 Received FDA Acceptance of LIQ861 NDA for Review Reported Final Safety and Tolerability Results for LIQ861 INSPIRE Trial Appointed Tushar Shah, M.D. as Chief Medical Officer Announced Definitive Agreement to Acquire RareGen, LLC Completed Public Offering of Common Stock Company to Host Webcast and Conference Call Today at 4:30 p.m. ETRESEARCH TRIANGLE PARK, N.C., Aug. 10, 2020 GLOBE NEWSWIRE -- Liquidia Technologies, Inc. NASDAQ: LQDA, a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT technology, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.The second quarter of 2020 was marked by progress as we continued to execute effectively against key milestones that strengthen our position for the launch of LIQ861 and the future value of our company, said Neal Fowler, Chief Executive Officer of Liquidia. The proposed acquisition of RareGen would be significant as it would provide Liquidia with a relevant sales force and, importantly, would bolster Liquidias ability to advance much needed treatment options for the PAH community. Combined with the closing of a 75 million public offering and the appointment of Tushar Shah, M.D. as Chief Medical Officer, I am confident that we have the resources and talent required to advance our mission as a company.Corporate Update Received FDA acceptance of LIQ861 NDA for regulatory review In April 2020, the U.S. Food and Drug Administration FDA accepted Liquidias New Drug Application NDA for LIQ861, the Companys lead product candidate as a potential treatment for patients with pulmonary arterial hypertension PAH, for review and provided a Prescription Drug User Fee Act PDUFA goal date of November 24, 2020. LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed and engineered using Liquidias novel PRINT technology with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler. Reported final LIQ861 safety and tolerability results from pivotal INSPIRE trial In April 2020, the Company reported final safety and tolerability results from the two-month endpoint of the open-label phase 3 trial, INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, for LIQ861. Of the 121 PAH patients, 113, or 93 percent, completed their two-month visit. The most common reported treatment-emergent adverse events TEAEs reported in four percent were cough 42 percent, headache 26 percent, throat irritation 16 percent, dizziness 11 percent, diarrhea 9 percent, chest discomfort 8 percent, nausea 7 percent, dyspnea 5 percent, flushing 5 percent and oropharyngeal pain 4 percent. These final primary endpoint findings are consistent with the safety and tolerability results previously reported. Appointed Tushar Shah, M.D. as Chief Medical Officer In May 2020, the Company announced the appointment of Tushar Shah, M.D. to the newly created position of Chief Medical Officer. In this role, Dr. Shah will oversee all aspects of research, clinical development, medical affairs and regulatory affairs. Dr. Shah has 27 years of pharmaceutical research and development experience, successfully advancing more than 20 products from early development to commercialization. Announced definitive agreement to acquire RareGen, LLC In June 2020, the Company announced it had entered into a definitive agreement to acquire RareGen, LLC, a portfolio company of PBM Capital, through an all-stock merger. Liquidia and RareGen will consolidate under a new holding company, named Liquidia Corporation, which is expected to trade on the Nasdaq Capital Market under the ticker symbol LQDA, as the successor to Liquidia Technologies following completion of the proposed merger. Completed 75 million public offering of common stock In July 2020, the Company announced the closing of an underwritten public offering of 9,375,000 shares of its common stock at a price of 8.00 per share, for total gross proceeds of 75 million, before deducting underwriting discounts and commissions and other offering expenses. Received complaint from United Therapeutics Corporation under Hatch-Waxman Act In June 2020, United Therapeutics Corporation UTC filed a complaint for patent infringement against the Company in the U.S. District Court for the District of Delaware asserting infringement of U.S. Patent Nos. 9,604,901 the 901 Patent and 9,593,066 the 066 Patent relating to United Therapeutics Tyvaso, a nebulized treprostinil solution for the treatment of PAH. The complaint is in response to the LIQ861 NDA filed with the FDA. The LIQ861 NDA was filed under the 505b2 regulatory pathway with Tyvaso as the reference