PART I. FINANCIAL INFORMATION Presents unaudited financial statements and management's discussion of financial condition and operations [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements of Astria Therapeutics, Inc. for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, fair value measurements, investments, commitments, and equity structure [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates | | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $76,319 | $59,820 | | Short-term investments | 182,859 | 268,312 | | Total current assets | 268,586 | 334,643 | | Total assets | $281,924 | $342,363 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $18,044 | $19,131 | | Total liabilities | 21,411 | 23,100 | | Total stockholders' equity | 260,513 | 319,263 | | Total liabilities and stockholders' equity | $281,924 | $342,363 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Details the company's revenues, expenses, and net loss over specific reporting periods | Operating Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $25,945 | $20,709 | $53,731 | $36,435 | | General and administrative | 9,875 | 8,094 | 19,084 | 16,518 | | Total operating expenses | 35,820 | 28,803 | 72,815 | 52,953 | | Loss from operations | (35,820) | (28,803) | (72,815) | (52,953) | | Interest and investment income | 2,889 | 4,647 | 6,235 | 8,888 | | Net loss | $(33,052) | $(24,172) | $(66,761) | $(44,100) | | Net loss per share - basic and diluted | $(0.57) | $(0.43) | $(1.15) | $(0.81) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Reports the company's net loss and other comprehensive income/loss components for specific periods | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(33,052) | $(24,172) | $(66,761) | $(44,100) | | Unrealized loss on short-term investments, net of tax of $0 | (76) | (31) | (179) | (45) | | Total other comprehensive loss | (76) | (31) | (179) | (45) | | Comprehensive loss | $(33,128) | $(24,203) | $(66,940) | $(44,145) | [Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity) Outlines changes in the company's equity accounts, including preferred stock and common stock, over time | (in thousands, except share data) | Balance at Dec 31, 2024 | Stock-based compensation expense | Unrealized loss on short-term investments | Net loss | Balance at Mar 31, 2025 | Stock-based compensation expense | Unrealized loss on short-term investments | Net loss | Balance at Jun 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Series X redeemable convertible preferred stock, value | $95,324 | — | — | — | $95,324 | — | — | — | $95,324 | | Common stock, par value | $57 | — | — | — | $57 | — | — | — | $57 | | Additional paid-in capital | $898,513 | $3,839 | — | — | $902,352 | $4,351 | — | — | $906,703 | | Accumulated deficit | $(674,794) | — | — | $(33,709) | $(708,503) | — | — | $(33,052) | $(741,555) | | Accumulated other comprehensive gain (loss) | $163 | — | $(103) | — | $60 | — | $(76) | — | $(16) | | Total stockholders' equity | $319,263 | $3,839 | $(103) | $(33,709) | $289,290 | $4,351 | $(76) | $(33,052) | $260,513 | | (in thousands, except share data) | Balance at Dec 31, 2023 | Issuance of common stock (underwriting) | Issuance of common stock (ATM) | Issuance of common stock (options/warrants) | Stock-based compensation expense | Unrealized loss on short-term investments | Net loss | Balance at Mar 31, 2024 | Issuance of common stock (options) | Stock-based compensation expense | Unrealized loss on short-term investments | Net loss | Balance at Jun 30, 2024 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Series X redeemable convertible preferred stock, value | $95,324 | — | — | — | — | — | — | $95,324 | — | — | — | — | $95,324 | | Common stock, par value | $41 | $10 | $3 | $1 | — | — | — | $55 | — | — | — | — | $55 | | Additional paid-in capital | $728,285 | $117,162 | $19,999 | $4,632 | $2,754 | — | — | $872,832 | $94 | $3,451 | — | — | $876,377 | | Accumulated deficit | $(580,534) | — | — | — | — | — | $(19,928) | $(600,462) | — | — | — | $(24,172) | $(624,634) | | Accumulated other comprehensive loss | — | — | — | — | — | $(14) | — | $(14) | — | — | $(31) | — | $(45) | | Total stockholders' equity | $243,116 | $117,172 | $20,002 | $4,633 | $2,754 | $(14) | $(19,928) | $367,735 | $94 | $3,451 | $(31) | $(24,172) | $347,077 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(70,076) | $(35,885) | | Net cash provided by (used in) investing activities | 86,575 | (194,334) | | Net cash provided by financing activities | — | 141,901 | | Net increase (decrease) in cash, cash equivalents and restricted cash | 16,499 | (88,318) | | Cash, cash equivalents and restricted cash, beginning of period | 59,820 | 175,693 | | Cash, cash equivalents and restricted cash, end of period | $76,319 | $87,375 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Nature of Business](index=12&type=section&id=1.%20Nature%20of%20Business) Describes the company's core business, product candidates, and financial viability - Astria Therapeutics, Inc. is a biopharmaceutical company focused on allergic and immunologic diseases. Its lead product candidate, navenibart, is in clinical development for hereditary angioedema (HAE), and STAR-0310 is in clinical development for atopic dermatitis (AD)[31](index=31&type=chunk) - As of June 30, 2025, the Company had an accumulated deficit of **$741.6 million** and **$259.2 million** in cash, cash equivalents, and short-term investments, sufficient to sustain operations for at least twelve months[33](index=33&type=chunk) - The Company has not generated product revenues and relies on equity financings, anticipating continued significant operating losses as it develops product candidates[34](index=34&type=chunk)[35](index=35&type=chunk) [2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the key accounting principles and methods used in preparing the financial statements - The financial statements are unaudited and prepared in accordance with U.S. GAAP, with certain disclosures condensed or omitted compared to annual reports. No material changes to significant accounting policies occurred during the three and six months ended June 30, 2025[36](index=36&type=chunk)[37](index=37&type=chunk) - The Company operates as one segment focused on allergic and immunologic diseases. Basic and diluted net loss per share were the same due to anti-dilutive common stock equivalents[42](index=42&type=chunk)[44](index=44&type=chunk) - New accounting pronouncements, ASU 2023-09 (Income Tax Disclosures) and ASU 2024-03/2025-01 (Expense Disaggregation), are being evaluated for their impact on future financial statement disclosures[49](index=49&type=chunk)[50](index=50&type=chunk) [3. Fair Value Measurements](index=15&type=section&id=3.%20Fair%20Value%20Measurements) Details the valuation methods and categorization of financial instruments measured at fair value - The Company measures cash equivalents and short-term investments at fair value on a recurring basis, categorizing them into Level 1 (quoted prices in active markets) and Level 2 (significant observable inputs) of the fair value hierarchy[51](index=51&type=chunk)[52](index=52&type=chunk) | Assets (in thousands) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | Total (June 30, 2025) | | :--- | :--- | :--- | :--- | | Money market funds | $35,772 | $— | $35,772 | | Reverse repurchase agreements | $— | $8,000 | $8,000 | | Short-term investments (Reverse repurchase agreements) | $— | $68,000 | $68,000 | | Short-term investments (Treasury notes) | $64,685 | $— | $64,685 | | Short-term investments (Treasury bills) | $41,984 | $— | $41,984 | | Short-term investments (Corporate debt securities) | $8,190 | $— | $8,190 | | **Total** | **$150,631** | **$76,000** | **$226,631** | | Assets (in thousands) | Level 1 (Dec 31, 2024) | Level 2 (Dec 31, 2024) | Total (Dec 31, 2024) | | :--- | :--- | :--- | :--- | | Money market funds | $30,610 | $— | $30,610 | | Short-term investments (Treasury notes) | $129,197 | $— | $129,197 | | Short-term investments (Reverse repurchase agreements) | $— | $100,000 | $100,000 | | Short-term investments (Treasury bills) | $39,115 | $— | $39,115 | | **Total** | **$198,922** | **$100,000** | **$298,922** | [4. Short-Term Investments](index=16&type=section&id=4.