Glucotrack, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Cautionary Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking statements include statements about our expectations, beliefs or intentions regarding our product development efforts, business, financial condition, results of operations, strategies and prospects. All statements other than statements of historical fact included in this Quarterly Report on Form 10-Q, including statements regarding our future activities, events or developments, including such things as future revenues, capital raising and financing, product development, clinical trials, regulatory approval, market acceptance, responses from competitors, capital expenditures (including the amount and nature thereof), business strategy and measures to implement strategy, competitive strengths, goals, expansion and growth of our business and operations, plans, references to future success, projected performance and trends, and other such matters, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “may,” “will,” “could,” “would,” “should” and other similar words and phrases, are intended to identify forward-looking statements. The forward-looking statements made in this Quarterly Report on Form 10-Q are based on certain historical trends, current conditions and expected future developments as well as other factors we believe are appropriate in the circumstances. These statements relate only to events as of the date on which the statements are made and we undertake no obligation to update publicly 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 Quarterly Report on Form 10-Q are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by us 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. Whether actual results will conform to our expectations and predictions is subject to a number of risks and uncertainties that may cause actual results to differ materially. Risks and uncertainties, the occurrence of which could adversely affect our business, include the risks identified under the caption “Risk Factors” included in our annual report on Form 10-K for the year ended December 31, 2023. The following discussion should be read in conjunction with the condensed consolidated financial statements and the notes thereto included in Item 1 of this Quarterly Report on Form 10-Q. Overview We are a medical device company focused on the design, development and commercialization of novel technologies for use by people with diabetes. We are currently developing an Implantable CBGM for those with Type 1 diabetes and insulin-dependent Type 2 diabetes. The Company was founded with a mission to develop Glucotrack®, a non-invasive glucose monitoring device designed to help people with diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot finger stick devices. The first generation Glucotrack, which successfully received CE Mark approval, obtained glucose measurements via a small sensor clipped onto one’s earlobe. A limited release beta test in Europe and the Middle East demonstrated the need for an updated product with improved accuracy and human factors. As the glucose monitoring landscape rapidly moved away from point-in-time measurement to continuous measurement since then, the Company recently determined that it would focus its efforts on developing its Implantable CBGM. As such, we have since withdrawn our CE Mark for Glucotrack and are no longer pursuing commercialization of this product or development of any further iterations. The Company is currently developing an Implantable CBGM for use by Type 1 diabetes patients as well as insulin-dependent Type 2 patients. Implant longevity is key to the success of such a device. We have continued to evolve our sensor chemistry following our successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor design. Recently we announced a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. We have also completed four animal studies with evolving prototype systems, all four of which consistently demonstrated a simple implant procedure, good functionality, and safety. The Company has also successfully demonstrated continuous glucose sensing in the epidural space via two additional animal trials, both of which demonstrated a simple implant procedure, good functionality, and safety. This latter approach is of importance for patients with painful diabetic neuropathy contemplating spinal cord stimulation therapy for their condition. The results of these animal trials were recently presented in poster form at the American Diabetes Association, the Diabetes Technology Society, and the DiabetesMine annual conferences. A regulatory submission has been made for a first in human study. This will be an acute study intended to demonstrate device performance and safety. All preparatory clinical activities are complete and the study is expected to initiate in Q4 2024, pending regulatory approval. In parallel, the Company is also preparing for a long-term clinical trial expected to begin in late Q2 2024. As part of this effort, the Company is working towards ISO13485 certification, an internationally agreed-upon standard of quality system requirements for the design, production, distribution, and sale of medical devices. The Company has successfully completed the first audit and is scheduled to complete the second audit in December 2024. A successful second audit results in certification of compliance to the standard, which is recognized and accepted by the FDA, the European Union, and many other geographies worldwide. We believe our technology, if successful, has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors that are either in the market or currently under development. 