HeartSciences Inc 10-Q for FY2024 Q2
HeartSciences Inc. (HSCS)
About this 10-Q
HeartSciences Inc filed this 10-Q on December 14, 2023, covering the quarter ended October 31, 2023 (FY2024 Q2).
Headline figures
Quarter ended October 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $3900
- Net loss
- $1.75M
- compared with a net loss of $1.81M a year earlier
- Diluted EPS
- -$0.16
- compared with -$0.22 a year earlier
1
ROC
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of December 14, 2023, the registrant had
2
HEART TEST LABORATORIES, INC.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements relate to our future plans, objectives, expectations and intentions and may be identified by terminology such as “may,” “will,” “should,” “expects,” “aims,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Readers are cautioned that these forward-looking statements are based on our current beliefs, expectations and assumptions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and those risks identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended April 30, 2023 filed with the Securities and Exchange Commission on July 19, 2023 ("2023 Annual Report on Form 10-K"). Therefore, actual results may differ materially and adversely from those expressed, projected or implied in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.
These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our device, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future.
Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things:
3
These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise for any reason.
The Company will continue to file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission (the “SEC”). Forward-looking statements speak only as of the dates specified in such filings. Except as expressly required under federal securities laws and the rules and regulations of the SEC, we do not undertake any obligation to update any forward-looking statements to reflect events or circumstances arising after any such date, whether as a result of new information or future events or otherwise. You should not place undue reliance on the forward-looking statements included in this report or that may be made elsewhere from time to time by us, or on our behalf. All forward-looking statements attributable to us are expressly qualified by these cautionary statements.
NOTE REGARDING COMPANY REFERENCES
Throughout this Quarterly Report on Form 10-Q, “HeartSciences”, the “Company,” “we,” “us” and “our” refer to Heart Test Laboratories, Inc. References to “Fiscal 2024” refer to the 12 months ending April 30, 2024 and references to “Fiscal 2023” refer to the 12 months ended April 30, 2023.
i
Table of Contents
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PART I. |
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Item 1. |
Condensed Unaudited Financial Statements: |
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Condensed Balance Sheets as of October 31, 2023 and April 30, 2023 |
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Condensed Statements of Operations for the three and six months ended October 31, 2023 and 2022 |
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Condensed Statements of Cash Flows for the six months ended October 31, 2023 and 2022 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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i
1
HEART TEST LABORATORIES, INC.
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Heart Test Laboratories, Inc.
Condensed Balance Sheets
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October 31, |
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April 30, |
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2023 |
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2023 |
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(Unaudited) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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Accounts receivable |
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Inventory, net |
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Prepaid expenses |
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Other current assets |
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Deferred offering costs |
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Total current assets |
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Property and equipment, net |
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Right-of-use assets, net |
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TOTAL ASSETS |
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$ |
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LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
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CURRENT LIABILITIES |
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Accounts payable |
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Accrued expenses |
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Operating lease liabilities |
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Current portion of notes payable net of amortization |
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Other current liabilities |
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Total current liabilities |
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LONG-TERM LIABILITIES |
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Notes payable |
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Accrued expenses |
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Operating lease liabilities, long-term |
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Total long-term liabilities |
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TOTAL LIABILITIES |
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STOCKHOLDERS (DEFICIT) EQUITY |
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Series A, B, and C convertible preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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TOTAL STOCKHOLDERS (DEFICIT) EQUITY |
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TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed unaudited financial statements.
1
2
Heart Test Laboratories, Inc.
Condensed Statements of Operations
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Three months ended October 31, |
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Six months ended October 31, |
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2023 |
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2022 |
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2022 |
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Revenue |
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$ |
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— |
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Cost of sales |
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Gross margin |
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Operating expenses: |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
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Other income (expense) |
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Interest expense |
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Other income |
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Total other (expense) income |
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Net loss |
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Net loss per share, basic and diluted |
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$ |
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Weighted average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these condensed unaudited financial statements.
2
3
Heart Test Laboratories, Inc.
Condensed Statements of Stockholders' Equity (Deficit) (Unaudited)
Three Month Periods Ended October 31, 2023 and 2022
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Series A Convertible |
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Series B Convertible |
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Series C Convertible |
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Total |
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Stock |
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Shares |
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Amount |
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Capital |
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Deficit |
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Deficit |
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BALANCE AT JULY 31, 2023 |
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$ |
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$ |
— |
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$ |
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$ |
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$ |
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Sale of common stock, net of fees |
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— |
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Warrants issued to nonemployees |
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Stock based compensation - management & other employees |
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— |
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Net loss |
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BALANCE AT OCTOBER 31, 2023 |
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$ |
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$ |
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$ |
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BALANCE AT JULY 31, 2022 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Common stock issued upon conversion of Series C Convertible Preferred Stock |
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Stock based compensation - management & other employees |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
BALANCE AT OCTOBER 31, 2022 |
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
The accompanying notes are an integral part of these condensed unaudited financial statements.
3
4
Heart Test Laboratories, Inc.
Condensed Statements of Stockholders' Equity (Deficit) (Unaudited)
Six Month Periods Ended October 31, 2023 and 2022
|
Series A Convertible |
|
|
Series B Convertible |
|
|
Series C Convertible |
|
|
Total |
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Total |
|
||||||||||||||||||||||||
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Stock |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Deficit |
|
||||||||||||
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
BALANCE AT APRIL 30, 2023 |
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Sale of common stock, net of fees |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock issued for consulting services |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock issued upon conversion of Series C Convertible Preferred Stock |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Warrants issued to nonemployees |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Stock based compensation - management & other employees |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
BALANCE AT OCTOBER 31, 2023 |
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
BALANCE AT APRIL 30, 2022 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Sale of common stock and warrants, net of fees |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock issued upon conversion of $1.5M Notes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock issued upon conversion of Bridge Notes and accrued interest |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock issued upon conversion of Series A and B Convertible Preferred Stock |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Common stock issued upon conversion of Series C Convertible Preferred Stock |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Stock based compensation - management & other employees |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Warrants issued to non-employees |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
BALANCE AT OCTOBER 31, 2022 |
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||||
The accompanying notes are an integral part of these condensed unaudited financial statements.
4
5
Heart Test Laboratories, Inc.
Statements of Cash Flows
|
|
Six months ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(Unaudited) |
|
|||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Depreciation |
|
|
|
|
|
|
||
Amortization of debt discounts and deferred financing costs |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Warrants issued to non-employees |
|
|
|
|
|
— |
|
|
Gain on settled accounts payable |
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
|
|
||
Changes in current assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
( |
) |
|
|
|
|
Inventory |
|
|
|
|
|
( |
) |
|
Prepaid and other current assets |
|
|
|
|
|
|
||
Deferred offering costs |
|
|
( |
) |
|
|
|
|
Accounts payable |
|
|
|
|
|
|
||
Accrued liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
||
Purchase of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
||
Issuance of common stock in IPO, net of fees |
|
|
— |
|
|
|
|
|
Issuance of warrants in IPO |
|
|
— |
|
|
|
|
|
Issuance of common stock under Equity Line, net of fees |
|
|
|
|
|
— |
|
|
Issuance of common stock under ATM Facility, net of fees |
|
|
|
|
|
|
||
Proceeds from shareholder note, net |
|
|
|
|
|
— |
|
|
Principal repayments of finance lease obligations |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net change in cash and cash equivalents during the period |
|
|
( |
) |
|
|
|
|
Cash and cash equivalents, beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
SUPPLEMENTAL DISCLOSURES OF NON-CASH TRANSACTIONS: |
|
|
|
|
|
|
||
Issuance of Common Stock for $1.5M Note conversions |
|
$ |
- |
|
|
$ |
|
|
Issuance of Common Stock for Bridge Note and accrued interest conversions |
|
$ |
- |
|
|
$ |
|
|
Issuance of Common Stock for Series A and B Preferred Stock conversions |
|
$ |
- |
|
|
$ |
|
|
Issuance of Common Stock for Series C Preferred Stock conversions |
|
$ |
|
|
$ |
|
||
Warrants issued as underwriter compensation |
|
$ |
- |
|
|
$ |
|
|
Issuance of Common Stock as consideration for consulting services |
|
$ |
|
|
$ |
— |
|
|
Issuance of Common Stock warrants in connection with MSW Note |
|
$ |
|
|
$ |
— |
|
|
Issuance of Common Stock warrants as consideration for consulting services |
|
$ |
|
|
$ |
— |
|
|
Issuance of Common Stock warrants in connection with note extensions |
|
$ |
|
|
$ |
— |
|
|
Financed insurance premiums |
|
$ |
|
|
$ |
|
||
Operating lease assets obtained in exchange for lease obligations |
|
$ |
- |
|
|
$ |
|
|
|
|
|
|
|
|
|
||
The accompanying notes are an integral part of these condensed unaudited financial statements.