%20Short-Term%20Investments) Provides a breakdown of the company's short-term investment portfolio and associated unrealized gains/losses | Short-Term Investments (in thousands) | Amortized Cost (June 30, 2025) | Fair Value (June 30, 2025) | | :--- | :--- | :--- | | Reverse repurchase agreements | $68,000 | $68,000 | | Treasury notes | $64,690 | $64,685 | | Treasury bills | $41,994 | $41,984 | | Corporate debt securities | $8,191 | $8,190 | | **Total** | **$182,875** | **$182,859** | | Short-Term Investments (in thousands) | Amortized Cost (Dec 31, 2024) | Fair Value (Dec 31, 2024) | | :--- | :--- | :--- | | Treasury notes | $129,064 | $129,197 | | Reverse repurchase agreements | $100,000 | $100,000 | | Treasury bills | $39,085 | $39,115 | | **Total** | **$268,149** | **$268,312** | - As of June 30, 2025, there were twenty-three short-term investments with an aggregate unrealized loss of **$79.9 million**, compared to two investments with **$9.8 million** unrealized loss at December 31, 2024. These unrealized losses are not recognized in operations as they are not credit-related and the Company intends to hold them until recovery[54](index=54&type=chunk)[56](index=56&type=chunk) [5. Accrued Expenses](index=17&type=section&id=5.%20Accrued%20Expenses) Lists the various accrued liabilities, including contracted costs, compensation, and professional fees | Accrued Expenses (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accrued contracted costs | $10,507 | $6,187 | | Accrued compensation | $3,309 | $5,084 | | Accrued professional fees | $1,937 | $1,963 | | Accrued other | $154 | $193 | | **Total** | **$15,907** | **$13,427** | [6. Leases](index=17&type=section&id=6.%20Leases) Details the company's lease obligations, right-of-use assets, and related rent expenses - In January 2024, the Company entered into a sublease for new office space in Boston, commencing June 1, 2024, and ending November 30, 2028. This operating lease resulted in a lease liability and ROU asset of approximately **$5.8 million** at inception[59](index=59&type=chunk) | Year Ending December 31, | Amount (in thousands) | | :--- | :--- | | 2025 | $663 | | 2026 | $1,608 | | 2027 | $1,640 | | 2028 | $1,531 | | **Total lease payments** | **$5,442** | | Less: imputed interest | $(676) | | **Total operating lease liabilities** | **$4,766** | - Rent expense for the three and six months ended June 30, 2025, was **$0.4 million** and **$0.8 million**, respectively, an increase from **$0.3 million** and **$0.4 million** for the same periods in 2024[60](index=60&type=chunk) [7. Commitments](index=18&type=section&id=7.%20Commitments) Outlines the company's significant contractual obligations, including license agreements and milestone payments - Under the Ichnos License Agreement (October 2023) for the OX40 portfolio (including STAR-0310), the Company paid a **$15.0 million** upfront fee and is obligated for up to **$305.0 million** in development, regulatory, and commercial milestones, plus tiered royalties[61](index=61&type=chunk)[62](index=62&type=chunk) - Clinical milestones for STAR-0310's Phase 1a trial were met, resulting in **$2.0 million** milestone payments during Q1 2025. For navenibart, clinical milestones for the ALPHA-ORBIT Phase 3 trial were met in Q1 2025, leading to **$2.2 million** milestone payments in April 2025[62](index=62&type=chunk)[63](index=63&type=chunk) [8. Stockholders' Equity](index=18&type=section&id=8.%20Stockholders'%20Equity) Describes the components of stockholders' equity, including preferred stock and common stock - As of June 30, 2025, the Company had **31,107** shares of Series X Preferred Stock outstanding, convertible into **5,184,591** shares of common stock[64](index=64&type=chunk) - There were **56,434,219** shares of common stock issued and outstanding as of June 30, 2025, with **150,000,000** shares authorized[65](index=65&type=chunk) [9. Reserved for Future Issuance](index=20&type=section&id=9.%20Reserved%20for%20Future%20Issuance) Details the common stock shares reserved for future issuance under various plans and agreements | Common Stock Reserved for Future Issuance | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Options outstanding to purchase common stock | 11,225,811 | 6,850,889 | | Reserved under incentive plans | 9,973,775 | 8,849,170 | | Warrants for the purchase of common stock | 8,367,373 | 8,367,373 | | Series X Preferred Stock | 5,184,591 | 5,184,591 | | Reserved under employee stock purchase plan | 55,216 | 49,139 | | **Total** | **34,806,766** | **29,301,162** | [10. Stock-Based Compensation](index=20&type=section&id=10.%20Stock-Based%20Compensation) Reports on stock option activity and the expense recognized for stock-based compensation | Stock Option Activity | Shares (June 30, 2025) | Weighted-Average Exercise Price (June 30, 2025) | | :--- | :--- | :--- | | Outstanding at December 31, 2024 | 6,850,889 | $13.75 | | Granted | 4,450,300 | $6.53 | | Cancelled or forfeited | (74,905) | $9.97 | | Expired | (473) | $682.65 | | **Outstanding at June 30, 2025** | **11,225,811** | **$10.89** | | Vested and exercisable at June 30, 2025 | 3,570,804 | $14.39 | | Vested and expected to vest at June 30, 2025 | 11,225,811 | $10.89 | | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $2,729 | $2,531 | $5,266 | $4,581 | | Research and development | $1,622 | $920 | $2,924 | $1,624 | | **Total** | **$4,351** | **$3,451** | **$8,190** | **$6,205** | - As of June 30, 2025, total unrecognized compensation expense for unvested stock options was **$44.8 million**, expected to be recognized over approximately **2.8** years[69](index=69&type=chunk) [11. Segment Reporting](index=21&type=section&id=11.%20Segment%20Reporting) Explains the company's operating segments and how performance is managed and assessed - The Company operates and manages its business as one reportable segment, focused on the discovery, development, and commercialization of novel therapeutics for allergic and immunologic diseases. Performance is assessed based on consolidated net loss[71](index=71&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) | Segment Expenses (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development: Navenibart | $11,082 | $7,935 | $22,911 | $15,071 | | Research and development: STAR-0310 | $5,738 | $5,710 | $13,174 | $8,685 | | General and administrative: Employee expenses | $3,330 | $2,736 | $6,854 | $5,598 | | Stock-based compensation expense | $4,351 | $3,451 | $8,190 | $6,205 | | Other income, net | $(2,768) | $(4,631) | $(6,054) | $(8,853) | | **Segment net loss** | **$33,052** | **$24,172** | **$66,761** | **$44,100** | [12. Subsequent Events](index=22&type=section&id=12.%20Subsequent%20Events) Discloses significant events that occurred after the reporting period but before the financial statements were issued - On August 6, 2025, the Company entered into a license agreement with Kaken Pharmaceutical, Co., Ltd. (Kaken) for the exclusive development and commercialization of navenibart in Japan for HAE prevention[79](index=79&type=chunk) - Under the Kaken License Agreement, Astria will receive an upfront payment of **$16.0 million**, potential additional commercialization and sales milestones of **$16.0 million**, and tiered royalties from mid-teens to **30%** of net sales[80](index=80&type=chunk) - Kaken will support Astria's ALPHA-ORBIT Phase 3 trial in Japan, handle regulatory submissions, and reimburse a portion of the navenibart Phase 3 program costs[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&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 operational results, highlighting the progress of its lead product candidates, navenibart and STAR-0310, and discussing financial performance, liquidity, capital resources, and future funding requirements [Overview](index=24&type=section&id=Overview) Introduces the company's strategic focus and lead product candidates in development - Astria Therapeutics is a biopharmaceutical company focused on allergic and immunologic diseases, aiming to develop first-choice