Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37467 Astria Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-3687168 (State or ...

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].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37467 Astria Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | --- | |---- ...

Clinical Trial Results - STAR-0215 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[79]. - STAR-0215 demonstrated a 96% reduction in monthly attack rate and 98% reduction in moderate and severe attacks in Cohort 2, with 100% of patients being attack-free in the first month after dosing[80]. - STAR-0215 has received Fast Track designation from the FDA for the treatment of hereditary angioedema[78]. - The company plans to initiate a pivotal Phase 3 trial for STAR-0215 in Q1 2025, with top-line results expected by year-end 2026[81]. - STAR-0310 is anticipated to enter Phase 1a clinical trials in Q1 2025, with initial results expected in Q3 2025[85]. - The company plans to expand enrollment in the ALPHA-STAR trial to a total of up to 28 patients to accelerate data collection for STAR-0215[81]. - The company anticipates initiating a Phase 3 pivotal trial for STAR-0215 in Q1 2025 and submitting an IND for STAR-0310 by year-end 2024[102]. Financial Performance - The company reported net losses of $19.9 million for the three months ended March 31, 2024, compared to $11.2 million for the same period in 2023, resulting in an accumulated deficit of $600.5 million[87]. - Research and development expenses totaled $15.7 million for the three months ended March 31, 2024, significantly higher than $8.0 million for the same period in 2023[92]. - General and administrative expenses rose by $2.9 million to $8.4 million for the three months ended March 31, 2024, an increase of 54% year-over-year[102]. - Total operating expenses for the three months ended March 31, 2024, were $24.2 million, up $10.7 million from $13.5 million in the same period of 2023[99]. - Net loss for the three months ended March 31, 2024, was $19.9 million, compared to a net loss of $11.2 million for the same period in 2023, reflecting an increase of $8.7 million[99]. - Other income, net increased by $1.9 million to $4.2 million for the three months ended March 31, 2024, an increase of 83% year-over-year[103]. - Net cash used in operating activities was $19.1 million for the three months ended March 31, 2024, compared to $13.3 million for the same period in 2023[111]. - Net cash provided by financing activities was $141.8 million for the three months ended March 31, 2024, primarily from the February 2024 Financing[114]. Cash Position and Funding - As of March 31, 2024, the company had $369.9 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2027[88]. - The company raised an aggregate of $823.3 million through equity financings from inception through March 31, 2024[105]. - The company expects its existing cash, cash equivalents, and short-term investments to fund operations into mid-2027[117]. - Future funding requirements will depend on clinical trial progress, collaboration agreements, and regulatory approval outcomes[117]. - The company does not have any committed external sources of funds and may rely on equity offerings, debt financings, and collaborations for financing[119]. - If additional funds are not raised when needed, the company may have to delay or terminate product development efforts[120]. - Material cash requirements as of March 31, 2024, are primarily related to sublease agreements for office space[121]. Commercialization and Market Competition - The costs of commercialization activities for product candidates that receive marketing approval will be significant and may not be fully covered by collaborators[117]. - The company acknowledges that product candidates may not achieve commercial success, impacting future revenues[118]. - The company’s ability to compete against other approved products will be critical for the success of STAR-0215 and STAR-0310[117]. - The license agreement with Ichnos includes potential milestone payments and tiered royalties contingent upon product development and regulatory milestones[122]. - The company may face dilution of stockholders' ownership interests if additional capital is raised through equity sales[119].

Core Insights - Astria Therapeutics, Inc. granted stock options to purchase 40,000 shares of its common stock as part of its 2022 Inducement Stock Incentive Plan [1][2] - The stock options were granted to two new employees as an inducement for their employment, in compliance with Nasdaq Listing Rule 5635(c)(4) [2] - The exercise price of the options is set at $14.98, equal to the closing price of Astria's common stock on the grant date, March 1, 2024 [2] Company Overview - Astria Therapeutics is focused on developing therapies for allergic and immunological diseases, with a mission to provide life-changing treatments [3] - The company's lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein, currently in clinical development for hereditary angioedema [3] - The second program, STAR-0310, is a monoclonal antibody OX40 antagonist in preclinical development for atopic dermatitis [3]

