[8-K] GlucoTrack, Inc. Reports Material Event

Rhea-AI Filing Summary

Cingulate Inc. (Nasdaq: CING, CINGW) filed a Form 8-K dated August 6 2025. Item 7.01 furnishes a press release (Ex. 99.1) disclosing that the company submitted a New Drug Application (NDA) to the U.S. FDA on July 31 2025 for CTx-1301 (dexmethylphenidate), its lead product candidate for attention-deficit/hyperactivity disorder (ADHD). Item 8.01 repeats the NDA submission detail as an “Other Event.” No financial results, earnings data, or major transactions are included. The filing does not categorize the furnished information as “filed,” thereby limiting Section 18 liability and incorporation by reference. Exhibit 104 provides the Inline XBRL cover page data.

Aside from the NDA disclosure, the 8-K contains standard securities registration, emerging-growth-company status, and signature blocks. There are no updates on review timelines, commercial plans, financing, or guidance.

Positive

• NDA submission for lead ADHD asset CTx-1301 marks advancement toward potential FDA approval.

Negative

• None.

Insights

Biotech Equity Analyst

TL;DR: NDA filing advances CTx-1301 toward FDA review; no financials disclosed.

Furnishing the NDA submission via Form 8-K signals regulatory progress for Cingulate’s lead ADHD candidate but provides no revenue, cost, or cash-runway metrics investors typically need to assess valuation or dilution risk. Because the information is furnished, not filed, it limits legal exposure while informing markets. Materiality depends on FDA acceptance and review outcomes, which remain undisclosed. In isolation, the event is directionally positive; however, its financial impact cannot yet be quantified.

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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): August 6, 2025

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, par value $0.001 per share		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 August 6, 2025, Glucotrack, Inc., a Delaware corporation (the “Company”), issued a press release (the “Press Release”). The Press Release is furnished herewith as Exhibit 99.1.

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 (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated August 6, 2025
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: August 6, 2025
	GLUCOTRACK, INC.
	By:	/s/ Paul Goode
	Name:	Paul Goode
	Title:	Chief Executive Officer

FAQ

What did Cingulate Inc. (CING) announce in its August 6 2025 Form 8-K?

The company reported that it submitted an NDA to the FDA on July 31 2025 for CTx-1301, its lead ADHD therapy.

Which FDA submission was disclosed in the filing?

An NDA (New Drug Application) for CTx-1301 (dexmethylphenidate) targeting ADHD.

Does the 8-K include any financial results or guidance?

No. The filing contains no financial statements, earnings data, or forward-looking guidance.

Is the information in Item 7.01 considered "filed" with the SEC?

No. The company states the Item 7.01 disclosure is "furnished," not "filed," limiting liability under Section 18.

What exhibits accompany this Form 8-K?

Exhibit 99.1 is the press release dated August 6 2025; Exhibit 104 is the Inline XBRL cover page file.