1/5/2021
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`Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary …
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`
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`LIQUIDIA ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR LIQ861 (TREPROSTINIL)
`NHALATION POWDER FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION
`
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`Liquidia Announces FDA Acceptance of New Drug Application for
`LIQ861 (treprostinil) Inhalation Powder for the Treatment of
`Pulmonary Arterial Hypertension
`
`April 8, 2020
`RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq:
`LQDA), a late-stage clinical biopharmaceutical company focused on the development and
`®
`commercialization of novel products utilizing its proprietary PRINT technology, today announced that the
`U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA)
`seeking marketing approval for LIQ861 for the treatment of pulmonary arterial hypertension (PAH). Under
`the Prescription Drug User Fee Act (PDUFA), the FDA has set a goal date of November 24, 2020. 
`
`LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using the Company’s
`novel PRINT technology and engineered with the goal of enhancing deep-lung delivery of treprostinil in
`PAH patients by means of a convenient, palm-sized dry powder inhaler. The NDA was submitted under the
`505(b)(2) regulatory pathway and includes data from three clinical studies to establish the safety,
`tolerability and pharmacokinetic prole of LIQ861.
`
`"FDA acceptance of this NDA is a signicant milestone for our company and our PRINT technology. PRINT
`was the cornerstone that allowed for the precise engineering and development of LIQ861 into its current
`form and serves as the foundation for all of our products in development,” said Neal Fowler, Chief
`Executive Ocer of Liquidia. “If approved, LIQ861 will represent an important step forward in addressing
`the unmet needs of PAH patients by providing a convenient alternative to existing therapies. We look
`forward to working closely with the FDA through the NDA review process.”
`
`About PAH
`
`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 decient 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.
`
`About Liquidia
`
`Liquidia 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, ecacy 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.
`
`Forward-Looking Statements
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`https://investors.liquidia.com/news-releases/news-release-details/liquidia-announces-fda-acceptance-new-drug-application-liq861
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`1/3
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`Liquidia's Exhibit 1049
`Page 1
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`1/5/2021
`
`Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary …
`
`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 nancial position, our
`strategic and nancial 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 timelines, including the ling of the New Drug Application (NDA) for LIQ861 or potential FDA
`approval of the NDA submission, and our ability to execute on our strategic or nancial initiatives, involve
`signicant risks and uncertainties and actual results could dier 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 nancial trends that we believe may aect
`our nancial condition, results of operations, business strategy, short-term and long-term business
`operations and objectives and nancial needs, including but not limited to whether the conditions for the
`closing of the private placement will be satised. These forward-looking statements are subject to a
`number of risks discussed in our lings with the Securities and Exchange Commission, including the impact
`of the coronavirus (COVID-19) outbreak on the Company and our nancial 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 dier 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 dier 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 Information
`
`Media:
`Michael Parks
`Corporate Communications
`484.356.7105
`michael.parks@liquidia.com
`
`Investors:
`Jason Adair
`Vice President, Corporate Development and Strategy
`919.328.4400
`jason.adair@liquidia.com
`
`Source: Liquidia Technologies, Inc.
`
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`https://investors.liquidia.com/news-releases/news-release-details/liquidia-announces-fda-acceptance-new-drug-application-liq861
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`2/3
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`Liquidia's Exhibit 1049
`Page 2
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`1/5/2021
`
`Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary …
`
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`Liquidia Technologies is a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using our proprietary PRINT
`technology to transform the lives of patients. PRINT technology is a particle engineering platform that enables precise production of uniform drug particles designed to improve the
`safety, ecacy and performance of a wide range of therapies. Currently, Liquidia is developing two product candidates from its own pipeline: LIQ861 for the treatment of pulmonary
`arterial hypertension (PAH) and LIQ865 for the treatment of local post-operative pain.
`
`PO Box 110085, Research Triangle Park, NC 27709
`Tel +1 919-328-4400
`Fax +1 919-328-4402
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`https://investors.liquidia.com/news-releases/news-release-details/liquidia-announces-fda-acceptance-new-drug-application-liq861
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`3/3
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`Liquidia's Exhibit 1049
`Page 3
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