GCTK

New in FY2025

• Our first product was removed from international markets as the Company withdrew its CE Mark by 2023.
• As of 2023, all commercialization and development efforts ceased of the first product.
• Our second and novel new product, Glucotrack CBGM, has not been approved for marketing in the United States or internationally and is currently under preclinical development.
• Our net losses for the years ended December 31, 2025 and 2024 were approximately $19.4 million and $22.6 million, respectively, and we had an accumulated deficit of approximately $151.8 million as of December 31, 2025.
• When we evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully.
• We anticipate that, as our operations expand and, assuming that our development, testing, pre-clinical studies and human clinical trials are successful, we will need to build and develop our marketing and sales capabilities.
• Maintaining and managing our future growth will impose significant added responsibilities on members of our management team.
• We have incurred net losses and negative cash flows from our operations and comprehensive loss since our inception and as of December 31, 2025, we had an accumulated deficit of $151.8 million.
• As of December 31, 2025, we had cash and cash equivalents of $7.4 million.
• There are no assurances that we will be able to raise additional capital or do so on terms favorable to us.
• Our recurring losses from operations and projected future cash flow requirements raise substantial doubt about our ability to continue as a going concern without sufficient capital resources and we have included explanatory information in the notes to our financial statements for the year ended December 31, 2025, with respect to this uncertainty, and the report of our independent registered public accounting firm with respect to our audited financial statements for the year ended December 31, 2025 included an emphasis of matter for this as well.
• Our consolidated financial statements do not include any adjustments that might result from the outcome of this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
• Our ability to continue as a going concern is dependent on our available cash, how well we manage that cash, and our operating requirements.
• If we are unable to raise additional capital when needed, we could be forced to curtail operations or take other actions such as implementing additional restructuring and cost reductions, disposing of one or more product lines and/or, selling or licensing intellectual property.
• If we are unable to continue as a going concern, we may be forced to liquidate our assets, which would have an adverse impact on our business and developmental activities.
• In such a scenario, the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.
• We will be required to demonstrate through multiple well-controlled clinical trials that Glucotrack CBGM or future product candidates, if any, are safe and effective for their intended uses.
• In addition, any of these regulatory authorities may also clear or approve a product candidate for fewer or more limited patient populations than we request or may grant clearance or approval contingent on the performance of costly post-marketing clinical trials.
• We are highly dependent on the success of our primary product candidate, Glucotrack CBGM, and cannot give any assurance that it will receive regulatory approval or clearance or be successfully commercialized.
• We are highly dependent on the success of our primary product candidate, Glucotrack CBGM.
• We believe that our ability to successfully compete will depend on, among other things: ● our ability to have partners manufacture and sell commercial quantities of any approved products to the market; ● acceptance of product candidates by physicians and other health care providers; ● the results of our clinical trials; ● our ability to recruit and enroll patients for our clinical trials; ● the efficacy, safety, performance and reliability of our product candidates; ● the speed at which we develop product candidates or required iterations thereon; ● our ability to obtain prompt and favorable FDA review and approval of an IDE to conduct our clinical trials; ● our ability to obtain prompt and favorable IRB review and approval at each of our clinical sites; ● our ability to commercialize and market any of our product candidates that may receive regulatory clearance or approval; ● our ability to design and successfully execute appropriate clinical trials; ● the timing and scope of regulatory clearances or approvals; ● appropriate coverage and adequate levels of reimbursement under private and governmental health insurance plans, including Medicare; and ● our ability to protect intellectual property rights related to our products.
• While GLP-1s have been used as a companion product in conjunction with CGM systems, such drugs could potentially compete with the Glucotrack CBGM and impact successful commercialization particularly as it applies to patients with Type 2 diabetes not dependent on insulin as well as those with pre-diabetes conditions.
• The completion of clinical trials in connection with our application for FDA approval could also be substantially delayed or prevented by several factors, including: ● delay or failure to obtain FDA IDE approval or renewal of such approval to conduct a clinical trial; ● slower than expected rates of patient recruitment and enrollment; ● failure of patients to complete the clinical trial; ● unforeseen safety issues; ● lack of efficacy evidenced during clinical trials; ● termination of clinical trials by one or more clinical trial sites; ● inability or unwillingness of patients or medical investigators to follow clinical trial protocols; ● inability to monitor patients adequately during or after the clinical study period; and, ● inability to meet safety and efficacy endpoints required by the FDA for market clearance.
• Our clinical trials may be suspended or terminated at any time by the FDA, other regulatory authorities, and/or the IRB for any given site or us.
• Any failure or significant delay in completing clinical trials for the Glucotrack CBGM or future product candidates, if any, could materially harm our financial results and the commercial prospects for our product candidates.
• Regulatory approval of a Class III medical device is not guaranteed, and the approval will take several years when factoring in clinical trial timelines.
• We believe that the degree of market acceptance will depend on a number of factors, including: ● timing of market introduction of competitive products; ● safety and efficacy of our product; ● prevalence and severity of any side effects; ● potential advantages or disadvantages over alternative treatments; ● strength of marketing, sales, and distribution support; ● price of our product candidates, both in absolute terms and relative to alternative treatments; and ● availability of coverage and reimbursement from government and other third-party payors.
• If the Glucotrack CBGM or our future product candidates, if any, fail to achieve sufficient reimbursement and coverage, we may not be able to generate significant revenue or achieve or sustain profitability.
• The reimbursement status and coverage of newly cleared or approved medical devices is uncertain, and failure to obtain adequate coverage and adequate reimbursement could limit our ability to market Glucotrack CBGM or future product candidates, if any, and may inhibit our ability to generate revenue from Glucotrack CBGM or our future product candidates, if any, that may be cleared or approved.
• We currently do not maintain product liability insurance in the United States and maintain product liability insurance in Australia up to $10.0 Million AUS Dollars per claim and in the aggregate.
• Regardless of whether we maintain product liability insurance coverage in any jurisdiction, including Australia or in the future the United States, we may be required to pay amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
• We do not own or operate manufacturing facilities for clinical or commercial production of Glucotrack CBGM, other than a research and prototyping lab.
• We, therefore, lack the internal capability to manufacture the Glucotrack CBGM on a commercial scale.
• The funding that we received through the Israeli Innovation Authority (“IIA”) for research and development activities restricts our ability to manufacture products or to transfer technology outside of Israel of its first product which we have taken off the market and no longer have available for sale.
• In 2023, the Company abandoned pursuit of its Israeli originated first generation product development programs, including the abandonment of any associated intellectual property and intangible assets.
• The Company is solely focused on its second product, which is uniquely designed and patented, under product and clinical development efforts in the United States.
• The Company’s Israeli subsidiary is in the process of dissolution and does not conduct any operating activities.
• On March 4, 2004, the IIA agreed to provide us with a grant of 420,000 New Israeli Shekels (“NIS”), or approximately $93 thousand at an exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive blood glucose monitor (the “development plan”).
• Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.
• Factors such as geopolitical events (including the ongoing wars in Iran, Ukraine and Israel and the risk of increased tensions between China and Taiwan), inflationary pressures, public health crises, and U.S. election cycles, and changes in government administration and policies have caused extreme volatility and disruptions in the capital and credit markets in recent years.

