Heartsciences Inc.

09/11/2025 | Press release | Distributed by Public on 09/11/2025 14:05

Quarterly Report for Quarter Ending July 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

We are a medical technology company focused on applying AI and innovative software technology to expand and improve ECG's (also known as an EKG) clinical usefulness. Our objective is to provide modernized ECG software and hardware platforms that will allow ECGs to be far more valuable cardiac screening tools by expanding clinical capabilities to detect a broader range of heart disease using Artificial Intelligence. We are seeking to provide both hardware and software solutions that can be used in almost any care setting worldwide, either via our MyoVista Insights cloud-based ECG management and AI-ECG algorithm hosting platform using one of the millions of ECG devices currently in clinical use or via our proprietary MyoVista wavECG device. We have been developing a cloud-based platform to modernize ECG management systems that can also host state-of-the-art AI-ECG algorithms on an ECG hardware agnostic basis (the "MyoVista Insights Cloud Platform"). The MyoVista wavECG, is a resting 12-lead ECG has been developed to host AI-ECG software algorithm(s) designed to make available on-device AI-ECG algorithms as well as conventional ECG information in the same test. We intend to offer a range of software-based AI-ECG algorithms, via each product. The MyoVista Insights Cloud Platform does not require FDA clearance. AI-ECG algorithms to be delivered on MyoVista Insights Cloud Platform or the MyoVista wavECG device would each require FDA clearance and, as yet, those are not available.

The AI-ECG algorithms are intended to provide diagnostic information which has traditionally required cardiac imaging. We believe the combination of a device agnostic cloud platform and MyoVista wavECG device would allow us to offer AI-ECG s algorithms developed by us or other third parties across a wide range of healthcare settings from large heath systems to frontline or point of care environments such as primary care.

Phase 1 of the MyoVista Insights Cloud Platform has been launched, and we expect revenues will come from a combination of install fees and SaaS based usage fees. We expect to adopt a recurring subscription revenues model for AI-ECG algorithms hosted on either the platform or device based on algorithm or device usage including proprietary device based consumable revenue. Our MyoVista Insights Cloud Platform has been designed to provide an algorithm marketplace and host third party AI-ECG algorithms, which increases its clinical value and our speed to market as well as reducing Research and Development ("R&D") costs associated with internal algorithm development.

On September 20, 2023, we entered into multiple definitive license agreements (each a "License Agreement" and collectively, the "License Agreements") with Mount Sinai to commercialize a range of AI-ECG algorithms covering a range of cardiovascular conditions developed by Mount Sinai as well as a memorandum of understanding for ongoing cooperation encompassing de-identified data access, on-going research, and the evaluation of the MyoVista wavECG device.

Our future success is dependent upon receiving FDA clearances for our products and additional funding may be required as part of achieving FDA clearance and thereafter would be required to support the sales launch, provide working capital and support further R&D.

We believe that there is currently no low-cost, front-line, medical device that is effective at screening broadly for many types of heart disease. As a result, we believe that frontline physicians face a significant challenge in determining if a patient has heart disease. Although many think of the ECG as the frontline test for heart disease, in 2012, the United States Preventive Services Task Force conducted an evaluation of conventional ECG testing and stated: "There is no good evidence the test, called an ECG, helps doctors predict heart risks any better than traditional considerations such as smoking, blood pressure and cholesterol levels in people with no symptoms."

ECG devices record the electrical signals of a patient's heart. The ECG is a ubiquitous, relatively low-cost, simple and quick test; it is portable and can be performed in a wide range of clinical settings by a non-specialist clinician or clinical aide. There are three basic categories of heart disease: electrical (such as an arrhythmia), structural (such as valvular disease) and ischemic (such as coronary artery disease, or CAD). Conventional resting ECGs have limited sensitivity in detecting structural and ischemic disease and are typically used for diagnosing cardiac rhythm abnormalities, such as atrial fibrillation, or acute coronary syndrome, such as a myocardial infarction

which is also known as a heart attack. However, traditional ECGs have a limited role in identifying cardiac dysfunction associated with structural and ischemic disease.

The Company has designed or licensed algorithms designed to help address these limitations and extend the clinical capability of an ECG to detect cardiac dysfunction and other heart disease types. We expect the first AI-ECG algorithm to be submitted for use on the MyoVista Insights Cloud Platform would be for detection of low ejection fraction, or systolic dysfunction, and based on one of those licensed from Mount Sinai.

