Astria Therapeutics Reports Third Quarter 2024 Financial Results and Provides a Corporate Update
ATXS 11.13.2024
Drug:STAR-0215 Navenibart
Drug:STAR-0310 STAR-0310
Diseases:Hereditary Angioedema
About Gravity Analytica
Recent News
- 01.23.2025 - Astria Therapeutics Announces Initiation of Phase 1a Trial of STAR-0310, a Potential Best-in-Class Monoclonal Antibody OX40 Antagonist for the Treatment of Atopic Dermatitis
- 01.13.2025 - Astria Therapeutics Announces Design of ALPHA-ORBIT Pivotal Phase 3 Trial of Navenibart in HAE
- 01.03.2025 - Astria Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Recent Filings
-- 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
Navenibart (STAR-0215)
- Navenibart was granted Orphan Drug Designation by the
U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by theEuropean 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 theEuropean Academy of Dermatology and Venerology inSeptember 2024 andGlobal Angioedema Forum (GAF) inOctober 2024 inCopenhagen, 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 inOctober 2024 and theCanadian Society of Allergy and Clinical Immunology (CSACI) conference inNovember 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
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
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
New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties.
Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
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 | ||||||||||||
Selected Consolidated Balance Sheets Data (In thousands) (Unaudited) | ||||||
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 | ||
Selected Consolidated Statements of Cash Flows Data (In thousands) (Unaudited) | ||||||||
| Nine Months Ended | ||||||||
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 | |||
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