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Astria Therapeutics, Inc. (ATXS)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered no product revenue and a larger operating loss, with collaboration revenue of $0.71M and net loss of $31.6M; EPS of $(0.55) missed Wall Street consensus of $(0.39), and revenue missed consensus ($10.67M est.) materially. Bold miss was driven by limited revenue recognition and higher R&D/G&A tied to Phase 3 activities and transaction-related costs .*
  • Strategic momentum continued: final ALPHA-STAR Phase 1b/2 results (n=29) reinforced robust attack prevention and favorable safety; ALPHA-ORBIT Phase 3 is progressing globally with top-line expected early 2027; ORBIT-EXPANSE long-term trial initiated .
  • Cash runway guidance maintained: $227.7M cash, cash equivalents and short-term investments, with runway into 2028 supported by a $16M Kaken upfront and expected Phase 3 cost reimbursement; deferred revenue recorded at $16.5M .
  • Catalyst: BioCryst acquisition (per-share consideration $8.55 cash + 0.59 BCRX shares) approved by both boards, expected to close in Q1 2026; pending stockholder and regulatory approvals .

What Went Well and What Went Wrong

What Went Well

  • Final ALPHA-STAR data across 29 HAE patients showed 84–92% mean and 93–100% median reduction in attack rate over six months, with strong quality-of-life improvements and favorable tolerability; “highly encouraging” and consistent with prior results, per CMO Christopher Morabito, M.D. .
  • Phase 3 execution advancing: ALPHA-ORBIT enrolling across 15 countries; ORBIT-EXPANSE initiated; top-line expected early 2027, supporting potential registration and patient-centric Q3M/Q6M dosing .
  • Strategic and financial positioning: $227.7M liquidity; $16M Kaken upfront with tiered royalties up to 30% and partial Phase 3 cost reimbursement; management reiterated runway into 2028 .

What Went Wrong

  • Material estimate misses: Q3 EPS $(0.55) vs $(0.39) est.; revenue $0.71M vs $10.67M est.; limited revenue recognition and increased spend drove the gap.*
  • Operating cost pressure: R&D up to $24.1M (+18% YoY) on ALPHA-ORBIT support and higher employee costs; G&A up to $10.7M (+25% YoY) with professional fees tied to the merger; other income fell on lower yields/assets .
  • Continued losses: net loss widened to $31.6M (vs $24.5M LY), reflecting higher OpEx and lower interest income .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Collaboration Revenue ($USD Millions)$0.00 $0.00 $0.71
Research & Development ($USD Millions)$27.79 $25.95 $24.15
General & Administrative ($USD Millions)$9.21 $9.88 $10.66
Total Operating Expenses ($USD Millions)$36.99 $35.82 $34.81
Loss from Operations ($USD Millions)$(36.99) $(35.82) $(34.10)
Other Income, net ($USD Millions)$3.29 $2.77 $2.46
Net Loss ($USD Millions)$(33.71) $(33.05) $(31.64)
Diluted EPS ($USD)$(0.58) $(0.57) $(0.55)
Weighted Avg Shares (Millions)58.01 58.01 58.01
MetricQ3 2025 ActualQ3 2025 Consensus
Revenue ($USD Millions)$0.71 $10.67*
Primary EPS ($USD)$(0.55) $(0.39)*
EPS – # of Estimates7*
Revenue – # of Estimates6*
Values marked with * retrieved from S&P Global.

KPIs and Balance Sheet Highlights:

KPIQ1 2025Q2 2025Q3 2025
Cash & Cash Equivalents ($USD Millions)$54.38 $76.32 $96.28
Short-term Investments ($USD Millions)$240.68 $182.86 $131.44
Total Liquidity (Cash+ST Inv, $USD Millions)$295.06 $259.18 $227.72
Accounts Receivable ($USD Millions)$0.00 $0.00 $17.24
Deferred Revenue – Current ($USD Millions)$0.00 $0.00 $4.50
Deferred Revenue – Long-term ($USD Millions)$0.00 $0.00 $12.04
Net Cash Used in Operating Activities ($USD Millions)$(34.02) $(70.08) (6M) $(102.37) (9M)

Note: Astria reports a single operating segment (Allergy & Immunology) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-levelFund operations into mid-2027 (Q1) Fund operations into 2028 (Q2, Q3) Raised in Q2; maintained in Q3
ALPHA-ORBIT Top-line TimingProgramEarly 2027 (Q1) Early 2027 (Q2, Q3) Maintained
STAR-0310 Phase 1a TimingProgramInitial results expected Q3 2025 (Q2) Initial Phase 1a data presented (Q3) Achieved
M&A Closing TimingCompany-levelN/ABioCryst acquisition expected Q1 2026 (Q3) New guidance

No revenue, margin, tax rate, OpEx or dividend guidance was provided beyond qualitative cash runway commentary .

