Corporate Presentation May 2025 1 FLS This presentation contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the expected timing of receipt of topline results from the navenibart ALPHA-ORBIT Phase 3 trial; the goals and objectives of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, including that they are designed to support registration of Q3M and Q6M navenibart administration; the expec ...

Summary of Astria Therapeutics Conference Call Company Overview - **Company**: Astria Therapeutics (ATXS) - **Focus**: Development of first-choice products for patients with allergic and immunologic diseases, emphasizing competitive efficacy, safety, and low treatment burden [1] Key Product Insights - **Lead Product**: Nivenabart, a monoclonal antibody targeting plasmacallicrin, currently in Phase III trials for hereditary angioedema (HAE) [1][2] - **Efficacy Data**: Nivenabart demonstrated over 90% reduction in attack rates in proof of concept trials, with potential for dosing every six months [2][10] - **Secondary Program**: STAR310, an OX40 receptor antagonist, with Phase I data expected later in the year [2] Clinical Trial Design and Expectations - **Phase III Trial**: Includes both Q3 and Q6 month dosing regimens, initiated in February 2025, with a focus on providing options for patients and physicians [16][20] - **Enrollment**: Positive enthusiasm from patients and physicians, with expectations for top-line data in early 2027 [20] - **Regulatory Strategy**: Data from the Alpha Solar trial will support FDA filing but is not critical for the pivotal trial [12][21] Market Opportunity - **HAE Market Size**: Expected to grow to approximately $5.4 billion by 2030, driven by earlier diagnoses and increased prophylactic therapy [13][14] - **Market Positioning**: Nivenabart is positioned to capture significant market share from existing therapies, particularly TEKHZYRO, due to its competitive profile and dosing convenience [15][25] Competitive Landscape - **Atopic Dermatitis**: STAR310 targets a significant unmet need in a growing market, particularly for patients inadequately controlled by existing therapies like Dupixent [29][30] - **Differentiation Strategy**: STAR310 aims to provide efficacy without the adverse effects associated with T cell killing, which is a concern with other therapies [33][34] Financial Position and Future Catalysts - **Cash Position**: Approximately $300 million, expected to sustain operations into mid-2027 [38] - **Upcoming Catalysts**: Key data releases include long-term safety and efficacy from the Alpha Solar trial and Phase I data for STAR310, with a focus on differentiating factors [38][39] Additional Insights - **Physician Feedback**: Physicians are interested in both dosing regimens for Nivenabart, indicating a potential for flexible treatment options based on patient needs [18][19] - **Market Research**: Indications show strong interest in Nivenabart's profile, suggesting a favorable reception among physicians for switching from existing therapies [25][26] This summary encapsulates the critical points discussed during the Astria Therapeutics conference call, highlighting the company's strategic focus, product pipeline, market opportunities, and financial outlook.