therapies[83](index=83&type=chunk) - Navenibart, a plasma kallikrein inhibitor, is the lead candidate for hereditary angioedema (HAE), with potential for best-in-class, market-leading treatment. STAR-0310, an OX40 antagonist, is in clinical development for atopic dermatitis (AD)[83](index=83&type=chunk) [Navenibart](index=24&type=section&id=Navenibart) Details the clinical development progress and key trial results for navenibart, a lead product candidate - Navenibart, a potential best-in-class monoclonal antibody for HAE, aims for long-acting attack prevention with Q3M/Q6M administration. It has Fast Track and Orphan Drug designations from the FDA and Orphan Medicinal Product Designation from the European Commission[84](index=84&type=chunk) - The global Phase 3 ALPHA-ORBIT trial for navenibart was initiated in February 2025, evaluating efficacy and safety in HAE patients, with topline results anticipated in early 2027. An associated long-term trial, ORBIT-EXPANSE, is also planned[85](index=85&type=chunk) | ALPHA-STAR Trial Results (6 months average) | Cohort 1 (450 mg single dose, n=4) | Cohort 2 (600 mg then 300 mg Q3M, n=6) | Cohort 3 (600 mg then 600 mg Day 28, n=6) | | :--- | :--- | :--- | :--- | | Reduction in monthly attack rate | 91% | 95% | 92% | | Reduction in moderate and severe attacks | 96% | 95% | 96% | | Reduction in acute rescue medication use | 94% | 94% | 91% | | Attack-free patients (through 3 months) | 50% | 67% | 67% | | Attack-free patients (through 6 months) | 25% | N/A | N/A | - Initial results from the ALPHA-SOLAR long-term open-label trial showed robust overall reduction in monthly attack rate (**92%**/**97%** mean/median) and favorable safety, with **50%** overall attack-freedom over **6** months[88](index=88&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) [STAR-0310](index=26&type=section&id=STAR-0310) Outlines the development status and differentiated profile of STAR-0310 for atopic dermatitis - STAR-0310, an OX40 antagonist, is being developed for moderate-to-severe atopic dermatitis (AD) to reduce disease activity and treatment burden, leveraging YTE half-life extension technology for infrequent dosing[94](index=94&type=chunk) - A Phase 1a trial in healthy subjects was initiated in January 2025, with early proof-of-concept results anticipated in Q3 2025. Data presented in June 2025 supports STAR-0310's differentiated profile as a potential best-in-class OX40 antagonist[95](index=95&type=chunk)[96](index=96&type=chunk) [Financial Overview](index=28&type=section&id=Financial%20Overview) Summarizes the company's financial performance, liquidity, and future funding requirements - The Company's business is highly dependent on the success of navenibart and STAR-0310. Net losses were **$66.8 million** for the six months ended June 30, 2025, compared to **$44.1 million** for the same period in 2024, with an accumulated deficit of **$741.6 million**[98](index=98&type=chunk) - As of June 30, 2025, cash, cash equivalents, and short-term investments totaled **$259.2 million**. This, combined with the Kaken upfront payment and expected reimbursements, is projected to fund operations into 2028[99](index=99&type=chunk) - Substantial additional funding will be required to complete the development and commercialization of product candidates and support future operations, as current capital is insufficient for full development[99](index=99&type=chunk) [Revenue](index=28&type=section&id=Revenue) States the company's current revenue generation status - As of June 30, 2025, the Company has not generated any revenue from product sales[100](index=100&type=chunk) [Research and Development Expenses](index=28&type=section&id=Research%20and%20Development%20Expenses) Details the components and trends of the company's research and development expenditures - R&D expenses primarily include employee-related costs, expenses for third-party CROs, lab supplies, manufacturing, and facilities. Costs are expensed as incurred, with nonrefundable advance payments deferred and capitalized[101](index=101&type=chunk)[102](index=102&type=chunk)[105](index=105&type=chunk) | R&D Expenses by Program (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Navenibart | $22,911 | $15,071 | | STAR-0310 | $13,174 | $8,685 | | Other programs | $854 | $497 | | Costs not directly allocated to programs | $16,792 | $12,182 | | **Total research and development expenses** | **$53,731** | **$36,435** | - R&D expenses are expected to increase in future periods due to ongoing clinical trials and development activities for navenibart and STAR-0310, with significant uncertainties regarding timing and costs to complete development[104](index=104&type=chunk) [General and Administrative Expenses](index=32&type=section&id=General%20and%20Administrative%20Expenses) Describes the nature and trends of the company's general and administrative costs - G&A expenses primarily consist of salaries, stock-based compensation for executive, finance, IT, business development, legal, and HR functions, along with facility costs, legal fees, and consulting services[108](index=108&type=chunk) - G&A expenses are anticipated to increase as the company grows, develops its product candidates, and potentially expands its pipeline[109](index=109&type=chunk) [Other Income (Expense)](index=32&type=section&id=Other%20Income%20(Expense)) Explains the sources and changes in the company's non-operating income and expenses - Other income (expense) includes interest and investment income from cash, cash equivalents, and short-term investments, net of accretion/amortization, and foreign currency fluctuations[110](index=110&type=chunk) [Critical Accounting Estimates](index=32&type=section&id=Critical%20Accounting%20Estimates) Confirms the status of critical accounting policies and estimates - No material changes to critical accounting policies were reported during the six months ended June 30, 2025, as compared to the 2024 Annual Report on Form 10-K[112](index=112&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Analyzes the financial performance for specific reporting periods, highlighting key drivers of change [Comparison of the Three Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares the financial results for the three-month periods, detailing changes in expenses and net loss | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Period-to-Period Change | | :--- | :--- | :--- | :--- | | Research and development | $25,945 | $20,709 | $5,236 | | General and administrative | $9,875 | $8,094 | $1,781 | | Total operating expenses | $35,820 | $28,803 | $7,017 | | Loss from operations | $(35,820) | $(28,803) | $(7,017) | | Other income, net | $2,768 | $4,631 | $(1,863) | | Net loss | $(33,052) | $(24,172) | $(8,880) | - Research and development expenses increased by **25%** (**$5.2 million**) due to higher navenibart and STAR-0310 expenses, and increased employee costs. General and administrative expenses rose by **22%** (**$1.8 million**) primarily from increased employee and professional services expenses[114](index=114&type=chunk) - Other income, net, decreased by **40%** (**$1.8 million**) due to a reduction in interest-earning assets and lower yields[115](index=115&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares the financial results for the six-month periods, detailing changes in expenses and net loss | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Period-to-Period Change | | :--- | :--- | :--- | :--- | | Research and development | $53,731 | $36,435 | $17,296 | | General and administrative | $19,084 | $16,518 | $2,566 | | Total operating expenses | $72,815 | $52,953 | $19,862 | | Loss from operations | $(72,815) | $(52,953) | $(19,862) | | Other income, net | $6,054 | $8,853 | $(2,799) | | Net loss | $(66,761) | $(44,100) | $(22,661) | - Research and development expenses increased by **47%** (**$17.3 million**), driven by a **$7.8 million** increase in navenibart expenses (including a **$2.2 million** milestone payment for ALPHA-ORBIT) and a **$4.5 million** increase in STAR-0310 expenses (including a **$2.0 million** milestone payment for Phase 1a