22 Our Senior Management team includes; CEO and President, Paul V. Goode PhD, who has a decorated career developing innovative medical technologies, including at Dexcom and MiniMed, CFO, James Cardwell, CPA who has over 16 years of experience as a Chief Financial Officer and Chief Operating Officer with a concentration in both SEC financial reporting and tax compliance, James P. Thrower PhD, Vice President of Engineering, a seasoned executive formerly of Sterling Medical Devices, Mindray DS USA and Dexcom, Inc., Mark Tapsak PhD, Vice President of Sensor Technology, a medical research scientist who brings over 25 years of experience in the diabetes industry, including previous senior roles at Dexcom and Medtronic, Drinda Benjamin, Vice President of Marketing, a medical device professional with over 20 years of experience in the medical device and diabetes industry with senior roles at Intuity Medical, Senseonics, Abbott Diabetes, and Medtronic Diabetes, Vincent Wong, Vice President of Quality, a medical device professional with 15 years of experience in quality system for implantable medical device manufacturing with senior roles at Cirtec Medical and TOMZ, and Sandie Martha, Vice President Clinical Operations, a medical device professional with over 20 years of experience in the medical device and diabetes industry with senior roles at Dexcom and GlySens. Andy Balo, formerly of Dexcom and St Jude Medical (now Abbott) and John Ballantyne, founder and formerly of Aldeveron have joined as independent board members. Several highly talented and accomplished executives joined the Company as senior advisors to the Board. These include Daniel McCaffrey MBA MA, a world-renowned behavioral scientist and digital health expert formerly at Samsung Health and Dexcom, Inc., and Dr. David C. Klonoff, world renowned endocrinologist and diabetes technology thought leader. We intend to continue to invest in our talent and to expand and strengthen all areas within the Company. Recent Events On April 22, 2024, we entered into a private placement agreement under which we issued 79,366 shares of our common stock at a price of $6.3 per share for aggregate gross proceeds of $500,000 to certain members of our executive management, Board of Directors and existing shareholders. On April 26, 2024, we held our Annual Meeting of Shareholders (the “Annual Meeting”) under which our stockholders approved, inter alia, the following proposals: (i) adoption of our 2024 Equity Incentive Plan; (ii) approved of an amendment to Article IV of our Certificate of Incorporation, as amended, to effect a reverse stock split of the Company’s Common Stock at a ratio of between one-for-five and one-for-thirty, with such ratio to be determined at the sole discretion of the Board of Directors. Following the Annual Meeting, on April 30, 2024, the Board of Directors approved a one-for-five reverse split of our issued and outstanding shares of Common Stock (the “Reverse Stock Split”). On May 17, 2024, we filed a Certificate of Amendment to the Company’s Certificate of Incorporation with the Secretary of State of the State of Delaware which effected the Reverse Stock Split. On June 27, 2024, the Board of Directors approved us to enter into note and warrant purchase agreements with certain investors, providing for the private placement of unsecured promissory notes in the aggregate principal amount of $100,000 (the “Notes”) and warrants (the “Warrants”) to purchase up to an aggregate of 300,000 shares of our Common Stock. The closing of the private placement occurred on July 1, 2024. The Notes bear simple interest at the rate of 3% per annum and are due and payable in cash on the earlier of: (a) twelve months from the date of the Note; or (b) the date we raise third-party equity capital in an amount equal to or in excess of $1,000,000 (the “Maturity Date”). We may prepay the Notes at any time prior to the Maturity Date without penalty. If an event of default occurs, the then-outstanding principal amount of the Notes plus any unpaid accrued interest will accelerate and become immediately payable in cash. Each Warrant has an exercise price of $4.95 per share. The Warrants are immediately exercisable and have a five-year term. On July 18, 2024, we entered into a series of convertible promissory notes with certain investors which including three of our directors and one member of our executive management, providing for the private placement of unsecured convertible promissory notes in the aggregate principal amount of $360,000 (the “Notes” and each a “Note”). The Notes bear simple interest at the rate of 8% per annum and are due and payable in cash on the earlier of: (a) the twelve-month anniversary of Note, or (b) the date of closing of a Qualified Financing (as defined above). Interest will be computed on the basis of a 365-day year. On July 30, 2024, we entered into a convertible promissory note and three warrant agreements (the “Warrants”) with an existing investor (the “Holder”), providing for the private placement of a secured convertible promissory note in the aggregate principal amount of $4,000,000 (the “Note”). The Note was not convertible until and the approval at a meeting of our stockholders. The Note bears simple interest at the rate of 8% per annum and is due and payable in cash on the earlier of: (i) 12 months anniversary of Note, or (ii) the date of closing of a Sale Transaction (as defined above) (the “Maturity Date”). The Note is secured by a first-priority security interest on all our assets. Each Warrant becomes exercisable 12 months after its issuance and has term of 10 years. The Warrants are exercisable for cash only and have no price-based antidilution. The first Warrant is for 2,133,334 shares at $1.875 per share. The second Warrant is for 1,523,810 shares at $2.625 per share. The third Warrant is for 1,185,186 shares at $3.375 per share. On August 23, 2024, two of the June 27 Investors entered into conversion agreements with us, pursuant to which we agreed to convert the principal amount, plus any accrued but unpaid interest pursuant to each of the June 27 Notes, totalling approximately $20,076 each, held by the Investors to Common Stock at a conversion price of $1.02 per share. On October 15, 2024, we issued 19,682 shares of common stock for each of the two of the June 27 Investors in respect of each respective debt converted. In satisfaction of the debt, we also issued to each of the two June 27 Investors three warrants (each an “August 23 Warrant”). Each August 23 Warrant becomes exercisable on August 16, 2025 and has term of 10 years. The August 23 Warrants are exercisable for cash only and have no price-based antidilution. The first August 23 Warrant is for 10,707 shares of Common Stock and is exercisable at $1.875 per share. The second August 23 Warrant is for 7,648 shares of Common Stock, exercisable