Astria Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update
Astria Therapeutics (NASDAQ:ATXS) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company initiated the ALPHA-ORBIT Phase 3 trial of navenibart for hereditary angioedema (HAE) in February 2025, with top-line results expected in early 2027.
Key financial metrics for 2024 include:
- Cash position of $328.1 million as of December 31, 2024
- Net loss of $94.3 million for full year 2024
- R&D expenses increased to $77.1 million
- G&A expenses rose to $34.5 million
The company expects its current cash position to fund operations into mid-2027. Phase 1b/2 ALPHA-STAR trial results showed 90-95% reduction in mean monthly attack rates. Additionally, Astria initiated a Phase 1a trial of STAR-0310 for atopic dermatitis, with initial results anticipated in Q3 2025.
Astria Therapeutics (NASDAQ:ATXS) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nei suoi programmi clinici. L'azienda ha avviato il trial di fase 3 ALPHA-ORBIT per il navenibart nel trattamento dell'angioedema ereditario (HAE) a febbraio 2025, con risultati preliminari attesi all'inizio del 2027.
I principali indicatori finanziari per il 2024 includono:
- Posizione di cassa di 328,1 milioni di dollari al 31 dicembre 2024
- Perdita netta di 94,3 milioni di dollari per l'intero anno 2024
- Le spese per R&S sono aumentate a 77,1 milioni di dollari
- Le spese generali e amministrative sono salite a 34,5 milioni di dollari
L'azienda prevede che l'attuale posizione di cassa sosterrà le operazioni fino a metà 2027. I risultati del trial di fase 1b/2 ALPHA-STAR hanno mostrato una riduzione del 90-95% delle medie mensili degli attacchi. Inoltre, Astria ha avviato un trial di fase 1a di STAR-0310 per la dermatite atopica, con risultati iniziali previsti per il terzo trimestre del 2025.
Astria Therapeutics (NASDAQ:ATXS) informó sobre sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en sus programas clínicos. La compañía inició el ensayo de fase 3 ALPHA-ORBIT de navenibart para el angioedema hereditario (HAE) en febrero de 2025, con resultados preliminares esperados a principios de 2027.
Los principales indicadores financieros para 2024 incluyen:
- Posición de efectivo de 328,1 millones de dólares al 31 de diciembre de 2024
- Pérdida neta de 94,3 millones de dólares para el año completo 2024
- Los gastos de I+D aumentaron a 77,1 millones de dólares
- Los gastos generales y administrativos aumentaron a 34,5 millones de dólares
La compañía espera que su posición de efectivo actual financie las operaciones hasta mediados de 2027. Los resultados del ensayo de fase 1b/2 ALPHA-STAR mostraron una reducción del 90-95% en las tasas de ataque mensuales promedio. Además, Astria inició un ensayo de fase 1a de STAR-0310 para la dermatitis atópica, con resultados iniciales anticipados para el tercer trimestre de 2025.
Astria Therapeutics (NASDAQ:ATXS)는 2024년 4분기 및 연간 재무 결과를 보고하며 임상 프로그램에서의 중요한 발전을 강조했습니다. 이 회사는 2025년 2월에 유전성 혈관부종(HAE)을 위한 navenibart의 ALPHA-ORBIT 3상 시험을 시작했으며, 초기 결과는 2027년 초에 예상됩니다.
2024년 주요 재무 지표는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 위치 3억 2810만 달러
- 2024년 전체 연간 순손실 9430만 달러
- 연구개발(R&D) 비용이 7710만 달러로 증가
- 일반 및 관리(G&A) 비용이 3450만 달러로 증가
회사는 현재 현금 위치가 2027년 중반까지 운영 자금을 지원할 것으로 예상하고 있습니다. 1b/2상 ALPHA-STAR 시험 결과는 월 평균 발작률이 90-95% 감소했음을 보여주었습니다. 추가로, Astria는 아토피 피부염 치료를 위한 STAR-0310의 1a상 시험을 시작했으며, 초기 결과는 2025년 3분기에 예상됩니다.