listed drug. Under the Hatch-Waxman Act, the FDA is automatically precluded from approving the LIQ861 NDA for up to 30 months, absent an earlier judgment unfavorable to UTC by the court with respect to the 901 Patent and 066 Patent. In July 2020, UTC filed an amended complaint in the lawsuit asserting infringement of U.S. Patent No. 10,716,793 the 793 Patent. The infringement allegations of the 793 Patent is separate from the 30-month regulatory stay on final approval of the NDA for LIQ861, which is only associated with the infringement allegations of the 901 Patent and the 066 Patent. On July 30, 2020, Judge Andrews, presiding over the Hatch-Waxman Litigation, conducted a scheduling conference and set a claim construction hearing in May 2021 and set the trial to begin in March 2022. Second Quarter 2020 Financial Results Revenues: No revenue was recorded for the second quarter of 2020, compared with 8.1 million for the second quarter of 2019. Revenue during the second quarter of 2019 was due to the recognition of 8.1 million of deferred revenue from our Inhaled Collaboration and Option Agreement with a subsidiary of GlaxoSmithKline plc, resulting from the third amendment to such agreement that was entered into in June 2019. Cost of Revenue: Cost of revenue was 0 for the second quarter of 2020, compared to 0.8 million for the second quarter of 2019. The decrease of 0.8 million was due to the decrease in revenue. Cost of revenue represents sub-licensing fees paid to The University of North Carolina at Chapel Hill, or UNC, when licensing revenue is recognized from the use of the intellectual property in-licensed from UNC. Research and Development RD: RD expenses were 8.5 million for the second quarter of 2020 compared with 10.7 million for the second quarter of 2019. The decrease of 2.2 million was primarily driven by a decrease in clinical trial related expenses of 2.8 million, partially offset by a 0.5 million increase in consulting fees. General and Administrative GA: GA expenses were 5.2 million for the second quarter of 2020, compared with 2.4 million for the second quarter of 2019. The increase of 2.8 million was primarily due to a 1.5 million increase in legal expenses due to the proposed RareGen acquisition, intellectual property, and litigation related expenses, and other general increases in salaries, consulting fees, audit and tax services and recruiting expenses. Interest Income: Interest income was 12,000 for the second quarter of 2020, compared with 220,000 for the second quarter of 2019, primarily due to lower interest rates in 2020 compared with 2019 and to a lesser extent, a decrease in cash balances held in interest bearing accounts during 2020 compared with 2019. Interest Expense: Interest expense was 211,000 for the second quarter of 2020, compared with 254,000 for the second quarter of 2019, primarily due to lower levels of debt during the second quarter of 2020 compared with the second quarter of 2019. Net Loss: Net loss was 13.9 million for the second quarter of 2020, compared with 5.9 million for the second quarter of 2019. The increase of 8.0 million was primarily due to zero revenue and cost of revenue recognized during the second quarter of 2020 compared with 8.1 million of revenue and 0.8 million cost of revenue during the second quarter of 2019. Additionally, an increase in general and administrative expenses was partially offset by a decrease in research and development expenses during the second quarter of 2020 compared with the second quarter of 2019. Cash Position and Shares Outstanding: As of June 30, 2020, cash and cash equivalents totaled 23.6 million and there were 28.4 million shares outstanding. On July 2, 2020, the Company completed an underwritten public offering of 9.375 million shares at a price of 8.00 per share, resulting in gross proceeds of 75.0 million and net proceeds of approximately 69.8 million after deducting underwriting discounts and commissions and other offering expenses.Webcast and Conference CallThe Company will host a webcast and conference call at 4:30 p.m. ET today to discuss financial results and provide a corporate update. The live call may be accessed by dialing 1-877-707-8711 domestic or 1-857-270-6219 international and entering the conference code: 7295403. A live and archived webcast of the call will also be available on the Events Presentations page of the Liquidia website.About LiquidiaLiquidia is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT technology to transform the lives of patients. 