5
6
Heart Test Laboratories, Inc.
Notes to Condensed Unaudited Financial Statements
Note 1. Basis of Presentation
Heart Test Laboratories, Inc. d/b/a HeartSciences (“HeartSciences” or the “Company”) is a medical technology company specializing in cardiovascular diagnostic technology. The Company is a Texas corporation and is headquartered in Southlake, Texas.
HeartSciences’ initial focus is on applying novel technology to extend the clinical indications for use of an electrocardiograph (“ECG”) device. HeartSciences’ first product candidate, the MyoVista, is a resting 12-lead ECG that will incorporate HeartSciences’ first AI-based algorithm that is being developed for use in a wide range of clinical settings and is designed to provide diagnostic information to a qualified healthcare professional on cardiac dysfunction which has traditionally only been provided using cardiac imaging. In addition, the MyoVista provides conventional ECG information. The Company plans to market its device, both domestically and internationally to various hospitals, clinics, and medical centers and manufacture the devices using outsourced production facilities. Additionally, the Company plans to deliver AI-based algorithms either through the MyoVista hardware or through a cloud-based platform to provide access to a range of AI-based ECG cardiovascular algorithms on an ECG hardware agnostic basis. To date the Company has had small amounts of revenue from key opinion leader engagement and establishment of distributor relationships outside the United States during the development and product improvement phase of the MyoVista. The Company is preparing to seek U.S. Food and Drug Administration (“FDA”) clearance of the MyoVista during the first half of calendar year 2024.
Note 2. Liquidity, Going Concern and Other Uncertainties
The Company is subject to a number of risks similar to those of early-stage companies, including dependence on key individuals and products, the difficulties inherent in the development of a commercial market, the need to obtain additional capital, competition from larger companies, and other technologies.
The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. At October 31, 2023 and April 30, 2023, the Company had an accumulated deficit of $
In March 2023, the Company entered into a purchase agreement and a registration rights agreement with an institutional investor, providing for the sale, from time to time at the discretion of the Company, of up to $
In September 2023, the Company entered into a Senior Unsecured Promissory Drawdown Loan Note (“MSW Note”) for up to $
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 $
6
7
Based on the Company’s forecasts and cashflow projections, management believes that current resources would be insufficient to fund operations to achieve commercialization. Additionally, the FDA can delay, limit or deny clearance of a medical device for many reasons outside the Company’s control which may involve substantial unforeseen costs.
The Company's continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings and strategic relationships. The Company expects no material commercial revenue in Fiscal 2024. Management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which would likely have a material adverse effect on the Company and its financial statements.
The condensed unaudited financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern for a reasonable period. See subsequent equity raises discussed in Note 9.
Note 3. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“US GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commissions (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements and notes thereto included in the 2023 Annual Report on Form 10-K.
Use of Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. The fair value of cash and cash equivalents approximates carrying value. At times, the Company’s cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”).
Inventory
All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred.
|
|
October 31, |
|
|
April 30, |
|
||
|
|
2023 |
|
|
2023 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Sub-assemblies |
|
|
|
|
|
|
||
Work in progress |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Reserve for obsolescence |
|
|
( |
) |
|
|
( |
) |
Total Inventory |
|
$ |
|
|
$ |
|
||
Inventory consists mainly of raw materials and components used in the current hardware build of the MyoVista. Devices and components are used for research and development purposes and device sales, which to date have been in international markets as sale of the MyoVista in the U.S. is subject to FDA clearance. The Company is partway through a new pivotal clinical validation study and device testing necessary for a revised FDA submission, which is targeted to take place during the first half of calendar year 2024. The Company believes that its hardware platform is in final form, however, prior to FDA clearance and market acceptance of the
7
8
MyoVista, further hardware changes could be necessary which could have an impact on net realizable values. The majority of the Company’s current inventory is intended for use to build finished products following regulatory clearance. Finished products do not contain materials that would degrade significantly over the useable life of the device and are considered to have a useable life of over
Research and Development Expenses
In accordance with ASC Topic 730, Accounting for Research and Development Costs, the Company accounts for research and development expenditures, including payments to collaborative research partners and regulatory filing costs, as research and development expenses. Accordingly, all research and development costs are charged to expense as incurred.
Property and Equipment
Property and equipment are recorded at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives. The range of estimated useful lives used to calculate depreciation is generally
The following is a summary of the Company’s property and equipment at October 31, 2023 and April 30, 2023:
|
|
October 31, |
|
|
April 30, |
|
||
|
|
2023 |
|
|
2023 |
|
||
Equipment |
|
$ |
|
|
$ |
|
||
Furniture & fixtures |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
Deferred Offering Costs
The Company capitalizes certain legal, professional, and other-third party charges, related to capital raises through a sale of Common Stock in its IPO or other ongoing equity financings, as deferred offering costs until fully consummated. On October 16, 2023, the Company filed an S-1/A registration statement which has not yet been declared effective by the SEC. These costs are deferred until the completion of the offerings at which time they are reclassified to additional paid-in-capital as a reduction of the offering proceeds. If the Company terminates the planned offering or there is a significant delay, all of the deferred offering costs will be immediately written off to operating expenses.
On March 10, 2023, the Company entered into the Equity Line. Deferred offering costs associated with the Equity Line are reclassified to additional paid in capital on a pro-rata basis over the term of the agreement.
In September 2023, the Company entered into an EDA to sell its Common Stock under the ATM Facility. Deferred offering costs associated with the ATM Facility are reclassified to additional paid in capital on a pro-rata basis.
As of October 31, 2023 and April 30, 2023, $
Fair Value Measurements
The accounting guidance establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset transaction between market participants on the measurement date. Where available, fair value is based on observable market prices or
8
9
is derived from such prices. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the assignment of an asset or liability within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement.
The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The carrying amounts of the Company’s financial instruments, which primarily include cash and cash equivalents, accounts payable and accrued expenses, approximate their fair values due to their short-term nature. The carrying amounts of the Company’s existing notes payable approximate their fair values at the stated interest rates and are reflective of the prevailing market rates.
Leases
The Company determines if a contract is or contains a lease at inception or modification of a contract. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period in exchange for consideration. Control over the use of the identified asset means the lessee has both (a) the right to obtain substantially all of the economic benefits from the use of the asset and (b) the right to direct the use of the asset. Right-of-use assets and liabilities are recognized based on the present value of future minimum lease payments over the expected lease term at commencement date. The Company measures and records a right-of-use asset and lease liability based on the discount rate implicit in the lease, if known. In cases where the discount rate implicit in the lease is not known, the Company measures the right-of-use assets and lease liabilities using a discount rate equal to the Company’s estimated incremental borrowing rate for loans with similar collateral and duration.