Astria Therapeutics (NASDAQ:ATXS) a publié ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en évidence des progrès significatifs dans ses programmes cliniques. L'entreprise a lancé l'
Les principaux indicateurs financiers pour 2024 incluent :
- Position de trésorerie de 328,1 millions de dollars au 31 décembre 2024
- Perte nette de 94,3 millions de dollars pour l'année 2024
- Les dépenses de R&D ont augmenté à 77,1 millions de dollars
- Les dépenses générales et administratives ont augmenté à 34,5 millions de dollars
L'entreprise s'attend à ce que sa position de trésorerie actuelle finance ses opérations jusqu'à la mi-2027. Les résultats de l'essai de phase 1b/2 ALPHA-STAR ont montré une réduction de 90-95 % des taux d'attaque mensuels moyens. De plus, Astria a lancé un essai de phase 1a de STAR-0310 pour la dermatite atopique, avec des résultats initiaux attendus au troisième trimestre de 2025.
Astria Therapeutics (NASDAQ:ATXS) berichtete über die finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 und hob dabei signifikante Fortschritte in seinen klinischen Programmen hervor. Das Unternehmen startete im Februar 2025 die ALPHA-ORBIT Phase-3-Studie zu navenibart bei hereditärem Angioödem (HAE), mit ersten Ergebnissen, die Anfang 2027 erwartet werden.
Wichtige Finanzkennzahlen für 2024 umfassen:
- Liquiditätsposition von 328,1 Millionen Dollar zum 31. Dezember 2024
- Nettoverlust von 94,3 Millionen Dollar für das gesamte Jahr 2024
- F&E-Ausgaben stiegen auf 77,1 Millionen Dollar
- Allgemeine und Verwaltungskosten erhöhten sich auf 34,5 Millionen Dollar
Das Unternehmen erwartet, dass die aktuelle Liquiditätsposition die Betriebe bis Mitte 2027 finanzieren kann. Die Ergebnisse der Phase 1b/2 ALPHA-STAR-Studie zeigten eine Reduktion der durchschnittlichen monatlichen Anfallraten um 90-95%. Darüber hinaus hat Astria eine Phase 1a-Studie zu STAR-0310 bei atopischer Dermatitis gestartet, mit ersten Ergebnissen, die im dritten Quartal 2025 erwartet werden.
- Strong cash position of $328.1M provides runway into mid-2027
- ALPHA-STAR trial showed impressive 90-95% reduction in monthly attack rates
- High market potential with 53% anticipated share for new HAE patients
- Successful initiation of ALPHA-ORBIT Phase 3 trial
- Pipeline expansion with STAR-0310 Phase 1a trial initiation
- Net loss increased to $94.3M in 2024 from $72.9M in 2023
- R&D expenses rose significantly to $77.1M from $42.1M
- G&A expenses increased to $34.5M from $25.7M
- Operating loss widened to $111.6M from $83.0M
Insights
Astria's Q4 report demonstrates solid clinical progression for its leading drug candidates while maintaining a strong financial position. With
The navenibart program shows particularly compelling potential in HAE with Phase 1b/2 data demonstrating
While R&D expenses increased to
The company has established clear clinical milestones with initial efficacy data expected mid-2025 for navenibart's extension trial and Q3 2025 for STAR-0310's Phase 1a results, providing near-term catalysts that could further validate their pipeline value.
Astria's clinical development strategy for navenibart demonstrates sophisticated trial design that maximizes chances of regulatory success while addressing patient needs. The ALPHA-ORBIT Phase 3 trial incorporates both Q3M and Q6M dosing regimens in a single pivotal study, an efficient approach that could accelerate time-to-market while providing dosing flexibility - a key differentiator in the competitive HAE landscape.
The 90-95% attack reduction observed in Phase 1b/2 positions navenibart favorably against current preventive HAE therapies. Most significant is the rapid onset coupled with durable efficacy extending to 6 months, suggesting potential best-in-class status. The strong pharmacokinetic/pharmacodynamic correlation with sustained plasma kallikrein inhibition provides mechanistic validation for the extended dosing intervals.
For STAR-0310, Astria has applied lessons from previous OX40 programs to engineer potentially superior characteristics. The reduced antibody-dependent cellular cytotoxicity on T-cells addresses a key safety concern with this drug class, potentially enabling a wider therapeutic window. The 26-day half-life in preclinical models suggests infrequent dosing possibilities, which could enhance patient compliance in the competitive atopic dermatitis market.
Both programs benefit from rational drug design principles with clear differentiation strategies focused on reducing treatment burden without compromising efficacy - a patient-centric approach increasingly valued by regulators, payers, and prescribers alike.
