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CI

Clene Inc. (CLNN)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS was -$0.85 (basic and diluted), missing Wall Street consensus of -$0.58*; revenue was $0.02M, below the $0.06M* consensus .
  • Operating expenses fell materially YoY (R&D $3.5M vs $4.5M; G&A $2.2M vs $3.4M), but “other expense” increased to $3.1M on warrant and derivative fair value changes, driving the EPS miss .
  • Regulatory timeline shifted: management now plans an ALS accelerated-approval NDA submission in Q1 2026 (previously targeted for Q4 2025) and expects first RESTORE-ALS Phase 3 patient in H1 2026 .
  • Cash runway extended into Q2 2026 (cash/equivalents $7.9M at quarter-end, plus $1.2M raised post Q3); financing terms and fair-value movements remain important to quarterly EPS volatility .

Note: *Values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • Cash runway extended into Q2 2026; cash/equivalents of $7.9M as of Sep 30 and $1.2M raised post-quarter support near-term execution .
  • FDA provided clear biomarker analysis pathways (NfL in NIH EAP, additional ALS biomarkers from HEALEY, and NfL in OLE), and management anticipates completion “shortly,” supporting planned accelerated-approval NDA .
  • MS program engagement progressed with a Type B end-of-Phase 2 meeting; FDA showed openness to cognition-focused endpoints beyond EDSS limitations, aligning with Clene’s broader treatment-effect strategy .

Management quotes:

  • “The three potential biomarker paths… include: (a) NfL analysis of our ongoing NIH-sponsored EAP; (b) additional ALS disease-specific biomarker changes… from the HEALEY ALS Platform Trial; and (c) NfL analysis of subjects in the OLE…” — Rob Etherington, CEO .
  • “The FDA aligned with Clene… and expressed openness to considering other potential primary endpoints, including cognition…” — company disclosure on MS EOP2 meeting .

What Went Wrong

  • EPS missed consensus (-$0.85 vs -$0.58*), primarily due to higher “other expense” from fair value changes in warrant and derivative liabilities (total other expense -$3.1M vs -$0.2M YoY) .
  • Revenue remained de minimis ($0.02M; product revenue $0, royalty $0.02M), limiting operating leverage and magnifying margin optics .
  • ALS NDA timing slipped to Q1 2026 from prior expectation of Q4 2025, elongating the regulatory catalyst window and potentially requiring incremental financing in 2026 .

Note: *Values retrieved from S&P Global.

Financial Results

P&L and EPS vs Prior Periods and Estimates

MetricQ1 2025Q2 2025Q3 2025
Total Revenue ($USD Millions)$0.081 $0.027 $0.015
Product Revenue ($USD Millions)$0.064 $0.001 $0.000
Royalty Revenue ($USD Millions)$0.017 $0.026 $0.015
R&D Expense ($USD Millions)$1.481 $3.514 $3.513
G&A Expense ($USD Millions)$2.656 $2.377 $2.150
Total Operating Expenses ($USD Millions)$4.157 $5.891 $5.663
Other Income (Expense), net ($USD Millions)$3.325 -$1.555 -$3.129
Net Loss ($USD Millions)-$0.751 -$7.419 -$8.777
EPS (Basic & Diluted) ($)-$0.09 -$0.78 -$0.85

Actual vs Wall Street Consensus (S&P Global)

Bold indicates significant beat/miss.

MetricQ1 2025 Estimate*Q1 2025 ActualQ2 2025 Estimate*Q2 2025 ActualQ3 2025 Estimate*Q3 2025 Actual
Revenue ($USD)$61,000*$81,000 $56,170*$27,000 $55,140*$15,000
EPS ($)-$0.90*-$0.09 -$0.47*-$0.78 -$0.58*-$0.85

Note: *Values retrieved from S&P Global.
Highlights: Q1 revenue and EPS were bold beats vs consensus; Q2/Q3 were bold misses vs consensus.

