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].

Financial Data and Key Metrics Changes - As of September 30, 2023, the company had $188.8 million in cash, cash equivalents, and short-term investments, with a recent $64 million underwritten offering completed in October 2023, expected to support operations into 2026 [26][27]. Business Line Data and Key Metrics Changes - The STAR-0215 program is positioned as a first-choice preventative treatment for Hereditary Angioedema (HAE), with promising Phase 1a data indicating potential for dosing every three to six months [5][6]. - STAR-0310, an anti-OX40 antibody, is being developed for atopic dermatitis, with plans for an IND submission by the end of 2024 and Phase 1a initiation expected in Q1 2025 [6][20]. Market Data and Key Metrics Changes - The atopic dermatitis market is projected to reach $26 billion by 2030, with STAR-0310 expected to be a significant player following Dupixent [20]. Company Strategy and Development Direction - The company aims to develop first-choice products that improve health outcomes for patients with allergic and immunological diseases, focusing on strong efficacy, low treatment burden, and favorable safety profiles [6][18]. - The development strategy prioritizes a three-month dosing regimen for STAR-0215, followed by a six-month option, based on market research indicating high interest from patients and healthcare providers [16][18]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of STAR-0215 to normalize the lives of HAE patients, with compelling data supporting its best-in-class profile [18]. - The company is looking to accelerate timelines for clinical trials and is actively engaging with the community to raise awareness and support for its programs [29][49]. Other Important Information - The ALPHA-STAR trial for STAR-0215 is progressing well, with initial proof-of-concept results expected in Q1 2024, and plans for a pivotal Phase 3 trial in Q1 2025 [15][27]. Q&A Session Summary Question: Can you talk about the accelerated timeline for Phase 1b data in HAE patients? - The timeline was accelerated due to achieving target enrollment in cohorts 1 and 2, allowing for an earlier interim analysis trigger [30]. Question: Will the Phase 3 design be similar to ASL targeting prekallikrein? - The Phase 3 trial is anticipated to be placebo-controlled, with a similar treatment period to other Phase 3 studies, focusing on changes from baseline and monthly attack rates [31]. Question: What data are you looking for in the upcoming ALPHA-STAR interim analysis? - The analysis will focus on changes from baseline on various efficacy parameters to inform the effectiveness of the drug [32]. Question: What do you consider a win in terms of reduction in HAE attack rates for the upcoming data readout? - A high proportion of patients being attack-free for predefined periods of time would be considered a significant win [38]. Question: Why is there less interest from doctors and patients for six-month dosing than three-month? - There may be perceptions of reduced efficacy with longer dosing intervals, and concerns about injection site pain associated with current formulations [40]. Question: What are you hearing from payers regarding the competitive landscape? - Payers are focused on efficacy, and the company aims to develop a treatment that provides comparable efficacy while enhancing patient compliance [45]. Question: Will the Phase 3 trial have a placebo arm, and will that impact enrollment? - It is expected that having a placebo arm will impact enrollment, but the company is working to mitigate this through strong proof-of-concept data and community support [49]. Question: What are the rate-limiting steps for accelerating the Phase 3 trial? - Key factors include analyzing data, obtaining regulatory input, and ensuring CMC processes do not impact timelines [51].

Astria Q3 2023 Corporate Update November 13, 2023 Forward Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: our expectations regarding the potential significance of the results from the Phase 1a clinical trial of STAR-0215; our expectations regarding the timing, nature, goals and results of our Phase 1b/2 ALPHA-STAR clinical trial of STAR-0215, including the expected ...

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 September 30, 2023 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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q | --- | --- | --- | |-------|-----------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 26-3687168 | | | | | | | | (IRS Employer | | | | Identification No.) | | (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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SEC ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (State or Other Jurisdiction of 75 State Street Suite 1400 02109 (ZipCode) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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. (Exa ...

Astria Therapeutics, Inc. (NASDAQ:ATXS) Q4 2022 Earnings Conference Call March 22, 2023 8:30 AM ET Company Participants Andrea Matthews - Senior Vice President, Corporate Affairs Jill Milne - Chief Executive Officer Andy Nichols - Chief Scientific Officer Andrew Komjathy - Chief Commercial Officer Chris Morabito - Chief Medical Officer Noah Clauser - Chief Financial Officer Conference Call Participants Hartaj Singh - Oppenheimer Oliver McCammon - LifeSci Capital, LLC Joe Pantginis - H.C. Wainwright Eun Yang ...