Executive Summary

No revenue in Q1 FY2025; operating investment stepped up to advance both device-based and cloud AI-ECG programs. Net loss widened to $2.05M on higher R&D and SG&A; diluted EPS improved to $(2.64) vs $(13.23) YoY on a much higher share count .
FDA 510(k) submission for MyoVista wavECG remains targeted for 1Q CY2025; hardware/software issues “believed to be resolved,” with validation expected to proceed expeditiously after a final pre-sub meeting .
Cloud “MyoVista Insights” Phase 1 (reporting, no AI) on track for completion by end-CY2024; first cloud AI algorithm (LVEF ≤40% via Mount Sinai) targeted for FDA submission in 2H CY2025 .
Balance sheet: $4.34M cash and $5.93M equity at 7/31; runway extended post-quarter with ~$1.9M net non‑dilutive financing and extension of a $0.5M note to Sep-2025. Cash drifted to $4.1M and equity to $4.0M by 10/31 in Q2 FY2025 .

What Went Well and What Went Wrong

What Went Well

Dual-track product strategy progressing: device-based MyoVista wavECG and cloud-native MyoVista Insights; management believes this versatility is a competitive advantage spanning hospital to mobile settings .
Regulatory momentum: wavECG 510(k) track intact for 1Q CY2025; algorithm adjustments nearing completion; pre-sub process set to finalize reporting/validation plan .
Ecosystem and visibility building: selected to demonstrate at the UN General Assembly Digital Health Symposium; IVI analysis highlights potential to significantly improve cardiovascular pathway efficiency .

What Went Wrong

No revenue again this quarter; the business remains pre-commercial pending FDA clearances .
Higher OpEx drove a wider net loss (R&D +117% YoY to $1.23M; SG&A +11% YoY), reflecting regulatory, platform development, and personnel costs .
Going-concern risk persists and internal control material weaknesses remain; management plans further financing and control remediation, but availability/timing are uncertain .

Financial Results

Income Statement vs Prior Year

Metric	Q1 FY2024 (ended 7/31/23)	Q1 FY2025 (ended 7/31/24)
Revenue ($USD Millions)	$0.00	$0.00
Research & Development ($USD Millions)	$0.57	$1.23
Selling, General & Administrative ($USD Millions)	$0.77	$0.85
Total Operating Expenses ($USD Millions)	$1.33	$2.08
Net Loss ($USD Millions)	$1.37	$2.05
Diluted EPS ($)	$(13.23)	$(2.64)
Weighted Avg Shares (000s)	103.3	777.7

Notes: No revenue in either period; EPS improved YoY despite higher loss due to significantly higher average shares outstanding .

Liquidity and Capitalization Trend (Oldest → Newest)

Metric	Q3 FY2024 (1/31/24)	Q4 FY2024 (4/30/24)	Q1 FY2025 (7/31/24)	Q2 FY2025 (10/31/24)
Cash & Cash Equivalents ($USD Millions)	$7.10	$5.80	$4.34	$4.10
Shareholders’ Equity ($USD Millions)	$8.60	$7.30	$5.93	$4.00
Notes Payable (current/long-term) ($USD)	N/A	N/A	$0 current; $0.50M LT	N/A

Additional financing actions: ~$1.9M net non-dilutive note closed in Sep-2024; $0.5M note extended to Sep-2025 .

Cash Flow (Quarter)

Metric	Q1 FY2024	Q1 FY2025
Net Cash Used in Operating Activities ($USD Millions)	$(1.40)	$(2.02)
Net Cash Provided by Financing Activities ($USD Millions)	$0.32	$0.55

No segments or product revenue KPIs are reported at this pre-commercial stage .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
MyoVista wavECG FDA submission (510(k))	Regulatory timing	“Around year-end 2024” (Q3 FY2024)	“First calendar quarter of 2025” (Q4 FY2024 and reaffirmed Q1 FY2025)	Pushed ~1 quarter (maintained this quarter)
MyoVista Insights Phase 1 (reporting platform)	Development timing	Phase 1 for FDA submission expected in CY Q4 2024 (FY2024 update)	Phase 1 completion by end-CY2024; reporting-only, no clearance required	Clarified scope; timing maintained
Cloud AI LVEF algorithm + Insights submission	Regulatory timing	Mid‑2025 target (FY2024 update)	2H CY2025 target for FDA submission	Slightly later window (mid → 2H)
Reimbursement context	Policy	—	CMS 2025 OPPS final rule includes company’s AI‑ECG categories (effective Jan-2025) (noted in Q2 FY2025)	New positive reimbursement tailwind (subsequent quarter)

Earnings Call Themes & Trends

No Q1 FY2025 earnings call transcript was available. Thematic evolution below reflects disclosures in recent quarters.

