Financial Performance - The company reported net losses of $44.1 million for the six months ended June 30, 2024, compared to $23.8 million for the same period in 2023, with an accumulated deficit of $624.6 million[72]. - Total operating expenses for the six months ended June 30, 2024, were $52.95 million, an increase of 85% from $28.6 million in the same period in 2023[82]. - The net loss for the six months ended June 30, 2024, was $44.1 million, compared to a net loss of $23.8 million for the same period in 2023, representing an increase of 85%[82]. - General and administrative expenses rose by 44% to $16.5 million for the six months ended June 30, 2024, from $11.5 million in the same period in 2023[85]. - Net cash used in operating activities was $35.9 million for the six months ended June 30, 2024, compared to $23.9 million for the same period in 2023[93]. - As of June 30, 2024, the company had an accumulated deficit of $624.6 million, indicating ongoing operating losses since inception[96]. Cash and Financing - As of June 30, 2024, the company had $354.7 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2027[72]. - The gross proceeds from the October 2023 Financing were $64.0 million, and from the February 2024 Financing were $125.0 million[71]. - The company raised an aggregate of $823.4 million through equity financings from inception through June 30, 2024[86]. - The October 2023 Financing raised gross proceeds of $64.0 million, with net proceeds of $59.5 million[88]. - In February 2024, the company closed a financing round, selling 10,340,000 shares for gross proceeds of $125.0 million and net proceeds of $117.2 million[89]. - The company sold 2,945,806 shares under the 2021 ATM Program for gross proceeds of $20.6 million and net proceeds of $20.0 million in the six months ended June 30, 2024[90]. - Net cash provided by financing activities was $141.9 million for the six months ended June 30, 2024, mainly from net proceeds of $117.2 million from the February 2024 Financing[95]. - The company expects existing cash and short-term investments to fund operations into mid-2027, including activities related to the navenibart program and STAR-0310 OX40 program[96]. - The company may need to seek additional funds sooner than planned due to uncertainties in research and development[98]. Research and Development - Navenibart achieved a 92% reduction in monthly attack rate and a 96% reduction in moderate and severe attacks in the 450 mg dose cohort after 6 months of follow-up[65]. - In the 600 mg dose cohort, there was a 96% reduction in monthly attack rate and 100% of patients were attack-free in the first month after dosing[67]. - The company plans to initiate a Phase 3 pivotal trial for Navenibart in Q1 2025, with top-line results expected by year-end 2026[67]. - STAR-0310 demonstrated a long mean half-life of 26 days in preclinical studies, compared to 10-14 days for typical non-half-life extended IgG antibodies[68]. - The company anticipates submitting an IND for STAR-0310 by year-end 2024 and initiating a Phase 1a clinical trial in Q1 2025[70]. - The company expects to incur significant research and development expenses in 2024 related to navenibart and STAR-0310, with higher expenses anticipated in upcoming quarters[80]. - The company plans to report additional data from the ALPHA-STAR trial in Q4 2024 and initial data from the ALPHA-SOLAR trial in mid-2025[67]. Other Financial Information - Research and development expenses increased by 128% to $20.7 million for the three months ended June 30, 2024, compared to $9.1 million for the same period in 2023[80]. - Other income, net increased by 83% to $4.6 million for the three months ended June 30, 2024, from $2.5 million in the same period in 2023[81]. - Material cash requirements as of June 30, 2024, are primarily related to sublease agreements for office space[99]. - The company has not generated any product revenues and relies on public offerings and private placements for financing[72]. - The company has not made any changes in internal control over financial reporting that materially affected its financial reporting during the six months ended June 30, 2024[102]. - The company has filed various certifications pursuant to the Sarbanes-Oxley Act of 2002, including those from the principal executive and financial officers[105]. - The report includes Inline XBRL documents for detailed financial data presentation[105]. - The Chief Financial Officer, Noah C. Clauser, signed the report on August 12, 2024, confirming its accuracy[106].

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].