Our first AI-ECG algorithm expected to be hosted on the MyoVista wavECG device has been designed by the Company and applies AI-machine learning to the signal processed ECG signal to develop a proprietary algorithm designed to detect the echocardiographic measure for impaired cardiac relaxation (e') (i.e. cardiac dysfunction). In July 2025, the American Society of Echocardiography ("ASE") released updated guidelines for evaluating Left Ventricular Diastolic Dysfunction ("LVDD"), placing increased emphasis on cardiac relaxation (e') and now requiring specific age-based threshold adjustments. Although we incorporated age-based measures, previously agreed with the FDA, we expect to update the algorithm to the new ASE published age-based measures prior to FDA submission and also make it available on both the MyoVista Insights Cloud Platform and MyoVista wavECG device.

Previously, we intended to combine, in a single FDA submission, the MyoVista wavECG and the impaired cardiac relaxation algorithm under two separate two product codes. We now intend to make separate submissions to the FDA for the device and software algorithm which we believe would simplify and speed up the FDA submission and clearance process and allow us to make the algorithm available on both the device and MyoVista Insights Cloud Platform.

The editorial comment associated with the study titled "Prediction of Abnormal Myocardial Relaxation from Signal Processed Surface ECG" presented below discusses recent applications of machine learning to data derived from surface 12-lead ECGs in relation to cardiac dysfunction:

"These represent some of the most significant advances in electrocardiography since its inception, which has historically had a limited, if any, role in the evaluation of cardiac dysfunction. In the past, our cardiovascular community was resigned to the fact that surface ECGs are poor indicators for cardiac dysfunction."

Khurram Nasir, MD, MPH, MSC, Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas, et. al.,Journal of American College of Cardiology Editorial Comment Volume 76 Number 8 2020.

Almost all forms of heart disease, including CAD and structural disease, affect heart muscle, or cardiac function prior to symptoms. Impaired cardiac function is first observed as impaired cardiac relaxation which is an early indicator of diastolic dysfunction and usually continues to increase in severity as heart disease progresses. The diastolic phase of the cardiac cycle occurs when the heart muscle relaxes (following contraction). Diastolic dysfunction may also be related to age-related cardiac dysfunction. Low ejection fraction, or systolic dysfunction, is a later stage of cardiac dysfunction and occurs when the heart pumps a reduced level of blood from the ventricles during contraction.

If we receive FDA clearances for our product candidates, our main target markets would be frontline healthcare environments in the U.S., to assist physician decision making in the cardiology referral process. Currently, cardiology referral decisions are often based on a patient's risk factors and/or a conventional ECG test. Accordingly, many patients with heart disease are left undetected while no current treatment or intervention is required for most patients referred for cardiac imaging. We believe that adding the capability to detect a broader range of cardiac conditions to the standard 12-lead resting ECG could help improve cardiac referral pathways and be valuable for patients, physicians, health systems and third-party payors.

New Class II devices, such as our products, require FDA premarket review. The MyoVista wavECG device along with its proprietary software and hardware is classified as a Class II medical device by the FDA. Premarket review and clearance by the FDA for these devices is generally accomplished through the 510(k) premarket notification process or De Novo classification request, or petition process. We previously submitted an FDA De Novo classification request in December 2019 for the MyoVista wavECG and, following feedback and communications with the FDA during and since that submission, we have been making modifications to our device, including its proprietary algorithm. We were previously planning a revised submission under the De Novo pathway, however, in December 2023 the FDA confirmed that we could submit the MyoVista wavECG device for clearance under the 510(k) pathway following the grant by the FDA in August 2023 of an industry-first De Novo clearance which created a new Class II product code for cardiovascular machine learning-based notification software. This was in respect of a hypertrophic cardiomyopathy algorithm and in late September 2023, the FDA cleared an algorithm for low ejection fraction (less than 40%) under the 510(k) pathway using this new product code. We finished the patient recruitment and core lab work for our FDA validation study and had been undertaking device and algorithm development testing for a revised FDA submission. Following the release by the American Society of Echocardiography of updated guidelines for evaluating LVDD in July 2025, and new age-based threshold adjustments we now intend to make separate

submissions to the FDA for the device and software algorithm. FDA submission of the MyoVista wavECG device is expected in the calendar 2025.

To date we have not yet entered into a discussion with the FDA regarding the first self-developed AI-ECG algorithm for the MyoVista Insights Cloud Platform. We expect that to fall under the 510(k) pathway and are aiming for an FDA submission of a low-ejection fraction algorithm during the first half of calendar 2026.

Recent Developments

Amendment to the Bylaws

On June 27, 2025, in connection with certain recent changes to the Texas Business Organizations Code ("TBOC") and in light of Texas law, the Board adopted certain amendments to the Company's Bylaws (the "Bylaw Amendments") in order to: (i) add a new section to provide for a jury trial waiver for "internal entity claims" as defined in the TBOC; (ii) add a new section to adopt an ownership threshold requiring any shareholder or group of shareholders to hold shares of common stock sufficient to meet an ownership threshold of at least 3% of the Company's issued and outstanding shares in order to institute or maintain a derivative proceeding; and (iii) make technical revisions to clarify the scope of the exclusive forum provision. The Bylaw Amendments, adopted in accordance with Texas law, became effective on June 27, 2025.

