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Phathom . PHARMACEUTICALS TM Phathom Pharmaceuticals Reports Second Quarter 2021 Results and Provides Update Regarding Key Clinical and Regulatory Milestones August 10 , 2021 • Pivotal Phase 3 PHALCON - EE trial topline data for vonoprazan in erosive esophagitis expected in October 2021 • Phase 2 PHALCON - NERD on - demand trial for vonoprazan in non - erosive reflux disease enrolling ahead of schedule with topline data now expected in the first quarter of 2022 FLORHAM PARK , N.J. , Aug. 10 , 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 second quarter of 2021 and provided an update on expected clinical and regulatory milestones . " Our execution against key priorities through the second quarter has advanced several critical catalysts which we expect will lay the foundation for Phathom's long - term success , " said Terrie Curran , Phathom's President and Chief Executive Officer . " We continue to progress our GERD development programs , which have the potential to address the unmet needs in a population of approximately 65 million people in the U.S. We are expecting topline data from our pivotal Phase 3 PHALCON - EE trial evaluating vonoprazan for erosive esophagitis ( EE ) in October 2021 and are now expecting topline data from our Phase 2 PHALCON - NERD trial evaluating vonoprazan as an on - demand treatment for non - erosive reflux disease ( NERD ) in Q1 2022. Additionally , we are nearing the submission of new drug applications ( NDAs ) to the FDA for both the dual and triple vonoprazan - based regimens for the treatment of H. pylori infection , now expected in September 2021. The anticipated progress over the next several months will be key to advancing our mission of changing the landscape in gastrointestinal diseases . " Clinical Development and Regulatory Timing Updates : • Phathom has accelerated its work on the NDAs for dual and triple vonoprazan - based regimens for the treatment of H. pylori infection and now expects to submit both NDAs in September 2021 instead of in the fourth quarter of 2021 . • Topline results from PHALCON - EE , a pivotal Phase 3 trial evaluating vonoprazan for the healing and maintenance of erosive esophagitis , are expected in October 2021 . • Topline results from the PHALCON - NERD on - demand Phase 2 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 . Second Quarter 2021 Financial Results : • Second quarter 2021 net loss was $ 36.6 million compared to $ 21.1 million for the second quarter of 2020 . • Second quarter 2021 net loss included a non - cash charge related to stock - based compensation of $ 4.2 million compared to the second quarter of 2020 non - cash charge related to stock - based compensation of $ 0.8 million . • Second quarter 2021 research and development expenses increased to $ 21.6 million compared to $ 14.9 million for the second quarter 2020 as a result of higher clinical trial costs , higher chemistry , manufacturing , and controls ( CMC ) costs , and higher personnel - related expenses . • Second quarter 2021 general and administrative expenses increased to $ 13.7 million compared to $ 5.2 million for the second quarter of 2020 due to the ongoing buildout of administrative and commercial functions . • As of June 30 , 2021 , cash and cash equivalents were $ 209.7 million . Cash and cash equivalents are expected to be sufficient to meet anticipated cash requirements into the fourth quarter of 2022 . About Vonoprazan Vonoprazan is an investigational , oral small molecule potassium - competitive acid blocker ( P - CAB ) . P - CABS are a novel class of medicines that block acid secretion in the stomach . Vonoprazan has shown the potential to have rapid , potent , and durable anti - secretory effects as a single agent in the treatment of gastroesophageal reflux disease ( GERD ) and in combination with antibiotics for the treatment of Helicobacter pylori ( H. pylori ) infection . The FDA has designated vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone as qualified infectious disease products ( QIDP ) and awarded them Fast Track status for the treatment of H. pylori infection . Phathom in - licensed the U.S. , European , and Canadian rights to vonoprazan from Takeda , which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America . About Phathom Pharmaceuticals , Inc. Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders . Phathom has in - licensed the exclusive rights in the United States , Europe , and Canada to vonoprazan , a novel potassium competitive acid blocker ( P - CAB ) in late - stage development for the treatment of acid - related disorders . For more information about Phathom , visit the Company's website at www.phathompharma.com or follow the Company on social media : LinkedIn at www.linkedin.com/company phathompharma and Twitter @PhathomPharma .