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 second quarter ended June 30,
2024.
Second Quarter 2024 and Recent Corporate
Highlights
- Submitted New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for Diazoxide Choline Extended-Release (DCCR)
for the treatment of Prader-Willi Syndrome (PWS) in individuals
four years and older who have hyperphagia.
- Closed on an 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 FDA for DCCR
for the treatment of adults and children ages four years and older
with genetically confirmed PWS who have hyperphagia.
- Presented data from the randomized withdrawal period of Study
C602 of DCCR in PWS in an oral presentation at the Annual Meeting
of the Endocrine Society (ENDO 2024), held June 1-4, 2024 in
Boston, Massachusetts.
- Joined the broad-market Russell 3000® Index at the conclusion
of the 2024 Russell US Indexes annual reconstitution, effective
July 1, 2024.
“The second quarter of 2024 saw substantial progress for Soleno,
highlighted by submission of an NDA to the FDA for DCCR. We look
forward to continuing to work with the FDA,” said Anish Bhatnagar,
M.D., Chief Executive Officer of Soleno Therapeutics. “Our launch
teams are diligently preparing for a potential launch of DCCR,
including development of market access strategies, sales force
sizing, and identifying medical education needs. With a strong
balance sheet, we are well-positioned to commercialize DCCR and
deliver a much-needed new therapy to patients with 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.
Second Quarter Ended June 30, 2024
Financial Results
As of June 30, 2024, Soleno had $294.6 million of
cash, cash equivalents and marketable securities.
Research and development expense was $12.3 and
$26.9 million for the three and six months ended June 30, 2024,
compared to $5.1 and $10.5 million in the same periods of 2023. The
increase was primarily due to increased personnel costs,
expenditures in support of our NDA submission and investments in
supply chain activities in preparation for commercial launch.
General and administrative expense was $10.9 and $19.4 million
for the three and six months ended June 30, 2024, compared to $3.2
and $6.0 million in the same periods of 2023. The increase was
primarily related to higher non-cash stock-based compensation
expense (see table), higher costs due to an increase in personnel
and higher professional services expenses and costs associated with
preparation for commercial launch.
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 sales of DCCR in accordance with the terms of our merger
agreement with Essentialis. The fair value of the liability for the
contingent consideration payable by us achieving two commercial
sales milestones of $100 million and $200 million in cumulative
revenue in future years was estimated to be $13.6 million as of
June 30, 2024, a $2.0 million increase from the estimate as of
December 31, 2023. During the six months ended June 30, 2023, the
estimate increased by $0.6 million from the $8.8 million estimate
as of December 31, 2022.
Total other income, net, was $3.0 and $5.1 million
for the three and six months ended June 30, 2024, and $0.2 and $0.3
million in the same periods of 2023. The increase was primarily due
to an increase in interest income driven by higher cash and cash
equivalents and marketable securities during the six months ended
June 30, 2024, compared to the six months ended June 30, 2023.
Net loss was approximately $21.9 million and $43.3
million, or $0.57 and $1.16 per basic and diluted share, for the
three and six months ended June 30, 2024, and $8.5 and $16.8
million, or $0.81 and $1.69 per basic and diluted share, in the
same periods 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 recently submitted an NDA to the FDA,
supported by its Phase 3 development program, for its lead
candidate, DCCR (diazoxide choline) extended-release tablets, a
once-daily oral tablet for the treatment of Prader-Willi syndrome