at $2.625 per share. The third August 23 Warrant is for 5,948 shares of Common Stock, exercisable at $3.375 per share. On September 5, 2024, one of the June 27 Investors and July 18 Investors entered into a conversion agreement with us, pursuant to which we agreed to convert outstanding board fees and the principal amount, plus any accrued but unpaid interest pursuant to the June 27 Investor’s June 27 Note, totalling $259,300, held by the Investor to Common Stock at a conversion price of $1.02 per share. On October 15, 2024, we issued 254,226 shares of common stock for the June 27 Investor in respect of the Debt converted. In satisfaction of the debt, we issued to the July 18 Investor three warrants (each an “September 5 Warrant”). Each September 5 Warrant becomes exercisable on August 16, 2025 and has term of 10 years. The September 5 Warrants are exercisable for cash only and have no price-based antidilution. The first September 5 Warrant is for 138,299 shares of Common Stock and is exercisable at $1.875 per share. The second September 5 Warrant is for 98,785 shares of Common Stock, exercisable at $2.625 per share. The third September 5 Warrant is for 76,833 shares of Common Stock, exercisable at $3.375 per share. The summary of our significant accounting policies is included under Item 7 - Management’s Discussion and Analysis of Financial Condition and Results of Operations of our fiscal 2023 Form 10-K. An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably possible could materially impact the financial statements. There have been no material changes to the critical accounting policies and estimates as filed in such report. 23 Liquidity and Capital Resources To date, we have not generated any revenues and have experienced net losses and negative cash flows from our activities. Since our incorporation, we have devoted substantially all our resources to research and product development and providing general and administrative support for these activities. Since our incorporation, we have incurred significant losses and negative cash flows from operations. During the nine months ended September 30, 2024, we incurred a net loss of approximately $12.5 million and used $9.0 million of cash in our operations. As of September 30, 2024, we had an accumulated deficit of approximately $122.7 million. We expect to continue to incur significant and increasing losses and do not expect positive cash flows from operations for the foreseeable future, and our net losses may fluctuate significantly from period to period depending on the timing of and expenditures on our research and development activities. As of September 30, 2024, the balance of cash and cash equivalents of approximately $346,000, together with the net proceeds in total amount of $8,873 which expected to be received upon closing of a public offering through registration statements on Form S-1 on November 14, 2024, is insufficient for the Company to realize its business plans for the twelve-month period subsequent to the reporting period. Results of Operations The following discussion of our operating results explains material changes in our results of operations for the three and nine months ended September 30, 2024 compared with the same periods ended September 30, 2023. The discussion should be read in conjunction with the financial statements and related notes included elsewhere in this report. Consolidated Results of Operations for the Three Months Ended September 30, 2024 and 2023 Research and development expenses Research and development expenses were approximately $2.1 million for the three-month period ended September 30, 2024, as compared to approximately $1.7 million for the prior-year period. The increase is attributable to ramping up product development actives. Research and development expenses consist primarily of salaries and other personnel-related expenses, materials, animal trials, production labor and other expenses. We expect research and development expenses to increase in 2025 and beyond, primarily due to hiring additional personnel, as well clinical trials for the Glucotrack CBGM; however, we may adjust or allocate the level of our research and development expenses based on available financial resources and based on our commercial needs, including the FDA registration process, specific requirements from customers, development of new Glucotrack CBGM models and others. Marketing expenses Marketing expenses were approximately $0.1 million for the three-month period ended September 30, 2024, as compared to $0 for the prior-year period. This increase is primarily attributable to business development personnel and professional marketing services. General and administrative expenses General and administrative expenses were approximately $1.1 million for the three-month period ended September 30, 2024, as compared to approximately $0.5 million for the prior-year period. The increase is attributable to professional fees we accrued during the period. General and administrative expenses consist primarily of professional services, salaries, consulting fees, insurance, travel expenses and other related expenses for executive, finance and administrative personnel, including stock-based compensation expenses. Other general and administrative costs and expenses include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal and accounting services. 