Core Viewpoint - Gossamer Bio reported a quarterly loss of $0.17 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.18, marking an earnings surprise of +5.56% [1] - The company has consistently surpassed consensus EPS estimates over the last four quarters [2] Financial Performance - Gossamer Bio posted revenues of $11.49 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 155.88%, compared to revenues of $95.84 million a year ago [2] - The company has also topped consensus revenue estimates four times in the last four quarters [2] Stock Performance - Gossamer Bio shares have increased approximately 139.9% since the beginning of the year, significantly outperforming the S&P 500's gain of 7.6% [3] Future Outlook - The company's earnings outlook will be crucial for investors, particularly in understanding how current consensus earnings expectations may evolve [4] - The current consensus EPS estimate for the upcoming quarter is -$0.18 on revenues of $5.78 million, and for the current fiscal year, it is -$0.69 on revenues of $28.57 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Gossamer Bio belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating potential challenges ahead [8]

[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)

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)](index=4&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, with detailed accounting notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time Condensed Consolidated Balance Sheets | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $26,309 | $46,074 | | Marketable securities | $186,609 | $248,444 | | Receivable from contracts with collaborators | $7,579 | $5,338 | | Prepaid expenses and other current assets | $15,401 | $10,032 | | **Total current assets** | **$235,898** | **$309,888** | | Property and equipment, net | $76 | $10 | | Operating lease right-of-use assets | $4,568 | $5,111 | | Other assets | $383 | $283 | | **Total assets** | **$240,925** | **$315,292** | | **LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)** | | | | Accounts payable | $1,876 | $2,319 | | Accrued research and development expenses | $15,601 | $10,455 | | Current contract liabilities | $23,472 | $17,050 | | Accrued expenses and other current liabilities | $12,645 | $15,186 | | **Total current liabilities** | **$53,594** | **$45,010** | | Long-term convertible senior notes | $198,009 | $197,523 | | Operating lease liabilities - long-term | $3,934 | $4,398 | | Long-term contract liabilities | $31,495 | $38,869 | | **Total liabilities** | **$287,032** | **$285,800** | | Common stock | $23 | $23 | | Additional paid-in capital | $1,302,437 | $1,296,848 | | Accumulated deficit | $(1,343,479) | $(1,268,568) | | Accumulated other comprehensive income (loss) | $(5,088) | $1,189 | | **Total stockholders' equity (deficit)** | **$(46,107)** | **$29,492** | | **Total liabilities and stockholders' equity** | **$240,925** | **$315,292** | * Cash and cash equivalents decreased from **$46,074 thousand** as of December 31, 2024, to **$26,309 thousand** as of June 30, 2025[10](index=10&type=chunk) * Total stockholders' equity (deficit) shifted from a positive **$29,492 thousand** as of December 31, 2024, to a deficit of **$(46,107) thousand** as of June 30, 2025[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net income or loss over specific reporting periods Condensed Consolidated Statements of Operations and Comprehensive Loss | (in thousands, except share and per share amounts) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue from sale of licenses | $— | $88,751 | $— | $88,751 | | Revenue from contracts with collaborators | $11,489 | $7,091 | $21,378 | $7,091 | | **Total revenue** | **$11,489** | **$95,842** | **$21,378** | **$95,842** | | Research and development | $41,575 | $35,086 | $79,616 | $67,478 | | General and administrative | $8,679 | $8,669 | $17,337 | $18,236 | | **Total operating expenses** | **$50,254** | **$43,755** | **$96,953** | **$85,714** | | **Income (loss) from operations** | **$(38,765)** | **$52,087** | **$(75,575)** | **$10,128** | | Interest income | $542 | $1,749 | $836 | $2,093 | | Interest expense | $(2,744) | $(2,916) | $(5,490) | $(6,045) | | Other income, net | $2,694 | $2,747 | $5,318 | $5,563 | | **Total other income, net** | **$492** | **$1,580** | **$664** | **$1,611** | | **Income (loss) before provision for income taxes** | **$(38,273)** | **$53,667** | **$(74,911)** | **$11,739** | | Provision for income taxes | $— | $4,435 | $— | $4,435 | | **Net income (loss)** | **$(38,273)** | **$49,232** | **$(74,911)** | **$7,304** | | Foreign currency translation | $(4,195) | $135 | $(6,098) | $16 | | Unrealized loss on marketable securities | $(69) | $(25) | $(179) | $(184) | | **Other comprehensive income (loss)** | **$(4,264)** | **$110** | **$(6,277)** | **$(168)** | | **Comprehensive income (loss)** | **$(42,537)** | **$49,342** | **$(81,188)** | **$7,136** | | Net income (loss) per share, basic | $(0.17) | $0.22 | $(0.33) | $0.03 | | Net income (loss) per share, diluted | $(0.17) | $0.22 | $(0.33) | $0.03 | | Weighted average common shares outstanding, basic | 227,275,466 | 226,221,202 | 227,048,022 | 225,978,219 | | Weighted average common shares outstanding, diluted | 227,275,466 | 238,543,102 | 227,048,022 | 225,978,219 | * Total revenue for the three months ended June 30, 2025, was **$11,489 thousand**, a significant decrease from **$95,842 thousand** for the same period in 2024, primarily due to the absence of revenue from the sale of licenses in 2025[13](index=13&type=chunk) * The Company reported a net loss of **$(38,273) thousand** for the three months ended June 30, 2025, compared to a net income of **$49,232 thousand** for the three months ended June 30, 2024[13](index=13&type=chunk) * For the six months ended June 30, 2025, the net loss was **$(74,911) thousand**, a substantial change from the net income of **$7,304 thousand** for the six months ended June 30, 2024[13](index=13&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) This statement tracks changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (Deficit) | (in thousands, except share amounts) | Common stock Shares | Common stock Amount | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive income (loss) | Total stockholders' equity (deficit) | | :----------------------------------- | :------------------ | :------------------ | :------------------------- | :------------------ | :-------------------------------------------- | :----------------------------------- | | Balance as of December 31, 2024 | 226,604,138 | $23 | $1,296,848 | $(1,268,568) | $1,189 | $29,492 | | Exercise of stock options | 112,617 | $— | $132 | $— | $— | $132 | | Stock-based compensation | — | $— | $2,405 | $— | $— | $2,405 | | Issuance of common stock pursuant to Employee Stock Purchase Plan | 504,507 | $— | $372 | $— | $— | $372 | | Net loss | — | $— | $— | $(36,638) | $— | $(36,638) | | Other comprehensive loss | — | $— | $— | $— | $(2,013) | $(2,013) | | Balance as of March 31, 2025 | 227,221,262 | $23 | $1,299,757 | $(1,305,206) | $(824) | $(6,250) | | Exercise of stock options | 101,266 | $— | $94 | $— | $— | $94 | | Stock-based compensation | — | $— | $2,586 | $— | $— | $2,586 | | Net loss | — | $— | $— | $(38,273) | $— | $(38,273) | | Other comprehensive loss | — | $— | $— | $— | $(4,264) | $(4,264) | | **Balance as of June 30, 2025** | **227,322,528** | **$23** | **$1,302,437** | **$(1,343,479)** | **$(5,088)** | **$(46,107)** | * The accumulated deficit increased from **$(1,268,568) thousand** as of December 31, 2024, to **$(1,343,479) thousand** as of June 30, 2025, reflecting ongoing net losses[16](index=16&type=chunk) * Total stockholders' equity (deficit) decreased significantly from **$29,492 thousand** at December 31, 2024, to a deficit of **$(46,107) thousand** at June 30, 2025[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement categorizes cash inflows and outflows from operating, investing, and financing activities over a period Condensed Consolidated Statements of Cash Flows | (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :---------------------------------------------------------------- | :----------------------------- | :----------------------------- | | **Cash flows from operating activities** | | | | Net income (loss) | $(74,911) | $7,304 | | Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | | | | Depreciation and amortization expense | $12 | $509 | | Stock-based compensation expense | $4,991 | $10,812 | | Amortization of operating lease right-of-use assets | $543 | $1,469 | | Amortization of long-term debt discount and issuance costs | $486 | $614 | | Amortization of premium on marketable securities, net of accretion of discounts | $(4,611) | $(6,040) | | Loss on disposal of property and equipment | $— | $316 | | Changes in operating assets and liabilities: | | | | Receivable from contracts with collaborators | $(2,241) | $(3,629) | | Prepaid expenses and other current assets | $(5,369) | $(2,692) | | Other assets | $(100) | $559 | | Operating lease liabilities | $(534) | $(1,620) | | Accounts payable | $(6,774) | $(4,441) | | Accrued expenses and other current liabilities | $363 | $(6,282) | | Accrued research and development expenses | $5,146 | $3,082 | | Accrued compensation and benefits | $(2,834) | $(2,476) | | Contract liabilities | $(952) | $66,696 | | Accrued interest expense | $— | $(135) | | **Net cash provided (used) in operating activities** | **$(86,785)** | **$64,046** | | **Cash flows from investing activities** | | | | Purchase of marketable securities | $(176,533) | $(279,739) | | Maturities of marketable securities | $242,800 | $282,300 | | Purchase of property and equipment | $(79) | $— | | **Net cash provided by investing activities** | **$66,188** | **$2,561** | | **Cash flows from financing activities** | | | | Proceeds from issuance of common stock pursuant to Employee Stock Purchase Plan | $372 | $348 | | Proceeds from the exercise of stock options | $226 | $— | | Proceeds from grant of equity option pursuant to Chiesi Collaboration Agreement | $— | $464 | | Principal repayments of long-term debt | $— | $(12,581) | | **Net cash provided by (used in) financing activities** | **$598** | **$(11,769)** | | Effect of exchange rate changes on cash and cash equivalents | $234 | $(70) | | **Net increase (decrease) in cash and cash equivalents** | **$(19,765)** | **$54,768** | | Cash and cash equivalents, at the beginning of the period | $46,074 | $32,109 | | **Cash and cash equivalents, at the end of the period** | **$26,309** | **$86,877** | * Net cash used in operating activities for the six months ended June 30, 2025, was **$(86,785) thousand**, a significant change from **$64,046 thousand** provided in the same period of 2024[19](index=19&type=chunk) * Net cash provided by investing activities increased to **$66,188 thousand** for the six months ended June 30, 2025, from **$2,561 thousand** in the prior year period[19](index=19&type=chunk) * Cash and cash equivalents at the end of the period decreased by **$19,765 thousand**, resulting in a balance of **$26,309 thousand** as of June 30, 2025[19](index=19&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the unaudited condensed consolidated financial statements, offering context to the financial figures presented [Note 1 - Description of Business](index=8&type=section&id=Note%201%20-%20Description%20of%20Business) This note outlines the company's core business, its focus on seralutinib for pulmonary hypertension, and its financial position * Gossamer Bio, Inc. is a late-stage, clinical biopharmaceutical company focused on developing and commercializing seralutinib for pulmonary hypertension (PH), including pulmonary arterial hypertension (PAH) and PH associated with interstitial lung disease (PH-ILD)[21](index=21&type=chunk) * As of June 30, 2025, the Company had an accumulated deficit of **$1,343.5 million**[23](index=23&type=chunk) * The Company expects to continue incurring significant operating losses and will need to raise additional capital, though management believes current working capital is sufficient for the next 12 months[24](index=24&type=chunk) [Note 2 - Summary of Significant Accounting Policies](index=8&type=section&id=Note%202%20-%20Summary%20of%20Significant%20Accounting%20Policies) This note details the accounting principles and significant estimates used in preparing the financial statements * The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim financial information and SEC instructions on Form 10-Q[25](index=25&type=chunk) * Management's significant estimates include accrued research and development expenses, stand-alone selling price of performance obligations, and estimated collaboration expenses[26](index=26&type=chunk) * Revenue is recognized when a customer obtains control of promised goods or services, following a five-step model that requires judgment in determining standalone selling prices and evaluating variable consideration[29](index=29&type=chunk)[30](index=30&type=chunk) * Chiesi was the Company's principal customer during the six months ended June 30, 2025, accounting for **100%** of its revenue and accounts receivable balance[36](index=36&type=chunk) [Note 3 - Balance Sheet Accounts and Supplemental Disclosures](index=12&type=section&id=Note%203%20-%20Balance%20Sheet%20Accounts%20and%20Supplemental%20Disclosures) This note provides additional details and breakdowns for specific balance sheet accounts and related disclosures Accrued Expenses and Other Current Liabilities (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :----------------------------- | :----------------------------- | | Accrued compensation and benefits | $9,161 | $11,995 | | Operating lease liabilities, short-term | $890 | $961 | | Accrued consulting fees | $1,002 | $841 | | Accrued interest | $833 | $833 | | Accrued legal fees | $14 | $65 | | Accrued accounting fees | $162 | $180 | | Accrued other | $583 | $311 | | **Total** | **$12,645** | **$15,186** | [Note 4 - Fair Value Measurements and Available for Sale Investments](index=14&type=section&id=Note%204%20-%20Fair%20Value%20Measurements%20and%20Available%20for%20Sale%20Investments) This note describes the valuation methodologies for financial instruments and details available-for-sale investments * The Company classifies its cash equivalents and available-for-sale investments within Level 1 or Level 2 of the fair value hierarchy[46](index=46&type=chunk) Fair Value of Financial Instruments (in thousands) | Asset Type | Total Fair Value (in thousands) | Level 