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Phathom PHARMACEUTICALS TM Phathom Pharmaceuticals Reports Third Quarter 2021 Results and Provides Key Clinical , Regulatory , and Business Updates November 8 , 2021 • Two New Drug Applications ( NDAs ) for vonoprazan - based treatment regimens for H. pylori infection were accepted for filing by FDA with six - month Priority Review granted ; PDUFA target action date of May 3 , 2022 • U.S. launch for both vonoprazan - based treatment regimens for H. pylori anticipated in the second half of 2022 , if approved • Positive Phase 3 trial results for vonoprazan in erosive esophagitis ( EE ) reported in October 2021 ; NDA submission targeted for the first quarter of 2022 FLORHAM PARK , N.J. , Nov. 08 , 2021 ( GLOBE NEWSWIRE ) -- Phathom Pharmaceuticals , Inc. ( Nasdaq : PHAT ) , a late clinical - stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases , today reported financial results for the third quarter of 2021 and provided updates regarding recent clinical , regulatory , and business progress . " Phathom continued its strong execution through the third quarter of 2021 , delivering impressive topline results from our pivotal Phase 3 PHALCON - EE study . The PHALCON - EE data adds to our excitement about vonoprazan's potential to satisfy large unmet patient needs in the U.S. and European erosive esophagitis market , " said Terrie Curran , Phathom's President and Chief Executive Officer . " With the recent acceptance of both NDAs for vonoprazan - based treatments in H. pylori , and the planned submission of an NDA for vonoprazan in EE in the first quarter of 2022 , we are enthusiastic about vonoprazan's potential to offer a novel treatment option to address the significant unmet needs that exist for so many patients across these prevalent acid - related disorders . " Clinical and Regulatory Updates : • The U.S. Food and Drug Administration ( FDA ) accepted NDAs for two convenience packs containing vonoprazan - based treatment regimens for adults with H. pylori infection : vonoprazan in combination with amoxicillin and clarithromycin ( " vonoprazan triple therapy " ) and vonoprazan in combination with amoxicillin ( " vonoprazan dual therapy " ) . The NDAs were granted Priority Review designation with a Prescription Drug User Fee Act ( PDUFA ) target action date of May 3 , 2022 . Phathom submitted the NDAs to the FDA on September 3 , 2021. The FDA previously designated vonoprazan dual and triple therapy as qualified infectious disease products ( QIDPs ) which , if approved , will provide vonoprazan five additional years of regulatory exclusivity . • If approved , the U.S. commercial launch for vonoprazan dual and triple therapy is anticipated in the second half of 2022 . • Vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON - EE , a pivotal Phase 3 trial evaluating vonoprazan for the healing and maintenance of healing of erosive esophagitis . Based on these results , Phathom expects to submit an NDA in the first quarter of 2022 seeking the following indications for vonoprazan : healing of all grades of EE and relief of heartburn , and maintenance of healing of all grades of EE and relief of heartburn . • Topline results from the Phase 2 PHALCON - NERD on - demand trial evaluating various doses of vonoprazan as an on - demand therapy for patients with non - erosive reflux disease are expected in the first quarter of 2022 . Recent Business and Financial Updates : • On September 17 , 2021 , Phathom secured an up to $ 200 million term loan facility from Hercules Capital ( Loan Agreement ) . One - hundred million dollars were drawn at closing and an additional $ 50 million became available upon the receipt of positive topline results in PHALCON - EE . The final $ 50 million tranche will become available upon the occurrence of both FDA approval of a vonoprazan - based regimen for the treatment of H. pylori , and FDA acceptance of filing of an NDA for vonoprazan for the treatment of erosive esophagitis . Third Quarter 2021 Financial Results : • Third quarter 2021 net loss was $ 36.7 million compared to $ 34.1 million for the third quarter of 2020 . • Third quarter 2021 net loss included a non - cash charge related to stock - based compensation of $ 4.4 million compared to the third quarter of 2020 non - cash charge related to stock - based compensation of $ 2.1 million . • Third quarter 2021 research and development expenses decreased to $ 16.6 million compared to $ 25.8 million for the third