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): December 3, 2024

GLUCOTRACK, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-41141	98-0668934
(State or Other Jurisdiction	(Commission	(IRS Employer
of Incorporation)	File Number)	Identification No.)

301 Rte 17 North, Ste. 800, Rutherford, NJ		07070
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (201) 842-7715

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 (see General Instruction A.2. below):

☐	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		GCTK		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 (17 CFR § 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).

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 7.01 Regulation FD Disclosure

On December 3, 2024, Glucotrack, Inc., a Delaware corporation (the “Company”) issued a press release (the “Press Release”) announcing the commencement of patient enrollment for the Company’s short-term human clinical study of its continuous blood glucose monitor. The Press Release is furnished as Exhibit 99.1 and incorporated into this Item 7.01 by reference.

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference into any filing with the Securities and Exchange Commission, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.		Description
99.1		Press Release, dated December 3, 2024
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.

Date: December 3, 2024

	GLUCOTRACK, INC.

	By:	/s/ Paul Goode
	Name:	Paul Goode
	Title:	Chief Executive Officer

Exhibit 99.1

GLUCOTRACK ANNOUNCES START OF ENROLLMENT FOR HUMAN CLINICAL STUDY OF CONTINUOUS BLOOD GLUCOSE MONITOR

Feasibility study underway for the Company’s novel continuous blood glucose monitor in patients with diabetes, with data expected within 6-8 weeks

Rutherford, NJ, December 3, 2024 (GLOBE NEWSWIRE) — Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, has announced the commencement of patient enrollment for its short-term human clinical study. The study will focus on the Company’s continuous blood glucose monitor (“CBGM”) and will include participants with both type 1 and type 2 diabetes. Data from the study is expected to be available within 6-8 weeks.

Unlike traditional continuous glucose monitors that measure glucose levels in interstitial fluid, Glucotrack’s CBGM measures glucose directly from blood, aiming to provide real-time readings without the lag time typically associated with interstitial glucose measurements. The CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution.

The prospective, single arm study is a short-term in-hospital study in which the CBGM sensor will be placed intravascularly for a period of four days. Study participants, who have been diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy, will participate in several fixed meal and glucose challenges during the study period.

The study is being conducted under Principal Investigator Dr. Alexandre Abizaid, MD, PhD. Dr. Abizaid is the Director of Interventional Cardiology at Instituto do Coração in São Paulo, Brazil, and a Visiting Professor of Medicine at Columbia University Medical Center in New York City. He is a key faculty member of the Cardiovascular Research Foundation in New York and a world-renowned interventional cardiologist who has conducted numerous first in human clinical studies in the cardiology field. The study will be conducted at Instituto do Coração (InCor) of the Hospital das Clínicas of Faculdade de Medicina da Universidade de São Paulo, which is widely considered the best cardiology hospital in Brazil and Latin America, according to Newsweek.

“Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM,” said Paul V. Goode, PhD, President & Chief Executive Officer of Glucotrack. “We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes.”

For more information about Glucotrack’s CBGM, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.

# # #

About Glucotrack, Inc.

Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.

Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024.

Contacts:

Investor Relations:

investors@glucotrack.com

Lisa Wilson

In-Site Communications

T: 917-543-9932

E: lwilson@insitecony.com

Media:

GlucotrackPR@icrinc.com

Cover	Dec. 03, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 03, 2024
Entity File Number	001-41141
Entity Registrant Name	GLUCOTRACK, INC.
Entity Central Index Key	0001506983
Entity Tax Identification Number	98-0668934
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	301 Rte 17 North
Entity Address, Address Line Two	Ste. 800
Entity Address, City or Town	Rutherford
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07070
City Area Code	(201)
Local Phone Number	842-7715
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	GCTK
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false