 |
|
Assets |
|
(Unaudited) |
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,874 |
|
|
$ |
14,602 |
|
Prepaid expenses and other current assets |
|
|
1,253 |
|
|
|
1,045 |
|
Total current assets |
|
|
9,127 |
|
|
|
15,647 |
|
Long-term assets |
|
|
|
|
|
|
Property and equipment, net |
|
|
22 |
|
|
|
26 |
|
Operating lease right-of-use assets |
|
|
53 |
|
|
|
131 |
|
Intangible assets, net |
|
|
10,207 |
|
|
|
10,693 |
|
Other long-term assets |
|
|
126 |
|
|
|
- |
|
Total assets |
|
$ |
19,535 |
|
|
$ |
26,497 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,778 |
|
|
$ |
1,777 |
|
Accrued compensation |
|
|
721 |
|
|
|
1,675 |
|
Accrued clinical trial site costs |
|
|
3,531 |
|
|
|
3,222 |
|
Operating lease liabilities |
|
|
39 |
|
|
|
155 |
|
Other current liabilities |
|
|
692 |
|
|
|
484 |
|
Total current liabilities |
|
|
7,761 |
|
|
|
7,313 |
|
Long-term liabilities |
|
|
|
|
|
|
2018 PIPE Warrant liability |
|
|
1 |
|
|
|
1 |
|
Contingent liability for Essentialis purchase price |
|
|
9,134 |
|
|
|
8,835 |
|
Total liabilities |
|
|
16,896 |
|
|
|
16,149 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized, no shares issued and
outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value,
100,000,000 shares authorized, 8,168,788 and 8,159,382 shares
issued and outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
|
8 |
|
|
|
8 |
|
Additional paid-in-capital |
|
|
248,393 |
|
|
|
247,762 |
|
Accumulated deficit |
|
|
(245,778 |
) |
|
|
(237,422 |
) |
Accumulated other comprehensive
income |
|
|
16 |
|
|
|
- |
|
Total stockholders’ equity |
|
|
2,639 |
|
|
|
10,348 |
|
Total liabilities and stockholders’ equity |
|
$ |
19,535 |
|
|
$ |
26,497 |
|
Soleno Therapeutics, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(unaudited) |
(In thousands except share and per share data) |
|
|
|
Three Months EndedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ |
5,316 |
|
|
$ |
3,988 |
|
General and administrative |
|
|
2,854 |
|
|
|
2,643 |
|
Change in fair value of contingent consideration |
|
|
299 |
|
|
|
(858 |
) |
Total operating expenses |
|
|
8,469 |
|
|
|
5,773 |
|
Operating loss |
|
|
(8,469 |
) |
|
|
(5,773 |
) |
Other income |
|
|
|
|
|
|
Change in fair value of warrants liabilities |
|
|
- |
|
|
|
27 |
|
Interest income |
|
|
113 |
|
|
|
22 |
|
Total other income |
|
|
113 |
|
|
|
49 |
|
Net loss |
|
$ |
(8,356 |
) |
|
$ |
(5,724 |
) |
|
|
|
|
|
|
|
Other comprehensive income
(loss) |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
16 |
|
|
|
(2 |
) |
Total comprehensive loss |
|
$ |
(8,340 |
) |
|
$ |
(5,726 |
) |
|
|
|
|
|
|
|
Net loss per common share, basic
and diluted |
|
$ |
(0.88 |
) |
|
$ |
(1.07 |
) |
Weighted-average common shares
outstanding used to calculate basic and diluted net loss per common
share |
|
|
9,447,350 |
|
|
|
5,334,712 |
|
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