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HeartSciences Inc. (HSCS)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 FY2025 delivered no revenue, a net loss of $2.08M, and EPS of $(2.27); operating loss was $(1.99)M as R&D investment and platform build-out continued .
  • Cash and equivalents ended at $4.1M with shareholders’ equity at $4.0M; management reiterated going-concern risks and the need for further capital to fund operations and regulatory/commercial milestones .
  • Regulatory execution remained the core focus: MyoVista wavECG 510(k) submission targeted around end of Q1 CY2025; Phase 1 of the cloud-native MyoVista Insights platform was completed by year-end 2024; Phase 2 AI-ECG reporting submission targeted for 2H CY2025 .
  • A key commercial catalyst emerged: AI-ECG algorithms (device and cloud) were included in CMS 2025 OPPS final rule effective January 2025, enabling reimbursement upon launch and potentially accelerating adoption .
  • Stock-reaction catalysts: FDA clinical validation and subsequent 510(k) submission, Phase 2 platform filing, and initial test-site deployments of MyoVista Insights in 2025; liquidity developments remain a watch item for near-term sentiment .

What Went Well and What Went Wrong

What Went Well

  • “By calendar year end, our Phase 1 MyoVista Insights cloud-native platform will be complete after millions of dollars of investment… we are in discussions for early deployment in test environments” — Andrew Simpson, CEO .
  • Pre-validation progressed for the first cloud-based LVEF (≤40%) algorithm licensed from Mount Sinai; FDA validation studies expected to use retrospective data, simplifying timelines and costs .
  • CMS inclusion for AI-ECG (device and cloud) in 2025 OPPS final rule effective Jan 2025, enabling reimbursement immediately upon commercial launch — a major adoption milestone .

What Went Wrong

  • No revenue in Q2 FY2025 (and Q1 FY2025), highlighting continued pre-commercial status and reliance on financing to fund operations .
  • Operating loss widened Y/Y as R&D and regulatory execution costs rose; R&D expense increased due to MyoVista Insights development and FDA submission support .
  • Going-concern risk reiterated; cash burn outpaced financing inflows, with management stating existing cash is insufficient for 12 months without additional capital .

Financial Results

MetricQ2 2024 (Oct 31, 2023)Q1 2025 (Jul 31, 2024)Q2 2025 (Oct 31, 2024)
Revenue ($USD)$3,900 $0 $0
Net Loss ($USD)$(1,748,378) $(2,051,689) $(2,082,918)
Diluted EPS ($)$(15.92) $(2.64) $(2.27)
Loss from Operations ($USD)$(1,569,943) $(2,075,667) $(1,985,033)
R&D Expense ($USD)$757,303 $1,224,931 $1,198,965
SG&A Expense ($USD)$815,020 $850,736 $786,068
Gross Margin ($USD)$2,380 N/A (no revenue)N/A (no revenue)

KPIs and liquidity:

KPIQ2 2024Q1 2025Q2 2025
Cash & Equivalents ($USD)N/A$4,339,778 $4,052,120
Shareholders’ Equity ($USD)N/A$5,933,958 $4,016,721
Working Capital ($USD)N/A$4.7M $2.4M

Notes:

  • No Wall Street consensus estimates were available via S&P Global for Q2 FY2025 due to API request limits; results vs estimates cannot be shown.
  • Management disclosed and discussed going-concern risk and the need for additional financing to fund operations through regulatory and commercialization milestones .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
MyoVista wavECG 510(k) submissionCY2025 timing“On track for first calendar quarter 2025” (Q1) “Around end of first calendar quarter 2025; expect FDA clinical validation in weeks, submission 1H 2025” (Q2/Q3) Slightly broadened window; submission shifted to 1H 2025
MyoVista Insights Phase 1CY2024“On track to complete by end of CY2024” (Q1) “Completed in Dec 2024; discussions for test sites in 2025” (Q3) Achieved
MyoVista Insights Phase 2 (AI-ECG reporting)CY2025“Target submission 2H 2025” (Q1) “Aiming for Phase 2 submission in 2H 2025” (Q2/Q3) Maintained
First cloud-based LVEF (≤40%) algorithm FDA pathCY2025“Pre-validation to begin; retrospective validation; target mid/2H 2025 submission” (Q1) “Pre-validation progressed/completed; retrospective validation; aim submission 2H 2025” (Q2/Q3) Maintained with execution progress
CMS OPPS reimbursement inclusionEffective dateNot stated previously“Included in CMS 2025 OPPS final rule; effective Jan 2025” (Q2/Q3) New/positive reimbursement development

Earnings Call Themes & Trends

No Q2 FY2025 earnings call transcript was available; themes are drawn from Q1/Q2/Q3 press releases and 10-Qs.