KPIs and Balance Sheet

MetricQ1 2025Q2 2025Q3 2025
Cash & Equivalents ($USD Millions)$9.832 $7.285 $7.925
Total Assets ($USD Millions)$25.314 $22.125 $22.311
Total Liabilities ($USD Millions)$30.287 $30.675 $34.668
Convertible Notes Payable ($USD Millions)$10.970 $11.134 $11.218

Margin Metrics (S&P Global)

MetricQ1 2025Q2 2025Q3 2025
Net Income Margin %-926.7%*-27,478.7%*-58,513.3%*

Note: *Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ALS NDA Submission TimingRegulatoryQ4 2025 (planned) Q1 2026 (planned) Lowered (timeline delayed)
RESTORE-ALS Phase 3 First PatientClinical OpsNot previously datedH1 2026 New specific timing
Cash RunwayLiquidityInto Q1 2026 Into Q2 2026 (incl. $1.2M raised post-Q3) Raised/extended

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was available in the document set.

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
ALS Biomarkers (NfL, survival)Preparing SAP; strong survival analyses; plan for accelerated approval in Q4 2025 Constructive FDA Type C; plan to analyze NfL in NIH EAP early Q4 2025 FDA proposed three biomarker paths; Type C planned to review analyses; NDA planned Q1 2026 Continued biomarker focus; NDA timing pushed
MS Program (EOP2)New evidence for remyelination; plan for EOP2 meeting Q3 Planning EOP2 Type B meeting EOP2 held; FDA open to cognition endpoints Positive regulatory dialogue
Cash Runway & FinancingRunway into Q3 2025 Runway into Q1 2026; added equity/debt Runway into Q2 2026; $1.2M raised post-Q3 Improving liquidity runway
Nasdaq Listing ComplianceMVLS deficiency notice; 180-day cure to Nov 3, 2025 ——Monitoring status; risk persists
PD Program——New preclinical data supporting CNM-Au8 mechanism in PD Pipeline breadth expanding

Management Commentary

  • ALS regulatory path: “The FDA recommended three potential paths… [EAP NfL], additional ALS disease-specific biomarkers… [HEALEY], and NfL in OLE… The Company anticipates completing these data analyses shortly which could support the filing of an NDA using the accelerated approval pathway.” — Rob Etherington, CEO .
  • MS endpoints alignment: “The FDA… expressed openness to considering other potential primary endpoints, including cognition, to evaluate broader treatment effects.” .
  • Financing and runway: Cash/equivalents $7.9M at quarter-end; runway into Q2 2026, including $1.2M raised after Q3 .

Q&A Highlights

No Q3 2025 earnings call transcript was available; no Q&A to summarize.

Estimates Context

  • Q3 2025: EPS -$0.85 missed -$0.58* consensus; revenue $0.015M missed $0.055M* consensus .
  • Q2 2025: EPS -$0.78 missed -$0.47*; revenue $0.027M missed $0.056M* .
  • Q1 2025: EPS -$0.09 beat -$0.90*; revenue $0.081M beat $0.061M* .
    Drivers: Non-cash fair value losses in Q3 (“other expense” -$3.1M) and minimal revenue base magnify EPS variance; lower R&D and G&A provide partial offsets .

Note: *Values retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory inflection remains intact but delayed: ALS accelerated-approval NDA target shifted to Q1 2026; watch completion of biomarker analyses and Type C meeting outcomes as near-term catalysts .
  • Liquidity runway improved to Q2 2026; however, convertible note terms and fair value marks can materially swing quarterly EPS and should be modeled carefully .
  • Expect sell-side to reflect the timeline shift and higher “other expense” volatility in near-term EPS estimates; R&D and G&A discipline persists .
  • MS program gained regulatory alignment on cognition endpoints—an underappreciated optionality for medium-term value if Phase 3 design proceeds .
  • De minimis revenue limits operating leverage; royalty contributions are small; focus remains on regulatory milestones rather than near-term commercial metrics .
  • Maintain vigilance on Nasdaq listing compliance risk window through Nov 3, 2025 (MVLS deficiency notice) .
  • Trading implications: Near-term stock moves likely tethered to biomarker readouts, FDA meeting updates, and financing steps; the NDA cadence shift is a key narrative pivot .

Appendix: Documents Read

  • Q3 2025 8-K and press release (Item 2.02; EX-99.1)
  • Q3 2025 8-K (Oct 14) corporate presentation pre-announcement
  • Q2 2025 press release and 8-K (Item 2.02; EX-99.1)
  • Q1 2025 8-K press release (Item 2.02) and MVLS notice
  • Additional Q3-relevant press releases (conference participation; PD preclinical data)

No Q3 2025 earnings call transcript was available in the document set.