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Spyre Therapeutics, Inc. (AGLE)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 marked Spyre’s transition into a clinical-stage biotech with initiation of dosing in the Phase 1 healthy volunteer trial of SPY001; interim PK/safety proof-of-concept data are expected by year-end 2024 .
  • Operating profile improved sequentially: net loss narrowed to $38.8M (EPS -$0.86) from $43.9M (EPS -$1.20) in Q1; R&D moderated to $32.6M and G&A fell to $11.5M versus Q1 levels, aided by higher interest income ($5.3M) from a larger marketable securities base .
  • Balance sheet remains strong with $426.3M in cash, equivalents, marketable securities, and restricted cash, extending runway well into 2027 and supporting multiple clinical readouts (SPY001, SPY002, SPY003) .
  • Street consensus (S&P Global) for Q2 revenue and EPS was unavailable; investor focus is on clinical catalysts rather than near-term P&L beats/misses—key stock reaction drivers are forthcoming data milestones on SPY001 (YE24) and SPY002 (1H25 interim HV data) .

What Went Well and What Went Wrong

What Went Well

  • Clinical execution: “Initiation of our Phase 1 trial of SPY001 represents an important transition… by this time next year, we expect to have reported Phase 1 data from our α4β7 and TL1A programs and have an ongoing Phase 1 trial of our IL-23 program” — CEO Cameron Turtle .
  • Capital position: $426.3M liquidity at 6/30/24 with runway “well into 2027,” supporting multiple readouts without near-term financing risk .
  • Portfolio advancement: SPY003 dev candidate nominated in June; SPY002 FIH remains on track for 2H24 with candidates designed for enhanced potency and extended half-life vs clinical-stage competitors .

What Went Wrong

  • No revenue recognized; model remains pre-commercial with reliance on financing to fund R&D (Q2 revenue $0 vs $0.69M in Q2’23) .
  • Elevated cash burn: net cash used in operations was $62.4M in Q2 and exceeded net loss due to timing of vendor payments, highlighting working capital swings .
  • YoY expense mix still heavy: R&D increased to $32.6M vs $17.4M in Q2’23 (pipeline build-out), with G&A at $11.5M vs $12.1M; while strategic, the pace underscores sustained opex needs ahead of efficacy data .

Financial Results

Quarterly P&L and Cash (oldest → newest)

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Millions)$0.00 $0.00 $0.00
R&D Expense ($USD Millions)$33.68 $34.93 $32.64
G&A Expense ($USD Millions)$14.07 $12.85 $11.51
Other Income (Expense) ($USD Millions)$(17.27) $3.95 $5.31
Net Loss ($USD Millions)$(63.18) $(43.86) $(38.84)
EPS (Basic/Diluted, $USD)$(4.05) $(1.20) $(0.86)
Weighted Avg Shares (Millions)15.61 36.51 45.32
Liquidity (Cash, Equivalents, Marketable Securities, Restricted Cash) ($USD Millions)$339.6 $485.0 $426.3
Net Cash Used in Operating Activities ($USD Millions)$31.0 $28.5 $62.4

Q2 YoY Comparison (Q2 2023 vs Q2 2024)

MetricQ2 2023Q2 2024
Revenue ($USD Millions)$0.69 $0.00
R&D Expense ($USD Millions)$17.39 $32.64
G&A Expense ($USD Millions)$12.06 $11.51
Other Income (Expense) ($USD Millions)$(57.83) $5.31
Net Loss ($USD Millions)$(217.08) $(38.84)
EPS ($USD)$(56.79) $(0.86)

Balance Sheet Highlights (oldest → newest)

MetricQ4 2023Q1 2024Q2 2024
Total Assets ($USD Millions)$341.86 $487.60 $436.07
Total Liabilities ($USD Millions)$73.29 $81.93 $61.68
Stockholders’ Equity ($USD Millions)$184.02 $152.27 $374.39

Note: Equity reflects preferred stock conversions and capital raises; Q2 equity increased due to conversion of Series B Preferred and common issuance .

Segment Breakdown

  • Not applicable; Spyre is pre-commercial with no revenue-segment reporting .

