Gossamer Bio (GOSS) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to earnings of $0.22 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +5.56%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.18 per share when it actually produced a loss of $0.16, delivering a surprise of +11.11%.Over the last four quarters, the ...

[Overview and Business Update](index=1&type=section&id=Gossamer%20Bio%20Announces%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) This section outlines Gossamer Bio's business, including management insights and updates on seralutinib's clinical development programs [Management Commentary](index=1&type=section&id=Management%20Commentary) Management commentary emphasizes the company's commercial transition and key upcoming clinical milestones for seralutinib in PH-ILD and PAH - Gossamer Bio is actively engaged in commercial planning with its partner, Chiesi Group, preparing to evolve from a clinical-stage to a commercial organization[2](index=2&type=chunk) - The company is preparing to initiate a global, registrational Phase 3 clinical study in PH-ILD (SERANATA Study), with the first clinical sites expected to be activated in **Q4 2025**[2](index=2&type=chunk) - The upcoming pivotal readout from the PROSERA Study in PAH is viewed as the foundation for seralutinib's potential multi-billion-dollar franchise, with topline results anticipated in **February 2026**[3](index=3&type=chunk)[8](index=8&type=chunk) [Seralutinib (GB002) Clinical Program Update](index=1&type=section&id=Seralutinib%20(GB002)%3A%20Inhaled%20PDGFR%2C%20CSF1R%20and%20c-KIT%20Inhibitor) This section details the clinical development progress of seralutinib for Pulmonary Arterial Hypertension and PH-Interstitial Lung Disease [Pulmonary Arterial Hypertension (PAH)](index=1&type=section&id=Pulmonary%20Arterial%20Hypertension%20(PAH)) The Phase 3 PROSERA study for PAH completed enrollment, with topline results expected in February 2026, showing a more severe patient population - Enrollment for the Phase 3 PROSERA Study was completed on **June 11th** with **390 Functional Class II and III PAH patients**[4](index=4&type=chunk) - The primary endpoint is the change in six-minute walk distance (6MWD) from baseline compared to placebo at week 24. Topline results are expected in **February 2026**[4](index=4&type=chunk)[8](index=8&type=chunk) Baseline Characteristics: PROSERA Phase 3 vs. TORREY Phase 2 | | PROSERA Phase 3* | TORREY Phase 2 | | :--- | :--- | :--- | | **Study Participants** | n = 390 | n = 86 | | **Mean 6MWD** | 374 meters | 408 meters | | **Mean NT-proBNP** | 987 ng/L | 628 ng/L | | **Functional Class III Patients** | 290 (74%) | 36 (42%) | [Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)](index=2&type=section&id=Pulmonary%20Hypertension%20Associated%20with%20Interstitial%20Lung%20Disease%20(PH-ILD)) The registrational Phase 3 SERANATA study for PH-ILD is set to begin in Q4 2025, enrolling 480 patients with 6MWD as the primary endpoint - The first clinical sites for the global, registrational Phase 3 SERANATA Study in PH-ILD are expected to be activated in **Q4 2025**[9](index=9&type=chunk) - The study will enroll approximately **480 patients** randomized 1:1:1 to receive **90mg seralutinib twice-daily**, **120mg seralutinib twice-daily**, or a placebo[9](index=9&type=chunk) - The primary endpoint is change in 6MWD from baseline at week 24, with key secondary endpoints including time to clinical worsening and change in forced vital capacity (FVC)[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Financial%20Results%20for%20Quarter%20Ended%20June%2030%2C%202025) This section presents Gossamer Bio's financial performance for Q2 2025, encompassing key highlights, statement of operations, and balance sheet [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Q2 2025 financial highlights show a net loss of $38.3 million, influenced by the absence of prior year's one-time license revenue - Cash, cash equivalents, and marketable securities totaled **$212.9 million** as of **June 30, 2025**, expected to fund operating and capital expenditures into **2027**[9](index=9&type=chunk) Q2 2025 vs Q2 2024 Financial Summary | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change Driver | | :--- | :--- | :--- | :--- | | **Collaboration Revenue** | $11.5 | $95.8 | Q2 2024 included a one-time $88.8M license sale | | **R&D Expenses** | $41.6 | $35.1 | Increased research and development activities | | **G&A Expenses** | $8.7 | $8.7 | Remained flat year-over-year | | **Net Income (Loss)** | ($38.3) | $49.2 | Primarily due to the one-time license revenue in 2024 | | **Net Income (Loss) Per Share** | ($0.17) | $0.22 | - | [Consolidated Statement of Operations](index=4&type=section&id=Gossamer%20Bio%20Statement%20of%20Operations) The consolidated statement of operations details a net loss of $38.3 million for Q2 2025, driven by reduced revenue and increased expenses Condensed Consolidated Statement of Operations (in thousands, except per share amounts) | | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | **Total revenue** | $11,489 | $95,842 | | **Total operating expenses** | $50,254 | $43,755 | | *Research and development* | $41,575 | $35,086 | | *General and administrative* | $8,679 | $8,669 | | **Income (loss) from operations** | ($38,765) | $52,087 | | **Net income (loss)** | ($38,273) | $49,232 | | **Net income (loss) per share, basic** | ($0.17) | $0.22 | [Consolidated Balance Sheet](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) The consolidated balance sheet as of June 30, 2025, shows $212.9 million in cash and a total stockholders' deficit of $46.1 million Condensed Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Cash, cash equivalents, and marketable securities** | $212,918 | $294,518 | | **Working capital** | $182,304 | $264,878 | | **Total assets** | $240,925 | $315,292 | | **Total liabilities** | $287,032 | $285,800 | | **Total stockholders' equity (deficit)** | ($46,107) | $29,492 | [Corporate Information](index=3&type=section&id=Corporate%20Information) This section provides an overview of Gossamer Bio and includes important forward-looking statements and associated risk disclosures [About Gossamer Bio](index=3&type=section&id=About%20Gossamer%20Bio) Gossamer Bio is a late-stage clinical biopharmaceutical company focused on developing seralutinib for PAH and PH-ILD - The company is a late-stage clinical biopharmaceutical company focused on developing and commercializing seralutinib for PAH and PH-ILD[10](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding clinical timelines, market opportunities, and financial runway, with associated risks - The press release contains forward-looking statements regarding clinical trial timelines (PROSERA data readout, SERANATA trial commencement), the market opportunity for seralutinib, and the company's financial runway[11](index=11&type=chunk) - Key risks that could cause actual results to differ include clinical trial delays, manufacturing and testing dependencies on third parties, unexpected adverse side effects of seralutinib, and unstable market conditions[11](index=11&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q _________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to_________. Commission File Number: 001-38796 GOSSAMER BIO, INC. (Exact name of Registrant as specified in its charte ...

