WARRINGTON, Pa., Aug. 10, 2016 /PRNewswire/ -- Windtree
Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused
on developing aerosolized KL4 surfactant therapies for respiratory
diseases, today reported financial results for the second quarter
ended June 30, 2016 and provided key
business updates.
Key Business and Financial Updates
- Enrollment in the AEROSURF phase 2b trial in RDS is ongoing and
the Company continues to be on track to announce top-line results
from this study in the first quarter of 2017.
- Following a planned Safety Review Committee review of the first
dose group, enrollment is proceeding in the second dose group
in the AEROSURF phase 2a clinical trial in 32 premature infants 26
to 28 week gestational age receiving nCPAP for RDS. This
study is designed to evaluate safety and tolerability of AEROSURF.
The Company anticipates completing enrollment in September and
releasing top-line results of this trial in late September or early
October 2016.
- The Company recently completed a Lung Deposition Study in
nonhuman primates. The study consists of a series of experiments
designed to assess the distribution and deposition of aerosolized
KL4 surfactant in the lung when administered using the Company's
innovative aerosol drug delivery technology. The Company is
finalizing the analysis of the study data and anticipates reporting
these results in September 2016.
- In the second quarter of 2016, the Company met with the FDA to
discuss key elements of the AEROSURF clinical development program.
The Company believes that these discussions reaffirmed its current
and planned approach to the clinical development program for
AEROSURF.
- In April, the Company completed the analysis of data collected
in the first phase of its Noninterventional Observational Study on
the treatment and outcomes of premature infants 26 to 34 week
gestational age with RDS. The study was initiated in 2015 and over
2,000 premature infants have been enrolled to date. The results of
the study have better informed our assessment of the unmet medical
need in RDS, the design of a potential Phase 3 trial, and the RDS
market opportunity. Based on this study, the Company has enhanced
some of the operational aspects of the AEROSURF phase 2
program.
- The Company recently announced that it has been awarded a Phase
II Small Business Innovation Research Grant (SBIR) valued at up to
$2.6 million from the National Heart,
Lung, and Blood Institute (NHLBI) of the National Institutes of
Health (NIH) to support the on-going AEROSURF phase 2b RDS clinical
trial. Under the terms of the grant, the Company has been awarded
$1.0 million initially and, over the
next two years, may be awarded up to an additional $1.6 million through the completion of the phase
2b clinical trial and one-year patient follow-up. The Company
also received a separate grant of $1.0
million under a previously announced Phase II SBIR grant
valued at up to $3.0 million to
support continued development of the Company's aerosolized KL4
surfactant as a potential medical countermeasure to mitigate acute
and chronic/late-phase radiation-induced lung injury.
- As of June 30, 2016, the Company
had cash and cash equivalents of $20.3
million.
"The second quarter of 2016 was one of meaningful progress for
Windtree and our AEROSURF phase 2 program," commented Craig Fraser, President and Chief Executive
Officer. "We expanded our clinical trial to include sites in
Europe and Latin America, conducted a successful meeting
with the FDA that will guide our AEROSURF development program,
completed collection and analysis of data from over 2,000 premature
infants in the Noninterventional Observational Study, and completed
the Lung Deposition Study in non-human primates. Our primary
objective for 2016 remains the rigorous and timely execution of the
AEROSURF phase 2 program while effectively managing existing cash
resources."
Select Financial Results for the Second Quarter ended
June 30, 2016
For the quarter ended June 30,
2016, the Company reported an operating loss of $10.0 million, compared to $10.4 million for the second quarter of 2015.
Grant revenue for the second quarter of 2016 and 2015 was
$0.1 million. Grant revenue
represents funds received and expended under SBIR grants from the
NIH to (i) in both 2015 and 2016, study the Company's aerosolized
KL4 surfactant as a medical countermeasure to mitigate acute and
chronic/late-phase radiation-induced lung injury; and, (ii) in
2015, provide support for the initial AEROSURF phase 2a clinical
trial in premature infants 29 to 34 week gestational age with
RDS.
Research and development expenses were $8.3 million for the second quarter of 2016,
compared to $7.1 million for the
second quarter of 2015. The increase was due to a $2.6 million increase in AEROSURF clinical trial
activities, including patient enrollment costs, ongoing clinical
site initiations and the manufacture of additional clinic-ready
aerosol delivery systems (ADS), partially offset by a decrease of
$1.3 million in manufacturing costs
following the closure of our manufacturing operations at our leased
facility in Totowa, NJ in
June 2015.
Selling, general and administrative expenses for the second
quarter of 2016 were $1.8 million,
compared to $3.4 million for the
second quarter of 2015. The decrease was primarily due to the
Company's decision in April 2015 to
voluntarily cease commercial and manufacturing activities for
SURFAXIN®, resulting in a reduction in workforce related primarily
to commercial infrastructure.
