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Liquidia Technologies Reports Third Quarter 2018 Financial Results and Provides Corporate Update
· Completed enrollment of the safety portion of our Ph3 LIQ861 (INSPIRE) clinical trial
· Two-week safety Ph3 LIQ861 data readout anticipated in the first quarter of 2019
· Dr. Stephen Bloch appointed as Chairman of the Board
· Management to host webcast and conference call today at 8 a.m. ET
RESEARCH TRIANGLE PARK, NC October 31, 2018 Liquidia Technologies, Inc. (Nasdaq:LQDA) (Liquidia), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients, today reports its financial results for the quarter ended September 30, 2018 and provides a corporate update.
We have made significant progress in the second half of 2018 with the closing of our IPO in July and the recent completion of enrollment for the safety portion of our pivotal Phase 3 clinical trial, INSPIRE, evaluating LIQ861 for the treatment of pulmonary arterial hypertension. Based on feedback from the U.S. FDA, we believe that this trial will support the NDA filing for LIQ861, which we are targeting to submit in late 2019, stated Neal Fowler, Chief Executive Officer of Liquidia. We are keenly focused on execution and we believe we are well-positioned to meet important milestones, including the anticipated readout of the two-week safety data for LIQ861 in the first quarter of 2019.
With todays news, we also announced the appointment of Dr. Bloch as Chairman of the Board. Dr. Bloch has been on the board of Liquidia since 2009 and as such, is well-prepared to guide the company through its next stage of growth, added Neal Fowler. Dr. Seth Rudnicks contributions over the last 10 years have been instrumental to the evolution of Liquidia and I am pleased that he will continue to serve as a valued member of Liquidias board. I want to thank them both for their support and guidance over the last several years.
· Completed enrollment of the safety portion of our single, open-label Phase 3 clinical trial (INSPIRE) evaluating LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of pulmonary arterial hypertension (PAH). As of October 24, 2018, 109 patients have enrolled in our INSPIRE trial and Liquidia has completed enrollment for the safety portion of the trial. We are currently focusing our efforts on completing patient enrollment in our one-directional crossover sub-study to compare bioavailability and pharmacokinetics (PK) of treprostinil as the patients transition from Tyvaso® to LIQ861. The primary objective of the INSPIRE study is to evaluate the long-term safety and tolerability of LIQ861. Of the total enrolled patient population, as of October 24, 2018, 104 patients have received at least two weeks of LIQ861. We expect to report two-week safety data in the first quarter of 2019 followed by PK results anticipated in the second quarter of 2019. We are targeting a new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) in late 2019.
The following information was filed by Liquidia Technologies Inc (LQDA) on Wednesday, October 31, 2018 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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