MORRISVILLE, N.C., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ:LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today reported financial results for the second quarter ended June 30, 2024. The company will host a webcast at 8:30 a.m. ET on August 7, 2024 to discuss the financial results and provide a corporate update. Dr. Roger Jeffs, Liquidia's Chief Executive Officer, said: "We continue to face no legal impediments for the FDA approval of YUTREPIA for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), and our commercial team stands ready to launch YUTREPIA contingent on the FDA's final approval. If approved, we firmly believe that the ease of administration and broad dosage spectrum of YUTREPIA will drive the treatment to become the preferred prostacyclin therapy of choice." Corporate Updates Progressed litigation, maintaining a clear legal path to full approval of YUTREPIAOn May 31, Judge Andrews of the U.S. District Court for the District of Delaware denied the motion for preliminary injunction filed by United Therapeutics (UTHR) in its lawsuit alleging that YUTREPIA infringes U.S. Patent No. 11,826,327 (‘327 patent). In addition, on March 29, the U.S. District Court for the District of Columbia has denied motions for a temporary restraining order and preliminary injunction requested by UTHR in its suit against the U.S. Food and Drug Administration (FDA). On May 7, both Liquidia and FDA filed motions to dismiss UTHR's complaint. While both lawsuits are continuing forward, these rulings reinforce the clear legal path for FDA to issue a final decision on the amended New Drug Application (NDA) for YUTREPIA for the treatment of both PAH and PH-ILD. Progressed clinical studies in YUTREPIA and presented new posters at the World Symposia on Pulmonary Hypertension During the World Symposia on Pulmonary Hypertension in Barcelona this summer, Liquidia presented two live thematic poster sessions and five encore presentations covering the company's investigational products, YUTREPIA™ (treprostinil) inhalation powder and L606 (liposomal treprostinil) inhalation suspension. The two new posters entitled: "Exploratory Efficacy Analysis of INSPIRE Open Label Extension Study with Inhaled Treprostinil (YUTREPIA™)" and "High Resolution Computed Tomography (HRCT) Chest Scans to Examine the Association Between Regional Drug Deposition of LIQ861 (YUTREPIA™) and Vasodilation in PH-ILD Population," along with the five encore presentations, can be found on the Publications section of Liquidia's website. Progressed L606 in clinic and presented summary of safety and dosing poster at the American Thoracic Society 2024 International Conference (ATS)In May at the ATS Conference in San Diego, Liquidia presented data related to the investigational use of L606 (liposomal treprostinil) inhalation suspension in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH or PH-ILD in the short-term and long-term. The trial is enrolling patients in two groups, a transition group and a naïve group. The transition group is comprised of participants with PAH or PH-ILD who transitioned from nebulized Tyvaso or Tyvaso DPI to L606. The naïve group is comprised of participants with PAH who have not previously received treprostinil therapy and added L606 to no more than two non-prostacyclin oral therapies. Second Quarter 2024 Financial Results Cash and cash equivalents totaled $133.1 million as of June 30, 2024, compared to $83.7 million as of December 31, 2023. Revenue was $3.7 million for the three months ended June 30, 2024, compared to $4.8 million for the three months ended June 30, 2023. Revenue related primarily to our promotion agreement with Sandoz pursuant to which we share profits from the sale of Treprostinil Injection in the United States (the Promotion Agreement). The decrease of $1.1 million was primarily due to the impact of lower sales quantities in the current year as compared to the same period in the prior year. Cost of revenue was $1.5 million for the three months ended June 30, 2024, compared to $0.7 million for the three months ended June 30, 2023. Cost of revenue related to the Promotion Agreement as noted above. The increase from the prior year was primarily due to our sales force expansion during the fourth quarter of 2023. Research and development expenses were $9.4 million for the three months ended June 30, 2024, compared to $17.7 million for the three months ended June 30, 2023. The decrease of $8.3 million or 47% was primarily due to a $10 million upfront license fee due to Pharmosa for the exclusive license in North America to develop and commercialize L606 recorded during the three months ended June 30, 2023. Additionally, there was a $1.4 million decrease in expenses related to our YUTREPIA program driven by expensing prelaunch inventory costs in the prior year. These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $1.5 million increase in personnel expenses (including stock-based compensation) related to increased headcount. General and administrative expenses were $20.0 million for the three months ended June 30, 2024, compared to $9.2 million for the three months ended June 30, 2023. The increase of $10.8 million or 116% was primarily due to a $6.3 million increase in personnel expenses (including stock-based compensation) driven by higher headcount and expansion of our sales force in the fourth quarter of 2023, a $2.2 million increase in commercial and consulting expenses in preparation for the potential commercialization of YUTREPIA, and a $0.9 million increase in legal fees related to our ongoing YUTREPIA-related litigation. Total other expenses, net was $0.7 million for both the three months ended June 30, 2024 and 2023. There was a $1.2 million increase in interest expenses attributable to the higher borrowings under the company's Revenue Interest Financing Agreement (RIFA) with HealthCare Royalty Partners (HCRx) as compared to the prior year, and a $1.1 million increase in interest income attributable to higher money market balances. Net loss for the three months ended June 30, 2024, was $27.9 million or $0.37 per basic and diluted share, compared to a net loss of $23.5 million, or $0.36 per basic and diluted share, for the three-month ended June 30, 2023. 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 ...