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available in our document catalog or public sources; themes are drawn from the press releases and 10-Q.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
HAE Product Performance (Navenibart)ALPHA-STAR final top-line (n=16) with 90–95% mean attack reduction; ALPHA-SOLAR initial long-term results consistent (92% mean reduction) Final ALPHA-STAR (n=29): 84–92% mean and 93–100% median reduction; 62–67% attack-free in expanded cohorts; favorable safety Strengthening evidence, consistent efficacy/safety
Phase 3 ExecutionALPHA-ORBIT enrolling; top-line early 2027; ORBIT-EXPANSE planned ALPHA-ORBIT sites open across 15 countries; ORBIT-EXPANSE initiated Progressing on plan
Regional/Partner StrategyKaken Japan license – $16M upfront, milestones, tiered royalties; partial Phase 3 cost reimbursement (Q2) Upfront received (Q4 timing stated), $16.5M deferred revenue; cost reimbursement noted Execution with financial recognition
Regulatory/LegalStandard forward-looking and risk factors disclosed Expanded risk factors: FDA RIF/shutdown delays; merger approvals; HSR timing risks Heightened macro/regulatory risk disclosure
R&D Execution (STAR-0310)Phase 1a initiated; initial POC expected Q3 2025 Initial Phase 1a healthy subject data presented: best-in-class profile signals (half-life up to 68 days; durable cytokine inhibition; no ADCC-related AEs) Positive POC signals; strategic options explored
Tariffs/Supply ChainNot emphasized previouslyTariff/supply chain risks disclosed (cost increases; global disruptions) Elevated macro mention

Management Commentary

  • CEO Jill C. Milne on strategic rationale: “We believe that the proposed transaction with BioCryst provides the best opportunity to advance navenibart… We also believe the acquisition represents a compelling outcome for Astria stockholders…” .
  • CMO Christopher Morabito on ALPHA-STAR: “The updated results from the full 29 patients… are highly encouraging and reinforce our confidence in navenibart’s profile… rapid onset, robust and durable efficacy, and a favorable safety and tolerability profile.” .
  • Program update: ALPHA-ORBIT designed to support global registration with Q3M/Q6M dosing arms; top-line early 2027; ORBIT-EXPANSE long-term trial enrollment started .

Q&A Highlights

A formal Q3 2025 earnings call transcript was not available. Key clarifications from filings and press releases:

  • Revenue recognition: $16.5M deferred revenue tied to Kaken upfront and R&D cost-sharing; $0.7M collaboration revenue recognized as performance obligations are met .
  • Expense drivers: R&D increased on ALPHA-ORBIT/ORBIT-EXPANSE support and employee costs; G&A rose on professional fees related to the merger .
  • Liquidity: $227.7M liquidity; runway into 2028 excluding merger effects .

Estimates Context

  • Q3 2025 EPS: Actual $(0.55) vs consensus $(0.39) → significant miss.*
  • Q3 2025 Revenue: Actual $0.71M vs consensus $10.67M → significant miss.*
  • Consensus coverage: EPS (7 estimates), Revenue (6 estimates).* Values retrieved from S&P Global.

Implications: Given recurring limited revenue recognition and elevated OpEx, consensus models likely need to recalibrate near-term revenue assumptions (collaboration timing) and OpEx intensity tied to Phase 3 and transaction costs .

Key Takeaways for Investors

  • Near-term stock driver is merger execution: watch Astria stockholder vote, HSR clearance, and Q1 2026 closing timing for the cash/stock consideration pathway .
  • Clinical momentum is intact: robust ALPHA-STAR final dataset and global Phase 3 progress underpin medium-term value; ORBIT-EXPANSE initiation adds long-term data continuity .
  • Liquidity supports the plan: $227.7M plus Kaken support extends runway into 2028 (standalone basis), reducing financing overhang pre-Phase 3 top-line .
  • Near-term P&L remains loss-making: expect continued elevated R&D/G&A until Phase 3 milestones; other income likely lower vs 2024 given asset/yield dynamics .
  • Modeling caution: Q3’s significant revenue/EPS misses suggest estimates may remain volatile; anchor expectations on collaboration revenue timing and OpEx cadence rather than product sales .*
  • Strategic optionality: STAR-0310’s initial Phase 1a signals (best-in-class half-life, cytokine suppression) could attract partnering interest; management is exploring options .
  • Risk watchlist: macro/regulatory (FDA resource constraints, government shutdown), merger conditions/termination fee exposure, and supply chain/tariff risks disclosed in 10-Q .

*Values retrieved from S&P Global.