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 ...

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 ...

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 ...

Astria Therapeutics, Inc. (NASDAQ:ATXS) Q3 2021 Earnings Conference Call November 10, 2021 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 Noah Clauser - Chief Financial Officer Conference Call Participants Hartaj Singh - Oppenheimer Suji Jeong - Jefferies Laura Chico - Wedbush Securities Joe Pantginis - H.C. Wainwright Operator Good day and thank ...

PART I. FINANCIAL INFORMATION [Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Presents Astria Therapeutics' unaudited condensed consolidated financial statements, showing asset and equity growth from financing and a net loss from a one-time IPR&D charge [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20September%2030%2C%202021%20and%20December%2031%2C%202020) Total assets and stockholders' equity significantly increased to **$135.1 million** and **$130.4 million** respectively, driven by cash and financing activities Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $131,777 | $24,930 | | Total current assets | $134,522 | $46,325 | | Total assets | $135,129 | $47,456 | | **Liabilities & Equity** | | | | Total liabilities | $4,700 | $6,787 | | Total stockholders' equity | $130,429 | $40,669 | | Total liabilities and stockholders' equity | $135,129 | $47,456 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20and%20nine%20months%20ended%20September%2030%2C%202021%20and%202020) The company reported a **$185.4 million** net loss for the nine months ended September 30, 2021, primarily due to a **$164.6 million** acquired IPR&D charge Statement of Operations Highlights (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,788 | $7,806 | $9,859 | $19,845 | | General and administrative | $4,110 | $3,057 | $10,992 | $8,612 | | Acquired in-process R&D | $0 | $0 | $164,617 | $0 | | Loss from operations | $(7,898) | $(10,863) | $(185,468) | $(28,457) | | Net loss | $(7,871) | $(10,862) | $(185,421) | $(28,322) | | Net loss per share | $(0.61) | $(3.36) | $(27.81) | $(9.56) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20three%20and%20nine%20months%20ended%20September%2030%2C%202021%20and%202020) Comprehensive loss for the three and nine months ended September 30, 2021, mirrored net loss due to immaterial other comprehensive loss items Comprehensive Loss (in thousands) | Period | Net Loss | Comprehensive Loss | | :--- | :--- | :--- | | Three Months Ended Sep 30, 2021 | $(7,871) | $(7,871) | | Nine Months Ended Sep 30, 2021 | $(185,421) | $(185,421) | | Three Months Ended Sep 30, 2020 | $(10,862) | $(10,863) | | Nine Months Ended Sep 30, 2020 | $(28,322) | $(28,322) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20for%20the%20three%20and%20nine%20months%20ended%20September%2030%2C%202021%20and%202020) Stockholders' equity significantly changed due to Series X Preferred Stock issuance, conversion to common stock, and a non-cash dividend, increasing additional paid-in capital - In the nine months ended Sep 30, 2021, the company issued Series X Preferred Stock valued at **$240.9 million** through the Quellis acquisition and a private placement[17](index=17&type=chunk) - During the same period, **54,622 shares** of Series X Preferred Stock were converted into **9,103,664 shares** of common stock, transferring **$168.9 million** from preferred stock value to additional paid-in capital[17](index=17&type=chunk)[27](index=27&type=chunk) - A non-cash dividend of **$24.4 million** was recorded related to a beneficial conversion feature and issuance costs on the convertible preferred stock[17](index=17&type=chunk)[42](index=42&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20nine%20months%20ended%20September%2030%2C%202021%20and%202020) Net cash increased by **$106.8 million** for the nine months ended September 30, 2021, driven by **$104.3 million** from financing activities Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,865) | $(24,424) | | Net cash provided by investing activities | $26,445 | $26,310 | | Net cash provided by financing activities | $104,267 | $40,829 | | **Net increase in cash** | **$106,847** | **$42,715** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the Quellis Biosciences acquisition, a **$164.6 million** IPR&D charge, **$110 million** private placement, and a 1-for-6 reverse stock split - On January 28, 2021, the company acquired Quellis Biosciences, whose lead product candidate is STAR-0215 for the treatment of hereditary angioedema (HAE)[22](index=22&type=chunk) - The Quellis acquisition was accounted for as an asset acquisition, resulting in a one-time charge of **$164.6 million** for acquired in-process research and development (IPR&D) with no alternative future use[45](index=45&type=chunk)[46](index=46&type=chunk)[49](index=49&type=chunk) - Concurrent with the acquisition, the company raised gross proceeds of approximately **$110.0 million** in the February 2021 Financing through the sale of Series X Preferred Stock[25](index=25&type=chunk) - A 1-for-6 reverse stock split of common stock was effected on August 19, 2021. All share and per-share amounts have been retrospectively adjusted[23](index=23&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot to STAR-0215 development, a **50%** R&D expense decrease, a **$164.6 million** IPR&D charge, and sufficient cash to fund operations through 2023 - The company's primary focus is now on STAR-0215, a monoclonal antibody inhibitor for treating hereditary angioedema (HAE), acquired through the Quellis acquisition in January 2021[67](index=67&type=chunk) - Key development milestones include submitting an IND for STAR-0215 in mid-2022, initiating a Phase 1 trial with initial results expected by the end of 2022, and a planned Phase 1b/2 trial in HAE patients in 2023[67](index=67&type=chunk) R&D Expense Breakdown (Nine Months Ended Sep 30, in thousands) | Program | 2021 | 2020 | | :--- | :--- | :--- | | STAR-0215 | $4,422 | $0 | | Edasalonexent | $660 | $13,765 | | Other research programs | $765 | $0 | | Unallocated Costs | $4,012 | $6,080 | | **Total R&D Expenses** | **$9,859** | **$19,845** | - The company recorded a **$164.6 million** expense for Acquired In-process Research and Development (IPR&D) in January 2021 related to the Quellis Acquisition[77](index=77&type=chunk)[91](index=91&type=chunk) - As of September 30, 2021, the company had **$131.8 million** in cash and cash equivalents, which is expected to be sufficient to support operating expenses through 2023[92](index=92&type=chunk)[102](index=102&type=chunk) [Qualitative and Quantitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Qualitative%20and%20Quantitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and cash equivalents, with a **10%** rate change deemed immaterial due to portfolio nature - The company's main market risk is interest rate sensitivity on its **$131.8 million** in cash and cash equivalents[108](index=108&type=chunk) - Due to the short-term and low-risk nature of the investment portfolio, management concludes that an immediate **10%** change in interest rates would not have a material effect on its financial position[108](index=108&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting - Management concluded that as of September 30, 2021, the company's disclosure controls and procedures were effective at the reasonable assurance level[109](index=109&type=chunk) - There were no material changes in internal control over financial reporting during the nine months ended September 30, 2021[110](index=110&type=chunk) PART II. OTHER INFORMATION [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the Annual Report on Form 10-K for a comprehensive discussion of material risk factors - The report refers to the Risk Factors section of the Annual Report on Form 10-K for the fiscal year ended December 31, 2020, for a discussion of material risks[112](index=112&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate amendments and officer certifications - Exhibits filed include amendments to the Certificate of Incorporation and By-laws, and officer certifications pursuant to the Sarbanes-Oxley Act[113](index=113&type=chunk)