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Glucotrack, Inc. (GCTK)·Q1 2025 Earnings Summary

Executive Summary

  • Pre-revenue quarter with widened loss driven primarily by non-cash fair value changes in warrant derivative liabilities; net loss was $6.83M and EPS was $(0.67) versus $(11.73) in Q1 2024 and $(0.91) in Q3 2024 .
  • Operating spend rose modestly (+18.6% YoY total opex), as G&A more than doubled, while R&D moderated; total operating expenses were $3.50M vs $2.95M in Q1 2024 .
  • Cash improved to $9.10M on March 31, 2025, supported by $6.40M of financing in Q1; management stated the 2025 operating plan is funded for trial initiation, but the 10-Q flags going-concern uncertainty and an estimated ~$15M cash need for the next 12 months if programs advance as planned .
  • Clinical/regulatory catalysts are central: ethics approval for the long-term Australia study (first implants expected July), participation in EU FORGETDIABETES artificial pancreas program, and IDE approval expected in Q4 2025; a shift from Q2 to Q3 2025 for first patient implants is a timing negative .

What Went Well and What Went Wrong

What Went Well

  • “I am pleased with the progress we made during the quarter and look forward to commencing our clinical study in Australia... well-differentiated, fully implantable, real-time, multi-year continuous blood glucose monitoring system,” said CEO Paul V. Goode, PhD .
  • Ethics approval received for the long-term Australian study; first implants expected by July, targeting up to 30 participants over one year with potential extension to three years .
  • Strategic collaborations and ecosystem positioning advanced: integration into FORGETDIABETES bionic pancreas initiative and AI/ML analytics collaboration with OneTwo Analytics to derive deeper clinical insights .

What Went Wrong

  • Net loss widened to $6.83M, primarily due to a $3.38M non-cash increase in derivative warrant liabilities and higher G&A; this overhang reflects complex financing structures from late 2024 .
  • Going-concern risk reiterated: company estimates ~$15.0M required over the next 12 months to fund operations if programs advance; ATM usage continued post-quarter .
  • Timeline slippage: first patient implants in Australia moved from “anticipated in Q2 2025” (prior guidance) to “anticipated in Q3 2025,” modestly delaying a key catalyst .

Financial Results

MetricQ1 2024Q3 2024Q1 2025
Revenue ($USD Millions)$0.0 $0.0 $0.0
Total Operating Expenses ($USD Millions)$2.951 $3.251 $3.498
Operating Loss ($USD Millions)$(2.951) $(3.251) $(3.498)
Net Loss ($USD Millions)$(2.927) $(5.087) $(6.833)
Diluted EPS ($USD)$(11.73) $(0.91) $(0.67)

Expense breakdown:

MetricQ1 2024Q3 2024Q1 2025
R&D ($USD Millions)$2.148 $2.063 $1.871
G&A ($USD Millions)$0.733 $1.063 $1.499
Selling & Marketing ($USD Millions)$0.070 $0.125 $0.128

Balance sheet snapshots:

MetricSep 30, 2024Dec 31, 2024Mar 31, 2025
Cash & Equivalents ($USD Millions)$0.346 $5.617 $9.100
Derivative Liabilities ($USD Millions)$0.037 $17.421 $0.177
Total Liabilities ($USD Millions)$4.848 $18.932 $2.354
Stockholders’ Equity ($USD Millions)$(4.022) $(13.000) $7.258
Total Assets ($USD Millions)$0.826 $5.932 $9.612

Cash flow KPIs:

MetricQ1 2024Q1 2025
Cash used in Operating Activities ($USD Millions)$(2.942) $(2.939)
Net Financing Proceeds ($USD Millions)$0.000 $6.395

Notes:

  • Company reported no revenues to date; margins (EBIT, net income margin) are not meaningful on zero revenue .
  • Q4 2024 quarterly P&L detail was not furnished; QoQ comparisons use Q3 2024 as the most recent reported quarter .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
First patient implants in Australia long-term study2025Q2 2025 anticipated Q3 2025 anticipated Lowered (timing delayed)
IDE approval (FDA) for long-term U.S. Pilot Study2025Q4 2025 anticipated Q4 2025 anticipated Maintained
Cash runway view2025/next 12 monthsSufficient to fund 2025 operating plan to initiate trials Not sufficient for at least next 12 months; ~$15M required if programs advance Lowered (more conservative liquidity stance)
Clinical data presentations2025Presenting at major conferences Presenting additional industry conferences Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was found in our corpus; themes below reflect filings and press releases.

