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EL

ENDRA Life Sciences Inc. (NDRA)·Q2 2025 Earnings Summary

Executive Summary

  • Pre-revenue quarter with narrowed losses: Q2 2025 net loss was $1.23M vs $2.23M in Q2 2024 as operating expenses fell 42% YoY to $1.30M, reflecting headcount and overhead reductions . Cash was $1.81M at 6/30/25 .
  • EPS beat: Diluted EPS of $(1.71) vs S&P Global consensus of $(2.27) as cost controls and modest other income (warrant liability revaluation) aided results; revenue was in line at $0.00* .
  • Regulatory path clarified: Company advanced De Novo plan for TAEUS Liver, adding a short validation study and FDA vetting of a ~250-subject pivotal trial design; aims to launch pivotal by year-end 2025 .
  • Product/tech progress: Redesigned TAEUS Liver probe and algorithms showed order-of-magnitude improvement vs MRI-PDFF in early testing; IP portfolio expanded to 85 issued patents .
  • Near-term catalysts: FDA feedback on trial design, initiation of pivotal study by year-end, and additional validation data; cost trajectory supports run-rate burn around ~$0.35–$0.37M per month (Q2 actual ~$1.1M burn) .

What Went Well and What Went Wrong

What Went Well

  • Material cost discipline: Operating expenses down 42% YoY to $1.30M; Q2 operating cash burn improved to $1.1M from $2.1M in Q2 2024 .
  • Technical performance: “Initial testing of the new design on a small patient population demonstrated an order-of-magnitude improvement in performance against the gold standard MRI-PDFF” .
  • Regulatory planning: Company “intends to conduct a hypothesis-driven, statistically powered prospective multisite clinical trial enrolling approximately 250 subjects…[and] expects…pivotal study by year-end,” with FDA vetting of design and endpoints .

What Went Wrong

  • Still pre-revenue: “We expect no revenue for the quarter ended June 30, 2025 and did not have revenue for the quarter ended June 30, 2024” .
  • Cash declined: Cash and equivalents fell to $1.81M at 6/30/25 from $2.06M at 3/31/25 as the company continues to fund development .
  • Dependence on financing/regulatory milestones: The 8-K notes capital needs and regulatory timing risks in forward-looking statements and in connection with the S-1 filing .

Financial Results

MetricQ2 2024Q1 2025Q2 2025Q2 2025 Consensus
Revenue ($)$0 N/A$0 $0.0*
Operating Expenses ($)$2,230,853 $1,469,282 $1,301,090 N/A
Operating Loss ($)$(2,230,853) $(1,469,282) $(1,301,090) N/A
Net Loss ($)$(2,229,153) $(1,036,330) $(1,225,912) N/A
Diluted EPS ($)$(0.08) $(1.86) $(1.71) $(2.27)*
Cash & Equivalents ($)N/A$2,064,874 $1,808,574 N/A
Weighted Avg Shares15,590 557,582 717,107 N/A

Notes: Margins are not meaningful due to zero revenue in the comparable periods .
Values with asterisks (*) retrieved from S&P Global.

KPIs

KPIQ2 2024Q1 2025Q2 2025
Operating cash burn from operations ($)$2,100,000 $1,200,000 $1,100,000
Operating expenses YoY change (%)N/AN/A-42%
Change in fair value of warrant liability (Other income) ($)N/A$408,562 $62,112
Issued patents (cumulative)N/A84 85

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Pivotal study launch timing (TAEUS Liver)2025EPosition to commence pivotal clinical trial after FDA pre-sub engagement Pave way to launch pivotal study by year-end; conduct short validation study; FDA vet of endpoints/protocol Maintained timeline; added validation and FDA alignment
De Novo trial design2025EProspective multicenter trial, ~250 subjects Prospective multicenter trial, ~250 subjects; final design/sample size to be vetted with FDA Maintained; added FDA vetting detail
Operating cash burn run-rateQ2–Q3 2025Expected ~ $0.35M/month Q2 actual $1.1M for quarter ($0.37M/month) In line with prior expectation

