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Glucotrack, Inc.

For the period ended Mar 31, 2025. Filed May 14, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 14, 2025

GCTK$1.39-32.2%Stored close · as of Oct 29, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-09-30; filed 2024-11-14.

0001493152-24-045894

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-03-31; filed 2025-05-14.

0001641172-25-010384

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 64 previous paragraphs and 60 current paragraphs.

15 unchanged; 11 reworded; 33 added; 36 removed; 2 previous and 1 current paragraphs rearranged.

Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (33)

Current report

2025 Reverse Stock Split and Increase in Authorized Common Stock

Current report

We filed with the Delaware Secretary of State a Certificate of Amendment to its Certificate of Incorporation which became effective at 4:30 p.m. on February 3, 2025, to implement a reverse stock split at a ratio of 1-for-20 (the “2025 Reverse Stock Split”) of the shares of our Common Stock. The 2025 Reverse Stock Split was approved by our stockholders at the special meeting of stockholders held on January 3, 2025 (the “Special Meeting”). All shares and per share numbers in the consolidated financial statements have been retroactively adjusted and are reflected on a post-reverse share split basis.

Current report

On January 3, 2025, we filed an amendment to our Certificate of Incorporation, as to increase the Company’s authorized shares of Common Stock from 100,000,000 to 250,000,000. On February 3, 2025, the stockholders approved at the Special Meeting the increase in our authorized shares of Common Stock from 100,000,000 to 250,000,000, as well as the full issuance of shares of Common Stock issuable by us upon the exercise of Series A Warrants and Series B Warrants (defined herein).

Current report

On December 17, 2024, we entered into an ATM sales agreement (the “Sales Agreement”) with Dawson James Securities, Inc. (“Dawson James”), pursuant to which we have agreed to issue and sell shares of Common Stock, having an aggregate offering price of up to $8.23 million, from time to time, through an “at-the-market” equity offering program under which Dawson James will act as sales agent (the “Agent”).

Current report

On March 21, 2025, we sold 12,377,967 shares of Common Stock at an average offering price of $0.304 per share pursuant to the Sales Agreement. for net proceeds of $3.6 million, after deducting fees owed to the Agent from such sale. The shares of Common Stock were offered by us pursuant to a prospectus supplement dated December 17, 2024, and accompanying prospectus dated October 3, 2024, which forms a part of our registration statement on Form S-3 (Registration No. 333-282297) (the “S-3 Registration Statement”), which was declared effective by the Securities and Exchange Commission, on October 3, 2024.

Current report

On February 4, 2025, we entered into a securities purchase agreement with certain institutional investors, relating to the registered direct offering and sale of an aggregate of 2,638,042 shares of Common Stock at an offering price of $1.15 per share. The net proceeds to us from the offering were approximately $2.7 million, after deducting fees owed to placement agent and other offering expenses. The February 2025 offering closed on February 5, 2025.

Current report

The shares of Common Stock from the February 2025 registered direct offering was offered by us pursuant to a prospectus supplement dated February 4, 2025, and accompanying prospectus dated October 3, 2024, which forms a part of our S-3 Registration Statement. Dawson James acted as the placement agent for the offerings pursuant to a placement agency agreement, dated February 4, 2025, by and between us and Dawson James.

Current report

Beginning on January 6, 2025, through March 15, 2025, we received exchange notices from certain holders of the Series B Warrants, with respect to an aggregate of 3,241,240 of the Series B Warrants, requiring the delivery of 9,723,724 shares of Common Stock according to the alternative cashless exercise, as applicable to the Series B Warrants under the November 2024 registered direct offering. The remaining 646 Series B Warrants are exchangeable for an aggregate of approximately 1,940 shares of Common Stock (subject to adjustment in the event of any stock dividend and split, reverse stock split, recapitalization, reorganization or similar transaction).

Current report

Mr. Cardwell’s resigned as Chief Financial Officer of the Company, and on January 28, 2025, our board of directors (the “Board”) appointed Peter C. Wulff as Chief Financial Officer of the Company.

Current report

Selling and marketing expenses consist primarily of personnel-related expenses and professional service costs.

Current report

Other income expense, consist primarily of the change in fair value of derivative liabilities, finance (income) expense and other (income) expense.

Current report

Research and development expenses were approximately $1,871 for the three-month period ended March 31, 2025, as compared to approximately $2,148 for the prior-year period. The decrease is attributable to a reduction in product and manufacturing fees we accrued during the period related to the development of the Glucotrack CBGM model.

Current report

Change in derivative liability for the three months ended March 31, 2025, was an increase of $3,376. The change is primarily due to adjustments of the estimated fair value of the Series A Warrants, and the settlement of Series B Warrants exercised during the current quarter. See Note 3B to the condensed consolidated financial statements.

Current report

Financing income, net was approximately $37 for the three-month period ended March 31, 2025, as compared to financing income of approximately $24 for the prior-year period. The increase is attributable to interest income received during the period.

Current report

As of March 31, 2025, we had $9,100 in cash and cash equivalents compared with $5,617 in cash and cash equivalents as of December 31, 2024. The net increase in cash and cash equivalents was attributable to the $6,395 received from financing activities offset by cash used in operating and investing activities of $2,928.

