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Astria Therapeutics, Inc. (ATXS)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 advanced Astria’s HAE program meaningfully: Phase 1a data at ACAAI confirmed STAR-0215’s potential for every 3- or 6‑month dosing with an estimated half-life up to 127 days and rapid attainment of therapeutic levels, de‑risking dosing strategy ahead of patient POC data .
  • Initial proof-of-concept data from the ALPHA-STAR Phase 1b/2 trial in HAE patients was accelerated to Q1 2024 (from prior mid‑2024 guidance), and management indicated the pivotal Phase 3 could begin in Q1 2025 pending POC results .
  • Financially, operating expenses rose as development scaled: R&D $13.3M (+73% y/y), G&A $6.9M (+46% y/y), net loss $17.7M (vs. $12.0M y/y); cash and short-term investments were $188.8M at 9/30/23, with October 2023 offering proceeds extending cash runway into 2026 .
  • Pipeline expanded with STAR‑0310 (OX40 antagonist) licensed from Ichnos, with IND planned by YE 2024 and Phase 1a start in Q1 2025, positioning Astria for multiple 2024–2025 catalysts across HAE and atopic dermatitis .
  • Wall Street consensus (S&P Global) for Q3 2023 EPS and revenue was unavailable; estimate comparisons cannot be made this quarter (values unavailable via S&P Global).

What Went Well and What Went Wrong

What Went Well

  • Phase 1a data validated long-acting profile and dosing optionality: “STAR‑0215 achieved potentially therapeutic levels in less than one day… estimated half‑life up to 127 days… PK modeling predicts every 3 or 6 month regimens to maintain sufficient drug levels; PD data showed inhibition for 140–224 days after single doses >100 mg” .
  • Program timelines pulled forward: ALPHA‑STAR initial POC in patients now expected Q1 2024; management aims to progress directly to pivotal Phase 3, anticipated to initiate Q1 2025 .
  • Cash runway strengthened: $188.8M at quarter-end, with $64.0M equity financing in October extending runway into 2026, supporting all activities up to Phase 3 initiation for STAR‑0215 and early clinical for STAR‑0310 .

What Went Wrong

  • Operating loss widened as development accelerated: Loss from operations was $(20.2)M vs. $(12.4)M y/y, reflecting higher clinical spend .
  • Net cash used in operating activities increased to $(14.3)M vs. $(10.2)M y/y, indicating heavier burn with program scaling .
  • Estimate benchmarking was not possible: S&P Global consensus for Q3 2023 EPS and revenue was unavailable, limiting beat/miss assessment this quarter (values unavailable via S&P Global).

Financial Results

Quarterly Trend (oldest → newest)

MetricQ1 2023Q2 2023Q3 2023
Revenues ($USD Millions)$0.0 $0.0 $0.0
R&D Expenses ($USD Millions)$8.033 $9.089 $13.338
G&A Expenses ($USD Millions)$5.460 $6.013 $6.898
Loss from Operations ($USD Millions)$(13.493) $(15.102) $(20.236)
Other Income, net ($USD Millions)$2.305 $2.536 $2.509
Net Loss ($USD Millions)$(11.188) $(12.566) $(17.727)
Net Loss per Share ($USD)$(0.40) $(0.45) $(0.63)
Cash & ST Investments ($USD Millions)$213.3 $203.0 $188.8

Note: Astria has not generated product revenues to date .

Year-over-Year (Q3 2023 vs Q3 2022)

MetricQ3 2022Q3 2023
R&D Expenses ($USD Millions)$7.698 $13.338
G&A Expenses ($USD Millions)$4.688 $6.898
Loss from Operations ($USD Millions)$(12.386) $(20.236)
Other Income, net ($USD Millions)$0.389 $2.509
Net Loss ($USD Millions)$(11.997) $(17.727)
Net Loss per Share ($USD)$(0.87) $(0.63)
Operating Cash Flow (Quarter) ($USD Millions)$(10.2) $(14.3)

KPIs (Program and Clinical)