-- ALPHA-ORBIT Pivotal Phase 3 Trial Evaluating Every 3- and Every 6-Month Administration of Navenibart (STAR-0215) in Hereditary Angioedema is Underway --
-- Initial Efficacy and Safety Data from Navenibart ALPHA-SOLAR Long-Term Extension Trial Expected Mid-2025 --
-- Phase 1a Trial of STAR-0310, a Potential Best-in-Class Monoclonal Antibody OX40 Antagonist, Ongoing with Initial Results Anticipated in Q3 2025 --
“2025 promises to be an exciting year for Astria, and we are building on the momentum from a successful 2024 with the initiation of two important clinical trials,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “With the ALPHA-ORBIT Phase 3 trial of navenibart, we are enabling the potential for HAE patients to break free from the gravity of their disease and supporting low treatment burden by including both every 3-month and every 6-month regimens in a single trial. We believe that navenibart has the potential to be the market-leading therapy for HAE, and we look forward to building on our track record of strong execution throughout the trial. We also initiated a clinical trial evaluating STAR-0310 in healthy subjects and expect these results will demonstrate STAR-0310’s differentiated profile in the third quarter this year.”
Navenibart (STAR-0215)
- Astria initiated the ALPHA-ORBIT pivotal Phase 3 trial of navenibart in people with hereditary angioedema (HAE) in February 2025, with top-line results expected in early 2027. The ALPHA-ORBIT trial is a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of navenibart over a 6-month treatment period in up to 135 adult and 10 adolescent patients with Type 1 or Type 2 HAE. Adult patients will be randomized to receive one of three navenibart dose arms: 1) an initial 600 mg dose and followed by 300 mg every 3-months (Q3M), 2) 600 mg every 6-months (Q6M), and 3) 600 mg Q3M, or placebo; adolescents will receive an initial 600 mg dose followed by 300 mg Q3M. The dose arms support the potential to provide patient-centric dosing flexibility to people with HAE. The primary endpoint is time-normalized monthly HAE attacks at 6 months, and a key secondary endpoint includes the proportion of participants who are attack-free at 6 months. After 6 months, patients may be eligible to enter a long-term trial called ORBIT-EXPANSE, in which all patients will be treated with navenibart and which will include a patient-centered flexible dosing period and assess the long-term safety and tolerability as well as efficacy of navenibart. The navenibart Phase 3 program will consist of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, which are designed to support registration globally.
-
Positive final top-line results from target enrollment in the Phase 1b/2 ALPHA-STAR trial of navenibart, announced in December 2024, showed rapid onset of robust and durable efficacy, favorable safety and tolerability, and pharmacokinetics and pharmacodynamics consistent with sustained plasma kallikrein inhibition for both Q3M and Q6M administration. Final results included reduction in mean monthly attack rate of 90
-95% and up to a67% attack-free rate over 6 months. - All of the 16 target enrollment patients from ALPHA-STAR have entered the ALPHA-SOLAR long-term open-label trial. Initial safety and efficacy data from ALPHA-SOLAR, with Q3M and Q6M administration, are expected mid-2025.
-
Physician market research (n=50) reinforced the potential for navenibart to be the market-leading therapy for HAE. Physicians anticipated that offering both Q3M and Q6M options would gain
53% of their patient share for those initiating preventative therapy for the first time based on the existing treatment landscape, and46% for those switching from currently available injectable and oral therapies. - Astria presented the ALPHA-ORBIT Phase 3 trial design and results on attack severity and use of rescue medication from the ALPHA-STAR Phase 1b/2 trial at the American Academy of Allergy, Asthma, & Immunology (AAAAI) in March 2025. The Company also presented ALPHA-STAR Phase 1b/2 results in an encore presentation in February 2025 at the Western Society of Allergy, Asthma, & Immunology (WSAAI) demonstrating that navenibart induced rapid improvements in Quality of Life (QoL) and HAE attack rates in patients in the ALPHA-STAR trial.
STAR-0310
- Astria is developing STAR-0310, an investigational high-potency and long-acting monoclonal antibody OX40 antagonist that incorporates YTE technology, for the treatment of atopic dermatitis (AD) and potentially other indications. STAR-0310 was intentionally designed to capitalize on the learnings of OX40 receptor and OX40 ligand programs with the goal of having the best overall OX40 therapy.
- The Company initiated a Phase 1a clinical trial of STAR-0310 in healthy subjects in January 2025. The Phase 1a trial is intended to assess the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants, with early proof-of-concept (POC) results expected in the third quarter of 2025.
