Astria Therapeutics(ATXS)

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Astria Therapeutics(ATXS) - 2023 Q3 - Earnings Call Transcript
2023-11-13 18:45
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 Therapeutics(ATXS) - 2023 Q3 - Earnings Call Presentation
2023-11-13 17:59
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 ...
Astria Therapeutics(ATXS) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
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 ...
Astria Therapeutics(ATXS) - 2023 Q2 - Quarterly Report
2023-08-06 16:00
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 ...
Astria Therapeutics(ATXS) - 2023 Q1 - Quarterly Report
2023-05-10 16:00
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(ATXS) - 2022 Q4 - Earnings Call Transcript
2023-03-22 16:59
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 ...
Astria Therapeutics(ATXS) - 2022 Q4 - Earnings Call Presentation
2023-03-22 14:48
Q4/FY 2022 Financial Results and Business Update March 22, 2023 Confidential 1 Forward Looking Statements Thispresentationandvariousremarkswemakeduringthispresentationcontainforward-lookingstatementswithinthemeaningofapplicablesecuritieslawsandregulationsincluding,butnotlimitedto,statements regarding: expectationsregardingthepotentialsignificanceofthepreliminaryandinitialresultsfromthePhase1aSTAR-0215trialandtheanticipatednatureandtimingofreceiptofthedatafromthetwoadditional cohortsinsuchtrial;expectationsr ...
Astria Therapeutics(ATXS) - 2022 Q4 - Annual Report
2023-03-21 16:00
Table of Contents or 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, 2022 ☐ 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 ...