STOCK TITAN

Glucotrack, Inc. (NASDAQ: GCTK) targets LT-100 single-injection study in 2026

(High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Glucotrack, Inc., through its wholly owned subsidiary Lōkahi Therapeutics, reported progress on the development strategy for LT-100, aiming to simplify dosing from a historical regimen of up to 15 intradermal injections per treatment visit to a single subcutaneous injection per visit.

In a Type C meeting with the U.S. Food and Drug Administration in May 2026, the company discussed its proposed clinical strategy. A subsequent nonclinical minipig study comparing systemic exposure for subcutaneous versus intradermal administration provided information supporting planned clinical evaluation of the single-injection approach. Subject to ongoing development activities and regulatory review, clinical evaluation of single-injection LT-100 is anticipated as early as the fourth quarter of 2026, with a potential initial readout during the first half of 2027.

Positive

  • None.

Negative

  • None.

Insights

Analyzing...

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Historical LT-100 injections per visit up to 15 intradermal injections Historical clinical trials administration of LT-100 per treatment visit
Planned LT-100 injections per visit single subcutaneous injection Target administration approach being evaluated for LT-100
Type C meeting date May 2026 Meeting with U.S. Food and Drug Administration on LT-100 strategy
Planned clinical evaluation start fourth quarter of 2026 Anticipated initiation of clinical evaluation of single-injection LT-100
Potential initial readout first half of 2027 Potential initial data from clinical evaluation of single-injection LT-100
Type C meeting regulatory
"During a <b>Type C meeting</b> with the U.S. Food and Drug Administration in May 2026"
intradermal medical
"historical administration approach requiring up to 15 <b>intradermal</b> injections per treatment visit"
Intradermal means delivering a drug or vaccine into the middle layer of the skin rather than into muscle or under the skin. Investors care because this delivery route can change how much of a product is needed, how fast it works, and what safety or regulatory testing is required—similar to placing a small patch inside the layers of a cake to get a different effect than spreading it on top.
subcutaneous medical
"can be simplified to a single <b>subcutaneous</b> injection per visit"
Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.
systemic exposure medical
"study designed to compare <b>systemic exposure</b> following subcutaneous and intradermal administration"
Systemic exposure refers to the level of risk that an individual or organization faces from potential problems within the entire financial system. It is like the amount of water in a boat that could be affected if the boat’s hull develops a leak; the more exposed, the greater the potential impact from widespread issues. Understanding systemic exposure helps investors gauge how vulnerable they might be to large-scale financial disruptions.
Investigational Device medical
"The Glucotrack CBGM is an <b>Investigational Device</b> and is limited by federal law"
An investigational device is a medical instrument, implant, or tool that is being tested in humans but has not yet received full regulatory approval for general use. Think of it as a prototype on a monitored test drive: investors watch these devices closely because trial results, safety findings, and approval decisions determine whether the product can reach patients, generate revenue, or create regulatory and commercial risk.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Learn about SEC filing dates

FAQ

What did Glucotrack (GCTK) announce about LT-100 in this 8-K?

Glucotrack, through Lōkahi Therapeutics, announced development progress on LT-100, focusing on simplifying administration from up to 15 intradermal injections per visit to a single subcutaneous injection, supported by an FDA Type C meeting and a nonclinical minipig study.

How is Lōkahi Therapeutics changing LT-100 administration for Glucotrack (GCTK)?

Lōkahi is evaluating whether LT-100 can shift from up to 15 intradermal injections per treatment visit to one subcutaneous injection. The goal is to maintain systemic exposure consistent with prior clinical experience while simplifying the administration strategy for future clinical development.

What is the planned clinical timeline for LT-100 under Glucotrack (GCTK)?

The company currently anticipates initiating clinical evaluation of single-injection LT-100 as early as the fourth quarter of 2026, with an initial readout potentially occurring during the first half of 2027, subject to ongoing development activities and regulatory review.

What was discussed in the FDA Type C meeting regarding Glucotrack (GCTK) asset LT-100?

In a Type C meeting with the U.S. Food and Drug Administration in May 2026, the company discussed its proposed clinical strategy for LT-100. This interaction helped define a path forward for evaluating a single subcutaneous injection administration approach in future clinical studies.

What is Lōkahi Therapeutics’ role within Glucotrack (GCTK)?

Lōkahi Therapeutics is a wholly owned subsidiary of Glucotrack and operates as a biopharmaceutical platform focused on overlooked therapeutic assets. It uses its ai² platform and ai² Futures Lab execution model to evaluate, acquire, and advance such assets, including LT-100.

