Quarterly Report for Quarter Ending October 31, 2025 (Form 10-Q)

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis is intended as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion should be read in conjunction with our unaudited financial statements and the notes presented herein included in this Quarterly Report on Form 10-Q and the audited financial statements and the related notes set forth in our 2025 Annual Report on Form 10-K. The discussion below contains forward-looking statements that are based upon our current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to inaccurate assumptions and known or unknown risks and uncertainties, including those identified in "Cautionary Note Regarding Forward-Looking Statements" and under "Risk Factors" as identified under Part 1, Item 1A of our 2025 Annual Report on Form 10-K.

Overview

HeartSciences is a healthcare information technology company focused on advancing electrocardiography ("ECG" or "EKG") through artificial intelligence ("AI"). The Company has developed MyoVista Insights™, a cloud-native, vendor- and device-agnostic ECG management platform designed to improve workflow efficiency, streamline data management, and support the deployment of third-party AI-ECG algorithms. MyoVista Insights is classified as a Medical Device Data System ("MDDS") and is exempt from U.S. Food and Drug Administration ("FDA") 510(k) requirements. HeartSciences has also developed the MyoVista® wavECG™ device, which provides conventional ECG functionality and is designed to host AI-ECG algorithms. The Company submitted the MyoVista wavECG device to the FDA for 510(k) premarket clearance in December 2025 and has licensed or developed additional AI-ECG algorithms that may be submitted for regulatory clearance in the future.

Version 1 of the MyoVista Insights platform was launched in May 2025 and subsequently updated with Version 1.1. The platform is designed to streamline ECG study organization, enhance waveform analysis, and simplify clinical workflows, enabling more efficient interpretation of ECG data. The Company expects to generate revenues from installation fees, software-as-a-service ("SaaS") usage fees, and fees associated with AI-ECG algorithms made available through the platform's AI-ECG marketplace.

The future success of the MyoVista® wavECG™ device is dependent on obtaining FDA clearance and the integration of an impaired cardiac relaxation (e') AI-ECG algorithm under development. Following the publication of updated American Society of Echocardiography ("ASE") guidelines for the assessment of Left Ventricular Diastolic Dysfunction ("LVDD"), including revised age-based thresholds for cardiac relaxation (e'), the Company elected to separate the FDA submissions for the MyoVista wavECG device and the impaired cardiac relaxation algorithm. Additional development and validation will be required for the impaired cardiac relaxation algorithm to align with the updated clinical standards.

The Company will require additional funding to support working capital, continued development and commercialization of MyoVista Insights, and regulatory clearance of the MyoVista wavECG device and the impaired cardiac relaxation AI-ECG algorithm.

MyoVista Insights is classified as a Medical Device Data System ("MDDS") and is exempt from U.S. Food and Drug Administration ("FDA") 510(k) premarket clearance requirements. In contrast, the MyoVista® wavECG™ device and related AI-ECG algorithms are regulated as Class II medical devices and are subject to FDA premarket review, generally through the 510(k) premarket notification process or, in certain cases, the De Novo classification process. In December 2025, the Company submitted the MyoVista wavECG device to the FDA for 510(k) premarket clearance.

Following the publication of updated guidelines by the American Society of Echocardiography ("ASE") for the assessment of Left Ventricular Diastolic Dysfunction ("LVDD"), including revised age-based thresholds for cardiac relaxation (e'), the Company determined that additional development and validation will be required for its impaired cardiac relaxation AI-ECG algorithm to align with the updated clinical standards

Recent Developments

Going Concern

On July 24, 2025, our independent registered public accounting firm issued an opinion on our audited financial statements, included in our Annual Report on Form 10-K for the year ended April 30, 2025, that contained an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern because we have experienced recurring losses, negative cash flows from operations, and limited capital resources.

Compliance with Nasdaq Listing Requirements

On March 19, 2025, we received a letter from Nasdaq stating that we were not in compliance with the minimum stockholders'equity requirement for continued listing on the Nasdaq Capital Market, under Listing Rule 5550(b)(1) (the "Minimum Stockholders' Equity Requirement"), because our stockholders' equity of $1,786,689 as reported in our Quarterly Report on Form 10-Q for the period ending January 31, 2025, was below the required minimum of $2.5 million, and because, as of January 31, 2025, we did not meet the alternative compliance standards, relating to the market value of listed securities of $25 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years.

On May 5, 2025, we submitted to Nasdaq a plan to regain compliance with the Minimum Stockholders' Equity Requirement. On May 14, 2025, Nasdaq notified us that they granted us an extension of up to 180 calendar days from March 19, 2025, or through September 15, 2025, to regain compliance.

