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]

Core Viewpoint - Gossamer Bio, Inc. reported its Q1 2025 financial results and provided a corporate update during the earnings call, highlighting key developments and future outlooks for the company [3]. Financial Results - The earnings call was initiated by Bryan Giraudo, the Chief Financial Officer and Chief Operating Officer, who presented the financial results for the first quarter of 2025 [2][3]. - Gossamer Bio issued a press release earlier in the day detailing its financial performance and corporate updates [3]. Management Team - The call featured key members of the management team, including Faheem Hasnain (Founder, Chairman, and CEO), Dr. Richard Aranda (Chief Medical Officer), Caryn Peterson (EVP, Regulatory Affairs), and Bob Smith (Chief Commercial Officer) [3]. Forward-Looking Statements - The management cautioned that the call would include forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those projected [4][5].

Group 1 - Gossamer Bio reported a quarterly loss of $0.16 per share, better than the Zacks Consensus Estimate of a loss of $0.18, and an improvement from a loss of $0.19 per share a year ago, resulting in an earnings surprise of 11.11% [1] - The company achieved revenues of $9.89 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 167.27%, compared to zero revenues a year ago [2] - Gossamer Bio shares have increased approximately 11.7% since the beginning of the year, outperforming the S&P 500's gain of 0.2% [3] Group 2 - The earnings outlook for Gossamer Bio is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.18 on revenues of $4.13 million, and -$0.66 on revenues of $26.3 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which Gossamer Bio belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] Group 3 - Gossamer Bio has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] - The estimate revisions trend for Gossamer Bio is currently mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6]

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]

Financial Performance - Cash, cash equivalents, and marketable securities totaled $258 million as of March 31, 2025[1] - Revenue from collaboration with Chiesi for the quarter ended March 31, 2025, was $9.9 million, including $6.6 million of cost reimbursement revenue[8] - Research and Development (R&D) expenses for the quarter were $38.0 million, compared to $32.4 million for the same period in 2024, representing an increase of 20.5%[8] - General and Administrative (G&A) expenses for the quarter were $8.7 million, a decrease from $9.6 million for the same period in 2024[8] - Net loss for the quarter was $36.6 million, or $0.16 basic net loss per share, compared to a net loss of $41.9 million, or $0.19 basic net loss per share, for the same period in 2024[8] Clinical Trials - Enrollment for the ongoing registrational Phase 3 PROSERA Study in PAH patients is expected to complete in early June 2025, with over 350 patients anticipated[1] - Topline results from the PROSERA Phase 3 Study are expected to be announced in February 2026[1] - The Phase 3 SERANATA Study in PH-ILD patients is expected to activate clinical sites in the fourth quarter of 2025, with approximately 480 patients to be randomized[7] - The PROSERA Study has enrolled 343 patients to date, with a target of 350 participants[6] - The primary endpoint of the PROSERA Study is the change in six-minute walk distance (6MWD) from baseline compared to placebo at week 24[6]

Financial Performance - Total revenue for the three months ended March 31, 2025, was $9.889 million, compared to $0 in the same period in 2024, representing a significant increase [127]. - The net loss for the three months ended March 31, 2025, was $36.638 million, an improvement of $5.290 million compared to a net loss of $41.928 million in 2024 [127]. - Revenue for the three months ended March 31, 2025, was $9.9 million, primarily from collaboration with Chiesi, including a one-time development cost reimbursement [128]. Research and Development - Research and development expenses for the three months ended March 31, 2025, were $38.041 million, an increase of $5.649 million from $32.392 million in 2024 [127]. - Research and development expenses increased to $38.0 million for the three months ended March 31, 2025, up from $32.4 million in the same period of 2024, reflecting a $5.6 million increase mainly due to costs for seralutinib [129]. - The company has an accumulated deficit of $1.305 billion as of March 31, 2025, reflecting the ongoing investment in research and development [111]. Expenses - General and administrative expenses decreased to $8.658 million in the first quarter of 2025 from $9.567 million in 2024, a reduction of $909,000 [127]. - General and administrative expenses decreased to $8.7 million for the three months ended March 31, 2025, down from $9.6 million in 2024, primarily due to a $1.6 million decrease in stock-based compensation [131]. Cash and Liquidity - As of March 31, 2025, the company had $257.9 million in cash, cash equivalents, and marketable securities, providing a solid financial foundation for ongoing operations [110]. - Cash, cash equivalents, and marketable securities totaled $257.9 million as of March 31, 2025, providing liquidity for ongoing operations [136]. - Net cash used in operating activities for the three months ended March 31, 2025, was $39.7 million, compared to $52.3 million in the same period of 2024 [143]. - Investing activities provided approximately $22.1 million of cash during the three months ended March 31, 2025, primarily from maturities of marketable securities [146]. - Financing activities generated $0.5 million of cash for the three months ended March 31, 2025, mainly from the issuance of common stock [148]. Future Outlook - The company expects to incur significant operating losses for the foreseeable future as it continues the development of seralutinib and seeks regulatory approvals [111]. - Future capital requirements will depend on various factors, including the costs of clinical trials for seralutinib and the ability to generate product revenues [152]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources until it can generate substantial product revenues [113]. - The company expects to finance cash needs through equity offerings, debt financings, or collaborations, but may face challenges in raising additional funds [153]. Clinical Development - The company anticipates activating the first clinical sites for the global registrational Phase 3 SERANATA Study for PH-ILD in the fourth quarter of 2025 [108]. - Under the Chiesi Collaboration Agreement, the total potential transaction value includes a one-time $160 million development cost reimbursement payment [112].