No formal revenue or EPS guidance was provided in Q2 materials reviewed .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Regulatory pathway (De Novo)Shift to prospective, statistically powered multicenter trial; pre-sub FDA engagement Validation study to confirm endpoints; FDA vetting of design/sample size; aim to launch pivotal by year-end Clearer path, added pre-pivotal validation
AI/technology enhancementsPlan to add AI features; integrate thermoacoustic + ultrasound; improve ergonomics and cost Redesigned probe + algorithms show order-of-magnitude improvement vs MRI-PDFF in early testing Tangible performance gains emerging
Cost structure/cash burnCost cuts; guide to ~$0.35M/month in Q2–Q3 2025 Q2 opex -42% YoY; burn $1.1M ($0.37M/month) Run-rate tracking guidance
IP portfolio84 patents at Q1 85 patents; new US patent on probe tuning Gradual expansion
Market strategy (metabolic/GLP-1)Pivot to metabolic disease and GLP-1 adjacencies; subscription model Continued focus on metabolic disease use cases; validation to support broader adoption Consistent execution
Clinical evidence base>110 subjects across wider SLD states at Q4; >100 at Q1 Short controlled validation study commencing; leverages redesigned probe Building evidence quality

Management Commentary

  • “Our redesigned TAEUS probe represents a major advancement…The early data are extremely encouraging, and our ongoing validation study is an important step toward aligning with the FDA and beginning our pivotal trial later this year.” — CEO Alexander Tokman .
  • “Operating expenses decreased 42% to $1.2M compared with $2.2M in the prior-year period.” (Business update) .
  • “ENDRA intends to conduct a hypothesis-driven, statistically powered prospective multisite clinical trial enrolling approximately 250 subjects…The final trial design and sample size will be vetted with the FDA…pave the way for the launch of ENDRA’s pivotal study by year-end.” .
  • Strategic pivot rationale to metabolic disease/GLP-1 ecosystems and subscription-based model (Q4/Q1 announcements) .

Q&A Highlights

No Q2 2025 earnings call transcript was available in the document set we reviewed; no analyst Q&A highlights to report [ListDocuments: none for earnings-call-transcript 2025-06-01 to 2025-09-30].

Estimates Context

  • Q2 2025 EPS: $(1.71) vs consensus $(2.27); result represents a beat likely driven by lower operating expenses and modest other income from warrant liability revaluation .
  • Q2 2025 Revenue: $0.00 vs consensus $0.00 (in line)* .
    Values with asterisks (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Cost execution is working: opex down 42% YoY and cash burn ~$1.1M in Q2 set up continued EPS outperformance vs low expectations if discipline persists .
  • Regulatory clarity improved: validation study + FDA-vetted pivotal design de-risk path to De Novo, with a stated aim to launch pivotal by year-end 2025—key stock catalysts ahead .
  • Technology step-up: redesigned probe/algorithms show early order-of-magnitude improvement vs MRI-PDFF, which, if replicated in pivotal, could strengthen the commercial narrative .
  • Still pre-revenue; financing and regulatory timing remain the principal overhangs (noted in forward-looking statements and S-1 context) .
  • Cash of $1.81M at Q2-end underscores need for prudent burn and potential capital raises as clinical programs scale .
  • IP strengthening (85 patents) supports potential for platform/licensing optionality beyond liver fat measurement over time .
  • Near-term trading setup: watch for FDA feedback/meeting outcomes, validation readouts, and announcement of pivotal trial initiation; absent these, stock likely tracks financing headlines and burn trajectory .

Sourcing and cross-references: Q2 2025 8‑K with preliminary highlights ; Q2 press release with full financials and business update ; Q1 2025 press release/8‑K ; Q4 2024 8‑K and strategy updates . Values with asterisks are retrieved from S&P Global.