KPIValueSource
Estimated half-life (Phase 1a)Up to 127 days
Time to reach therapeutic level (600 mg)~11 hours
PD inhibition duration140–224 days (dose-dependent)
Dosing strategyEvery 3 months prioritized; 6 months to follow
ALPHA-STAR POC timingQ1 2024
Phase 3 initiation targetQ1 2025
Cash runwayInto 2026 (post Oct financing)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ALPHA-STAR initial POC (HAE)Q1 2024Mid‑2024 (Q4’22 update) Q1 2024 Raised/Accelerated
STAR‑0215 Phase 3 startQ1 2025Not specifically dated in prior releases Q1 2025 New specific timeline
STAR‑0215 dosing approachClinical strategyNot specifiedPrioritize q3‑month dosing; add q6‑month optionNew detail
STAR‑0310 IND (OX40, AD)YE 2024Not specifiedYE 2024 New
STAR‑0310 Phase 1a startQ1 2025Not specifiedQ1 2025; initial data Q3 2025 New
Cash runwayCompany-levelThrough H1 2025 (12/31/22) Into 2026 (incl. Oct 2023 $64M) Raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2023, Q2 2023)Current Period (Q3 2023)Trend
R&D execution (ALPHA‑STAR)ALPHA‑STAR initiated Feb 2023; initial data expected mid‑2024 Enrollment progressing; interim analysis triggering earlier; POC data accelerated to Q1 2024 Positive acceleration
Dosing regimen & PK/PDPhase 1a initial results suggested q3–q6 months dosing; more data expected Q4 2023 ACAAI data confirm q3/q6 potential; PK half-life up to 127 days; sustained PD inhibition Validation strengthened
RegulatoryFDA Fast Track for STAR‑0215 (July 2023) Continued alignment; Phase 3 design planning underway Advancing readiness
Market/payer dynamicsNot detailedPayers focus on efficacy; class managed; compliance advantages emphasized; awareness building via medical affairs Market shaping ongoing
Competitive landscapeNot detailedManagement cites ADRX constraints and 6‑month dosing challenge at lower doses; sees better technical/regulatory success odds for STAR‑0215 Favorable positioning
Geography/enrollmentEarly trials in U.S. and Canada Phase 3 intended as global trial; placebo in Phase 3 may modestly affect enrollment, mitigated by strong profile and outreach Scale expanding

Management Commentary

  • “We now expect to deliver initial proof-of-concept results in Q1 2024… and… anticipate Phase 3 pivotal trial in the first quarter of 2025” – Jill C. Milne, CEO .
  • “Based on these data, we estimate the half-life of 0215 to be up to 127 days… both 3‑ and 6‑month regimens could be successful in preventing HAE attacks” – Chris Morabito, CMO .
  • “Following the October financing, we expect our cash to support our current operating plan into 2026” – Noah Clauser, CFO .
  • “We intend to prioritize clinical development for every 3‑month administration followed by a 6‑month dosing option, enabling patient choice” – Andrew Komjathy, CCO .

Q&A Highlights

  • Timeline acceleration: Interim analysis trigger achieved earlier given enrollment progress in Cohorts 1–2; meaningful patient POC data targeted in Q1 2024 .
  • Phase 3 design: Anticipated placebo-controlled, ~6‑month treatment period with primary endpoint as change from baseline in monthly attack rates vs placebo; no active comparator planned .
  • Placebo considerations: Phase 1b/2 avoids placebo (robust run-in baseline); Phase 3 will include placebo; enrollment impact mitigated by global footprint and strong profile/awareness .
  • Dosing preferences: Slightly greater patient/HCP preference for q3‑month vs q6‑month, but both well‑received; citrate‑free formulation expected to reduce injection site pain .
  • Payer feedback: Class managed; efficacy and compliance key; medical affairs to expand awareness among KOLs and broader community .
  • Competitor read‑through: ADRX dose limitations may preclude q6‑month dosing at lower dose; Astria sees stronger technical/regulatory outlook for STAR‑0215 .

Estimates Context

  • Wall Street consensus estimates via S&P Global for Q3 2023 revenue and EPS were unavailable; as a result, beat/miss versus estimates cannot be assessed this quarter (values unavailable via S&P Global).
  • Investors should focus on operational milestones (Q1 2024 POC, Q4 2023 Phase 1a updates) and cash runway into 2026 when modeling near‑term expectations .

Key Takeaways for Investors

  • Phase 1a data substantively de‑risk STAR‑0215’s long‑acting dosing strategy (q3/q6 months), supporting a first‑choice prophylactic HAE positioning thesis .
  • Near‑term catalyst: Q1 2024 ALPHA‑STAR POC in patients; successful suppression of attacks (including attack‑free proportions) could accelerate pivotal execution and valuation .
  • Pivotal readiness: Phase 3 design planning is active; global footprint and patient/HCP enthusiasm likely support enrollment despite placebo control .
  • Balance sheet supports execution: $188.8M at quarter‑end plus $64.0M in Oct extends runway into 2026, funding STAR‑0215 to Phase 3 start and STAR‑0310 through Phase 1a .
  • Pipeline optionality: STAR‑0310 (OX40) provides 2024–2025 milestones in AD with potential best‑in‑class safety/efficacy profile; diversifies beyond HAE .
  • Watch payer dynamics and awareness: Efficacy/compliance benefits are decisive; Astria’s medical affairs expansion and citrate‑free formulation may enhance differentiation .
  • Stock catalysts over next 6–12 months: Q4 2023 Phase 1a updates (healthy subjects), Q1 2024 POC (patients), IND at YE 2024 (STAR‑0310), and Phase 3 initiation target Q1 2025 for STAR‑0215 .