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 fourth quarter and full-year
ended December 31, 2023.
Full Year 2023 and Recent Corporate
Highlights
- Announced positive statistically significant top-line data from
the randomized withdrawal period of Study C602, a long-term
treatment study of DCCR (Diazoxide Choline) Extended-Release
tablets for the treatment of Prader-Willi syndrome (PWS) in
September 2023.
- The study met its primary endpoint, demonstrating a highly
statistically significant difference in change from baseline in
HQ-CT total score for DCCR compared to placebo (p=0.0022).
- Secondary endpoints of Clinical Global Impression of Severity
(CGI-S) and Clinical Global Impression of Improvement (CGI-I) both
showed strong trends towards worsening in the placebo group
compared to DCCR (p=0.08 and 0.09), respectively.
- DCCR continued to be generally well-tolerated in the randomized
withdrawal period with no new or unexpected safety signals.
- Planned submission of a New Drug Application (NDA) for DCCR in
PWS remains on track for mid-2024, after receipt of pre-NDA meeting
minutes from the U.S. Food and Drug Administration. The FDA stated
that the potential for data from the DCCR clinical program to
provide substantial evidence of effectiveness will be a matter of
review following the submission of an NDA.
- Closed on gross proceeds of approximately $129 million from an
underwritten public offering of common stock and concurrent private
placement of common stock and pre-funded warrants in October 2023,
and received $43.1 million from the sale and exercise of warrants
issued in connection with the December 2022 Securities Purchase
Agreement.
- Strengthened leadership team with appointments of Meredith
Manning, M.B.A as Chief Commercial Officer, Dairine Dempsey, Ph.D.
as Vice President, Europe and Lauren Budesheim, M.S. as Vice
President of Human Resources.
“Following recent feedback from the FDA, Soleno remains focused
on preparing an NDA submission for DCCR in PWS mid-2024,” said
Anish Bhatnagar, M.D., Chief Executive Officer of Soleno
Therapeutics. “We believe data from our extensive clinical program,
including highly statistically significant top-line results from
the randomized withdrawal period of Study C602, supports that DCCR
has the potential to be a safe and effective therapy for patients
with PWS. With our strengthened leadership team and balance sheet,
we are ideally positioned to carry out our corporate strategy and,
if approved, deliver a new treatment option for PWS patients.”
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.
Fourth Quarter and Full Year Ended December 31, 2023
Financial Results
As of December 31, 2023, Soleno had cash and cash equivalents of
approximately $169.7 million, which includes $129 million received
upon the closing of the public offering and concurrent private
placement in October 2023, and $43.1 million received from the sale
and exercise of warrants issued in connection with the December
2022 Securities Purchase Agreement. The Company may receive an
additional $16.9 million from the exercise of the remaining
warrants issued pursuant to the December 2022 Securities Purchase
Agreement.
Research and development expenses were $8.7 million for the
quarter ended December 31, 2023, compared to $3.8 million in the
same period of 2022, and $25.2 million for the year ended December
31, 2023, compared to $15.3 million for the year ended 2022. The
increase was primarily due to increased clinical trials costs,
manufacturing efforts, and expenditures in support of our NDA
submission.
General and administrative expenses were $4.1 million for the
quarter ended December 31, 2023, compared to $2.4 million in the
same period of 2022, and $13.5 million for the year ended December
31, 2023, compared to $9.8 million for the year ended 2022. The
increase was primarily related to higher stock-based compensation
expense, higher costs because of an increase in headcount and
higher professional and consulting expenses in 2023.
Soleno is obligated to make cash payments of up to a maximum of
$21.2 million to the former Essentialis stockholders upon the
achievement of certain commercial milestones associated with the
future sales of DCCR in accordance with the terms of Soleno’s 2016
merger agreement with Essentialis. The fair value of the liability
for the contingent consideration payable by the Company upon
achieving two commercial sales milestones of $100 million and $200
million in revenue in future years was estimated to be $11.5
million as of December 31, 2023, a $1.1 million increase from the
estimate as of September 30, 2023.
Total other income (expense), net, was $2.6 million for the
quarter ended December 31, 2023, and $0.1 million in the same
period of 2022. For the year, total other income (expense), net,
was $2.4 million for 2023, and $0.3 million for 2022. Other income
(expense) consists of interest income and changes in the fair value
of the Company’s warrant liability.
Net loss was approximately $11.3 million, or $0.33 per basic and
diluted share, for the quarter ended December 31, 2023, and $5.5
million, or $0.58 per basic and diluted share, in the same period
of 2022.
Net loss for the year ended December 31, 2023, was approximately
$39.0 million, or $2.36 per basic and diluted share, compared to a
net loss of approximately $24.1 million, or $2.87 per basic and
diluted share, for the year ended December 31, 2022.
