WARRINGTON, Pa., March 29, 2021 /PRNewswire/ -- Windtree
Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical
device company focused on advancing multiple late-stage
interventions for acute cardiovascular and pulmonary disorders,
today reported financial results for the fourth quarter and year
ended December 30, 2020 and provided
key business updates.
Key Business and Financial Updates
- Completed an equity financing raising approximately
$30 million in gross proceeds during
the first quarter of 2021, before deducting underwriting discounts
and commissions and other estimated offering expenses, in a total
offering of 9,230,500 shares of its common stock. Net proceeds from
the offering were approximately $27.3
million. Cash and cash equivalents as of December 31, 2020 were $16.9 million.
- Dosed the first patient in the Phase 2 global clinical study of
Istaroxime for the treatment of Early Cardiogenic Shock in severe
acute heart failure patients. Cardiogenic shock is a severe form of
heart failure marked by critically low blood pressure. This study
builds upon observations from the acute heart failure program and
will assess istaroxime's ability to improve blood pressure in these
patients and is expected to be completed in the second half of
2021.
- Dosed the first patient in its Phase 2 clinical trial studying
lucinactant, the Company's KL4 surfactant, in acute lung injury in
adults with COVID-19 associated acute respiratory distress syndrome
(ARDS). The study is designed to evaluate key physiological
measures and is expected to be completed in mid-2021.
- Announced the issuance of a new U.S. Patent covering technology
on its redesigned AEROSURF Device. The new patent (U.S. Patent No.
10,874,818) covers features of the aerosol delivery system (ADS)
for the updated AEROSURF device. The redesigned device may support
enhanced clinical outcomes by potentially allowing for reduced time
to initial administration of the KL4 surfactant and reduced time
intervals between doses compared to the phase 2 prototype. The
patent protects device elements that will facilitate modification
for use in a wider range of patients including adults with
respiratory disease for drug delivery. The new patent extends the
AEROSURF device protection until 2039.
- Appointed three new Directors to the Company's Board of
Directors: Evan Loh, MD, Ms.
Leslie Williams, and Rob Scott, MD.
"2020 was a transformational and productive year that has set up
a potentially event-driven 2021 for Windtree. We achieved an
important milestone last year of completing a public financing and
listing on Nasdaq, which led to the launch of our Phase 2 trial of
istaroxime for the treatment of early cardiogenic shock in heart
failure patients, the start of a COVID-19 Lung Injury study with
KL4 surfactant and furthering other clinical and business
development programs which are potential catalysts for growth,"
said Craig Fraser, President and
Chief Executive Officer of Windtree. "With the start of the Phase 2
trial in Early Cardiogenic Shock last year, we are on our way to
developing this potential second indication for istaroxime as we
work to build upon the positive phase 2a and 2b studies in the fundamental initiative of
progressing it as a new therapy in acute heart failure.
Additionally, given the pandemic, we saw an opportunity to
potentially help patients by leveraging our substantial
pre-clinical and clinical development work to further evaluate the
potential for lucinactant to treat COVID-19 related lung injury. We
believe investing in our assets and programs creates opportunity
for value creation for the company and our shareholders." Mr.
Fraser further added, "The successful completion of this most
recent financing provides the cash and runway to continue to help
fuel these current and planned development activities. We welcome
the many new U.S. healthcare investors who participated in the
financing and look forward to keeping everyone updated on our
progress as we anticipate another year of important
milestones."
Select Financial Results for the Fourth Quarter ended
December 31, 2020
For the fourth quarter ended December 31,
2020, the Company reported an operating loss of $7.0 million, compared to an operating loss of
$4.6 million in the fourth quarter of
2019.
Research and development expenses were $3.5 million for the fourth quarter of 2020,
compared to $2.1 million for the
fourth quarter of 2019. The increase in research and
development expenses is primarily due to costs related to the
clinical development of istaroxime.
General and administrative expenses for the fourth quarter of
2020 were $3.4 million, compared to
$2.4 million for the fourth quarter
of 2019.
