WARRINGTON, Pa., May 12, 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 first quarter
ended March 31, 2016 and provided key
business updates. The Company will also host a conference call
today at 8:00 a.m. EDT.
Key Business and Financial Updates
- Recently achieved an important milestone in the AEROSURF® phase
2b clinical trial in respiratory distress syndrome (RDS) with the
initiation of sites and enrollment at selected clinical sites in
Canada, Europe and Latin
America. The Company continues to expect to release
top-line results from this study in the first quarter of 2017.
- Enrollment is ongoing in the AEROSURF phase 2a clinical trial
in 32 premature infants 26 to 28 week gestational age (GA)
receiving nCPAP for RDS, which is designed to evaluate safety and
tolerability of AEROSURF. The Company continues to expect to
release top-line results from this study in the third quarter of
2016.
- In April, 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 first phase of its
Noninterventional Observational Study to collect data on the
treatment and outcomes of premature infants 26 to 34 week GA with
RDS. The study was initiated in 2015 and over 1,700 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. Additionally, based on this study, the Company has
enhanced some of the operational aspects of the AEROSURF phase 2
program.
- The Company continued to advance its Lung Deposition Study in
nonhuman primates. This study consists of a series of experiments
to assess the distribution and deposition of aerosolized KL4
surfactant in the lung when using the Company's innovative aerosol
drug delivery technology. The Company continues to expect to
complete the final phase of the study and report results in the
third quarter of 2016.
- As of March 31, 2016, the Company
had cash and cash equivalents of $29.4
million.
"The first quarter of 2016 was one of meaningful progress for
Windtree," commented Craig Fraser,
President and Chief Executive Officer. "We expanded our AEROSURF
phase 2 program to include sites in Europe and Latin
America, conducted a successful meeting with the FDA that
will guide our AEROSURF development program, collected data from
over 1,700 premature infants in the Noninterventional Observational
Study, and advanced the Lung Deposition Study. 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 First Quarter ended
March 31, 2016
For the quarter ended March 31,
2016, the Company reported an operating loss of $13.9 million, compared to $11.2 million for the first quarter of 2015.
Grant revenue for the first quarter of 2016 was $0.1 million, compared to $0.2 million for the first quarter of 2015. Grant
revenue for 2016 represents funds received and expended under a
$1.0 million Phase II SBIR grant from
the National Institutes of Allergy and Infectious Diseases (NIAID)
of the National Institutes of Health (NIH) to study the Company's
aerosolized KL4 surfactant as a medical countermeasure to mitigate
acute and chronic/late-phase radiation-induced lung injury.
Grant revenue for 2015 represents funds received and expended under
(i) a $1.9 million SBIR grant from
the National Heart, Lung and Blood Institute (NHLBI) of the NIH to
provide support for the initial AEROSURF phase 2a clinical trial in
premature infants 29 to 34 week GA with RDS; and, (ii) a
$1.0 million Phase II SBIR grant from
NIAID to study the Company's aerosolized KL4 surfactant as a
medical countermeasure to mitigate acute and chronic/late-phase
radiation-induced lung injury.
Research and development expenses were $10.4 million for the first quarter of 2016,
compared to $7.1 million for the
first quarter of 2015. The increase was primarily due to a
$3.4 million increase in AEROSURF
clinical trial activities, including patient enrollment costs,
ongoing clinical site initiations and the manufacture of additional
clinic-ready AEROSURF Delivery Systems.
Selling, general and administrative expenses for the first
quarter of 2016 were $3.7 million,
compared to $3.4 million for the
first quarter of 2015. During the first quarter of 2016, the
Company recorded a severance charge of $1.2
million under the terms of our former CEO's separation
agreement, including $0.2 million
related to stock-based compensation expense for certain common
stock options that will continue to vest through the 18-month
severance period. Excluding this charge, selling, general and
administrative expenses decreased $0.9
million in the first quarter of 2016 compared to the
comparable period in 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 first quarter of 2016 was $0.6 million, compared to $1.2 million for the first 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. (Deerfield), 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 $13.9
million ($1.70 per basic
share) on 8.2 million weighted-average common shares outstanding
for the quarter ended March 31, 2016,
compared to a net loss of $12.2
million ($1.96 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 first
quarter of 2016 were $9.3 million and included $1.5 million of 2015 employee incentive
compensation payments. The Company anticipates second quarter 2016
net cash outflows before financing activities of approximately
$8.5 million.
As of March 31, 2016, the Company
had cash and cash equivalents of $29.4
million, an amount the Company anticipates is sufficient to
support the planned completion of the AEROSURF phase 2b clinical
program and fund operations through the first quarter of 2017. In
addition, as of March 31, 2016, the
Company reported accounts payable and accrued expenses of
$14.6 million, including $4.1 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
March 31, 2016, which is expected to
be filed today with the Securities and Exchange Commission, which
includes discussion about the Company's business plans and
operations, financial condition, and results of operations.
