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EP

Eledon Pharmaceuticals, Inc. (ELDN)·Q1 2024 Earnings Summary

Executive Summary

  • Eledon reported Q1 2024 net loss of $10.3M ($0.34 EPS), improving year-over-year by $0.5M and $0.41 EPS as R&D spend declined; cash and short-term investments were $42.9M excluding a subsequent $50.0M private placement .
  • The oversubscribed $50.0M private placement closed May 9, 2024, extending liquidity runway to December 2025 and reducing near-term financing risk; management still flags going-concern risk absent further capital in future years .
  • Clinical execution advanced: BESTOW Phase 2 enrollment hit 12 participants, tegoprubart used post the first-ever kidney xenotransplant, and updated Phase 1b data showed overall mean eGFR of 70.5 and no key CNI-associated side effects .
  • Near-term catalysts: June 2024 Phase 1b/OLE data update and BESTOW enrollment completion targeted by year-end 2024—potential stock reaction drivers as efficacy/safety narrative evolves .
  • No earnings call transcript or consensus estimates were available via S&P Global to benchmark results; comparisons to Street are not provided (we attempted retrieval but were unable due to data access limits).

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum and broad-transplant optionality: “significant progress … reinforces tegoprubart’s potential to become the first-line immunosuppressive treatment option of choice” (CEO) .
  • Strong Phase 1b kidney data and safety: overall mean eGFR 70.5 at timepoints after day 30; no hyperglycemia, new-onset diabetes, or tremor; no graft loss or death; two patients at one year had mean eGFRs above 90 .
  • Capital raised on improved terms: oversubscribed $50.0M private placement (price $2.37/share or $2.369 per pre-funded warrant) extends runway and supports pre-commercial activities .

What Went Wrong

  • Going-concern and future financing need: despite the May financing and runway through Dec 2025, management still notes substantial doubt if additional capital is not raised beyond current plans .
  • Dilution overhang and warrant overhang: significant outstanding warrants and potential future tranche financing could pressure the stock and further dilute holders .
  • Enrollment pace and messaging inconsistency: BESTOW enrollment cited as 12 participants in Q4 2023 and again “12th participant in March 2024,” creating potential confusion on timing; completion still guided for end-2024 .

Financial Results

Quarterly Trend (oldest → newest)

MetricQ3 2023Q4 2023Q1 2024
Net Loss ($USD Millions)$10.3 $9.6 $10.3
EPS (Basic & Diluted, $)$(0.35) $(0.32) $(0.34)
R&D Expense ($USD Millions)$7.9 $7.1 $7.4
G&A Expense ($USD Millions)$3.3 $3.3 $3.5
Cash & Short-Term Investments ($USD Millions)$59.6 $51.1 $42.9 (excl. $50M proceeds)

Key drivers: R&D decreased year-over-year in Q1 due to lower clinical material and CRO costs; G&A was up on higher stock-based comp .

YoY Comparison (Q1 2023 → Q1 2024)

MetricQ1 2023Q1 2024
Net Loss ($USD Millions)$10.8 $10.3
EPS (Basic & Diluted, $)$(0.75) $(0.34)
R&D Expense ($USD Millions)$8.1 $7.4
G&A Expense ($USD Millions)$3.0 $3.5

Estimates vs Actuals

  • Wall Street consensus via S&P Global was unavailable; we attempted retrieval but could not obtain data. As a result, no estimates comparison is provided.

Clinical KPIs and Execution

KPIQ3 2023Q4 2023Q1 2024
Phase 1b Kidney eGFRAggregate mean >70 at all timepoints after day 90 OLE first participant eGFR 91 at one year Overall mean 70.5 after day 30; two at one year >90
Safety SignalsNo hyperglycemia, new-onset diabetes, tremor; no graft loss/death
BESTOW EnrollmentFirst participant dosed 12 participants enrolled 12th participant enrolled in March
Xenotransplant UseGenetically modified heart (pig→human) Genetically modified kidney (pig→human) use Noted continuation of xenotransplant immunosuppression use

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 1b/OLE data updateQ2 2024“Second quarter 2024” “June 2024” (ATC update) Clarified date
BESTOW Enrollment Completion2024“End of 2024” “End of 2024” Maintained
Liquidity RunwayThrough 2025Not specified“Sufficient liquidity through December 2025” post-financing Raised
Islet Cell Transplant (ICT) Pilot2024“Dose first participant in 2024” First participant treated at University of Chicago; tegoprubart included Achieved

Note: Enrollment timing references show potential inconsistency (Q4 reported 12; Q1 cites 12th in March). We flag for diligence in future updates .

Earnings Call Themes & Trends

No earnings call transcript was available for Q1 2024 despite targeted searches; themes are derived from filings and press releases.

TopicPrevious Mentions (Q-2: Q3’23; Q-1: Q4’23)Current Period (Q1’24)Trend
R&D execution (kidney)eGFR >70 after day 90; BESTOW first dose Overall mean eGFR 70.5; continued safety; OLE ongoing Positive, consistent
XenotransplantationHeart pig→human immunosuppression Kidney pig→human immunosuppression acknowledged Expanding use cases
Islet cell transplantationPlanned pilot and collaborations First participant treated, tegoprubart included Execution achieved
Financing/liquidityCash $51.1M YE; dilution risk $50.0M private placement; runway to Dec 2025; going concern still highlighted Liquidity improved; risk persists
Regulatory/legalOrphan designations; risk disclosures Ongoing risk factor emphasis; going-concern Stable risk profile

Management Commentary

  • “We are pleased with the significant progress made so far this year … This progress reinforces tegoprubart’s potential to become the first-line immunosuppressive treatment option of choice for a broad range of transplant procedures.” — David-Alexandre C. Gros, M.D., CEO (Q1 release) .
  • “Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs.” — CEO (Q4 release) .
  • “We were thrilled … updated results from our ongoing Phase 1b study … tegoprubart demonstrated … potential to preserve, but also to improve graft function compared to current standard of care.” — CEO (Q3 release) .

Q&A Highlights

  • Not available. We searched for a Q1 2024 earnings call transcript and found none; therefore no Q&A themes can be provided from a call transcript.

Estimates Context

  • We attempted to retrieve S&P Global consensus EPS and revenue estimates for Q1 2024, but the data was unavailable due to access limits; thus, comparisons vs Street are not provided. We searched explicitly for “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for recent quarters without success.

Key Takeaways for Investors

  • Liquidity improved: the $50.0M private placement extends runway to December 2025, supporting clinical execution and pre-commercial planning; monitor remaining financing pathways and warrant exercises for dilution risk .
  • Clinical de-risking: Phase 1b kidney data show sustained eGFR and favorable safety profile; June 2024 update is a near-term catalyst that could sharpen the efficacy narrative .
  • Execution in BESTOW: enrollment completion by year-end 2024 is pivotal; any delays could push timelines—watch site activation and enrollment rates .
  • Platform breadth: tegoprubart’s use in islet cell transplantation and xenotransplantation expands optionality and potential value beyond kidney allografts .
  • Risk management: going-concern language remains despite extended runway; dilution overhang from warrants and potential tranche financings persists—position sizing should reflect capital-raising cadence .
  • Trading implications (near term): June clinical data and BESTOW enrollment updates could drive momentum; adverse safety/efficacy signals would be negative swing factors .
  • Medium-term thesis: if tegoprubart can demonstrate superiority versus tacrolimus on eGFR/graft outcomes with fewer side effects, it could reshape post-transplant immunosuppression—focus on BESTOW’s primary endpoint (12-month eGFR) and secondary outcomes .