Clene Inc. (CLNN)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was operationally lean with materially lower OpEx; reported net loss improved to $0.8M ($0.09 per share) vs $11.1M ($1.73 per share) YoY, aided by non-cash gains in warrant and derivative liabilities and lower interest expense .
• Revenue was $0.081M, above S&P Global consensus of $0.061M; EPS beat consensus as reported by the company, reflecting lower operating spend and favorable other income; the company’s EPS (-$0.09) differs from S&P’s “Primary EPS actual” (-$0.50), likely classification differences — see Estimates Context *.
• Regulatory trajectory advanced: FDA SAP meeting in Q2, NfL biomarker analysis in Q3, and NDA submission targeted for Q4 2025 (narrowed from “H2 2025”), establishing clear near-term catalysts .
• Cash and equivalents were $9.8M (runway into Q3 2025); however, Nasdaq notified CLNN of non-compliance with the $35M MVLS standard, with a remediation window through Nov 3, 2025 — a notable overhang .

What Went Well and What Went Wrong

What Went Well

• OpEx reset: Research & development was $1.5M versus $5.9M YoY; G&A fell to $2.7M from $3.4M, helped by NIH EAP grant offsets and lower personnel/investor relations expenses .
• Non-cash tailwinds: $3.3M “other income” driven by changes in fair value of derivative and warrant liabilities and lower interest expense supported the large YoY improvement in net loss .
• Regulatory clarity and clinical momentum: management emphasized alignment with FDA for accelerated approval via NfL biomarker, and survival benefits from CNM-Au8 in HEALEY ALS analyses; “Prolonging survival for people living with ALS is the critical mission for Clene…” — Rob Etherington, CEO .

What Went Wrong

• Access to capital remains tight: cash of $9.8M funds operations into Q3 2025, increasing urgency to execute on regulatory path and financing options .
• Listing risk: Nasdaq MVLS deficiency notice; CLNN must regain ≥$35M MVLS for 10 consecutive business days by Nov 3, 2025, or face delisting proceedings .
• Revenues remain de minimis (product $64K, royalty $17K), reinforcing dependence on external funding and regulatory progress rather than commercial cash flows .

Financial Results

P&L and Cash vs prior quarters

Asterisk (*) indicates values retrieved from S&P Global.

Revenue breakdown

Key operating metrics

YoY highlights: Net loss improved from $(11.1)M in Q1 2024 to $(0.8)M in Q1 2025, and EPS from $(1.73) to $(0.09), driven by lower OpEx and non-cash gains .

Guidance Changes

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was found; company appears not to have published one around results timing. Reference: investor press page and SEC filings .

Management Commentary

• “Prolonging survival for people living with ALS is the critical mission for Clene… we are in active preparations to potentially submit an NDA under the Accelerated Approval pathway for ALS in the fourth quarter of 2025.” — Rob Etherington, President & CEO .
• “Clene has a scheduled meeting in the second quarter of 2025 with the FDA to finalize its SAP for CNM-Au8 NfL biomarker data… analysis will occur in the third quarter of 2025 to support the planned submission…” .
• Clinical evidence: HEALEY ALS cross-regimen analyses observed covariate‑adjusted RMST improvement of 4.1 months and a 44% mortality risk reduction in a more severe subgroup (baseline NfL >33 pg/mL; TRICALS risk –6.5 to –2.5) .

Q&A Highlights

• No Q1 2025 earnings call transcript was available; no formal Q&A could be analyzed. Reference investor pages for materials around results .

Estimates Context

Notes:

• S&P Global “Primary EPS actual” for Q1 2025 shows (0.4995), which differs from company-reported diluted EPS of (0.09); this likely reflects methodology/classification differences (e.g., normalization) — anchor comparisons on company EPS for reported results and use S&P for consensus benchmarking .
• Asterisk (*) indicates values retrieved from S&P Global.

Key Takeaways for Investors

• Execution on FDA roadmap is the central value driver: Q2 SAP meeting, Q3 NfL analysis, and Q4 2025 NDA submission create a defined catalyst path; successful biomarker concordance and acceptance are pivotal .
• Operative lean quarter: R&D and G&A reductions and favorable non-cash items produced a sharp YoY improvement; watch sustainability of lower OpEx vs upcoming Phase 3 RESTORE-ALS spend .
• Clinical signal persists: survival benefits in HEALEY analyses (RMST +4.1 months; subgroup HR 0.556) strengthen the case for accelerated approval and the RESTORE-ALS confirmatory design .
• Liquidity extended but still finite: $9.8M cash and runway into Q3 2025 reduces immediate pressure; additional capital may be needed ahead of confirmatory trial and NDA filing .
• Listing overhang: the MVLS deficiency notice introduces a distinct risk; corporate actions, progress on catalysts, or market re-rating will likely be needed to regain compliance .
• Trading implications: headline sensitivity around FDA interactions (SAP alignment, NfL analysis read‑out) and any NDA timing updates; watch for financing moves and potential volatility tied to listing compliance developments .

*Values retrieved from S&P Global.