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Liquidia Technologies Reports First Quarter 2019
Financial Results and Provides Corporate Update
Recent Phase 3 Data Highlight Clinical Relevance of LIQ861 in Treating Pulmonary Arterial Hypertension
On Track for Planned New Drug Application (NDA) Submission for LIQ861 in Late 2019
Continued Pipeline Progress Leveraging Proprietary Print® Technology
Management to Host Webcast and Conference Call Today at 8:00 a.m. ET
RESEARCH TRIANGLE PARK, NC May 2, 2019 Liquidia Technologies, Inc. (Nasdaq: LQDA) (Liquidia), a late-stage clinical biopharmaceutical company, today reported its financial results for the quarter ended March 31, 2019 and provided a corporate update.
Liquidia has started the year strong, delivering on our clinical timelines and driving towards an NDA submission for LIQ861, our lead program to treat patients with pulmonary arterial hypertension (PAH), stated Neal Fowler, Chief Executive Officer of Liquidia. We met the primary endpoint of safety and tolerability in our pivotal Phase 3 clinical trial (INSPIRE). We have also started to present data on the patient benefits from LIQ861 as demonstrated by favorable functional and patient-reported outcomes measured in exploratory endpoints.
Based on this data and our interactions with clinicians and patients, we believe LIQ861 is safe, well-tolerated and has utility as a first-line prostacyclin in PAH. If approved, LIQ861 will be the first-to-market inhaled dry powder treprostinil that can be delivered using a convenient, palm-sized device, with the potential to maximize the therapeutic benefits of treprostinil by safely delivering higher doses into the lungs, concluded Mr. Fowler.
Recent Corporate Highlights
· Met the primary endpoint of the INSPIRE study by demonstrating safety and tolerability of 861 at the two-month timepoint. LIQ861 was observed to be well-tolerated in 109 patients, 60% of whom were naïve to prostacyclin therapy (Add-Ons) and 40% of whom transitioned from Tyvaso. Both patient groups remained on therapy with 93% of patients completing at least two months of treatment, thereby meeting the studys primary endpoint. LIQ861 was evaluated at doses exceeding 150 mcg capsule strength with no study-drug related serious adverse events. Most treatment-related adverse events were mild to moderate, consistent with prostacyclin therapy, and observed in the first two weeks of treatment. Liquidia anticipates submitting the NDA for LIQ861 to the U.S. Food and Drug Administration (FDA) in late 2019.
· Presented data on LIQ861 from the INSPIRE trial highlighting safety and tolerability along with preliminary data on functional and patient outcomes. The presentation at the 39th International Society for Heart & Lung Transplantation (ISHLT) Meeting in April 2019 provided detailed results by patient group on the adverse event profile, duration of treatment and two of the exploratory endpoints. Specifically, at the two-month timepoint, the functional measure of median six-minute walk distance was maintained or improved in both the Add-On and Tyvaso transition groups. Additionally, patients in both groups reported physical and emotional improvements in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire.
· Initiated Phase 2-enabling toxicology studies for LIQ865 in the first quarter of 2019. Our second product candidate, LIQ865, is an injectable, non-opioid, sustained-release formulation of bupivacaine for the management of local post-operative pain.
The following information was filed by Liquidia Technologies Inc (LQDA) on Thursday, May 2, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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