Windtree Eliminates $15 Million Contingent Liability to Deerfield Management Company
25 1월 2024 - 10:30PM
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 IstaroximeIstaroxime 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 StatementsThis 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
Epsteinmepstein@kendallir.com
Windtree Therapeutics (NASDAQ:WINT)
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부터 11월(11) 2024 으로 12월(12) 2024
Windtree Therapeutics (NASDAQ:WINT)
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