On September 16, 2025, we received a letter from Nasdaq informing the Company that the Nasdaq Listing Qualifications staff has confirmed that the Company has regained compliance with the Minimum Stockholders' Equity Requirement, and that the Company is therefore in compliance with Nasdaq's listing requirements. The Company's Common Stock and public warrants continue to be listed on Nasdaq.

Patents

In June 2025, we were granted a foundational patent from the USPTO covering the estimation of echocardiography parameters indicative of heart function using an ECG.

FDA Breakthrough Device Designation

In June 2025, we were granted "Breakthrough Device" designation by the FDA for our aortic stenosis ECG algorithm.

Streeterville Note Purchase Agreement and Promissory Note

In September 2024, the Company entered into a Note Purchase Agreement (the "Note Purchase Agreement"), with Streeterville Capital, LLC, an accredited investor ("Streeterville"), pursuant to which the Company issued to Streeterville an unsecured note in the original principal amount of $2,510,000 (the "Streeterville Note"). The Streeterville Note carried an OID of $500,000, and $10,000 was reimbursement for Streeterville's transaction expenses. Additionally, the Company incurred debt financing costs of $159,700. As a result, the Company received aggregate net proceeds of approximately $1.9 million in connection with the issuance of the Streeterville Note. As of the date of this Quarterly Report, the Company and Streeterville has exchanged $2,060,000 in aggregate principal and $45,000 in accrued interest for 597,578 shares of the Company's Common Stock and the Company has repaid in cash $450,000 of principal. The issuance of the shares were made pursuant to the exemption from the registration requirements afforded by Section 3(a)(9) of the Securities Act.

Series D Preferred Stock Offering and Certificate of Designations of Series D Preferred Stock

On March 10, 2025, the Company entered into a selling agency agreement (the "Placement Agent Agreement") with Digital Offering LLC ("Digital Offering") to act as sole placement agent (the "Placement Agent") on a "best efforts" offering of up to 4,285,714 Units, with each Unit consisting of (a) one share of our Series D Convertible Preferred Stock (the "Series D Preferred Stock") and (b) one warrant to purchase one share of our Common Stock, $0.001 par value, for a total of 4,285,714 shares of our Series D Preferred Stock and warrants to purchase up to an aggregate of 4,285,714 shares of our Common Stock (collectively, the "Offering"), pursuant to certain subscription agreements with certain investors, upon which each investor must complete a Subscription Agreement and submit the applicable subscription price as set forth therein. The offering price is $3.50 per Unit, for a maximum offering amount of $15.0 million worth of Units. Each warrant is exercisable at any time from the date of issuance through the third anniversary from the date of issuance, unless earlier redeemed, and is exercisable to purchase one share of Common Stock at $5.00 per share, subject to customary adjustment.

Pursuant to the Placement Agent Agreement, the Placement Agent will be entitled to receive from each closing of the Offering (i) a cash fee of 7% of the gross proceeds received by the Company from such closing, (ii) warrants (the "Agent Unit Warrants") to purchase 3% of the total number of Units sold by the Company at such closing (the "Agent Units") at an exercise price of $4.375 per Agent Unit Warrant, with each Agent Unit consisting of one share of Series D Preferred Stock (the "Agent Preferred Shares") and one Warrant (the "Agent Warrants" and the shares of Common Stock underlying such Agent Warrants, the "Agent Warrant Shares"), and (iii) reimbursement of certain of its out-of-pocket expenses. Digital Offering is acting on a "reasonable best efforts" basis, in connection with the Offering and is under no obligation to purchase any of the Units or arrange for the sale of any specific number or dollar amount of shares of the Units.

The Company refers to the offering therein as the "Series D Preferred Stock Offering". On February 10, 2025, in connection with the Series D Preferred Stock Offering, the Company's board of directors adopted a Certificate of Designations of Series D Preferred Stock to be filed with the Secretary of State of the State of Texas (the "TX Secretary") to create, out of the Company's authorized but unissued preferred stock, the Series D Preferred Stock. The Company filed the Certificate of Designations of Series D Preferred Stock with the TX Secretary on May 21, 2025.

As of the date of this Quarterly Report, we have issued 1,912,383 Units consisting of shares of Series D Preferred Stock and Warrants to purchase shares of Common Stock for gross proceeds of approximately $6.7 million. As of the date of this Quarterly Report, no Agent Units have been issued and 1,332,544 shares of Series D Preferred Stock have been converted into 1,332,544 shares of Common Stock.

