Astria Therapeutics Reports Third Quarter 2024 Financial Results and Provides a Corporate Update
Astria Therapeutics (NASDAQ:ATXS) reported Q3 2024 financial results and provided updates on its key programs. The company's lead drug candidate navenibart is on track for Phase 3 initiation in Q1 2025, with final ALPHA-STAR trial results expected in Q4 2024. Initial results showed 90-96% reduction in HAE attack rates. The company reported cash position of $344.3 million, Q3 net loss of $24.5 million ($0.42 per share), and increased R&D expenses to $20.5 million. Their second program, STAR-0310 for atopic dermatitis, is progressing toward IND submission by year-end 2024.
Astria Therapeutics (NASDAQ:ATXS) ha riportato i risultati finanziari del terzo trimestre 2024 e fornito aggiornamenti sui suoi programmi chiave. Il principale candidato farmaco dell'azienda, navenibart, è in procinto di avviare la fase 3 nel primo trimestre del 2025, con i risultati finali dello studio ALPHA-STAR attesi per il quarto trimestre del 2024. I risultati iniziali hanno mostrato una riduzione del 90-96% nei tassi di attacco da HAE. L'azienda ha riportato una posizione finanziaria di $344.3 milioni, una perdita netta nel terzo trimestre di $24.5 milioni ($0.42 per azione) e un aumento delle spese per R&S a $20.5 milioni. Il loro secondo programma, STAR-0310 per la dermatite atopica, sta progredendo verso la sottomissione dell'IND entro la fine del 2024.
Astria Therapeutics (NASDAQ:ATXS) informó los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre sus programas clave. El principal candidato a fármaco de la compañía, navenibart, está en camino de iniciar la fase 3 en el primer trimestre de 2025, con los resultados finales del ensayo ALPHA-STAR esperados para el cuarto trimestre de 2024. Los resultados iniciales mostraron una reducción del 90-96% en las tasas de ataque de HAE. La compañía reportó una posición de efectivo de $344.3 millones, una pérdida neta en el tercer trimestre de $24.5 millones ($0.42 por acción) y un aumento en los gastos de I+D a $20.5 millones. Su segundo programa, STAR-0310 para la dermatitis atópica, está avanzando hacia la presentación del IND antes de que finalice 2024.
Astria Therapeutics (NASDAQ:ATXS)는 2024년 3분기 재무 결과를 발표하고 주요 프로그램에 대한 업데이트를 제공했습니다. 회사의 주요 약물 후보인 navenibart는 2025년 1분기에 3상 시험을 시작할 예정이며, ALPHA-STAR 시험의 최종 결과는 2024년 4분기에 기대되고 있습니다. 초기 결과는 HAE 공격률이 90-96% 감소했음을 보여주었습니다. 회사는 $344.3 백만의 현금 잔고와 3분기 순손실 $24.5 백만 ($0.42 주당), 연구개발 비용이 $20.5 백만 증가했다고 보고했습니다. 두 번째 프로그램인 STAR-0310은 아토피 피부염을 위한 것으로, 2024년 연말까지 IND 제출을 향해 진전되고 있습니다.
Astria Therapeutics (NASDAQ:ATXS) a annoncé les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur ses programmes clés. Le principal candidat médicamenteux de l'entreprise, navenibart, est en bonne voie pour le lancement de la phase 3 au premier trimestre 2025, avec les résultats finaux de l'essai ALPHA-STAR attendus pour le quatrième trimestre 2024. Les résultats préliminaires ont montré une réduction de 90 à 96 % des taux d'attaque d'HAE. L'entreprise a déclaré une position de liquidités de $344.3 millions, une perte nette de $24.5 millions au troisième trimestre ($0.42 par action), et une augmentation des dépenses de R&D à $20.5 millions. Leur deuxième programme, STAR-0310 pour la dermatite atopique, progresse vers la soumission de l'IND d'ici la fin de 2024.
Astria Therapeutics (NASDAQ:ATXS) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und Updates zu seinen wichtigsten Programmen bereitgestellt. Der Hauptkandidat des Unternehmens, navenibart, ist auf Kurs für den Beginn der Phase 3 im ersten Quartal 2025, wobei die endgültigen Ergebnisse der ALPHA-STAR-Studie im vierten Quartal 2024 erwartet werden. Erste Ergebnisse zeigten eine Reduktion der HAE-Angriffsrate um 90-96%. Das Unternehmen berichtete von einer liquiden Position von $344.3 Millionen, einem Nettoverlust im dritten Quartal von $24.5 Millionen ($0.42 pro Aktie) und einer Erhöhung der F&E-Ausgaben auf $20.5 Millionen. Ihr zweites Programm, STAR-0310 für atopische Dermatitis, macht Fortschritte in Richtung IND-Einreichung bis Ende 2024.
- Strong cash position of $344.3 million, sufficient to fund operations into mid-2027
- Navenibart demonstrated 90-96% reduction in HAE attack rates in Phase 1b/2 trial
- All 16 original ALPHA-STAR trial patients entered long-term open-label study
- Net loss increased to $24.5 million from $17.7 million year-over-year
- R&D expenses increased to $20.5 million from $13.3 million year-over-year
- G&A expenses rose to $8.5 million from $6.9 million year-over-year
Insights
The Q3 results reveal significant financial metrics and strategic positioning. With
The cash position is particularly strong, providing ample runway for both the Phase 3 navenibart trial and STAR-0310 development. The increased operating expenses align with clinical development progression, suggesting disciplined capital deployment toward value-creating activities. The company's financial strategy appears well-structured to support its pipeline advancement without immediate capital needs.