The Company elected to not apply the recognition requirements to leases of all classes of underlying assets that, at the commencement date, have a lease term of
Stock-Based Compensation
The Company accounts for employee and non-employee share-based compensation in accordance with the provisions of ASC 718, Compensation – Stock Compensation. Under ASC 718, share-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense over the requisite service period (generally the vesting period of the equity grant).
The estimated fair value of Common Stock option awards is calculated using the Black-Scholes option pricing model, based on key assumptions such as fair value of Common Stock, expected volatility, and expected term. These estimates require the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free rate and (iv) expected dividend yields. As there has not been a historic public market for the Company’s Common Stock, management has determined the expected stock price volatility at the time of grant of the option by considering a number of objective and subjective factors, including stock price volatility of comparable companies that are publicly available and based on the industry, stage of life cycle, size and financial leverage of such other comparable companies.
Management has estimated the expected term of its Common Stock options using the “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option due to its lack of sufficient historical data. The risk-free interest rates for periods within the expected term of the option are based on the US Treasury securities with a maturity date that commensurate with the expected term of the associated award. There is no expected dividend yield since the Company has never paid cash dividends and does not expect to pay cash dividends in the foreseeable future.
9
10
For stock options issued to employees and non-employees, the fair value of stock-based awards is recognized as compensation expense over the requisite service period, which is defined as the period during which an employee is required to provide service in exchange for an award. The Company uses a straight-line attribution method for all grants that include only a service condition. The Company accounts for forfeitures when they occur. Stock-based compensation expense recognized in the financial statements is reduced by actual awards forfeited.
Net Loss Per Common Share
Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common shareholders by the weighted-average number of shares of Common Stock outstanding during the period, without consideration of potentially dilutive securities.
Diluted net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of Common Stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, convertible preferred stock, stock options, Common Stock subject to repurchase related to early exercise of stock options, convertible stock warrants and convertible notes are considered to be potentially dilutive securities. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods.
Common Stock Warrants
When the Company issues warrants to purchase Common Stock in connection with financing transactions, the warrants are valued based on Black-Scholes models and the fair value is recorded to additional paid-in-capital.
Revenue Recognition
In accordance with ASC 606, Revenue from Contracts with Customers, revenue is recognized when a customer obtains control of promised goods or services. The guidance focuses on the core principle for revenue recognition, which is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company recognizes revenue in accordance with ASC 606, which provides a five-step model for recognizing revenue from contracts with customers as follows:
A contract with a customer exists when (i) the Company enters into a legally enforceable contract with a customer, through a purchase order, that defines each party’s rights regarding the products to be transferred and identifies the payment terms related to these products, (ii) the contract has commercial substance and, (iii) the Company determines that collection of substantially all consideration for products that are transferred is probable based on the customer’s intent and ability to pay the promised consideration. The only performance obligation is to create and ship the product and each product has separate, distinct pricing. Performance obligations are met and revenue is recognized at a point in time when the order for its goods are shipped FOB manufacturer and control is transferred.
The transaction price is determined based on the amount expected to be entitled to in exchange for transferring the product to the customer net of any transaction price adjustments. The Company’s payment terms to customers generally range from
Payment terms fall within the one-year guidance for the practical expedient which allows the Company to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. The Company accepts product returns at its discretion or if the product is defective as manufactured. Historically, the actual product returns have been immaterial to the Company’s financial statements. The Company elected to treat shipping and handling costs as a fulfillment cost and included them in the cost of goods sold as incurred. Costs associated with product sales include commissions. The Company applies the practical expedient and recognizes commissions as expense when incurred because the expense is incurred at a point in time and the amortization period is less than one year. Commissions are recorded as selling expense.
10
11
The Company did not recognize material revenues during the three and six month periods ended October 31, 2023 and 2022. The Company’s revenues do not require significant estimates or judgments. The Company is not a party to contracts that include multiple performance obligations or material variable consideration. As of October 31, 2023 and April 30, 2022, the Company did
Income Taxes
The Company accounts for income taxes under the asset and liability method, which requires recognition of deferred tax assets, subject to valuation allowances, and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. Management considers many factors when assessing the likelihood of future realization of deferred tax assets, including recent cumulative experience by taxing jurisdiction, expectations of future taxable income or loss, the carry-forward periods available to the Company for tax reporting purposes, and other relevant factors.
A valuation allowance is established if it is more likely than not that all or a portion of the net deferred tax assets will not be realized.
Accruals for uncertain tax positions are provided for in accordance with applicable accounting standards. The Company may recognize the tax benefits from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. Judgement is required in assessing the future tax consequences of events that have been recognized in the financial statements or tax returns.
Based on its analysis, management has determined that it has not incurred any liability for unrecognized tax benefits as of October 31, 2023 and April 30, 2022.
The Company may be subject to potential examination by U.S. federal, U.S. states or foreign jurisdiction authorities in the areas of income taxes. These potential examinations may include questioning the timing and amount of deductions, the nexus of income among various tax jurisdictions and compliance with U.S. federal, U.S. state and foreign tax laws.
The Company is subject to income taxes in the U.S. federal jurisdiction and franchise taxes in the State of Texas. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. Generally, the Company is no longer subject to income tax examinations by major taxing authorities for years before 2018.
Note 4. Debt
Debt consists of the following:
|
|
October 31, |
|
|
April 30, |
|
||
|
|
2023 |
|
|
2023 |
|
||
$1M Notes |
|
$ |
|
|
$ |
|
||
MSW Note |
|
$ |
|
|
|
— |
|
|
Less: current maturities |
|
|
( |
) |
|
|
( |
) |
Notes payable, long-term |
|
$ |
— |
|
|
$ |
|
|
$1M Notes and Loan and Security Agreement
In April 2020, the Company entered into a loan and security agreement (the “$1M Loan and Security Agreement”) pursuant to which a secured promissory note in the original principal amount of $
11
12
The $1M Loan and Security Agreement was amended again on November 3, 2021, extending the maturity to
The $1M Loan and Security Agreement was further amended on January 24, 2023 to (i) extend the maturity date of the FRV Note to
The $1M Loan and Security Agreement was further amended on September 29, 2023 to amend the dates on which principal and accrued interest is due under the JQA Note, such that interest accrued since June 28, 2022 will be due and payable on
In November 2023, the principal amount of the JQA Note and accrued interest thereon in the amount of $
The $1M Loan and Security Agreement accrues interest at a rate of
As of October 31, 2023 and April 30, 2023, accrued interest was approximately $
MSW Note
On September 6, 2023, the Company entered into the MSW Note with Matthews Holdings Southwest, Inc., (the “Lender”). The MSW Note provides for an unsecured drawdown loan of up to $
The MSW Note bears no interest, except upon an event of default, at which time, interest accrues at a rate of
In September 2023, the Company drew $
In November 2023, the MSW Note converted into Common Stock of the Company. See further discussion in Note 9.
