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Liquidia Technologies, Inc. 419 Davis Drive, Suite 100 Morrisville, NC 27560 MEDIA RELEASE www.liquidia.com Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatmen

Key Takeaway: Liquidia Technologies, Inc. 419 Davis Drive, Suite 100 Morrisville, NC 27560 MEDIA RELEASE www.liquidia.com Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension CRL does not ci

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Liquidia Technologies, Inc.
419 Davis Drive, Suite 100
Morrisville, NC 27560
MEDIA RELEASE
www.liquidia.com
Liquidia Receives Complete Response Letter
from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
CRL does not cite need for additional
CRL focuses on drug CMC and device biocompatibility
Conference Call Scheduled for Today at
RESEARCH TRIANGLE PARK, N.C., November
25, 2020 - Liquidia Technologies, Inc., a wholly owned subsidiary of Liquidia Corporation (NASDAQ: LQDA), today announced
that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company's New Drug Application
(NDA) for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH).
In the CRL, the FDA stated that it is unable to approve the NDA at this time. The CRL identified the need for additional information
and clarification on chemistry, manufacturing and controls (CMC) data pertaining to the drug product and device biocompatibility.
Liquidia does not believe that the items raised in the CRL will be a barrier to the ultimate approval of LIQ861.
The FDA also reconfirmed the need to
conduct on-site pre-approval inspections (PAIs) of two of Liquidia's U.S. manufacturing facilities before the application
can be approved. The FDA noted it had been unable to conduct these inspections during the initial review cycle due to COVID-19
related travel restrictions.
The CRL did not cite the need to conduct
further clinical studies, nor did the FDA require additional studies related to toxicology or clinical pharmacology. Of note, Liquidia
believes that it can address the items raised in the CRL without delaying the otherwise projected launch timing of LIQ861 in the
second half of 2022, subject to FDA approval.
"We remain very confident in
LIQ861 and are committed to working closely with the FDA to address these items to support its approval," said Neal Fowler,
Chief Executive Officer at Liquidia. "With more than 70 patients now having received LIQ861 for more than two years in our
clinical trials, Liquidia remains committed to PAH patients who we believe are underserved with currently available treatment options."
Webcast and Conference Call
Liquidia will host a webcast and conference call Wednesday, November 25, 2020 at 9:00 a.m. ET to discuss this regulatory
update for LIQ861. The live call may be accessed by dialing 1-877-707-8711 (domestic) or 1-857-270-6219 (international) and entering
the conference code: 3295968. A live and archived webcast of the call will also be available on the Events & Presentations page
of the Liquidia website.
Liquidia Technologies, Inc.
419 Davis Drive, Suite 100
Morrisville, NC 27560
MEDIA RELEASE
www.liquidia.com
LIQ861 is an investigational inhaled
dry powder formulation of treprostinil designed using Liquidia's PRINT technology with the goal of enhancing deep-lung
delivery using a convenient, palm-sized dry powder inhaler ("DPI") for the treatment of pulmonary arterial hypertension
(PAH). PRINT technology enables development of drug particles that are precise and uniform in size, shape, weight and
composition that are engineered for optimal deposition in the lung following oral inhalation. Liquidia believes LIQ861 can
overcome the limitations of current inhaled therapies and has the potential to maximize the therapeutic benefits of treprostinil
in treating PAH by safely delivering higher doses into the lungs. Liquidia has completed an open-label, multi-center
phase 3 clinical study of LIQ861 in patients diagnosed with PAH known as INSPIRE, or Investigation of the Safety and Pharmacology
of Dry Powder Inhalation of Treprostinil.
PAH is a chronic, progressive disease
caused by the hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Treprostinil
is a synthetic analog of prostacyclin, a vasoactive mediator essential to normal lung function that is deficient in patients with
PAH. PAH is a rare disease, with an estimated prevalence in the United States of approximately 30,000 patients. The exact cause
of PAH is often unknown and, although the symptoms are treatable, there is no known cure for the disease.
Liquidia Technologies, Inc., a wholly
owned subsidiary of Liquidia Corporation, is a late-stage clinical biopharmaceutical company focused on the development and
commercialization of novel products using its proprietary PRINT technology to transform the lives of patients. PRINT is a
particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy
and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates
for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension (PAH) and LIQ865 for
the treatment of local post-operative pain. Liquidia is headquartered in Research Triangle Park, NC. For more information,
please visit www.liquidia.com.
Liquidia Technologies, Inc.
419 Davis Drive, Suite 100
Morrisville, NC 27560
MEDIA RELEASE
www.liquidia.com
Cautionary Statements Regarding
Forward-Looking Statements
This 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 anticipated submission contents and timelines, including potential resubmission
of the NDA following our receipt of a CRL in November 2020, the potential for eventual FDA approval of the NDA for LIQ861,
the timeline or outcome related to our patent litigation pending in the U.S. District Court for the District of Delaware or
its inter partes review with the Patent Trial and Appeal Board (PTAB), the issuance of patents by the U.S. Patent
and Trademark Office (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 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 Liquidia's
filings with the SEC, including the impact of the coronavirus (COVID-19) outbreak on our company and our financial condition
and results of operations, 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.
Corporate Communications
Vice President, Corporate Development and Strategy
Last updated: Nov 25, 2020