and 47 more.

Gone since FY2024

• Our initial product, Glucotrack CBGM, has not been approved for marketing in the United States and is currently under preclinical development.
• We continue to incur research and development and selling, marketing and general and administrative expenses related to our operations, development and commercialization of our first product.
• Our operating losses for the years ended December 31, 2024 and 2023 were approximately $22.6 million and $7.1 million, respectively, and we had an accumulated deficit of approximately $132.0 million as of December 31, 2024.
• As we continue to evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully.
• We anticipate that, as our operations expand and, assuming that our development, testing, studies and trials are successful, we will need to expand our manufacturing, marketing and sales capabilities by contracting with third parties.
• Maintaining these relationships and managing our future growth will impose significant added responsibilities on members of our management team.
• We have incurred net losses and negative cash flows from our operations and comprehensive loss since our inception and as of December 31, 2024, we had an accumulated deficit of $132.5 million.
• These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
• We will be required to demonstrate through well-controlled clinical trials that Glucotrack CBGM or future product candidates, if any, are safe and effective for their intended uses.
• In addition, any of these regulatory authorities may also clear or approve a product candidate for fewer or more limited uses than we request or may grant clearance or approval contingent on the performance of costly post-marketing clinical trials.
• We are highly dependent on the success of our product candidate, Glucotrack CBGM, and cannot give any assurance that it will receive regulatory approval or clearance or be successfully commercialized.
• We are highly dependent on the success of our product candidate, Glucotrack CBGM.
• We believe that our ability to successfully compete will depend on, among other things: ● our ability to have partners manufacture and sell commercial quantities of any approved products to the market; ● acceptance of product candidates by physicians and other health care providers; ● the results of our clinical trials; ● our ability to recruit and enroll patients for our clinical trials; ● the efficacy, safety, performance and reliability of our product candidates; ● the speed at which we develop product candidates; ● our ability to obtain prompt and favorable IRB review and approval at each of our clinical sites; ● our ability to commercialize and market any of our product candidates that may receive regulatory clearance or approval; ● our ability to design and successfully execute appropriate clinical trials; ● the timing and scope of regulatory clearances or approvals; ● appropriate coverage and adequate levels of reimbursement under private and governmental health insurance plans, including Medicare; and ● our ability to protect intellectual property rights related to our products.
• While we believe that GLP-1s are a companion product and can be used in conjunction with CGM systems, such drugs could potentially compete with the Glucotrack CBGM and impact successful commercialization.
• The completion of clinical trials in connection with our application for FDA approval could also be substantially delayed or prevented by several factors, including: ● slower than expected rates of patient recruitment and enrollment; ● failure of patients to complete the clinical trial; ● unforeseen safety issues; ● lack of efficacy evidenced during clinical trials; ● termination of clinical trials by one or more clinical trial sites; ● inability or unwillingness of patients or medical investigators to follow clinical trial protocols; and ● inability to monitor patients adequately during or after treatment.
• Our clinical trials may be suspended or terminated at any time by the FDA, other regulatory authorities, the IRB for any given site or us.
• Any failure or significant delay in completing clinical trials for Glucotrack® or future product candidates, if any, could materially harm our financial results and the commercial prospects for our product candidates.
• Regulatory approval of a PMA or PMA supplement is not guaranteed, and the approval will take several years when factoring in clinical trial timelines.
• We believe that the degree of market acceptance will depend on a number of factors, including: ● timing of market introduction of competitive products; ● safety and efficacy of our product; ● prevalence and severity of any side effects; ● potential advantages or disadvantages over alternative treatments; ● strength of marketing and distribution support; ● price of our product candidates, both in absolute terms and relative to alternative treatments; and ● availability of coverage and reimbursement from government and other third-party payors.
• If the Glucotrack CBGM or our future product candidates, if any, fail to achieve market acceptance, we may not be able to generate significant revenue or achieve or sustain profitability.
