ENDRA Life Sciences Inc. (NDRA)·Q3 2024 Earnings Summary

Executive Summary

• Q3 2024 execution was focused on regulatory and clinical milestones with accelerated pilot enrollment (~40 subjects over the past two months), activation of LMU University Hospital in Germany, and development of AI/ML/DL data-analysis features for TAEUS; operating expenses fell 52% YoY to $1.5M and 32% QoQ, reflecting restructuring and non-recurring items .
• Net loss was $2.4M vs. $3.1M YoY and $2.2M QoQ; Q3 included a net non-cash warrant-related charge of $0.911M; cash and equivalents were $4.7M at quarter-end .
• Management reiterated focus on preparing a De Novo submission; prior commentary targeted mid-2025 for filing following pilot and pivotal studies; Q3 emphasized clinical data collection and cost discipline to extend runway .
• Potential stock-reaction catalysts: clinical data disclosures (e.g., AASLD poster on high-BMI patients), progress toward pivotal study design, and listing stability following Nasdaq compliance regained on Nov 21, 2024 .

What Went Well and What Went Wrong

What Went Well

• Accelerated subject recruitment with nearly 40 subjects enrolled/scanned over the past two months; additional sites may activate; real-world evidence to inform pivotal study and De Novo submission .
• Operating expenses down 52% YoY to $1.5M and down 32% QoQ, driven primarily by G&A reductions and non-recurring items; realized $3.1M in annualized savings from restructuring .
• Management highlighted a refined go-to-market strategy and new AI/ML/DL features to improve data accuracy and operator ease-of-use on TAEUS; quote: “We are laser focused on securing the clinical data necessary to support a new De Novo regulatory filing…while significantly reducing operating expenses to extend our cash runway” — Alexander Tokman, Acting CEO .

What Went Wrong

• Continued pre-revenue profile and ongoing net losses; Q3 net loss was $2.4M, including a $0.911M non-cash warrant-related charge from the last financing .
• Sequential cash decline to $4.7M from $6.4M (Q2), reflecting operations and restructuring, despite prior capital raise; runway management remains critical .
• No Q3 earnings call transcript; management intends to hold periodic update calls tied to major events, limiting immediate investor Q&A in the quarter .

Financial Results

Notes:

• Management reported OpEx declines vs. prior year (52%) and prior quarter (32%) .
• Q3 included warrant-related non-cash items (net charge $0.911M) affecting net loss .
• Share count/ EPS comparability reflects reverse split dynamics, evidenced by outsized EPS in Q3 vs. prior quarters .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are laser focused on securing the clinical data necessary to support a new De Novo regulatory filing with the FDA… while significantly reducing operating expenses to extend our cash runway.” — Alexander Tokman, Acting CEO .
• “During the past two months, nearly 40 subjects were enrolled and scanned… findings from these pilot studies will be used to inform a pivotal study… [for] De Novo request to the FDA.” .
• “We will fundamentally change our FDA regulatory strategy… switching from retrospective data to a hypothesis-driven, statistically-powered prospective clinical trial, pre-vetted through FDA.” — Ziad Rouag, Head of Regulatory and Clinical Affairs (Q2 call) .
• “Based on our current projections, our cash runway funds the company into the first half of 2025.” — Richard Jacroux, CFO (Q2 call) .

Q&A Highlights

• Timeline to FDA submission: Management reiterated plan to complete pilot study, initiate pivotal early next year, and target De Novo submission by mid-2025 .
• Strategic path implementation: Over 9–12 months, execute clinical program, finalize regulatory submission, and develop longer-term metabolic biomarker strategy; licensing optionality noted .
• Beachhead market focus: Hepatology may not be the primary entry point; emphasis on primary care and broader segments in go-to-market recalibration .
• Note: No Q3 earnings call; management plans periodic business update calls aligned with major events .

Estimates Context

• Wall Street consensus via S&P Global for NDRA’s Q3 2024 EPS and revenue was unavailable due to limited coverage; no sell-side estimates found to compare against reported results [GetEstimates errors; see tool response].
• Implication: Estimate-driven “beat/miss” framing is not applicable; investor focus should remain on operating expense trajectory, cash runway, regulatory milestones, and clinical data cadence .

KPIs and Operating Execution

Key Takeaways for Investors

• Cost discipline is taking hold: OpEx down 52% YoY and 32% QoQ; restructuring delivered ~$3.1M annualized savings; this is the primary lever extending runway into 2025 .
• Regulatory path is clearer: Pilot data gathering accelerated; multi-center pivotal study to underpin De Novo submission remains the core 2025 catalyst .
• Technology differentiation: AI/ML/DL features aim to improve measurement accuracy and operator usability — important for adoption in primary care settings .
• Clinical evidence broadening: High-BMI patient data at AASLD highlights TAEUS performance in challenging cases, supporting clinical utility claims .
• Liquidity and listing risk mitigated: Post-offering cash raised (Q2) and regained Nasdaq minimum bid compliance (Nov 21) reduce downside operational/listing risks near-term .
• Execution watchpoints: Monitor subject enrollment pace, pivotal study initiation timing, and any FDA feedback; delays could pressure the runway and thesis .
• Trading implications: Near-term moves likely tied to clinical/regulatory disclosures and communications cadence; absence of revenue/coverage reduces estimate-driven volatility, shifting focus to milestone timing and listing stability .

Cross-References and Disclosures

• Q3 press release with financial tables: operating expenses, net loss, warrant charges, cash balance .
• Q3 8-K Item 2.02 (press release furnished): narrative and highlights .
• Other Q3 press release: AASLD high-BMI poster acceptance and details .
• Prior quarters: Q2 press release and 8-K including transcript and financial tables; cash raise and runway commentary .
• Q1 press release and 8-K: pre-sub FDA process, King’s College installation, and financial tables .
• Nasdaq compliance press release (Nov 22, 2024) .

Bolded beats/misses are not included due to lack of sell-side consensus coverage via S&P Global for EPS and revenue in Q3 2024; estimates unavailable.