Corporate Overview - Astria Therapeutics, Inc. is focused on developing therapies for allergic and immunological diseases, with lead programs STAR-0215 for hereditary angioedema (HAE) and STAR-0310 for atopic dermatitis (AD) [10] Financial Results - As of December 31, 2023, the company had cash, cash equivalents, and short-term investments totaling $246.5 million, an increase from $188.8 million as of September 30, 2023 [6] - Net cash used in operating activities for Q4 2023 was $30.2 million, compared to $10.7 million for Q4 2022, while the full year 2023 net cash used was $68.4 million, up from $43.5 million in 2022 [7][9] - Research and development expenses for Q4 2023 were $11.7 million, compared to $9.6 million in Q4 2022, and for the full year 2023, they were $42.1 million, up from $34.3 million in 2022 [8] - General and administrative expenses for Q4 2023 were $7.3 million, compared to $4.7 million in Q4 2022, with full year expenses of $25.7 million versus $19.2 million in 2022 [8] - The operating loss for Q4 2023 was $34.2 million, compared to $14.3 million in Q4 2022, and the full year loss was $83.0 million, up from $53.5 million in 2022 [9] Product Development Updates - The ALPHA-STAR Phase 1b/2 trial for STAR-0215 is on track, with initial proof-of-concept results expected in Q1 2024, assessing safety, tolerability, and efficacy in HAE patients [3] - STAR-0310 is in preclinical development, with an IND submission expected by year-end 2024 and a Phase 1a trial planned to start in Q1 2025 [4] Recent Financing - In February 2024, Astria closed an underwritten offering of 10,340,000 shares of common stock, raising approximately $125.0 million before expenses [5]