Clinical Development - Navenibart is in clinical development for hereditary angioedema (HAE) and has received Fast Track and Orphan Drug designations from the FDA [80]. - The Phase 3 trial of navenibart, ALPHA-ORBIT, involves up to 135 adults and 10 adolescents, with top-line results expected in early 2027 [81]. - STAR-0310 is in early clinical development, with a Phase 1a trial initiated in January 2025, and early proof-of-concept results anticipated in Q3 2025 [87]. - Initial proof-of-concept data for navenibart from the ALPHA-STAR trial showed a 91% reduction in monthly attack rate and 50% of patients being attack-free at 3 months [86]. - The ongoing ALPHA-SOLAR trial will provide long-term safety and efficacy data for navenibart, with initial results expected in mid-2025 [84]. Financial Performance - The company reported net losses of $33.7 million for Q1 2025, compared to $19.9 million for Q1 2024, with an accumulated deficit of $708.5 million as of March 31, 2025 [90]. - Research and development expenses for navenibart were $11.8 million for Q1 2025, up from $7.1 million in Q1 2024, while STAR-0310 expenses were $7.4 million compared to $3.0 million in the same period [95]. - Research and development expenses increased by $12.1 million to $27.8 million for the three months ended March 31, 2025, representing a 77% increase compared to the same period in 2024 [106]. - General and administrative expenses rose by $0.8 million to $9.2 million for the three months ended March 31, 2025, an increase of 9% from the previous year [106]. - Net loss for the three months ended March 31, 2025, was $33.7 million, compared to a net loss of $19.9 million for the same period in 2024, reflecting an increase of $13.8 million [105]. - Net cash used in operating activities was $34.0 million for the three months ended March 31, 2025, compared to $19.1 million for the same period in 2024 [114]. - The company incurred an accumulated deficit of $708.5 million as of March 31, 2025, primarily due to ongoing research and development activities [119]. - Other income, net decreased by $0.9 million to $3.3 million for the three months ended March 31, 2025, a decrease of 22% from the previous year [107]. Funding and Capital Requirements - As of March 31, 2025, the company had $295.1 million in cash and equivalents, expected to fund operations into mid-2027 [91]. - The company plans to seek additional funding to support the development and commercialization of navenibart and STAR-0310 due to significant capital requirements [91]. - The company expects to need substantial additional funding to complete the development and commercialization of its product candidates, including navenibart and STAR-0310 [111]. - The company raised an aggregate of $839.2 million through equity financings since inception, including private placements and registered offerings [108]. - The company expects to finance its cash needs through equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements, with no committed external source of funds currently available [122]. - If the company raises funds through collaborations or licensing arrangements, it may have to relinquish valuable rights to its technologies or grant licenses on unfavorable terms [123]. Regulatory and Commercialization Risks - The company faces uncertainty regarding the outcome, timing, and costs of seeking regulatory approvals for its product candidates, which could impact commercialization activities [125]. - The company has potential obligations under its license agreement with Ichnos for STAR-0310, which includes milestone payments and tiered royalties contingent upon development and regulatory approval milestones [127]. - The company has incurred costs related to preparing, filing, and prosecuting patent applications, as well as maintaining and protecting its intellectual property rights [125]. - The company anticipates that its commercial revenues will not be generated for several years, if at all, necessitating reliance on additional financing [121]. - The company has no assurance that it will achieve commercial success with its product candidates, including navenibart and STAR-0310 [121]. Operational Considerations - The company anticipates an increase in general and administrative expenses as it continues to grow and develop its product pipeline [100]. - The company’s headcount growth and associated costs will be a factor in its future financial performance [125]. - The company’s agreements with CROs and third-party manufacturers are generally cancelable with prior notice, and its non-cancelable obligations under these agreements are not considered material [126]. - As of March 31, 2025, the company has material contractual obligations including a sublease requiring monthly payments of $0.1 million from September 1, 2024, until November 30, 2028, and milestone payments of $2.2 million and $2.0 million for clinical trials of navenibart and STAR-0310, respectively, which were met during the three months ended March 31, 2025 [124].

Astria Therapeutics (ATXS) 2025 Conference May 07, 2025 10:30 AM ET Speaker0 Morning, everybody, and welcome to day one of the Citizens Life Science Conference. My name is John Wallabin, senior analyst here. We're pleased to have Astria Therapeutics and CEO, Jill Millney, joining us today. Astria is a company we launched coverage on, I think, earlier this year in January. We've been covering the hereditary angioedema space for quite some time, and I think this is one of the more compelling pipeline candidat ...

