Astria Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update
- None.
- Increase in operating losses due to acquired in-process R&D expense for STAR-0310 license agreement.
- Net loss increased to $72.9 million for the full year 2023 compared to $51.8 million in 2022.
- Net cash used in operating activities rose to $30.2 million for Q4 2023 from $10.7 million in Q4 2022.
Insights
Reviewing Astria Therapeutics' financial results reveals a strategic emphasis on their lead programs, STAR-0215 and STAR-0310. The cash position of $246.5 million, bolstered by the recent underwritten offering, suggests a solid runway into mid-2027. This financial stability is vital for investors, as it indicates the company can sustain its operations without the immediate need for additional capital. However, the increased operating loss and net loss, both quarterly and annually, reflect the capital-intensive nature of R&D in the biopharmaceutical industry. Investors should monitor the burn rate and consider the potential dilutive effects of future financings.
The progress of STAR-0215 and STAR-0310 is of particular interest. STAR-0215's advancement into a pivotal Phase 3 program, pending successful proof-of-concept results, could position it as a first-choice preventative therapy for HAE. Its favorable safety profile and potential for infrequent dosing are competitive advantages. On the other hand, STAR-0310's preclinical promise as a best-in-class OX40 antagonist for atopic dermatitis could fill a significant market need. However, the inherent risks of drug development, such as clinical trial failures or regulatory setbacks, could impact both the timeline and the financial outlook of Astria.
From a market perspective, the therapeutic areas targeted by Astria—HAE and atopic dermatitis—represent markets with high unmet needs and substantial commercial potential. The company's strategic focus on these areas could lead to significant market penetration, provided the clinical outcomes are positive. The anticipation of initial proof-of-concept data for STAR-0215 and the IND submission for STAR-0310 are milestones that could influence investor sentiment and stock volatility. It is crucial for stakeholders to understand the competitive landscape and regulatory environment, as these factors will be key determinants of Astria's success in bringing these therapies to market.
-- ALPHA-STAR Trial of STAR-0215 Initial Proof-of-Concept Data in HAE Patients Expected Q1 2024 --
-- STAR-0310, Potential Best-in-Class OX40 Program for the Treatment of Atopic Dermatitis, on Track for Expected IND Submission by Year-End 2024 and Phase 1a Initiation in Q1 2025 --
“We have strong conviction in the potential for STAR-0215 to be the first-choice preventative therapy for HAE,” said Jill C. Milne, Chief Executive Officer at Astria Therapeutics. “Our final data from the Phase 1a trial demonstrate that STAR-0215, in addition to having a trusted modality and proven mechanism, has a favorable safety profile with low risk of injection site pain and has the potential to achieve rapid and durable protection against HAE attacks. We are looking forward to sharing initial proof-of-concept data in HAE patients this quarter and believe they could support dosing as infrequently as every six months. STAR-0310 for atopic dermatitis also remains on track for expected preclinical results later this year and an IND submission by year-end.”
STAR-0215
- The ALPHA-STAR Phase 1b/2 trial of STAR-0215 in people with hereditary angioedema (HAE) is on track. Initial proof-of-concept results are expected in the first quarter of 2024. ALPHA-STAR is a global, open-label, proof-of-concept trial assessing single and multiple doses of STAR-0215 in patients with HAE types I and II. The trial is evaluating safety and tolerability, changes in HAE attack rate, pharmacokinetics (PK), pharmacodynamics (PD), and quality-of-life assessments. The initial proof-of-concept results are expected to inform on three and six month dosing and include efficacy results in the form of attack rate reduction, safety and tolerability, PK, and PD. Additionally, the company expects to have data from single and multiple doses in patients.
- Pending proof-of-concept results from the ALPHA-STAR trial, Astria expects to progress directly to a pivotal Phase 3 program which is anticipated to initiate in the first quarter of 2025.
- A Long-Term Open-Label Trial, ALPHA-SOLAR, has been initiated and is enrolling participants from ALPHA-STAR, with data from participants who have received multiple doses of STAR-0215 now accruing. The trial is assessing the long-term safety, tolerability, and efficacy of STAR-0215. Participants are receiving STAR-0215 every three or six months.
-
Final results from the Phase 1a trial were shared at the AAAAI Annual Meeting in
Washington D.C. These results confirm early proof of concept in healthy subjects for STAR-0215 as a potential preventative HAE therapy with a favorable safety profile, long half-life, and durable PD.
STAR-0310
- Astria is developing STAR-0310, a monoclonal antibody OX40 antagonist that incorporates YTE technology, for the treatment of atopic dermatitis (AD).
- STAR-0310, a preclinical stage program, has the potential to have the best-in-class profile in AD. Astria expects to submit an Investigational New Drug (IND) application for STAR-0310 by year-end 2024 and plans to initiate a Phase 1a clinical trial in healthy subjects in the first quarter of 2025, with initial results from the trial expected in the third quarter of 2025.