(PWS). 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) |
|
|
|
|
|
|
|
June 30,2024 |
|
|
December 31,2023 |
|
Assets |
(Unaudited) |
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
57,024 |
|
|
$ |
169,681 |
|
Marketable securities |
|
209,099 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
1,379 |
|
|
|
1,677 |
|
Total current assets |
|
267,502 |
|
|
|
171,358 |
|
Long-term assets |
|
|
|
|
|
Property and equipment, net |
|
19 |
|
|
|
12 |
|
Operating lease right-of-use assets |
|
268 |
|
|
|
407 |
|
Intangible assets, net |
|
7,777 |
|
|
|
8,749 |
|
Long-term marketable securities |
|
28,482 |
|
|
|
- |
|
Other long-term assets |
|
83 |
|
|
|
165 |
|
Total assets |
$ |
304,131 |
|
|
$ |
180,691 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
3,716 |
|
|
$ |
3,149 |
|
Accrued compensation |
|
2,149 |
|
|
|
3,135 |
|
Accrued clinical trial site costs |
|
1,863 |
|
|
|
3,393 |
|
Operating lease liabilities |
|
296 |
|
|
|
273 |
|
Other current liabilities |
|
1,126 |
|
|
|
1,555 |
|
Total current liabilities |
|
9,150 |
|
|
|
11,505 |
|
Long-term liabilities |
|
|
|
|
|
Contingent liability for Essentialis purchase price |
|
13,587 |
|
|
|
11,549 |
|
Common stock purchase liability |
|
637 |
|
|
|
— |
|
Long-term lease liabilities |
|
— |
|
|
|
130 |
|
Total liabilities |
|
23,374 |
|
|
|
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, 38,386,779 and 31,678,159 shares
issued and outstanding at June 30, 2024 and December 31, 2023,
respectively |
|
38 |
|
|
|
32 |
|
Additional paid-in-capital |
|
600,534 |
|
|
|
433,885 |
|
Accumulated other comprehensive
loss |
|
(153 |
) |
|
|
- |
|
Accumulated deficit |
|
(319,662 |
) |
|
|
(276,410 |
) |
Total stockholders’ equity |
|
280,757 |
|
|
|
157,507 |
|
Total liabilities and stockholders’ equity |
$ |
304,131 |
|
|
$ |
180,691 |
|
|
|
|
|
|
|
|
|
Soleno Therapeutics, Inc.Condensed
Consolidated Statements of Operations and Comprehensive
Loss(unaudited)(In thousands except share
and per share data) |
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
12,342 |
|
|
$ |
5,141 |
|
|
$ |
26,944 |
|
|
$ |
10,457 |
|
General and administrative |
|
10,889 |
|
|
|
3,169 |
|
|
|
19,361 |
|
|
|
6,023 |
|
Change in fair value of contingent consideration |
|
1,637 |
|
|
|
313 |
|
|
|
2,038 |
|
|
|
612 |
|
Total operating expenses |
|
24,868 |
|
|
|
8,623 |
|
|
|
48,343 |
|
|
|
17,092 |
|
Operating loss |
|
(24,868 |
) |
|
|
(8,623 |
) |
|
|
(48,343 |
) |
|
|
(17,092 |
) |
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrants liabilities |
|
— |
|
|
|
1 |
|
|
|
— |
|
|
|
1 |
|
Interest income, net |
|
3,014 |
|
|
|
147 |
|
|
|
5,091 |
|
|
|
260 |
|
Total other income, net |
|
3,014 |
|
|
|
148 |
|
|
|
5,091 |
|
|
|
261 |
|
Net loss |
$ |
(21,854 |
) |
|
$ |
(8,475 |
) |
|
$ |
(43,252 |
) |
|
$ |
(16,831 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
(loss) |
|
|
|
|
|
|
|
|
|
|
|
Net unrealized loss on marketable securities |
|
(46 |
) |
|
|
— |
|
|
|
(151 |
) |
|
|
— |
|
Foreign currency translation adjustment |
|
(1 |
) |
|
|
(16 |
) |
|
|
(2 |
) |
|
|
— |
|
Total comprehensive loss |
$ |
(21,901 |
) |
|
$ |
(8,491 |
) |
|
$ |
(43,405 |
) |
|
$ |
(16,831 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic
and diluted |
$ |
(0.57 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.16 |
) |
|
$ |
(1.69 |
) |
Weighted-average common shares
outstanding used to calculate basic and diluted net loss per common
share |
|
38,631,565 |
|
|
|
10,423,598 |
|
|
|
37,419,968 |
|
|
|
9,938,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Soleno Therapeutics, Inc.Stock-based
Compensation Expense(In thousands) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Research and development |
$ |
2,705 |
|
$ |
470 |
|
$ |
5,166 |
|
$ |
652 |
General and administrative |
|
4,455 |
|
|
734 |
|
|
8,439 |
|
|
1,183 |
Total |
$ |
7,160 |
|
$ |
1,204 |
|
$ |
13,605 |
|
$ |
1,835 |
Soleno Therapeutics (NASDAQ:SLNO)
過去 株価チャート
から 8 2024 まで 9 2024
Soleno Therapeutics (NASDAQ:SLNO)
過去 株価チャート
から 9 2023 まで 9 2024