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Spyre Therapeutics, Inc. (AGLE)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 centered on repositioning toward IBD with SPY001 (anti-α4β7) and SPY002 (anti‑TL1A) on track for INDs in H1 2024 and H2 2024, respectively; management added interim readout timing and reiterated a cash runway into 2026 .
  • Financials reflected transition dynamics: revenue $0.0M vs $0.2M prior-year, R&D up to $24.7M vs $12.0M, and net loss widened to $(40.1)M vs $(18.2)M, driven by a $25.4M non‑cash forward contract liability expense partly offset by a $14.6M gain on the pegzilarginase asset sale .
  • Corporate actions included a 1‑for‑25 reverse split in September, leadership additions (CFO and CLO), and a November 21 stockholder vote to allow preferred-to-common conversion and increase authorized shares—potentially important for capital structure flexibility .
  • Key near-term catalysts: SPY001 healthy‑volunteer interim PK data by year‑end 2024, SPY002 healthy‑volunteer interim data in H1 2025, and an IL‑23 (SPY003) IND/CTN in 2025 .

What Went Well and What Went Wrong

What Went Well

  • Strengthened liquidity: $204.9M in cash, cash equivalents, marketable securities, and restricted cash at 9/30/23; runway guided into 2026 .
  • Portfolio execution on timelines: SPY001 and SPY002 INDs on track for 2024; SPY003 (IL‑23 p19) targeting IND/CTN in 2025; management believes binding/PK profile for SPY002 exceeds clinical‑stage TL1A peers .
  • Monetization of legacy asset: Completed pegzilarginase sale; recognized a $14.6M gain in Q3 and indicated CVR distribution of net proceeds to holders in November 2023 .
  • Quote: “We have made significant progress in our first quarter following the Spyre acquisition towards our goal of creating new, best‑in‑class medicines for patients with IBD.” — Cameron Turtle, COO .

What Went Wrong

  • No revenue in Q3 (vs $0.174M in Q3 2022), while R&D (+$12.7M YoY) and G&A (+$1.6M YoY) increased as the IBD pipeline ramped and legal/severance costs rose .
  • Significant non‑cash P&L noise: $(25.4)M change in fair value of forward contract liability (linked to Series A preferred) drove net other expense to $(21.8)M in Q3 .
  • Net loss widened to $(40.1)M vs $(18.2)M prior‑year despite a $(14.6)M gain on sale of IPR&D; elevated spend and non‑cash items overshadowed operating progress .

Financial Results

Metric (USD)Q3 2022Q1 2023Q2 2023Q3 2023
Revenue$0.174M $0.198M $0.688M $0.000M
R&D Expense$11.977M $13.776M $17.386M $24.660M
G&A Expense$6.952M $5.228M $12.062M $8.584M
Total Other (Expense) Income$0.312M $0.348M $(57.828)M $(21.767)M
Net Loss$(18.234)M $(18.422)M $(217.081)M $(40.107)M
EPS (Basic/Diluted)$(4.84) $(0.20) $(2.27) $(9.34)

Notes and drivers:

  • Q3 2023 other expense included a $(25.4)M non‑cash forward contract liability expense; operating expenses were partly offset by a $(14.6)M gain on sale of IPR&D .
  • Q2 2023 reflected one‑time acquired IPR&D expense $130.5M and $(58.2)M forward contract liability expense (Spyre acquisition accounting), inflating the net loss .

Liquidity

Metric (USD)3/31/20236/30/20239/30/2023
Cash, Cash Equivalents, Marketable Securities, and Restricted Cash$39.8M $236.7M $204.9M

Select Unusual/Non‑recurring Items

ItemQ2 2023Q3 2023
Acquired IPR&D Expense$130.486M $(0.298)M (credit)
Gain on Sale of IPR&D$(14.609)M (gain)
Change in Fair Value of Forward Contract Liability$(58.170)M $(25.360)M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SPY001 IND (anti‑α4β7)H1 2024H1 2024 H1 2024 Maintained
SPY001 HV Interim PKYE 2024YE 2024 YE 2024 Maintained
SPY002 IND (anti‑TL1A)H2 2024H2 2024 H2 2024 Maintained
SPY002 HV Interim DataH1 2025H1 2025 H1 2025 Maintained
SPY003 IND/CTN (IL‑23 p19)2025Not previously specified2025 New
Cash RunwayNot previously specifiedInto 2026 New

Earnings Call Themes & Trends

Note: No Q3 2023 earnings call transcript was found in our document set; themes below reflect press releases.

TopicQ1 2023Q2 2023Q3 2023Trend
Strategic focusPre‑Spyre; rare disease portfolio, exploring strategic alternatives Completed Spyre acquisition; pivot to IBD Continued execution on IBD pipeline Clear pivot to IBD sustained
Financing/liquidity$39.8M cash at 3/31 $210M private placement; $236.7M cash at 6/30 $204.9M at 9/30; runway into 2026 Strong but stepping down with spend
Pipeline timelinesSPY001/002 INDs in 2024; HV data cadence set Timelines maintained; SPY003 IND/CTN added for 2025 Consistent; expanding scope
Legacy asset monetizationEMA review noted; no sale Pegzilarginase sale to Immedica Gain recognized; CVR payment expected Nov. 2023 Monetization completed
Corporate actionsReverse split (1‑for‑25); CFO/CLO hires; Nov. 21 vote on preferred conversion/authorized shares Governance/structure alignment

Management Commentary

  • “We have made significant progress in our first quarter following the Spyre acquisition towards our goal of creating new, best‑in‑class medicines for patients with IBD… offer the potential to meaningfully improve both efficacy and convenience relative to today's standard of care.” — Cameron Turtle, COO .
  • Execution highlights reiterated: SPY001 in IND‑enabling with FIH in H1 2024 and interim HV PK by YE 2024; SPY002 FIH in H2 2024 with interim HV data H1 2025; SPY003 targeting IND/CTN in 2025 .
  • Corporate focus: Leadership additions, share reverse split, and stockholder vote to enable preferred conversion and increase authorized shares .

Q&A Highlights

  • No public Q3 2023 earnings call transcript was available in our document set; therefore, no Q&A highlights or guidance clarifications beyond the press release could be assessed.

Estimates Context

  • S&P Global consensus estimates for revenue and EPS for Q3 2023 and the prior two quarters were unavailable for AGLE in our S&P GI data connection at the time of review; as a result, we cannot assess beats/misses versus consensus for this quarter.

Key Takeaways for Investors

  • Cash runway into 2026 reduces near‑term financing overhang as R&D scales for dual lead programs .
  • All major clinical timelines maintained (SPY001/002 INDs in 2024; SPY001 interim PK by YE 2024; SPY002 interim data in H1 2025), with the IL‑23 program added for 2025, reinforcing multi‑asset optionality in IBD .
  • P&L remains noisy due to non‑cash items (forward contract liability) and one‑time items (acquired IPR&D, gain on legacy asset sale); underlying operating burn stepped up with IBD build‑out .
  • Governance/capital structure milestones (reverse split, preferred conversion vote) are potential catalysts for index compliance and financing flexibility .
  • Legacy program monetization complete; CVR holders expected to receive net proceeds from the Immedica transaction, removing a distraction and sharpening the IBD focus .
  • Near‑term stock drivers: clinical start and early PK signals from SPY001 in 2024; clarity on preferred conversion outcome; continued balance sheet visibility versus planned spend .

Financial statement extracts and comparisons are sourced from the company’s Q3 2023, Q2 2023, and Q1 2023 8‑K press releases and attached financials .