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CI

Clene Inc. (CLNN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results: revenue of $0.09M* and diluted EPS of -$1.61*, both below S&P Global consensus (revenue $0.13M, EPS -$0.95; 6 estimates), reflecting limited commercial activity and ongoing R&D investment [Values retrieved from S&P Global].
  • Year-end cash and cash equivalents were $12.2M, with a new $10.0M partially convertible note (12% fixed; 65% convertible at $5.67) extending runway into Q2 2025 .
  • Regulatory momentum: FDA provided a potential accelerated approval pathway contingent on expanded NfL biomarker analyses; NDA submission targeted for H2 2025 and confirmatory Phase 3 RESTORE-ALS to begin mid-2025 .
  • Key catalyst: clarity on FDA statistical plan (Q2 2025) and EAP NfL analysis (Q3 2025), which could drive estimate revisions and stock re-rating around accelerated approval prospects .

What Went Well and What Went Wrong

What Went Well

  • FDA signaled a regulatory path for accelerated approval in ALS if additional EAP NfL data substantiate prior findings; Clene plans NDA in H2 2025 and to initiate RESTORE-ALS mid-2025 .
  • Management highlighted concordance goals between NIH-sponsored EAP NfL data and HEALEY results; CEO: “We intend to use this NfL surrogate biomarker data as a basis to file our NDA in the second half of 2025” .
  • Corporate financing: $10.0M note replaced $7.85M Avenue balance at lower rate and extended runway; terms include 12% fixed rate and conversion at $5.67 (30% premium to signing day close) .

What Went Wrong

  • Q4 missed consensus revenue and EPS, reflecting minimal revenue base and non-cash/financing items impacting the P&L [Values retrieved from S&P Global].
  • Liquidity declined to $12.2M at year-end from $35.0M the prior year, tightening operating flexibility absent further financing or partnership cash .
  • No Q4 earnings call transcript available in our source set, limiting insight into near-term OpEx cadence and detailed regulatory Q&A; reliance on press releases for qualitative context (Q2–Q4) .

Financial Results

Quarterly Comparison vs Prior Periods and YoY

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Thousands)170*91*87*91*
Net Income ($USD Thousands)-10,173*-6,785*-7,986*-13,549*
Diluted EPS ($USD)-1.58*-1.06*-1.22*-1.61*
EBITDA ($USD Thousands)-9,508*-6,977*-7,409*-8,250*
Total Operating Expenses ($USD Thousands)10,100*7,482 7,902 8,746*
Cash and Equivalents ($USD Thousands)28,821 21,682 14,645 12,155

Asterisk denotes values retrieved from S&P Global.

Q4 2024 vs S&P Global Consensus

MetricConsensusActualSurprise# of Estimates
Revenue ($USD Thousands)13091-30%6
Primary EPS ($USD)-0.95-1.36Miss6

Values retrieved from S&P Global. Note: EPS from S&P reflects Primary EPS; the quarterly table above uses “Diluted EPS - Continuing Operations” from S&P fundamentals, which may differ methodologically.

Full-Year Context (FY 2024 vs FY 2023)

MetricFY 2023FY 2024
Total Revenue ($USD Thousands)654 342
R&D Expense ($USD Thousands)26,655 20,058
G&A Expense ($USD Thousands)14,418 13,307
Net Loss ($USD Thousands)49,504 39,400
Net Loss per Share ($USD)-9.43 -5.67
Cash, Cash Equivalents & Marketable Securities ($USD Thousands)35,000 12,200

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough Q1 2025 (post-Oct financing) —Into Q2 2025 Raised runway by ~1 quarter
NDA submission (CNM-Au8 in ALS)2024 potential (Q2 press release optimism) H2 2025 targeted Pushed out; now after Q2/Q3 2025 analyses
FDA statistical analysis plan meetingEarly 2025 expectation Q2 2025 Timing specified
EAP NfL biomarker analyses completionQ2 2025 planned Q3 2025 execution window Clarified sequence
RESTORE-ALS Phase 3 initiationDesign presented (Oct 2024) Mid-2025 enrollment start Firmed start
Debt facilityAmended Avenue in Sep 2024 New $10.0M note; 12% fixed; 65% convertible at $5.67 Refinanced; improved terms

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
FDA accelerated approval in ALSType C briefing submitted; optimism on 2024 filing FDA provided roadmap; NDA targeted H2 2025; statistical plan in Q2 2025; EAP NfL analyses Q3 2025 Path clearer; timeline extended; still constructive
NfL biomarker strategyHEALEY OLE data; 28% mean NfL reduction in responders; survival linkage FDA recommends leveraging EAP NfL; aim for concordance with HEALEY Deeper biomarker work; regulatory emphasis
Survival outcomes~60% reduced death risk vs PRO-ACT controls (ENCALS) HEALEY RMST +4.1 months; subgroup median +11.9 months; HR 0.556 Additional survival analyses; stronger subgroup signal
Financing & runwayReverse split; $21.7M cash (Q2); runway into Q4 2024 $7.3M raise; new $10.0M note; $12.2M cash at YE; runway into Q2 2025 Extended but tight; continued need for capital
Safety profileNo SAEs related to CNM-Au8 reported >800 patient-years; no significant safety concerns or SAEs related Stable, supportive
MS programVISIONARY-MS LTE completion; ongoing analyses Continuing long-term effect analyses on vision/cognition Steady secondary focus

Management Commentary

  • CEO Rob Etherington: “We intend to use this NfL surrogate biomarker data as a basis to file our NDA in the second half of 2025 for potential Accelerated Approval… we are incredibly motivated by our mission to help people suffering with ALS…” .
  • On FDA pathway: “We are incredibly grateful for the FDA’s willingness to consider how the available data from our expanded access programs may be able to support… accelerated regulatory pathway… Clene plans to include the additional data in an NDA submission… in mid-2025.” .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in our source set; therefore, Q&A detail, guidance clarifications, and tonal shifts cannot be assessed beyond prepared remarks and press releases .

Estimates Context

  • Q4 2024: Revenue $0.091M vs consensus $0.130M (miss), Primary EPS -$1.36 vs consensus -$0.95 (miss); both based on 6 estimates. Potential revisions may track regulatory timing and financing runway [Values retrieved from S&P Global].

Key Takeaways for Investors

  • Regulatory: FDA’s openness to an accelerated approval pathway contingent on robust EAP NfL analyses sets up a 2025 regulatory catalyst path (Q2 statistical plan, Q3 analyses, H2 NDA filing) .
  • Clinical signal: Additional survival analyses and NfL biomarker relationships strengthen the mechanistic and clinical narrative, particularly in higher NfL burden subgroups .
  • Liquidity: YE cash of $12.2M and a $10.0M note push runway into Q2 2025, but incremental capital (equity/partnering) likely needed to bridge to NDA submission and Phase 3 enrollment .
  • Near-term trading setup: Stock may react to FDA statistical plan alignment (Q2) and EAP NfL readouts (Q3); misses vs Q4 consensus underscore sensitivity to regulatory milestones over near-term financials .
  • Model updates: Consensus likely to recalibrate timelines and cash needs given NDA moved to H2 2025 and Phase 3 initiation mid-2025; limited revenue and non-cash P&L items complicate EPS trajectory .
  • Risk factors: Regulatory uncertainty around NfL as a reasonably likely surrogate endpoint and the magnitude of change needed to predict clinical benefit; ongoing financing needs .
  • Strategic: Continued focus on ALS; MS remains an option value with ongoing analyses from VISIONARY-MS .