Glucotrack, Inc.

Current report

On May 15, 2026, we received a second letter from Nasdaq notifying us that our Form 10-Q for the period ended March 31, 2026, indicates that we no longer meet the $2,500,000 minimum stockholders’ equity requirement for continued listing set forth under Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”), and we do not meet the alternatives of market value of listed securities or net income from continuing operations. Accordingly, the failure to comply with the Minimum Stockholders’ Equity Requirement has become an additional basis for delisting. The Nasdaq Staff further notified us that failure to meet the Minimum Stockholders’ Equity Requirement will be considered in its decision regarding our continued listing on the Nasdaq Capital Market. We presented our views with respect to this additional deficiency to the Panel at the hearing on June 18, 2026. On July 30, 2026, we received an additional Staff Determination from Nasdaq confirming that our Business Combination with Lokahi will constitute a business combination that results in a “Change of Control” pursuant to Listing Rule 5110(a). Accordingly, the post-transaction entity will be required to satisfy all of Nasdaq’s initial listing criteria and complete Nasdaq’s initial listing process prior to the conversion of the Preferred Stock issued in connection with the Business Combination. There can be no assurance that we will be successful in our appeal, that the Panel will grant our request for continued listing, that our initial listing application will be approved, or that we will be able to regain compliance with the Bid Price Rule, Minimum Stockholders’ Equity Requirement, or maintain compliance with any applicable Nasdaq listing requirements.

Current report

Risks Related to the Business Combination and Related Transactions

Current report

The Merger may not produce the anticipated benefits, and the Company may be unable to successfully integrate the acquired business.

Current report

Although the Merger has been completed, the Company may not realize the anticipated benefits of the Merger, including expected synergies, growth opportunities, or cost savings. The Company’s ability to achieve these benefits depends on a number of factors, including the successful integration of the Lokahi business, which may be more difficult, time-consuming or costly than expected.

Current report

The Company may incur additional costs and liabilities arising from the Merger.

Current report

Following the closing of the Merger, the Company may continue to incur significant costs related to integration, restructuring, professional fees, and other transaction-related expenses. In addition, the Company may be subject to liabilities arising from the Lokahi business that were not known or fully quantified at the time the Merger Agreement was entered into.

Current report

The Merger Agreement may continue to affect the Company’s operations and capital structure.

Current report

Certain provisions of the Merger Agreement, including those governing the issuance of the Merger Consideration in connection with the Business Combination, continue to apply following the closing of the Merger and may limit the Company’s flexibility with respect to capital structure, financings, or other corporate actions.

Current report

Risks Related To Lokahi

Current report

References in this sub-section to the “Company,” “we,” “us,” or “our” refer to Lokahi Therapeutics, Inc., a Nevada corporation.

Current report

We are in the intermediate stages of clinical development for our product candidate LT-100, formerly known as Apitox, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

Current report

We are a clinical stage biopharmaceutical company in the process of developing LT-100, an intradermally administered bee venom-based toxin. Our focus is primarily on developing innovative therapies that address inflammation and pain management symptoms associated with knee osteoarthritis (OA) and, to a lesser extent, multiple sclerosis (MS). LT-100 is currently marketed and sold by Apimeds Inc. (“Apimeds Korea”) in South Korea as “Apitoxin” for the treatment of OA. Lokahi is not associated with the market, sale and revenues generated from Apitoxin in South Korea, and LT-100 has not yet been approved by the FDA for any indication. On August 2, 2021, we entered into a Business Agreement with Apimeds Inc. (“Apimeds Korea”), pursuant to which Apimeds Korea granted us a sublicensable, royalty-bearing license to utilize all prior clinical development data associated with LT-100, and to advance clinical research, develop, manufacture, commercialize and sell LT-100 in the United States (the “Business Agreement”).

Current report

To date, we have devoted substantially all of our resources to performing research and development, undertaking preclinical and clinical studies and enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such activities. As an organization, we have not yet demonstrated an ability to conduct sales and marketing activities necessary for successful commercialization or arrange for a third party to conduct these activities on our behalf. Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history.

Current report

Our current portfolio includes one product candidate, and we do not expect to generate revenue from our product candidate in the near future. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives, including with respect to our clinical candidate. We are transitioning from an early stage research and development company to a late stage development company, with a focus on delivering Phase III clinical data establishing LT-100 as a viable commercial candidate. We may not be successful in this transition.

Current report

We have incurred significant net losses since inception and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve profitability.