12
13
Note 5. Stockholders’ (Deficit) Equity
Preferred Stock
The Company authorized
Series C Preferred Stock
The Series C Preferred Stock was originally issued at $
At October 31, 2023 and April 30, 2023, there were
Holders of the Series C Preferred Stock are entitled to receive dividends at an annual rate of $
Each share of Series C Preferred Stock is convertible, at the option of the holder at any time, into such number of fully paid and non-assessable shares of Common Stock determined by dividing the original issue price of $
During the six months ended October 31, 2023,
At December 14, 2023, the Series C Preferred Stock were convertible into
Common Stock
The Company’s Certificate of Formation, as amended, authorizes
During the six months ended October 31, 2023, the Company issued
|
|
Number of Shares |
|
|
Issuance of Common Stock under Equity Line |
|
|
|
|
Issuance of Common Stock under ATM Facility |
|
|
|
|
Issuance of Common Stock as payment for consulting services rendered |
|
|
|
|
Conversion of Series C convertible preferred stock to Common Stock |
|
|
|
|
Issued during the six months ended October 31, 2023 |
|
|
|
|
|
|
|
|
|
Summary table of common stock share transactions: |
|
|
|
|
Balance at April 30, 2023 |
|
|
|
|
Issued in Fiscal 2024 |
|
|
|
|
Balance at October 31, 2023 |
|
|
|
|
On March 10, 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 $
13
14
Lincoln Park to purchase shares of Common Stock, subject to limitations in both volume and dollar amount. The purchase price of the shares that may be sold to Lincoln Park under the agreement is the lower of (i) the lowest sale price on the date of purchase, or (ii) the average of the three lowest closing prices in the prior ten business days. Concurrently with the purchase agreement, the Company entered into a registration rights agreement, pursuant to which the Company filed a registration statement on Form S-1 with the SEC on March 22, 2023. This registration statement was declared effective by the SEC on
On September 18, 2023, the Company entered into an EDA with Maxim Group LLC as sales agent pursuant to which the Company may offer and sell up to $
During the six months ended October 31, 2023, the Company issued
The holders of Common Stock are entitled to receive dividends whenever funds and assets are legally available and when declared by the board of directors, subject to the rights of holders of Preferred Stock outstanding.
Common Stock Warrants
The Company has issued warrants to investors in connection with funding or for services rendered and these warrants are convertible into a number of shares of the Company’s Common Stock for a period of
The following is a summary of warrant activity during the six months ended October 31, 2023:
|
|
Warrants |
|
|
Exercise Price |
|
Weighted Average Strike Price per Share |
|
||
Balance, April 30, 2023 |
|
|
|
|
$ |
|
$ |
|
||
Issued |
|
|
|
|
$ |
|
$ |
|
||
Forfeited |
|
|
( |
) |
|
$ |
|
$ |
|
|
Balance, October 31, 2023 |
|
|
|
|
$ |
|
$ |
|
||
In September 2023, the Company issued warrants in lieu of a facility fee under the MSW Note to purchase
In September 2023, the Company issued warrants to purchase up to
In October 2023, the Company issued $
Note 6. Stock-based Compensation
The Company grants certain employees and board members stock option awards where vesting is contingent upon a service period, as it believes that such awards better align the interests of its employees with those of its shareholders. Stock option awards are granted with an exercise price equal to or above the market price of the Company’s stock at the date of grant. Certain stock option awards provide for accelerated vesting if there is a change in control, as defined in the Nonstatutory Stock Option Agreement. Unvested stock options forfeit when an employee leaves the Company.
14
15
Time-based grants generally vest quarterly based on
2023 Equity Incentive Plan
On March 15, 2023, the Company's Board of Directors adopted the 2023 Equity Incentive Plan (the “Equity Incentive Plan”), subject to shareholder approval. The Equity Incentive Plan provides for the grant of nonstatutory stock options, incentive stock options, restricted stock, restricted stock units, performance units, performance shares, and other share-based awards. Pursuant to the Equity Incentive Plan, the Company is authorized to issue up to
The following is a summary of service-based stock option activity during the six months ended October 31, 2023:
|
|
Number of |
|
|
Weighted |
|
|
Average |
|
|||
Outstanding - April 30, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
Options forfeited |
|
|
( |
) |
|
|
|
|
|
— |
|
|
Outstanding - October 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Non-vested at October 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
Vested at October 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
The following is a summary of performance-based stock option activity during the six months ended October 31, 2023:
|
|
Number of |
|
|
Weighted |
|
|
Average |
|
|||
Outstanding - April 30, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
Options forfeited |
|
|
( |
) |
|
|
|
|
|
— |
|
|
Outstanding - October 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Non-vested at October 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
Vested at October 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|||
As of October 31, 2023, there was approximately $
Note 7. Income Taxes
The tax effects of temporary differences and carry-forwards that give rise to significant portions of the deferred tax assets and liabilities are presented below:
15
16
|
|
October 31, |
|
|
April 30, |
|
||
|
|
2023 |
|
|
2023 |
|
||
Deferred tax assets (liabilities): |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net operating loss carryforwards |
|
$ |
|
|
$ |
|
||
Start-up costs |
|
|
|
|
|
|
||
Stock option and warrant payments |
|
|
|
|
|
|
||
Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Research and development credits |
|
|
|
|
|
|
||
Research and development warrants |
|
|
|
|
|
|
||
Total deferred tax assets, net |
|
|
|
|
|
|
||
Valuation Allowance |
|
|
( |
) |
|
|
( |
) |
Net Deferred Tax Assets |
|
$ |
|
|
$ |
|
||
For the six months ended October 31, 2023 and the year ended April 30, 2023, the Company’s cumulative net operating loss for federal income tax purposes was approximately $
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Based upon the projections for future taxable income over the periods in which the deferred tax assets are deductible, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences, and therefore, a full valuation allowance has been recorded at October 31, 2023 and April 30, 2023.
Note 8. Commitments and Contingencies
Operating Leases
The Company has a long-term operating lease for office, industrial, and laboratory space which was entered into in May 2017.
The Company records right-of-use assets and liabilities at the present value of the fixed lease payments over the term at the commencement date. The Company uses its incremental borrowing rate of
Information related to the Company’s right-of-use assets and lease liabilities consist of the following:
|
|
October 31, |
|
|
|
|
2023 |
|
|
Right-of-use assets |
|
$ |
|
|
|
|
|
|
|
Lease liabilities, current |
|
$ |
|
|
Lease liabilities, net of current portion |
|
|
|
|
Total lease liabilities |
|
$ |
|
|
|
|
|
|
|
Weighted average remaining term (in years) |
|
|
|
|
Weighted average discount rate |
|
|
% |
|
16
17
As of October 31, 2023, future maturities of lease liabilities due under lease agreements for the fiscal year ended are as follows:
2024 (balance of fiscal year) |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Thereafter |
|
|
|
|
Total future lease payments |
|
|
|
|
Less imputed interest |
|
|
( |
) |
Total operating lease liabilities |
|
$ |
|
Litigation
From time to time, the Company may be subject to legal proceedings and claims that arise in the ordinary course of business. The Company does not believe that the outcome of those matters will have a material adverse effect to the financial position, operating results or cash flows. However, there can be no assurance such legal proceedings will not have a material impact.
The Company is not aware of any material claims outstanding or pending against the Company as of October 31, 2023.
Royalty Agreements
In 2013, the Company entered into an agreement (“Technology Agreement”) with its founder, conveying ownership of all intellectual property and rights to the Company. As part of that agreement, the Company will make royalty payments, based upon paid MyoVista device unit sales, as follows:
The royalty obligation has a first priority security interest and pledge on the covered technology (as defined in the Technology Agreement, which essentially is comprised of the intellectual property of the MyoVista device) in priority to the debt holders of the $
Upon (i) the aggregate payment of $
In the event of a bankruptcy of the Company, any balance of the $
In December 2015, the Company entered into an agreement with The University Court of The University of Glasgow (“Glasgow”) for a non-exclusive license of the Glasgow algorithm interpretive analysis for the conventional ECG trace. The agreement was amended in March 2023, and as part of the agreement, the Company is required to make royalty payments, based upon MyoVista device unit sales dependent on sale volumes per year, subject to minimum annual fees. To date, such amounts have been expensed to research and development as the Glasgow algorithm has been part of the device development and will form part of the submission for FDA clearance of the MyoVista device.
Collaboration Agreements
On November 29, 2022, the Company entered into a multi-year Collaboration Agreement with Rutgers, The State University of New Jersey, to develop AI-based ECG algorithms for new or improved ECG indications, which is expected to accelerate our product development pipeline and further expand the clinical value of an ECG for low-cost detection of heart disease.
