Executive Summary

Q4 2024 focused on regulatory execution and cost containment: cash used in operations declined to $1.5M in Q4 vs $2.2M in Q4 2023, while year-end cash was $3.2M .
Reported Q4 operating expenses rose to $4.3M vs $1.5M YoY due to a $2.3M non-cash inventory valuation charge; net loss was $4.2M vs $1.5M YoY, with management emphasizing underlying improvement excluding one-time items .
S&P Global consensus EPS for Q4 2024 was -$4.10*, while S&P’s actual EPS registered +$25.2*; NDRA’s press release did not disclose quarterly EPS and cited one-time non-cash items—investors should treat the S&P EPS figure with caution given share count and warrant accounting impacts (Values retrieved from S&P Global).
Strategic pivot: management announced an expanded TAEUS biomarker strategy targeting GLP-1-related metabolic care settings, AI-enabled features, integrated device design, and a subscription model; pivotal De Novo trial plan (~250 subjects) and >110 subject scans across sites support regulatory readiness .
Corporate event: NDRA regained compliance with Nasdaq minimum bid price in November 2024, removing a listing overhang and enabling focus on execution .

What Went Well and What Went Wrong

What Went Well

Accelerated clinical data collection with >110 subjects scanned across LMU Munich and Ann Arbor sites; ~20% of new data from S2/S3 steatosis improves design optimization and pivotal trial planning .
Cost discipline: average cash used in operations down to ~$0.5M/month in Q4, and expected to reach ~$0.35M/month in Q2–Q3 2025, preserving runway while advancing TAEUS .
Clear regulatory path: shift to a prospective, multicenter, statistically powered pivotal trial (~250 subjects) pre-vetted with FDA; pilot sites initiated and alignment confirmed via prior engagements .

What Went Wrong

Q4 operating expenses spiked to $4.3M on a $2.3M non-cash inventory valuation charge tied to strategic realignment; net loss widened to $4.2M vs $1.5M YoY .
Prior-year comparison benefitted from a $1.0M non-cash bonus reversal gain, making Q4 2023 artificially low—complicates YoY optics .
Warrants and capital structure volatility were a focus in 2H 2024; Q3 included a net non-cash warrant charge of $0.911M, and earlier financing dynamics created complexity for EPS comparability .

Financial Results

Metric	Q2 2024	Q3 2024	Q4 2024
Operating Expenses ($USD Millions)	$2.231	$1.509	$4.300
Net Loss ($USD Millions)	$2.229	$2.354	$4.200
Diluted EPS ($USD)	$(0.08)	$(9.54)	Not disclosed in press release
Cash and Equivalents (Period-end, $USD Millions)	$6.401 (as of 6/30/24)	$4.745 (as of 9/30/24)	$3.229 (as of 12/31/24)
Cash Used in Operations (Quarter)	Not disclosed	Not disclosed	$1.500

Notes:

NDRA did not disclose quarterly revenue; statements of operations show operating expenses and net loss without revenue lines .
Q4 EPS not provided in the press release; S&P Global reported EPS actual and estimates separately (see Estimates Context).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash used in operations (avg/month)	Q4 2024 actual	N/A	~$0.50M/month in Q4 2024	N/A (reported actual)
Cash used in operations (avg/month)	Q2–Q3 2025	N/A	~$0.35M/month expected	New outlook (lower burn)
Regulatory submission timing	Mid-2025 target	No specific prior date	Goal to submit De Novo by mid-2025 (per Q2 call)	New timeline clarity
Pivotal trial design	Pivotal multicenter ~250 subjects	Prior approach relied on retrospective data	Prospective, multicenter, statistically powered; design vetted with FDA	Strategy revised (enhanced rigor)
Go-to-market focus	Metabolic care incl. GLP-1	Prior emphasis on hepatology/radiology	Expanded target segments and subscription model	Strategic pivot

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024 Call)	Previous Mentions (Q3 2024 PR)	Current Period (Q4 2024 8-K/PR)	Trend
Regulatory strategy	Prospective pivotal trial; FDA pre-submission; mid-2025 submission goal	Continued pilot data collection to inform pivotal; cost reductions	Revised De Novo approach; multicenter pivotal ~250 subjects; >110 scans	Execution advancing; design clarity increasing
AI/technology initiatives	Patent growth; platform potential	AI/ML/DL features under development	AI features planned to improve accuracy; integration of thermoacoustic + ultrasound	Scope expanding; productization focus
Go-to-market focus	Building evidence; Europe/U.S. sites; disciplined expansion	Refocusing resources; activating LMU; IP expansion	Pivot to GLP-1-related metabolic markets; subscription model; primary care focus	Strategic redirection toward broader TAM
Cost structure / cash burn	Raised capital; runway into 1H 2025	Operating expenses down 52% YoY; restructuring savings	Q4 cash used ops down to $1.5M; outlook ~$0.35M/month (Q2–Q3 2025)	Improving cash efficiency
Clinical data	Early pilot sites; alignment on design	LMU site active; recruiting; industry meeting poster accepted	>110 subjects scanned; broadened disease-state coverage; pivotal prep	Data depth and breadth improving