trial)[117](index=117&type=chunk)[118](index=118&type=chunk) - General and administrative expenses increased by **16%** (**$2.6 million**) due to a **$2.2 million** increase in employee expenses (including stock-based compensation) and higher general office/facilities expenses. Other income, net, decreased by **32%** (**$2.8 million**) due to lower interest-earning assets and yields[119](index=119&type=chunk)[120](index=120&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, funding history, and future capital needs - Since inception through June 30, 2025, the Company raised **$839.2 million** through equity financings. As of June 30, 2025, cash, cash equivalents, and short-term investments were **$259.2 million**, expected to fund operations into 2028 with the Kaken upfront payment and reimbursements[121](index=121&type=chunk)[122](index=122&type=chunk) - The current operating plan includes supporting navenibart's ALPHA-ORBIT Phase 3 trial and STAR-0310's Phase 1a trial. However, existing capital is insufficient to complete the development of any product candidates, necessitating substantial additional funding[122](index=122&type=chunk)[123](index=123&type=chunk) - The 2021 ATM Program was completed in Q1 2024, raising **$20.0 million** net proceeds in the six months ended June 30, 2024. A new 2024 ATM Program for up to **$150.0 million** was established in March 2024, with no activity in the six months ended June 30, 2025[125](index=125&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) Analyzes the company's cash movements across operating, investing, and financing activities [Comparison of the Six Months Ended June 30, 2025 and 2024](index=35&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares cash flow activities for the six-month periods, highlighting significant changes | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(70,076) | $(35,885) | | Net cash provided by (used in) investing activities | $86,575 | $(194,334) | | Net cash provided by financing activities | $— | $141,901 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $16,499 | $(88,318) | [Net Cash Used in Operating Activities](index=35&type=section&id=Net%20Cash%20Used%20in%20Operating%20Activities) Explains the primary drivers behind cash used in the company's core operations - Net cash used in operating activities increased to **$70.1 million** for the six months ended June 30, 2025, from **$35.9 million** in 2024, primarily due to a higher net loss (**$66.8 million**) and a **$10.3 million** net increase in net assets[127](index=127&type=chunk)[128](index=128&type=chunk) [Net Cash Provided by (Used in) Investing Activities](index=35&type=section&id=Net%20Cash%20Provided%20by%20(Used%20in)%20Investing%20Activities) Details the cash flows related to the company's investment activities, particularly short-term investments - Net cash provided by investing activities was **$86.6 million** for the six months ended June 30, 2025, a significant change from **$194.3 million** used in 2024. This shift was driven by **$1.4 billion** in sales and maturities of short-term investments, partially offset by **$1.3 billion** in purchases[129](index=129&type=chunk)[130](index=130&type=chunk) [Net Cash Provided by Financing Activities](index=35&type=section&id=Net%20Cash%20Provided%20by%20Financing%20Activities) Describes the cash flows generated from or used in financing activities, such as equity offerings - No cash was provided by financing activities for the six months ended June 30, 2025. In contrast, **$141.9 million** was provided in the same period of 2024, primarily from a **$117.2 million** public offering and **$20.0 million** from the 2021 ATM Program[131](index=131&type=chunk)[132](index=132&type=chunk) [Funding Requirements](index=37&type=section&id=Funding%20Requirements) Outlines the company's anticipated capital needs and strategies for securing future funding - The Company's primary capital uses include clinical and manufacturing costs, R&D services, compensation, and regulatory expenses. Despite current cash runway into 2028, significant additional funding will be required to complete product development and commercialization[133](index=133&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) - Future funding depends on clinical trial progress, collaboration terms, regulatory approvals, commercialization costs, competition, and intellectual property protection. The Company expects to rely on equity offerings, debt financings, and collaborations[135](index=135&type=chunk)[137](index=137&type=chunk) - Failure to raise adequate capital could lead to delays, reductions, or termination of product development and commercialization efforts, or unfavorable licensing terms[138](index=138&type=chunk) [Material Cash Requirements from Known Contractual Obligations](index=38&type=section&id=Material%20Cash%20Requirements%20from%20Known%20Contractual%20Obligations) Identifies significant future cash outflows from contractual agreements and commitments - Material contractual obligations include a sublease requiring monthly payments of **$0.1 million** until November 2028, and **$2.2 million** in clinical milestone payments for the ALPHA-ORBIT Phase 3 trial paid in April 2025[139](index=139&type=chunk) - The Company has cancelable agreements with CROs and manufacturers. License and research agreements, such as with Ichnos for STAR-0310 and for navenibart, include potential milestone and royalty payments contingent on future events[140](index=140&type=chunk)[141](index=141&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the company's disclosure controls and procedures, concluding their effectiveness as of June 30, 2025, and reporting no material changes in internal control over financial reporting during the period [Management's Evaluation of our Disclosure Controls and Procedures](index=38&type=section&id=Management's%20Evaluation%20of%20our%20Disclosure%20Controls%20and%20Procedures) Reports on management's assessment of the effectiveness of the company's disclosure controls - Management, including the principal executive and financial officers, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025[143](index=143&type=chunk) - They concluded that the disclosure controls and procedures were effective at the reasonable assurance level, designed to ensure timely and accurate reporting of information[142](index=142&type=chunk)[143](index=143&type=chunk) [Changes in Internal Control over Financial Reporting](index=40&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) States whether any material changes occurred in the company's internal control over financial reporting - There were no changes in internal control over financial reporting during the period covered by this report that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[144](index=144&type=chunk) PART II. OTHER INFORMATION Provides additional information, including updated risk factors and a list of exhibits [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section supplements the risk factors from the annual report, detailing new or updated risks related to collaborations, U.S. trade policy, and potential disruptions at government agencies like the FDA, all of which could materially impact the company's business, financial condition, and development timelines [Collaborations and Partnerships Risks](index=41&type=section&id=Collaborations%20and%20Partnerships%20Risks) Details potential challenges and adverse impacts associated with the company's collaborative agreements - The license agreement with Kaken Pharmaceutical Co., Ltd. for navenibart in Japan, and any future collaborations, may not lead to successful development, regulatory approval, or commercialization of products[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - Collaborators may have conflicting priorities, insufficient resource allocation, or may terminate agreements, potentially delaying development, increasing costs, or negatively impacting market penetration[147](index=147&type=chunk)[150](index=150&type=chunk) - Disagreements with collaborators over proprietary rights, development course, or pricing decisions could cause delays, litigation, or adverse impacts on product candidates[151](index=151&type=chunk)[153](index=153&type=chunk) [U.S. Trade Policy Risks](index=44&type=section&id=U.S.