KPIs (Program Milestones)

ProgramQ4 2023Q1 2024Q2 2024
SPY001 (α4β7, extended half-life)IND-enabling; ECCO data showed 22-day NHP half-life (3x vs vedolizumab) Completed 28-day GLP tox; on track for FIH in Q2; interim PK/safety YE24 Initiated dosing in Phase 1 healthy volunteers; interim data YE24
SPY002 (TL1A, monomer+trimer binding, extended half-life)Two leads nominated; NHP half-life ~24 days; FIH in 2H24 Exercised IP license; FIH in 2H24; interim HV data 1H25 FIH remains on track in 2H24; interim HV data 1H25
SPY003 (IL‑23 p19, extended half-life)Preclinical; dev candidate nomination mid-2024; IND-enabling 2H24 Preclinical; nomination expected mid-2024 Dev candidate nominated in June; IND-enabling 2H24; FIH in 1H25

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearRunway “into 2H26” (as of FY23) Runway “well into 2027” (as of Q1/Q2) Raised
SPY001 FIH StartQ2 2024“On track to begin FIH in Q2 2024” “Initiated dosing in June 2024” Achieved
SPY001 Interim PK/SafetyYE 2024“Interim data YE24” “Interim data YE24” Maintained
SPY002 FIH Start2H 2024“Begin FIH in 2H24” “On track to begin FIH in 2H24” Maintained
SPY002 Interim HV Data1H 2025“Interim HV data 1H25” “Interim HV data 1H25” Maintained
SPY003 Dev Candidate NominationMid-2024“Nominate dev candidate mid-2024” “Nominated in June 2024” Achieved
SPY003 IND-enabling Start2H 2024“IND-enabling in 2H24” “IND-enabling in 2H24” Maintained
SPY003 FIH Start1H 2025“FIH in 1H25” “FIH in 1H25” Maintained

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript located; trends compiled from quarterly press releases.

TopicPrevious Mentions (Q4 2023 and Q1 2024)Current Period (Q2 2024)Trend
R&D executionIND-enabling and ECCO data (SPY001/002); set stage for 2024 clinical entries SPY001 FIH dosing initiated; SPY003 candidate nominated; SPY002 FIH timing reaffirmed Strengthening execution
Financing/cash runway$180M (Dec 2023) and $180M (Mar 2024) financings; runway into 2H26 then updated Liquidity $426.3M; runway well into 2027 Improved runway
Regulatory/legal/macroStandard risk disclosures incl. BIOSECURE Act, geopolitics Similar cautionary statements continued Unchanged risk framing
Rational combinations in IBDPlan Phase 2 combos in 2025 2025 Phase 2 evaluation reiterated Consistent strategy
Competitive positioningTL1A and IL‑23 p19 positioned as potentially best-in-class; extended half-life claims Reiterated potency/half-life advantages; expanded SPY003 timeline Confidence maintained

Management Commentary

  • “Initiation of our Phase 1 trial of SPY001 represents an important transition… we expect to have reported Phase 1 data from our α4β7 and TL1A programs… and have an ongoing Phase 1 trial of our IL‑23 program” — Cameron Turtle, CEO .
  • “We believe each of these agents has the possibility to become a best-in-class monotherapy for the treatment of IBD… [and] ideal building blocks for rational therapeutic combinations” — Cameron Turtle, CEO .
  • “With a clean safety profile in SPY001’s 28‑day GLP toxicity study… we expect to report interim PK and safety data… by the end of this year” — Cameron Turtle, CEO (Q1 release) .

Q&A Highlights

  • No Q2 2024 earnings call transcript was available; no Q&A disclosures found in company documents or 8‑K exhibits for the period .

Estimates Context

  • Attempted to retrieve S&P Global consensus for Q2 2024 EPS and revenue; data were unavailable due to a CIQ mapping issue for AGLE, thus no Wall Street consensus comparisons are provided [SpgiEstimatesError from tool].
  • Investor focus should remain on clinical timelines rather than near-term revenue/EPS given pre-commercial status; any future consensus adjustments will likely hinge on SPY001 YE24 interim PK/safety and SPY002 1H25 interim HV data .

Key Takeaways for Investors

  • Clinical catalysts approaching: SPY001 interim PK/safety by YE24; SPY002 FIH initiation 2H24 with interim HV data 1H25; SPY003 IND-enabling in 2H24 and FIH in 1H25—these are likely stock drivers .
  • Liquidity of $426.3M and runway well into 2027 reduce financing overhang through multiple readouts, supporting multi-asset de-risking .
  • Sequential P&L improvement (net loss, EPS, opex) and higher interest income reflect disciplined execution and benefit of larger securities balance while pre-revenue .
  • Cash burn remains substantial (Q2 op cash use $62.4M), with timing effects; monitor opex trajectory vs trial progress through YE24/H1’25 .
  • Competitive claims (enhanced potency/half-life in TL1A and IL‑23 p19) position assets for potentially improved efficacy/convenience; head-to-head data and human PK will be critical validation next steps .
  • No consensus estimate data available; in the absence of P&L beats/misses, narrative is driven by clinical milestones and portfolio execution cadence [SpgiEstimatesError].
  • Near-term trading setup: anticipate event-driven volatility around YE24 SPY001 interim data; medium-term thesis hinges on multi-program validation and combination therapy strategy execution .