WARRINGTON, Pa., May 13, 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 first quarter ended
March 31, 2021 and provided key
business updates.
Key Business and Financial Updates
- Expanded the participating countries and sites in the Company's
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 the ability of
istaroxime 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 safety and
physiological measures and is expected to be completed in Q3
2021.
- Completed an equity financing raising approximately
$30.0 million in gross proceeds
during the first quarter of 2021, before deducting underwriting
discounts and commissions and other estimated offering expenses.
Net proceeds from the offering were approximately $27.4 million.
- Announced pursuit of additional expedited patent protection for
our lead asset istaroxime with the filing of a Track One
prioritized patent application with the U.S. Patent and Trademark
Office for a patent stemming from an application previously filed
under the Patent Cooperation Treaty. Under the Track One program,
the new istaroxime patent is expected to receive review and final
disposition within a year of priority status being granted, rather
than the customary three-year examination for non-prioritized
examinations.
- Extended the scientific collaboration with the University of
Milan-Bicocca for further characterization and development of the
Company's oral SERCA2a compounds for the potential treatment of
chronic and acute human heart failure.
"With additional countries and sites opening and dosing patients
in our Phase 2 global clinical study of istaroxime for the
treatment of Early Cardiogenic Shock in severe acute heart failure
patients and the first patient dosed in our Phase 2 study of
lucinactant in acute lung injury in adults with COVID-19 associated
ARDS, our first quarter was off to a very productive start," said
Craig Fraser, President and Chief
Executive Officer of Windtree. "As we look to the rest of the year,
we see several potential value-creating milestones with data
readouts anticipated in both Phase 2 trials. Additionally, we are
actively engaged on the business development front, and are
encouraged by the level of interest. Importantly, with the
successful completion of a financing this quarter, our balance
sheet provides the runway to continue to help fuel these current
and planned development activities. We are focused on execution and
a year of important milestones."
Select Financial Results for the First Quarter ended
March 31, 2021
For the first quarter ended March 31,
2021, the Company reported an operating loss of $9.1 million, compared to an operating loss of
$6.7 million in the first quarter of
2020.
Research and development expenses were $4.4 million for the first quarter of 2021,
compared to $3.5 million for the
first quarter of 2020. 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 first quarter of
2021 were $4.7 million, compared to
$3.2 million for the first quarter of
2020.
The Company reported a net loss of $9.0
million ($0.51 per basic
share) on 17.7 million weighted-average common shares outstanding
for the first quarter ended March 31,
2021, compared to a net loss of $6.5
million ($0.48 per basic
share) on 13.7 million weighted average common shares outstanding
for the comparable period in 2020.
As of March 31, 2021, the Company
reported cash and cash equivalents of $38.5
million.
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, 2021, which will be filed
with the Securities and Exchange Commission on May 13, 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
+++++++++
Condensed
Consolidated Balance Sheets
|
|
|
|
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2021
|
|
2020
|
|
|
Unaudited
|
|
|
ASSETS
|
|
|
|
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
38,490
|
|
$
16,930
|
Prepaid expenses and
other current assets
|
|
851
|
|
1,188
|
Total current
assets
|
|
39,341
|
|
18,118
|
|
|
|
|
|
Property and
equipment, net
|
|
879
|
|
924
|
Restricted
cash
|
|
154
|
|
154
|
Operating lease
right-of-use assets
|
|
2,747
|
|
917
|
Intangible
assets
|
|
77,090
|
|
77,090
|
Goodwill
|
|
15,682
|
|
15,682
|
Total
assets
|
|
$
135,893
|
|
$
112,885
|
|
|
|
|
|
LIABILITIES &
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
939
|
|
$
1,161
|
Accrued
expenses
|
|
3,744
|
|
3,813
|
Operating lease
liabilities - current portion
|
|
392
|
|
805
|
Loans payable -
current portion
|
|
2,409
|
|
352
|
Total current
liabilities
|
|
7,484
|
|
6,131
|
|
|
|
|
|
Operating lease
liabilities - non-current portion
|
|
2,438
|
|
201
|
Loans payable -
non-current portion
|
|
-
|
|
2,423
|
Restructured debt
liability - contingent milestone payments
|
|
15,000
|
|
15,000
|
Other
liabilities
|
|
2,800
|
|
2,800
|
Deferred tax
liabilities
|
|
16,683
|
|
16,778
|
Total
liabilities
|
|
44,405
|
|
43,333
|
|
|
|
|
|
Stockholders'
Equity:
|
|
|
|
|
Preferred stock,
$0.001 par value; 5,000,000 shares authorized; 0 shares issued and
outstanding at March 31, 2021 and December 31, 2020
|
|
-
|
|
-
|
Common stock, $0.001
par value; 120,000,000 shares authorized at March 31, 2021 and
December 31, 2020; 26,257,089 and 16,921,506 shares issued at March
31, 2021 and December 31, 2020, respectively; 26,257,065 and
16,921,482 shares outstanding at March 31, 2021 and December 31,
2020, respectively
|
|
26
|
|
17
|
Additional paid-in
capital
|
|
821,165
|
|
790,277
|
Accumulated
deficit
|
|
(726,649)
|
|
(717,688)
|
Treasury stock (at
cost); 24 shares
|
|
(3,054)
|
|
(3,054)
|
Total stockholders'
equity
|
|
91,488
|
|
69,552
|
Total liabilities
& stockholders' equity
|
|
$
135,893
|
|
$
112,885
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2021
|
|
2020
|
|
|
|
|
|
Expenses:
|
|
|
|
|
Research and
development
|
|
$
4,410
|
|
$
3,461
|
General and
administrative
|
|
4,669
|
|
3,242
|
Total operating
expenses
|
|
9,079
|
|
6,703
|
Operating
loss
|
|
(9,079)
|
|
(6,703)
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
Interest
income
|
|
50
|
|
89
|
Interest
expense
|
|
(41)
|
|
(44)
|
Other income,
net
|
|
109
|
|
124
|
Total other (expense)
income, net
|
|
118
|
|
169
|
|
|
|
|
|
Net loss
|
|
$
(8,961)
|
|
$
(6,534)
|
|
|
|
|
|
Net loss per common
share
|
|
|
|
|
Basic and
diluted
|
|
$
(0.51)
|
|
$
(0.48)
|
|
|
|
|
|
Weighted average
number of common shares outstanding
|
|
|
|
|
Basic and
diluted
|
|
17,695
|
|
13,697
|
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SOURCE Windtree Therapeutics, Inc.