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 ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Astria Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, changes in stockholders' equity, cash flows, and related notes for the periods ended June 30, 2023 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to **$207.1 million** from **$230.6 million** at year-end 2022, driven by reduced short-term investments, while total liabilities and stockholders' equity also decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $133,958 | $20,525 | | Short-term investments | $69,000 | $205,912 | | **Total Assets** | **$207,053** | **$230,633** | | **Liabilities & Equity** | | | | Total current liabilities | $6,598 | $9,060 | | **Total Liabilities** | **$6,651** | **$9,417** | | **Total Stockholders' Equity** | **$200,402** | **$221,216** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a **net loss of $12.6 million** for Q2 2023, an increase from the prior year, while the six-month net loss decreased to **$23.8 million** due to higher other income Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $9,089 | $6,617 | $17,122 | $16,975 | | General and administrative | $6,013 | $4,832 | $11,473 | $9,852 | | **Loss from operations** | **($15,102)** | **($11,449)** | **($28,595)** | **($26,827)** | | Total other income, net | $2,536 | $199 | $4,841 | $253 | | **Net loss** | **($12,566)** | **($11,250)** | **($23,754)** | **($26,574)** | | Net loss per share | ($0.45) | ($0.86) | ($0.85) | ($2.04) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$23.9 million** for the six months ended June 30, 2023, offset by **$137.1 million** from investing activities, resulting in a **$113.4 million** net increase in cash Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($23,949) | ($22,620) | | Net cash provided by (used in) investing activities | $137,072 | ($33,899) | | Net cash provided by financing activities | $310 | $0 | | **Net increase (decrease) in cash** | **$113,433** | **($56,519)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's biopharmaceutical focus on rare diseases, particularly **STAR-0215** for HAE, and confirm **$203.0 million** in cash and investments are sufficient for at least twelve months of operations - The company is a biopharmaceutical firm focused on developing novel therapeutics for rare and niche allergic and immunological diseases, with its lead product candidate, **STAR-0215**, in clinical development for **hereditary angioedema (HAE)**[29](index=29&type=chunk) - As of June 30, 2023, the company had **$203.0 million** in cash, cash equivalents, and short-term investments, which management estimates is sufficient to sustain operations for at least twelve months from the financial statement issuance date[31](index=31&type=chunk) - The company maintains an at-the-market (ATM) offering program with Jefferies, with **$50.0 million** of common stock available for sale as of June 30, 2023; no sales were made under this program during the first six months of 2023[30](index=30&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, highlighting **STAR-0215** clinical progress, increased operating expenses, and liquidity, with cash expected to fund operations through the **first half of 2025** [Overview](index=19&type=section&id=Overview) Astria Therapeutics focuses on rare allergic and immunological diseases, with **STAR-0215** as its lead candidate for HAE, having completed Phase 1a and initiated the Phase 1b/2 ALPHA-STAR trial - The company's lead product candidate is **STAR-0215**, a monoclonal antibody inhibitor of plasma kallikrein for the treatment of **hereditary angioedema (HAE)**[78](index=78&type=chunk) - The vision for **STAR-0215** is to become the first-choice preventative **HAE treatment** with administration every three or six months, aiming to normalize patients' lives[79](index=79&type=chunk) - The company initiated the **Phase 1b/2 ALPHA-STAR trial** in February 2023 and expects initial data from single and multiple dose cohorts in **mid-2024**; a long-term open-label trial, **ALPHA-SOLAR**, is planned to start in **Q4 2023**[81](index=81&type=chunk)[83](index=83&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Q2 2023 R&D expenses increased **37% to $9.1 million** and G&A expenses rose **24% to $6.0 million**, while other income significantly increased due to financing proceeds - Research and development expenses for Q2 2023 **increased by $2.5 million (37%)** year-over-year, primarily due to the advancement of the **STAR-0215 program** into two clinical trials (Phase 1a and Phase 1b/2)[101](index=101&type=chunk) - General and administrative expenses for Q2 2023 **increased by $1.2 million (24%)** year-over-year, mainly due to higher professional services and employee-related costs to support clinical trial initiation and company growth[102](index=102&type=chunk)[103](index=103&type=chunk) - Other income, net, **increased by $4.6 million** for the six months ended June 30, 2023, compared to the same period in 2022, primarily due to higher investment and interest income from the net proceeds of the December 2022 Financing[108](index=108&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held **$203.0 million** in cash and investments, expected to fund operations through the **first half of 2025**, bolstered by **$107.6 million** from December 2022 financing - The company had **$203.0 million** in cash, cash equivalents, and short-term investments as of June 30, 2023[109](index=109&type=chunk) - Based on the current operating plan, the company expects its existing cash to be sufficient to fund operating expenses and capital expenditure requirements through the **first half of 2025**[111](index=111&type=chunk) - In December 2022, the company closed an underwritten public offering with net proceeds of **$107.6 million**, significantly strengthening its capital resources[113](index=113&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were **effective** as of June 30, 2023, with **no material changes** in internal control over financial reporting during the quarter - Management, with the participation of the principal executive officer and principal financial officer, concluded that the company's disclosure controls and procedures were **effective** at a reasonable assurance level as of June 30, 2023[129](index=129&type=chunk) - There were **no changes in internal control over financial reporting** during the six months ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[130](index=130&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the comprehensive risk factors detailed in the company's **Annual Report on Form 10-K for the fiscal year ended December 31, 2022** - The report refers stakeholders to the detailed risk factors previously disclosed in the company's **Annual Report on Form 10-K for the fiscal year ended December 31, 2022**[132](index=132&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section provides an **index of exhibits** filed with the **Quarterly Report on Form 10-Q**, including corporate governance documents, material agreements, and officer certifications - An **index of exhibits** filed with the **Form 10-Q** is provided, including corporate bylaws, certificates of incorporation, material agreements, and required officer certifications under the Sarbanes-Oxley Act[133](index=133&type=chunk)[134](index=134&type=chunk)