Current report

We are a clinical stage biopharmaceutical company that was formed on December 1, 2025. Investment in clinical stage companies is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidates will not gain regulatory approval or become commercially viable. We have not generated any revenue from product sales. As a result, we are not profitable and have incurred losses in each year since inception. Our net losses were $5,889,447 and $8,098,087 for the three and six months ended June 30, 2026, respectively, compared to $2,639,139 and $3,041,536 for the corresponding prior-year periods. Because we were formed on December 1, 2025, the financial information presented in these risk factors has been prepared on a standalone carve-out basis, derived from the historical financial records of our former parent Apimeds Pharmaceuticals US, Inc. (“Apimeds US”) The prior-year comparative amounts reflect periods during which we did not operate as a separate company, and include allocations of costs that may not be indicative of the results we would have achieved had we operated on a standalone basis, or of our future results. As of June 30, 2026, we had an accumulated deficit of $8,805,260 and a total stockholders’ deficit of $6,740,718.

Current report

We expect to continue to spend significant resources to fund research and development of, and seek regulatory approvals for, our product candidate. We expect to incur substantial and increasing operating losses over the next several years. As a result, our accumulated deficit will also increase significantly. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital. We may never be profitable and, if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Current report

We will require substantial additional funding to finance our operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.

Current report

As of June 30, 2026, we had cash and cash equivalents of $53,186, total current assets of $2,289,183 against total current liabilities of $9,136,120, resulting in a working capital deficit of $6,846,937. Net cash used in operating activities was $3,624,474 for the six months ended June 30, 2026. These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months from the date of this filing, and we will require substantial additional capital to fund our current operating plans. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. We expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements or any combination of these approaches. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, including the trading price of our parent company’s common stock. Our future capital requirements will depend on many factors, including:

Current report

Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of our product candidate or other research and development initiatives. Our license agreements may also be terminated if we are unable to meet the payment obligations or milestones under the agreements. We could be required to seek collaborators for our product candidate at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our products in markets where we otherwise would seek to pursue development ourselves.

Current report

The report of our independent registered public accounting firm on our financial statements for the period from January 1, 2025, through December 31, 2025 on a standalone basis included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern. If we are unable to raise additional capital as and when needed, our business, financial condition and results of operations will be materially and adversely affected, and we may be forced to delay our development efforts, limit our activities and reduce research and development costs.

Current report

If we are unable to continue as a going concern, we may have to liquidate our assets, and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. The inclusion of a going concern explanatory paragraph by our independent registered public accounting firm, our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect our parent company’s share price and our ability to raise new capital, enter into licensing and collaboration arrangements or other contractual relationships with third parties and otherwise execute our development strategy.

Current report

Our rights to the LT-100 program derive from a settlement agreement, and any challenge to or failure of performance under that agreement could impair our ability to develop the program.

Current report

Our rights to the LT-100 program were acquired pursuant to a Confidential Settlement and Mutual Release Agreement entered into in April 2026 among Apimeds US, MindWave Innovations Inc., us, Erik Emerson, Inscobee Inc. and Apimeds Inc., which resolved disputes arising from the December 1, 2025 merger between Apimeds US and MindWave. Under the settlement we secured the rights relating to the LT-100 program, including the associated intellectual property, regulatory materials, development data and manufacturing information. As consideration, we delivered $3 million in cash and assumed certain liabilities of Apimeds US. The assumed liabilities may prove greater than we currently estimate and satisfying them will consume cash that would otherwise be available to fund development of LT-100. Our ability to develop and commercialize LT-100 also depends on the continued effectiveness of the settlement and on the parties’ performance of their remaining obligations under it. If the settlement were challenged, rescinded or found unenforceable in whole or in part, if any party failed to perform, or if new disputes arose among the parties concerning the scope of the transferred rights or the liabilities we assumed, we could lose or have impaired our rights to some or all of the LT-100 program assets, incur substantial legal costs and management distraction, and be delayed in or prevented from advancing the program. We also remain dependent on Apimeds Korea under the Business Agreement for the licensed “Apitox” name and related rights, and the settlement does not eliminate the risks described elsewhere in these risk factors relating to that relationship.

Current report

We have identified material weaknesses in our internal control over financial reporting, and the failure to remediate these material weaknesses may adversely affect our business, investor confidence in our parent company, our financial results and the market value of our parent company’s common stock.

Current report

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Management identified a material weakness in our internal control over financial reporting. Specifically, the Company does not currently have sufficiently documented procedures or control activities in place to support a reliable financial reporting process. This includes an absence of controls over the review and approval of journal entries, segregation of duties, reconciliations, and other fundamental accounting processes.

