Core Insights - Liquidia Corporation is hosting its first Research & Development Day on October 28, 2025, in New York City, focusing on innovative therapies for rare cardiopulmonary diseases [1][3] Group 1: Event Details - The R&D Day will feature presentations from Liquidia's management and key opinion leaders in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2] - The agenda will include updates on L606, an investigational sustained-release formulation, and the flagship product YUTREPIA™ [2][3] - The event is intended for institutional investors and sell-side analysts, with options for in-person attendance and live webcasting [3][4] Group 2: Product Information - L606 is a twice-daily administered investigational formulation of treprostinil, utilizing a proprietary liposomal formulation for controlled drug release [5] - YUTREPIA is an inhaled dry-powder formulation of treprostinil designed for improved exercise ability in patients with PAH and PH-ILD, developed using Liquidia's PRINT® technology [6][7] - Liquidia is also marketing Treprostinil Injection, a fully substitutable generic of Remodulin for PAH treatment [7]

Core Viewpoint - Liquidia Corporation reported strong early commercial performance and clinical evidence for its newly approved product YUTREPIA, indicating significant market demand and potential for growth in treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2][3][5] Company Highlights - The FDA approved YUTREPIA on May 23, 2025, and it was commercially launched in June 2025, with over 900 unique patient prescriptions and more than 550 patient starts recorded within 11 weeks post-launch [6][7] - The initial demand for YUTREPIA has exceeded expectations, with 75% of prescriptions converting to treatment starts in the first six weeks [7] - Liquidia has signed a lease for approximately 70,000 square feet of additional manufacturing space, targeted for occupancy in 2026, to support continued growth [7] - The company received $50 million under its financing agreement with Healthcare Royalty following the first commercial sale of YUTREPIA [7] Clinical Evidence - The ongoing ASCENT study has shown positive interim data, with median improvements in six-minute walk distance of 21.5 meters at Week 8 and 31.5 meters at Week 16, reinforcing YUTREPIA's tolerability and efficacy profile [4][8] - The study fully enrolled 54 patients, with no discontinuations due to drug-related adverse events, indicating a favorable safety profile [4][8] Financial Performance - As of June 30, 2025, Liquidia reported cash and cash equivalents of $173.4 million, a slight decrease from $176.5 million at the end of 2024 [9][27] - Product revenue for the second quarter of 2025 was $6.5 million, marking the first revenue recognition following YUTREPIA's approval [9][28] - Service revenue decreased to $2.3 million from $3.7 million in the same period last year, primarily due to unfavorable gross-to-net returns [10][28] - Research and development expenses decreased by 36% to $6.0 million, reflecting a shift towards commercialization activities [12][28] - Selling, general and administrative expenses increased by 95% to $38.8 million, driven by higher personnel costs and legal fees related to ongoing litigation [13][28] - The net loss for the second quarter was $41.6 million, or $0.49 per share, compared to a net loss of $28.7 million, or $0.38 per share, in the prior year [14][28]

Core Viewpoint - Liquidia Corporation is focused on the potential commercialization of YUTREPIA, an inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), with an FDA decision expected by May 24, 2025 [2][3][8]. Corporate Updates - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA, setting a PDUFA goal date of May 24, 2025, coinciding with the expiration of regulatory exclusivity for Tyvaso DPI [3][8]. - A U.S. District Court dismissed a cross-claim from United Therapeutics challenging the NDA amendment for YUTREPIA, allowing Liquidia to proceed without legal hindrance [4][8]. - Liquidia completed enrollment of Cohort A in the ASCENT study, with over 50 patients, showing promising results in dosing and tolerability [5][8]. Financial Position - Liquidia entered into a sixth amendment with HealthCare Royalty, allowing for up to an additional $100 million in financing to support the development of YUTREPIA and other clinical trials [6][8]. - As of March 31, 2025, cash and cash equivalents were $169.8 million, a decrease from $176.5 million at the end of 2024 [7][8]. - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily from a promotion agreement with Sandoz [9][8]. Expenses and Losses - Research and development expenses decreased by 31% to $7.0 million in Q1 2025, down from $10.1 million in Q1 2024, due to a shift in focus towards commercialization [11][8]. - General and administrative expenses rose by 48% to $30.1 million in Q1 2025, attributed to increased personnel costs and legal fees [12][8]. - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [14][8].