On September 20, 2023, the Company entered into multiple definitive license agreements (each a “License Agreement” and collectively, the “License Agreements”) with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) to commercialize a range of AI cardiovascular algorithms 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. The License Agreements, of which
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18
there are eleven in total, cover rights to thirteen AI cardiovascular algorithms, two data science methods for use with ECG waveforms and three filed patents.
The closing of the transactions contemplated under the Securities Purchase Agreement (the “MTS Transaction”), dated as of September 20, 2023 (the “Securities Purchase Agreement”), by and between the Company and Mount Sinai, and the effectiveness of the licenses under the License Agreements, are subject to the satisfaction or waiver of certain conditions, including a condition that the Company must complete one or more financings in which the Company receives aggregate gross proceeds of at least $
Note 9. Subsequent Events
The Company has evaluated subsequent events after the balance sheet date of October 31, 2023, through the date of filing.
During November 2023, the Company sold
On November 9, 2023, the Company entered into Amendment No. 1 to the EDA with Maxim, pursuant to which the Company may sell up to $
On November 16, 2023, the Company issued warrants to purchase up to
On November 16, 2023, the Company entered into a note conversion letter agreement with John Q. Adams (the “Adams Note Conversion Letter Agreement”). Pursuant to the Adams Note Conversion Letter Agreement, in consideration for the conversion of the principal and interest in the amounts of $
On November 16, 2023, the Company entered into a note conversion letter agreement with the Lender (the “MSW Note Conversion Letter Agreement”). Pursuant to the MSW Note Conversion Letter Agreement, in consideration for the conversion of the aggregate amount of $
On November 16, 2023, and pursuant to the Securities Purchase agreement, the Company issued to Mount Sinai the following:
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The License Agreements may be terminated by Mount Sinai if the Company does not receive an aggregate gross total proceeds of at least $
On November 27, 2023, the Company's Board of Directors approved and entered into Amendment No. 1 to the Equity Incentive Plan, subject to shareholder approval, to increase the initial number of shares currently issuable under the Plan from
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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 2023 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 2023 Annual Report on Form 10-K.
Overview
We are a medical technology company focused on applying innovative AI-based technology to an ECG, also known as an “EKG,” to expand and improve an ECG’s clinical usefulness. Our objective is to make an ECG a far more valuable cardiac screening tool. HeartSciences’ first product candidate for FDA clearance, the MyoVista, is a resting 12-lead ECG that will incorporate HeartSciences’ first AI-based algorithm designed to provide diagnostic information related to cardiac dysfunction as well as conventional ECG information in the same test. In the future, we intend to incorporate additional AI-based algorithms in the MyoVista and develop a cloud-based platform to provide access to a range of AI-based ECG cardiovascular algorithms on an ECG hardware agnostic basis. The AI-based ECG algorithms provide diagnostic information related to structural heart disease which traditionally has only been available through the use of cardiac imaging. We believe, the MyoVista is particularly well suited for a frontline or point of care clinical setting and the initial revenue model, which involves the use of the MyoVista hardware, associated software and consumables for each test, is expected to be “razor-razorblade” as the cable connection to the electrodes used with the MyoVista are proprietary to HeartSciences, and new electrodes are used for every test performed. As further algorithms are made commercially available via the MyoVista or cloud-based platform we would expect to adopt revenue models based on algorithm usage and/or recurring subscriptions.
On September 20, 2023, we entered into multiple definitive license agreements (each a “License Agreement” and collectively, the “License Agreements”) with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) to commercialize a range of AI-based cardiovascular algorithms 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. The License Agreements, of which there are eleven in total, cover rights to thirteen AI-based cardiovascular algorithms, two data science methods for use with ECG waveforms and three filed patents. These License Agreements closed on December 1, 2023.
Neither the MyoVista hardware, nor any of the AI-based ECG algorithms, are cleared for marketing by the FDA and our future success is dependent upon receiving FDA clearances. Additional funding may be required as part of achieving FDA clearance and thereafter would be required to support the sales launch of the MyoVista into the U.S., provide working capital and support further research and development (“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.
HeartSciences has designed or licensed algorithms to help address these limitations and extend the clinical capability of an ECG to detect cardiac dysfunction or specific cardiovascular disease types. The first AI algorithm to be incorporated into the MyoVista has been designed by the Company and applies AI learning to the signal processed ECG signal to develop a proprietary algorithm designed to detect cardiac dysfunction caused by heart disease and/or age cardiac dysfunction. We recently proposed adjustment of the echocardiographic measurement thresholds to the FDA to reflect recent clinical findings in respect of ≥ 60 year old patients which we
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believe will further increase the clinical value of the algorithm. The FDA has now confirmed this approach and we are in the process of updating our algorithm to reflect these updated echo measurement thresholds. The MyoVista has not yet received FDA clearance.
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.
If we receive FDA clearance for our first product candidates, the MyoVista hardware and its associated cardiac dysfunction algorithm, our main target markets would be frontline healthcare environments in the U.S., such as primary care, 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 cardiac dysfunction to a 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 the MyoVista, require FDA premarket review. The MyoVista 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 and, following feedback and communications with the FDA during and since that submission, we have been making modifications to our device, including our proprietary algorithm. We are part-way through a new, pivotal clinical validation study and have been undertaking device and algorithm development testing for a revised FDA submission. In August 2023, the FDA granted an industry first De Novo clearance and created a new Class II product code for cardiovascular machine learning-based notification software in respect of a hypertrophic cardiomyopathy algorithm and in December 2023 we received confirmation from the FDA that a change to submit the MyoVista, including it’s AI algorithm, under the 510(k) pathway would be acceptable. The 510(k) pathway is more common than De Novo and, on average, has a faster decision process than De Novo by the FDA. As a result, we now expect a revised submission to be filed during the first half of calendar year 2024. Assuming a submission under 510(k) in the first half of calendar year 2024, we would anticipate a determination by the FDA in 2024 which, if successful, would provide the ability to market and sell the MyoVista in the U.S. If successful, additional funding would be required to support the sales launch of the MyoVista in the U.S., provide working capital and support further R&D.
Recent Developments
Compliance with Nasdaq Listing Requirements
On December 21, 2022, we received notice from the Listing Qualifications Staff of The Nasdaq Stock Market, LLC, or 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 $1,082,676 as reported in our Quarterly Report on Form 10-Q for the quarter ended October 31, 2022 was below the required minimum of $2.5 million, and because, as of October 31, 2022, we did not meet the alternative compliance standards, relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.
On February 3, 2023, we submitted to Nasdaq a plan to regain compliance with the Minimum Stockholders’ Equity Requirement. On February 8, 2023, Nasdaq notified us that they granted us an extension of up to 180 calendar days from December 21, 2022, or through June 19, 2023, to regain compliance. On June 20, 2023, we received a delist determination letter from Nasdaq advising us that Nasdaq determined that we did not meet the terms of the extension by the June 19, 2023 deadline.
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On June 27, 2023, we submitted a hearing request to the Nasdaq Hearing Panel (the “Panel”) to appeal the delisting determination. In response to our request for a hearing, on June 27, 2023, we received a letter from Nasdaq stating that its delisting action has been stayed, pending a final decision by the Panel and a hearing will be held on August 17, 2023.
On August 2, 2023, we received a letter from the Listing Qualifications staff of Nasdaq indicating that, based upon the closing bid price of the Company’s Common Stock for the last 30 consecutive business days, the Company no longer met the requirement to maintain a minimum bid price of $1 per share (the “Minimum Bid Price Requirement”). In accordance with Nasdaq listing rules, we have until January 29, 2024 to regain compliance with the Minimum Bid Price Requirement. In the event we do not regain compliance during this period, we may be eligible to seek an additional 180 calendar day compliance period if we meet the Nasdaq continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the Minimum Bid Price Requirement, and provide written notice to Nasdaq of our intent to cure the deficiency during this second compliance period.