%20Trade%20Policy%20Risks) Outlines potential adverse effects on the business due to changes in U.S. trade policies, including tariffs and import investigations - Changes in U.S. trade policy, including tariffs (e.g., **10%** baseline, **20%** on China, **25%** on Canada/Mexico for non-USMCA goods), could materially adversely impact the business[158](index=158&type=chunk) - A Section 232 investigation into pharmaceutical imports could lead to additional tariffs, increasing clinical manufacturing costs, especially given reliance on third-party contract manufacturers outside the U.S. (e.g., China)[159](index=159&type=chunk)[161](index=161&type=chunk) - Supply chain disruptions, increased raw material costs, and delays in product development and commercialization are potential consequences of new tariff policies or trade restrictions[161](index=161&type=chunk) [FDA and Government Agency Disruptions Risks](index=45&type=section&id=FDA%20and%20Government%20Agency%20Disruptions%20Risks) Addresses the risks posed by potential disruptions at regulatory bodies like the FDA, affecting product development and approval timelines - Disruptions at the FDA, including leadership/personnel losses, reorganization, and budget cuts (e.g., RIF in April 2025), could negatively impact guidance, review, and approval timelines for product candidates[162](index=162&type=chunk)[163](index=163&type=chunk) - Uncertainty exists regarding the impact of regulatory reform measures and government shutdowns on the FDA's ability to conduct operations and review activities, potentially delaying PDUFA reviews[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) - Prolonged government shutdowns affecting regulatory agencies like the SEC could significantly impact the business, including access to public markets and necessary capital[166](index=166&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) This section states that no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the second quarter of 2025[167](index=167&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including various certifications, the stock incentive plan, and Inline XBRL documents | Exhibit Number | Exhibit Description | | :--- | :--- | | 10.1* | Second Amended and Restated 2015 Stock Incentive Plan, as amended | | 31.1* | Certification of principal executive officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 31.2* | Certification of principal financial officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 32.1** | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of The Sarbanes Oxley Act of 2002, by the Registrant's principal executive officer and principal financial officer | | 101.INS | Inline XBRL Instance Document | | 101.SCH | Inline XBRL Taxonomy Extension Schema Document | | 101.CAL | Inline XBRL Taxonomy Calculation Linkbase Document | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB | Inline XBRL Taxonomy Label Linkbase Document | | 101.PRE | Inline XBRL Taxonomy Presentation Linkbase Document | | 104 | Cover Page Data File | SIGNATURES Confirms the official signing and submission of the report by authorized personnel - The report was duly signed on behalf of Astria Therapeutics, Inc. by Noah C. Clauser, Chief Financial Officer (Principal Financial Officer), on August 12, 2025[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)

Navenibart (STAR-0215) for Hereditary Angioedema (HAE) - Navenibart is designed for a better patient experience with potential for Q3M and Q6M administration[9, 5] - The estimated HAE market is expected to grow from $3.2 billion in 2024 to $5.4 billion in 2030[14] - A global Phase 3 pivotal trial is ongoing to assess the efficacy and safety of Navenibart for Q3M and Q6M administration in HAE, with a 3:3:3:2 randomization (n=135)[17, 18] - ALPHA-STAR Phase 1b/2 results showed Navenibart achieved 91-95% attack rate reduction, 25-67% attack-free rate, 95-96% reduction in moderate and severe attack rate, and 91-94% reduction in attacks requiring rescue medication[29] - QSP model-predicted change in time-normalized monthly HAE attack rate shows 91-93% reduction with 600mg Q6M, 96-99% reduction with 600mg loading and 300mg Q3M, and 83-87% reduction with 600mg Q3M[41] - Market research indicates Navenibart Q3M & Q6M is expected to gain 46% total patient share from switches and 53% from newly initiating preventative therapies[50, 53] STAR-0310 for Atopic Dermatitis (AD) - The estimated moderate-to-severe AD market is expected to grow from $7 billion in 2023 to $26 billion in 2030[59] - STAR-0310 is a high affinity, next-generation anti-OX40 antibody with potential for low volume, infrequent SC delivery and a patent expiring in 2044[74, 75] - STAR-0310 has an estimated mean half-life of 26 days in cynomolgus monkeys, suggesting potential for administration as infrequently as once every 6 months in humans[87, 88] - A Phase 1a trial of STAR-0310 in healthy subjects has been initiated, with initial results expected in Q3 2025[91] Financial Position - As of March 31, 2025, the company had $295.1 million in cash, cash equivalents, and short-term investments[97] - The company expects its cash to fund operations into mid-2027[97]

Summary of Astria Therapeutics Conference Call Company Overview - **Company**: Astria Therapeutics (ATXS) - **Focus**: Development of first-choice products for patients with allergic and immunologic diseases, emphasizing competitive efficacy, safety, and low treatment burden [1] Key Product Insights - **Lead Product**: Nivenabart, a monoclonal antibody targeting plasmacallicrin, currently in Phase III trials for hereditary angioedema (HAE) [1][2] - **Efficacy Data**: Nivenabart demonstrated over 90% reduction in attack rates in proof of concept trials, with potential for dosing every six months [2][10] - **Secondary Program**: STAR310, an OX40 receptor antagonist, with Phase I data expected later in the year [2] Clinical Trial Design and Expectations - **Phase III Trial**: Includes both Q3 and Q6 month dosing regimens, initiated in February 2025, with a focus on providing options for patients and physicians [16][20] - **Enrollment**: Positive enthusiasm from patients and physicians, with expectations for top-line data in early 2027 [20] - **Regulatory Strategy**: Data from the Alpha Solar trial will support FDA filing but is not critical for the pivotal trial [12][21] Market Opportunity - **HAE Market Size**: Expected to grow to approximately $5.4 billion by 2030, driven by earlier diagnoses and increased prophylactic therapy [13][14] - **Market Positioning**: Nivenabart is positioned to capture significant market share from existing therapies, particularly TEKHZYRO, due to its competitive profile and dosing convenience [15][25] Competitive Landscape - **Atopic Dermatitis**: STAR310 targets a significant unmet need in a growing market, particularly for patients inadequately controlled by existing therapies like Dupixent [29][30] - **Differentiation Strategy**: STAR310 aims to provide efficacy without the adverse effects associated with T cell killing, which is a concern with other therapies [33][34] Financial Position and Future Catalysts - **Cash Position**: Approximately $300 million, expected to sustain operations into mid-2027 [38] - **Upcoming Catalysts**: Key data releases include long-term safety and efficacy from the Alpha Solar trial and Phase I data for STAR310, with a focus on differentiating factors [38][39] Additional Insights - **Physician Feedback**: Physicians are interested in both dosing regimens for Nivenabart, indicating a potential for flexible treatment options based on patient needs [18][19] - **Market Research**: Indications show strong interest in Nivenabart's profile, suggesting a favorable reception among physicians for switching from existing therapies [25][26] This summary encapsulates the critical points discussed during the Astria Therapeutics conference call, highlighting the company's strategic focus, product pipeline, market opportunities, and financial outlook.

