Executive Summary

NDRA delivered a materially improved cost profile: Q1 2025 operating expenses fell ~47% YoY to $1.47M, driving net loss improvement to $(1.04)M vs $(2.78)M in Q1 2024, aided by a warrant liability fair value gain and prior cost reductions .
EPS beat a thinly covered consensus: GAAP EPS of $(1.86) vs S&P Global consensus of $(3.91); revenue remained $0, in line with consensus $0.0, consistent with pre-commercial status . Estimates based on 1 covering analyst, so results should be interpreted with caution.*
Strategic pivot to metabolic disease and GLP-1 ecosystems continued: management emphasized a “blood pressure cuff for the liver,” AI-enabled next-gen TAEUS, a subscription model, and a revised De Novo FDA path anchored by a ~250-subject pivotal trial .
Liquidity: Cash and equivalents were $2.06M at 3/31/25; post-quarter ATM proceeds of $0.8M brought cash to $2.5M as of 4/30/25, extending runway as OpEx declines .
Near-term stock catalysts: clarity on pivotal study design/timing, incremental pilot data vs MRI-PDFF, and financing runway updates; management has signaled periodic calls tied to major events rather than routine quarterly calls .

What Went Well and What Went Wrong

What Went Well

Cost structure reset: Total OpEx fell to $1.47M (Q1 2025) from $2.78M (Q1 2024), reflecting restructuring and lower G&A/R&D, improving quarterly net loss to $(1.04)M from $(2.78)M .
Strategic focus and product roadmap: Management reiterated a pivot to metabolic disease workflows (GLP-1 ecosystem), AI-powered enhancements, integrated thermoacoustic/ultrasound, and compact, lower-cost design to drive adoption and scalability .
Regulatory path clarified: Company moved from retrospective data to a hypothesis-driven, statistically powered, multicenter pivotal (~250 subjects), with ongoing pilot data (100+ subjects to date) vs MRI-PDFF to optimize device and trial design .

Management quote: “Our TAEUS technology has the potential to shift the paradigm—providing earlier detection, broader access and enabling more personalized management of disease through accurate and inexpensive assessment of liver fat…” — Alexander Tokman, CEO .

What Went Wrong

Pre-revenue status persists: No product revenue; reliance on financing and cost control to extend runway; cash at quarter-end was $2.06M before $0.8M ATM proceeds in April .
Limited estimate coverage: Only one analyst contributed to Q1 estimates, reducing the signaling value of the EPS beat [GetEstimates Q1 2025].
Execution risk in regulatory pivot: Successful De Novo depends on pivotal study design/quality and FDA alignment; management notes dependence on additional capital and regulatory approvals as key risks .

Financial Results

YoY income statement comparison (Q1 2024 → Q1 2025)

Metric	Q1 2024	Q1 2025
Research & Development ($)	$1,041,526	$528,685
Sales & Marketing ($)	$238,660	$68,991
General & Administrative ($)	$1,500,355	$871,606
Total Operating Expenses ($)	$2,780,541	$1,469,282
Operating Loss ($)	$(2,780,541)	$(1,469,282)
Other Income (Expense), net ($)	$4,841	$432,952 (incl. warrant FV gain)
Net Loss ($)	$(2,775,700)	$(1,036,330)
GAAP EPS ($)	$(449.58)	$(1.86)
Weighted Avg Shares	6,174	557,582

Notes: EPS comparability is affected by changes in share count (reverse split effects evident in the YoY share base) .

Sequential trend snapshot (Q3 2024 → Q4 2024 → Q1 2025)

Metric	Q3 2024	Q4 2024	Q1 2025
Total Operating Expenses ($)	$1,509,014	$4,300,000 (one-time charges)	$1,469,282
Net Loss ($)	$(2,354,090)	$(4,200,000)	$(1,036,330)
Cash used in ops (monthly)	—	~$0.5M/mo (Q4 2024)	—

Q4 2024 OpEx includes a $2.3M non-cash inventory valuation charge; Q4 also benefited YoY from a $1.0M non-cash reversal in 2023, inflating YoY change .

Liquidity

Metric	Q3 2024	Q4 2024	Q1 2025
Cash & Equivalents ($)	$4,745,187	$3,229,480	$2,064,874
Cash post-ATM ($)	—	—	$2,500,000 as of 4/30/25

EPS vs Estimates (S&P Global)

Metric	Q1 2025 Actual	Q1 2025 Consensus	Surprise
GAAP EPS ($)	$(1.86)	$(3.91)*	+$2.05 (beat)
Revenue ($)	$0 [context: no revenue reported]	$0.0*	In line

Estimates marked * retrieved from S&P Global. Source: S&P Global consensus via GetEstimates (1 estimate).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash used in operations (monthly)	Q4 2024 vs Q2–Q3 2025	~$0.5M/mo in Q4 2024	~$.35M/mo expected in Q2–Q3 2025	Lowered burn rate
Pivotal study design	2025+	Retrospective/limited-subject approach	Prospective, multicenter pivotal; ~250 subjects	Revised/expanded
Commercial model	Launch model	—	Subscription-based monthly access (no upfront capex)	New model

No revenue, margin, or tax-rate guidance provided in Q1 materials .

