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Spyre Therapeutics, Inc. (AGLE)·Q4 2023 Earnings Summary

Executive Summary

  • Spyre reported Q4 2023 total revenue of $0.00 and a net loss of $63.2M ($4.05 loss per share), reflecting the pivot to preclinical IBD programs and non-cash liabilities tied to CVRs; cash and investments were $339.6M with runway into 2H 2026 .
  • Operating momentum: SPY001 updated NHP half-life of 22 days (>3x vs vedolizumab) with FIH start in H1 2024 and interim proof-of-concept PK by YE 2024; SPY002 on track for FIH in H2 2024 after NHP half-life of 24 days and subnanomolar binding to TL1A monomers/trimers .
  • Corporate strengthening: $180M private placement (Dec-23), name change to Spyre Therapeutics, CEO appointment, and listing under SYRE on Nasdaq (Feb-24) .
  • Street estimates were unavailable via S&P Global for Q4 2023; no beat/miss analysis provided due to missing mapping (see Estimates Context) [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • Strengthened balance sheet and runway: $339.6M cash, cash equivalents, marketable securities, and restricted cash as of 12/31/23; runway into 2H 2026 following $180M private placement in Dec-23 .
  • Pipeline advancements: SPY001 demonstrated an updated 22-day half-life in NHPs (>3× vs vedolizumab), supporting extended subcutaneous dosing; FIH targeted H1 2024 with interim PK by YE 2024 .
  • Strategic clarity and leadership: Corporate name change to Spyre Therapeutics, appointment of CEO Cameron Turtle, and addition of industry veteran Mark McKenna to the Board to drive IBD-focused execution .
    • Quote: “In 2023, we built the foundation required to advance our mission of creating IBD therapies that provide meaningful improvements in both efficacy and convenience…” — Cameron Turtle, CEO .

What Went Wrong

  • Elevated quarterly loss and opex: Net loss rose to $63.2M in Q4 2023 (vs $18.8M YoY), with R&D $33.7M and G&A $14.1M, reflecting preclinical/manufacturing scale-up and stock comp/professional fees .
  • Other expense headwinds: $17.3M other expense primarily from increased CVR liability tied to higher likelihood of pegzilarginase reimbursement milestones in Europe, partially offset by interest income .
  • Limited revenue contribution: Q4 2023 revenue was $0.00 (vs $0.17M in Q4 2022), consistent with the transition away from legacy programs and pre-commercial IBD focus .

Financial Results

Quarterly Trend (oldest → newest)

MetricQ2 2023Q3 2023Q4 2023
Revenue ($USD Millions)$0.69 $0.00 $0.00
Net Loss ($USD Millions)$(217.08) $(40.11) $(63.18)
Net Loss per Share ($USD)$(2.27) $(9.34) $(4.05)
R&D Expense ($USD Millions)$17.39 $24.66 $33.68
G&A Expense ($USD Millions)$12.06 $8.58 $14.07
Other (Expense) Income ($USD Millions)$(57.83) $(21.77) $(17.27)
Operating Cash Flow ($USD Millions)——$(31.00)

YoY Comparison

MetricQ4 2022Q4 2023
Revenue ($USD Millions)$0.17 $0.00
Net Loss ($USD Millions)$(18.82) $(63.18)
Net Loss per Share ($USD)$(5.00) $(4.05)
R&D Expense ($USD Millions)$14.25 $33.68
G&A Expense ($USD Millions)$5.08 $14.07

KPIs and Balance Sheet (oldest → newest)

KPIQ2 2023Q3 2023Q4 2023
Cash, Cash Equivalents, Marketable Securities, Restricted Cash ($USD Millions)$236.7 $204.9 $339.6
Cash RunwayInto 2026 Into 2026 Into 2H 2026
Gain on Sale of IPR&D ($USD Millions)$—$14.61 $1.84

Note: Spyre does not report gross margin or EBITDA; margins are not applicable given immaterial revenue in the period .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SPY001 FIH startH1 2024“Expected to enter FIH in H1 2024” “On track to begin FIH in H1 2024; interim PK by YE 2024; target human half-life >35 days (allometric scaling)” Maintained; expanded detail
SPY001 dosing concept2024 outlook“Potential Q8–Q12 week SC interval (POC PK expected YE 2024)” “Expect PK to support q8–q12 week SC dosing; interim data YE 2024” Maintained
SPY002 FIH startH2 2024“Expected IND/first-in-human in H2 2024” “Begin FIH in H2 2024; interim HV data H1 2025; subnanomolar binding to monomer/trimer; NHP half-life 24 days” Maintained; enhanced potency/PK detail
SPY003 (IL-23 p19)2024–2025“IND/CTN expected in 2025” “Nominate development candidate mid-2024; IND-enabling in H2 2024” Clarified milestones; timeline intact
Cash runwayThrough 2026“Into 2026” “Into 2H 2026” Clarified (more specific)