Clinical Development - Navenibart is in clinical development for hereditary angioedema (HAE) and has received Fast Track and Orphan Drug designations from the FDA [80]. - The Phase 3 trial of navenibart, ALPHA-ORBIT, involves up to 135 adults and 10 adolescents, with top-line results expected in early 2027 [81]. - STAR-0310 is in early clinical development, with a Phase 1a trial initiated in January 2025, and early proof-of-concept results anticipated in Q3 2025 [87]. - Initial proof-of-concept data for navenibart from the ALPHA-STAR trial showed a 91% reduction in monthly attack rate and 50% of patients being attack-free at 3 months [86]. - The ongoing ALPHA-SOLAR trial will provide long-term safety and efficacy data for navenibart, with initial results expected in mid-2025 [84]. Financial Performance - The company reported net losses of $33.7 million for Q1 2025, compared to $19.9 million for Q1 2024, with an accumulated deficit of $708.5 million as of March 31, 2025 [90]. - Research and development expenses for navenibart were $11.8 million for Q1 2025, up from $7.1 million in Q1 2024, while STAR-0310 expenses were $7.4 million compared to $3.0 million in the same period [95]. - Research and development expenses increased by $12.1 million to $27.8 million for the three months ended March 31, 2025, representing a 77% increase compared to the same period in 2024 [106]. - General and administrative expenses rose by $0.8 million to $9.2 million for the three months ended March 31, 2025, an increase of 9% from the previous year [106]. - Net loss for the three months ended March 31, 2025, was $33.7 million, compared to a net loss of $19.9 million for the same period in 2024, reflecting an increase of $13.8 million [105]. - Net cash used in operating activities was $34.0 million for the three months ended March 31, 2025, compared to $19.1 million for the same period in 2024 [114]. - The company incurred an accumulated deficit of $708.5 million as of March 31, 2025, primarily due to ongoing research and development activities [119]. - Other income, net decreased by $0.9 million to $3.3 million for the three months ended March 31, 2025, a decrease of 22% from the previous year [107]. Funding and Capital Requirements - As of March 31, 2025, the company had $295.1 million in cash and equivalents, expected to fund operations into mid-2027 [91]. - The company plans to seek additional funding to support the development and commercialization of navenibart and STAR-0310 due to significant capital requirements [91]. - The company expects to need substantial additional funding to complete the development and commercialization of its product candidates, including navenibart and STAR-0310 [111]. - The company raised an aggregate of $839.2 million through equity financings since inception, including private placements and registered offerings [108]. - The company expects to finance its cash needs through equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements, with no committed external source of funds currently available [122]. - If the company raises funds through collaborations or licensing arrangements, it may have to relinquish valuable rights to its technologies or grant licenses on unfavorable terms [123]. Regulatory and Commercialization Risks - The company faces uncertainty regarding the outcome, timing, and costs of seeking regulatory approvals for its product candidates, which could impact commercialization activities [125]. - The company has potential obligations under its license agreement with Ichnos for STAR-0310, which includes milestone payments and tiered royalties contingent upon development and regulatory approval milestones [127]. - The company has incurred costs related to preparing, filing, and prosecuting patent applications, as well as maintaining and protecting its intellectual property rights [125]. - The company anticipates that its commercial revenues will not be generated for several years, if at all, necessitating reliance on additional financing [121]. - The company has no assurance that it will achieve commercial success with its product candidates, including navenibart and STAR-0310 [121]. Operational Considerations - The company anticipates an increase in general and administrative expenses as it continues to grow and develop its product pipeline [100]. - The company’s headcount growth and associated costs will be a factor in its future financial performance [125]. - The company’s agreements with CROs and third-party manufacturers are generally cancelable with prior notice, and its non-cancelable obligations under these agreements are not considered material [126]. - As of March 31, 2025, the company has material contractual obligations including a sublease requiring monthly payments of $0.1 million from September 1, 2024, until November 30, 2028, and milestone payments of $2.2 million and $2.0 million for clinical trials of navenibart and STAR-0310, respectively, which were met during the three months ended March 31, 2025 [124].

Summary of Astria Therapeutics Conference Call Company Overview - **Company**: Astria Therapeutics (ATXS) - **Focus**: Development of first-choice products for allergic and immunologic diseases, particularly hereditary angioedema (HAE) [5][6] Key Products and Pipeline - **Lead Program**: Nivenabart - **Type**: Monoclonal antibody inhibitor of plasma calacrine - **Efficacy**: Demonstrated over 90% attack rate reduction in phase 1b/2 trial with dosing options of every three months or six months [6][12][17] - **Market Potential**: Expected market size for HAE to reach approximately $5.4 billion by 2030, driven by earlier diagnosis, increased use of preventative therapies, and geographic expansion [12] - **Competitive Advantage**: Aims to be a first-choice option due to its favorable dosing schedule and efficacy profile compared to existing treatments like TEXYRO, which requires bi-weekly dosing [19][13] - **Second Program**: STAR310 - **Type**: Monoclonal antibody antagonist of the OX40 receptor - **Current Status**: In phase 1a trial with initial results expected in Q3 [8][59] - **Mechanism**: Designed to avoid safety issues seen in previous OX40 programs, aiming for a differentiated profile in treating atopic dermatitis [61][62] Market Landscape and Competitive Analysis - **HAE Market**: Competitive with several existing therapies, but Nivenabart's unique dosing schedule and efficacy could position it as a market leader [9][14] - **Patient Willingness to Switch**: Evidence suggests patients are open to switching to new therapies that offer better efficacy and tolerability [15][16] - **Regulatory Strategy**: Phase 3 trial designed to test both dosing regimens (every three and six months) globally, with a focus on patient experience [30][66] Clinical Trial Insights - **Phase 1b/2 Trial Results**: Showed significant reductions in attack rates and severity of attacks, with a favorable safety profile [17][28] - **Phase 3 Trial Design**: Single trial to support both dosing regimens, with a primary endpoint of attack rate reduction at six months [29][30] - **Long-term Data**: Upcoming data from the Alpha Solar trial expected to provide insights into long-term safety and efficacy [24][67] Financial Position and Future Milestones - **Cash Position**: Strong cash reserves expected to last until mid-2027, covering key milestones for Nivenabart [66] - **Upcoming Milestones**: - Mid-year: Alpha Solar long-term extension data for Nivenabart - Q3: Phase 1a data for STAR310 [67] Conclusion - Astria Therapeutics is positioned to make significant strides in the treatment of hereditary angioedema and atopic dermatitis with its innovative therapies, Nivenabart and STAR310. The company is focused on delivering compelling clinical data and navigating a competitive landscape to establish itself as a leader in these therapeutic areas.

