Gossamer Bio(GOSS)
Search documents
Gossamer Bio(GOSS) - 2021 Q2 - Earnings Call Transcript
2021-08-10 02:55
Financial 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]
Gossamer Bio (GOSS) Investor Presentation - Slideshow
2021-03-01 19:18
go frame bio 1 Corporate Presentation February 2021 Forward Looking Statement This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results ...
Gossamer Bio(GOSS) - 2020 Q4 - Earnings Call Transcript
2021-02-27 07:35
Financial Data and Key Metrics Changes - The company ended 2020 with $512 million in cash and cash equivalents, maintaining a robust balance sheet that is expected to provide sufficient capital resources into the second half of 2023 [11] - R&D expenses for Q4 2020 were $38.9 million, down from $42.6 million in Q4 2019, while full-year R&D expenses increased to $160.9 million from $143.4 million in 2019 [11] - The net loss for Q4 2020 was $64.6 million, or approximately $0.88 per share, compared to a net loss of $54.7 million, or $0.89 per share, in Q4 2019 [12] Business Line Data and Key Metrics Changes - The company is advancing four clinical product candidates: seralutinib (GB002), GB004, GB1275, and GB001, with ongoing Phase II trials for GB002 and GB004 [5][9] - In-process R&D expenses for Q4 2020 were $5.3 million, significantly up from $1.6 million in Q4 2019, primarily due to a $15 million amendment to the in-license agreement of GB004 [11] Market Data and Key Metrics Changes - The company is focusing on severe unmet needs in the PAH and IBD markets, with seralutinib and GB004 targeting these populations [6][8] - The SHIFT-UC study for GB004 is expected to enroll approximately 195 patients with mild to moderate ulcerative colitis, while the TORREY study for seralutinib aims to enroll about 80 PAH patients [7][8] Company Strategy and Development Direction - The company views 2021 as a year of focused execution, with plans to share Phase II top-line data for seralutinib and GB004 in 2022 [5] - The management emphasizes the importance of a robust preclinical pipeline and plans to outline a new clinical program later in the spring [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical trials and the potential for transformative treatments in their respective markets [6][10] - The company is taking proactive measures to mitigate the impact of the COVID-19 pandemic on clinical trial timelines and data integrity [36][37] Other Important Information - The company will not advance GB001 into further clinical trials without a partner, indicating a strategic focus on collaboration for future development [10][31] - The management highlighted the importance of safety profiles in their drug candidates, particularly in the context of IBD treatments [40] Q&A Session Summary Question: Can you provide more details on the disease clearance secondary endpoint for GB004? - The management indicated that disease clearance is a new concept and that they expect around 20% or more to be meaningful, but regulatory guidance on this endpoint is still evolving [15][16] Question: What measures are being taken to ensure timelines for the SHIFT-UC study amid COVID-19? - The management mentioned geographic distribution of sites, user-friendly protocols, and strong relationships with investigators as key strategies to ensure timelines are met [19][21] Question: How do you envision the pipeline in 12 to 18 months? - The management anticipates progressing their preclinical pipeline and hopes to outline a new clinical program, aiming for a fifth program to enter the clinic [26][27] Question: What is the status of interactions with regulators regarding GB001? - The management reported constructive interactions with regulators and confirmed a clinical path forward for GB001, but emphasized the need for a partner before advancing to Phase III [30][31] Question: What are the expectations for GB1275 moving forward? - The management indicated that positive Phase I data could lead to exploring other tumor types, but the current focus remains on immuno-oncology [32][33]
Gossamer Bio (GOSS) Investor Presentation - Slideshow
2020-11-18 01:15
go frame bio 1 Corporate Presentation November 2020 Forward Looking Statement This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results ...
Gossamer Bio(GOSS) - 2020 Q3 - Earnings Call Transcript
2020-11-11 04:13
Start Time: 16:30 January 1, 0000 5:30 PM ET Gossamer Bio, Inc. (NASDAQ:GOSS) Q3 2020 Earnings Conference Call November 10, 2020, 16:30 PM ET Company Participants Sheila Gujrathi - Co-Founder and CEO Bryan Giraudo - CFO Luisa Salter-Cid - Chief Scientific Officer Richard Aranda - SVP, Head of Clinical Development Conference Call Participants Tyler Van Buren - Piper Sandler Joseph Schwartz - SVB Leerink Geoff Meacham - Bank of America Merrill Lynch Josh Schimmer - Evercore ISI Carter Gould - Barclays Emma Ne ...
Gossamer Bio (GOSS) Investor Presentation - Slideshow
2020-06-12 20:43
1 Corporate Presentation June 2020 Forward Looking Statement This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and a ...
Gossamer Bio(GOSS) - 2020 Q1 - Earnings Call Presentation
2020-05-13 16:12
Confidential Corporate Presentation May 2020 Forward Looking Statement This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of cur ...
Gossamer Bio(GOSS) - 2020 Q1 - Earnings Call Transcript
2020-05-13 03:20
Gossamer Bio, Inc. (NASDAQ:GOSS) Q1 2020 Earnings Conference Call May 12, 2020 4:30 PM ET Company Participants Bryan Giraudo - Chief Financial Officer Sheila Gujrathi - Co-founder & Chief Executive Officer Luisa Salter-Cid - Chief Scientific Officer Richard Aranda - Senior Vice President Conference Call Participants Joseph Schwartz - SVB Leerink Eliana Merle - Cantor Fitzgerald Carter Gould - Barclays Tyler Van Buren - Piper Sandler David Hoang - SMBC Operator Ladies and gentlemen, thank you for standing by ...
Gossamer Bio(GOSS) - 2019 Q3 - Earnings Call Transcript
2019-11-13 00:29
Gossamer Bio, Inc. (NASDAQ:GOSS) Q3 2019 Earnings Conference Call November 12, 2019 4:30 PM ET Company Participants Bryan Giraudo - Chief Financial Officer Sheila Gujrathi - Co-founder & Chief Executive Officer Jakob Dupont - Chief Medical Officer Luisa Salter-Cid - Chief Scientific Officer Conference Call Participants Joseph Schwartz - SVB Leerink Operator Good afternoon, and welcome to the Gossamer Bio Third Quarter 2019 Earnings Call. Today's call will feature updates from Gossamer Bio's management team ...
Gossamer Bio (GOSS) Investor Presentation - Slideshow
2019-10-04 18:16
Confidential Corporate Presentation Forward Looking Statement This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and ...