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
AI/technology initiativesNo AI themes in Q3 2024 10-Q; focus on device development Collaboration with OneTwo Analytics to apply AI/ML to clinical data Emerging focus on analytics
Regulatory milestonesQ3: ISO certification underway; first-in-human planning Ethics approval in Australia; IDE expected Q4 2025 Progressing; timelines clarified
Product performanceQ4: first-in-human study completed; no serious adverse events Reinforced feasibility; planning long-term multicenter study Advancing clinical validation
Regional trendsQ3: planning OUS trials Australia long-term study initiation and TGA notification before enrollment OUS clinical execution
R&D executionQ3: multiple animal studies; preclinical progress R&D down modestly YoY; study readiness Transitioning to clinical
Macro/financingQ3: financing complexity incl. warrants and notes ATM usage; registered direct; going-concern disclosure Ongoing capital needs
Quality systemsQ3: ISO audit in process ISO 13485:2016 certification achieved Completed milestone

Management Commentary

  • “We remain focused on strengthening our capital structure and ensuring that we have the runway to bring our potentially life-improving technology to the millions of diabetes patients who need it most.” — Paul V. Goode, PhD, President & CEO .
  • “This technology shows great promise... The ability to directly measure glucose in blood rather than interstitial fluid could represent a significant advancement.” — Prof. David O’Neal (Principal Investigator), on Australia study .
  • “We are thrilled to be part of the groundbreaking FORGETDIABETES initiative... Integration into automated insulin delivery systems is a key priority.” — Paul V. Goode, PhD .
  • “We are excited to leverage [OneTwo’s] substantial analytics experience to identify, assess and quantify the potential long-term benefits of the CBGM technology.” — Paul V. Goode, PhD .

Q&A Highlights

  • No Q1 2025 earnings call transcript found; no Q&A available in our corpus to extract clarifications or tone changes [ListDocuments returned none].

Estimates Context

  • S&P Global consensus estimates for Q1 2025 EPS and Revenue were unavailable; no data returned. Values retrieved from S&P Global.*
  • Actuals: Revenue $0.0, EPS $(0.67). Benchmarking to consensus is not possible this quarter due to lack of coverage .
MetricQ1 2025 ConsensusQ1 2025 Actual
Revenue ($USD Millions)N/A*$0.0
Primary EPS ($USD)N/A*$(0.67)

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • The quarter’s widened loss was largely a non-cash artifact of warrant derivative valuation; underlying operating spend rose modestly while R&D declined, consistent with clinical transition planning .
  • Cash improved via financing; nevertheless, management’s formal going-concern disclosure and ~$15M estimated need over 12 months signal continued capital dependence — expect further ATM/offerings to bridge to catalysts .
  • Clinical catalysts in H2’25–Q4’25 are central: first Australian implants now in Q3’25 and IDE in Q4’25; any slippage or acceleration will be a primary stock driver .
  • Strategic positioning is strengthening: ISO 13485 achieved, EU bionic pancreas integration, and AI analytics partnership broaden the technology and ecosystem narrative .
  • Near-term trading: watch for enrollment/implant initiation updates (July target) and interim study signals; liquidity events can be dilutive but are likely at this stage.
  • Medium-term thesis: execution on long-term safety/accuracy, reducing device/wearable burden, and direct blood measurement differentiation vs. interstitial CGM peers are potential value creators if regulatory timelines hold .
  • Risk monitor: financing terms/derivative overhang, timeline shifts (Q2→Q3 implant), and ongoing Nasdaq compliance history suggest elevated volatility until clinical data matures .

Appendix: Additional Data Points

  • Non-cash change in fair value of derivative liabilities: +$3.376M in Q1 2025 .
  • Weighted average shares: 10,160,725 in Q1 2025; impact from warrant exchanges and offerings post reverse splits .
  • Company operates a single segment (Glucotrack CBGM Product Segment) .