Clinical Development and Trials - Navenibart is in clinical development for hereditary angioedema (HAE) and aims to be a best-in-class monoclonal antibody with long-acting, effective attack prevention [25]. - In the Phase 1b/2 trial (ALPHA-STAR), navenibart demonstrated a 91% reduction in monthly attack rate and a 96% reduction in moderate and severe attacks over six months [28]. - The Phase 3 trial (ALPHA-ORBIT) for navenibart began in February 2025, with top-line results expected in early 2027, evaluating up to 135 adults and 10 adolescents [27]. - The ALPHA-SOLAR trial is ongoing to assess long-term safety and efficacy of navenibart, with initial data expected in mid-2025 [33]. - The Phase 1a clinical trial of navenibart involved 41 healthy subjects, with no serious adverse events reported and a low risk of injection pain [45]. - A total of 29 patients were enrolled in the ALPHA-STAR trial to accelerate data collection for potential regulatory filings [47]. - The FDA granted IND clearance for STAR-0310 for the treatment of AD in December 2024, with a Phase 1a clinical trial initiated in January 2025 [58]. - STAR-0310 is being developed for moderate-to-severe AD, with competitive factors including safety, efficacy, and pricing [69]. Market Potential and Competitive Landscape - The global HAE therapy market was estimated at $2.8 billion in 2023 and is projected to grow to $5.4 billion by 2030, driven by earlier diagnoses and increased treatment adoption [42]. - STAR-0310, a monoclonal antibody OX40 antagonist, is being developed for atopic dermatitis (AD) and other allergic diseases, with a potential market growth from $7 billion in 2022 to $26 billion by 2030 [55]. - The competitive landscape for HAE treatments includes four FDA-approved therapies for long-term prevention, with navenibart expected to compete directly with TAKHZYRO [67]. - CSL Behring's garadacimab has completed Phase 3 development for preventative treatment of HAE and is approved in the EU, Australia, and the UK under the brand name ANDEMBRY [68]. - Ionis Pharmaceuticals' donidalorsen has completed Phase 3 development for preventative treatment with a PDUFA date set for August 21, 2025 [68]. - KalVista's sebetralstat for on-demand treatment of HAE has completed Phase 3 development with a PDUFA date set for June 17, 2025 [68]. Regulatory Designations and Compliance - Navenibart received Fast Track and Orphan Drug designations from the FDA, and Orphan Medicinal Product Designation from the European Commission for HAE treatment [26]. - The FDA requires sponsors to conduct adequate and well-controlled human clinical trials to establish the safety and efficacy of proposed drug products [93]. - The FDA's regulations require that pharmaceutical products be manufactured in compliance with cGMPs, which include specific requirements for facilities and processes [124]. - The FDA may impose clinical holds on trials if there are safety concerns, which can delay or suspend the trial until issues are resolved [95]. - The FDA requires that clinical trial results be registered and disclosed on clinicaltrials.gov, with potential delays in result disclosure [115]. Drug Development and Approval Process - The IND process requires a 30-day waiting period after submission before clinical trials can commence, allowing the FDA to review the application for safety and quality [94]. - Clinical trials are divided into four phases, with Phase 3 trials typically required for marketing approval, focusing on evaluating the drug's effectiveness and safety in a larger patient population [107]. - The FDA aims to review 90% of New Molecular Entity (NME) applications within ten months of acceptance for filing, and priority review applications within six months [133]. - The FDA may grant accelerated approval for drugs that provide meaningful therapeutic advantages for serious conditions based on surrogate endpoints [150]. - A Complete Response Letter (CRL) indicates that an application will not be approved in its current form and outlines deficiencies that must be addressed [143]. Intellectual Property and Exclusivity - The company has five patent families directed to navenibart, with expiration dates ranging from 2042 to 2045 depending on the application [75][78][79]. - Orphan drug designation provides seven years of exclusivity for drugs treating rare diseases, with specific conditions for approval [179]. - Patent term restoration allows for up to five years of extension for patents lost during development and FDA review [184]. - Pediatric exclusivity can extend regulatory exclusivity by six months if a pediatric study is completed [181]. Company Operations and Workforce - As of December 31, 2024, the company had 78 full-time employees, with 45 engaged in research and development [87]. - The company relies on third-party manufacturers for the production of navenibart and STAR-0310, ensuring compliance with cGMPs [86].

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].

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].