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)

RESEARCH TRIANGLE PARK, N.C., Jan. 27, 2020 — 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).

Liquidia Technologies Reports Positive Interim LIQ861 Safety Data on 109 Patients from Pivotal INSPIRE Trial

RESEARCH TRIANGLE PARK, NC, Jan. 07, 2019 — Liquidia Technologies, Inc. (Nasdaq:LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients, today reported positive interim safety data from its open-label, multicenter Phase 3 clinical trial (INSPIRE) evaluating LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of pulmonary arterial hypertension (“PAH”). The safety data at the two-week timepoint addresses the U.S. Food and Drug Administration’s (“FDA”) data request for inclusion in a New Drug Application (“NDA”) submission. Liquidia anticipates submitting the full NDA for LIQ861 to the FDA in late 2019.

Liquidia Technologies Announces Pricing of Initial Public Offering

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Liquidia Technologies, Inc. (the “Company”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients, today announced the pricing of its initial public offering of 4,545,455 shares of common stock at a public offering price of $11.00 per share, before underwriting discounts and commissions, for gross proceeds of $50.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 681,818 additional shares of common stock at the initial public offering price, less the underwriting discount. The Company’s common stock is expected to begin trading on the Nasdaq Capital Market under the ticker symbol “LQDA” on July 26, 2018. The offering is expected to close on July 30, 2018 subject to customary closing conditions.

Jefferies and Cowen are acting as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow are acting as co-managers.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 25, 2018. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com; or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 274-2806 or by fax at (631) 254-7140.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

ABOUT LIQUIDIA TECHNOLOGIES

Liquidia Technologies, Inc. (“Liquidia”) is a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics 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 and LIQ865 for the treatment of local post-operative pain. Liquidia’s lead product candidate, LIQ861, currently being evaluated in a Phase 3 clinical trial (INSPIRE), is designed to improve the therapeutic profile of treprostinil by enhancing deep-lung delivery and achieving higher dose levels than current inhaled therapies by using a convenient, disposable dry powder inhaler. LIQ865, for which Liquidia has recently completed a U.S. Phase 1b clinical trial, is designed to deliver sustained-release particles of bupivacaine, a non-opioid anesthetic, to treat local post-operative pain for three to five days through a single administration. In addition to developing its own product candidates, Liquidia collaborates with leading pharmaceutical companies to develop their own product candidates across a wide range of therapeutic areas, molecule types and routes of administration, leveraging Liquidia’s PRINT®technology.

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Source: Liquidia Technologies, Inc.

Liquidia Technologies, Inc.
Jennifer Almond, 919-328-4389
media@liquidia.com

Liquidia Initiates Phase 3 Clinical Trial of LIQ861 in Patients with Pulmonary Arterial Hypertension

RESEARCH TRIANGLE PARK, NC – January 3, 2018 – Liquidia Technologies, Inc., a late-stage clinical biopharmaceutical company focused on improving the performance of medicine by precisely engineering drug particles, today announced the initiation of a Phase 3 clinical trial evaluating LIQ861 for the treatment of pulmonary arterial hypertension (PAH). LIQ861, developed using Liquidia’s proprietary PRINT® technology, is a powder formulation of treprostinil designed for deep-lung delivery using a disposable, dry powder inhaler (DPI). PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries, which often results in heart failure. Previously approved by the U.S. Food and Drug Administration (FDA) in oral, nebulized and parenteral formulations, treprostinil is a synthetic analog of prostacyclin, a vasoactive mediator deficient in patients with PAH yet essential to normal lung function to regulate vessel tone.

Liquidia Technologies Announces Positive Phase 1 Data for LIQ865, Sustained-Delivery PRINT® Formulation of Bupivacaine for Post-Surgical Pain Relief

RESEARCH TRIANGLE PARK, NC – May 24, 2017 – Liquidia Technologies, Inc., today announced initial data from its LIQ865 internal clinical development program, which is a PRINT® formulation for the sustained-delivery of free base bupivacaine for post-surgical pain relief. The phase 1 trial, marking the first evaluation of LIQ865 in humans, was a randomized, controlled, double-blind study evaluating the safety, pharmacokinetic profile and pharmacodynamic response of a single-ascending dose in healthy adult males. Topline data indicate that LIQ865 doses were well tolerated and the pharmacodynamic response was consistent with a local anesthetic effect lasting for three or more days.

Liquidia Technologies and GlaxoSmithKline Advance Existing Collaboration; GlaxoSmithKline Exercises Option for Inhaled Therapeutics

RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2015 — Liquidia Technologies today announced that GlaxoSmithKline (GSK) has exercised its option under a Collaboration and Option Agreement signed in 2012 to exclusively license the right to research, develop, and commercialize inhaled therapeutics derived from the company’s proprietary PRINT® technology. Through this collaboration, Liquidia and GSK will continue to work together with the goal of advancing inhaled therapeutics into clinical studies.