Amendment No. 3 to the Equity Distribution Agreement

On August 3, 2025, the Company entered into Amendment No. 3 to the Original EDA (the "Third Amended EDA" and, collectively with the Amendments to the EDA, the "EDA") with Maxim Group pursuant to which the Company may offer and sell, from time to time, up to $25,000,000 of shares of Common Stock and the parties further agreed that Maxim will be entitled to compensation at a commission rate equal to 4.0% of the gross sales price per share sold pursuant to the EDA up to a maximum of $11,036,310 in gross proceeds to the Company, and 3.0% of the gross sales price per share sold pursuant to the EDA from any gross proceeds to the Company in excess of such amount; provided, however, that in no event will the Company issue or sell through the Sales Agent such number of shares of Common Stock that would cause the Company or the offering of its shares of Common Stock to not satisfy the eligibility and transaction requirements for use of Form S-3 (including General Instruction I.B.6 of Form S-3). Pursuant to General Instruction I.B.6 of Form S-3, in no event will the Company sell the shelf securities in a public primary offering with a value exceeding more than one-third of the aggregate market value of the Company's voting and non-voting ordinary shares held by non-affiliates in any 12-month period as long as the aggregate market value of the Company's outstanding ordinary shares held by non-affiliates is less than $75 million. During the 12 calendar months prior to, the Company has not sold any shares of Common Stock pursuant to General Instruction I.B.6 of Form S-3.

Results of Operations

Revenues

Revenues, which have been minimal to date, consist mainly of sales of devices, electrodes and other supplies in the establishment of distributor relationships outside the U.S. during the approval, development and improvement of the MyoVista wavECG.

Cost of Sales

Cost of sales consists primarily of costs related to materials, components and subassemblies. Cost of sales also includes certain direct costs such as those incurred for shipping and freight.

Operating Expenses

Our operating expenses have consisted solely of R&D expenses and selling, general and administrative expenses.

Research and Development Expenses

Our R&D activities primarily consist of clinical, regulatory, engineering and research work associated with our MyoVista wavECG device and MyoVista Insights platform. R&D expenses include payroll and personnel-related costs for our R&D, clinical and regulatory personnel, including expenses related to stock-based compensation for such employees, consulting services, clinical trial expenses, regulatory expenses, prototyping and testing. R&D expenses also include costs attributable to clinical trial expenses including clinical trial design, site development and study costs, data, related travel expenses, the cost of products used for clinical activities, internal and external costs associated with regulatory compliance and patent costs. We have expensed R&D costs as they have been incurred.

Selling, General and Administrative Expenses

Our selling, general and administrative expenses consist of payroll and personnel-related costs for field support personnel, business development, consulting, stock-based compensation, and for administrative personnel that support our general operations such as executive management and financial accounting. Selling, general and administrative expenses also include costs attributable to professional fees for legal and accounting services, premises costs, IT, insurance, consulting, recruiting fees, travel expenses and depreciation.

Interest Expense

Interest expense relates to our outstanding debt and related amortization of debt discount and deferred offering costs.

Other Income (Expense), Net

Other income (expense), net primarily consists of interest earned on cash balances.

The following table summarizes our results of operations for the periods presented on our statement of operations data.

Summary of Statements of Operations for the three and six months ended October 31, 2025 compared with the three and six months ended October 31, 2024:

Revenues were $2,000 and $4,000, and cost of sales were $1,000 and $2,000 for the three and six months ended October 31, 2025 and there were no revenues for the three and six months ended October 31, 2024. Our revenues in the fiscal years have been mainly generated from suppliers in the establishment of distributor relationships outside the United States as part of obtaining feedback during product development and improvement of the MyoVista wavECG.

Research and development expenses were $0.7 million and $1.7 million for the three and six months ended October 31, 2025, representing a decrease of $473,000, or 39%, and a decrease of $0.7 million, or 29%, when compared to the same periods in 2024. The decrease is primarily due to reduced cloud consulting costs as we have completed phase 1 of our MyoVista Insights platform and lower costs due to capitalization of software costs associated with the MyoVista Insights platform.

Selling, general, and administrative expenses were approximately $1.3 million and $2.2 million for the three and six months ended October 31, 2025, representing an increase of $562,000, or 71%, and an increase of $589,000, or 36%, when compared to the same periods in 2024. The increase is primarily due to approximately $484,000 increase in stock compensation expense and $70,000 in compensation expense related to personnel and hiring expenses during the quarter ended October 31, 2025, offset by reductions in marketing costs, professional fees related to the Reverse Stock Split, and patent costs in an aggregate amount of approximately $91,000.

Interest expense was $280,000 and $463,000 for the three and six months ended October 31, 2025, representing an increase of $162,000, or 137%, and an increase of $323,000, or 231%, when compared to the same periods in 2024. Interest expense in Fiscal 2025 is related to interest on the FRV Note and interest and debt service amortization on the Streeterville Note. During the quarter ended October 31, 2025, the outstanding principal balance of the Streeterville Note has been repaid in full and as a result, the Company wrote off the remaining balance of unamortized OID and debt issuance costs of approximately $264,000 to interest expense.

Other income of $2,000 and $5,000 during the three and six months ended October 31, 2025 is related to interest earned on our cash balances.