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. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. While there can be no assurance that the Company will be able to regain compliance with all applicable Nasdaq continued listing requirements, the Company continues to implement various steps taken to date, and is evaluating its available options, to resolve the deficiency and regain compliance with the Minimum Stockholders' Equity Requirement as soon as possible by the above referenced deadline.

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 $1,805,000 in aggregate principal for 506,348 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 1,556,409 Units consisting of shares of Series D Preferred Stock and Warrants to purchase shares of Common Stock for gross proceeds of approximately $5.4 million. As of the date of this Quarterly Report, no Agent Units have been issued and 1,054,549 shares of Series D Preferred Stock have been converted into 1,054,549 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). As of July 31, 2025, the aggregate market value of the Company's outstanding shares of Common Stock held by non-affiliates was $14,737,609, which was calculated based on 2,276,253 outstanding shares of Common Stock held by non-affiliates on July 31, 2025 and a price per share of $5.73, which was the closing price of the Common Stock on July 10, 2025 and is the highest closing sale price of Common Stock on the Nasdaq Capital Market within the prior 60 days. 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 Cloud 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.

Three Months Ended July 31,

2025

2024

$ Change

% Change

(In thousands, except percentages, unaudited)

Revenue

$

2

$

-

2

-

%

Cost of sales

1

-

1

-

%

Gross margin

1

-

1

-

%

Operating expenses:

Research and development

997

1,225

(228

)

(19

)%

Selling, general and administrative

878

851

27

3

%

Total operating expenses

1,874

2,076

(201

)

(10

)%

Loss from operations

(1,874

)

(2,076

)

201

(10

)%

Other income (expense):

Interest expense

(184

)

(23

)

(161

)

715

%

Other income

3

47

(44

)

(94

)%

Total other income (expense), net

(181

)

24

(205

)

(839

)%

Net loss

$

(2,055

)

$

(2,052

)

$

(3

)

0

%

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

Revenues were $2,000 and cost of sales were $1,000 for the three months ended July 31, 2025. 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 $997,000 for the three months ended July 31, 2025, representing a decrease of $228,000, or 19% 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 Cloud Platform providing an initial functioning platform as a basis for FDA submission and clearance contemporaneous with our first cloud-based AI-ECG algorithm.

Selling, general, and administrative expenses were approximately $878,000 for the three months ended July 31, 2025, representing an increase of $27,000, or 3% when compared to the same periods in 2024. The increase is primarily due to approximately $100,000 increase in stock compensation expense during the quarter ended July 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 $81,000.

Interest expense was $184,000 for the three months ended July 31, 2025, representing an increase of $161,000 or 715% 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.

Other income of $3,000 during the three months ended July 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 $2.1 million for the period ended July 31, 2025. As of July 31, 2025, we had an accumulated deficit of $78.2 million and stockholder's equity of $3.1 million and working capital of $1.4 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 three months ended July 31, 2025, the Company issued 1,317,689 Units for gross proceeds of approximately $4.6 million. Subsequent to July 31, 2025, the Company issued 238,720 Units for gross proceeds of approximately $0.8 million, and there was approximately $9.6 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. There were no shares issued under the ATM during the three months ended July 31, 2025, and there was approximately $4.3 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 three months ended July 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 July 31, 2025, we had cash and cash equivalents balance of approximately $2.8 million, an increase of $1.7 million from $1.1 million as of April 30, 2025.

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

Three Months Ended July 31,

U.S. dollars, in thousands

2025

2024

(Unaudited)

Net cash used in operating activities

$

(1,953

)

$

(2,019

)

Net cash used in investing activities

$

(1

)

$

(1

)

Net cash provided by financing activities

$

3,648

$

552

Net change in cash and cash equivalents during the period

$

1,694

$

(1,468

)

Operating Activities

Net cash used by our operating activities of $1.9 million during the three months ended July 31, 2025 is primarily due to our net loss of $2.1 million, plus $316,000 in non-cash expenses less $215,000 of net changes in operating assets and liabilities.

Net cash used by our operating activities of $2.0 million during the three months ended July 31, 2024 is primarily due to our net loss of $2.1 million, plus $98,000 in non-cash expenses less $65,000 of net changes in operating assets and liabilities.

Financing Activities

Net cash provided by financing activities of $3.6 million during the three months ended July 31, 2025 is primarily from the issuance of Series D Preferred Stock and warrants.

Net cash provided by financing activities of $0.6 million during the three months ended July 31, 2024 is primarily from the issuance of Common Stock under the Equity Line and the ATM Facility.

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.

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