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,
2024.
First Quarter 2024 and Recent Corporate
Highlights
- Closed on approximately $158.7
million underwritten public offering of 3,450,000 shares of common
stock at a public offering price of $46.00 per share, which
includes the exercise in full by the underwriters of their
overallotment option to purchase additional shares.
- Granted Breakthrough Therapy
Designation by the U.S. Food and Drug Administration (FDA) for
Diazoxide Choline Extended-Release (DCCR) for the treatment of
adults and children ages four years and older with genetically
confirmed Prader-Willi syndrome (PWS) who have hyperphagia.
- Planned submission of a New Drug
Application (NDA) for DCCR in PWS remains on track for
mid-2024.
- Published peer-reviewed paper
featuring the comparison of results from the Company’s Phase 3
placebo-controlled study (C601) and open-label extension study
(C602) evaluating DCCR in patients with PWS to data from the PATH
for PWS (PATH) natural history study in the Journal of
Neurodevelopmental Disorders. The article, entitled, Behavioral
Changes in Patients with Prader-Willi Syndrome Receiving Diazoxide
Choline Extended-Release Tablets Compared to the PATH for PWS
Natural History Study showed there to be significant improvements
in hyperphagia and other PWS-associated behaviors with DCCR
compared with natural history, and can be found here.
- 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.
“Soleno’s top priority remains NDA submission for DCCR in PWS,”
said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno
Therapeutics. “Receiving Breakthrough Therapy Designation from the
FDA for DCCR was a significant milestone, and we are working
diligently to ensure a timely NDA submission. In parallel, our
commercial team has begun preparations for a potential commercial
launch of DCCR. We believe DCCR has the potential to significantly
improve the lives of people living with PWS, and, if approved,
could be a foundational therapy in the treatment of PWS.”
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 Ended March 31, 2024 Financial
Results
As of March 31, 2024, Soleno had $42.8 million of cash and cash
equivalents, $106.8 million of short-term investments, and $8.8
million of long-term investments. In addition, in May 2024, the
Company received $148.8 million in net proceeds from the Closing of
a public offering, bringing pro forma cash reserves to a total of
$307.2 million.
Research and development expense was $14.6 million for the three
months ended March 31, 2024, compared to $5.3 million in the same
period of 2023. The increase was primarily due to increased
headcount cost, expenditures in support of our NDA submission and
CMC project investment in preparation for commercial launch.
General and administrative expense was $8.5 million for the
three months ended March 31, 2024, compared to $2.9 million in the
same period of 2023. 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.
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 $12.0
million as of March 31, 2024, a $0.4 million increase from the
estimate as of December 31, 2023.
Total other income, net, was $2.1 million for the three months
ended March 31, 2024, and $0.1 million in the same period of 2023.
The increase was primarily due to an increase in interest income
driven by higher cash and cash equivalents, short-term and
long-term investments during the three months ended March 31, 2024,
compared to the three months ended March 31, 2023.
Net loss was approximately $21.4 million, or $0.59 per basic and
diluted share, for the quarter ended March 31, 2024, and $8.4
million, or $0.88 per basic and diluted share, in the same period
of 2023.
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 and
Breakthrough Designations 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, filing
of an NDA, 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
|
Soleno Therapeutics, Inc.Condensed
Consolidated Balance Sheets(In thousands except share and
per share data) |
|
|
|
|
|
|
|
|
|
March 31,2024 |
|
|
December 31,2023 |
|
Assets |
|
(Unaudited) |
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
42,847 |
|
|
$ |
169,681 |
|
Short-term investments |
|
|
106,780 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
1,596 |
|
|
|
1,677 |
|
Total current assets |
|
|
151,223 |
|
|
|
171,358 |
|
Long-term assets |
|
|
|
|
|
|
Property and equipment, net |
|
|
27 |
|
|
|
12 |
|
Operating lease right-of-use assets |
|
|
338 |
|
|
|
407 |
|
Intangible assets, net |
|
|
8,263 |
|
|
|
8,749 |
|
Long-term investments |
|
|
8,821 |
|
|
|
- |
|
Other long-term assets |
|
|
165 |
|
|
|
165 |
|
Total assets |
|
$ |
168,837 |
|
|
$ |
180,691 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
8,022 |
|
|
$ |
3,149 |
|
Accrued compensation |
|
|
1,226 |
|
|
|
3,135 |
|
Accrued clinical trial site costs |
|
|
2,395 |
|
|
|
3,393 |
|
Operating lease liabilities |
|
|
310 |
|
|
|
273 |
|
Other current liabilities |
|
|
1,511 |
|
|
|
1,555 |
|
Total current liabilities |
|
|
13,464 |
|
|
|
11,505 |
|
Long-term liabilities |
|
|
|
|
|
|
Contingent liability for Essentialis purchase price |
|
|
11,950 |
|
|
|
11,549 |
|
Long-term lease liabilities |
|
|
37 |
|
|
|
130 |
|
Total liabilities |
|
|
25,451 |
|
|
|
23,184 |
|
Commitments and contingencies
(Note 6) |
|
|
|
|
|
|
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, 33,337,079 and 31,678,159 shares
issued and outstanding at March 31, 2024 and December 31, 2023,
respectively |
|
|
33 |
|
|
|
32 |
|
Additional paid-in-capital |
|
|
441,267 |
|
|
|
433,885 |
|
Accumulated other comprehensive
loss |
|
|
(106 |
) |
|
|
- |
|
Accumulated deficit |
|
|
(297,808 |
) |
|
|
(276,410 |
) |
Total stockholders’ equity |
|
|
143,386 |
|
|
|
157,507 |
|
Total liabilities and stockholders’ equity |
|
$ |
168,837 |
|
|
$ |
180,691 |
|
|
|
|
|
|
|
|
|
|
|
Soleno Therapeutics, Inc.Condensed
Consolidated Statements of Operations and Comprehensive
Loss(unaudited)(In thousands except share
and per share data) |
|
|
|
|
Three Months EndedMarch 31, |
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
Research and development |
$ |
14,602 |
|
|
$ |
5,316 |
|
General and administrative |
|
8,472 |
|
|
|
2,854 |
|
Change in fair value of contingent consideration |
|
401 |
|
|
|
299 |
|
Total operating expenses |
|
23,475 |
|
|
|
8,469 |
|
Operating loss |
|
(23,475 |
) |
|
|
(8,469 |
) |
Other income, net |
|
|
|
|
|
Interest income, net |
|
2,077 |
|
|
|
113 |
|
Total other income, net |
|
2,077 |
|
|
|
113 |
|
Net loss |
$ |
(21,398 |
) |
|
$ |
(8,356 |
) |
|
|
|
|
|
|
Other comprehensive income
(loss) |
|
|
|
|
|
Net unrealized loss on marketable securities |
|
(105 |
) |
|
|
— |
|
Foreign currency translation adjustment |
|
(1 |
) |
|
|
16 |
|
Total comprehensive loss |
$ |
(21,504 |
) |
|
$ |
(8,340 |
) |
|
|
|
|
|
|
Net loss per common share, basic
and diluted |
$ |
(0.59 |
) |
|
$ |
(0.88 |
) |
Weighted-average common shares
outstanding used to calculate basic and diluted net loss per common
share |
|
36,208,371 |
|
|
|
9,447,350 |
|
|
|
|
|
|
|
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