"estimate, " "expect," "goals," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would," or "vision," 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 Astria's 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 Astria's 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 the following 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; 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 preclinical studies, including of navenibart and STAR-0310, may not be replicated in clinical trials, that the preliminary or interim results from clinical trials may not be indicative of the final results, that the results of early stage clinical trials, such as the results from the navenibart Phase 1a clinical trial and the initial results from the ALPHA-STAR trial, may not be replicated in later stage clinical trials, including additional and final results from the ALPHA-STAR trial or the planned navenibart Phase 3 development program; 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 FDA 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 navenibart, STAR-0310, and any other future development candidates, and devices for such product candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates, and devices for such product candidates, on a cost-effective and timely basis, and to develop dosages and formulation for navenibart, STAR-0310, 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 navenibart, STAR-0310, and any other future product candidates; our potential dependence on collaboration partners; competition with respect to navenibart, STAR-0310, or any of our other future product candidates; the risk that survey results and market research may not be accurate predictors of the commercial landscape for HAE, the ability of navenibart to compete in HAE and the anticipated position and attributes of navenibart in HAE based on clinical data to date, its preclinical profile, pharmacokinetic modeling, market research and other data; risks with respect to the ability of STAR-0310 to compete in AD and the anticipated position and attributes of STAR-0310 in AD based on its preclinical profile; 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 "Risk Factors" section of our Annual Report on Form 10-K for the period ended December 31, 2023 and in other filings that we may make with the Securities and Exchange Commission.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Astria 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 Astria's forward-looking statements. Neither Astria, 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 Astria's views as of any date subsequent to the date hereof.

 
 
                         Astria Therapeutics, Inc. 
                   Consolidated Statements of Operations 
              (In thousands, except share and per share data) 
                                 (Unaudited) 
 
                        Three Months Ended      Nine Months Ended September 
                          September 30,                     30, 
                    --------------------------  ---------------------------- 
                        2024          2023          2024          2023 
                     ----------    ----------    ----------    ---------- 
 
Operating 
 expenses: 
  Research and 
   development      $    20,510   $    13,338   $    56,945   $    30,460 
  General and 
   administrative         8,504         6,898        25,022        18,371 
                     ----------    ----------    ----------    ---------- 
    Total 
     operating 
     expenses            29,014        20,236        81,967        48,831 
                     ----------    ----------    ----------    ---------- 
Loss from 
 operations             (29,014)      (20,236)      (81,967)      (48,831) 
Other income 
 (expense): 
  Interest and 
   investment 
   income                 4,517         2,527        13,405         7,404 
  Other expense, 
   net                      (37)          (18)          (72)          (54) 
                     ----------    ----------    ----------    ---------- 
    Total other 
     income, net          4,480         2,509        13,333         7,350 
                     ----------    ----------    ----------    ---------- 
Net loss                (24,534)      (17,727)      (68,634)      (41,481) 
Net loss per share 
 attributable to 
 common 
 shareholders - 
 basic and 
 diluted            $     (0.42)  $     (0.63)  $     (1.24)  $     (1.48) 
                     ==========    ==========    ==========    ========== 
Weighted-average 
 common shares 
 outstanding used 
 in net loss per 
 share - basic and 
 diluted             57,820,458    28,040,173    55,542,074    28,002,663 
                     ==========    ==========    ==========    ========== 
 
 
 
                        Astria Therapeutics, Inc. 
                Selected Consolidated Balance Sheets Data 
                              (In thousands) 
                                (Unaudited) 
 
                                            September 30,    December 31, 
                                                2024             2023 
                                           ---------------  -------------- 
Assets 
  Cash and cash equivalents                 $       80,899   $     175,530 
  Short-term investments                           263,384          71,000 
  Right-of-use asset                                 5,390             363 
  Other current and long-term assets                11,966           7,773 
                                               -----------      ---------- 
Total assets                                       361,639         254,666 
Liabilities and stockholders' equity 
  Current portion of operating lease 
   liabilities                                       1,377             329 
  Long term portion of operating lease 
   liabilities                                       4,261               - 
  Other current and long-term liabilities           14,347          11,221 
                                               -----------      ---------- 
Total liabilities                                   19,985          11,550 
Total stockholders' equity                  $      341,654   $     243,116 
 
 
 
                       Astria Therapeutics, Inc. 
          Selected Consolidated Statements of Cash Flows Data 
                             (In thousands) 
                               (Unaudited) 
 
                                     Nine Months Ended September 30, 
                                 --------------------------------------- 
                                          2024               2023 
                                     --------------       ----------- 
Net cash used in operating 
 activities                       $         (63,850)     $    (38,207) 
Net cash (used in) provided by 
 investing activities                      (188,146)          137,068 
Net cash provided by financing 
 activities                                 157,202               420 
                                     --------------       ----------- 
Net (decrease) increase in 
 cash, cash equivalents and 
 restricted cash                  $         (94,794)     $     99,281 
                                     ==============       =========== 
 

View source version on businesswire.com: https://www.businesswire.com/news/home/20241113654925/en/

 
    CONTACT:    Astria Contact: 

Investor Relations and Media:

Elizabeth Higgins

investors@astriatx.com

(END) Dow Jones Newswires

November 13, 2024 16:10 ET (21:10 GMT)