Windtree Therapeutics Announces Engagement of
Strategic Advisor to Support Assessment of Strategic
Alternatives
WARRINGTON, PA, January 31, 2024
-- InvestorsHub NewsWire -- Windtree Therapeutics, Inc. (“Windtree”
or the “Company”) (NasdaqCM:
WINT), a biotechnology company focused on advancing late-stage
interventions for critical cardiovascular disorders, today
announced that it has engaged Ladenburg Thalmann & Co. Inc.
(“Ladenburg”) to evaluate strategic alternatives for the Company
with the goal of maximizing stockholder
value.
"We are pleased with the
progress we have made in advancing our cardiovascular portfolio,
most importantly progressing istaroxime in clinical trials in
cardiogenic shock, as well as the recently announced licensing deal
with Lee's Pharmaceuticals for the Greater China-Asia Pacific
region. We believe this non-dilutive licensing deal along with
significantly cutting cash burn and the agreement for the
elimination of the $15 million contingent liability with Deerfield
has resulted in both a potentially expanded clinical development
program and a stronger balance sheet," said Craig Fraser,
Windtree's President and Chief Executive Officer. "While
there has been positive data and progress, we believe the
opportunity is under-recognized and under-valued in the current
financial markets, however, it has resulted in in-bound business
development interest. Given this, the Company has engaged a
strategic advisor to help coordinate and assess these opportunities
with the intent to maximize shareholder value."
Windtree is making this
announcement to inform shareholders and the public that in addition
to the active execution of the next steps in our cardiogenic shock
program outlined in our corporate deck and filings, the Company is
also engaging in discussions for strategic alternatives with the
goal of maximizing value for stockholders. Beyond traditional
licensing, the Company will explore the potential for an
acquisition, merger, further licensing, company sale or other
strategic transactions. There can be no assurances that the process
or discussions will result in an attractive transaction, nor
as to its outcome or timing and the Company has not made any
decisions at this point in time. The engagement of Ladenburg as
strategic advisor is intended to support the board's process and
assessment of opportunities.
About
Istaroxime
Istaroxime is a
first-in-class dual-mechanism therapy designed to improve both
systolic and diastolic cardiac function. Istaroxime is a positive
inotropic agent that increases myocardial contractility through
inhibition of Na+/K+- ATPase with a complimentary mechanism that
facilitates myocardial relaxation through activation of the SERCA2a
calcium pump on the sarcoplasmic reticulum enhancing calcium
reuptake from the cytoplasm. Data from multiple Phase 2 studies in
patients with early cardiogenic shock or acute decompensated heart
failure demonstrate that istaroxime infused intravenously
significantly improves cardiac function and blood pressure without
increasing heart rate or the incidence of cardiac rhythm
disturbances.
About Windtree
Therapeutics, Inc.
Windtree Therapeutics, Inc.
is advancing late-stage interventions for cardiovascular disorders
to treat patients in moments of crisis. Using new scientific and
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 cardiogenic shock and acute decompensated heart
failure. Windtree's heart failure platform includes follow-on
pre-clinical SERCA2a activator assets as well. In pulmonary care,
Windtree has focused on facilitating the transfer of the KL4
surfactant platform, to its licensee, Lee's Pharmaceutical (HK)
Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in
Windtree's portfolio is rostafuroxin, a novel precision drug
product targeting hypertensive patients with certain genetic
profiles.
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 success and advancement of the clinical
development programs for istaroxime 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, and other
materials on a timely basis and in sufficient amounts; risks
relating to rigorous regulatory requirements, including that: (i)
the U.S. Food and Drug Administration 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 that the Company may never
realize the value of its intangible assets and have to incur future
impairment charges; 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; the rate and degree of market
acceptance of the Company's product candidates, if approved; the
economic and social consequences of the COVID-19 pandemic
and the impacts of political unrest, including as a result of
geopolitical tension, including the conflict
between Russia and Ukraine, the
People's Republic of China and the Republic of
China (Taiwan), and the evolving events in Israel and Gaza,
and any sanctions, export controls or other restrictive actions
that may be imposed by the United States and/or other
countries which could have an adverse impact on the Company's
operations, including through disruption in supply chain or access
to potential international clinical trial sites, and through
disruption, instability and volatility in the global markets, which
could have an adverse impact on the Company's ability to access the
capital markets. These and other risks are described in the
Company's periodic reports, including its 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.
Contact
Information:
Eric Curtis
ecurtis@windtreetx.com