Liquidity, Capital Resources, and Going Concern Considerations

We have incurred losses each year since inception and have experienced negative cash flows from operations in each year since inception. We incurred a net loss of $4.4 million for the period ended October 31, 2025. As of October 31, 2025, we had an accumulated deficit of $80.5 million and stockholder's equity of $4.2 million and working capital of $2.2 million.

Based on our current business plan assumptions and expected cash burn rate, we believe that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding our ability to continue as a going concern.

On March 10, 2025, the Company commenced an offering on a "best efforts" basis for a maximum of up to 4,285,714 Units. Each Unit (each a "Unit" and collectively the "Units") consists of one (1) share of Series D Convertible Preferred Stock, par value $0.001 per share (the "Series D Preferred Stock"), and one (1) warrant the ("Warrants"), each to purchase one (1) share of the Company's Common Stock. The Units will be sold at an offering price of $3.50 per Unit, for a maximum offering amount of $15.0 million worth of units. During the six months ended October 31, 2025, the Company issued 1,912,383 Units for gross proceeds of approximately $6.7 million. There was approximately $8.3 million available for issuance as of the financial statement issuance date. We expect any proceeds received from the offering will be used for working capital and general corporate purposes.

In September 2023, the Company entered into an Equity Distribution Agreement ("EDA") with an institutional investor, pursuant to which the Company may offer and sell an aggregate of up to $3.25 million of its shares of Common Stock in At-the-Market offerings ("ATM Facility"). In November 2023, the EDA was further amended increasing the aggregate amount of Common Stock that may be sold under the ATM Facility to up to $15.0 million, and further amended again in August 2025, increasing the aggregate amount of Common Stock that may be sold under the ATM Facility from to up to $25.0 million. The Company is eligible to sell up to $14.7 million worth of shares of Common Stock as the aggregate market value of the Company's shares of Common Stock eligible for sale under the EDA is subject to limitations of General Instruction I.B.6 of Form S-3 until such time that the Company's public float equals or exceeds $75.0 million. In the event the aggregate market value of the Company's outstanding Common Stock held by non-affiliates equals or exceeds $75.0 million, then the one-third limitation on sales set forth in General Instruction I.B.6 of Form S-3 shall not apply to additional sales made pursuant to the EDA. During the six months ended October 31, 2025, the Company issued and sold 48,858 shares under the ATM Facility for net proceeds of approximately $0.2 million. There was approximately $4.2 million available for issuance as of the financial statement issuance date. We expect any proceeds received from the ATM Facility will be used for working capital and general corporate purposes.

In March 2023, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park") providing for the purchase, from time to time at the Company's discretion, of up to $15.0 million of the Company's Common Stock, over the thirty-six (36) month term of the purchase agreement ("Equity Line"). There were no shares issued under the equity line during the six months ended October 31, 2025. As of the date of this Quarterly Report, the Company has issued and sold an aggregate 253,617 shares of Common Stock, including 1,625 commitment shares, under the Equity Line receiving gross proceeds of approximately $2.2 million and there was approximately $12.8 million available for issuance under the Equity Line. We expect any proceeds received from the Equity Line will be used for working capital and general corporate purposes.

Our cash requirements are, and will continue to be, dependent upon a variety of factors. We expect to continue devoting significant capital resources to R&D, clinical studies and go-to-market strategies. We will need to continue to raise capital through the sale of additional equity securities, debt, or capital inflows from strategic partnerships, however we can provide no assurance that that we will be able to consummate the sale of any such securities or strategic relationships will be available on terms acceptable to us, if at all.

Since our inception, we have raised capital through the public and private sale of debt and equity. As of October 31, 2025, we had cash and cash equivalents balance of approximately $2.0 million, an increase of $0.9 million from $1.1 million as of April 30, 2025.

The table below presents our cash flows for the periods indicated:

Operating Activities

Net cash used by our operating activities of $4.3 million during the six months ended October 31, 2025 is primarily due to our net loss of $4.4 million, plus $1.1 million in non-cash expenses less $961,000 of net changes in operating assets and liabilities.

Net cash used by our operating activities of $4.2 million during the six months ended October 31, 2024 is primarily due to our net loss of $4.1 million, plus $243,000 in non-cash expenses less $311,000 of net changes in operating assets and liabilities.

Financing Activities

Net cash provided by financing activities of $5.2 million during the six months ended October 31, 2025 is primarily from the issuance of Series D Preferred Stock and warrants.

Net cash provided by financing activities of $2.4 million during the six months ended October 31, 2024 is primarily from the issuance of Common Stock under the Equity Line, ATM Facility, and net proceeds from the Streeterville Note.

Critical Accounting Policies and Estimates

There have been no material changes to our critical accounting policies and estimates from the information provided in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," included in our 2025 Annual Report on Form 10-K.