Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of rare diseases, today provided a corporate update and
announced financial results for the three and nine months ended
September 30, 2017.
“We continue to achieve significant progress in advancing our
DCCR clinical development program for the treatment of PWS,” said
Anish Bhatnagar, M.D., Chief Executive Officer of Soleno
Therapeutics. “Our most recent key accomplishments include
the receipt of constructive guidance from the EMA regarding the
regulatory pathway in Europe for DCCR for the treatment of PWS, and
the positive opinion received from the EMA recommending DCCR for
designation as an orphan medicinal product. Importantly, we
recently regained compliance with NASDAQ listing requirements, and
our stock continues to be listed on The NASDAQ Capital
Market. Looking ahead, we remain focused on finalizing the
protocol for our Phase III, randomized, double-blind
placebo-controlled study that will treat approximately
100 patients and is now expected to commence in the first
quarter of 2018.”
Recent Corporate Highlights
- Received scientific advice from the Committee for Medicinal
Products for Human Use of the European Medicines Agency (EMA)
regarding Diazoxide Choline Controlled-Release (DCCR) tablet for
the treatment of Prader-Willi syndrome (PWS), a rare and complex
genetic neurobehavioral/metabolic disorder affecting appetite,
growth, metabolism, cognitive function, and behavior.
o Received positive guidance on key elements of Phase III
program
- Presented updated safety and efficacy data from the pilot
clinical trial of DCCR for the treatment of PWS at the 10th
International Meeting of Pediatric Endocrinology demonstrating a
significant improvement from baseline in hyperphagia, as well as
several other key parameters, such as body fat, lean body mass,
aggressive behaviors, and lipid profile.
- Regained compliance with NASDAQ listing requirements
- Received a positive opinion recommending DCCR for designation
as an orphan medicinal product for the treatment of PWS by EMA’s
Committee for Orphan Medicinal Products
- Issued multiple new U.S. patents for the use of DCCR o
Patent number 9,757,384 covers DCCR for the use of reducing
aggressive behaviors in a subject with PWS or Smith-Magenis
syndrome, a rare disorder with a distinct genetic basis, but a
natural history similar to that of PWS o Patent number
9,782,416 covers the use of diazoxide to treat hyperphagia in a
subject with PWS
Third Quarter Ended September 30, 2017 Financial Results
for Continuing Operations
As a result of the decision to sell NeoForce, Inc. and either
divest or partner the CoSense and Serenz businesses, all revenue
and expenses of these businesses have been excluded from continuing
operations for all periods herein and reported as discontinued
operations. All assets and liabilities of these businesses have
been classified as assets held for sale on the balance sheet. All
prior period information has been recast to conform to this
presentation.
Research and development expenses in the third quarter of 2017
were $1.0 million, compared to $0.7 million for the same period in
2016. The increase was primarily due to an increase in DCCR
clinical activities.
General and Administrative expenses in the third quarter of 2017
were $1.7 million, compared to $1.3 million for the same period in
2016. The increase was primarily due to the amortization from
the acquisition of intangibles from the completed Essentialis
merger in March 2017.
Net loss from continuing operations for the third quarter of
2017 was $2.6 million, or $0.24 per share, compared to a net loss
of $1.8 million, or $0.56 per share, for the third quarter in
2016.
Net loss from discontinued operations for the third quarter of
2017 was $1.2 million, or $0.11 per share, compared to a net loss
of $1.0 million, or $0.31 per share, for the third quarter in
2016.
Net loss for the third quarter of 2017 was $3.8 million, or
$0.35 per share, compared to a net loss of $2.8 million, or $0.87
per share, for the third quarter in 2016.
Nine-Months Ended September 30, 2017 Financial Results
for Continuing Operations
As a result of the decision to sell NeoForce, Inc. and either
divest or partner the CoSense and Serenz businesses, all revenue
and expenses of these businesses have been excluded from continuing
operations for all periods herein and reported as discontinued
operations. All assets and liabilities of these businesses have
been classified as assets held for sale on the balance sheet. All
prior period information has been recast to conform to this
presentation.
Research and development expenses in the nine months ended
September 30, 2017, were $2.0 million, essentially flat when
compared to the same period in 2016.
General and Administrative expenses in the nine months ended
September 30, 2017, were $4.9 million, compared to $4.5
million for the same period in 2016. The increase was
primarily due to the amortization from the acquisition of
intangibles from the completed Essentialis merger in March
2017.
The change in fair value of warrants income for the nine months
ended September 30, 2017, was $29,000, which represented a decrease
in the fair value of the Series A and Series C Warrants compared to
the value of the warrants at December 31, 2016. The change in
fair value of warrants income for the nine months ended September
30, 2016, was $1.3 million, which represented an increase in
the fair value of the Series A, Series B and Series C Warrants
compared to the value of the warrants at December 31,
2015.
