Astria Therapeutics, Inc. (ATXS)·Q4 2024 Earnings Summary

Executive Summary

• Astria reported Q4 2024 net loss of $25.6M and EPS of $0.44, with operating loss of $29.6M; R&D and G&A rose as Phase 3 navenibart activities ramped and STAR-0310 advanced . Versus Q3 2024, net loss modestly increased (Q3: $24.5M, EPS $0.42) on higher G&A; versus Q4 2023, EPS improved from $0.86 despite higher operating investments .
• Liquidity remains strong: cash, cash equivalents and short-term investments were $328.1M at Dec 31, 2024, with runway into mid-2027, aided by lower quarterly operating cash burn vs Q3 ($17.4M in Q4 vs $28.0M in Q3) .
• Clinical execution progressed: ALPHA-ORBIT pivotal Phase 3 for navenibart initiated in Feb 2025; ALPHA-SOLAR long-term extension data expected mid-2025; STAR-0310 Phase 1a initiated in Jan 2025 with initial results anticipated in Q3 2025 .
• Guidance/timeline update: navenibart Phase 3 topline shifted from “by year-end 2026” (prior) to “early 2027” (current), reflecting finalized global design with Q3M and Q6M dosing in a single trial .
• Stock catalysts near term: ALPHA-SOLAR interim read (mid-2025) and STAR-0310 Phase 1a initial data (Q3 2025); pivotal program underway, but topline timing push could temper expectations until mid-2025 data de-risks durability and safety .

What Went Well and What Went Wrong

What Went Well

• Phase 3 start achieved: ALPHA-ORBIT initiated across Q3M and Q6M arms in a single pivotal 6‑month trial, simplifying registration pathway; CEO emphasized potential for market-leading profile and dosing flexibility .
• Robust Phase 1b/2 efficacy confirmed: final ALPHA-STAR results showed 90–95% mean monthly attack-rate reduction and up to 67% attack‑free rate over 6 months, with favorable safety and tolerability .
• Strong liquidity and extended runway: $328.1M cash, cash equivalents and ST investments and runway into mid‑2027, covering the Phase 3 program and STAR‑0310 Phase 1a .

What Went Wrong

• Timeline push: topline for the pivotal Phase 3 moved from “by year-end 2026” to “early 2027,” extending the path to a registrational readout .
• Higher operating spend: Q4 R&D ($20.2M) and G&A ($9.4M) increased year over year due to trial start‑up and organization scale-up, pressuring losses near term .
• Limited disclosure/coverage: no formal Q4 earnings call transcript located; management commentary relied on press release and conference Q&A, which may limit depth of financial Q&A color .

Financial Results

P&L Summary (Quarterly)

Liquidity and Cash Flow (Quarterly)

Clinical KPIs (ALPHA‑STAR Efficacy)

Note: Astria does not report commercial revenue; consolidated statements of operations in press releases present operating expenses only, consistent with a pre‑revenue profile .

Guidance Changes

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was found; themes reflect press release and a March 4 conference Q&A .

Management Commentary

• CEO on 2025 setup: “2025 promises to be an exciting year… With the ALPHA‑ORBIT Phase 3 trial of navenibart… we believe that navenibart has the potential to be the market‑leading therapy for HAE…” .
• Phase 3 strategy: “Based on the regulatory interactions we had… the pivotal Phase III study… incorporates both the Q3‑month and the Q6‑month… dosing regimens in a single 6‑month trial.” .
• Dose selection rationale: “Data‑driven selection… aiming for efficacy… on par with… TAKHZYRO, the current market leader, or better.” .
• Market adoption potential: “Physicians… would use navenibart in 53% of newly diagnosed patients and 46% of patients switching from current therapies.” .
• STAR‑0310 design: “High potency… low ADCC… potential for dosing as infrequently as every six months due to its long half‑life…” .

Q&A Highlights

• Phase 3 arms and flexibility: Three adult arms (600mg→300mg Q3M; 600mg Q6M; 600mg Q3M) to allow patient‑centric dosing; placebos convert to highest dose in extension .
• Enrollment sentiment: Trusted mechanism (plasma kallikrein mAb) supports physician/patient enthusiasm; adolescents included (10 planned) .
• Durability read: ALPHA‑SOLAR interim mid‑2025 to assess 12–18 months on Q3M and Q6M dosing; all 16 ALPHA‑STAR patients entered extension .
• Market share expectations: Physician research indicates ~50% share potential for new and switch patients, driven by infrequent dosing .
• IP runway: Composition of matter filing targeting coverage through 2042; dosing patents through 2043 (if granted) .

Estimates Context

• S&P Global consensus EPS and revenue estimates for Q4 2024 and prior quarters were unavailable at time of query due to data access limits. As a pre‑commercial biotech, Astria does not report product revenue; therefore, result‑vs‑estimate comparisons are not presented .

Key Takeaways for Investors

• Liquidity and runway support execution: $328.1M cash/ST investments and runway into mid‑2027 cover pivotal navenibart and STAR‑0310 early clinical milestones, reducing financing risk near term .
• Clinical momentum sustained: Phase 3 initiated with Q3M/Q6M flexibility; final PoC shows robust efficacy and attack‑free rates, with mid‑2025 durability data as the next inflection point .
• Timeline reset to early 2027 topline: Adjust expectations for registrational readout; the single, global design may streamline approval pathways but extends investor time horizon .
• Near‑term catalysts likely to drive sentiment: ALPHA‑SOLAR interim durability/safety (mid‑2025) and STAR‑0310 Phase 1a initial results (Q3 2025) can validate long‑acting profiles and broaden pipeline value .
• Spending uptick reflects scaling: Elevated R&D/G&A tied to Phase 3 start‑up and STAR‑0310 IND/Phase 1a; monitor quarterly burn and discipline as programs advance .
• Market positioning constructive: Physician research and KOL feedback suggest convenience (Q6M/Q3M) and trusted mechanism could capture meaningful prophylaxis share despite entrenched therapies .
• Competitive watch: Gene therapy/RNA entrants bear monitoring; Astria’s rapid onset, dosing infrequency, and safety profile aim to differentiate in HAE prophylaxis .