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Liquidia Liquidia Reports First Quarter 2021 Financial Results and Provides Corporate Update May 13 , 2021 - Doubled the market opportunity for Treprostinil Injection by adding subcutaneous delivery - Resubmitted New Drug Application for LIQ861 ( treprostinil ) Inhalation Powder - Improved financial position with private placement and access to new credit facility Company to host webcast and conference call today at 8:30 a.m. ET - MORRISVILLE , N.C. , May 13 , 2021 ( GLOBE NEWSWIRE ) -- Liquidia Corporation ( NASDAQ : LQDA ) ( " Liquidia " or the " Company " ) today reported financial results for the quarter ended March 31 , 2021. The Company will host a webcast and conference call at 8:30 a.m. ET to discuss the first quarter financial results and provide a corporate update . Damian deGoa , Liquidia's Chief Executive Officer , said : “ This first quarter has been an important time of transition and re - structuring for the company as it strengthens its position and commitment to the products and patients that we support . We believe that our renewed focus and financial discipline are essential in order for the company to achieve its objectives in 2021 and beyond . " Corporate Update Enabled subcutaneous delivery of generic Treprostinil Injection , providing lower cost option to all patients on branded Remodulin . On March 26 , 2021 , the U.S. Food and Drug Administration ( " FDA " ) cleared the 510 ( k ) application submitted by Liquidia PAH's manufacturing partner , Chengdu Shifeng Medical Technologies LTD ( " Chengdu " ) for the RG 3ml Medication Cartridge which is indicated for use with the CADD - MS 3 pump . It is anticipated that Chengdu will start selling the RG 3ml Medication Cartridge in May , enabling the subcutaneous delivery of Treprostinil Injection for the first time . Until now , Treprostinil Injection could only be delivered by intravenous administration . The availability of the new cartridge will more than double the addressable market for Treprostinil Injection , which has been provided to patients with the same level of high - touch support and services as the branded product but at a lower cost since 2019 . Resubmitted NDA for LIQ861 ( treprostinil ) Inhalation Powder for the treatment of Pulmonary Arterial Hypertension ( PAH ) . On May 7 , 2021 , the Company resubmitted its New Drug Application ( " NDA " ) for LIQ861 in response to the Complete Response Letter ( " CRL " ) received in November 2020. The resubmitted NDA was informed by discussion with FDA during a Type A meeting in January 2021 and included additional information and clarification on chemistry , manufacturing and controls 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 . The Company anticipates that the FDA will classify the resubmitted NDA , if accepted , as a Class 2 Resubmission , which would result in a six - month review cycle from the date of resubmission . 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 " ) . In January 2021 , the Company submitted a petition for IPR of U.S. Patent 10,716,793 ( the " 793 patent " ) , which was added in July 2020 to the Hatch - Waxman complaint filed by United Therapeutics . A decision by the PTAB whether to institute an IPR related to the ' 793 patent is expected in the third quarter of 2021 and , if instituted , a decision would be expected approximately 12 months from the date on which the IPR is instituted . A favorable decision invalidating this patent may also be considered by the court in the concurrent Hatch - Waxman litigation . Unless the Hatch - Waxman litigation is resolved earlier , the statutory 30 - month regulatory stay as a result of the Hatch - Waxman litigation will expire in October 2022 . Strengthened financial position by reducing annual net spending and increasing available cash resources . During the course of this year , the Company has taken several actions to improve the balance sheet as it progresses towards potential value - creating events in 2021 and 2022 . Management implemented measures that reduced net annual spending in 2021 by more than 40 % compared to 2020 , which included , among other measures , reducing internal staff and consulting spending , refinancing equipment leases , and terminating development of LIQ865 to treat post - operative pain . The Company also refinanced its former credit facility with a new facility through Silicon Valley Bank that provides interest - only payments for 24 months , eliminating more than $ 10 million in required principal repayments over the next two years , while also providing access to an additional $ 10 million upon the achievement of key milestones paralleling FDA review of LIQ861 . Lastly , the Company raised $ 21.7 million in April 2021 by entering a common stock purchase agreement with certain institutional investors led by Caligan Partners LP . At closing , David Johnson , a Partner and Co - Founder of Caligan Partners LP , was appointed to the board of directors of Liquidia Corporation as a Class II Director and a member of the Audit Committee . First Quarter 2021 Financial Results Cash totaled $ 53.6 million and $ 65.3 million as of March 31 , 2021 and December 30 , 2020 , respectively . This cash total does not include proceeds from the private placement of common stock in April 2021 . Revenue of $ 3.1 million was recognized for the three months ended March 31 , 2021 as compared to no revenue for the three months ended March 31 , 2020. Revenue recognized during 2021 related 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 March 30 , 2021 , compared to no cost of revenue for the three months ended March 31 , 2020. Cost of revenue recognized during 2021 related to the promotion agreement as noted above . Research and development expenses were $ 6.1 million for the three months ended March 31 , 2021 compared with $ 10.8 million for the three months ended March 31 , 2020 , a decrease of $ 4.7 million or 44.1 % . The decrease primarily related to lower expenses from our LIQ861 clinical program , which was substantially completed prior to filing the NDA in April 2020 , lower expenses from our LIQ865 clinical program , and lower employee and consulting expenses .