1 (in thousands) | Level 2 (in thousands) | | :----------------------------- | :------------------------------ | :--------------------- | :--------------------- | | Money market funds | $22,829 | $22,829 | $— | | U.S. Treasury and agency securities | $41,466 | $41,466 | $— | | Commercial paper | $104,315 | $— | $104,315 | | Corporate debt securities | $40,828 | $— | $40,828 | * The fair value of the Company's 2027 Notes was **$105.0 million** as of June 30, 2025, and **$110.0 million** as of December 31, 2024, classified as Level 2[50](index=50&type=chunk) * All available-for-sale debt securities, totaling **$186,609 thousand** as of June 30, 2025, have contractual maturities of less than one year[53](index=53&type=chunk) [Note 5 - Indebtedness](index=17&type=section&id=Note%205%20-%20Indebtedness) This note details the company's debt obligations, including convertible senior notes and terminated credit facilities * The Credit Facility with MidCap Financial Trust was terminated on May 3, 2024, with a **$7.7 million** payment of the outstanding debt balance[55](index=55&type=chunk) * The Company issued **$200.0 million** aggregate principal amount of 5.00% convertible senior notes due 2027 on May 21, 2020, maturing June 1, 2027[56](index=56&type=chunk) 2027 Convertible Senior Notes (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Principal amount | $200,000 | $200,000 | | Unamortized debt discount | $(1,865) | $(2,321) | | Unamortized debt issuance cost | $(126) | $(156) | | **Net carrying amount** | **$198,009** | **$197,523** | * Total interest expense related to the 2027 Notes for the six months ended June 30, 2025, was **$5,486 thousand**, including contractual interest and amortization of debt discount and issuance costs[64](index=64&type=chunk) [Note 6 - Licenses, Asset Acquisitions and Contingent Consideration](index=18&type=section&id=Note%206%20-%20Licenses,%20Asset%20Acquisitions%20and%20Contingent%20Consideration) This note outlines the company's licensing agreements, asset acquisitions, and potential future contingent payments * The Company holds an exclusive worldwide license from Pulmokine, Inc. for seralutinib, with obligations for future development, regulatory, and sales milestone payments totaling up to **$283.0 million**, plus tiered royalties[67](index=67&type=chunk) * Milestone payments made include **$5.5 million** upfront (Oct 2017), **$5.0 million** for Phase 2 initiation (Jan 2021), and **$10.0 million** for Phase 3 initiation (Jan 2024, accrued in 2023)[68](index=68&type=chunk) * As of June 30, 2025, no other milestones had been accrued as the underlying contingencies had not yet been met[68](index=68&type=chunk) [Note 7 - Stockholders' Equity](index=19&type=section&id=Note%207%20-%20Stockholders'%20Equity) This note provides details on the company's equity structure, including stock options and the Chiesi Equity Option * On May 3, 2024, the Company granted Chiesi an Equity Option to purchase common stock, allowing Chiesi's beneficial ownership not to exceed **9.9%** of outstanding shares, with a purchase price of **107.5%** of the 30-trading day VWAP, but no less than **$1.63 per share**[70](index=70&type=chunk) * The Equity Option was valued at **$0.5 million** and is included in additional paid-in capital[70](index=70&type=chunk) [Note 8 - Equity Incentive Plans](index=19&type=section&id=Note%208%20-%20Equity%20Incentive%20Plans) This note describes the company's various equity incentive plans and stock-based compensation expenses * As of June 30, 2025, **2,691,904 shares** were available for issuance under the 2023 Inducement Plan, and **12,378,782 shares** were available under the 2019 Plan (which was amended in 2025 to increase authorized shares by **11,350,000**)[72](index=72&type=chunk)[73](index=73&type=chunk) * The 2019 Employee Stock Purchase Plan (ESPP) had **6,307,346 shares** available for issuance as of June 30, 2025, with **504,507 shares** issued during the six months ended June 30, 2025[74](index=74&type=chunk) Stock Option Activity | Metric | Value | | :---------------------------------- | :---------------- | | Outstanding as of December 31, 2024 | 34,416,337 | | Options granted | 15,038,174 | | Options exercised | (213,883) | | Options forfeited/cancelled | (967,677) | | **Outstanding as of June 30, 2025** | **48,272,951** | | Weighted Average Exercise Price (June 30, 2025) | $1.70 | | Aggregate Intrinsic Value (June 30, 2025) | $6,729k | Stock-Based Compensation Expense (in thousands) | Period | Research and development (in thousands) | General and administrative (in thousands) | Total (in thousands) | | :-------------------------------- | :-------------------------------------- | :-------------------------------------- | :------------------- | | Three months ended June 30, 2025 | $1,328 | $1,258 | $2,586 | | Three months ended June 30, 2024 | $2,495 | $2,506 | $5,001 | | Six months ended June 30, 2025 | $2,466 | $2,525 | $4,991 | | Six months ended June 30, 2024 | $5,423 | $5,389 | $10,812 | [Note 9 - Commitments and Contingencies](index=22&type=section&id=Note%209%20-%20Commitments%20and%20Contingencies) This note discloses the company's contractual obligations, including operating leases and potential legal contingencies * On July 9, 2024, the Company entered into a 63-month lease for new office space, commencing August 1, 2024, with a base rent of **$109,605 per month** (effective October 1, 2024) subject to annual **3%** increases[85](index=85&type=chunk) Lease Costs (in thousands) | Period | Operating Lease Cost (in thousands) | Short-term Lease Cost (in thousands) | Total Lease Cost (in thousands) | | :-------------------------------- | :---------------------------------- | :--------------------------------- | :-------------------------- | | Three months ended June 30, 2025 | $359 | $5 | $364 | | Three months ended June 30, 2024 | $779 | $7 | $786 | | Six months ended June 30, 2025 | $851 | $11 | $862 | | Six months ended June 30, 2024 | $1,557 | $21 | $1,578 | Future Undiscounted Operating Lease Payments (in thousands) | Year ending December 31 | Undiscounted Rent Payments (in thousands) | | :---------------------- | :--------------------------------------- | | 2025 (remaining 6 months) | $708 | | 2026 | $1,417 | | 2027 | $1,406 | | 2028 | $1,448 | | 2029 | $1,237 | | **Total Undiscounted Rent Payments** | **$6,216** | | Present value discount | $(1,392) | | **Present Value of Lease Payments** | **$4,824** | [Note 10 - Significant Agreements and Contracts](index=23&type=section&id=Note%2010%20-%20Significant%20Agreements%20and%20Contracts) This note details major collaboration agreements, particularly the global partnership with Chiesi for seralutinib * On May 3, 2024, the Company entered into a global collaboration and license agreement with Chiesi for the development and commercialization of seralutinib for PAH and PH-ILD, granting Chiesi exclusive worldwide licenses[89](index=89&type=chunk)[90](index=90&type=chunk) * Under the agreement, Chiesi paid an upfront, nonrefundable payment of **$160 million**, and the Company is eligible for up to **$146 million** in regulatory milestones and **$180 million** in sales milestones, with equal sharing of U.S. commercial profits/losses and mid-to-high teens percentage royalties on ROW net sales[93](index=93&type=chunk) Contract Liabilities Related to Chiesi Collaboration Agreement (in thousands) | Metric | 2025 (in thousands) | 2024 (in thousands) | | :------------------------------------------------------------------------------------------------ | :------------------ | :------------------ | | Balance, December 31 | $55,919 | $— | | Payments received in advance | $— | $159,536 | | Revenue from sale of US license | $— | $(76,686) | | Revenue from sale of ROW license | $— | $(12,050) | | Revenue from PAH R&D service performance obligations satisfied during reporting period | $(6,144) | $(3,398) | | Revenue from PH-ILD R&D service performance obligations satisfied during reporting period | $(1,133) | $(60) | | Effect of exchange rate changes on contract liabilities | $6,325 | $(646) | | **Balance, June 30** | **$54,967** | **$66,696** | * As of June 30, 2025, the contract liability of **$55.0 million** related to the Chiesi Collaboration Agreement is expected to be recognized over **3.5 years**, with **$23.5 million** classified as current and **$31.5 million** as long-term[102](index=102&type=chunk) [Note 11 - Segment Reporting](index=26&type=section&id=Note%2011%20-%20Segment%20Reporting) This note clarifies that the company operates as a single segment, with all revenue from the Chiesi Collaboration Agreement * The Company operates as a single operating segment, with all revenue derived from the Chiesi Collaboration Agreement and wholly attributable to the United States[105](index=105&type=chunk) Segment Net Loss (in thousands) | Metric | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :---------------------- | :------------------------------------------ | :------------------------------------------ | | Total revenue | $21,378 | $95,842 | | Less: Seralutinib R&D | $79,616 | $62,343 | | Less: Other segment items | $17,337 | $23,371 | | Interest income | $(836) | $(2,093) | | Interest expense | $5,490 | $6,045 | | Other income, net | $(5,318) | $(5,563) | | **Segment net loss** | **$(74,911)** | **$7,304** | [Note 12 - Income Taxes](index=27&type=section&id=Note%2012%20-%20Income%20Taxes) This note explains the company's income tax provisions, effective tax rates, and valuation allowances * The annual effective tax rate from continuing operations was **0%** for the three and six months ended June 30, 2025, due to a full valuation allowance, compared to **7.6%** and **4.1%** for the respective periods