www.astriatx.com<\/a>, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.<\/p>\nAbout STAR-0215:<\/b><\/p>\n
\nSTAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our vision is for STAR-0215 to be the first-choice preventative treatment for people with HAE dosed once every three or six months and to make substantial progress towards normalizing their lives. The Phase 1b\/2 ALPHA-STAR trial evaluating STAR-0215 in HAE patients is ongoing, with proof-of-concept results expected in mid-2024.<\/p>\n
Forward Looking Statements<\/b><\/p>\n
\nThis press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: expectations regarding the potential significance of the results from the Phase 1a STAR-0215 trial and the anticipated nature and timing of receipt of additional data from the trial; expectations regarding the timing and nature of the anticipated proof of concept results from the ALPHA-STAR Phase 1b\/2 clinical trial; the longer term development plans for STAR-0215, including the plan, pending proof-of-concept results from the ALPHA-STAR trial, to progress directly to a pivotal trial; our plans to initiate a long-term open label trial in the second half of this year; the potential attributes and differentiated profile of STAR-0215 as a treatment for HAE, including those suggested by the results from the STAR-0215 Phase 1a trial, market research, mechanistic modeling and patient feedback, and our goals and vision for STAR-0215; the potential commercial opportunity for STAR-0215 in HAE and the likelihood that it can effectively compete in HAE, assuming its approved; the need for effective treatments for HAE and the expected growth of the HAE market; the potential for three and six-month administration and suppression of HAE attacks of STAR-0215; the Company\u2019s anticipated cash runway; and the Company\u2019s goal to meet the unmet needs of patients with rare and niche allergic and immunological diseases. The use of words such as, but not limited to, \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cgoals,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwill,\u201d or \u201cwould\u201d and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company\u2019s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of the Company\u2019s product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and\/or competitive factors, including the COVID-19 pandemic; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of pre-clinical studies may not be replicated in clinical studies, that the preliminary results from the Phase 1a trial may not be indicative of the final results, that the results of early stage clinical studies, such as the preliminary and initial unblinded results from the Phase 1a trial, may not be replicated in later stage clinical studies, including the ALPHA-STAR trial, the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the U.S. Food and Drug Administration and other regulatory authorities on our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including investigational review boards at such sites, and other review bodies with respect to STAR-0215 and any other future development candidates; our ability to manufacture sufficient quantities of drug substance and drug product for STAR-0215 and any other future product candidates on a cost-effective and timely basis, and to develop dosages and formulation for STAR-0215 and any other future product candidates that are patient-friendly and competitive; our ability to develop biomarker and other assays, along with the testing protocols therefore; our ability to obtain, maintain and enforce intellectual property rights for STAR-0215 and any other future product candidates; our potential dependence on collaboration partners; competition with respect to STAR-0215 or any of our other future product candidates; the risk that the clinical results to date, survey results and market research may not be accurate predictors of the commercial landscape for HAE, the ability of STAR-0215 to compete in HAE and the anticipated position and attributes of STAR-0215 in HAE based on its clinical data to date, pre-clinical profile, mechanistic and other modeling, market research, patient feedback and other data; our ability to manage our cash usage and the possibility of unexpected cash expenditures; our ability to obtain necessary financing to conduct our planned activities and to manage unplanned cash requirements; the risks and uncertainties related to our ability to recognize the benefits of any additional acquisitions, licenses or similar transactions; and general economic and market conditions; as well as the risks and uncertainties discussed in the \u201cRisk Factors\u201d section of our Annual Report on Form 10-K for the period ended December 31, 2022 and in other filings that we make with the Securities and Exchange Commission (\u201cSEC\u201d). New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. The Company may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on the Company\u2019s forward-looking statements. Neither the Company, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company\u2019s views as of any date subsequent to the date hereof.<\/p>\n
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