Welcome to our dedicated page for Astria Therapeutics SEC filings (Ticker: ATXS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Parsing a biotech filing is hard enough鈥攄ecoding one from a rare-disease innovator like Astria Therapeutics (ATXS) can feel impossible. Trial costs, milestone payments, and antibody engineering jargon stretch each 10-K well past 200 pages, and critical updates often surface first in an 8-K the morning data drop hits.
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- 10-K annual report 10-K simplified鈥攔isk factors around hereditary angioedema programs and detailed R&D spend
- 10-Q quarter-over-quarter cash burn analysis and pipeline progress
- Form 4 executive stock transactions Form 4 with context on option grants
- 8-K trial readouts, partnership announcements, and other ATXS 8-K material events explained
- DEF 14A proxy statement executive compensation tied to clinical milestones
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Astria Therapeutics, Inc. filed a Form S-8 to register additional securities under its Second Amended and Restated 2015 Stock Incentive Plan (as amended), the 2015 Employee Stock Purchase Plan and the 2022 Inducement Stock Incentive Plan (as amended). The filing incorporates prior S-8 registrations by reference, attaches plan documents and counsel consents, and is signed by CEO Jill C. Milne and other officers and directors. The registrant is incorporated in Delaware and lists its principal executive offices in Boston, Massachusetts.
Astria Therapeutics reported results from its unaudited Form 10-Q showing $76.3 million in cash and $182.9 million in short-term investments, totaling $259.2 million of available liquidity and an accumulated deficit of $741.6 million. For the six months ended June 30, 2025, the company recorded a net loss of $66.8 million (basic and diluted loss per share $1.15), compared with a $44.1 million loss a year earlier. Total assets were $281.9 million versus $342.4 million at year-end 2024.
Clinical and business developments are centered on navenibart and STAR-0310. Astria initiated the global Phase 3 ALPHA-ORBIT trial for navenibart with topline results expected in early 2027 and continues the long-term ORBIT-EXPANSE program. Prior ALPHA-STAR and ALPHA-SOLAR data showed robust reductions in monthly HAE attack rates (~92% overall) and attack-free rates up to 67% in cohorts, with favorable tolerability reported. Subsequent to period end, Astria licensed navenibart rights in Japan to Kaken for a $16.0 million upfront payment, potential $16.0 million in milestones and tiered royalties (mid-teens to 30%), plus support and cost reimbursement for the Phase 3 program.
R&D spending increased to $53.7 million for the six months, up from $36.4 million, reflecting Phase 3 and STAR-0310 activity. Management estimates current resources, together with the Kaken upfront payment and reimbursements, are expected to fund operations into 2028, but the company states it will need substantial additional funding to complete development and commercialization.
Astria Therapeutics (ATXS) signed an exclusive license with Kaken Pharmaceutical for Japanese rights to navenibart, its long-acting plasma-kallikrein mAb for hereditary angioedema (HAE). Kaken will lead development, regulatory submissions and commercialization in Japan and will support Astria鈥檚 ALPHA-ORBIT Phase 3 trial.
Financial terms: Astria receives a $16 million upfront, up to $16 million in commercial/sales milestones, and tiered royalties ranging from the mid-teens to 30 % of net sales. Royalties run until the later of patent or regulatory exclusivity expiry, or 10 years after first sale.
The upfront plus partial Phase 3 cost reimbursements extend Astria鈥檚 cash runway into 2028, covering completion of the Phase 3 program for navenibart and the Phase 1a study of STAR-0310. Management cautions that substantial additional funding will still be needed to finish development and commercialization.
The agreement includes a joint steering committee, Kaken鈥檚 right of first negotiation for non-HAE indications, and termination rights for breach, insolvency, safety issues or at Kaken鈥檚 convenience (90-day notice).
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