What other technologies is Glucotrack (GCTK) developing besides LT-100?

Beyond LT-100, Glucotrack, through its subsidiary Glucotrack Technologies, is developing a long-term implantable continuous blood glucose monitoring system. The Glucotrack CBGM is described as an Investigational Device limited by U.S. federal law to investigational use.

What key risks does Glucotrack (GCTK) highlight in connection with LT-100 and its business?

Glucotrack cites risks including the need to raise additional capital, merger integration risks, timing and receipt of regulatory approvals, clinical trial enrollment and conduct, future distribution agreements, ability to hire and retain personnel, and other risks described in its SEC filings.
false 0001506983 0001506983 2026-07-29 2026-07-29 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): July 29, 2026

 

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 July 29, 2026, Glucotrack, Inc., a Delaware corporation (the “Company”), issued a joint press release with Lokahi Therapeutics Inc (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 July 29, 2026
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: July 30, 2026  
   
  GLUCOTRACK, INC.
     
  By: /s/ Erik Emerson
  Name: Erik Emerson
  Title: Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

Lōkahi Therapeutics™ Advances LT-100 Development Strategy Toward Single-Injection Administration

 

FDA Type C Meeting and Nonclinical Study Advance Strategy to Transition LT-100 from 15 Injections to One

 

RUTHERFORD, N.J., and LA JOLLA, CA, July 29, 2026 – Lōkahi Therapeutics™ Inc., a wholly owned subsidiary of Glucotrack, Inc. (NASDAQ: GCTK), today announced progress in its LT-100 development strategy focused on evaluating whether a historical administration approach requiring up to 15 intradermal (ID) injections per treatment visit can be simplified to a single subcutaneous (SC) injection per visit. During a Type C meeting with the U.S. Food and Drug Administration in May 2026, the Company discussed its proposed clinical strategy for LT-100. Following that meeting, Lōkahi completed a nonclinical minipig study designed to compare systemic exposure following subcutaneous and intradermal administration of LT-100. The results provided important information to support the Company’s planned clinical evaluation of a single-injection administration approach.

 

Building on the Type C meeting and the results of the nonclinical study, Lōkahi is preparing for the next phase of LT-100 development, which is expected to include clinical evaluation of LT-100 administered as a single subcutaneous injection. Subject to completion of ongoing development activities and regulatory review, the Company currently anticipates initiating clinical evaluation of this administration approach as early as the fourth quarter of 2026, with an initial readout potentially occurring during the first half of 2027.

 

Historically, in clinical trials, LT-100 has been administered through up to 15 intradermal injections per treatment visit. Lōkahi’s current development objective is to determine whether that administration approach can be simplified to a single subcutaneous injection while maintaining a development strategy informed by prior clinical experience.

 

“The difference between 15 injections and one injection speaks for itself,” said Erik Emerson, Chief Executive Officer of Lōkahi Therapeutics™. “The Type C meeting helped define a path forward. We then completed the work necessary to evaluate that path, and the results give us confidence to move toward clinical evaluation of this simplified administration strategy. Our focus now is preparing to test this approach in the clinic.”

 

 

 

 

“Our objective was straightforward,” said Susan Kramer, Senior Vice President of Development at Lōkahi Therapeutics™. “We wanted to understand whether subcutaneous administration could achieve systemic exposure consistent with prior clinical experience using intradermal administration. The study provided this and other important information to guide the next stage of LT-100 clinical development.”

 

About Lōkahi Therapeutics™

 

Lōkahi Therapeutics is a capital-efficient biopharmaceutical platform company focused on identifying, evaluating, acquiring, and advancing overlooked therapeutic assets. Through its ai² platform and ai² Futures Lab execution model, Lōkahi integrates cross-functional expertise and disciplined decision-making to drive strategic development and long-term value creation. For more information, visit www.lokahithera.com.

 

About Glucotrack, Inc.

 

Glucotrack, Inc. (NASDAQ: GCTK) operates Lōkahi and, through its subsidiary Glucotrack Technologies, Inc., is also focused on the design, development, and commercialization of novel technologies for people with diabetes, including a long-term implantable continuous blood glucose monitoring system. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use. For more information, please visit 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 “anticipate”, “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 merger integration; 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; 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, 2025 as filed with the SEC on March 30, 2026.

 

Contact:

 

Glucotrack

 

GlucotrackPR@icrinc.com

 

Lōkahi Therapeutics™

 

ir@lokahithera.com

 

 

 

Filing Exhibits & Attachments

6 documents