Liquidia Submits New Drug Application for LIQ861 (treprostinil) inhalation powder to U.S. Food and Drug Administration for the Treatment …
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`LIQUIDIA SUBMITS NEW DRUG APPLICATION FOR LIQ861 (TREPROSTINIL) INHALATION POWDER TO
`U.S. FOOD AND DRUG ADMINISTRATION FOR THE TREATMENT OF PULMONARY ARTERIAL
`HYPERTENSION (PAH)
`
`Liquidia Submits New Drug Application for LIQ861 (treprostinil)
`inhalation powder to U.S. Food and Drug Administration for the
`Treatment of Pulmonary Arterial Hypertension (PAH)
`
`January 27, 2020
`RESEARCH TRIANGLE PARK, N.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc.
`(Nasdaq:LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development
`of products using its proprietary PRINT® technology, today announced the submission of its New Drug
`Application (NDA) to the U.S. Food and Drug Administration (FDA) for LIQ861. 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 for the treatment of
`pulmonary arterial hypertension (PAH). 
`
`The NDA has been 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. The open-label Phase 3
`study, known as INSPIRE (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of
`Treprostinil) (NCT03399604), included 121 PAH patients who transitioned from stable doses of the
`reference listed drug or added LIQ861 to no more than two approved non-prostacyclin oral PAH therapies.
`The company also completed pharmacokinetic studies to establish the bioavailability of LIQ861 relative to
`the bioavailability of the reference listed drug.
`
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`Neal Fowler, Chief Executive Ocer of Liquidia, said, "The submission of the NDA for LIQ861 in the U.S. is a
`signicant milestone for our company and our goal to address an important unmet need in the delivery of
`inhaled therapy for PAH patients. We would like to sincerely thank the patients, their families and the
`clinical investigators for their participation in the LIQ861 clinical program, and we look forward to working
`closely with the FDA during the review process.”
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`About LIQ861
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`Jan 5, 2021 12:07 PM EST
`
`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 benets 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.
`
`About Liquidia
`
`late-stage clinical biopharmaceutical company focused on the development and
`is a
`Liquidia
`commercialization of therapeutics using its proprietary PRINT® technology to transform the lives of
`patients. Currently, Liquidia is focused on the development of two product candidates using its PRINT
`particle engineering platform: LIQ861 for the treatment of pulmonary arterial hypertension and LIQ865 for
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`https://investors.liquidia.com/news-releases/news-release-details/liquidia-submits-new-drug-application-liq861-treprostinil
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`Liquidia's Exhibit 1042
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`Liquidia Submits New Drug Application for LIQ861 (treprostinil) inhalation powder to U.S. Food and Drug Administration for the Treatment …
`
`the treatment of local post-operative pain. Having been evaluated in a phase 3 clinical trial (INSPIRE),
`LIQ861 is designed to improve the therapeutic prole of treprostinil with the goal of enhancing deep-lung
`delivery and achieving higher dose levels than current inhaled therapies by using a convenient, palm-sized
`dry powder inhaler. LIQ865, for which Liquidia has completed two phase 1 clinical trials, is designed to
`deliver sustained-release particles of bupivacaine, a non-opioid anesthetic, to treat local post-operative
`pain for three to ve days through a single administration.
`
`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 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 FDA acceptance of
`the NDA submission and potential approval thereof, 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, 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
`
`Investors & Media:
`Jason Adair
`Vice President, Corporate Development and Strategy
`919.328.4400
`jason.adair@liquidia.com
`
`Source: Liquidia Technologies, Inc.
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`Liquidia Submits New Drug Application for LIQ861 (treprostinil) inhalation powder to U.S. Food and Drug Administration for the Treatment …
`
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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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`Liquidia's Exhibit 1042
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