• The coverage and reimbursement status of newly cleared or approved medical devices is uncertain, and failure to obtain adequate coverage and adequate reimbursement could limit our ability to market Glucotrack CBGM or future product candidates, if any, and may inhibit our ability to generate revenue from Glucotrack CBGM or our future product candidates, if any, that may be cleared or approved.
• There is significant uncertainty related to the third-party coverage and reimbursement of newly cleared or approved medical devices.
• We currently maintain product liability insurance up to $5,000 per claim and in the aggregate.
• Although we have product liability coverage, we may have to pay amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
• We do not own or operate manufacturing facilities for clinical or commercial production of Glucotrack CBGM, other than a prototype lab.
• We have no experience in medical device manufacturing and lack the resources and the capability to manufacture the Glucotrack CBGM on a commercial scale.
• The funding that we received through the Israeli Innovation Authority (“IIA”) for research and development activities restricts our ability to manufacture products or to transfer technology outside of Israel.
• On March 4, 2004, the IIA agreed to provide us with a grant of 420 New Israeli Shekels (“NIS”), or approximately $93 at an exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive blood glucose monitor (the “development plan”).
• In late 2023, the Company abandoned pursuit of its Israeli originated first generation product development programs top focus solely on its next generation CBGM product development efforts for FDA market approval.
• In order to remain listed on Nasdaq, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance requirements.
• However, we timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”) and paid the fee, which resulted in a stay of any suspension or delisting action pending the hearing.
• The Compliance Letter noted, that because the Company’s bid price has closed below the minimum required by the Bid Price Rule following the November Offering (defined blow), the Panel has determined to impose on the Company a Discretionary Panel Monitor, pursuant to Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Compliance Letter, to ensure that the Company maintains long-term compliance with the Minimum Stockholders’ Equity Requirement, the Bid Price Rule, and all of Nasdaq’s continued listing requirements.
• There can be no assurance that we will be able to continue to maintain compliance with Nasdaq’s continued listing requirements, the Bid Price Rule, or other Nasdaq listing requirements.
• If we are not able to comply with applicable listing standards, our shares of Common Stock will be subject to delisting.
• If Nasdaq delists our Common Stock from trading on its exchange for failure to meet comply with the Bid Price Rule, or any other listing standards, we and our stockholders could face significant material adverse consequences including, but not limited to: ● a limited availability of market quotations for our securities; ● a reduction in liquidity and market price of our Common Stock; ● a reduction in the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise equity financing; ● a determination that our Common Stock is a “penny stock,” which will require brokers trading in our Common Stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our Common Stock; ● a limited amount of analyst coverage; and ● a decreased ability to issue additional securities or obtain additional financing in the future.
• We identified material weaknesses related to our internal control over financial reporting as of December 31, 2024 and concluded that internal control over financial reporting as at December 31, 2024 were not effective.
• The market price of our Common Stock has been volatile and may continue to be volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment.
• The market price of our Common Stock has been and may continue to be highly volatile.
• Our stock price could be subject to wide fluctuations in response to a variety of factors, including, without limitation: ● results of trials or studies; ● the announcement of new products or product enhancements by us or our competitors; ● developments concerning intellectual property rights and regulatory approvals; ● variations in our and our competitors’ results of operations; ● changes in earnings estimates or recommendations by securities analysts, if the Common Stock is covered by analysts; ● developments in the medical device industry; ● the results of product liability or intellectual property lawsuits; ● sales, or the perception that future sales may occur, of equity securities or issuance of debt; ● future issuances of Common Stock or other securities; ● the addition or departure of key personnel; ● changes in state, provincial, or federal regulations affecting us and our industry; ● economic, political, and other external factors; ● announcements by us or our competitors of acquisitions, investments or strategic alliances; and ● general market conditions and other factors, including factors unrelated to our operating performance.
• We cannot assure you that any patents that will issue, that may issue or that may be licensed to us will be enforceable or valid or will not expire prior to the commercialization of our product candidates, thus allowing others to more effectively compete with us.