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EP

Eledon Pharmaceuticals, Inc. (ELDN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was operationally active but financially loss-making: net loss was $44.6M and basic EPS was $(0.64), driven in part by a non-cash loss from warrant remeasurement ($20.9M) as operating spend increased alongside clinical progress .
  • Liquidity strengthened: cash, cash equivalents, and short-term investments rose to $140.2M at 12/31/24 (from $78.2M at 9/30/24), extending runway to end‑2026, supported by an oversubscribed $85M underwritten offering in October 2024 .
  • Clinical catalysts advanced: completed Phase 2 BESTOW enrollment four months early (Q3), positive initial tegoprubart islet‑transplant data (2/3 insulin independence), and its use in a landmark pig‑kidney xenotransplant at MGH; topline BESTOW data expected in Q4 2025 .
  • Estimates context: Wall Street consensus via S&P Global was unavailable at the time of writing; beats/misses against consensus cannot be assessed.

What Went Well and What Went Wrong

What Went Well

  • Accelerated clinical execution: BESTOW Phase 2 enrollment completed ~4 months ahead of plan (120 participants), indicating strong site/patient engagement and trial momentum .
  • Positive early efficacy signals: islet‑transplant data showed potentially the first human cases of insulin independence with an anti‑CD40L regimen without tacrolimus; 2/3 subjects insulin independent and the third reduced insulin >60% within three days; tolerability acceptable .
  • Strategic positioning and confidence: “We are entering 2025 from a position of balance sheet strength… on track to deliver topline results from our Phase 2 BESTOW trial in Q4 2025,” CEO David‑Alexandre C. Gros, M.D. .

What Went Wrong

  • Higher operating spend and dilution: R&D rose to $17.9M in Q4 (vs $16.5M in Q3), and G&A to $6.8M (vs $4.0M in Q3), reflecting increased development, manufacturing, and compensation expenses .
  • Non‑cash volatility impacted reported results: Q4 loss included a $(20.9)M non‑cash warrant liability change, reversing Q3’s $96.4M non‑cash gain that had driven a one‑time net income of $77.0M and $1.05 basic EPS .
  • Accounting complexity persisted: prior restatement and reclassification of warrant liabilities (Q2) underscored ongoing non‑cash mark‑to‑market impacts and contributed to headline volatility .

Financial Results

Quarterly P&L and Liquidity (oldest → newest)

MetricQ2 2024Q3 2024Q4 2024
Net Income (Loss) ($USD Millions)—$77.0 $(44.6)
Basic EPS ($)—$1.05 $(0.64)
R&D Expense ($USD Millions)—$16.5 $17.9
G&A Expense ($USD Millions)—$4.0 $6.8
Non‑cash Change in Warrant Liabilities ($USD Millions)—$96.4 (gain) $(20.9) (loss)
Cash + Short‑Term Investments ($USD Millions)—$78.2 $140.2
Cash & Cash Equivalents Only ($USD Millions)$83.6 $6.8 $20.5
Short‑Term Investments ($USD Millions)—$71.4 $119.6
Weighted‑Avg Basic Shares (Millions)—51.9 48.5

Notes:

  • Q3 net income and EPS were primarily driven by non‑cash fair‑value gains; excluding this, Q3 would have been a $(19.5)M net loss (company-reported non‑GAAP view) .
  • Q4 headline loss reflects higher operating expenses and non‑cash warrant remeasurement loss .

Year-over-Year (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024YoY Δ
R&D Expense ($USD Millions)$7.1 $17.9 +$10.8
G&A Expense ($USD Millions)$3.3 $6.8 +$3.5
Net Income (Loss) ($USD Millions)$(30.1) $(44.6) $(14.5)
Basic EPS ($)$(1.00) $(0.64) +$0.36

Segment breakdown: not applicable; Eledon is a clinical‑stage company without commercial segment revenues reported in the releases .

