Overall, the consensus for Astria stock is a “Strong Buy.” Among the 10 analysts covering the company, nine give it a “Strong Buy” rating, and one suggests holding. The average price target of $29.89 indicates potential 253.7% upside from current levels. Meanwhile, the high price target of $49 implies the stock could surge by as much as 479.8% over the next year.In the second quarter, research and development expenses rose to $25.9 million, reflecting higher costs related to Navenibart’s Phase 3 trial and o ...

Hereditary Angioedema (HAE) - Navenibart - Navenibart aims to be the first-choice therapy for preventative treatment of HAE, with potential for quarterly (Q3M) and semi-annual (Q6M) administration[15, 6] - Phase 1b/2 data suggests Navenibart's efficacy could match or exceed existing treatments while reducing treatment burden[16] - The Phase 3 program, including ALPHA-ORBIT and ORBIT-EXPANSE trials, is designed to support global registration, with topline data expected in early 2027[18] - ALPHA-STAR and SOLAR trials showed a mean attack rate reduction of 91-95% across all doses, with an overall mean of 92%[24] - The ALPHA-SOLAR trial demonstrated consistent efficacy with a longer median follow-up of 9.1 months, showing a 92% attack rate reduction from baseline[28, 29] - Market research indicates that offering both Q3M and Q6M dosing options could increase market adoption, with 53% of patients initiating preventative therapy and 46% switching preventative therapy preferring Q3M & Q6M options[32] Atopic Dermatitis (AD) - STAR-0310 - STAR-0310 targets the OX40 pathway and has the potential to become the first-choice OX40 therapy for Atopic Dermatitis[45] - The U S commercial opportunity for moderate-to-severe AD is projected to reach $22 billion by 2030[35, 36, 44] - Phase 1a data demonstrates a best-in-class 68-day half-life, supporting potential for every-six-month dosing[51, 71, 77] - Phase 1a data showed broad and durable pharmacodynamic effect across Type 1, 2, and 3 inflammation, with maximal suppression achieved within one week and sustained for at least 16-20 weeks[63, 68, 77]

Core Viewpoint - Astria Therapeutics, Inc. (ATXS) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on a company's changing earnings picture, which is crucial for near-term stock price movements [2][4]. - Rising earnings estimates for Astria Therapeutics indicate an improvement in the company's underlying business, likely leading to a higher stock price [5][10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7][9]. - Only the top 20% of Zacks-covered stocks receive a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [10]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2025, Astria Therapeutics is expected to earn -$2.09 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 10.1% over the past three months [8].

Astria Therapeutics, Inc. (ATXS) closed the last trading session at $7.43, gaining 11.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $29.33 indicates a 294.8% upside potential.The average comprises nine short-term price targets ranging from a low of $16.00 to a high of $49.00, with a standard deviation of $9.19. While the lowest estimate indicates an increase of 115.3% from the ...

Core Insights - Astria Therapeutics, Inc. (ATXS) has reached a significant support level and has experienced a "golden cross" where its 50-day simple moving average has crossed above its 200-day simple moving average, indicating potential bullish momentum [1][2]. Technical Analysis - A golden cross is a technical chart pattern that suggests a bullish breakout may occur, formed when a stock's short-term moving average surpasses a longer-term moving average [2]. - The successful golden cross event consists of three stages: the stock price bottoms out, the shorter moving average crosses above the longer moving average, and the stock maintains upward momentum [3]. Performance Metrics - ATXS has seen a rally of 19.8% over the past four weeks, indicating strong performance [4]. - The company currently holds a 3 (Hold) rating on the Zacks Rank, suggesting it may be positioned for a breakout [4]. - The earnings outlook for ATXS is positive, with no earnings estimates cut and five revisions higher in the past 60 days, leading to an increase in the Zacks Consensus Estimate [4]. Investment Consideration - Given the technical indicators and positive earnings revisions, ATXS is recommended for investors' watchlists [5].