Seralutinib Partnership with Chiesi - Chiesi will provide a $160 million immediate development reimbursement to Gossamer[13] - Gossamer and Chiesi will split US profits 50/50, with mid-to-high teens royalties to Gossamer ex-US[13] - Regulatory milestones could reach up to $146 million, and sales milestones up to $180 million[13] - R&D costs will be split 50/50 worldwide, with Gossamer leading global development and US commercialization of PAH & PH-ILD[13] - Gossamer has a pro forma cash position of approximately $396 million[20, 38] Seralutinib in PAH - Seralutinib is in an ongoing registrational Phase 3 trial for PAH, with topline results expected in Q4 2025[13, 24, 26] - The PROSERA Phase 3 study is a double-blind, placebo-controlled trial with 175 patients per arm[26] - The US has approximately 30,000 to 50,000 PAH patients, with a 5-year survival rate of 57%[13, 22, 23, 35] Seralutinib in PH-ILD - The US has approximately 60,000 to 100,000 PH-ILD patients[13, 29, 35] - The median 5-year survival for PH-ILD patients is 23%[13, 35] - A Phase 3 study in PH-ILD is expected to begin in mid-2025[13, 20] - Only one therapy is approved for PH-ILD in the US[29, 30, 35]

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 cash and cash equivalents of $257.9 million, indicating a robust balance sheet [23] - Recognized revenue for the quarter was $9.9 million, which includes $6.6 million in cost reimbursements from collaboration with Chiesi [23] - 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 [24] - 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 [24] Business Line Data and Key Metrics Changes - The company is focused on the development of saralutinib for pulmonary hypertension, with significant progress in the PROCERA study, which is nearing completion of patient enrollment [5][6] - The PROCERA study has enrolled 343 patients, with expectations to complete enrollment by early June 2025 [8][9] - The baseline characteristics of enrolled patients indicate a more severe population compared to previous studies, which may enhance the likelihood of a successful treatment outcome [10][12] Market Data and Key Metrics Changes - The company is expanding its global footprint for patient enrollment in the PROCERA study, with significant participation expected from regions like Latin America and Asia Pacific [36] - The company anticipates that the broader global reach will yield a patient population with lower comorbidities, potentially leading to a greater magnitude of treatment effect [36][39] Company Strategy and Development Direction - The company aims to position saralutinib as a first-in-class treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [5][17] - The strategic partnership with Chiesi Group is crucial for the global registrational phase III study in PHILD, highlighting the commitment to innovation and addressing unmet medical needs [19][27] - The company is focused on generating comprehensive and differentiated outcomes in both phase III trials to establish saralutinib as a backbone therapy in PAH [26][28] Management's Comments on Operating Environment and Future Outlook - Management emphasized the substantial unmet need in PAH and PHILD, with a commitment to developing safe and effective therapies [25] - The management expressed optimism about the likelihood of achieving positive results in the PROCERA study, given the targeted patient population and the treatment's potential [9][10] - The company is preparing for the potential launch of saralutinib in early 2027, anticipating a market reset as patients transition from existing therapies [115] Other Important Information - The company has achieved a significant milestone with the closure of new patient screening in the PROCERA study [6] - The primary endpoint for the PROCERA study is the change in six-minute walk distance at 24 weeks, which is a critical measure for evaluating treatment efficacy [20] Q&A Session Summary Question: Have you considered stopping enrollment in PROCERA to report data this year? - Management decided to continue enrollment due to high demand and a commitment to patients and physicians, ensuring the right patient population is included [30][32] Question: How does the global recruitment impact results? - The broader global footprint is expected to yield a patient population with lower comorbidities, potentially leading to a greater magnitude of treatment effect [36][39] Question: What are the powering assumptions for PROCERA? - The study is powered based on a 30-meter treatment effect on six-minute walk distance, with over 90% power given the sample size [49][87] Question: What is the expected clinical meaningful effect for six-minute walk distance? - A clinically meaningful effect is considered to be an improvement of 20 meters or more, given the safety profile and potential for long-term progression prevention [75] Question: What are the implications of the open-label extension data? - The open-label extension data suggests a potential for continued improvement over time, which could position saralutinib favorably in the market [100][101]

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]