Current report

We have a history of recurring losses, and as of March 31, 2025, we have an accumulated deficit of $139,283. During the three months ended March 31, 2025, we recorded a net loss of $6,833. Our primary requirements for liquidity have been to fund product and clinical development activities and to satisfy our general corporate and working capital needs.

Current report

Subsequent to March 31, 2025, we sold 3,056,956 shares of Common Stock through the ATM Sales Agreement at an average offering price of $0.183 per share for net proceeds of $543, after deducting fees owed to the Agent from such sale.

Current report

Based on our operating plans, we do not expect that our current cash and cash equivalents as of March 31, 2025, will be sufficient to fund our operating, investing, and financing cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated. The Company estimates it will require approximately $15.0 million in cash to fund operations over this period. Based upon this review and our current financial condition, the Company has concluded that substantial doubt exists as to our ability to continue as a going concern. We have raised and believe we will continue to be able to raise additional capital through debt financing, private or public equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing. However, there can be no assurances that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our clinical trials or other operations. If any of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors.” Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements on commercially acceptable terms favorable to us, or at all.

Current report

To date, we have not yet commercialized the Glucotrack CBGM. Further development and commercialization efforts are expected to require substantial additional expenditure. Therefore, we are dependent upon external sources for financing our operations. As of March 31, 2025, we have incurred an accumulated deficit of $139,283. In addition, we have generated operating losses and negative operating cash flow for all reported periods. As of March 31, 2025, the balance of cash and cash equivalents amounted to $9,100.

Current report

During the three months ended March 31, 2025, we received approximately $6,396 through public offerings. In addition, subsequent to the balance sheet date, we received $261 through the sale of shares of Common Stock. We plan to finance our operations through the sale of debt or equity securities (including the S-3 Registration Statement). There can be no assurance that we will succeed in obtaining the necessary financing or generating sufficient revenue from sale of the Glucotrack CBGM in order to continue our operations as a going concern.
Removed paragraphs (36)

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

To date, we have not generated any revenues and have experienced net losses and negative cash flows from our activities.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

Consolidated Results of Operations for the Nine Months Ended September 30, 2024 and 2023

Previous report

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.

Previous report

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.

Previous report

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 liabilitiesand $0.3 million in discount amortization and interest expenses.

Previous report

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.

Previous report

Cash Flows for the Nine Months Ended September 30, 2024 and 2023

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.
Reworded paragraphs (11)

Previous wording

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.

Current wording

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 continuous blood glucose monitor (“CBGM”), the Glucotrack CBGM, for those with Type 1 diabetes and insulin-dependent Type 2 diabetes.

Previous wording

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.

Current wording

The Glucotrack CBGM is being developed 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 the sensor chemistry following the successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor design. Recently we announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. We have also completed multiple animal studies with initial prototype systems which demonstrated a simple implant procedure with good safety and functionality. The results of both were presented in poster form at the 2024 American Diabetes Association annual conference.

Previous wording

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.

Current wording

A regulatory submission has been made for a first in human study outside of the United States. This will be an acute study intended to demonstrate device performance and safety. All preparatory clinical activities and applicable regulatory approvals are complete. In parallel, we are also preparing for a long-term clinical trial outside the United States that is expected to begin in the second quarter of 2025.

Previous wording

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.

Current wording

General and administrative expenses consist primarily of professional services, salaries, 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.

Previous wording

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.

Current wording

Research and development expenses consist primarily of salaries and other personnel-related expenses, including stock-based compensation expenses, materials, travel expenses, clinical trials and other expenses. We expect research and development expenses to increase in 2025 and beyond, primarily due to expanding clinical trial activities, hiring additional personnel, as well the development of 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, development of new Glucotrack CBGM models and other product candidates.

Previous wording

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.

Current wording

The following discussion of our operating results explains material changes in our results of operations for the three-months ended March 31, 2024 compared with the same periods ended March 31, 2023. The discussion should be read in conjunction with the financial statements and related notes included elsewhere in this report.

Previous wording

Marketing expenses were approximately $0.3 millionfor 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.

Current wording

General and administrative expenses were approximately $1,499 for the three-month period ended March 31, 2025, as compared to approximately $733, for the prior-year period. The increase is primarily attributable to increased legal and professional fees, personnel costs and placement agent fees.

Previous wording

Marketing expenses were approximately $0.1 millionfor 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.

Current wording

Selling and marketing expenses were approximately$128 for the three-month period ended March 31, 2025, as compared to $70 for the prior-year period. This increase is primarily attributable to increased professional marketing services.

Previous wording

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.

Current wording

Net loss was approximately $6,833 million for the three-months’ period ended March 31, 2025, as compared to approximately $2,927 million for the prior-year period. The increase in net loss is primarily attributed to the increase in general and administrative expenses and the fair value change of the derivative liability, as described above.

Previous wording

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.

Current wording

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 Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025. 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.

Previous wording

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.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Further to the above progress on the Glucotrack CBGM, we have also successfully demonstrated continuous glucose sensing in the epidural space. This latter approach is of importance for patients with diabetes already contemplating spinal cord stimulation therapy for their condition.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

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.

Previous report — wording carried elsewhere

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.