Form 8-K - Current report

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 14, 2023

Heart Test Laboratories, Inc.

(Exact name of Registrant as Specified in Its Charter)


Texas	001-41422	26-1344466
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

550 Reserve Street, Suite 360
Southlake, Texas		76092
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 682 237-7781

n/a

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	HSCS	The Nasdaq Stock Market LLC
Warrants	HSCSW	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On September 14, 2023, Heart Test Laboratories, Inc. (the "Company") issued a press release providing information regarding the Company's financial and operating results for the quarter ended July 31, 2023, and other business updates. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information contained in Item 2.02 of this report and Exhibit 99.1 to this report shall not be deemed to be "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), and shall not be incorporated by reference into any filings made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.


Exhibit No.		Description
99.1		Press Release dated September 14, 2023
Exhibit 104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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 hereunto duly authorized.


			HEART TEST LABORATORIES, INC.

Date:	September 14, 2023	By:	/s/ Andrew Simpson
		Name: Title:	Andrew Simpson President, Chief Executive Officer and Chairman of the Board of Directors

Exhibit 99.1

HeartSciences Reports First Quarter Fiscal 2024 Financial Results

Southlake, TX, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today provided a business update and reported financial results for the first quarter fiscal 2024 ended July 31, 2023.

Key Milestones during Fiscal Q1 2024 and to date:

•

Appointed FJ Medical as distributor for the Nordic countries of Denmark, Sweden, Norway and Finland;

•

Engaged MedPhy Technologies as importer and distributor of MyoVista® wavECG™ and related supplies in India;

•

Selected by PanaceaFlo Ltd to be used in its frontline cardiovascular risk screening evaluation study in Ireland. Initial screening to include 250 patients, in collaboration with the innovation Value Institute and Maynooth University College, Kildare;

•

Adopted in commercial, clinical use with focus on preventative screening and diagnostics by Naya Imaging Center in Hvidore, Denmark;

•

Expanded intellectual property portfolio, bringing total patents to 41 (nine U.S., 32 internationally); and

•

Completed patient enrollment for the MyoVista® multi-center pivotal study; targeting FDA submission in late 2023.

Andrew Simpson, Chief Executive Officer of HeartSciences, said, “We welcomed our fiscal year 2024 with key advancements on our objective to become the technology of choice in frontline healthcare settings to help physicians screen and diagnose at risk patients earlier, with MyoVista® used in commercial, clinical practice settings for preventative care, as well as in clinical studies evaluating for cardiovascular risk screening.” Mr. Simpson added, “Despite the significant limitations for conventional ECG, we estimate the global diagnostic ECG market at $10 billion. By bringing new clinical capabilities to the ECG, we believe HeartSciences is at the forefront as we integrate AI technology to make the ECG a more valuable tool for heart disease screening and detection, potentially increasing the addressable market manyfold. We are targeting FDA submission of MyoVista® in late 2023 and are focused on increasing market awareness of our technology.”

There were no revenues for the first quarter of fiscal year 2024. As of July 31, 2023, cash and cash equivalents were approximately $576,000. In March 2023, the Company entered into an Equity Line with an institutional investor, providing for periodic sales of up to $15.0 million of the Company’s common stock at its sole discretion and, in September 2023, the Company entered into a senior unsecured promissory note for drawdowns up to $1,000,000. The Company continues to carefully manage costs.

Complete financial results have been filed in a Form 10-Q with the Securities and Exchange Commission and is available on the Company’s website.

About HeartSciences

Heart Test Laboratories, Inc. d/b/a HeartSciences is 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. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making an ECG a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. The business model, which involves the use of the MyoVista® Device and consumables for each test, is expected to be "razor-razorblade" as the electrodes used with the MyoVista® are proprietary to HeartSciences, and new electrodes are required for every test performed.

For more information, please visit: https://www.heartsciences.com. Twitter: @HeartSciences

Contacts:

HeartSciences
Gene Gephart
+1-737-414-9213 (US)
info@heartsciences.com

Investors
Gilmartin Group
Vivian Cervantes
investorrelations@heartsciences.com

Document And Entity Information	Sep. 14, 2023
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 14, 2023
Entity Registrant Name	Heart Test Laboratories, Inc.
Entity Central Index Key	0001468492
Entity Emerging Growth Company	true
Securities Act File Number	001-41422
Entity Incorporation, State or Country Code	TX
Entity Tax Identification Number	26-1344466
Entity Address, Address Line One	550 Reserve Street, Suite 360
Entity Address, City or Town	Southlake
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	76092
City Area Code	682
Local Phone Number	237-7781
Entity Information, Former Legal or Registered Name	n/a
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock
Trading Symbol	HSCS
Security Exchange Name	NASDAQ
Warrant [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrants
Trading Symbol	HSCSW
Security Exchange Name	NASDAQ