Management Commentary

“We are laser focused on securing the clinical data necessary to support a new De Novo regulatory filing with the FDA - above all other initiatives...” — Alexander Tokman, acting CEO (Q3 press release) .
“We are switching from the use of retrospective data to a hypothesis-driven, statistically-powered prospective clinical trial, which is pre-vetted through FDA.” — Alexander Tokman (Q2 2024 call) .
“SLD...affects over two billion people globally...there is an unmet need for a cost-effective, simple-to-use and accurate point-of-care test...We believe our TAEUS technology is uniquely positioned to fill this gap...” — Alexander Tokman (strategy press release) .

Q&A Highlights

Timeline clarification: Management targeted completing clinical work and submitting De Novo by mid-2025; emphasized sequential pilot-to-pivotal pathway and FDA engagement .
Strategic implementation pace: Management outlined 6 operational changes and expected improved execution over 6–12 months; reiterated focus on clinical data and commercialization roadmap .
Geographic focus: Prioritized disciplined commercialization first in Europe and the U.S., with Asia considered subsequently via existing anchors (Vietnam distributor, Shanghai General Hospital) .

Estimates Context

S&P Global consensus EPS:
- Q4 2024: -$4.10* vs actual +$25.2*; Q3 2024: -$62.30* vs actual -$9.54; Q2 2024: -$122.50* vs actual -$0.08. Number of EPS estimates: 1 for each period.*
S&P Global consensus revenue:
- Q2–Q4 2024 and FY 2024: $0.00* with 1 estimate each.*
Caution: NDRA’s press materials did not disclose quarterly EPS for Q4 and highlighted one-time non-cash items; the S&P EPS figures likely reflect complex share/warrant accounting and should be interpreted prudently (Values retrieved from S&P Global).

Metric	Q2 2024	Q3 2024	Q4 2024	FY 2024
EPS Consensus Mean ($)	-122.50*	-62.30*	-4.10*	-47.46*
EPS Actual ($)	-0.08	-9.54	+25.2*	-56.94 (annual)
EPS - # of Estimates	1*	1*	1*	1*
Revenue Consensus Mean ($)	0.00*	0.00*	0.00*	0.00*
Revenue - # of Estimates	1*	1*	1*	1*

*Values retrieved from S&P Global.

Key Takeaways for Investors

Regulatory pathway is clearer and more rigorous (prospective, multicenter pivotal, ~250 subjects), increasing the likelihood of a successful De Novo outcome if data support endpoints .
Cash efficiency is improving materially; Q4 cash used ops at $1.5M with roadmap to ~$0.35M/month, reducing financing urgency while executing clinical/regulatory priorities .
Strategic pivot toward metabolic care and GLP-1 patient management broadens TAM and aligns TAEUS with fast-growing therapeutic categories; device integration and AI features should enhance usability and adoption .
One-time non-cash charges (inventory valuation) distorted Q4 optics; underlying operating trajectory appears improved when excluding these items, but continued discipline is needed .
Nasdaq compliance regained in November 2024 removes listing risk and allows focus on catalysts like clinical data milestones and FDA engagement .
Near-term trading: headline-driven moves likely around pivotal trial design finalization, additional site activations, and data readouts; watch for updates on De Novo timing and monthly cash-burn trajectory .
Medium-term thesis: if TAEUS validates clinically versus MRI-PDFF and delivers point-of-care economics, subscription model in primary care/metabolic clinics could drive adoption; regulatory success is the gating factor .

Appendix: KPIs and Operational Metrics

KPI	Q2 2024	Q3 2024	Q4 2024
Subjects scanned (cumulative at pilot sites)	25 (through refocused program)	~40 enrolled in past two months, LMU site activated	>110 total scans across LMU + Ann Arbor; ~20% S2/S3
Patents issued (global)	81	82	Not updated in Q4 PR
Cash used in operations (avg/month)	Not disclosed	Not disclosed	~$0.50M/month
Planned pivotal trial size	Prospective; expanding from ~20 to ~250 subjects	Informing pivotal via pilots	~250 subjects; multicenter; pre-submission FDA alignment

Source Documents Read

Q4 2024 8-K with Exhibits 99.1 (financial results) and 99.2 (strategy update) .
Q4-related press releases: Nasdaq compliance (Nov 22, 2024) ; AASLD poster acceptance (Nov 12, 2024) .
Prior quarters: Q3 2024 8-K and press release ; Q2 2024 press release; Q2 earnings call transcript .

Note: No Q4 2024 earnings call transcript was found during document search—management indicated a move to periodic business update calls catalyzed by major events .

ENDRA Life Sciences Inc. (NDRA)·Q4 2024 Earnings Summary