Gossamer Bio(US:GOSS)2021-08-10 02:55Financial Data and Key Metrics Changes - The company ended Q2 2021 with cash and cash equivalents of $405.9 million, which is expected to fund operations into the second half of 2023 [37] - Research and development expenses increased to approximately $44.3 million in Q2 2021 from $38.7 million in the same period in 2020 [38] - General and administrative expenses decreased slightly to $11.3 million in Q2 2021 from $11.7 million in Q2 2020 [38] - The net loss for Q2 2021 was $59.8 million, equating to $0.80 per share, compared to a net loss of $66.9 million or $1.00 per share in the same period in 2020 [38] Business Line Data and Key Metrics Changes - The company is focused on two lead clinical programs: Seralutinib and GB004, with Phase 2 data readouts expected in the first half of 2022 [7][8] - Seralutinib is currently enrolling patients in the TORREY study, while GB004 is enrolling in the SHIFT-UC study, both aiming for clinical data in 2022 [8][33] Market Data and Key Metrics Changes - The SHIFT-UC study for GB004 is enrolling 195 patients with active ulcerative colitis, aiming for clinical remission at 12 weeks [8] - The TORREY study for Seralutinib is enrolling 80 patients with pulmonary arterial hypertension, focusing on changes in pulmonary vascular resistance at 24 weeks [9][30] Company Strategy and Development Direction - The company branded 2021 as a year of execution, setting the stage for transformative developments in 2022 [7] - Gossamer Bio is discontinuing clinical activities related to GB1275, focusing resources on the promising Phase 2 programs of Seralutinib and GB004 [35][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the timelines for data readouts despite the ongoing challenges posed by the COVID-19 pandemic [41] - The potential for GB004 to disrupt treatment paradigms in inflammatory bowel disease was highlighted, emphasizing its non-immunosuppressive profile [8][46] Other Important Information - The company plans to present further biomarker analysis from the Phase 1b study of GB004 at the upcoming Virtual European Respiratory Society Meeting [29] - The company is optimistic about the safety profile of GB004 and its potential to be a backbone therapy for IBD patients [46] Q&A Session Summary Question: Current status and pace of enrollment in TORREY and SHIFT-UC - Management refrained from commenting on specific enrollment data but reiterated guidance for top-line data in the first half of 2022 [41] Question: Thoughts on GB004 and payer access - Management believes GB004's non-immunosuppressive approach could position it favorably in the treatment paradigm, potentially appealing to payers [46] Question: Open-label portion for the TORREY study and increasing conversion rates - Management indicated that the TORREY study is designed to be user-friendly and has learned from the Phase 1 experience [52] Question: Focus on oncology in the pipeline - Oncology remains a focus for the company, with several preclinical agents aimed at oncology indications [56] Question: Clinical relevance of improvements in NT-proBNP and 6-minute walk distance - Management emphasized caution in interpreting results from only two patients but found the directionality of the data encouraging [65] Question: Time course of cough during the open-label extension - Cough was predominantly mild and did not lead to discontinuation of the drug [71] Question: Impact on expenses from winding down the GB1275 program - The financial impact is minimal, allowing the company to focus on advancing other programs [72] Question: Timeline for topline data from TORREY or SHIFT-UC - Management maintained that both programs are expected to read out in the first half of 2022 [75]