- Astria intends to present information on the preclinical profile of STAR-0310 at upcoming scientific conferences in 2024.
Underwritten Offering
-
In February 2024, Astria closed an underwritten offering of 10,340,000 shares of common stock for gross proceeds of approximately
$125.0 million - The financing was led by RA Capital Management, with participation from Perceptive Advisors, Venrock Healthcare Capital Partners, TCGX, Driehaus Capital Management, and Adage Capital Partners L.P. in addition to other existing shareholders.
Fourth Quarter and Full Year 2023 Financial Results
Cash Position: As of December 31, 2023, Astria had cash, cash equivalents and short-term investments of
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 Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in preclinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on X and Instagram @AstriaTx and on Facebook and LinkedIn.
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 timing of release of initial proof-of-concept data from such trial, and that favorable results from such trial could allow us to move directly into a Phase 3 pivotal trial of STAR-0215 as a potential treatment for HAE; the expected timing of the start of the Phase 3 pivotal trial of STAR-0215; the potential for STAR-0215 to have the best-in-class profile in HAE, the potential therapeutic benefits of STAR-0215 as a treatment for HAE and our vision and goals for the program; the potential for STAR-0310 to have the best-in-class profile in AD and the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the timing of regulatory filings for STAR-0310; expectations regarding the timing of initiation and planned design of clinical trials for STAR-0310; the expectations regarding the timing and nature of anticipated data for planned trials of STAR-0310; our goals and vision for STAR-0310; anticipated cash runway; and the 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,” “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 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 Phase 1a clinical trial, may not be replicated in later stage clinical trials, 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
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.
(Audited) |
|||||||||
| Year Ended December 31, | |||||||||
|
2023 |
|
|
2022 |
|
||||
| Operating expenses: | |||||||||
| Research and development | $ |
42,127 |
|
$ |
34,264 |
|
|||
| General and administrative |
|
25,704 |
|
|
19,239 |
|
|||
| Acquired in-process research and development |
|
15,199 |
|
|
- |
|
|||
| Total operating expenses |
|
83,030 |
|
|
53,503 |
|
|||
| Loss from operations |
|
(83,030 |
) |
|
(53,503 |
) |
|||
| Other income (expense): | |||||||||
| Interest and investment income |
|
10,201 |
|
|
1,724 |
|
|||
| Other expense, net |
|
(62 |
) |
|
(55 |
) |
|||
| Total other income, net |
|
10,139 |
|
|
1,669 |
|
|||
| Net loss |
|
(72,891 |
) |
|
(51,834 |
) |
|||
| Net loss per share attributable to common shareholders - basic and diluted | $ |
(2.42 |
) |
$ |
(3.55 |
) |
|||
| Weighted-average common shares outstanding used in net loss per share - basic and diluted |
|
30,123,316 |
|
|
14,620,618 |
|
|||
Astria Therapeutics, Inc. Selected Consolidated Balance Sheets Data (In thousands) (Audited) |
||||||
| December 31, | December 31, | |||||
|
2023 |
|
2022 |
|||
| Assets | ||||||
| Cash and cash equivalents | $ |
175,530 |
$ |
20,525 |
||
| Short-term investments |
|
71,000 |
|
205,912 |
||
| Right-of-use asset |
|
363 |
|
948 |
||
| Other current and long-term assets |
|
7,773 |
|
3,248 |
||
| Total assets |
|
254,666 |
|
230,633 |
||
| Liabilities and stockholders’ equity | ||||||
| Current portion of operating lease liabilities |
|
329 |
|
582 |
||
| Long term portion of operating lease liabilities |
|
- |
|
357 |
||
| Other current and long-term liabilities |
|
11,221 |
|
8,478 |
||
| Total liabilities |
|
11,550 |
|
9,417 |
||
| Total stockholders’ equity | $ |
243,116 |
$ |
221,216 |
||
Astria Therapeutics, Inc. Selected Consolidated Statements of Cash Flows Data (In thousands) (Audited) |
||||||||
| Year Ended December 31, | ||||||||
|
2023 |
|
|
2022 |
|
|||
| Net cash used in operating activities | $ |
(68,445 |
) |
$ |
(43,533 |
) |
||
| Net cash provided by (used in) by investing activities |
|
135,052 |
|
|
(167,129 |
) |
||
| Net cash provided by financing activities |
|
88,398 |
|
|
144,721 |
|
||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ |
155,005 |
|
$ |
(65,941 |
) |
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240304317219/en/
Astria:
Investor Relations and Media:
Elizabeth Higgins
investors@astriatx.com
Source: Astria Therapeutics, Inc.
FAQ
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