The Company attended an August 17, 2023 hearing before the Panel, and requested the continued listing of its securities on the Nasdaq Capital Market pending its return to compliance with the Minimum Stockholder's Equity Requirement and Minimum Bid Price Requirement.
On August 28, 2023, the Company received a decision from the Panel granting the Company's request for continued listing on the Nasdaq Capital Market, subject to the Company demonstrating compliance with the Minimum Stockholders’ Equity Requirement on or before November 21, 2023, and certain other conditions. In addition, the Company has until January 29, 2024, to demonstrate compliance with the Minimum Bid Price Requirement.
On November 22, 2023, the Company was formally notified by the Panel that the Company has demonstrated compliance with the Minimum Stockholders’ Equity Requirement. The Company will be subject to a Mandatory Panel Monitor through November 22, 2024.
Patents
In August 2023, we were issued a notice of patent allowance from the European Patent Office covering quantification by an ECG of key echocardiographic measures of heart function using AI methods.
In September 2023, we were issued a notice of patent allowance from the Brazilian Patent and Trademark Office and the United Arab Emirates Ministry of Economy covering MyoVista wavelet technology utilizing AI for early detection of heart disease.
MSW Note
On September 7, 2023, we entered into the MSW Note with Matthews Southwest Holdings, Inc., for an unsecured drawdown loan of up to $1,000,000, drawn in installments consisting of (i) $250,000 on or prior to September 8, 2023, (ii) $250,000 on or prior to September 20, 2023, and (iii) further drawdowns of up to $500,000 in such amounts and such times to be mutually agreed upon between the Company and Matthews Southwest Holdings, Inc. In September 2023, we drew down $0.5 million pursuant to the terms of the note and issued 1,000,000 warrants to purchase shares of Common Stock in lieu of a facility fee.
On November 16, 2023, we entered into the MSW Note Conversion Letter Agreement with the Lender. Pursuant to the MSW Note Conversion Letter Agreement, in consideration for the conversion of the aggregate principal and interest amount due under the MSW Note, on November 16, 2023, we (i) issued to the Lender 3,125,000 shares of common stock at a conversion price of $0.16 per share; and (ii) entered into the MSW Warrant Amendment Agreement with the Lender, amending the Existing MSW Warrants to reduce the exercise price of an aggregate of 1,000,000 Existing MSW Warrants to $0.16 per share.
Equity Distribution Agreement
On September 18, 2023, we entered into an EDA with Maxim Group LLC as sales agent pursuant to which we may offer and sell up to $3.25 million of our shares of Common Stock in an at-the-market offering. The shares may be issued and sold from time to time through or to the placement agent acting as sales agent or principal pursuant to our shelf registration statement on Form S-3 (the “Shelf S”), as filed with the SEC on September 18, 2023. Pursuant to General Instruction I.B.6 of Form S, we may not sell the shelf securities in a public primary offering with a value exceeding more than one of the aggregate market value of its voting and non-voting ordinary shares held by non-affiliates in any 12 month period as long as the aggregate market value of our outstanding ordinary shares held by non-affiliates is less than $75 million. The $3.25 million shares comprised of Common Stock that may be offered, issued and sold under the at-the-market offering prospectus is included in the $50.0 million of securities that may be offered, issued, and sold by us under the base prospectus of the Shelf S-3. The Shelf S-3 was declared effective by the SEC on September 28, 2023. On November 9, 2023, we entered into Amendment No.1 of the EDA with Maxim pursuant to which, we may issue and sell up to
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$10.0 million worth of shares of Common Stock from time to time through the sales agent. On November 11, 2023, we entered into Amendment No. 2 of the EDA with Maxim pursuant to which, we may issue and sell up to $15.0 million shares of Common Stock through the sales agent. During November and December 2023, we sold 40,175,218 shares of Common Stock under the ATM Facility, receiving gross proceeds of $9.7 million and net proceeds of approximately $9.2 million after Maxim fees, legal fees and other costs.
Debt conversion
As previously disclosed in our Current Report on Form 8-K filed with the SEC on January 24, 2023, we entered into Amendment No. 4 to the $1M Loan and Security Agreement with FRV and John Q. Adams. Pursuant to the $1M Loan and Security Agreement, a secured promissory note in the original principal amount of $500,000 was issued to FRV and a secured promissory note in the original principal amount of $500,000 was issued to John Q. Adams. The Loan and Security Agreement was further amended on September 29, 2023 to amend the dates on which principal and accrued interest is due under the JQA Note. As consideration for such extension, we issued FRV and Mr. Adams $1M Lender Warrants to purchase an aggregate of 200,000 shares of Common Stock at an exercise price of $0.44 per share.
On November 16, 2023, we entered into the Adams Note Conversion Letter Agreements with Mr. Adams. Pursuant to the Adams Note Conversion Letter Agreement, in consideration for the conversion of the principal and interest amounts due under the JQA Note, on November 16, 2023, we: (1) issued 3,656,288 shares of Common Stock to Mr. Adams; and (2) entered into the Adams Warrant Amendment, amending the $1M Lender Warrants owned by Adams to reduce the exercise price of an aggregate of 107,575 $1M Lender Warrants to $0.16 per share.
Mount Sinai Agreement
On September 20, 2023, we entered into the License Agreements with Mount Sinai to commercialize a range of AI cardiovascular algorithms developed by Mount Sinai as well as a memorandum of understanding for ongoing cooperation encompassing de data access, on research, and the evaluation of the MyoVista. The License Agreements, of which there are eleven in total, cover rights to thirteen AI cardiovascular algorithms, two data science methods for use with ECG waveforms and three filed patents.
The closing of the MTS Transaction, dated as of September 20, 2023, by and between us and Mount Sinai, and the effectiveness of the licenses under the License Agreements, are subject to the satisfaction or waiver of certain conditions, including a condition that we must complete the Financing Requirement prior to December 31, 2023. On November 15, 2023, we satisfied the Financing Requirement and, accordingly, the licenses under the License Agreements were deemed effective.
On November 16, 2023, and pursuant to the Securities Purchase agreement, the Company issued to Mount Sinai the following:
The License Agreements may be terminated by Mount Sinai if the Company does not meet the Additional Financing Requirement by June 30, 2024. Registration rights related to the MTS Securities provide that on or prior to the date of one hundred and fifty days (150) days after the closing date, the Company shall prepare and file with the SEC a Registration Statement on Form S-1 (or such other form as applicable) covering the resale under the Securities Act of the MTS Securities issued to Mount Sinai, subject to any limitations imposed by the Nasdaq Rules. On December 1, 2023, the Company satisfied the Additional Financing Requirement.
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.
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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 research and development expenses and selling, general and administrative expenses.
Research and Development Expenses
Our research and development activities primarily consist of clinical, regulatory, engineering and research work associated with our MyoVista device. Research and development expenses include payroll and personnel-related costs for our research and development, clinical and regulatory personnel, including expenses related to stock-based compensation for such employees, consulting services, clinical trial expenses, regulatory expenses, prototyping and testing. Research and development 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 research and development 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 loan facilities and convertible notes.