The clinical development strategy shows promising momentum. Navenibart's
STAR-0310's development in atopic dermatitis shows strategic differentiation with its 26-day half-life and reduced ADCC activity compared to competitors. This could translate to better safety profiles and dosing convenience. The rapid progression to IND submission and Phase 1a trials indicates confident program execution based on strong preclinical data.
-- Navenibart (STAR-0215), the Potential Market-Leading Therapy for the Treatment of Hereditary Angioedema, on Track for Expected Phase 3 Initiation in Q1 2025 --
-- Final 3- and 6-Month Results from the ALPHA-STAR Trial of Navenibart Expected in Q4 2024 --
-- STAR-0310 Investigational New Drug (IND) Application Submission On-Track for Year-End 2024 --
-- Phase 1a Trial of STAR-0310 in Healthy Subjects Expected to Initiate in Q1 2025 --
“We had another strong quarter of execution for both navenibart and STAR-0310,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “We are excited about the opportunity for navenibart to be the market-leading therapy for HAE. We expect that navenibart’s profile, including infrequent dosing, low risk of pain, and trusted mechanism and modality, will give both patients and physicians confidence when choosing a medicine for HAE. We are engaged with regulators on finalizing our Phase 3 design and have manufactured clinical supplies for the Phase 3, which we expect to initiate in Q1 2025. STAR-0310 is also progressing as planned. We are on track with our IND submission before year-end and plan to initiate a Phase 1a trial in Q1 2025. We are intentionally designing the STAR-0310 program to capitalize on the learnings and address the liabilities of other OX40 and OX40L therapies to create what we believe will be the best-overall OX40 program. We plan to maintain this momentum and are looking forward to an exciting 2025.”
Navenibart (STAR-0215)
-
Navenibart was granted Orphan Drug Designation by the
U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency (EMA) for the treatment of HAE. - Astria is in discussion with global regulatory authorities and is finalizing the design for the Phase 3 trial of navenibart in people with HAE. Clinical supplies have been manufactured and are ready to support the Phase 3 trial. Pending regulatory feedback, the Company plans to initiate the Phase 3 program in Q1 2025 and expects top-line results by year-end 2026. The goal is to enable patients to choose what works best for them by developing both Q3M and Q6M dosing options. The Company believes navenibart will be life-changing for HAE patients and has the opportunity to become the market leading HAE treatment.
-
Initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 trial of navenibart in people with HAE demonstrate that administration of navenibart once or twice over six months reduced monthly attack rates by 90
-96% in HAE patients at 3 and 6 months, supporting the potential for chronic administration of navenibart two or four times per year. Additionally, navenibart was well-tolerated with no serious adverse events and no discontinuations. The Company plans to report final data from ALPHA-STAR target enrollment in Q4 of 2024. - All of the original 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.
-
Astria presented initial results from the ALPHA-STAR trial of navenibart at the European Academy of Dermatology and Venerology in September 2024 and Global Angioedema Forum (GAF) in October 2024 in
Copenhagen, Denmark . Astria also presented the design of the ALPHA-SOLAR Long-Term Open-Label trial at GAF. - Results presented at the American College of Allergy Asthma and Immunology (ACAAI) conference in October 2024 and the Canadian Society of Allergy and Clinical Immunology (CSACI) conference in November 2024 demonstrated 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, a high affinity monoclonal antibody OX40 antagonist that incorporates YTE technology, for the treatment of atopic dermatitis (AD).
- Preclinical results support the potential for STAR-0310 to have the best-in-class OX40 inhibitor profile. STAR-0310 exhibits a long mean half-life of 26 days in cynomolgus monkeys, compared to 10-14 days in a typical non-half-life extended IgG1 antibody, and has comparable potency to rocatinlimab. Additionally, by design there is significantly less antibody-dependent cellular cytotoxicity (ADCC) with STAR-0310 compared to rocatinlimab. Reduction in ADCC activity has the potential for a more favorable safety profile and potentially wider therapeutic window for STAR-0310.
- Astria is on track with our IND submission to FDA for STAR-0310 before year-end 2024 and plans to initiate a Phase 1a clinical trial in healthy subjects in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025.
Third Quarter 2024 Financial Results
Cash Position: As of September 30, 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 immunological diseases. Our lead program, navenibart (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 about the potential significance of the initial results from the Phase 1b/2 ALPHA-STAR clinical trial of navenibart; the expected timing of the release of additional data from the ALPHA-STAR trial; the expected timing of initiation and receipt of topline results from the planned navenibart Phase 3 program; 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 OX40 inhibitor profile and to be the best overall OX40 program and the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the timing of an IND submission for STAR-0310; expectations regarding the timing of initiation of a Phase 1a trial for STAR-0310 and the timing of receipt of early proof-of-concept results from such trial; 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. Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) |
||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 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/
Astria Contact:
Investor Relations and Media:
Elizabeth Higgins
investors@astriatx.com
Source: Astria Therapeutics, Inc.
FAQ
What were Astria Therapeutics (ATXS) Q3 2024 financial results?
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