Conference Call and Webcast Details
The Company will also host a live teleconference and webcast,
including a slide presentation, today at 8:00 a.m. EDT to
discuss the 2016 first quarter financial results along with
providing other business updates. The live webcast and archive of
the conference call can be accessed at
http://windtreetx.investorroom.com/events.
For "listen-only" participants and those who wish to take part
in the question and answer portion of the call, dial (877) 870-4263
(domestic) or (412) 317-0790 (international). After placing the
call, request to be joined into the Windtree Therapeutics
conference call. A replay of the conference call will be
accessible one hour after completion through May 19, 2016 by dialing (877) 344-7529 (domestic)
or (412) 317-0088 (international) and referencing conference ID
number 10085848.
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). A phase 2b clinical trial in up to 240 premature
infants was initiated late last year 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. The Company remains
on track to complete enrollment in this trial by the end of 2016
and release top-line results in the first quarter of 2017.
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
Therapeutics' 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, which may be subject to potentially significant
delays or regulatory holds, or fail; risks that Windtree
Therapeutics 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
maintaining continued compliance with The Nasdaq Capital Market
listing requirements; risks related to technology transfers to
contract manufacturers and problems or delays encountered by
Windtree Therapeutics, 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 Therapeutics 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 Therapeutics' 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 Therapeutics'
efforts to maintain and protect the patents and licenses related to
its products; and other risks and uncertainties described in
Windtree Therapeutics' 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.
Windtree
Therapeutics, Inc.
|
Condensed
Consolidated State of Operations
|
(in thousands, except
per share data)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March 31,
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
2016
|
|
2015
|
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales
|
|
$
–
|
|
$
7
|
|
|
Grant
revenue
|
|
75
|
|
184
|
|
|
|
|
|
75
|
|
191
|
|
|
|
|
|
|
|
|
|
Operating
expenses:(1)
|
|
|
|
|
|
|
Cost of product
sales
|
|
–
|
|
929
|
|
|
Research and
development
|
|
10,360
|
|
7,082
|
|
|
Selling, general and
administrative
|
|
3,657
|
|
3,353
|
|
|
|
Total
expenses
|
|
14,017
|
|
11,364
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(13,942)
|
|
(11,173)
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of common stock warrant
|
|
|
|
|
|
|
Liability
|
|
223
|
|
(31)
|
|
|
Interest
expense
|
|
(622)
|
|
(1,208)
|
|
|
Other income /
(expense), net
|
|
440
|
|
233
|
|
Net loss
|
|
$
(13,901)
|
|
$
(12,179)
|
|
|
|
|
|
|
|
|
|
Net loss per common
share
|
|
$
(1.70)
|
|
$
(1.96)
|
|
|
|
|
|
|
|
|
|
Weighted avg. common
shares outstanding
|
|
8,191
|
|
6,114
|
|
|
|
|
|
|
|
|
|
(1) For the three
months ended March 31, 2016 and 2015, non-cash charges for
depreciation and stock-based compensation were $0.7 million ($0.3
million in R&D and $0.4 million in S, G & A) and $0.8
million ($0.4 million in R&D and $0.4 million in S,G & A),
respectively.
|
Windtree
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
|
|
2016
|
|
2015
|
ASSETS
|
|
(Unaudited)
|
|
|
Current
Assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
29,400
|
|
$
38,722
|
|
Prepaid interest,
current portion
|
|
1,435
|
|
1,710
|
|
Prepaid expenses and
other current assets
|
|
500
|
|
362
|
|
|
|
Total current
assets
|
|
31,335
|
|
40,794
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
1,100
|
|
1,039
|
Restricted
cash
|
|
225
|
|
225
|
Prepaid interest,
non-current portion
|
|
2,050
|
|
2,319
|
|
|
Total
Assets
|
|
$
34,710
|
|
$
44,377
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
|
$
14,647
|
|
$
10,845
|
|
Common stock warrant
liability
|
|
–
|
|
223
|
|
|
|
Total current
liabilities
|
|
14,647
|
|
11,068
|
|
|
|
|
|
|
|
|
Long-term
debt
|
|
25,000
|
|
25,000
|
Other
liabilities
|
|
40
|
|
43
|
Stockholders'
Equity
|
|
(4,977)
|
|
8,266
|
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
34,710
|
|
$
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-first-quarter-2016-financial-results-and-provides-business-updates-300267390.html
SOURCE Windtree Therapeutics, Inc.