Windtree Eliminates $15 Million Contingent
Liability to Deerfield Management Company
WARRINGTON, PA, January 25, 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 the Company entered an Exchange and Termination
Agreement with affiliates of Deerfield Management Company
(collectively, "Deerfield") pursuant to which Deerfield has agreed
to terminate its rights under the Company's 2017 Exchange and
Termination Agreement to receive up to $15,000,000 in development
and commercial milestone payments associated with
AEROSURF®, an acute
pulmonary drug/device combination intended to treat premature
infants with respiratory distress syndrome. Windtree out-licensed
global rights to AEROSURF® in
2022.
"We appreciate the support of Deerfield in our efforts to
strengthen our financial position with the completion of this
transaction and the expected elimination the $15 million contingent
liability. As a result, we believe we have meaningfully
strengthened and simplified our balance sheet," said Craig Fraser,
Windtree's President and Chief Executive Officer. In
addition, our lead asset, istaroxime, is progressing in two ongoing
clinical trials in cardiogenic shock and we recently announced a
new regional license with Lee's Pharmaceuticals intended to
initiate Phase 3 work in acute heart failure and potentially
provide non-dilutive revenue. Along with significantly cutting our
cash burn rate since the second half of 2022, I believe we have
strengthened the company through recent transactions such as this
one. We look forward to keeping our shareholders updated on our
progress."
In exchange for Deerfield terminating its rights to receive any
milestone payments, the Company agreed to issue to Deerfield
608,272 shares of the Company's common stock and to pay Deerfield a
$100,000 cash payment upon execution of the agreement. In addition,
the Company agreed to pay Deerfield an additional $100,000 on the
earlier of (i) January 24, 2025 or (ii) the Company receiving a
specified amount of gross proceeds from debt or equity financings
occurring on or after the agreement date.
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 Lyophilized Lucinactant and
AEROSURF®
Lyophilized lucinactant is an investigational synthetic peptide
(KL4 surfactant) containing drug product that is being developed to
improve the management of RDS in premature infants who may not have
fully developed natural lung surfactant and may require surfactant
therapy to sustain life. AEROSURF® (lucinactant for
inhalation) is a drug/device combination designed to deliver
aerosolized KL4 surfactant noninvasively using our proprietary ADS
technology and potentially may meaningfully reduce the use of
invasive endotracheal intubation and mechanical ventilation. The
KL4 and AEROSURF® program was
globally out-licensed to Lee's Pharmaceutical and Zhaoke
Pharmaceutical in 2022.
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:
Matt Epstein
mepstein@kendallir.com