24 Finance (income) expenses net Finance expenses, net was approximately $1.9 million for the three-month period ended September 30, 2024, as compared to finance income of approximately $0.001 million for the prior-year period. This increase was primarily due to $1.5 million in revaluation expenses incurred from settlement of financial liabilities and $0.3 million in discount amortization and interest expenses. Net Loss Net loss was approximately $5.1 million for the three-month period ended September 30, 2024, as compared to approximately $2.2 million for the prior-year period. The increase in net loss is attributable primarily to the increase in our operating expenses, as described above. Consolidated Results of Operations for the Nine Months Ended September 30, 2024 and 2023 Research and development expenses Research and development expenses were approximately $7.8 million for the nine-month period ended September 30, 2024, as compared to approximately $3.0 million for the prior-year period. The increase is attributable to professional fees we accrued during the period. Research and development expenses consist primarily of salaries and other personnel-related expenses, materials, animal trials and other expenses. We expect research and development expenses to increase in 2025 and beyond, primarily due to hiring additional personnel, as clinical trials for the Glucotrack CBGM; however, we may adjust or allocate the level of our research and development expenses based on available financial resources and based on our commercial needs, including the FDA registration process, specific requirements from customers, development of new Glucotrack CBGM models and others. Marketing expenses Marketing expenses were approximately $0.3 million for the nine-month period ended September 30, 2024, as compared to $0 for the prior-year period. This increase is primarily attributable to business development personnel and professional marketing services. General and administrative expenses General and administrative expenses were approximately $2.6 million for the nine-month period ended September 30, 2024, as compared to approximately $1.7 million for the prior-year period. The increase is attributable to professional fees we accrued during the period. General and administrative expenses consist primarily of professional services, salaries, consulting fees, insurance, travel expenses and other related expenses for executive, finance and administrative personnel, including stock-based compensation expenses. Other general and administrative costs and expenses include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal and accounting services. Finance (income) expenses, net Finance expenses, net was approximately $1.8 million for the nine-month period ended September 30, 2024, as compared to finance income, net of approximately $0.002 million for the prior-year period. This increase was primarily due to $1.5 million in revaluation expenses incurred from settlement of financial liabilities and $0.3 million in discount amortization and interest expenses. Net Loss Net loss was approximately $12.5 million for the nine-month period ended September 30, 2024, as compared to approximately $4.7 million for the prior-year period. The increase in net loss is attributable primarily to the increase in our operating expenses, as described above. 25 Cash Flows for the Nine Months Ended September 30, 2024 and 2023 Operating Activities Net cash used in operating activities for the nine-month period ended September 30, 2024 was approximately $9.0 million primarily due to the net loss of approximately $12.5 million offset by non-cash charges of $2.3 million and an increase in working capital excluding cash of $1.2 million. Net cash used in operating activities for the nine-month periods ended September 30, 2023 was approximately $4.1 million primarily due to the net loss of $4.7 million. Investing Activities Net cash used in investing activities was $0.1 million and $0 for the nine-month periods ended September 30, 2024 and 2023, respectively. Net cash used in investing activities primarily reflects the purchasing of fixed assets. Financing Activities Net cash provided by financing activities was approximately $5.0 million and $8.7 million for the nine-month periods ended September 30, 2024 and 2023, respectively. Net cash provided by financing activities primarily reflects the proceeds received from private placement transaction in 2024 versus net proceeds received upon completion of public offering. Off-Balance Sheet Arrangements As of September 30, 2024, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K. Critical Accounting Policies This Management’s Discussion and Analysis of Financial Condition and Results of Operations discuss our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In connection with the preparation of our financial statements, we are required to make assumptions and estimates about future events and apply judgments that affect the reported amounts of assets, liabilities, expenses and the related disclosures. We base our assumptions, estimates and judgments on historical experience, current trends and other factors that management believes to be relevant at the time our condensed consolidated financial statements are prepared. On a regular basis, management reviews the accounting policies, assumptions, estimates and judgments to ensure that our financial statements are presented fairly and in accordance with U.S. GAAP. However, because future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates, and such differences could be material. Going Concern Uncertainty The development of the implantable continuous glucose sensor product is expected to require substantial further expenditures. We remain dependent upon external sources for financing our operations. Since inception, we have incurred substantial accumulated losses and negative operating cash flow and have a significant accumulated deficit. We do not have any committed external source of funds or other support for our development efforts, and we cannot be certain that additional funding will be available on acceptable terms, or at all. Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, government funding, strategic alliances, licensing arrangements, and other marketing or distribution arrangements, any of which may include terms that may adversely affect our stockholders’ rights. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may have to significantly delay, scale back or discontinue our development or commercialization initiatives. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline. We believe that our cash on hand as of September 30, 2024, together with the net proceeds expected to be received upon closing of a public offering through registration statements on Form S-1 on November 14, 2024, will not provide sufficient working capital to fund its current operations and animal trial program for the development of its Implantable CGM for a period of twelve-months subsequent to the reporting period. Item 3. Quantitative and Qualitative Disclosures About Market Risk. Not required for smaller reporting companies. 26