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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180725005966/en/

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.”

Liquidia Technologies Inc. Studies Show PRINT® Engineered Particles Hold Promise in the Delivery of Respiratory Therapeutics

RESEARCH TRIANGLE PARK, N.C.-May 12, 2012-(BUSINESS WIRE)–Liquidia Technologies today announced the results of two newly-released studies that illustrate the unique benefits of the company’s proprietary PRINT® (Particle Replication In Non-Wetting Templates) platform in the development of advanced respiratory therapeutics. Despite the high prevalence of lung disease, optimizing critical parameters of respiratory therapeutics to improve their pulmonary distribution and effectiveness has remained a challenge for the biopharmaceutical industry. These studies demonstrate how the PRINT platform can be used for respiratory drugs by precisely engineering particles with controlled shape, size, and chemistry, all characteristics that could lead to better lung delivery and therapeutic performance. Aspects of these findings were published in the Journal of Drug Delivery and presented at the Respiratory Drug Delivery Conference being held May 13-17, 2012 in Phoenix, Arizona.

Big Business Appeal of Nanotechnology on Display in Durham

 

DURHAM, N.C., April 2, 2012 – Starting Tuesday night with a speaker reception at the headquarters of the Center of Innovation for NanoBiotechnology (COIN), the fourth annual Nanotechnology Commercialization Conference will kick off with United States Congressman GK Butterfield in attendance.

The event, in Durham this year, features local, national and international nanotech commercialization leaders who will discuss topics such as how to grow this sector through university research, thoughtful regulatory guidance, corporate partnerships and increased investment.

The lunch keynote on Wednesday includes four heavy hitters from North Carolina and will be hosted and moderated by Chris William of the PBS show Carolina Business Review.

This fireside chat includes former CEO of the North Carolina Biotech Center, Charles Hamner, and now Chairman of the Hamner Institute. The discussion also includes John Hardin, the Executive Director of the Office of Science and Technology, who works with the NC Department of Commerce on science and technology policy. Finally, the CEO of a global leader of nanobiotechnology, and from our own backyard, Neal Fowler of Liquidia will discuss his experience and vision from the private sector.

The idea of the panel is how to create the infrastructure to create more companies like Liquidia that license technology from our leading research universities, develop the technology, attract investment capital, attract management and retain and attract the best and the brightest talent to the region.