Executive Summary

Q2 2025 was operationally focused on FDA engagement for CNM-Au8 in ALS and MS, while financials reflected minimal revenue and increased non-cash other expense; the company reiterated plans to submit an ALS NDA by end-2025 and extended cash runway into Q1 2026 .
EPS missed Wall Street consensus: actual EPS was -$0.78 vs consensus of -$0.47*, and revenue was $0.03M vs $0.06M*, driven by negligible product sales and higher non-cash losses in warrant/derivative liabilities; consensus coverage had six estimates* (EPS), (Revenue), [GetEstimates Q2 2025]*.
Cost discipline continued: R&D fell 16% YoY and G&A fell 28% YoY, reflecting personnel reductions and lower legal/IP and stock-based compensation expenses .
Financing actions in August amended December 2024 converts (maturity extended to Feb 13, 2027; interest PIK; principal start postponed) and added $1.5M senior secured converts to bolster liquidity, supporting the runway extension .
Near-term stock catalysts: Type C FDA meeting on ALS survival (Q3), NfL biomarker analysis (early Q4), Type B end-of-Phase 2 for MS (Q3), and NDA submission timing by end-2025 .

What Went Well and What Went Wrong

What Went Well

Extended liquidity runway: cash and equivalents of $7.3M at quarter-end plus $1.9M equity and $1.5M convert post-quarter provide runway into Q1 2026 .
Regulatory momentum: constructive FDA Type C feedback on NfL analysis; second Type C planned to review survival benefit; Type B end-of-Phase 2 MS meeting scheduled for Q3 .
Cost controls: R&D fell to $3.5M (from $4.2M YoY) and G&A fell to $2.4M (from $3.3M YoY) due to personnel cost savings and lower stock comp and legal/IP spend .
- Management quote: “These meetings and biomarker analyses represent the final steps to our potential submission of an NDA under the accelerated approval pathway for ALS by the end of 2025.” — Rob Etherington, CEO .

What Went Wrong

Estimates miss: EPS -$0.78 vs -$0.47* consensus; revenue $0.03M vs $0.06M*, reflecting negligible product royalty streams; non-cash losses in derivative and warrant liabilities pressured other income/expense [GetEstimates Q2 2025]*.
YoY net loss widened to -$7.4M vs -$6.8M due to negative other income/expense, despite lower operating expenses .
Listing risk persisted from Q1: Nasdaq MVLS deficiency notice with a 180-day window to regain compliance by November 3, 2025 (contextual headwind) .

Financial Results

Metric	Q2 2024	Q1 2025	Q2 2025
Total Revenue ($USD Thousands)	$91	$81	$27
Product Revenue ($USD Thousands)	$64	$64	$1
Royalty Revenue ($USD Thousands)	$27	$17	$26
R&D Expense ($USD Thousands)	$4,150	$1,481	$3,514
G&A Expense ($USD Thousands)	$3,314	$2,656	$2,377
Loss from Operations ($USD Thousands)	$(7,391)	$(4,076)	$(5,864)
Other Income (Expense), net ($USD Thousands)	$606	$3,325	$(1,555)
Net Loss ($USD Thousands)	$(6,785)	$(751)	$(7,419)
EPS (Basic & Diluted) ($USD)	$(1.06)	$(0.09)	$(0.78)

Segment/revenue breakdown:

Revenue Breakdown	Q2 2024	Q1 2025	Q2 2025
Product ($USD Thousands)	$64	$64	$1
Royalty ($USD Thousands)	$27	$17	$26
Total ($USD Thousands)	$91	$81	$27

KPIs and balance sheet items:

KPI	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Cash Equivalents ($USD Thousands)	$12,155	$9,832	$7,285
Convertible Notes Payable (non-current, $USD Thousands)	$10,816	$10,970	$11,134
Common Stock Warrant Liabilities ($USD Thousands)	$4,541	$2,031	$2,546
Derivative Liabilities ($USD Thousands)	$1,804	$657	$1,096
Weighted Avg Shares (Basic & Diluted)	6,423,182	8,824,673	9,523,592

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through	Into Q3 2025	Into Q1 2026	Raised
ALS NDA Submission Timing	Q4 2025	Q4 2025 (planned)	By end-2025 (planned)	Maintained
ALS NfL Biomarker Analysis Timing	Timing	Q3 2025 (planned)	Early Q4 2025	Pushed later
ALS Type C Meeting (Survival Benefit)	Q3 2025	Not specified prior	Scheduled Q3 2025	New/Specified
MS Type B End-of-Phase 2 Meeting	Q3 2025	Planned Q3 2025	Scheduled Q3 2025	Maintained
Debt Facility/Convert Terms	Ongoing	$10M converts (Dec 2024)	Dec 2024 notes amended (maturity to Feb 13, 2027; principal start to Sep 13, 2026; interest PIK; optional equity conversion) and added $1.5M senior secured converts (12% PIK)	Liquidity enhanced

Earnings Call Themes & Trends

Transcript not found in available filings; themes below reflect disclosures across quarters.