Clinical Development - STAR-0215 is in clinical development for hereditary angioedema (HAE) and has the potential to be a best-in-class monoclonal antibody with administration every three or six months[26]. - The Phase 1a clinical trial of STAR-0215 demonstrated a favorable safety profile, with no serious adverse events and an estimated half-life of up to 109 days[28]. - Initial results from the Phase 1b/2 trial (ALPHA-STAR) are expected in Q1 2024, which will include safety, tolerability, pharmacokinetics, pharmacodynamics, and HAE attack-rate reduction data[30]. - 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[33]. - The Phase 1b trial for STAR-0310 in patients with AD is planned for the second half of 2025, with results expected in Q2 2026[33]. - Initial proof-of-concept data for STAR-0215 in HAE patients is expected in Q1 2024, with a Phase 3 pivotal trial anticipated to start in Q1 2025 if results are positive[40]. - The company plans to submit an IND for STAR-0310 by the end of 2024 and initiate a Phase 1a clinical trial in Q1 2025[51]. - The company has completed process and formulation development for STAR-0215 and is set to start process characterization and subsequent validation, ensuring sufficient material for clinical needs[74]. - The company has initiated cell line, process, and formulation development for STAR-0310, expanding its product pipeline[74]. - The company acknowledges that clinical trials may not yield results predictive of future success, and setbacks in late-stage trials are possible[213]. - Clinical trials for STAR-0215 are expected to be longer due to the dosing schedule of every three months or potentially less frequently[218]. - STAR-0310 clinical trials will be larger and more expensive compared to STAR-0215 due to its indication for a non-rare disease[218]. - Risks of clinical development include failure to demonstrate efficacy, insufficient patient enrollment, and potential regulatory disapproval[218]. - Delays in clinical trials could harm the commercial prospects of product candidates and delay revenue generation[218]. - Adverse events during trials could lead to significant delays or failure to obtain regulatory approval[218]. - The company faces heightened risks in drug development for rare diseases due to smaller patient populations[218]. Market Potential - The global market for HAE therapy is strong and growing, with an unmet medical need for effective treatments[27]. - The HAE treatment market was estimated to be over $2 billion in 2022 and is projected to grow to $4.5 billion by 2027, driven by earlier diagnoses and increased treatment adoption[37]. - The moderate-to-severe AD treatment market was approximately $7 billion in 2022 and is expected to grow to $26 billion by 2030 due to increased drug treatment rates and new therapies[48]. - Market research indicates strong interest from U.S. physicians and HAE patients for a product with the potential profile of STAR-0215[38]. - The competitive landscape for HAE and AD treatments is significant, with many companies developing alternative therapies that may impact market share[56][60]. Product Development - STAR-0310, a preclinical product candidate for atopic dermatitis (AD), is anticipated to submit an investigational new drug application (IND) by year-end 2024[33]. - STAR-0310 is being developed as a potential best-in-class treatment for AD, utilizing YTE half-life extension technology for infrequent dosing[43]. - STAR-0310 aims to address the unmet need for safe and effective therapies for moderate and severe AD patients, targeting multiple T cell pathways[46]. - STAR-0310 has shown potential for better efficacy compared to existing biologics, with preclinical studies indicating lower antibody-dependent cellular cytotoxicity[47]. - The company is exploring STAR-0310 for additional allergic and immunological indications, including asthma and chronic urticaria[52]. - The company is developing a drug device combination product for STAR-0215, indicating ongoing innovation in product offerings[74]. Regulatory Environment - STAR-0215 has received Fast Track designation from the FDA for the treatment of HAE, indicating its potential significance in addressing this condition[27]. - Regulatory processes for drug approval require substantial time and financial resources, including compliance with FDA regulations and obtaining necessary approvals[78]. - The FDA aims to review 90% of applications for New Molecular Entities (NMEs) within ten months of acceptance for filing, and 90% of priority review applications within six months[118]. - The FDA requires at least two adequate and well-controlled clinical trials to establish the effectiveness of a new product, although a single trial may suffice under certain circumstances[121]. - The FDA's acceptance of foreign clinical trial data for U.S. marketing approval is contingent upon compliance with GCP regulations and validation through on-site inspections if necessary[101]. - The FDA issues either a Complete Response Letter (CRL) or an approval letter after evaluating drug applications, determining that the drug is effective and its benefits outweigh risks[122]. - The FDA strictly regulates marketing and promotion of approved products, allowing promotion only for approved indications[140]. - Manufacturers must maintain compliance with regulatory requirements post-approval, or risk withdrawal of approval[139]. Intellectual Property - STAR-0215 and STAR-0310 have patent protections that could extend until 2042 and 2044 respectively, assuming all maintenance fees are paid[65][67]. - The patent term for STAR-0215 and STAR-0310 may be extended under the Hatch-Waxman Act, potentially adding up to five years beyond the original patent expiration[70][71]. - The company has in-licensed multiple patent families related to its product candidates, enhancing its intellectual property portfolio[68]. - Patent term restoration under the Hatch-Waxman Act allows for a limited extension of up to five years for patents lost during product development and FDA review, but cannot exceed a total of 14 years from the product's approval date[150]. Financial Considerations - Significant investment and access to commercial manufacturing capacity will be required for the development and commercialization of STAR-0215 and STAR-0310[207]. - The application user fee for federal fiscal year 2024 is approximately $4.05 million, with an annual program fee of $416,734 per eligible prescription product[116]. - The U.S. government is focusing on pharmaceutical pricing transparency and reducing costs under Medicare and Medicaid[189]. - The IRA caps Medicare out-of-pocket drug costs at $4,000 in 2024 and $2,000 in 2025, shifting some costs to drug manufacturers[194]. Workforce and Culture - As of December 31, 2023, the company employed 59 full-time employees, with 33 primarily engaged in research and development activities, including 14 with Ph.D. degrees[75]. - The company aims to attract, retain, and motivate employees through market-based cash compensation and equity incentive plans, which consist solely of stock options[76]. - The company emphasizes creating an inclusive environment where diversity is valued, considering its workforce as one of its biggest assets[77].

Core Viewpoint - Astria Therapeutics, Inc. has announced the pricing of an underwritten offering of 10,340,000 shares of its common stock at a price of $12.09 per share, aiming to raise approximately $125 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on or about February 1, 2024, pending customary closing conditions [1]. - The financing was led by RA Capital Management, with participation from several notable investors including Perceptive Advisors and Venrock Healthcare Capital Partners [2]. - Jefferies and Evercore ISI are acting as joint book-running managers for the offering, with LifeSci Capital serving as the lead manager [2]. Group 2: Company Overview - Astria Therapeutics is focused on developing therapies for allergic and immunological diseases, with its lead program STAR-0215 being a monoclonal antibody inhibitor of plasma kallikrein for hereditary angioedema [5]. - The company is also developing STAR-0310, a monoclonal antibody OX40 antagonist for atopic dermatitis, which is currently in preclinical development [5]. Group 3: Regulatory Information - The securities are being offered under a shelf registration statement on Form S-3, which was declared effective by the SEC on December 29, 2023 [3]. - A final prospectus supplement will be filed with the SEC and will be available for public access [3].