Company Performance - Gossamer Bio reported a quarterly loss of $0.15 per share, better than the Zacks Consensus Estimate of a loss of $0.17, and an improvement from a loss of $0.21 per share a year ago, representing an earnings surprise of 11.76% [1] - The company posted revenues of $9.38 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 19.63%, compared to zero revenues a year ago [2] - Gossamer Bio has surpassed consensus EPS estimates two times over the last four quarters [2] Stock Performance - Gossamer Bio shares have increased by approximately 48.1% since the beginning of the year, contrasting with a decline of 4.8% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.19 on $5 million in revenues, and for the current fiscal year, it is -$0.70 on $23.66 million in revenues [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Gossamer Bio belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Gossamer Bio's stock performance [5]

Financial Performance - Cash, cash equivalents, and marketable securities totaled $294.5 million as of December 31, 2024[11] - Net loss for Q4 2024 was $33.0 million, or $0.15 per share, compared to a net loss of $48.1 million, or $0.21 per share, for the same period in 2023[10] - Total revenue for the full year ended December 31, 2024, was $114.7 million, with $90.7 million from license sales and $24.0 million from contracts with collaborators[10] - The accumulated deficit as of December 31, 2024, was $1.27 billion, compared to $1.21 billion at the end of 2023[11] Research and Development - Research and Development (R&D) expenses for Q4 2024 were $36.1 million, up from $30.0 million in Q4 2023, while full-year R&D expenses were $138.5 million compared to $135.3 million in 2023[10] - A registrational Phase 3 clinical trial in PH-ILD is expected to commence in the second half of 2025[1] - The PROSERA Phase 3 study in PAH is on track for topline data readout in Q4 2025, with enrollment ongoing[1] - Seralutinib received Orphan Drug Designation for PAH in Japan, which may support a marketing application pending clinical trial results[8] General and Administrative Expenses - General and Administrative (G&A) expenses for Q4 2024 were $9.4 million, slightly up from $9.1 million in Q4 2023, with full-year G&A expenses at $36.1 million compared to $38.5 million in 2023[10] Cash Flow and Funding - The company expects its current cash and marketable securities to fund operations into the first half of 2027[8]

Forward-Looking Statements - The annual report includes forward-looking statements regarding future operations and financial performance, particularly related to seralutinib[15]. - The company does not plan to publicly update or revise forward-looking statements unless required by law[16]. - The report emphasizes the importance of not giving undue weight to estimates and projections due to inherent uncertainties[15]. - The report includes cautionary statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[16]. Clinical Trials and Regulatory Filings - The company anticipates ongoing and planned preclinical studies and clinical trials for seralutinib, with regulatory filings and approvals expected in the near future[15]. Market Data and Estimates - Estimates and statistical data regarding market size and growth are included, but these involve assumptions and limitations[15]. - The report contains industry and market data derived from both internal estimates and independent research[18]. Risks and Uncertainties - The company acknowledges risks and uncertainties that may cause actual results to differ materially from projections[16]. Company Information - The company maintains a website for posting press releases and SEC filings, which are available free of charge[19]. - The company’s trademarks and tradenames are acknowledged, with a note on the convenience of their presentation in the report[17].

Company Overview - Gossamer Bio is a clinical-stage biopharmaceutical company focused on developing treatments for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1] Product Development - The main drug in development is Seralutinib, which is an inhaled tyrosine kinase inhibitor targeting specific pathways related to PAH and PH-ILD [1]