Current report

The material weakness did not result in any material misstatements to the Company’s financial statements, and management has concluded that the Company’s financial statements and other financial information included in its Quarterly Report fairly and accurately present the Company’s financial condition, results of operations, and cash flows for the periods in accordance with GAAP.

Current report

We have begun exploring remedial efforts to address the underlying causes of the material weaknesses. There can be no assurance that any remedial efforts we take, if any, will be sufficient to remediate the control deficiencies that led to our material weaknesses in our internal controls over financial reporting or prevent future material weaknesses or control deficiencies from occurring.

Current report

If the Company fails to remediate the material weaknesses or any future deficiencies, or fails to otherwise maintain the adequacy of its internal controls, that could result in a restatement of the Company’s financial statements for prior periods, a decline in the market value of the Company’s common stock, one or more investigations or enforcement actions by state or federal regulatory agencies, stockholder lawsuits, or other adverse actions requiring the Company to incur defense costs or pay fines, settlements, or judgments.

Current report

Risks Related to Our Business and Industry

Current report

The Company is reliant on its key supplier.

Current report

We contract directly with a United States company for the supply of dried bee venom and have exclusivity in the field of pharmaceutical use. The exclusivity exception is for sales of bee venom to Apimeds Korea for use outside the United States. The agreement may be terminated upon mutual written consent of both parties. Termination of this agreement, variations in their terms or the failure of our key supplier to comply with its obligations under its agreement (including if our key supplier were to become insolvent) could have a material adverse effect on the Company’s consolidated financial results and on your investment.

Current report

If we are unable to successfully develop, receive regulatory approval for, and commercialize our product candidate or future product candidates, our business will be harmed.

Current report

Our product candidate remains in clinical development, and we have not yet completed a pivotal trial. The FDA permitted our investigational new drug application for LT-100 to proceed in 2014, and we began enrolling subjects. In May 2026, we held a Type C meeting with the FDA’s Division of Anesthesiology, Addiction Medicine and Pain Medicine to discuss the proposed development pathway for LT-100. We are evaluating whether the historical administration approach requiring up to 15 intradermal injections per treatment visit can be simplified to a single subcutaneous injection per visit, and we have completed a nonclinical minipig study comparing systemic exposure following subcutaneous and intradermal administration. There is no assurance that the FDA will accept a modified administration approach, or that a single-injection presentation will prove safe or effective. Our product candidate will require additional preclinical and/or clinical development, regulatory approval, obtaining manufacturing supply, capacity, and expertise, building a commercial organization or successfully outsourcing commercialization, substantial investment, and significant marketing efforts, before we generate any revenue from product sales. We do not have any products that are approved for commercial sale, and we may never be able to develop or commercialize marketable products.

Current report

Our ability to generate revenue from our product candidate, which we do not expect will occur for several years, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of our product candidate. The success of our product candidate or any other product candidates that we develop or otherwise may acquire will depend on several factors, including:

Current report

If we do not succeed with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize the product candidate we develop, which would materially harm our business. If we do not receive marketing approvals for any product candidate we develop, we may not be able to continue our operations. Even if regulatory approvals are obtained, we could experience significant delays or an inability to successfully commercialize our current and any future product candidates we develop, which would materially harm our business. If we are not able to generate sufficient revenue through the sale of any current or future product candidate, we may not be able to continue our business operations or achieve profitability.

Current report

The FDA regulatory approval process is lengthy and time-consuming and may lead to significant delays in the clinical development and regulatory approval of our product candidate.

Current report

The time required to obtain approval from the FDA is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of FDA. Any delay in obtaining FDA and/or other necessary regulatory approvals in the United States for any investigational new drug and failure to receive such approvals would have an adverse effect on the investigational new drug’s potential commercial success and on our business, prospects, financial condition, and results of operations.

Current report

We have not obtained regulatory approval for any product candidate. We have not previously submitted a Biologic License Application (“BLA”) to the FDA. It is possible that none of our current or future product candidates will ever obtain regulatory approval from the FDA. The novel nature of our product candidate may create further challenges in obtaining regulatory approval. The regulatory approval pathway for our product candidate may be uncertain, complex, expensive, and lengthy, and approval may not be obtained. In addition, factors outside our control, such as government shutdowns, natural disasters, and public health emergencies, could disrupt business at the FDA, which could result in delays of reviews, approvals and communications with FDA related to our clinical trials and product candidates.

Current report

Our current and future product candidate could fail to receive regulatory approval for many reasons, including the following: