Astria Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides a Corporate Update
Astria Therapeutics, Inc. (NASDAQ:ATXS) provided a corporate update and financial results for Q4 2022 and the full year. The company is advancing STAR-0215 for hereditary angioedema (HAE) treatment, with promising Phase 1a results showing a potential half-life of up to 117 days. The ALPHA-STAR Phase 1b/2 trial is underway, with proof-of-concept results expected in mid-2024. As of December 31, 2022, Astria reported cash and short-term investments of $226M, ensuring operational funding through mid-2025. The net loss for Q4 was $13.3M, reflecting a slight increase from the previous year.
- Cash and short-term investments of $226M as of December 31, 2022, securing operations through mid-2025.
- Promising initial Phase 1a results of STAR-0215 demonstrate it as a potential long-acting preventative therapy for HAE.
- ALPHA-STAR Phase 1b/2 trial initiated, with initial results expected in mid-2024.
- Increased net loss of $13.3M for Q4 2022 compared to $9.5M in Q4 2021.
- R&D expenses rose to $9.6M for Q4 2022, reflecting higher costs associated with STAR-0215's development.
-- ALPHA-STAR Phase 1b/2 Trial in People with HAE Underway with Initial Proof-of-Concept Results Anticipated Mid-2024 --
-- Phase 1a Results Support STAR-0215’s Target Profile as a Long-Acting Plasma Kallikrein Inhibitor with Estimated Half-Life of up to 117 Days --
-- Ended 4Q 2022 with Cash, Cash Equivalents, and Short-term Investments of
-- Webcast Today at
“We made excellent progress with our STAR-0215 program in 2022, culminating in the promising initial Phase 1a results. These results support our vision for STAR-0215 to be the first-choice preventative therapy for HAE,” said
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Positive preliminary results from the Phase 1a clinical trial of STAR-0215 in healthy subjects were announced in
December 2022 and initial unblinded results from the first three cohorts were presented at theAmerican Academy of Allergy Asthma , and Immunology Annual Meeting (AAAAI) inFebruary 2023 . STAR-0215 was well-tolerated at all doses studied. The results showed rapid and sustained drug levels, with an estimated half-life of up to 117 days and sustained target engagement with plasma kallikrein inhibition for at least three months. These results establish early proof of concept for STAR-0215 as a long-acting preventative therapy for HAE. -
The Company initiated the ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with
HAE in February 2023 . Initial proof-of-concept results are expected in mid-2024. The ALPHA-STAR trial is a global, open-label, proof-of-concept trial enrolling patients with HAE types I and II that is evaluating safety and tolerability, changes in HAE attack rate, pharmacokinetics, pharmacodynamics, and quality-of-life assessments. Following an initial run-in period, qualifying participants will be enrolled in either single or multiple dose cohorts. Data from up to 18 participants will evaluate efficacy and safety, and comparisons will be made against data collected in the run-in period. Pending proof-of-concept results from the ALPHA-STAR trial,Astria expects to progress directly to a pivotal trial. -
Astria is also evaluating the potential for administration of STAR-0215 every six months in additional cohorts in the Phase 1a trial, with preliminary results expected in the fourth quarter of 2023. These data, in conjunction with the ALPHA-STAR results, are expected to inform plans for the pivotal trial.
Webcast Information
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The Company will host a webcast today at
8:30am ET . Interested parties may join the webcast via the Investors section of theAstria website, www.astriatx.com or with following the link https://lifescievents.com/event/astria-therapeutics-event/. The webcast will be archived for 90 days.
Fourth Quarter and Full Year 2022 Financial Results
Cash Position: In
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Operating Loss: Loss from operations was
Net Loss: Net loss was
Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was
About
About STAR-0215:
STAR-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.
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: expectations regarding the potential significance of the preliminary results from the Phase 1a STAR-0215 trial and the anticipated nature and timing of receipt of the data from the two additional cohorts in such trial; expectations regarding the timing and nature of the anticipated proof of concept results from the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215; the longer term development plans for STAR-0215, including the plan, assuming positive results, to move directly from the ALPHA-STAR trial into a pivotal trial; the potential attributes and differentiated profile of STAR-0215 as a treatment for HAE, including those suggested by the preliminary and initial results from the STAR-0215 Phase 1a trial and market research, 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; the potential for six-month dosing of STAR-0215; the Company’s anticipated cash runway; and the Company’s 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, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” 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’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 Company’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 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 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
Consolidated Statements of Operations (In thousands, except share and per share data) (Audited) |
||||||||||||
Three Months Ended |
Year Ended |
|||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||
Operating expenses: | ||||||||||||
Research and development | $ |
9,591 |
$ |
5,693 |
$ |
34,264 |
$ |
15,552 |
||||
General and administrative |
|
4,699 |
|
3,816 |
|
19,239 |
|
14,807 |
||||
Acquired in-process research and development |
|
- |
|
- |
|
164,617 |
||||||
Total operating expenses |
|
14,290 |
|
9,509 |
|
53,503 |
|
194,976 |
||||
Loss from operations |
|
(14,290) |
|
(9,509) |
|
(53,503) |
|
(194,976) |
||||
Other income (expense): | ||||||||||||
Interest and investment income |
|
1,018 |
|
32 |
|
1,724 |
|
122 |
||||
Other expense, net |
|
9 |
|
(16) |
|
(55) |
|
(58) |
||||
Total other income, net |
|
1,027 |
|
16 |
|
1,669 |
|
64 |
||||
Net loss |
|
(13,263) |
|
(9,493) |
|
(51,834) |
|
(194,912) |
||||
Dividend on convertible preferred stock related to beneficial conversion feature and issuance costs |
|
- |
|
- |
|
- |
|
(24,437) |
||||
Net loss attributable to common shareholders | $ |
(13,263) |
$ |
(9,493) |
$ |
(51,834) |
$ |
(219,349) |
||||
Net loss per share attributable to common shareholders - basic and diluted | $ |
(0.72) |
$ |
(0.74) |
$ |
(3.55) |
$ |
(24.58) |
||||
Weighted-average common shares outstanding used in net loss per share - basic and diluted |
|
18,417,203 |
|
12,830,782 |
|
14,620,618 |
|
8,925,173 |
||||
Selected Consolidated Balance Sheets Data (In thousands) (Audited) |
||||||
|
|
|||||
2022 |
2021 |
|||||
Assets | ||||||
Cash and cash equivalents | $ |
20,525 |
$ |
86,508 |
||
Short-term investments |
|
205,912 |
|
39,000 |
||
Right-of-use asset |
|
948 |
|
394 |
||
Other current and long-term assets |
|
3,248 |
|
1,612 |
||
Total assets |
|
230,633 |
|
127,514 |
||
Liabilities and stockholders’ equity | ||||||
Current portion of operating lease liabilities |
|
582 |
|
365 |
||
Long-term portion of operating lease liabilities |
|
357 |
|
- |
||
Other current and long-term liabilities |
|
8,478 |
|
4,838 |
||
Total liabilities |
|
9,417 |
|
5,203 |
||
Total stockholders’ equity | $ |
221,216 |
$ |
122,311 |
||
Selected Consolidated Statements of Cash Flows Data (In thousands) (Audited) |
||||||
Year Ended |
||||||
2022 |
2021 |
|||||
Net cash used in operating activities | $ |
(43,533) |
$ |
(30,151) |
||
Net cash used in by investing activities |
|
(167,129) |
|
(12,555) |
||
Net cash provided by financing activities |
|
144,721 |
|
104,284 |
||
Net (decrease) increase in cash, cash equivalents and restricted cash | $ |
(65,941) |
$ |
61,578 |
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FAQ
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