Summary of Conference Call for Gossamer Bio (GOSS) and Highland Copper Gossamer Bio (GOSS) Industry Overview - Gossamer Bio is a clinical stage biopharmaceutical company focused on developing cerulutinib for treating pulmonary hypertension [1] Key Updates - Completion of screening for the phase three global registrational study, PROCERIS, with top-line data expected in February 2025 [1] - Enrollment is anticipated to exceed the initial target of 350 patients due to high enthusiasm for the study [3] - The company is targeting a patient population that is significantly sicker than in previous studies, which is expected to yield a more pronounced treatment effect [2] - A second global registrational study for pulmonary hypertension associated with interstitial lung disease (PH-ILD) is set to begin in Q4 2025, targeting a market twice the size of PAH with minimal competition [3][4] Clinical Trial Insights - The phase three study aims to ensure that physicians treating PAH patients are also engaged in the upcoming PH-ILD study, fostering long-term relationships and sales potential [5] - Preclinical data presented at the American Thoracic Society conference highlighted the efficacy of saralutamide, generating significant enthusiasm [7] Market Potential - The potential market for PH-ILD is approximately 100,000 patients in the U.S., while idiopathic pulmonary fibrosis (IPF) represents millions, indicating a significant unmet medical need [8] Financial Position - Gossamer ended the quarter with approximately $230 million in cash, with a partnership with Chiesi Pharmaceuticals for cost-sharing on future projects [9] Intellectual Property - The company holds a composition of matter patent with a five-year extension, potentially extending protection until 2039 [10] Patient Outcomes - Data from open-label extensions of the phase two study indicate that patients have experienced significant improvements, allowing them to resume near-normal lives [12] Future Outlook - The company is optimistic about the upcoming top-line data from the phase three study and is committed to providing updates throughout the year [14] Highland Copper Industry Overview - Highland Copper is advancing the Copperwood project in Michigan, which is one of the few fully permitted copper projects in the U.S. [18] Project Development - The Copperwood project is positioned to address the domestic supply-demand imbalance for copper, with significant progress made in site work and detailed engineering [19][20] - Environmental mitigations are being implemented, including a 700-acre wetland preservation area [21] Community Engagement - Strong community support has been established, with local and federal legislators backing the project [25][29] Engineering and Financing - Detailed engineering is underway, with a goal of reaching 40% completion to facilitate project financing [33] - The company is exploring various funding avenues, including private equity and federal sources, to support project development [36] Regional Significance - The UP region, known as Copper Country, has historical mining significance, and Highland aims to revitalize this area through responsible mining practices [34] Future Goals - The company is focused on achieving key catalysts throughout the year, aiming for a construction decision and project financing by early 2026 [27][38]

Gossamer Bio (GOSS) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Company Participants Bryan Giraudo - COO & CFOFaheem Hasnain - Co-Founder, CEO & ChairmanRichard Aranda - Chief Medical OfficerJoseph Schwartz - Senior Managing DirectorBob Smith - CCOCaryn Peterson - EVP - Regulatory AffairsPatrick Trucchio - Managing DirectorLaura Chico - Managing DirectorDaniel Krizay - VP - Biotech Equity Research Conference Call Participants Andreas Argyrides - Managing Director & Senior Analyst - BiotechnologyYasmeen R ...

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $257.9 million in cash and cash equivalents and marketable securities, indicating a robust balance sheet [22] - Recognized revenue for the quarter was $9.9 million, which included $6.6 million in cost reimbursements from collaboration with Chiesi [22] - R&D expenses increased to $38 million from $32.4 million in the same period of 2024, while G&A expenses decreased to $8.7 million from $9.6 million [23] - The net loss for Q1 2025 was $36.6 million, or $0.16 per share, compared to a net loss of $41.9 million, or $0.19 per share, in Q1 2024 [23] Business Line Data and Key Metrics Changes - The company reported significant progress in the enrollment of the PROCERA study for saralutinib, with 343 patients already enrolled and more in screening [7][8] - The baseline characteristics of enrolled patients indicate a mean six-minute walk distance of approximately 376 meters, which is lower than previous studies, suggesting a more severe patient population [10] - The mean NT proBNP level in the PROCERA study is 96 ng/L, indicating a more severe population compared to previous studies [11] Market Data and Key Metrics Changes - The company highlighted the substantial unmet need in the PAH and PHILD markets, with only one approved treatment for PHILD in the US and limited options globally [17] - The PROCERA study has a global footprint, with significant patient enrollment expected from regions like Latin America and Asia Pacific, which may yield a larger treatment effect [38] Company Strategy and Development Direction - The company aims to position saralutinib as a first-in-class treatment for PAH and PHILD, with a focus on achieving comprehensive and differentiated outcomes in both phase three trials [27] - The partnership with Chiesi Group is crucial for the global registrational phase three study in PHILD, emphasizing the commitment to innovation and patient care [18] - The company is exploring the potential for saralutinib to address both pulmonary hypertension and underlying interstitial lung disease, which could differentiate it from existing therapies [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the likelihood of achieving positive results in the PROCERA study, citing the successful enrollment of the targeted patient population [6][9] - The company is committed to maintaining high standards to ensure long-term clinical and commercial success for saralutinib, aiming to become a backbone therapy in PAH [27] - Management noted the growing demand for new therapies in PAH and PHILD, highlighting the potential for saralutinib to capture significant market share [26] Other Important Information - The company anticipates completing the blinded portion of the PROCERA study by Q4 2025, with top-line results expected in February 2026 [8] - The SERENADA study for PHILD is set to begin site activations in Q4 2025, with a focus on addressing the unmet needs in this patient population [20] Q&A Session Summary Question: Consideration of stopping enrollment in PROCERA - Management decided to continue enrollment due to high demand and commitment to patients and physicians, ensuring quality and appropriate patient selection [30][32] Question: Influence of global recruitment on results - The broader global footprint in PROCERA is expected to yield a more favorable patient population, potentially leading to a larger treatment effect [35][38] Question: Changes in powering assumptions and enrollment criteria - Stringent enrollment criteria contributed to longer enrollment times, but the study maintains over 90% power based on sample size and expected treatment effect [47] Question: Safety profile of saralutinib - The safety profile remains clean, and the design of the molecule is intended to minimize off-target effects, positioning it as a competitive advantage [49] Question: Baseline measures and future updates - The company does not expect significant changes to baseline data and will provide updates as enrollment completes [57] Question: Clinical impact of open-label extension data - Positive feedback from the KOL community regarding open-label extension data has increased interest in PROCERA enrollment, indicating strong commercial potential [92][94] Question: Regulatory expectations for six-minute walk improvement - The FDA has agreed to the powering and magnitude of effect being targeted, with a focus on clinically meaningful improvements [83]

Gossamer Bio (GOSS) M&A Announcement May 06, 2024 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Gossamer Bio Announcement Presentation. I will now turn the presentation over to Brian Dorado. Speaker1 Thank you, operator, and thank you all for joining us on this momentous morning for Gossamer in the field of pulmonary hypertension drug development. Before we begin, please note that certain information discussed on the call today is covered under the Safe Harbor provision of the ...