The following table summarizes our results of operations for the periods presented on our statement of operations data.
|
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Three months ended October 31, |
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|
|
|
|
|
|
Six months ended October 31, |
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|
|
|
|
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|
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|
2023 |
|
|
2022 |
|
|
$ Change |
|
|
% Change |
|
|
2023 |
|
|
2022 |
|
|
$ Change |
|
|
% Change |
|
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|
|
(In thousands, except percentages, unaudited) |
|
|
(In thousands, except percentages, unaudited) |
|
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Revenue |
|
$ |
4 |
|
|
$ |
— |
|
|
$ |
4 |
|
|
|
— |
% |
|
$ |
4 |
|
|
$ |
3 |
|
|
$ |
1 |
|
|
|
22 |
% |
Cost of sales |
|
|
2 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
% |
|
|
2 |
|
|
|
2 |
|
|
|
(1 |
) |
|
|
(25 |
)% |
Gross margin |
|
|
2 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
% |
|
|
2 |
|
|
|
1 |
|
|
|
1 |
|
|
|
104 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
757 |
|
|
|
849 |
|
|
|
(92 |
) |
|
|
(11 |
)% |
|
|
1,323 |
|
|
|
1,283 |
|
|
|
40 |
|
|
|
3 |
% |
Selling, general and administrative |
|
|
815 |
|
|
|
925 |
|
|
|
(110 |
) |
|
|
(12 |
)% |
|
|
1,580 |
|
|
|
1,922 |
|
|
|
(342 |
) |
|
|
(18 |
)% |
Total operating expenses |
|
|
1,572 |
|
|
|
1,774 |
|
|
|
(202 |
) |
|
|
|
|
|
2,903 |
|
|
|
3,205 |
|
|
|
(302 |
) |
|
|
(9 |
)% |
|
Loss from operations |
|
|
(1,570 |
) |
|
|
(1,774 |
) |
|
|
204 |
|
|
|
|
|
|
(2,901 |
) |
|
|
(3,204 |
) |
|
|
303 |
|
|
|
(9 |
)% |
|
Interest expense |
|
|
(178 |
) |
|
|
(33 |
) |
|
|
(146 |
) |
|
|
444 |
% |
|
|
(215 |
) |
|
|
(176 |
) |
|
|
(38 |
) |
|
|
22 |
% |
Other income |
|
|
- |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
(100 |
)% |
|
|
— |
|
|
|
2 |
|
|
|
(2 |
) |
|
|
(100 |
)% |
Other income (expense), net |
|
|
(178 |
) |
|
|
(33 |
) |
|
|
(146 |
) |
|
|
444 |
% |
|
|
(215 |
) |
|
|
(176 |
) |
|
|
(38 |
) |
|
|
22 |
% |
Net loss |
|
$ |
(1,748 |
) |
|
$ |
(1,807 |
) |
|
$ |
58 |
|
|
|
|
|
$ |
(3,115 |
) |
|
$ |
(3,380 |
) |
|
$ |
265 |
|
|
|
(8 |
)% |
|
Summary of Statements of Operations for the three and six months ended October 31, 2023 compared with the three and six months ended October 31, 2022:
Revenues were $4,000 and costs of sales were $2,000 for the three months ended October 31, 2023. Revenues were $4,000 and costs of sales were $2,000 for the six months ended October 31, 2023 compared to revenues of $3,000 and costs of sales of $2,000 for
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the six months ended October 31, 2022. Our revenues to date have been mainly generated in the establishment of distributor relationships outside the United States as part of obtaining feedback during product development and improvement. The decrease in revenue, and related decrease in cost of sales, is due to our proactive reduction in new international distributor engagement in the run up to FDA submission and until we update our certificate of conformity, called a CE Mark, under the new European Union Medical Device Regulation regime to reflect hardware and software improvements being incorporated into the device for FDA submission.
Research and development expenses were $757,000 and $1.3 million for the three and six months ended October 31, 2023, representing a decrease of $92,000, or 11%, and an increase of $40,000, or 3%, when compared to the same periods in 2022. For the three months ended October 31, 2023, decrease is primarily due to reductions in clinical trial related expenditures resulting from the completion of patient enrollment in our clinical study for FDA submission. For the six months ended October 31, 2023, the increase is primarily due to personnel expenses.
Selling, general, and administrative expenses were $815,000 and $1.6 million for the three and six months ended October 31, 2023, representing a decrease of $110,000, or 12%, and a decrease of $342,000, or 18%, when compared to the same periods in 2022. For the three and six months ended October 31, 2023, the decrease is primarily due to reduction in legal expenses, reduced D&O insurance premiums, and related supplier credits.
Interest expense during the three and six months ended October 31, 2023, of $178,000 and 215,000, respectively, is related to interest on the $1M Loan and Security Agreement, warrants issued as consideration for extension of the JQA interest maturity date in October 2023, and interest and debt service amortization related to MSW Note. Interest expense during the three and six months ended October 31, 2022 of $33,000 and $176,000, respectively, is related to interest on the $1M Loan and Security Agreement and debt service amortization related to the Bridge Notes for approximately half of the quarter ended July 31, 2022. All of the Bridge Notes and accrued interest were converted to equity upon consummation of the IPO in June 2022.
Liquidity and Capital Resources
Going Concern Considerations
We have incurred significant losses and have experienced negative cash flows from operations since inception. At October 31, 2023, we had an accumulated deficit of $63.9 million and stockholder's deficit of $1.6 million compared to an accumulated deficit of $60.8 million and stockholder's equity of $0.2 million as of April 30, 2023. At October 31, 2023, we incurred a net loss of $3.1 million for the six month period then ended and a net loss of $3.4 million for the six month period ended October 31, 2022.
During the year ended April 30, 2023, we raised approximately $5.2 million in net proceeds from the sale of Common Stock and Warrants in our IPO and raised approximately $1.3 million from warrant exercises.
On March 10, 2023, we entered into the Lincoln Park Purchase Agreement providing for the purchase, from time to time at our discretion, of up to $15.0 million of our Common Stock, over the 36-month term of the agreement. Actual sales of shares of Common Stock will depend on a variety of factors to be determined by us from time to time. The net proceeds received from these purchases will depend on the frequency and prices at which we sell shares of our Common Stock to Lincoln Park. As of the date of this Quarterly Report, we have received approximately $1.1 million from the sale of Common Stock pursuant to the Lincoln Park Purchase Agreement. We expect that any proceeds received from such sales to Lincoln Park will be used for working capital and general corporate purposes.
On September 18, 2023, we entered into an EDA with Maxim Group LLC as sales agent pursuant to which we may offer and sell up to $3.25 million of our shares of Common Stock in at-the-market offerings. The EDA was further amended on November 9, 2023 and again on November 17, 2023, to increase the amount of shares of Common Stock we may sell to up to $15.0 million. The shares may be issued and sold from time to time through or to the placement agent acting as sales agent or principal pursuant to our shelf registration statement on the Shelf S-3, as filed with the SEC on September 18, 2023. As of the date of this Quarterly Report, we have received approximately $9.2 million in net proceeds, after Maxim fees, legal fees and other costs, from the sale of Common Stock pursuant to the amended EDA. We expect that any proceeds received from such sales under the ATM Facility will be used for working capital and general corporate purposes
In September 2023, the Company entered into the MSW Note for up to $1.0 million, drawn in installments consisting of (i) $0.25 million on or prior to September 8, 2023, (ii) ) $0.25 million on or prior to September 20, 2023, and (iii) further drawdowns of up to $0.5 million in such amounts and such times to be mutually agreed upon between the Company and lender. As of October 31, 2023, the Company has drawn $0.5 million pursuant to the terms of the note. In November 2023, the MSW Note was converted into shares of Common Stock.
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26
As of the date of this Annual Report, we have begun the process of an offering with Maxim Group, for the sale of up to $8.0 million worth of shares of our Common Stock, on a best-efforts basis. This offering has not yet been declared effective by the SEC.
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.
Liquidity
Since our inception, we have raised capital through the public and private sale of debt and equity. As of October 31, 2023, we had cash of approximately $0.1 million and negative working capital of approximately $1.7 million.