About PWSThe 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, 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.
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 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
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 PWS, recently completed its Phase 3
development program to support a planned NDA submission. 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 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 projected timeline of our NDA
submission, whether FDA will agree with our interpretation of the
data or the adequacy of data to support an NDA, 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 RitchieLifeSci
Advisors, LLC212-915-2578
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Soleno Therapeutics, Inc. Condensed
Consolidated Balance Sheets (In thousands except share and
per share data) |
|
|
|
|
|
December 31,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
169,681 |
|
|
$ |
14,602 |
|
Prepaid expenses and other current assets |
|
|
1,677 |
|
|
|
1,045 |
|
Total current assets |
|
|
171,358 |
|
|
|
15,647 |
|
Long-term assets |
|
|
|
|
|
|
Property and equipment, net |
|
|
12 |
|
|
|
26 |
|
Operating lease right-of-use assets |
|
|
407 |
|
|
|
131 |
|
Intangible assets, net |
|
|
8,749 |
|
|
|
10,693 |
|
Other long-term assets |
|
|
165 |
|
|
|
— |
|
Total assets |
|
$ |
180,691 |
|
|
$ |
26,497 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable, net |
|
$ |
3,149 |
|
|
$ |
1,777 |
|
Accrued compensation |
|
|
3,135 |
|
|
|
1,675 |
|
Accrued clinical trial site costs |
|
|
3,393 |
|
|
|
3,222 |
|
Operating lease liabilities |
|
|
273 |
|
|
|
155 |
|
Other current liabilities |
|
|
1,555 |
|
|
|
484 |
|
Total current liabilities |
|
|
11,505 |
|
|
|
7,313 |
|
Long-term liabilities |
|
|
|
|
|
|
2018 PIPE Warrant liability |
|
|
- |
|
|
|
1 |
|
Contingent liability for Essentialis purchase price |
|
|
11,549 |
|
|
|
8,835 |
|
Long-term lease liabilities |
|
|
130 |
|
|
|
— |
|
Total liabilities |
|
|
23,184 |
|
|
|
16,149 |
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
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, 31,678,159
and 8,159,382 shares issued and outstanding at December 31, 2023
and December 31, 2022, respectively |
|
|
32 |
|
|
|
8 |
|
Additional paid-in-capital |
|
|
433,885 |
|
|
|
247,762 |
|
Accumulated deficit |
|
|
(276,410 |
) |
|
|
(237,422 |
) |
Total stockholders’ equity |
|
|
157,507 |
|
|
|
10,348 |
|
Total liabilities and stockholders’ equity |
|
$ |
180,691 |
|
|
$ |
26,497 |
|
|
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Soleno Therapeutics, Inc.Condensed
Consolidated Statements of Operations (In thousands except
share and per share data) |
|
|
|
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Three Months EndedDecember
31, |
|
For the Years EndedDecember
31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,689 |
|
|
|
$ |
3,810 |
|
|
|
$ |
25,189 |
|
|
$ |
15,265 |
|
General and administrative |
|
|
4,410 |
|
|
|
|
2,402 |
|
|
|
|
13,481 |
|
|
|
9,844 |
|
Change in fair value of contingent consideration |
|
|
1,081 |
|
|
|
|
(602 |
) |
|
|
|
2,714 |
|
|
|
(712 |
) |
Total operating expenses |
|
|
13,910 |
|
|
|
|
5,610 |
|
|
|
|
41,384 |
|
|
|
24,397 |
|
Operating loss |
|
|
(13,910 |
) |
|
|
|
(5,610 |
) |
|
|
|
(41,384 |
) |
|
|
(24,397 |
) |
Other
income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability |
|
|
470 |
|
|
|
|
(1 |
) |
|
|
|
(182 |
) |
|
|
30 |
|
Interest income |
|
|
2,144 |
|
|
|
|
125 |
|
|
|
|
2,578 |
|
|
|
300 |
|
Total other income (expense), net |
|
|
2,614 |
|
|
|
|
124 |
|
|
|
|
2,396 |
|
|
|
330 |
|
Net
loss |
|
$ |
(11,296 |
) |
|
|
$ |
(5,486 |
) |
|
|
$ |
(38,988 |
) |
|
$ |
(24,067 |
) |
Net loss
per common share, basic and diluted |
|
$ |
(0.33 |
) |
|
|
$ |
(0.58 |
) |
|
|
$ |
(2.36 |
) |
|
$ |
(2.87 |
) |
Weighted-average common shares outstanding used to calculate basic
and diluted net loss per common share |
|
|
34,441,721 |
|
|
|
|
9,440,347 |
|
|
|
|
16,492,132 |
|
|
|
8,397,088 |
|
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