Earnings release
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gossamerbio Gossamer Bio Announces Second Quarter 2021 Financial Results and Provides Corporate Update August 9 , 2021 - Seralutinib and GB004 continue to enroll ongoing Phase 2 TORREY and SHIFT - UC clinical trials for Pulmonary Arterial Hypertension ( PAH ) and Ulcerative Colitis ( UC ) , respectively- - Gossamer Announces Seralutinib Open Label Extension Data in PAH Patients - - Gossamer to Discontinue Clinical Development of GB1275 - - Cash , cash equivalents and marketable securities totaled $ 406 million as of June 30 , 2021 - SAN DIEGO -- ( BUSINESS WIRE ) -- Aug . 9 , 2021-- Gossamer Bio , Inc. ( Nasdaq : GOSS ) , a clinical - stage biopharmaceutical company focused on discovering , acquiring , developing and commercializing therapeutics in the disease areas of immunology , inflammation and oncology , today announced its financial results for the second quarter of 2021 and provided a corporate update . " I am tremendously proud of the dedication and perseverance the Gossamer team has shown this year , pressing forward with the execution of two Phase 2 studies for our lead clinical programs , seralutinib and GB004 , in the face of operational challenges presented by the pandemic , " said Faheem Hasnain , Co - Founder , Chairman and Chief Executive Officer of Gossamer . " We are also very happy to share data from the first extended clinical experience of seralutinib , the first such data from an inhaled kinase inhibitor in patients with PAH . Though the pandemic limited the number of patients who were able to continue onto the OLE , these patient experiences provide additional evidence supporting the potential of seralutinib to improve the lives of PAH patients . " Clinical - Stage Product Candidate Updates Seralutinib ( GB002 ) : Inhaled PDGFR , CSF1R and C - KIT Inhibitor for PAH • While the conduct of the Phase 1b study of seralutinib in patients with Functional Class II and III PAH was interrupted by the COVID - 19 pandemic , two of the eight patients that completed the two - week Phase 1b study were also able to complete the optional 6 - month open - label extension period . • Both patients entered and completed the extension study on three classes of background therapy , including oral prostacyclins . o No serious adverse events were reported , and no safety concerns identified with longer term treatment over a six - month period at a twice daily 90mg dose . o In both patients , decreases in NT - proBNP , a biomarker for right heart strain , and increases in six - minute walk distance , a potential registrational endpoint for PAH , were observed . • Enrollment is ongoing in the TORREY Study , a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard - of - care therapy . The primary endpoint is change in pulmonary vascular resistance ( PVR ) from baseline at week 24. Topline data from the TORREY study are expected in the first half of 2022 , subject to developments in the ongoing COVID - 19 pandemic . • Additional exploratory biomarker data from the completed seralutinib two - week Phase 1b in eight PAH patients will be presented via ePoster at the Virtual European Respiratory Society ( ERS ) International Congress 2021 being held virtually from September 5 - 8 , 2021. Abstract content will be available online at the ERS website , starting on August 23 , 2021 , two weeks prior to the beginning of the virtual ERS Congress . ePoster details : o ePoster Title : Evidence of Target Engagement and Pathway Modulation : Biomarker Analysis of the Phase 1b Inhaled Seralutinib Study o Session Date : Sunday , September 5 , 2021 o Session Time : 1:15 pm CEST / 7:15 am EDT / 4:15 am PDT GB004 : Oral , Gut - Targeted HIF - 1a Stabilizer for Inflammatory Bowel Disease ( IBD ) • Enrollment is ongoing in the SHIFT - UC Study , a Phase 2 clinical trial in patients with active UC despite treatment with 5 - ASAs . The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT - UC study are expected in the first half of 2022 , subject to developments in the ongoing COVID - 19 pandemic . • Additional post - hoc analysis of clinical data from the completed GB004 Phase 1b in patients with active UC will be presented at the United European Gastroenterology ( UEG ) Virtual Week 2021 being held virtually from October 3 - 5 ,