Clinical Development and Trials - Navenibart is in clinical development for hereditary angioedema (HAE) and aims to be a best-in-class monoclonal antibody with long-acting, effective attack prevention [25]. - In the Phase 1b/2 trial (ALPHA-STAR), navenibart demonstrated a 91% reduction in monthly attack rate and a 96% reduction in moderate and severe attacks over six months [28]. - The Phase 3 trial (ALPHA-ORBIT) for navenibart began in February 2025, with top-line results expected in early 2027, evaluating up to 135 adults and 10 adolescents [27]. - The ALPHA-SOLAR trial is ongoing to assess long-term safety and efficacy of navenibart, with initial data expected in mid-2025 [33]. - The Phase 1a clinical trial of navenibart involved 41 healthy subjects, with no serious adverse events reported and a low risk of injection pain [45]. - A total of 29 patients were enrolled in the ALPHA-STAR trial to accelerate data collection for potential regulatory filings [47]. - The FDA granted IND clearance for STAR-0310 for the treatment of AD in December 2024, with a Phase 1a clinical trial initiated in January 2025 [58]. - STAR-0310 is being developed for moderate-to-severe AD, with competitive factors including safety, efficacy, and pricing [69]. Market Potential and Competitive Landscape - The global HAE therapy market was estimated at $2.8 billion in 2023 and is projected to grow to $5.4 billion by 2030, driven by earlier diagnoses and increased treatment adoption [42]. - STAR-0310, a monoclonal antibody OX40 antagonist, is being developed for atopic dermatitis (AD) and other allergic diseases, with a potential market growth from $7 billion in 2022 to $26 billion by 2030 [55]. - The competitive landscape for HAE treatments includes four FDA-approved therapies for long-term prevention, with navenibart expected to compete directly with TAKHZYRO [67]. - CSL Behring's garadacimab has completed Phase 3 development for preventative treatment of HAE and is approved in the EU, Australia, and the UK under the brand name ANDEMBRY [68]. - Ionis Pharmaceuticals' donidalorsen has completed Phase 3 development for preventative treatment with a PDUFA date set for August 21, 2025 [68]. - KalVista's sebetralstat for on-demand treatment of HAE has completed Phase 3 development with a PDUFA date set for June 17, 2025 [68]. Regulatory Designations and Compliance - Navenibart received Fast Track and Orphan Drug designations from the FDA, and Orphan Medicinal Product Designation from the European Commission for HAE treatment [26]. - The FDA requires sponsors to conduct adequate and well-controlled human clinical trials to establish the safety and efficacy of proposed drug products [93]. - The FDA's regulations require that pharmaceutical products be manufactured in compliance with cGMPs, which include specific requirements for facilities and processes [124]. - The FDA may impose clinical holds on trials if there are safety concerns, which can delay or suspend the trial until issues are resolved [95]. - The FDA requires that clinical trial results be registered and disclosed on clinicaltrials.gov, with potential delays in result disclosure [115]. Drug Development and Approval Process - The IND process requires a 30-day waiting period after submission before clinical trials can commence, allowing the FDA to review the application for safety and quality [94]. - Clinical trials are divided into four phases, with Phase 3 trials typically required for marketing approval, focusing on evaluating the drug's effectiveness and safety in a larger patient population [107]. - The FDA aims to review 90% of New Molecular Entity (NME) applications within ten months of acceptance for filing, and priority review applications within six months [133]. - The FDA may grant accelerated approval for drugs that provide meaningful therapeutic advantages for serious conditions based on surrogate endpoints [150]. - A Complete Response Letter (CRL) indicates that an application will not be approved in its current form and outlines deficiencies that must be addressed [143]. Intellectual Property and Exclusivity - The company has five patent families directed to navenibart, with expiration dates ranging from 2042 to 2045 depending on the application [75][78][79]. - Orphan drug designation provides seven years of exclusivity for drugs treating rare diseases, with specific conditions for approval [179]. - Patent term restoration allows for up to five years of extension for patents lost during development and FDA review [184]. - Pediatric exclusivity can extend regulatory exclusivity by six months if a pediatric study is completed [181]. Company Operations and Workforce - As of December 31, 2024, the company had 78 full-time employees, with 45 engaged in research and development [87]. - The company relies on third-party manufacturers for the production of navenibart and STAR-0310, ensuring compliance with cGMPs [86].

Financial Performance - Net loss for 2024 was $94,260,000, up from $72,891,000 in 2023, indicating a 29.2% increase in losses[16] - The net loss for Q4 2024 was $25.6 million, compared to a net loss of $31.4 million in Q4 2023, reflecting a 18% improvement[10] - The operating loss for Q4 2024 was $29.6 million, a decrease of 13% from $34.2 million in Q4 2023[9] - Net loss per share attributable to common shareholders improved to $(1.68) in 2024 from $(2.42) in 2023[16] - The net loss per share for Q4 2024 was $0.44, down from $0.86 per share in Q4 2023, representing a 49% reduction[11] Cash and Investments - As of December 31, 2024, Astria had cash, cash equivalents, and short-term investments of $328.1 million, up from $246.5 million as of December 31, 2023, indicating a 33% increase year-over-year[6] - Cash and cash equivalents decreased to $59,820,000 in 2024 from $175,530,000 in 2023, a decline of 66.0%[18] - Net cash used in operating activities was $(81,212,000) in 2024, compared to $(68,445,000) in 2023, representing a 18.5% increase in cash outflow[20] - Net cash provided by financing activities rose to $157,202,000 in 2024 from $88,398,000 in 2023, an increase of 77.8%[20] Operating Expenses - Total operating expenses for 2024 increased to $111,558,000 from $83,030,000 in 2023, representing a 34.5% increase[16] - Research and development expenses for Q4 2024 were $20.2 million, a 73% increase from $11.7 million in Q4 2023, driven by external expenses for clinical trials[7] - Research and development expenses rose significantly to $77,106,000 in 2024, compared to $42,127,000 in 2023, marking a 83.1% increase[16] - General and administrative expenses for Q4 2024 were $9.4 million, up 29% from $7.3 million in Q4 2023, attributed to stock-based compensation and company growth[8] Assets and Liabilities - Total assets increased to $342,363,000 in 2024, up from $254,666,000 in 2023, reflecting a growth of 34.3%[18] - Total stockholders' equity increased to $319,263,000 in 2024, up from $243,116,000 in 2023, a growth of 31.3%[18] - Total liabilities increased to $23,100,000 in 2024 from $11,550,000 in 2023, a rise of 99.0%[18] Clinical Trials - The ALPHA-ORBIT Phase 3 trial of navenibart commenced in February 2025, with top-line results expected in early 2027, involving up to 135 adult and 10 adolescent patients[3] - Initial efficacy and safety data from the ALPHA-SOLAR long-term extension trial of navenibart are expected in mid-2025[1] - The Phase 1a trial of STAR-0310 is ongoing, with initial results anticipated in Q3 2025, aiming to demonstrate its differentiated profile[2]

Company Performance - Astria Therapeutics, Inc. (ATXS) has gained approximately 25.9% year-to-date, significantly outperforming the Medical sector, which has returned an average of -2.7% [4] - The Zacks Consensus Estimate for ATXS' full-year earnings has increased by 4.5% over the past 90 days, indicating improving analyst sentiment and a positive earnings outlook [3] Industry Comparison - Astria Therapeutics, Inc. is part of the Medical - Biomedical and Genetics industry, which includes 501 individual stocks and currently ranks 69 in the Zacks Industry Rank. This industry has seen an average loss of 9.7% this year, highlighting ATXS's superior performance [5] - In contrast, Abbott (ABT), another stock in the Medical sector, has a year-to-date return of 2.3% and belongs to the Medical - Products industry, which is ranked 85 and has moved up by 11.4% year-to-date [4][6] Sector Overview - The Medical sector consists of 1021 individual stocks and currently holds a Zacks Sector Rank of 3, which measures the strength of the sector groups based on the average Zacks Rank of individual stocks [2] - The Zacks Rank system emphasizes earnings estimates and revisions, with ATXS currently holding a Zacks Rank of 2 (Buy), indicating a favorable outlook compared to the broader market [3]