Liquidia Technologies Names Robert A. Lippe Chief Operations Officer

RESEARCH TRIANGLE PARK, NC July 14, 2015 – Liquidia Technologies today announced it has named Robert A. Lippe as the Company’s Chief Operations Officer, effective immediately. Mr. Lippe has responsibility for manufacturing research, process development, operations, quality control and compliance and will be a key member of the senior management team.

Liquidia Technologies Announces Extension of Collaboration with PATH to Develop Next Generation Pneumococcal Vaccine

RESEARCH TRIANGLE PARK, NC– May 21, 2013 – Liquidia Technologies today announced that its collaborative agreement with PATH, a global health nonprofit organization, has been extended. The extension of this agreement allows for the continuation of preclinical proof-of-concept studies on a next generation pneumococcal vaccine. If successful, the vaccine could potentially allow for broadened efficacy and manufacturing efficiencies that translate to greater access to the vaccine by the global population. Pneumonia kills approximately 1.3 million children under the age of five years every year—more than any other illness. Nearlyhalf of these deaths are caused by Streptococcus pneumoniae, a bacterium that has many variations globally and is becoming increasingly resistant to antibiotics.

“We are exceptionally proud of the work we have done with PATH and excited about the opportunity to continue this work with them,” said Neal Fowler, Chief Executive Officer at Liquidia Technologies. “Our shared goal to improve vaccine performance and reduce manufacturing costs using our transformative technology remains unchanged as does our confidence that this collaboration has the potential to significantly impact the spread of pneumonia in the developing world.”

Nanotechnology firm Liquidia plans new ophthalmology company

MORRISVILLE, N.C. — Nanotechnology company Liquidia Technologies plans to form a new ophthalmology company with an experimental glaucoma treatment expected to start clinical trials in 2014.

Morrisville-based Liquidia said today that the new company would be able to advance Liquidia’s efforts to create products in ophthalmology and other therapeutic areas while also maximizing the return for the company’s investors. WRAL Tech Wire reported in February that Liquidia was considering spinning out one or more companies this year.

Liquidia offered few other details in today’s announcement, other than to say it would have more information later in the second quarter. In a statement, CEO Neal Fowler said that the structure for creating and financing the new company will be considered for other assets and therapeutic areas.

Liquidia’s proprietary “PRINT” technology enables a nanoparticle manufacturer to control the size and shape of the nanoparticles. Changing the size and shape of a nanoparticle can improve drug delivery and reduce side effects. Vaccines were Liquidia’s first target, a pursuit that GlaxoSmithKline liked enough to strike a licensing deal that gave GSK exclusive rights to develop new vaccines with the technology.

Liquidia said in today’s announcement that it independent from the new ophthalmology business, Liquidia will continue to focus on vaccine and pulmonary product development, including the work that has already begun under the GSK partnership.

Liquidia’s technology is a platform technology that has medical as well as consumer product applications. Fowler has acknowledged a partnership with Proctor & Gamble (NYSE: PG). In February, Fowler said that Liquidia’s PRINT technology can be used to make nanoparticles that improve how a product is delivered to the skin. At the time, he said an ophthalmology company could be spun out first, followed by a consumer product with P&G. 

LipoScience Receives FDA Clearance for Vantera Clinical Analyzer

RALEIGH, N.C.–(BUSINESS WIRE)–September 5, 2012–LipoScience, Inc., an in vitro diagnostic company committed to advancing patient care in cardiovascular, metabolic and other diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera® Clinical Analyzer.

The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology. Ease-of-use and walk-away automation provide efficient workflow to maximize laboratory resources while producing high quality results.

“LipoScience is pioneering a new field of personalized diagnostics based on NMR technology,” said Rick Brajer, Chief Executive Officer of LipoScience. “The FDA clearance of our Vantera Clinical Analyzer is a pivotal event that advances our vision of decentralizing our technology and becoming a clinical standard of care.”

The first assay cleared on this new in vitro diagnostic platform is low density lipoprotein particle number (LDL-P). LDL-P is a key component of LipoScience’s NMR LipoProfile® test, which provides physicians and their patients with actionable information to personalize management of risk for heart disease from a single blood sample. To date, over 8 million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart health.

“Historically, all NMR LipoProfile tests have been performed at LipoScience’s CLIA-certified laboratory in North Carolina,” said Tom Clement, Vice President of Regulatory and Quality Affairs. “The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S., as well as at leading medical centers and hospital outreach laboratories, in order to drive both geographic expansion and the technology adoption necessary for successful execution of our market conversion strategy.”

About LipoScience, Inc. 

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary diagnostic test, the NMR LipoProfile® test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 8 million NMR LipoProfile tests have been ordered. LipoScience’s automated clinical analyzer, Vantera has recently been cleared by the FDA and will be placed with national and regional clinical laboratories. LipoScience is driving toward a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of metabolic and other diseases. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.