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Eledon Pharmaceuticals, Inc. (ELDN)·Q2 2024 Earnings Summary

Executive Summary

  • Eledon delivered a preliminary Q2 2024 update focused on clinical execution and balance sheet strength while announcing a non-cash accounting restatement (warrants reclassified as liabilities) and delaying the Q2 Form 10‑Q; detailed P&L items (revenue/EPS) were not reported for the quarter .
  • Liquidity improved materially with an oversubscribed $50.0M private placement; period-end cash was approximately $83.6M, and management now expects runway through December 2025 .
  • Clinical momentum continued: updated Phase 1b data (13 participants) showed overall mean eGFR 70.5 mL/min/1.73m² after day 30 and two patients >90 mL/min/1.73m² at one year; Phase 2 BESTOW reached 80 enrolled by July with completion targeted by year-end 2024 .
  • Risk factor emerged: a material weakness in ICFR related to equity instrument accounting and restatement of prior financials; management emphasized this is non-cash and not expected to impact operations or cash runway .

What Went Well and What Went Wrong

  • What Went Well

    • Liquidity and runway: $50.0M private placement increased quarter-end cash to ~$83.6M; runway expected through Dec 2025 .
      “We have entered the second half of the year with a strong balance sheet…” — CEO David‑Alexandre C. Gros, M.D. .
    • Clinical execution: 80 participants enrolled in Phase 2 BESTOW as of July; enrollment completion remains on track by year-end 2024 .
    • Phase 1b data quality: Updated data (n=13) showed overall mean eGFR 70.5 mL/min/1.73m² after day 30; two participants >90 mL/min/1.73m² at one year, supporting potential vs. calcineurin inhibitor SOC .
  • What Went Wrong

    • Accounting restatement: Warrants reclassified as liabilities under ASC 815-40; prior filings require restatement and should no longer be relied upon .
    • Material weakness: Identified in internal control over financial reporting for equity instruments; disclosure controls deemed not effective over specified periods .
    • Reporting delay: Q2 10‑Q filing delayed due to restatement process; Company furnished preliminary operating update instead of full quarterly financial statements .

Financial Results

Note: The Company furnished a preliminary Q2 business update and disclosed a restatement/delay of the Q2 10‑Q; revenue, EPS, and full P&L were not reported for Q2 2024. Liquidity metrics and qualitative financial notes were provided.

MetricQ4 2023Q1 2024Q2 2024
Revenue ($USD Millions)Not disclosed Not disclosed Not reported; 10‑Q delayed
Net Loss ($USD Millions)$(9.6) $(10.3) Not reported; 10‑Q delayed
Diluted EPS ($)$(0.32) $(0.34) Not reported; 10‑Q delayed
R&D Expense ($USD Millions)$7.1 $7.4 Not reported; 10‑Q delayed
G&A Expense ($USD Millions)$3.3 $3.5 Not reported; 10‑Q delayed
Cash and Cash Equivalents (period-end) ($USD Millions)$4.6 cash; $46.5 short‑term investments disclosed separately ~$42.9 cash, cash equivalents & short‑term investments ~$83.6 cash and cash equivalents (includes $50.0M financing)

Additional financial notes for Q2 2024:

  • Non-cash restatement for warrant liabilities; not expected to impact cash, short-term investments, or cash runway .
  • Management expects sufficient liquidity through December 2025 .

KPIs and Operating Metrics

KPIQ4 2023Q1 2024Q2 2024
Phase 2 BESTOW enrollment (participants)12 enrolled 12 enrolled as of March 80 enrolled by July; targeting completion by YE2024
Phase 1b eGFR performanceAggregate mean eGFR >70 at post‑90 day timepoints Update referenced (no numeric detail provided) Overall mean eGFR 70.5 after day 30; two pts >90 at one year

Estimate Comparison (S&P Global)

  • Consensus estimates (revenue/EPS) for Q2 2024 were not available from S&P Global at the time of analysis; therefore estimate comparisons are omitted. We will update when available.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BESTOW enrollment completion2024Complete enrollment by YE2024 Complete enrollment by YE2024 Maintained
Updated interim Phase 1b/OLE dataMid‑2025Not previously specifiedMid‑2025 update planned New timing disclosure
Liquidity runwayThrough Dec 2025Not previously disclosedSufficient liquidity through Dec 2025 New disclosure

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was posted; themes below reflect company press releases and 8‑K disclosures.