in 2024[107](index=107&type=chunk) * No provision for income taxes was recorded for the three and six months ended June 30, 2025, while a **$4.4 million** provision was recorded for the same periods in 2024[107](index=107&type=chunk)[140](index=140&type=chunk) [Note 13 - Subsequent Events](index=27&type=section&id=Note%2013%20-%20Subsequent%20Events) This note confirms the evaluation of events occurring after the reporting period, with no material impacts identified * The Company evaluated all subsequent events and transactions through the filing date and found no material events that impacted the condensed consolidated financial statements or disclosures[108](index=108&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=28&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the Company's financial condition and results of operations, highlighting key financial performance metrics, liquidity, capital resources, and future funding requirements [Forward-Looking Statements](index=28&type=section&id=Forward-Looking%20Statements) This section cautions readers about forward-looking statements, highlighting inherent risks and uncertainties * This report contains forward-looking statements regarding future results, financial position, business strategies, R&D plans, regulatory approvals, and commercialization timing for seralutinib[110](index=110&type=chunk) * These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially, as described in the 'Risk Factors' section[110](index=110&type=chunk)[111](index=111&type=chunk) * The Company does not plan to publicly update or revise any forward-looking statements unless required by applicable law[111](index=111&type=chunk) [Overview](index=28&type=section&id=Overview) This section provides a high-level summary of the company's business, strategic partnerships, and financial performance * Gossamer Bio is a late-stage clinical biopharmaceutical company focused on developing seralutinib for pulmonary hypertension (PH), with topline data from the Phase 3 PROSERA Study in PAH expected in February 2026[112](index=112&type=chunk) * The Company entered a strategic global partnership with Chiesi in May 2024 for seralutinib development and commercialization[112](index=112&type=chunk)[116](index=116&type=chunk) * As of June 30, 2025, the Company had **$212.9 million** in cash, cash equivalents, and marketable securities, but incurred a net loss of **$74.9 million** for the six months ended June 30, 2025, contributing to an accumulated deficit of **$1,343.5 million**[114](index=114&type=chunk)[115](index=115&type=chunk) * Future cash needs are expected to be financed through equity offerings, debt financings, or collaborations, as product sales revenue is not anticipated until regulatory approval[117](index=117&type=chunk) [Components of Results of Operations](index=29&type=section&id=Components%20of%20Results%20of%20Operations) This section explains the key drivers of revenue and expenses, including R&D, G&A, and other income/expense items * All revenue to date has been generated from the Chiesi Collaboration Agreement, comprising a one-time development cost reimbursement for licenses and ongoing cost-sharing payments for R&D services[118](index=118&type=chunk) * Research and development expenses, primarily for seralutinib's preclinical and clinical development, are recognized as incurred and are expected to continue for the foreseeable future[120](index=120&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) * General and administrative expenses, consisting mainly of salaries, employee-related costs, and professional fees, are expected to continue to support the Company's infrastructure and public company operations[125](index=125&type=chunk)[126](index=126&type=chunk) * Other income (expense), net, includes interest income, investment accretion, interest expense related to the Credit Facility (prior to termination) and 2027 Notes, research and development tax credit, and other miscellaneous items[127](index=127&type=chunk) [Results of Operations – Comparison of the Three and Six Months Ended June 30, 2025 and 2024](index=31&type=section&id=Results%20of%20Operations%20%E2%80%93%20Comparison%20of%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section analyzes the financial performance for the current and prior periods, focusing on revenue, expenses, and net income/loss Results of Operations (in thousands) | Metric | Three months ended June 30, 2025 (in thousands) | Three months ended June 30, 2024 (in thousands) | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Total Revenue | $11,489 | $95,842 | $21,378 | $95,842 | | Research and development expenses | $41,575 | $35,086 | $79,616 | $67,478 | | General and administrative expenses | $8,679 | $8,669 | $17,337 | $18,236 | | Other income, net | $492 | $1,580 | $664 | $1,611 | | Net Income (loss) | $(38,273) | $49,232 | $(74,911) | $7,304 | * Total revenue decreased by **$84.4 million** for the three months and **$74.5 million** for the six months ended June 30, 2025, compared to 2024, primarily due to the absence of revenue from the sale of licenses in 2025[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) * Research and development expenses increased by **$6.5 million** for the three months and **$12.1 million** for the six months ended June 30, 2025, mainly driven by increased costs for seralutinib preclinical and clinical trials[133](index=133&type=chunk)[134](index=134&type=chunk) * Net income shifted to a net loss of **$(38.3) million** for the three months and **$(74.9) million** for the six months ended June 30, 2025, from net income in the prior year periods, reflecting the revenue decrease and increased R&D expenses[130](index=130&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and future capital requirements to sustain operations * The Company has incurred substantial operating losses since inception, resulting in an accumulated deficit of **$1,343.5 million** as of June 30, 2025[141](index=141&type=chunk) * Operations have been financed primarily by proceeds from equity financings (**$1,393.2 million**), 2027 Notes, and the Chiesi Collaboration Agreement (**$160.0 million** upfront payment and **$19.8 million** in reimbursements as of June 30, 2025)[144](index=144&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) Cash Flow Summary (in thousands) | Activity | Six months ended June 30, 2025 (in thousands) | Six months ended June 30, 2024 (in thousands) | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net cash provided by (used in) operating activities | $(86,785) | $64,046 | | Net cash provided by investing activities | $66,188 | $2,561 | | Net cash provided by (used in) financing activities | $598 | $(11,769) | | Effect of exchange rate changes | $234 | $(70) | | **Net increase (decrease) in cash and cash equivalents** | **$(19,765)** | **$54,768** | * Management believes existing cash, cash equivalents, and marketable securities (**$212.9 million** as of June 30, 2025) will be sufficient to fund operations through at least the next 12 months[144](index=144&type=chunk)[158](index=158&type=chunk) * Future capital requirements are dependent on R&D costs, clinical trial progress, manufacturing, regulatory review, intellectual property, and commercialization efforts, necessitating additional capital through equity, debt, or collaborations[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[164](index=164&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=37&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This section states that there have been no material changes to the Company's market risk disclosures, including interest rate risk, foreign currency exchange risk, and inflation risk, since the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 * There have been no material changes to the Company's market risk, including interest rate risk, foreign currency exchange risk, and inflation risk, from the discussion provided in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024[162](index=162&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=37&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the principal executive and financial officers, concluded that the Company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025. There have been no material changes in internal control over financial reporting during the quarter * Management, with the participation of the principal executive officer and principal financial officer, concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[166](index=166&type=chunk) * There have been no changes in the Company's internal control over financial reporting during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, its internal control over financial reporting[167](index=167&type=chunk) [ITEM 1. LEGAL PROCEEDINGS](index=39&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The Company is not currently subject to any material legal proceedings, though it may be involved in claims incident to the ordinary course of business, which could adversely impact the company regardless of outcome * The Company is not currently subject to any material legal proceedings[169](index=169&type=chunk) * From time to time, the Company may be involved in legal proceedings or subject to claims incident to the ordinary course of business, which could have an adverse impact due to defense and settlement costs, diversion of resources, and other factors[169](index=169&type=chunk) [ITEM 1A. RISK FACTORS](index=39&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section highlights that there have been no material changes to previously disclosed risk factors, except for new legislative and healthcare reform measures that may increase the difficulty and cost