Liquidia Corporation Announces Updates to Operations Leadership
19 January 2024 - 10:30PM
Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company)
announced today updates and promotions to its operations leadership
in advance of the potential approval and launch of YUTREPIA™
(treprostinil) inhalation powder. Michael Kaseta, Chief Financial
Officer (CFO), has added the role of Chief Operating Officer (COO)
to his responsibilities effective on January 15, 2023. In his
expanded role as COO/CFO, Mr. Kaseta will be responsible for
several key areas in addition to finance, including human
resources, information technology, quality, manufacturing, and
business strategy. In connection with this change, Michael Hunter
was also promoted to Senior Vice President of Manufacturing
Operations, where he will manage all day-to-day manufacturing and
supply chain operations internally and externally. Simultaneously,
former Chief Operations Officer, Robert Lippe, will transition out
of the Company over a three-month period.
Dr. Roger Jeffs, Chief Executive Officer, said: “I am delighted
to announce these promotions. Michael Kaseta’s financial and
operational oversight will further solidify our capabilities as we
rapidly become a more fulsome commercial enterprise upon the
potential launch of YUTREPIA. Michael Hunter’s promotion not only
signifies our commitment to fostering talent and promoting from
within, but also recognizes his contribution over the last 17 years
to making PRINT Technology a commercially-attractive manufacturing
platform.”
About YUTREPIA™(treprostinil) inhalation
powder
YUTREPIA is an investigational, inhaled dry powder formulation
of treprostinil delivered through a convenient, low-resistance,
palm-sized device. On November 5, 2021, the FDA issued a tentative
approval for YUTREPIA for the treatment of pulmonary arterial
hypertension (PAH) to improve exercise ability in adult patients
with New York Heart Association (NYHA) Functional Class II-III
symptoms. In July 2023, Liquidia filed an amendment to its New Drug
Application for YUTREPIA, seeking to add PH-ILD to the label. The
FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of
January 24, 2024 for the amendment. Previously, the FDA has
confirmed that YUTREPIA may add the treatment of PH-ILD to the
label for YUTREPIA without additional clinical studies. YUTREPIA
was designed using Liquidia’s PRINT® technology, which enables the
development of drug particles that are precise and uniform in size,
shape, and composition, and that are engineered for enhanced
deposition in the lung following oral inhalation. Liquidia has
completed INSPIRE, or Investigation of the Safety and Pharmacology
of Dry Powder Inhalation of Treprostinil, an open-label,
multi-center phase 3 clinical study of YUTREPIA in patients
diagnosed with PAH who are naïve to inhaled treprostinil or who are
transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA was
previously referred to as LIQ861 in investigational studies.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on
the development and commercialization of products in pulmonary
hypertension and other applications of its PRINT® Technology. The
Company operates through its two wholly owned subsidiaries,
Liquidia Technologies, Inc. (Liquidia Technologies) and Liquidia
PAH, LLC (Liquidia PAH). Liquidia Technologies has developed
YUTREPIA™ (treprostinil) inhalation powder for the treatment of PAH
and PH-ILD. Liquidia Technologies is also developing L606, an
investigational liposomal formulation of treprostinil administered
twice-daily with a short-duration next-generation nebulizer, for
use in North America. Liquidia PAH provides for the
commercialization of pharmaceutical products to treat pulmonary
disease, such as generic Treprostinil Injection. For more
information, please visit www.liquidia.com.
Cautionary Statements Regarding Forward-Looking
StatementsThis press release may include forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
other than statements of historical facts, including statements
regarding our future results of operations and financial position,
our strategic and financial initiatives, our business strategy and
plans and our objectives for future operations, are forward-looking
statements. Such forward-looking statements, including statements
regarding clinical trials, clinical studies and other clinical work
(including the funding therefor, anticipated patient enrollment,
safety data, study data, trial outcomes, timing or associated
costs), regulatory applications and related submission contents and
timelines, including the potential for final FDA approval of the
NDA for YUTREPIA, the timeline or outcome related to patent
litigation in the U.S. District Court for the District of Delaware
or inter partes review proceedings conducted at the PTAB, including
appeals of decisions in any such proceedings, the issuance of
patents by the USPTO and our ability to execute on our strategic or
financial initiatives, involve significant risks and uncertainties
and actual results could differ materially from those expressed or
implied herein. The favorable decisions of lower tribunals are not
determinative of the outcome of the appeals of the decisions. The
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would,” and similar expressions are
intended to identify forward-looking statements. We have based
these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our financial condition, results
of operations, business strategy, short-term and long-term business
operations and objectives and financial needs. These
forward-looking statements are subject to a number of risks
discussed in our filings with the SEC, as well as a number of
uncertainties and assumptions. Moreover, we operate in a very
competitive and rapidly changing environment and our industry has
inherent risks. New risks emerge from time to time. It is not
possible for our management to predict all risks, nor can we assess
the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements we may make. In light of these risks, uncertainties and
assumptions, the future events discussed in this press release may
not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking
statements. Nothing in this press release should be regarded as a
representation by any person that these goals will be achieved, and
we undertake no duty to update our goals or to update or alter any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact InformationMedia &
Investors:Jason AdairChief Business
Officer919.328.4400jason.adair@liquidia.com
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