Interest expense for the second quarter of 2016 was $0.6 million, compared to $1.3 million for the second quarter of 2015. The
decrease in interest expense was due to the July 2015 restructuring of our long-term debt
with affiliates of Deerfield Management Company, L.P., which
resulted in the write-off of previously capitalized debt discount
costs which were being amortized to interest expense.
The Company reported a net loss of $10.6
million ($1.29 per basic
share) on 8.2 million weighted-average common shares outstanding
for the quarter ended June 30, 2016,
compared to a net loss of $11.3
million ($1.82 per basic
share) on 6.1 million weighted average common shares outstanding
for the comparable period in 2015.
Net cash outflows before financing activities for the second
quarter of 2016 were $9.1 million.
As of June 30, 2016, the Company
had cash and cash equivalents of $20.3
million. Based on current projections and development
timelines, the Company anticipates that it has sufficient cash to
support its operations through the planned completion of the
AEROSURF phase 2b clinical trial and the release of top line
results, which is expected in the first quarter of 2017. In
addition, as of June 30, 2016, the
Company reported accounts payable and accrued expenses of
$15.1 million, including $4.5 million due under the collaboration
agreement with the Battelle Memorial Institute, and long-term debt
with Deerfield of $25 million. The debt is payable in two equal
installments of $12.5 million in each
of February 2018 and 2019. The
payment due in February 2018 may be
deferred if certain conditions are satisfied.
Readers are referred to, and encouraged to read in its entirety,
the Company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2016, which is expected to
be filed today with the Securities and Exchange Commission, and
includes discussion about the Company's business plans and
operations, financial condition, and results of operations.
The Company plans on updating investors in September and
providing a comprehensive update on the AEROSURF development
program including the ongoing AEROSURF phase 2a and 2b clinical
trials in premature infants, the Lung Deposition Study in nonhuman
primates, and other business updates.
About AEROSURF®
Windtree's lead product candidate is
AEROSURF, a novel, investigational drug/device product that
combines the Company's proprietary KL4 surfactant and
aerosolization technologies. AEROSURF is being developed to
potentially reduce or eliminate the need for endotracheal
intubation and mechanical ventilation in the treatment of premature
infants with respiratory distress syndrome (RDS). Enrollment
is ongoing in a phase 2b clinical trial in up to 240
premature infants to study AEROSURF in premature infants 26 to
32-week gestational age receiving nasal continuous positive airway
pressure (nCPAP) for RDS, compared to infants receiving nCPAP
alone. The phase 2b trial is a global trial with clinical
sites in North America,
Europe and Latin America.
About Windtree Therapeutics
Windtree Therapeutics,
Inc. is a clinical-stage biotechnology company focused on
developing novel surfactant therapies for respiratory diseases
and other potential applications. Windtree's proprietary technology
platform includes a synthetic, peptide-containing surfactant (KL4
surfactant) that is structurally similar to endogenous pulmonary
surfactant and novel drug-delivery technologies being developed to
enable noninvasive administration of aerosolized KL4
surfactant. Windtree is focused initially on improving the
management of respiratory distress syndrome (RDS) in premature
infants and believes that its proprietary technology may make it
possible, over time, to develop a pipeline of KL4 surfactant
product candidates to address a variety of respiratory diseases for
which there are few or no approved therapies.
For more information, please visit the Company's website at
www.windtreetx.com.
Forward-Looking Statements
To the extent that
statements in this press release are not strictly historical, all
such statements are forward-looking, and are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are subject to
certain risks and uncertainties that could cause actual results,
including projections of future cash balances and anticipated cash
outflows, to differ materially from the statements made.
Examples of such risks and uncertainties include: risks related to
Windtree's AEROSURF development program and other development
programs that we may undertake in the future, which may involve
time-consuming and expensive pre-clinical studies and clinical
trials and which may be subject to potentially significant delays
or regulatory holds, or fail; risks that Windtree will be unable to
secure significant additional capital as needed, and may be unable
in a timely manner, if at all, to identify potential strategic
transactions (including strategic partnerships and other
transactions) that would provide funding and support product
development, regulatory and, if approved, commercialize our
products, or to access debt or equity financings, which could
result in substantial equity dilution; risks related to the
Company's receipt of a deficiency notification from The NASDAQ
Stock Market concerning its failure to comply with The Nasdaq
Capital Market listing requirements and the Company's ability to
regain compliance in a timely manner, if at all; risks related to
technology transfers to contract manufacturers and problems or
delays encountered by Windtree, contract manufacturers or suppliers
in manufacturing drug products, drug substances, aerosol delivery
systems (ADS) and other materials on a timely basis and in
sufficient amounts; risks relating to rigorous regulatory
requirements, including that: (i) the FDA or other regulatory
authorities may not agree with Windtree on matters raised during
regulatory reviews, may require significant additional activities,
or may not accept or may withhold or delay consideration of
applications, or may not approve or may limit approval of
Windtree's products, and (ii) changes in
the national or international political and regulatory environment
may make it more difficult to gain regulatory approvals; risks
related to Windtree's efforts to maintain and protect the patents
and licenses related to its products; and other risks and
uncertainties described in Windtree's filings with the Securities
and Exchange Commission including the most recent reports on Forms
10-K, 10-Q and 8-K, and any amendments thereto.