Financial Performance - The company reported net losses of $68.6 million for the nine months ended September 30, 2024, compared to $41.5 million for the same period in 2023[65]. - The company has an accumulated deficit of $649.2 million as of September 30, 2024, and has not generated any product revenues[65]. - Net loss for the nine months ended September 30, 2024, was $68.63 million, an increase of $27.15 million or 65% compared to a net loss of $41.48 million in the prior year[74]. - Other income, net increased by $6.0 million to $13.3 million for the nine months ended September 30, 2024, a 82% increase from $7.3 million in the same period of 2023[77]. - For the nine months ended September 30, 2024, net cash used in operating activities was $63.9 million, compared to $38.2 million for the same period in 2023[83]. - Net cash used in investing activities was $188.1 million for the nine months ended September 30, 2024, primarily due to purchases of short-term investments totaling $3.5 billion[83]. - Net cash provided by financing activities was $157.2 million for the nine months ended September 30, 2024, driven by net proceeds from the February 2024 Financing and ATM Programs[85]. Cash and Funding - As of September 30, 2024, the company had $344.3 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2027[65]. - The gross proceeds from the October 2023 Financing were $64.0 million, and from the February 2024 Financing were $125.0 million[64]. - Existing cash, cash equivalents, and short-term investments are expected to fund operations into mid-2027, covering ongoing clinical trials and development activities[86]. - The company expects to finance future cash needs through equity offerings, debt financings, and collaborations, with no committed external sources of funds[88]. - The company sold 1,504,619 shares under the 2024 ATM Program for gross proceeds of $15.6 million in the three months ended September 30, 2024[81]. Research and Development - Research and development expenses increased by $26.5 million to $56.9 million for the nine months ended September 30, 2024, representing an 87% increase compared to the same period in 2023[75]. - Research and development expenses for the three months ended September 30, 2024, were $20.5 million, a 54% increase from $13.3 million in the same period of 2023[72]. - The company expects to incur significant research and development expenses in 2024 related to clinical trials for navenibart and STAR-0310, with higher expenses anticipated over the next several quarters[72]. Clinical Trials and Product Development - Navenibart achieved a 92% reduction in monthly attack rate and a 96% reduction in moderate and severe attacks in Cohort 1 after 6 months of follow-up[57]. - In Cohort 2, a 600 mg dose followed by a 300 mg dose resulted in a 96% reduction in monthly attack rate and 67% of patients were attack-free after 6 months[59]. - The company plans to initiate a Phase 1a clinical trial for STAR-0310 in healthy subjects in Q1 2025, with initial results expected in Q3 2025[63]. - The company aims to start a Phase 3 pivotal trial for Navenibart in Q1 2025, with top-line results expected by year-end 2026[59]. - STAR-0310 exhibited a long mean half-life of 26 days in preclinical studies, compared to 10-14 days for typical non-half-life extended IgG antibodies[60]. - Navenibart has received Fast Track and Orphan Drug designations from the FDA for the treatment of hereditary angioedema[57]. Operating Expenses - General and administrative expenses rose by $6.6 million to $25.0 million for the nine months ended September 30, 2024, a 36% increase from the prior year[77]. - General and administrative expenses for the three months ended September 30, 2024, increased by $1.6 million to $8.5 million, a 23% increase from the prior year[72]. - Total operating expenses for the nine months ended September 30, 2024, were $81.97 million, up $33.14 million or 68% from $48.83 million in the same period of 2023[74]. - Total operating expenses for the three months ended September 30, 2024, were $29.01 million, up $8.78 million or 43% from $20.24 million in the same period of 2023[71]. Internal Controls - The company has not made any changes to its internal control over financial reporting that materially affected its financial reporting during the nine months ended September 30, 2024[92].

Financial Performance - The company reported net losses of $44.1 million for the six months ended June 30, 2024, compared to $23.8 million for the same period in 2023, with an accumulated deficit of $624.6 million[72]. - Total operating expenses for the six months ended June 30, 2024, were $52.95 million, an increase of 85% from $28.6 million in the same period in 2023[82]. - The net loss for the six months ended June 30, 2024, was $44.1 million, compared to a net loss of $23.8 million for the same period in 2023, representing an increase of 85%[82]. - General and administrative expenses rose by 44% to $16.5 million for the six months ended June 30, 2024, from $11.5 million in the same period in 2023[85]. - Net cash used in operating activities was $35.9 million for the six months ended June 30, 2024, compared to $23.9 million for the same period in 2023[93]. - As of June 30, 2024, the company had an accumulated deficit of $624.6 million, indicating ongoing operating losses since inception[96]. Cash and Financing - As of June 30, 2024, the company had $354.7 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2027[72]. - The gross proceeds from the October 2023 Financing were $64.0 million, and from the February 2024 Financing were $125.0 million[71]. - The company raised an aggregate of $823.4 million through equity financings from inception through June 30, 2024[86]. - The October 2023 Financing raised gross proceeds of $64.0 million, with net proceeds of $59.5 million[88]. - In February 2024, the company closed a financing round, selling 10,340,000 shares for gross proceeds of $125.0 million and net proceeds of $117.2 million[89]. - The company sold 2,945,806 shares under the 2021 ATM Program for gross proceeds of $20.6 million and net proceeds of $20.0 million in the six months ended June 30, 2024[90]. - Net cash provided by financing activities was $141.9 million for the six months ended June 30, 2024, mainly from net proceeds of $117.2 million from the February 2024 Financing[95]. - The company expects existing cash and short-term investments to fund operations into mid-2027, including activities related to the navenibart program and STAR-0310 OX40 program[96]. - The company may need to seek additional funds sooner than planned due to uncertainties in research and development[98]. Research and Development - Navenibart achieved a 92% reduction in monthly attack rate and a 96% reduction in moderate and severe attacks in the 450 mg dose cohort after 6 months of follow-up[65]. - In the 600 mg dose cohort, there was a 96% reduction in monthly attack rate and 100% of patients were attack-free in the first month after dosing[67]. - The company plans to initiate a Phase 3 pivotal trial for Navenibart in Q1 2025, with top-line results expected by year-end 2026[67]. - STAR-0310 demonstrated a long mean half-life of 26 days in preclinical studies, compared to 10-14 days for typical non-half-life extended IgG antibodies[68]. - The company anticipates submitting an IND for STAR-0310 by year-end 2024 and initiating a Phase 1a clinical trial in Q1 2025[70]. - The company expects to incur significant research and development expenses in 2024 related to navenibart and STAR-0310, with higher expenses anticipated in upcoming quarters[80]. - The company plans to report additional data from the ALPHA-STAR trial in Q4 2024 and initial data from the ALPHA-SOLAR trial in mid-2025[67]. Other Financial Information - Research and development expenses increased by 128% to $20.7 million for the three months ended June 30, 2024, compared to $9.1 million for the same period in 2023[80]. - Other income, net increased by 83% to $4.6 million for the three months ended June 30, 2024, from $2.5 million in the same period in 2023[81]. - Material cash requirements as of June 30, 2024, are primarily related to sublease agreements for office space[99]. - The company has not generated any product revenues and relies on public offerings and private placements for financing[72]. - The company has not made any changes in internal control over financial reporting that materially affected its financial reporting during the six months ended June 30, 2024[102]. - The company has filed various certifications pursuant to the Sarbanes-Oxley Act of 2002, including those from the principal executive and financial officers[105]. - The report includes Inline XBRL documents for detailed financial data presentation[105]. - The Chief Financial Officer, Noah C. Clauser, signed the report on August 12, 2024, confirming its accuracy[106].