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
R&D execution (Kidney transplant)Phase 1b data supported safety/tolerability; BESTOW at 12 enrolled Phase 1b updated data (n=13) with overall mean eGFR 70.5; BESTOW at 80 enrolled by July Improving momentum
Competitive positioning vs CNIsPotential to reduce SOC side effects highlighted CEO reiterates potential to displace CNIs as first‑line Reinforced
Financing/liquidityYear-end cash/investments ~$51.1M $50M private placement; ~$83.6M cash at 2Q end; runway to Dec 2025 Strengthened
Regulatory/legal/accountingNo material weaknesses disclosed previouslyWarrant liability restatement; material weakness in ICFR identified Negative development
Pipeline expansionXenotransplant/islet efforts noted (Q4/Q1) Continued emphasis on kidney transplant program; timing for further updates provided Steady

Management Commentary

  • “We have entered the second half of the year with a strong balance sheet following our oversubscribed $50 million private placement… we continue to believe that tegoprubart has the potential to displace calcineurin inhibitors… as a first-line immunosuppression agent for patients undergoing kidney transplant.” — David‑Alexandre C. Gros, M.D., CEO .
  • “As of this week, we have already enrolled two-thirds of the projected study participants… We remain on track to complete enrollment by the end of the year.” — David‑Alexandre C. Gros, M.D., CEO (on BESTOW) .
  • Prior context: “Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs.” — CEO, Q4/FY 2023 release .
  • Accounting update: Management reported the non‑cash restatement for warrant classification and emphasized no expected impact to cash, cash equivalents, short-term investments, or cash runway .

Q&A Highlights

  • No Q2 2024 earnings call transcript or Q&A was posted; the Company furnished a preliminary operating update and disclosed a delayed Q2 10‑Q due to restatement work .

Estimates Context

  • S&P Global consensus (revenue, EPS) for Q2 2024 was unavailable at the time of analysis; as a result, comparisons vs. estimates are not included. We will update this section once S&P Global data can be retrieved.

Key Takeaways for Investors

  • Balance sheet de‑risked: $50M private placement and ~$83.6M quarter-end cash support development into late 2025, reducing near-term financing risk .
  • Clinical trajectory solid: Phase 1b eGFR data remain encouraging (overall mean 70.5 post day‑30; two >90 at one year); BESTOW enrollment pace suggests high clinical interest and execution .
  • Accounting overhang: Restatement and ICFR material weakness introduce governance risk and near-term reporting uncertainty; management asserts non‑cash, no runway impact .
  • Catalysts: BESTOW enrollment completion by YE2024 and mid‑2025 Phase 1b/OLE update create newsflow; subsequent to Q2, Company announced BESTOW enrollment completion (Sept 4) and top-line timing (4Q25), reinforcing medium-term visibility .
  • Watch for 10‑Q filing/resolution of restatement: Timely completion and clarity on any non‑cash P&L impacts will be important for reducing uncertainty and broadening investor participation .
  • Thesis check: If BESTOW confirms clinically meaningful graft function (eGFR) vs tacrolimus with an improved tolerability profile, tegoprubart could become a differentiated immunosuppression option in kidney transplantation, a segment with long-standing unmet needs .

Appendix: Source Highlights

  • Q2 2024 8‑K (Item 2.02 and 4.02) with preliminary operating update, restatement details, and liquidity .
  • Q2 2024 preliminary press release (clinical and cash updates) .
  • Q2 2024 relevant press in quarter: Phase 1b updated data (June 3) ; BESTOW enrollment update (July 29) .
  • Prior quarters for trend: Q1 2024 8‑K and press release (net loss, EPS, expenses, cash) ; Q4/FY 2023 8‑K and press release (expenses, EPS, cash/investments) .