Core Insights - Astria Therapeutics is highlighted as an exciting company that has recently been covered by Cantor, indicating a positive outlook for its future developments [1][2] Company Overview - The session features CEO Jill Milne, who is expected to provide introductory comments and an overview of Astria's current state and future outlook as the year concludes [2]

Summary of Astria Therapeutics Conference Call Company Overview - **Company**: Astria Therapeutics - **Focus**: Developing medicines for allergic and immunologic diseases, with a lead program, navenibart, targeting hereditary angioedema (HAE) [2][4] Key Programs 1. **Navenibart** - **Type**: Monoclonal antibody inhibitor of plasma kallikrein - **Current Stage**: Phase 3 development - **Efficacy**: Over 90% attack rate reduction in HAE patients from Phase 1/2 trials [2] - **Enrollment**: Active in multiple countries including the U.S., U.K., Canada, South Africa, Hong Kong, with European and Japanese sites upcoming [4] - **Top Line Data**: Expected in early 2027 [2] 2. **STAR-0310** - **Type**: Monoclonal antibody antagonist of the OX40 receptor - **Upcoming Data**: Oral presentation of Phase 1a healthy subject data at EADV [3] Market Insights - **Japan Market**: - Third largest market for HAE treatments, with a significant opportunity for growth [12] - Partnership with Kaken to raise awareness and engage key opinion leaders (KOLs) [12] - Historical data shows approximately 9% of patients in similar trials come from Japan [14] - **U.S. Market**: - Approximately 70% of HAE patients are on preventative therapies, with potential for growth [44] - **European Market**: - Interest in partnerships for commercialization, similar to Japan [17] Competitive Landscape - **Navenibart's Position**: Expected to succeed on its own merit due to robust efficacy and low treatment burden compared to existing therapies [20] - **Market Dynamics**: New launches in the HAE space may influence patient switching behavior; however, navenibart's unique profile is anticipated to maintain its competitive edge [20][44] Product Differentiation - **Dosing Regimen**: Navenibart offers infrequent dosing (every 3 or 6 months), which is a significant improvement over existing therapies [11][20] - **Injection Experience**: Navenibart designed to minimize injection site reactions, addressing patient concerns about pain associated with current treatments [25][26] - **Safety Profile**: No adverse effects on platelets or liver enzymes reported in studies [28] Future Developments - **Data Updates**: Annual data cuts from the AlphaSolar extension trial expected, with ongoing engagement from patients [23] - **OX40 Mechanism**: STAR-0310 is designed to target activated T cells, potentially offering improved efficacy and safety compared to first-generation OX40 therapies [34][35] Strategic Considerations - **Market Evolution**: Anticipated shifts in the HAE market as new products emerge; older, more burdensome therapies may lose market share [44] - **Gene Editing Products**: Expected to be niche due to the established efficacy of current therapies; convenience of infrequent dosing may outweigh the appeal of oral therapies [46] Conclusion - Astria Therapeutics is positioned to make significant strides in the HAE market with navenibart and STAR-0310, focusing on patient-centric design and robust clinical data to support its competitive advantage [47]

Core Viewpoint - Astria Therapeutics, Inc. (ATXS) has seen an 8.3% increase in share price over the past four weeks, closing at $6.76, with a potential upside of 333.9% based on Wall Street analysts' mean price target of $29.33 [1] Price Targets - The average price target consists of nine estimates ranging from a low of $16.00 to a high of $49.00, with a standard deviation of $9.19, indicating variability among analysts [2] - The lowest estimate suggests a 136.7% increase from the current price, while the highest estimate indicates a potential upside of 624.9% [2] Analyst Consensus and Earnings Estimates - Analysts are optimistic about ATXS's earnings prospects, as indicated by a trend of upward revisions in earnings estimates, which historically correlates with stock price movements [11] - Over the last 30 days, five earnings estimates have been revised upward, leading to a 10.1% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank - ATXS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential for upside in the near term [13] Conclusion on Price Targets - While the consensus price target may not be a reliable measure of the extent of potential gains, it does provide a directional guide for price movement [14]

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]