The Company reported a net loss of $7.5
million ($0.44 per basic
share) on 16.9 million weighted-average common shares outstanding
for the fourth quarter ended December 31,
2020, compared to a net loss of $7.4
million ($0.64 per basic
share) on 11.5 million weighted average common shares outstanding
for the comparable period in 2019.
Select Financial Results for the year ended December 31, 2020
For the year ended December 31,
2020, the Company reported an operating loss of $30.3 million, compared to an operating loss of
$24.9 million in 2019.
Research and development expenses were $15.4 million in 2020, compared to $12.7 million in 2019. The increase in
research and development expenses is primarily due to costs related
to the clinical development of istaroxime and AEROSURF.
General and administrative expenses for 2020 were $14.9 million, compared to $12.4 million in 2019.
The Company reported a net loss of $32.6
million ($2.08 per basic
share) on 15.7 million weighted-average common shares outstanding
for the year ended December 31, 2020,
compared to a net loss of $27.5
million ($2.51 per basic
share) on 10.9 million weighted average common shares outstanding
in 2019.
As of December 30, 2020, the
Company reported cash and cash equivalents of $16.9 million. During the first quarter of 2021,
the Company completed an equity financing raising $27.3 million in net proceeds.
Readers are referred to, and encouraged to read in its entirety,
the Company's Annual Report on Form 10-K for the year ended
December 31, 2020, which will be
filed with the Securities and Exchange Commission on March 29, 2021, which includes detailed
discussions about the Company's business plans and operations,
financial condition and results of operations.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing multiple late-stage
interventions for acute cardiovascular and pulmonary disorders to
treat patients in moments of crisis. Using new clinical approaches,
Windtree is developing a multi-asset franchise anchored around
compounds with an ability to activate SERCA2a, with lead candidate
istaroxime being developed as a first-in-class treatment for acute
heart failure and early cardiogenic shock in heart failure.
Windtree has also focused on developing AEROSURF® as a non-invasive
surfactant treatment for premature infants with respiratory
distress syndrome, and is facilitating transfer of clinical
development of AEROSURF® to its licensee in Asia, Lee's
HK, while Windtree evaluates other uses for its synthetic KL4
surfactant for the treatment of acute pulmonary conditions
including lung injury due to viral, chemical and radiation induced
insults. Also, in its portfolio is rostafuroxin, a novel precision
drug product targeting hypertensive patients with certain genetic
profiles.
For more information, please visit the Company's website
at www.windtreetx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. The Company may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could,"
"might," "will," "should" or other words that convey uncertainty of
future events or outcomes to identify these forward-looking
statements. Such statements are based on information available to
the Company as of the date of this press release and are subject to
numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from the Company's
current expectations. Examples of such risks and uncertainties
include: risks and uncertainties associated with the ongoing
economic and social consequences of the COVID-19 pandemic,
including any adverse impact on the Company's clinical trials or
disruption in supply chain; the success and advancement of
the clinical development programs for istaroxime, AEROSURF®,
KL4 surfactant and the Company's other product candidates; the
Company's ability to secure significant additional capital as and
when needed; the Company's ability to access the debt or equity
markets; the Company's ability to manage costs and execute on its
operational and budget plans; the results, cost and timing of the
Company's clinical development programs, including any delays to
such clinical trials relating to enrollment or site initiation;
risks related to technology transfers to contract manufacturers and
manufacturing development activities; delays encountered by the
Company, 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 the