-
The
U.S. Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application for STAR-0310 in December 2024. - Preclinical data supporting the differentiated profile of STAR-0310 was presented at AAAAI in March 2025. STAR-0310 demonstrated an estimated mean half-life of 26 days in cynomolgus monkeys and STAR-0310 preserved T-cells. STAR-0310 significantly reduced antibody-dependent cellular cytotoxicity (ADCC) on activated T-cells and regulatory T-cells when compared to other anti-OX40 monoclonal antibodies. Reduction in ADCC activity has the potential for a more favorable safety profile and potentially wider therapeutic window for STAR-0310, which the Company believes provides the potential to drive more efficacy.
Fourth Quarter and Full Year 2024 Financial Results
Cash Position: As of December 31, 2024, 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 immunologic diseases. Our lead program, navenibart (STAR-0215), is an investigational monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is an investigational monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on 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: 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 expected timing of release of initial safety and efficacy data from the ALPHA-SOLAR trial; our goal of developing two dosing options for navenibart; the potential for navenibart in the HAE market, including the potential to be the market leading treatment in HAE, the potential therapeutic and other benefits of navenibart as a treatment for HAE, and our vision and goals for the program; the potential for STAR-0310 to have the best-in-class monoclonal antibody OX40 antagonist and be the best overall OX40 therapy and the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the nature and timing of receipt of early proof-of-concept results from such trial, including our expectation that such results will demonstrate STAR-0310’s differentiated profile; the potential to develop STAR-0310 in additional indications; our goals and vision for STAR-0310; anticipated cash runway; and the goal of bringing life changing therapies to patients and families affected by allergic and immunological diseases and to become a leading allergy and immunology company. 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, 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.
|
|||||||||
| Year Ended December 31, | |||||||||
|
2024 |
|
|
2023 |
|
||||
| Operating expenses: | |||||||||
| Research and development | $ |
77,106 |
|
$ |
42,127 |
|
|||
| General and administrative |
|
34,452 |
|
|
25,704 |
|
|||
| Acquired in-process research and development |
|
- |
|
|
15,199 |
|
|||
| Total operating expenses |
|
111,558 |
|
|
83,030 |
|
|||
| Loss from operations |
|
(111,558 |
) |
|
(83,030 |
) |
|||
| Other income (expense): | |||||||||
| Interest and investment income |
|
17,360 |
|
|
10,201 |
|
|||
| Other expense, net |
|
(62 |
) |
|
(62 |
) |
|||
| Total other income, net |
|
17,298 |
|
|
10,139 |
|
|||
| Net loss |
|
(94,260 |
) |
|
(72,891 |
) |
|||
| Net loss per share attributable to common shareholders - basic and diluted | $ |
(1.68 |
) |
$ |
(2.42 |
) |
|||
| Weighted-average common shares outstanding used in net loss per share - basic and diluted |
|
56,161,249 |
|
|
30,123,316 |
|
|||
Astria Therapeutics, Inc.
|
||||||
December 31, |
December 31, |
|||||
2024 |
2023 |
|||||
| Assets | ||||||
| Cash and cash equivalents | $ |
59,820 |
$ |
175,530 |
||
| Short-term investments |
|
268,312 |
|
71,000 |
||
| Right-of-use asset |
|
5,114 |
|
363 |
||
| Other current and long-term assets |
|
9,117 |
|
7,773 |
||
| Total assets |
|
342,363 |
|
254,666 |
||
| Liabilities and stockholders’ equity | ||||||
| Current portion of operating lease liabilities |
|
1,384 |
|
329 |
||
| Long term portion of operating lease liabilities |
|
3,969 |
|
- |
||
| Other current and long-term liabilities |
|
17,747 |
|
11,221 |
||
| Total liabilities |
|
23,100 |
|
11,550 |
||
| Total stockholders’ equity | $ |
319,263 |
$ |
243,116 |
||
Astria Therapeutics, Inc.
|
||||||||
| Year Ended December 31, | ||||||||
|
2024 |
|
|
2023 |
|
|||
| Net cash used in operating activities | $ |
(81,212 |
) |
$ |
(68,445 |
) |
||
| Net cash (used in) provided by investing activities |
|
(191,863 |
) |
|
135,052 |
|
||
| Net cash provided by financing activities |
|
157,202 |
|
|
88,398 |
|
||
| Net (decrease) increase in cash, cash equivalents and restricted cash | $ |
(115,873 |
) |
$ |
155,005 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20250311385614/en/
Astria:
Investor Relations and Media:
Elizabeth Higgins
investors@astriatx.com
Source: Astria Therapeutics, Inc.
FAQ
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