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Windtree
Therapeutics, Inc.
|
|
|
|
Condensed
Consolidated Statement of Operations
|
|
|
|
(in thousands, except
per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product
sales
|
$
–
|
|
$
–
|
|
$
–
|
|
$
7
|
|
Grant
revenue
|
106
|
|
75
|
|
181
|
|
259
|
|
|
|
106
|
|
75
|
|
181
|
|
266
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
(1)
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
–
|
|
–
|
|
–-
|
|
929
|
|
Research and
development
|
8,316
|
|
7,129
|
|
18,676
|
|
14,211
|
|
Selling, general and
administrative
|
1,783
|
|
3,383
|
|
5,440
|
|
6,736
|
|
|
Total
expenses
|
10,099
|
|
10,512
|
|
24,116
|
|
21,876
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(9,993)
|
|
(10,437)
|
|
(23,935)
|
|
(21,610)
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of common stock warrant
|
|
|
|
|
|
|
|
|
liability
(1)
|
–
|
|
469
|
|
223
|
|
438
|
|
Interest income /
(expense), net
|
(632)
|
|
(1,259)
|
|
(1,247)
|
|
(2,466)
|
|
Other income /
(expense), net
|
1
|
|
(99)
|
|
434
|
|
133
|
Net loss
|
$
(10,624)
|
|
$
(11,326)
|
|
$
(24,525)
|
|
$
(23,205)
|
|
|
|
|
|
|
|
|
Net loss per common
share – basic and diluted
|
$
(1.29)
|
|
$
(1.82)
|
|
$
(2.99)
|
|
$
(3.78)
|
|
|
|
|
|
|
|
|
Weighted avg. common
shares outstanding – basic and diluted
|
8,238
|
|
6,125
|
|
8,215
|
|
6,119
|
|
|
|
|
|
|
|
|
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(1)
Material non-cash items
include the change in fair value of certain outstanding warrants
accounted for as derivative liabilities, and in operating expenses,
depreciation and stock-based compensation. For the three
months ended June 30, 2016 and 2015, the charges for depreciation
and stock-based compensation were $0.3 million ($0.2 million in
R&D and $0.1 million in S, G & A) and $0.5 million ($0.3
million in R&D and $0.2 million in S, G & A), respectively.
For the six months ended June 30, 2016 and 2015, the charges for
depreciation and stock-based compensation were $1.0 million ($0.5
million in R&D and $0.5 million in S, G & A) and $1.3
million ($0.7 million in R&D and $0.6 million in S, G & A),
respectively.
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Windtree
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
|
|
|
2016
|
|
2015
|
ASSETS
|
|
(Unaudited)
|
|
|
Current
Assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
20,330
|
|
$
38,722
|
|
Prepaid interest,
current portion
|
|
1,164
|
|
1,710
|
|
Prepaid expenses and
other current assets
|
|
454
|
|
362
|
|
|
|
Total current
assets
|
|
21,948
|
|
40,794
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
1,048
|
|
1,039
|
Restricted
cash
|
|
225
|
|
225
|
Prepaid interest,
non-current portion
|
|
1,777
|
|
2,319
|
|
|
Total
Assets
|
|
$
24,998
|
|
$
44,377
|
|
|
|
|
|
|
|
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LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
|
$
15,055
|
|
$
10,845
|
|
Common stock warrant
liability
|
|
–
|
|
223
|
|
|
|
Total current
liabilities
|
|
15,055
|
|
11,068
|
|
|
|
|
|
|
|
|
Long-term
debt
|
|
25,000
|
|
25,000
|
Other
liabilities
|
|
162
|
|
43
|
Stockholders'
Equity
|
|
(15,219)
|
|
8,266
|
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
24,998
|
|
$
44,377
|
Note: All share and per share amounts related to
common stock have been adjusted to reflect the 1-for-14 reverse
stock split made effective on January 22,
2016.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/windtree-therapeutics-reports-second-quarter-2016-financial-results-and-provides-key-business-updates-300312016.html
SOURCE Windtree Therapeutics, Inc.