Net loss from continuing operations for the nine months ended
September 30, 2017, was $7.6 million, or $0.85 per share, compared
to a net loss of $5.3 million, or $1.73 per share, for the same
period in 2016.
Net loss from discontinued operations for the nine months ended
September 30, 2017, was $3.0 million, or $0.34 per share, compared
to a net loss of $4.1 million, or $1.35 per share, for the same
period in 2016.
Net loss for the nine months ended September 30, 2017, was $10.6
million, or $1.19 per share, compared to a net loss of $9.5
million, or $3.08 per share, for the same period in 2016.
Cash and cash equivalents at September 30, 2017, totaled $5.6
million, compared to $2.7 million at December 31, 2016.
About PWS
PWS is a rare and complex genetic
neurobehavioral/metabolic disorder affecting appetite, growth,
metabolism, cognitive function and behavior. The committee on
genetics of the American Academy of Pediatrics states PWS affects
both genders equally and occurs in people from all geographic
regions: its estimated incidence is one in 15,000 to 25,000 live
births. This disorder is typically characterized by hyperphagia, a
chronic feeling of insatiable hunger, 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, in the absence of effective limitations to
access to food, can lead to morbid obesity. In a global survey
conducted by the Foundation for Prader-Willi Research, 96.5% of
respondents (parent and caregivers) rated hyperphagia, which is the
unrelenting hunger that severely diminishes the quality of life for
patients and their families, 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.
About Diazoxide Choline
Controlled-Release Tablet
Diazoxide choline controlled-release tablet is a
novel, proprietary controlled-release, crystalline salt formulation
of diazoxide, which is administered once-daily. The parent
molecule, diazoxide, as an oral suspension, has been used for
decades in thousands of patients in a few rare diseases in
neonates, children and/or adults, but not in PWS. Soleno
conceived of and is pursuing an extensive patent portfolio relating
to various aspects of the therapeutic use of diazoxide and DCCR in
patients with PWS. The DCCR development program is supported by
positive data from two completed Phase II clinical studies and five
completed Phase I clinical studies in various metabolic
indications, as well as a pilot study in PWS patients. In the
PWS pilot study, DCCR showed promise in addressing the hallmark
symptoms of PWS, most notably hyperphagia. DCCR has received
Orphan Drug Designation from the US FDA and a positive opinion for
orphan designation from the EMA for the treatment of PWS.
About Soleno Therapeutics,
Inc.
Soleno Therapeutics, Inc. (Soleno) is focused on
the development and commercialization of novel therapeutics for the
treatment of rare diseases. The company is currently
advancing its lead candidate, DCCR, a once-daily oral tablet for
the treatment of PWS, into a Phase III clinical development program
in early 2018. Soleno, through its wholly-owned subsidiary,
Capnia, Inc., continues to market Capnia’s innovative medical
device, the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor,
which measures ETCO and is used by hospitals to detect hemolysis in
newborns. It is expected that CoSense will be monetized and will
not be a focus for the company in the long-term.
For more information, please visit
www.soleno.life.
Forward-Looking Statements
This press release contains forward-looking
statements that are subject to many risks and uncertainties.
Forward-looking statements include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things, our ability to
initiate the Phase III clinical development program of DCCR in PWS
by the end of 2017.
We may use terms such as "believes,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should," "approximately" or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Although we believe that we have
a reasonable basis for each forward-looking statement contained
herein, we caution you that forward-looking statements are not
guarantees of future performance and that our actual results of
operations, financial condition and liquidity, and the development
of the industry in which we operate may differ materially from the
forward-looking statements contained in this presentation. As a
result of these factors, we cannot assure you that the
forward-looking statements in this presentation will prove to be
accurate. Additional factors that could materially affect actual
results can be found in Soleno’s Form 10-Q filed with the
Securities and Exchange Commission on August 11, 2017, including