Topic	Previous Mentions (Q4 FY 2024, Q1 2025)	Current Period (Q2 2025)	Trend
ALS FDA Pathway (Accelerated Approval)	FDA guidance on NfL surplus data; NDA planned in H2’25	Type C feedback on NfL SAP; second Type C on survival; NDA by end-2025	Continued progress
ALS Survival Benefit (HEALEY Platform)	New analyses: RMST +4.1 months; subgroup HR 0.556	Survival benefit to be reviewed in Q3 Type C meeting	From analysis to regulatory review
NfL Biomarker	Q3 analysis planned (NIH EAP)	Early Q4 analysis planned	Slight timing shift later
MS Program	Phase 2 VISIONARY-MS open-label extension improvements; end-of-Phase 2 planned Q3	End-of-Phase 2 Type B meeting scheduled Q3	Milestone scheduled
Liquidity/Financing	$10M debt facility replacing Avenue; cash $12.2M YE’24	Runway into Q1 2026; converts amended; +$1.5M new converts; +$1.9M equity	Improved runway

Management Commentary

“We look forward to engaging with the FDA in our upcoming meeting this quarter focused on the extensive survival data that CNM-Au8 has generated in ALS patients…final steps to our potential submission of an NDA under the accelerated approval pathway for ALS by the end of 2025.” — Rob Etherington, President & CEO .
“Cash and cash equivalents of $7.3 million as of June 30, 2025, together with $1.9 million raised in equity and a $1.5 million increase in its convertible debt facility subsequent to June 30, 2025, provides cash runway into the first quarter of 2026.” — Company statement .

Q&A Highlights

No Q2 2025 earnings call transcript was available in the document catalog or public sources searched. We searched for “earnings-call-transcript” filings and external investor pages and found none specific to CLNN’s Q2 call content [ListDocuments: earnings-call-transcript none] .

Estimates Context

Metric	Consensus (Q2 2025)	Actual (Q2 2025)	Delta vs Consensus
Primary EPS Consensus Mean	-$0.47*	-$0.78	-$0.31
Revenue Consensus Mean ($USD)	$0.06M*	$0.03M	-$0.03M
Primary EPS – # of Estimates	6*	—	—
Revenue – # of Estimates	6*	—	—

Values marked with an asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

Liquidity runway extended to Q1 2026 via equity and convert actions; monitoring additional financing options prudent given tiny revenue base .
Regulatory catalysts are near-term: Type C (ALS survival) in Q3, NfL biomarker analysis early Q4, Type B (MS) in Q3, and targeted NDA submission by end-2025; outcomes will likely drive stock reaction .
Financial profile remains R&D-driven with minimal revenue; expect continued sensitivity of reported EPS to non-cash fair value changes in derivatives/warrants .
EPS and revenue missed consensus this quarter; absent commercial revenue, estimate revisions may hinge on regulatory clarity and trial execution milestones rather than near-term sales trends [GetEstimates Q2 2025]*.
Debt amendments (maturity extension, PIK interest, delayed principal start) reduce near-term cash obligations and offer optionality (equity conversion), but increase leverage/new dilutive overhang risk .
Maintain focus on confirmatory RESTORE-ALS Phase 3 startup and design, as it underpins the accelerated approval framework and long-term commercial viability .
Nasdaq listing compliance from Q1 notice remains a background risk factor until MVLS is restored; corporate actions or catalysts may be needed to resolve this by the deadline .

Sources: Q2 2025 8-K and exhibit press release ; Q2 2025 standalone press release ; Q1 2025 8-K press release ; FY 2024 press release ; S&P Global consensus via GetEstimates (Q2 2025)*; Clene investor site and GlobeNewswire press release confirmations .

Clene Inc. (CLNN)·Q2 2025 Earnings Summary