of obtaining marketing approval and commercializing seralutinib, potentially affecting pricing and reimbursement * There have been no material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, except as set forth in this report[170](index=170&type=chunk) * Recently enacted legislation, future legislation, and healthcare reform measures may increase the difficulty and cost for the Company to obtain marketing approval for and commercialize seralutinib, potentially affecting prices and reimbursement[171](index=171&type=chunk)[175](index=175&type=chunk)[178](index=178&type=chunk) * Heightened governmental scrutiny in the United States of pharmaceutical pricing practices and state-level legislation designed to control pricing could negatively impact the Company's business, results of operations, financial condition, and prospects[175](index=175&type=chunk)[180](index=180&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=40&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section indicates that there were no unregistered sales of equity securities and no issuer repurchases of equity securities during the reporting period * There were no unregistered sales of equity securities during the period[182](index=182&type=chunk) * There were no issuer repurchases of equity securities during the period[183](index=183&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=40&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This item is not applicable to the Company for the reporting period * This item is not applicable[184](index=184&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=40&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the Company for the reporting period * This item is not applicable[186](index=186&type=chunk) [ITEM 5. OTHER INFORMATION](index=41&type=section&id=ITEM%205.%20OTHER%20INFORMATION) During the three months ended June 30, 2025, none of the Company's officers or directors adopted or terminated any Rule 10b5-1 trading plans * During the three months ended June 30, 2025, none of the Company's officers or directors adopted or terminated any contract, instruction, or written plan for the purchase or sale of its securities intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)[187](index=187&type=chunk) [ITEM 6. EXHIBITS](index=41&type=section&id=ITEM%206.%20EXHIBITS) This section provides an index of exhibits filed or furnished as part of this Quarterly Report on Form 10-Q, including organizational documents, debt instruments, equity incentive plans, and certifications * The Exhibit Index includes organizational documents (Amended and Restated Certificate of Incorporation, Bylaws), debt instruments (Indenture for 2027 Notes), equity incentive plans (2019 Incentive Award Plan), and various certifications (CEO, CFO, XBRL)[189](index=189&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) This section contains the duly authorized signatures of the Registrant's President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer and Chief Operating Officer (Principal Financial and Accounting Officer), certifying the report on behalf of Gossamer Bio, Inc * The report is signed by Faheem Hasnain, President and Chief Executive Officer (Principal Executive Officer), and Bryan Giraudo, Chief Financial Officer and Chief Operating Officer (Principal Financial and Accounting Officer), on August 5, 2025[193](index=193&type=chunk)[194](index=194&type=chunk)

Market Overview - U.S. stock futures are lower, with Dow futures down approximately 100 points on Monday [1] - Ultragenyx Pharmaceutical Inc. shares fell 8% to $27.15 after receiving a Complete Response Letter from the FDA for its gene therapy UX111 [1] Company-Specific Movements - MiNK Therapeutics, Inc. shares dropped 31% to $44.25 after a significant 730% increase on Friday due to a publication announcement [3] - Above Food Ingredients Inc. shares decreased 21.3% to $2.84 following a 134% rise on Friday after announcing a merger agreement [3] - Newegg Commerce, Inc. shares fell 11.3% to $43.66 after a 71% gain on Friday [3] - CEL-SCI Corporation shares declined 11% to $3.08 after an 8% drop on Friday, following a partnership announcement with a Saudi Arabian company [3] - Unusual Machines, Inc. shares slipped 8% to $11.13 after a 39% increase on Friday [3] - Gossamer Bio, Inc. shares fell 6.6% to $1.2700 after completing enrollment in a Phase 3 study for pulmonary arterial hypertension [3] - Gilat Satellite Networks Ltd. shares decreased 4.1% to $7.22 after announcing over $22 million in orders from satellite operators [3] - KalVista Pharmaceuticals, Inc. shares dipped 4% to $13.94 after reporting a wider-than-expected quarterly loss [3] - Apple Inc. shares fell 1% to $209.22 amid a significant management reshuffle, with CEO Tim Cook remaining in charge despite challenges [3]

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]