WARRINGTON, Pa., Aug. 21, 2017 /PRNewswire/
-- Windtree Therapeutics, Inc. (OTCQB: 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, 2017.
"The second quarter of 2017 was marked with continued progress
in the AEROSURF® development program and for the Company. We
completed enrollment in the AEROSURF phase 2b clinical trial and
released top-line results in late June. While the top-line results
did not meet the specified endpoint, which we believe is due in
large part to unexpected treatment interruptions, we are very
encouraged that, when excluding patients with treatment
interruptions, the 50 minute dose exhibited a positive treatment
effect with a safety profile comparable to that of control. We look
forward to finalizing a regulatory and clinical plan to incorporate
our next generation aerosol delivery system (ADS) into our program,
as we pursue a path potentially to advance AEROSURF into phase 3
development," commented Craig
Fraser, President and Chief Executive Officer. "In addition,
in June we announced an exclusive license agreement with Lee's
Pharmaceutical (HK) Limited ("Lee's Pharm") for the development and
commercialization of our KL4 surfactant products in select Asian
markets. And finally, we recently announced our efforts to
undertake a financial restructuring program to provide short-term
financing and improve the Company's capital structure for the
long term. If we are successful, we believe our Company will be
better positioned to achieve long-term financial sustainment and to
realize the full potential of AEROSURF and our KL4 surfactant and
aerosol delivery platforms."
Select Financial Results for the Second Quarter ended
June 30, 2017
For the quarter ended June 30,
2017, the Company reported an operating loss of $6.1 million, compared to $10.0 million for the second quarter of 2016.
Grant revenue for the second quarter of 2017 was $1.1 million compared to $0.1 million for the second quarter of 2016.
Grant revenue for 2017 primarily represents funds received and
expended under a Small Business Innovation Research (SBIR) grant
from the National Heart, Lung, and Blood Institute (NHLBI) of the
National Institutes of Health (NIH) to support the AEROSURF phase
2b clinical trial.
Research and development expenses were $5.5 million for the second quarter of 2017,
compared to $8.3 million for the
second quarter of 2016. The decrease was due to (i) reductions in
AEROSURF phase 2 clinical development program costs including
decreases in clinical trial site initiation costs and production of
aerosol delivery systems; and (ii) cost reduction measures
initiated in the second quarter of 2016.
General and administrative expenses were $1.8 million for the second quarter of 2017 and
2016.
Interest expense for the second quarter of 2017 and 2016 was
$0.6 million and primarily represents
interest expense on $25 million of
long-term debt.
The Company reported a net loss of $6.8
million for the second quarter of 2017, compared to a net
loss of $10.6 million for the
comparable period in 2016.
In addition, in the second quarter of 2017, the Company reported
a $0.5 million non-cash deemed
dividend on preferred stock, resulting in a net loss attributable
to common shareholders of $7.3
million ($0.76 per basic
share) on 9.6 million weighted-average common shares outstanding,
compared to a net loss attributable to common shareholders of
$10.6 million ($1.29 per basic share) on 8.2 million weighted
average common shares outstanding for the comparable period in
2016.
As of June 30, 2017, the Company
had cash and cash equivalents of $2.5
million. Net operating cash outflows before financing
activities for the second quarter of 2017 were $5.5 million. In addition, as of
June 30, 2017, the Company reported
current liabilities of $25.4 million
(including $12.5 million of long-term
debt, current portion) and long-term debt of $12.5 million. The current portion of long-term
debt is due in February 2018. The
non-current portion of long-term debt is due in February 2019.
The Company recently announced a financial restructuring plan to
provide short-term financing and improve the Company's capital
structure. Components of the plan include (i) up to a potential
$3.9 million loan from Lee's Pharm
("Lee's Loan") payable to the Company in three equal installments
in August, September and October 2017
with the initial installment of $1.3
million received by the Company on August 15, 2017; (ii) a potential $10 million share purchase by Lee's Pharm to
acquire a controlling interest in the Company; and (iii) a
potential Deerfield loan
restructuring resulting in retirement of $25
million in long-term debt.
As of August 15, 2017, after
receipt of the initial advance under the Lee's Loan, the Company
had cash and cash equivalents of approximately $2.9 million and currently anticipates that,
assuming receipt of the two additional installments under the Lee's
Loan, and before any additional financings, it will have sufficient
cash resources to fund its operations through
November 2017.
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, 2017 which includes
discussion about the Company's business plans and operations,
financial condition and results of operations.
