LQDA Liquidia Corporation

Liquidia Corporation (NASDAQ: LQDA) announced today the company will present seven posters related to its product pipeline at the 7th World Symposia of Pulmonary Hypertension (WSPH) taking place June 29 to July 1, 2024, in Barcelona, Spain. The posters outlined below address the clinical investigations of Liquidia’s investigational products, YUTREPIA™ (treprostinil) inhalation powder and L606 (liposomal treprostinil) inhalation suspension sustained-release formulation to treat people with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Rajeev Saggar, MD, Chief Medical Officer at Liquidia, said: “Since 1973, the World Symposia on Pulmonary Hypertension has contributed to the ongoing scientific advancement of our field. We are delighted to present seven thematic posters on the world stage showcasing YUTREPIA and L606. We look forward to initiating a global, pivotal placebo-controlled efficacy trial of L606 in PH-ILD later this year.”

Liqudia’s posters will be presented on Sunday, June 30, 2024, from 5:15 – 6:30 p.m. CEST and include:

Live Thematic Poster Sessions

Abstract B83 – Exploratory Efficacy Analysis of INSPIRE Open Label Extension Study with Inhaled Treprostinil (YUTREPIA™). Presented by Savan Patel, Liquidia Technologies.

Abstract B87 – High Resolution Computed Tomography (HRCT) Chest Scans to Examine the Association Between Regional Drug Deposition of LIQ861 (YUTREPIA™) and Vasodilation in PH-ILD Population. Presented by Benjamin Lavon, MS, Fluidda.

Encore Thematic Poster Sessions

Abstract B85 - A Phase 3, 2-Part, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Liposomal Treprostinil Inhalation Suspension (L606) in Subjects with PAH and PH-ILD. Presented by Michelle Ghofrani, MD, Liquidia Technologies.

Abstract B86 – Safety and Tolerability of LIQ861 (YUTREPIA™) in Pulmonary Arterial Hypertension (PAH): Results from INSPIRE Study. Presented by Savan Patel, Liquidia Technologies.

Abstract B89 – The ASCENT Study: An Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension. Presented by Dawn Fleming, Liquidia Technologies.

Abstract B90 – Risk Assessment in Pulmonary Arterial Hypertension (PAH): Insights from the INSPIRE Study with LIQ861 (YUTREPIA™). Presented by Savan Patel, Liquidia Technologies.

Abstract B93 – Clinical Pharmacokinetics of an Extended-Release Formulation of Inhaled Liposomal Treprostinil (L606) to Reduce Dosing Frequency. Michelle Ghofrani, MD, Liquidia Technologies.

Following the presentations, the posters will be available on the Liquidia’s website at https:/liquidia.com/products-and-pipeline/publications.

About YUTREPIA™ (treprostinil) Inhalation PowderYUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. The FDA previously issued tentative approval of YUTREPIA for the PAH indication in November 2021. In July 2023, Liquidia filed an amendment to its New Drug Application for YUTREPIA, seeking to add PH-ILD to the label. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension, with the objective of informing YUTREPIA’s dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861 in investigational studies.

About L606 (liposomal treprostinil) inhalation suspensionL606 is an investigational, sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer. The L606 suspension uses Pharmosa Biopharm’s proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period and potentially mitigating local and systemic side effects. L606 is currently being evaluated in an open-label study in the United States for the treatment of PAH and PH-ILD with a planned global, pivotal, placebo-controlled efficacy study for the treatment of PH-ILD.

About Liquidia CorporationLiquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology. The company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc.  and Liquidia PAH, LLC. Liquidia Technologies has developed YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease PH-ILD. Liquidia Technologies is also developing L606, an investigational liposomal formulation of treprostinil administered twice-daily with a next-generation nebulizer, for use in North America. Liquidia PAH provides for the commercialization of pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection. For more information, please visit www.liquidia.com.

Tyvaso® is a registered trademark of United Therapeutics Corporation.

Cautionary Statements Regarding Forward-Looking StatementsThis 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 submission contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, the timeline or outcome related to patent litigation in the U.S. District Court for the District of Delaware or inter partes review proceedings conducted at the PTAB or other litigation instituted by United Therapeutics or others, including rehearings or appeals of decisions in any such proceedings, the issuance of patents by the 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 favorable decisions of courts or other tribunals are not determinative of the outcome of the appeals or rehearings of the decisions. 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 our filings with the SEC, 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.

Contact Information

Investors:Jason Adair Chief Business Officer919.328.4350jason.adair@liquidia.com 

Media: Patrick WallaceDirector, Corporate Communications919.328.4383patrick.wallace@liquidia.com