TopicPrevious Mentions (Q-2: FY2024 PR; Q-1: Q1 FY2025)Current Period (Q2 FY2025)Trend
AI-ECG strategy (device + cloud)Expanded to both device and cloud; marketplace concept; large algorithm library (FY2024) Reinforced dual approach; Phase 1 cloud complete by YE2024; marketplace strategy reiterated Improving execution
Regulatory pathwayShift to 510(k) for device; Q1: 510(k) target Q1 CY2025 Q2: final pre-submission requested; Q3: FDA clinical validation imminent; 510(k) submission in 1H CY2025 Advancing
Reimbursement (CMS)New codes beginning; foundational year (FY2024) Explicit inclusion in CMS 2025 OPPS; effective Jan 2025; higher rate than conventional ECG Positive
R&D executionBeta of platform; algorithm work; IP expansion (FY2024) Platform Phase 1 completion; LVEF pre-validation progressed/completed with Rutgers; continued IP On plan
Liquidity/Going-concernFY2024 cash $5.8M; equity $7.3M; funding raises Q1 cash $4.3M; Q2 cash $4.1M; going-concern risk highlighted; Streeterville note proceeds deployed Deteriorated; financing needed

Management Commentary

  • “We end calendar 2024 in a strong position… HeartSciences is the only Company developing across the board ECG solutions to upgrade archaic devices, clinical capabilities, and reporting and management systems” — Andrew Simpson, CEO .
  • “Phase 1 MyoVista Insights cloud-native platform will be complete… feedback has been excellent and we are in discussions for early deployment in test environments” .
  • “Our MyoVista wavECG is approaching FDA submission… suitable for many frontline healthcare settings and territories around the world” .
  • “CMS has already established reimbursement for AI-ECG at a rate significantly higher than that of conventional ECG… highlights the significant commercial opportunity” .

Q&A Highlights

  • No public earnings call transcript was found for Q2 FY2025; no Q&A details available [List: 0 transcripts].

Estimates Context

  • Wall Street consensus estimates (revenue, EPS) via S&P Global were unavailable for Q2 FY2025 due to API request limits; comparison to consensus cannot be provided at this time.
  • Investors should assume near-term estimate adjustments hinge on regulatory timing (device FDA validation/510(k) submission) and test-site deployments of the cloud platform rather than revenue/EPS beats/misses in the pre-commercial phase .

Key Takeaways for Investors

  • Pre-commercial execution continues: zero revenue; operating losses driven by R&D and regulatory spend; liquidity and going-concern disclosures merit close monitoring .
  • Regulatory catalyst stack: MyoVista wavECG FDA clinical validation and 510(k) submission in 1H CY2025; Phase 2 cloud platform submission in 2H CY2025; LVEF algorithm submission targeted 2H CY2025 .
  • Reimbursement tailwind: CMS OPPS inclusion effective Jan 2025 for AI-ECG could accelerate adoption and pricing relative to conventional ECG once products are cleared .
  • Commercial readiness: Phase 1 of MyoVista Insights completed; test-site deployments planned for 2025; device-cloud dual approach provides broader coverage across care settings .
  • Financing path is critical: watch ATM/Equity Line usage and additional debt/equity raises to bridge to FDA clearance and initial commercialization .
  • IP/clinical partnerships strengthen pipeline: Mount Sinai licensed algorithms and Rutgers collaboration provide breadth and validation leverage .
  • Trading implications: Stock likely sensitive to FDA timeline updates, reimbursement clarity, and financing activity; confirmation of clinical validation and submission could be near-term positive catalysts .