Topic	Previous Mentions (Q-2: Q3 FY2024; Q-1: Q4 FY2024)	Current Period (Q1 FY2025)	Trend
Regulatory pathway (510(k) shift)	510(k) pathway confirmed; nearing submission with algorithm update and validation prep	510(k) submission remains targeted for 1Q CY2025; hardware/software issues believed resolved; final pre-sub then validation	Steady progress; timing reaffirmed
Cloud platform (Insights)	Beta in place; Phase 1 expected CY Q4 2024; marketplace vision with third-party algorithms	Phase 1 completion by end-CY2024; Pre-validation starting for LVEF; target FDA submission 2H CY2025	Execution advancing; submission window slightly later
Financing/runway	Equity line/ATM activity; stronger cash/EQ at FY end	$1.9M net non-dilutive note closed post-quarter; $0.5M loan extended	Runway extended; still going-concern risk
External validation & KOLs	Irish Garda screening program; EU field use feedback; UN symposium invitation	UN demonstration confirmed; IVI analysis indicates efficiency gains; KOL engagement more active	Visibility and advocacy improving
Reimbursement	—	— (noted subsequently in Q2 FY2025: CMS 2025 OPPS final rule)	Positive policy setup (effective Jan-2025)

Management Commentary

“We made material progress on both the MyoVista Insights cloud-platform, its first related algorithm, and the MyoVista wavECG device in recent months… We are laying the long-term foundations to solve the diagnostic gap for the early detection of heart disease” — Andrew Simpson, CEO .
“Our team remains focused on getting through regulatory submission for the MyoVista wavECG as quickly as practical… bring a successful conclusion to many years and several tens of millions of dollars of investment in R&D, clinical studies and regulatory work” .
“Feedback on our MyoVista Insights platform has been positive… As a software based medical device many of the most time-consuming development and regulatory requirements associated with a hardware-based device are avoided” .

Q&A Highlights

No earnings call/Q&A transcript was available for Q1 FY2025; no analyst Q&A themes to report [earnings-call-transcript search returned none].

Estimates Context

We attempted to retrieve S&P Global consensus for Q1 FY2025 EPS and revenue but the data were unavailable at the time of request (SPGI daily limit exceeded). As such, we cannot present a vs-consensus comparison for this quarter. Estimates may be sparse for a pre-revenue micro-cap with limited analyst coverage.

Key Takeaways for Investors

Near-term catalyst: wavECG 510(k) submission targeted for 1Q CY2025; any successful pre-sub/validation milestones or clearance would be material for sentiment and valuation .
Medium-term: cloud platform Phase 1 completing by end-CY2024; LVEF algorithm/Insights submission aimed for 2H CY2025, expanding the TAM beyond device-only channels .
Reimbursement setup improving (effective Jan-2025 per Q2 FY2025 disclosure), supporting commercial adoption once products clear FDA .
Financial runway modest: cash drifted to ~$4.1M by 10/31; company added ~$1.9M net non-dilutive debt and extended a $0.5M note; going-concern risk persists until approvals/commercialization and/or more capital is secured .
Execution risk: increased R&D and SG&A spending elevated cash burn ($2.02M operating cash outflow in Q1); timing slippage remains possible given regulatory dependencies .
Strategic positioning: dual device/cloud approach plus third‑party algorithm marketplace could accelerate rollout and reduce R&D burden if executed, with growing KOL support and visibility (UN/IVI) .

Supporting Sources: Q1 FY2025 8‑K and press release ; Q1 FY2025 10‑Q financials and MD&A ; Q4 FY2024 update ; Q3 FY2024 update ; financing PR ; IVI analysis PR ; UN symposium PR ; Q2 FY2025 8‑K (subsequent context) .

Heart Test Laboratories, Inc. (HSCS)·Q1 2025 Earnings Summary