Liquidia Corporation announced the receipt of $50 million from Healthcare Royalty (HCRx) following two significant milestones: the U.S. District Court for the Middle District of North Carolina denying United Therapeutics Corporation's request for a preliminary injunction and temporary restraining order, and the first commercial sale of YUTREPIA (treprostinil) inhalation powder.
The funding represents the sixth amendment to Liquidia's financing agreement with HCRx and brings the total received funding to $175 million of the $200 million potential total. An additional $25 million remains available upon mutual agreement if Liquidia achieves aggregate net sales of YUTREPIA exceeding $100 million by June 30, 2026.
Commercial Launch and Financial Structure
Michael Kaseta, Liquidia's Chief Financial Officer and Chief Operating Officer, emphasized the strategic importance of the funding: "We are grateful for the continued partnership with HCRx and pleased with the early stages of YUTREPIA's launch. The proceeds from HCRx will further accelerate our launch execution, advance our clinical pipeline, and support the expansion of future manufacturing operations, including the build-out of our newly leased manufacturing facility."
The $50 million funding is subject to a fixed payment schedule through 2033, with aggregate payments to HCRx capped at 175% of total amounts funded. A true-up payment may be required if HCRx's internal rate of return falls below the minimum threshold of 13% for this funding tranche.
Clarke Futch, Chairman and Chief Executive Officer of HCRx, stated: "Today's news reflects an important milestone in Liquidia's commercial execution of YUTREPIA and further strengthens our confidence in the company's long-term vision. We are pleased to support Liquidia as it further advances the commercial launch of YUTREPIA and prepares to expand future manufacturing capabilities to meet growing market demand in the years ahead."
YUTREPIA's Clinical Profile and Market Position
YUTREPIA is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. The drug was developed using Liquidia's proprietary PRINT technology, which enables precise and uniform drug particles engineered for enhanced lung deposition following oral inhalation.
The therapy is indicated for treating pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Clinical effectiveness was established through studies that predominantly included patients with NYHA Functional Class III symptoms, with PAH etiologies including idiopathic or heritable PAH (56%) and PAH associated with connective tissue diseases (33%).
For PH-ILD patients, the pivotal study included patients with idiopathic interstitial pneumonia (45%) inclusive of idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema (25%), and WHO Group 3 connective tissue disease (22%).
Addressing Significant Unmet Medical Need
PAH affects an estimated 45,000 diagnosed and treated patients in the United States. The rare, chronic, progressive disease is caused by narrowing, thickening, or stiffening of pulmonary arteries that can lead to right heart failure and death. Currently, no cure exists for PAH, making symptom alleviation, functional class maintenance, and disease progression delay the primary treatment goals.
PH-ILD represents an even larger patient population, with current estimates exceeding 60,000 patients in the United States. This condition encompasses up to 200 different pulmonary diseases, and any level of PH in ILD patients is associated with poor 3-year survival. The population size in many underlying ILD diseases remains uncertain due to underdiagnosis and lack of approved treatments until March 2021, when inhaled treprostinil received its first approval for this indication.
Clinical Development and Safety Profile
Liquidia completed the INSPIRE trial (NCT03399604), an open-label, multi-center phase 3 clinical study of YUTREPIA in PAH patients naïve to inhaled treprostinil or transitioning from Tyvaso (nebulized treprostinil). The company is currently conducting the ASCENT trial (NCT06129240) to evaluate safety and tolerability in PH-ILD patients and inform dosing and tolerability profiles.
The most common adverse reactions with YUTREPIA (≥10%) include cough, headache, throat irritation, and dizziness. As a pulmonary and systemic vasodilator, treprostinil may produce symptomatic hypotension in patients with low systemic arterial pressure and inhibits platelet aggregation, increasing bleeding risk.
Strategic Positioning and Future Outlook
Liquidia's strong financial position following this funding milestone reinforces management's confidence in achieving profitability without additional capital requirements. The company is developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for PAH treatment.
Healthcare Royalty, with over $5 billion invested in more than 90 biopharmaceutical products since inception, continues to demonstrate confidence in Liquidia's commercial execution and long-term vision for addressing rare cardiopulmonary diseases.
