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Liquidia Liquidia Reports Second Quarter 2021 Financial Results and Provides Corporate Update August 10 , 2021 • Launched subcutaneous delivery of Treprostinil Injection , doubling market opportunity • Resubmitted New Drug Application ( NDA ) for LIQ861 ( treprostinil ) inhalation powder • Improved balance sheet with private placement and increased financial discipline • Company to host webcast and conference call today at 8:30 a.m. ET MORRISVILLE , N.C. , Aug. 10 , 2021 ( GLOBE NEWSWIRE ) -- Liquidia Corporation ( NASDAQ : LQDA ) ( " Liquidia " or the " Company " ) today reported financial results for the quarter ended June 30 , 2021. The Company will host a webcast and conference call at 8:30 a.m. Eastern Daylight Time to discuss the second quarter financial results and provide a corporate update . Damian deGoa , Liquidia's Chief Executive Officer , said : " We continue to execute on our corporate priorities and strengthen the company's position . We are excited to have overcome the restrictions that were placed on the CADD - MS 3 cartridges so that we can offer generic Treprostinil Injection to all PAH patients on Remodulin and to offer meaningful savings to the healthcare system . We are in the early stages of the launch of the RG 3ml Medication Cartridge but are encouraged by the increased interest in Treprostinil Injection now that it is available through both intravenous and subcutaneous administration . " Corporate Update Launched subcutaneous delivery of generic Treprostinil Injection , providing access to all pulmonary arterial hypertension ( PAH ) patients . On May 21 , 2021 , Liquidia PAH's manufacturing partner began selling the RG 3ml Medication Cartridge for use with the CADD - MS 3 pump to administer subcutaneous treprostinil injection . Since its commercial launch two years ago , Treprostinil Injection has only been used through intravenous administration . The cartridges required to operate the CADD - MS 3 pump were not available to patients using generic Treprostinil Injection due to restrictions imposed by other companies . The introduction of the RG 3ml Medication Cartridge will more than double the addressable market for Treprostinil Injection . Resubmitted and confirmed FDA acceptance for review of NDA for LIQ861 for the treatment of PAH . On June 2 , 2021 , the FDA accepted for review the New Drug Application ( NDA ) resubmission for LIQ861 ( treprostinil ) inhalation powder . The resubmitted NDA included additional information and clarification on chemistry , manufacturing , and controls ( CMC ) pertaining to the drug product as well as data on device biocompatibility . No additional data from clinical trials or studies related to toxicology or clinical pharmacology was required . In accepting the NDA for review , the FDA confirmed that the resubmission was a complete , class 2 response to the previous action letter issued in November 2020 and set a PDUFA goal date of November 7 , 2021. The FDA's pre - approval inspection of the Company's Morrisville , NC facility is on - going . If the FDA determines , following its substantive review of the NDA , that all requirements for approval have been met , the FDA may issue tentative approval on a timeline generally informed by the PDUFA goal date . The FDA may then issue a final approval after the expiration of the 30 - month regulatory stay in October 2022 or an earlier judgment by the court that is unfavorable to United Therapeutics who initiated related Hatch - Waxman litigation . Continued to defend right to advance innovation for PAH patients . In support of LIQ861 , the Company is actively involved in Hatch - Waxman litigation brought by United Therapeutics Corporation ( United Therapeutics ) , as well as pursuing inter partes review ( IPR ) of certain related patents at the U.S. Patent Trial and Appeal Board ( PTAB ) of the United States Patent and Trademark Office ( USPTO ) . On May 24 , Judge Andrews , presiding over the Hatch - Waxman Litigation , conducted a claim construction hearing . The Court subsequently issued an order that two of the terms under consideration would be given their plain and ordinary meaning and ruling in Liquidia's favor regarding a third term . Two of the terms that were under consideration at the claim construction hearing remain under consideration by the Court . The trial date has been set for March 28-30 , 2022 . In related IPR proceedings , the PTAB held a hearing on June 23 , 2021 , with respect to U.S. Patent No. 9,604,901 ( ‘ 901 patent ) . A final written decision determining the validity of the challenged claims of the ' 901 patent is expected in October 2021 , approximately 12 months from institution of the IPR . The PTAB also considering the petition submitted by Liquidia in January of this year for IPR of U.S. Patent No. 10,716,793 ( the ' 793 patent ) . The PTAB's decision on whether to institute the IPR for the ' 793 patent is expected in August 2021 , and if instituted , would conclude with a final written decision within 12 months from institution . Maintained financial discipline from reduced annual net spending and increased available cash resources . The Company's balance sheet has benefited from several actions taken during the first half of 2021 , including a decrease in net annual spending by reducing internal staff and consultants , refinancing equipment leases , and refinancing the credit facility . In addition , the Company raised $ 21.7 million in April 2021 by entering a common stock purchase agreement with certain institutional investors , after which David Johnson , a Partner and Co - Founder of Caligan Partners LP , was appointed to the board of directors of Liquidia Corporation . Second Quarter 2021 Financial Results Cash totaled $ 67.9 million and $ 65.3 million as of June 30 , 2021 , and December 30 , 2020 , respectively . Revenue of $ 3.4 million was recognized for the three months ended June 30 , 2021 , as compared to no revenue for the three months ended June 30 , 2020. Revenue recognized during 2021 related primarily to the promotion agreement with Sandoz Inc. , after the acquisition of Liquidia PAH in November 2020 . Cost of revenue was $ 0.7 million for the three months ended June 30 , 2021 , compared to no cost of revenue for the three months ended June 30 , 2020. Cost of revenue recognized during 2021 related to the promotion agreement as noted above . Research and development expenses were $ 4.6 million for the three months ended June 30 , 2021 , compared with $ 8.5 million for the three months