under the caption titled "Risk Factors." Soleno expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578
|
Soleno Therapeutics,
Inc.(formerly known as Capnia,
Inc.)Condensed Consolidated Balance
Sheets(In thousands except share and per share
data) |
|
|
September 30, 2017 |
|
December 31, 2016 |
Assets |
(Unaudited) |
|
|
Current assets |
|
|
|
Cash and
cash equivalents |
$ |
5,647 |
|
|
$ |
2,726 |
|
Accounts
receivable |
— |
|
|
3 |
|
Restricted cash |
35 |
|
|
35 |
|
Prepaid
expenses and other current assets |
145 |
|
|
247 |
|
Current
assets held for sale |
563 |
|
|
790 |
|
Total
current assets |
6,390 |
|
|
3,801 |
|
Long-term assets |
|
|
|
Property
and equipment, net |
55 |
|
|
54 |
|
Other
intangible assets, net |
19,353 |
|
|
— |
|
Other
assets |
126 |
|
|
126 |
|
Long-term
assets held for sale |
458 |
|
|
1,584 |
|
Total
assets |
$ |
26,382 |
|
|
$ |
5,565 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current
liabilities |
|
|
|
Accounts
payable |
642 |
|
|
411 |
|
Accrued
compensation and other current liabilities |
976 |
|
|
1,050 |
|
Current
liabilities held for sale |
113 |
|
|
246 |
|
Total
current liabilities |
1,731 |
|
|
1,707 |
|
Long-term
liabilities |
|
|
|
Series A
warrant liability |
289 |
|
|
194 |
|
Series C
warrant liability |
20 |
|
|
86 |
|
Other
long-term liabilities |
1,132 |
|
|
62 |
|
Long-term
liabilities held for sale |
— |
|
|
81 |
|
Total
liabilities |
3,172 |
|
|
2,130 |
|
Commitments and
contingencies (Note 8) |
|
|
|
Stockholders’
equity |
|
|
|
Preferred Stock, $.001
par value, 10,000,000 shares authorized: |
|
|
|
Series B
convertible preferred stock, 13,780 are designated at September 30,
2017 and December 31, 2016; 10,049 and 12,780 shares issued and
outstanding at September 30, 2017 and at December 31, 2016,
respectively. Liquidation value of zero. |
— |
|
|
— |
|
Common stock, $0.001
par value, 100,000,000 shares authorized, 9,970,538 and 3,357,390
shares issued and outstanding at September 30, 2017 and
December 31, 2016, respectively. (Note 14) |
10 |
|
|
4 |
|
Additional
paid-in-capital |
132,154 |
|
|
101,743 |
|
Accumulated
deficit |
(108,954 |
) |
|
(98,312 |
) |
Total
stockholders’ equity |
23,210 |
|
|
3,435 |
|
Total
liabilities and stockholders’ equity |
$ |
26,382 |
|
|
$ |
5,565 |
|
|
Soleno Therapeutics,
Inc.(formerly known as Capnia,
Inc.)Condensed Consolidated Statements of
Operations(unaudited)(In
thousands except share and per share data) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating expenses |
|
|
|
|
|
|
|
Research
and development |
$ |
982 |
|
|
$ |
708 |
|
|
$ |
2,046 |
|
|
$ |
1,959 |
|
Sales and
marketing |
— |
|
|
— |
|
|
26 |
|
|
— |
|
General
and administrative |
1,707 |
|
|
1,260 |
|
|
4,900 |
|
|
4,532 |
|
Total
expenses |
2,689 |
|
|
1,968 |
|
|
6,972 |
|
|
6,491 |
|
Operating
loss |
(2,689 |
) |
|
(1,968 |
) |
|
(6,972 |
) |
|
(6,491 |
) |
Interest and other
income (expense) |
|
|
|
|
|
|
|
Interest
Income |
4 |
|
|
— |
|
|
7 |
|
|
— |
|
Change in
fair value of warrants liabilities income (expense) |
130 |
|
|
200 |
|
|
(29 |
) |
|
1,295 |
|
Cease-use
expense |
4 |
|
|
— |
|
|
3 |
|
|
(94 |
) |
Other
expense |
— |
|
|
(9 |
) |
|
(602 |
) |
|
(26 |
) |
Interest
and other income (expense), net |
138 |
|
|
191 |
|
|
(621 |
) |
|
1,175 |
|
Loss from continuing
operations |
(2,551 |
) |
|
(1,777 |
) |
|
(7,593 |
) |
|
(5,316 |
) |
Loss from discontinued
operations: |
|
|
|
|
|
|
|
Operating
loss |
(1,027 |
) |
|
(973 |
) |
|
(2,841 |
) |
|
(4,136 |
) |
Loss on
sale of assets |
(208 |
) |
|
— |
|
|
(208 |
) |
|
— |
|
Total |
(1,235 |
) |
|
(973 |
) |
|
(3,049 |
) |
|
(4,136 |
) |
Net loss |
$ |
(3,786 |
) |
|
$ |
(2,750 |
) |
|
$ |
(10,642 |
) |
|
$ |
(9,452 |
) |
Loss per common share
from continuing operations, basic and diluted (Note 14) |
$ |
(0.24 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.73 |
) |
Loss per common share
from discontinued operations, basic and diluted (Note 14): |
|
|
|
|
|
|
|
Operating |
$ |
(0.09 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.35 |
) |
Loss on
sale of assets |
$ |
(0.02 |
) |
|
$ |
— |
|
|
$ |
(0.02 |
) |
|
$ |
— |
|
Total |
$ |
(0.11 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.35 |
) |
Net loss per common
share, basic and diluted (Note 14) |
$ |
(0.35 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.19 |
) |
|
$ |
(3.08 |
) |
Weighted-average common
shares outstanding used to calculate basic and diluted net loss per
common share (Note 14) |
10,766,608 |
|
|
3,152,306 |
|
|
8,936,255 |
|
|
3,072,729 |
|
|
|
|
|
|
|
|
|
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