Earnings Call Themes & Trends

No Q4 2023 earnings call transcript found in our document search; analysis below synthesizes themes from Q2–Q4 press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2023)Trend
Financing and runwayQ2: $210M Series A financing and $236.7M cash; strategic pivot to IBD . Q3: $204.9M cash; runway into 2026 .$339.6M cash after $180M private placement; runway into 2H 2026 .Strengthened balance sheet; extended runway
SPY001 (α4β7)Q2/Q3: FIH expected H1 2024; aim for q8–q12 week SC dosing .NHP half-life updated to 22 days (>3× vs vedolizumab); FIH H1 2024; interim PK YE 2024 .Positive validation; operationally on track
SPY002 (TL1A)Q2/Q3: Picomolar binding to monomer/trimer; FIH H2 2024 .NHP half-life 24 days; subnanomolar binding and potency; FIH H2 2024; HV data H1 2025 .Reinforced differentiation; on track
SPY003 (IL-23 p19)Q3: IND/CTN expected 2025; SEQUENCE data supports p19 focus .Candidate nomination mid-2024; IND-enabling H2 2024 .Milestones pulled forward with clarity
Legacy asset monetizationQ2: Sold pegzilarginase rights to Immedica; CVR arrangement . Q3: $14.6M gain on sale; CVR and forward liability impacts .Additional $1.8M gain; higher CVR liability driving $17.3M other expense .Transition largely complete; CVR dynamics persist

Management Commentary

  • Strategic focus and execution: “Beginning with a highly unique portfolio of three promising drug candidates… we capitalized the company with nearly $400 million… As we look forward to 2024… we enter clinical studies across multiple programs and begin to demonstrate potential best-in-class properties.” — Cameron Turtle, CEO .
  • Program ambition and timelines: “We anticipate initiating Phase 2 evaluation of rational therapeutic combinations in IBD patients in 2025.” — Cameron Turtle, CEO .
  • TL1A opportunity: “TL1A has emerged as one of the most promising targets in IBD… lead candidates bind both TL1A monomers and trimers and have… half-lives that potentially exceed all clinical-stage TL1A antibodies.” .

Q&A Highlights

No Q4 2023 earnings call transcript was available in our search; therefore, there are no Q&A highlights or clarifications to report from a call [ListDocuments showed none].

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2023 EPS and revenue was unavailable due to missing CIQ mapping for AGLE/SYRE at the time of query; accordingly, comparisons to consensus cannot be provided [GetEstimates error].
  • Based on primary filings, Spyre did not provide financial guidance metrics (revenue/margins) typical of commercial-stage companies; operational guidance focuses on clinical timelines and cash runway .

Key Takeaways for Investors

  • Balance sheet optionality: $339.6M cash and investments and runway into 2H 2026 support multiple clinical readouts and reduces near-term financing overhang .
  • Differentiation thesis: Updated NHP PK for SPY001 (22-day half-life) and SPY002 (24-day half-life; subnanomolar binding to monomer/trimer TL1A) strengthen the potential for infrequent subcutaneous dosing and best-in-class profiles .
  • Clinical catalysts: FIH initiations for SPY001 (H1 2024) and SPY002 (H2 2024), with SPY001 interim PK by YE 2024 and SPY002 interim HV data H1 2025, set a steady cadence of data events that can drive sentiment .
  • Operational ramp implications: Elevated R&D and G&A reflect scale-up; expect opex to remain elevated as programs enter the clinic, with CVR liability potentially introducing P&L volatility .
  • Legacy asset tail risk: CVR liability linked to pegzilarginase reimbursement could continue to affect “Other expense” line; monitor European reimbursement milestones .
  • Strategy coherence: Name change, leadership additions, and Board strengthening indicate commitment to IBD focus and readiness for clinical execution .
  • Trading setup: Near-term stock catalysts are tied to FIH starts and PK readouts; absence of revenue and margins shifts investor focus to clinical data quality and pipeline differentiation .