The table below presents our cash flows for the periods indicated:
|
|
Six months ended October 31, |
|
|||||
U.S. dollars, in thousands |
|
2023 |
|
|
2022 |
|
||
|
|
(Unaudited) |
|
|||||
Net cash used in operating activities |
|
$ |
(2,392 |
) |
|
$ |
(2,892 |
) |
Net cash (used in) provided by investing activities |
|
$ |
(7 |
) |
|
$ |
(7 |
) |
Net cash provided by financing activities |
|
$ |
839 |
|
|
$ |
5,057 |
|
Net change in cash and cash equivalents during the period |
|
$ |
(1,560 |
) |
|
$ |
2,158 |
|
Operating Activities
Net cash used by our operating activities of $2.4 million during the six months ended October 31, 2023 is primarily due to our net loss of $3.1 million plus $561,000 in non-cash expenses plus $162,000 of net changes in operating assets and liabilities.
Net cash used by our operating activities of $2.9 million during the six months ended October 31, 2022 is primarily due to our net loss of $3.4 million plus $141,000 in non-cash expenses plus $347,000 of net changes in operating assets and liabilities.
Financing Activities
Net cash provided by financing activities of $0.8 million during the six months ended October 31, 2023 is primarily from the issuance of Common Stock under the Equity Line, ATM Facility, and net proceeds from the MSW Note.
Net cash provided by financing activities of $5.1 million during the six months ended October 31, 2022 is primarily from the issuance of Common Stock in our IPO.
From November 1, 2023, through the date of filing, the Company has raised additional capital of approximately $9.3 million, net of fees, from the Equity Line and 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 2023 Annual Report on Form 10-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not required to be provided by a smaller reporting company.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
The Company has adopted and maintains disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized and reported within the time periods specified in the rules of the SEC. The Company's disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to
26
27
management to allow timely decisions regarding required disclosure. Based upon the most recent evaluation of internal controls over financial reporting, our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer) determined that our disclosure controls and procedures were not effective as of October 31, 2023 as a result of identified material weaknesses in our internal control over financial reporting. The identified material weaknesses were as follows: (i) lack of proper approval processes and review processes and documentation for such reviews; (ii) we did not maintain sufficient U.S. GAAP and SEC accounting resources commensurate with those required of a public company; and (iii) insufficient number of staff to maintain optimal segregation of duties and levels of oversight. We have taken and continue to take remedial steps to improve our internal controls over financial reporting, which includes hiring additional accounting and financial reporting personnel and implementing additional policies, procedures, and controls. We cannot assure you that these measures will significantly improve or remediate the material weaknesses described above. Management is monitoring the effectiveness of these and other processes, procedures and controls and will make any further changes deemed appropriate. Management believes the foregoing actions will effectively remediate the material weaknesses, however, our material weaknesses will not be considered remediated until the above controls are in place for a period of time, the controls are tested, and management concludes that these controls are properly designed and operating effectively.
Changes in Internal Control Over Financial Reporting
Except as described above with respect to the remediation steps we are taking, there have been no changes in our internal control over financial reporting during the quarter ended October 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
CEO and CFO Certifications
Exhibits 31.1 and 31.2 to this Quarterly Report are the Certifications of our Chief Executive Officer and Interim Chief Financial Officer, respectively. These Certifications are required in accordance with Section 302 of the Sarbanes-Oxley Act (the “Section 302 Certifications”). This Item 4 of this Quarterly Report, which you are currently reading, is the information concerning the evaluation referred to above and in the Section 302 Certifications and this information should be read in conjunction with the Section 302 Certifications for a more complete understanding of the topics presented.
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28
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
There are no actions, suits, proceedings, inquiries or investigations before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of the Company, threatened against or affecting the Company, our Common Stock, any of our officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect on the Company.
Item 1A. Risk Factors.
For a discussion of risk factors, please refer to Item 1A of our 2023 Annual Report on Form 10-K. There have been no material changes to the risk factors contained in Item 1A of our 2023 Annual Report on Form 10-K. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On November 16, 2023, the Company issued 3,656,288 shares of Common Stock following the conversion of the JQA Note.
On November 16, 2023, the Company issued 3,125,000 shares of Common Stock following the conversion of the MSW Note.
On November 16, 2023, the Company issued 4,854,853 shares of Common Stock pursuant to the MTS Transaction.
There were no other sales of equity securities during the period covered by this Quarterly Report on Form 10-Q that were not registered under the Securities Act and were not previously reported in a Current Report on Form 8-K filed by the Company.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
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29
Item 6. Exhibits.
Exhibit Number |
|
Description |
1.1 |
|
|
1.2 |
|
|
1.3 |
|
|
1.4 |
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
3.4 |
|
|
3.5 |
|
|
4.1 |
|
|
4.2 |
|
|
4.3 |
|
|
4.4 |
|
|
4.5 |
|
|
4.6 |
|
|
4.7 |
|
|
4.8 |
|
|
4.9 |
|
|
4.10 |
|
|
4.11 |
|
|
4.12 |
|
|
4.13 |
|
|
4.14 |
|
|
4.15 |
|
29
30
4.16 |
|
|
10.1 |
|
|
10.2 |
|
|
10.3 |
|
|
10.4 |
|
|
10.5 |
|
|
10.6 |
|
|
10.7 |
|
|
10.8 |
|
|
10.9 |
|
|
10.10 |
|
|
10.11 |
|
|
10.12 |
|
|
10.13 |
|
|
10.14 |
|
|
10.15 |
|
|
10.16 |
|
|
10.17 |
|
|
10.18 |
|
|
10.19 |
|
|
10.20 |
|
|
10.21 |
|
|
10.22 |
|
|
10.23 |
|
30
31
10.24 |
|
|
10.25 |
|
|
10.26† |
|
|
10.27† |
|
|
10.28† |
|
|
10.29 |
|
|
10.30 |
|
|
10.31 |
|
|
10.32 |
|
|
10.33 |
|
|
10.34 |
|
|
10.35 |
|
|
10.36 |
|
|
10.37 |
|
|
10.38 |
|
|
10.39 |
|
|
10.40 |
|
|
10.41 |
|
|
10.42 |
|
|
10.43 |
|
|
10.44 |
|
|
10.45 |
|
|
10.46 |
|
|
10.47 |
|
|
10.48 |
|
31
32
31.1* |
|
|
31.2* |
|
|
32.1** |
|
|
32.2** |
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
101.INS* |
|
Inline XBRL Instance Document |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
* Filed herewith
** Furnished herewith
† Management contract or compensatory arrangement
32
33
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
Heart Test Laboratories, Inc. |
|
|
|
|
|
Date: December 14, 2023 |
|
By: |
/s/ Andrew Simpson |
|
|
Name: |
Andrew Simpson |
|
|
Title: |
President, Chief Executive Officer, and Chairman of the Board of Directors (Principal Executive Officer) |
|
|
|
|
Date: December 14, 2023 |
|
By: |
/s/ Danielle Watson |
|
|
Name: |
Danielle Watson |
|
|
Title: |
Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer) |
|
|
|
|
33
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Andrew Simpson, certify that:
Date: December 14, 2023 |
|
By: |
/s/ Andrew Simpson |
|
|
|
Andrew Simpson |
|
|
|
President, Chief Executive Officer, and Chairman of the Board of Directors (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Danielle Watson, certify that:
Date: December 14, 2023 |
|
By: |
/s/ Danielle Watson |
|
|
|
Danielle Watson |
|
|
|
Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Heart Test Laboratories, Inc. (the “Company”) for the period ended October 31, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Andrew Simpson, as the Chief Executive Officer of the Company, hereby, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
Date: December 14, 2023 |
|
By: |
/s/ Andrew Simpson |
|
|
|
Andrew Simpson |
|
|
|
President, Chief Executive Officer, and Chairman of the Board of Directors (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Heart Test Laboratories, Inc. (the “Company”) for the period ended October 31, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Danielle Watson, as the Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
Date: December 14, 2023 |
|
By: |
/s/ Danielle Watson |
|
|
|
Danielle Watson |
|
|
|
Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer) |