Company 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 the Company's product candidates, and
(ii) changes in the national or international political and
regulatory environment may make it more difficult to gain
regulatory approvals and risks related to the Company's efforts to
maintain and protect the patents and licenses related to its
product candidates; risks related to the size and growth potential
of the markets for the Company's product candidates, and the
Company's ability to service those markets; the Company's ability
to develop sales and marketing capabilities, whether alone or with
potential future collaborators; and the rate and degree of market
acceptance of the Company's product candidates, if
approved. These and other risks are described in the Company's
periodic reports, including the annual report on Form 10-K,
quarterly reports on Form 10-Q and current reports on Form 8-K,
filed with or furnished to the Securities and Exchange Commission
and available at www.sec.gov. Any forward-looking statements
that the Company makes in this press release speak only as of the
date of this press release. The Company assumes no obligation to
update forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
Tables to Follow
+++++++++
Consolidated
Balance Sheets
|
|
|
|
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2020
|
|
December 31,
2019
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
16,930
|
|
$
22,578
|
Prepaid expenses and
other current assets
|
|
1,188
|
|
1,283
|
Total current
assets
|
|
18,118
|
|
23,861
|
|
|
|
|
|
Property and
equipment, net
|
|
924
|
|
798
|
Restricted
cash
|
|
154
|
|
154
|
Operating lease
right-of-use assets
|
|
917
|
|
1,390
|
Intangible
assets
|
|
77,090
|
|
77,090
|
Goodwill
|
|
15,682
|
|
15,682
|
Total
assets
|
|
$
112,885
|
|
$
118,975
|
|
|
|
|
|
LIABILITIES &
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,161
|
|
$
1,708
|
Collaboration and
device development payable, net
|
|
-
|
|
1,972
|
Accrued
expenses
|
|
3,813
|
|
3,226
|
Operating lease
liabilities - current portion
|
|
805
|
|
750
|
Loans payable -
current portion
|
|
352
|
|
161
|
Total current
liabilities
|
|
6,131
|
|
7,817
|
|
|
|
|
|
Operating lease
liabilities - non-current portion
|
|
201
|
|
794
|
Loans payable -
non-current portion
|
|
2,423
|
|
4,608
|
Restructured debt
liability - contingent milestone payments
|
|
15,000
|
|
15,000
|
Other
liabilities
|
|
2,800
|
|
-
|
Deferred tax
liabilities
|
|
16,778
|
|
15,821
|
Total
liabilities
|
|
43,333
|
|
44,040
|
|
|
|
|
|
Stockholders'
Equity:
|
|
|
|
|
Preferred stock,
$0.001 par value; 5,000,000 shares authorized; 0 shares issued and
outstanding at December 31, 2020 and 2019
|
|
-
|
|
-
|
Common stock, $0.001
par value; 120,000,000 shares authorized at December 31, 2020 and
2019; 16,921,506 and 13,697,419 shares issued at December 31, 2020
and 2019, respectively; 16,921,482 and 13,697,395 shares
outstanding at December 31, 2020 and 2019, respectively
|
|
17
|
|
14
|
Additional paid-in
capital
|
|
790,277
|
|
763,097
|
Accumulated
deficit
|
|
(717,688)
|
|
(685,122)
|
Treasury stock (at
cost); 24 shares
|
|
(3,054)
|
|
(3,054)
|
Total stockholders'
equity
|
|
69,552
|
|
74,935
|
Total liabilities
& stockholders' equity
|
|
$
112,885
|
|
$
118,975
|
Consolidated
Statements of Operations
|
|
|
|
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
2020
|
|
2019
|
|
|
|
|
|
Revenues:
|
|
|
|
|
License revenue with
affiliate
|
|
$
-
|
|
$
198
|
Total
revenues
|
|
-
|
|
198
|
|
|
|
|
|
Expenses:
|
|
|
|
|
Research and
development
|
|
15,373
|
|
12,687
|
General and
administrative
|
|
14,944
|
|
12,404
|
Total operating
expenses
|
|
30,317
|
|
25,091
|
Operating
loss
|
|
(30,317)
|
|
(24,893)
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
Net loss on debt
extinguishment
|
|
-
|
|
(1,794)
|
Interest
income
|
|
122
|
|
153
|
Interest
expense
|
|
(125)
|
|
(495)
|
Other (expense),
net
|
|
(2,246)
|
|
(446)
|
Total other (expense),
net
|
|
(2,249)
|
|
(2,582)
|
|
|
|
|
|
Net loss
|
|
$
(32,566)
|
|
$
(27,475)
|
|
|
|
|
|
Net loss per common
share
|
|
|
|
|
Basic and
diluted
|
|
$
(2.08)
|
|
$
(2.51)
|
|
|
|
|
|
Weighted average
number of common shares outstanding
|
|
|
Basic and
diluted
|
|
15,654
|
|
10,928
|
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SOURCE Windtree Therapeutics, Inc.