Clinical and Operational KPIs (oldest → newest)

KPIQ2 2024Q3 2024Q4 2024
BESTOW Phase 2 Enrollment80 enrolled 120; enrollment completed ~4 months early Topline expected Q4 2025
Islet Transplant Outcomes—2/3 insulin independence; 3rd −60% insulin in 3 days Positive initial data reiterated; tacrolimus‑free regimen
Xenotransplant (Pig Kidney)——Tegoprubart used; patient discharged, off dialysis post‑op
Cash RunwaySufficient through Dec 2025 (post $50M placement) To end of 2026 (incl. Oct financing) To end of 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2026To end of 2026 (post Oct ’24 financing) To end of 2026 Maintained
Phase 1b Kidney Transplant – Interim Updates2025Mid‑2025 Summer 2025 Slightly refined timing
Phase 2 BESTOW – Topline ResultsQ4 2025Q4 2025 Q4 2025 Maintained
Islet Transplant – Additional Data20252025 follow‑up 2025 updated interim data Maintained

Earnings Call Themes & Trends

TopicQ-2 (Q2 2024)Q-1 (Q3 2024)Current Period (Q4 2024)Trend
R&D Execution80 enrolled in BESTOW; Phase 1b data presented (eGFR mean 70.5) Completed BESTOW enrollment early On track for Q4 2025 topline Positive execution, schedule confidence
Financing/Liquidity$50M private placement; runway to Dec 2025 $85M underwritten offering; runway to end‑2026 Runway confirmed to end‑2026 Strengthening balance sheet
Islet Transplant (T1D)—2/3 insulin independence; tacrolimus‑free regimen Positive initial data reiterated Encouraging early efficacy and tolerability
Xenotransplantation——Tegoprubart central to MGH pig‑kidney transplant; patient off dialysis Expanding potential indications
Manufacturing/CMC—Higher CMC spend cited Continued clinical supply and manufacturing costs Scaling to support trials
Accounting/WarrantsReclassification/restatement disclosed Large non‑cash gain drives headline profit Non‑cash loss reverses effect Ongoing non‑cash volatility

Note: No earnings call transcript was available in our document set for Q4 2024; themes are synthesized from company filings and press releases.

Management Commentary

  • Strategic positioning: “We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients… we are on track to deliver topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.” — David‑Alexandre C. Gros, M.D., CEO .
  • Development confidence: “We believe tegoprubart has best‑in‑class potential… Recent encouraging data… combined with our accelerated enrollment… and strong capital position… has put us in a strong position to advance tegoprubart’s development.” — David‑Alexandre C. Gros, M.D. .

Q&A Highlights

  • Not applicable; no earnings call transcript or published Q&A was available for Q4 2024 in the document set.

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable at the time of writing; we cannot assess beats/misses versus consensus.

Key Takeaways for Investors

  • Liquidity is robust and runway extended to end‑2026 after the $85M offering; this should support execution through key 2025 milestones including BESTOW topline in Q4 2025 .
  • Clinical momentum is tangible: early islet‑transplant signals (insulin independence) and high‑profile xenotransplant use broaden tegoprubart’s potential beyond kidney allograft, potentially expanding the long‑term opportunity set .
  • Expect continued P&L volatility from non‑cash warrant remeasurement; investors should focus on operating expense trends and clinical milestones rather than headline GAAP swings .
  • Operating spend is scaling with development and manufacturing; monitor R&D cadence and G&A growth for dilution of runway or need for incremental financing ahead of Phase 2 readout .
  • Near‑term trading catalysts: additional interim Phase 1b data (summer 2025) and ongoing visibility into islet‑transplant outcomes; any favorable updates could drive sentiment into BESTOW topline .
  • Medium‑term thesis: If BESTOW demonstrates safety/efficacy sufficient to displace calcineurin inhibitors in kidney transplant, tegoprubart could reset the immunosuppression landscape, with optionality in islet and xenotransplant indications .

Sources: Q4 2024 8‑K and Exhibit 99.1 press release (Mar 20, 2025) ; Q4 press release (Mar 20, 2025) ; Q3 2024 press release and 8‑K (Nov 12, 2024) ; Oct 29, 2024 press releases (financing; islet data) ; Aug 14, 2024 Q2 update press release .