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: the risk that, as a
development company, with limited resources and no operating
revenues, the Company's ability to continue as a going concern in
the near term is highly dependent upon the success of AEROSURF
clinical trials and whether they are sufficient to support a
strategic or financing transaction and enable initiation of phase 3
development; risks that Windtree will be unable to secure
significant additional capital as needed, if at all, whether
through debt or equity financings, which could result in
substantial equity dilution, or other strategic transaction that
would also provide support for product development, regulatory and,
if approved, commercialize our products, ; risks related to trading
of the Company's common stock on the OTCQB® market; risks
related to Windtree's AEROSURF development program and other
development programs 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 related to the development of
aerosol delivery systems (ADS) and related components; risks
related to technology transfers to contract manufacturers and
problems or delays encountered by Windtree, contract manufacturers
or third party suppliers and service providers in manufacturing,
testing and releasing 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.
|
|
|
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)
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Grant
revenue
|
$
1,147
|
|
$
106
|
|
$
1,366
|
|
$
181
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
(1)
|
|
|
|
|
|
|
|
|
Research and
development
|
5,483
|
|
8,316
|
|
11,896
|
|
18,676
|
|
General and
administrative
|
1,804
|
|
1,783
|
|
3,726
|
|
5,440
|
|
|
Total
expenses
|
7,287
|
|
10,099
|
|
15,622
|
|
24,116
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(6,140)
|
|
(9,993)
|
|
(14,256)
|
|
(23,935)
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of common stock warrant liability
|
|
–
|
|
–
|
|
–
|
|
223
|
|
|
|
|
|
|
|
|
|
Other income /
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
income
|
3
|
|
5
|
|
6
|
|
12
|
|
Interest
expense
|
(615)
|
|
(637)
|
|
(1,226)
|
|
(1,259)
|
|
Other
income
|
–
|
|
1
|
|
–
|
|
434
|
Net loss
|
$
(6,752)
|
|
$
(10,624)
|
|
$
(15,476)
|
|
$
(24,525)
|
|
|
|
|
|
|
|
|
Deemed dividend on
preferred stock
|
(532)
|
|
–
|
|
(4,136)
|
|
–
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders
|
$
(7,284)
|
|
$
(10,624)
|
|
$
(19,612)
|
|
$
(24,525)
|
|
|
|
|
|
|
|
|
Net loss per common
share – basic and diluted
|
$
(0.76)
|
|
$
(1.29)
|
|
$
(2.10)
|
|
$
(2.99)
|
|
|
|
|
|
|
|
|
Weighted avg. common
shares outstanding – basic and diluted
|
9,634
|
|
8,238
|
|
9,317
|
|
8,215
|
|
|
|
|
|
|
|
|
|
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(1)
Material non-cash items
include depreciation and stock-based compensation included in
operating expenses. For each of the three months ended June
30, 2017 and 2016, the charges for depreciation and stock-based
compensation were $0.3 million ($0.2 million in R&D and $0.1
million in G & A). For the six months ended June 30, 2017
and 2016, the charges for depreciation and stock-based compensation
were $0.7 million ($0.4 million in R&D and $0.3 million in G
& A) and $0.9 million ($0.4 million in R&D and $0.5 million
in G & A), respectively.
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|
|
|
|
|
|
|
|
|
|
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Windtree
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
2,528
|
|
$
5,588
|
|
Prepaid interest,
current portion
|
|
1,094
|
|
1,094
|
|
Prepaid expenses and
other current assets
|
|
318
|
|
512
|
|
|
|
Total current
assets
|
|
3,940
|
|
7,194
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
977
|
|
1,054
|
Restricted
cash
|
|
225
|
|
225
|
Prepaid interest,
non-current portion
|
|
683
|
|
1,226
|
|
|
Total
Assets
|
|
$
5,825
|
|
$
9,699
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
Accounts payable,
collaboration payable, accrued expenses and current portion of
long-term debt
|
|
$
25,384
|
|
$
13,391
|
|
|
|
|
|
|
|
|
Long-term debt,
non-current portion
|
|
12,500
|
|
25,000
|
Other
liabilities
|
|
124
|
|
138
|
Stockholders'
Equity
|
|
(32,183)
|
|
(28,830)
|
|
|
Total Liabilities and
Stockholders' Equity
|
|
$
5,825
|
|
$
9,699
|
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SOURCE Windtree Therapeutics, Inc.