Earnings Call Themes & Trends

Management has indicated periodic update calls tied to major events; no Q1 2025 earnings call transcript was furnished. Future calls are expected around regulatory/clinical/commercial milestones .

Topic	Q3 2024 (prior-2)	Q4 2024 (prior-1)	Q1 2025 (current)	Trend
AI/technology enhancements	Introduced AI/ML/DL data analysis features to improve accuracy and ease-of-use	Continued development to enhance accuracy/usability	Next-gen TAEUS to include AI to boost diagnostic accuracy	Building capability
Regulatory path	Accelerating pilot enrollment; preparing for De Novo	Pivot to prospective, multicenter pivotal; pre-sub FDA engagement	Hypothesis-driven pivotal (~250 subjects) confirmed; >100 pilot subjects scanned vs MRI-PDFF	Greater rigor and scale
Cost structure/cash burn	Annualized savings; OpEx down 52% YoY; cash $4.7M	Burn ~$0.5M/mo Q4; target ~$0.35M/mo in Q2–Q3’25	Q1 burn $1.2M; OpEx $1.47M	Improving efficiency
Market strategy (GLP-1 ecosystem)	Focused go-to-market workstreams	Announced enhanced strategy for GLP-1-related metabolic markets	Reinforced “blood pressure cuff for the liver”; four customer segments	Clearer positioning
IP portfolio	82 issued patents globally	—	84 issued patents globally (including 2 in China)	Expanding assets
Clinical evidence	~40 subjects in prior 2 months; LMU site activated	>110 subjects scanned across sites	>100 subjects assessed vs MRI-PDFF; ongoing pilot informs pivotal	Growing dataset

Management Commentary

“Obesity, type 2 diabetes and other metabolic diseases…adding in excess of $800 billion annually to U.S. healthcare costs…Our TAEUS technology has the potential to shift the paradigm…” — Alexander Tokman, CEO .
On market approach: four priority segments include pharma/CROs for GLP-1 trials, concierge practices, bariatric/metabolic/endocrinology clinics, and primary care .
On regulatory strategy: moving to a statistically powered, hypothesis-driven, multicenter pivotal (~250 subjects) to support a De Novo submission; pilot data are informing design and device optimization .

Q&A Highlights

No Q1 2025 earnings call transcript was furnished; management previously indicated it will hold periodic update calls catalyzed by major regulatory/clinical/commercial developments .
Any clarifications on guidance and timelines were conveyed through press releases (subscription model, pivotal design, burn-rate objectives) .

Estimates Context

EPS: Actual $(1.86) vs S&P Global consensus $(3.91), a beat of $2.05; coverage is limited (1 estimate), so the surprise signal is less robust.
Revenue: $0 vs $0.0* consensus; pre-commercial trajectory remains intact.*
Implications: Given the cost controls and burn trajectory, estimate revisions (where they exist) are more likely on OpEx/cash usage than revenue/EPS near-term; milestone-driven updates (pivotal trial design/start, pilot dataset maturation, financing) could drive estimate dispersion.

Estimates marked * retrieved from S&P Global. Source: S&P Global consensus via GetEstimates (Q1 2025).

Key Takeaways for Investors

Cost discipline is the near-term lever: OpEx down to $1.47M with Q1 burn of $1.2M; cash $2.06M at quarter-end and $2.5M at April 30 following ATM—monitor financing cadence vs planned pivotal trial ramp .
Strategy tightens around GLP-1-enabled metabolic care pathways, with AI-enabled next-gen TAEUS and a low-friction subscription model—commercial model should reduce adoption barriers in primary care and clinical research settings .
Regulatory clarity rising but execution risk remains: the shift to a ~250-subject, multicenter pivotal strengthens the De Novo case but requires capital, site execution, and continued alignment with FDA .
EPS “beat” vs a single estimate underscores improved expense control; with no revenue, valuation sensitivity hinges on regulatory/clinical milestones and liquidity runway rather than near-term P&L growth [GetEstimates].
Watch for: (1) pivotal trial protocol specifics/timelines; (2) additional MRI-PDFF-correlated pilot data; (3) financing updates and cash burn vs target ~$0.35M/mo in Q2–Q3 2025; (4) early customer pilots under the subscription model .

ENDRA Life Sciences Inc. (NDRA)·Q1 2025 Earnings Summary