What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-05-14 · 259 added, 248 removed, 2 unchanged (100% of the section changed)

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

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, 2024.

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.

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.

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.

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.

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.

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.

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.

Recent Events

2025 Reverse Stock Split and Increase in Authorized

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

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.

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).

ATM Sales Agreement

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

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.

Registered Direct Offering

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.

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

Note Regarding Forward-Looking Statements

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

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

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

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, 2024.

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.

Company was incorporated on May 18, 2010 under the laws of the State of Delaware.

We are currently developing an implantable

continuous blood glucose monitor (“CBGM”).

The Glucotrack CBGM is a long-term fully implantable continuous glucose

monitor (CGM), consisting of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate

with a mobile application.

It measures glucose directly from the blood, eliminating the lag time associated with interstitial fluid

glucose monitors.

Designed for a three-year sensor life with continuous, accurate blood glucose monitoring, the system offers a more

convenient and less burdensome solution for people with diabetes, with no on-body wearable component and minimal calibration

requirements.

Glucotrack CBGM is being developed for use by diabetes patients who are dependent on daily glucose monitoring to manage their disease.

These include patients who have the following conditions:

Type 1 diabetes, Type 2 insulin-dependent diabetes, Type 2 diabetes using basal

insulin and Type 2 diabetes at risk for hypoglycemia.

have continued to evolve our sensor chemistry following the results of an initial in-vitro feasibility study.

In 2024, 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.

We believe that implant accuracy and longevity

is key to the success for long term use.

initiated a first-in-human (“FIH”) short-term clinical study outside of the United States in fourth quarter of 2024 and completed

the study in first quarter of 2025.

We recently presented results at the 2025 American Diabetes Association annual conference at the

Innovation Hub podium as well as a poster.

The ADA presentation reported that the FIH clinical study met all primary and secondary endpoints

with no procedure or device related serious adverse events reported from implant through seven days post-removal of the CBGM sensor lead.

The system also demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99%

data capture rate, and no procedure or device-related serious adverse events.

These findings validate the safety and performance of the

system which measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional

continuous glucose monitoring systems.

The MARD value demonstrates very high accuracy and compares favorably to commercially available

The FIH study also confirmed the function of the CBGM sensor lead in the subclavian vein.

Placement and removal procedures

were successfully performed by interventional cardiologists.

are preparing for a long-term clinical study outside the United States to evaluate the device’s performance and safety over an

initial period of 1 year.

We obtained regulatory approval during the second quarter 2025 and patient enrollment is expected to begin in

the third quarter of 2025.

the second quarter 2025, we initiated discussions with the Food & Drug Administration (“FDA”) in preparations for a pre-investigational

device exemption (“IDE”) submission.

The discussions pertain to the protocol study design and related requirements to secure

IDE approval for future long-term human clinical trials in the United States.

We expects to file the IDE submission to the FDA during

the fourth quarter of 2025.

believe our technology, if successful, has the potential to be a long-term, implantable system that continually measures blood glucose

levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration.

Reverse Stock Splits and Increase in Authorized Common Stock

2025 1-for-20 Reverse Stock Split

filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30

on February 3, 2025, to implement a reverse stock split at a ratio of 1-for-20 (the “February 2025 Reverse Stock Split”)

of the shares of our Common Stock.

The February 2025 Reverse Stock Split was approved by our stockholders at the special meeting of stockholders

held on January 3, 2025 (the “Special Meeting”).

January 3, 2025, we filed an amendment to our Certificate of Incorporation 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).

2025 1-for-60 Reverse Stock Split

filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30

on June 13, 2025, to implement a reverse stock split at a ratio of 1-for-60 (the “June 2025 Reverse Stock Split”) of

the shares of its Common Stock.

The June 2025 Reverse Stock Split was approved by the Company’s stockholders at the 2025 annual

meeting of the stockholders held on May 22, 2025.

shares, options and warrants to purchase shares of Common Stock and loss per share amounts have been adjusted to give retroactive effect

to the February and June 2025 reverse share splits, (the “Reverse Stock Splits”) for all periods presented in these interim

consolidated financial statements.

Any fractional shares resulting from the Reverse Stock Splits were rounded up to the nearest whole

Sales Agreement

December 17, 2024, we entered into an ATM sales agreement (the “Sales Agreement”) with Dawson James Securities, Inc.

James”), pursuant to which we agreed to issue and sell shares of Common Stock, having an aggregate offering price of up to $8,230, from time to time, through an “at-the-market” equity offering program (the “ATM Program”) under which

Dawson James will act as sales agent (the “Agent”).

March 21, 2025, we sold 206,300 shares of Common Stock at an average offering price of $18.24 per share pursuant to the Sales Agreement,

for net proceeds of $3,643, after deducting fees owed to the Agent from such sale.

the three months ended June 30, 2025, we sold 414,785 shares of Common Stock at an average offering price of $10.74 per share pursuant

to the Sales Agreement for net proceeds of $4,320, after deducting fees owed to the Agent from such sale.

As of June 30, 2025,

there was no remaining capacity available under the ATM Program.

shares of Common Stock sold in conformance to the Sales Agreement 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

333-282297) (the “S-3 Registration Statement”), which was declared effective by the Securities and Exchange Commission,

on October 3, 2024.

Direct Offering

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 43,968 shares of Common Stock at an offering price of $69.00 per share (the “February 2025

The net proceeds to us from the February 2025 Offering were approximately $2,752, after deducting fees owed to

placement agent and other offering expenses.

The February 2025 Offering closed on February 5, 2025.

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.

Warrant Exchange

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).

Appointment of Peter C.

Wulff as Chief Financial

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.

Financial Overview

Operating Expenses

General and Administrative

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.

Research and Development

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.

Selling and Marketing

Selling and marketing expenses consist primarily of

personnel-related expenses and professional service costs.

Other (Income) Expense

Other income expense, consist primarily of the change

in fair value of derivative liabilities, finance (income) expense and other (income) expense.

Results of Operations

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

Consolidated Results of Operations for the Three

Months ended March 31, 2025 and 2024

General and administrative expenses

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.

Research and development expenses

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.

Selling and marketing expenses

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.

Change in Derivative Liability

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

Financing income (expenses), net

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.

is attributable to interest income received during the period.

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.

Liquidity and Capital Resources

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.

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.

primary requirements for liquidity have been to fund product and clinical development activities and to satisfy our general corporate

and working capital needs.

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.

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.

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.

shares of Common Stock from the February 2025 Offering were 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.

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 54,021 of the Series B Warrants, requiring the delivery of 162,603 shares of Common Stock according to the alternative

cashless exercise provision of the Series B Warrants sold in the November 2024 registered direct offering.

The remaining 11 Series B

Warrants are exchangeable for 11 shares of Common Stock (subject to adjustment in the event of any stock dividend and split, reverse

stock split, recapitalization, reorganization or similar transaction).

June 30, 2025, we repurchased 49,668 Series A Warrants from existing warrant holders for $160.

The fair value of the Series A Warrants

on the date of exercise was $65, resulting in a loss on repurchase of $95.

Wulff as Chief Financial Officer

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.

and Administrative

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.

and Development

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;

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.

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

(Income) Expense

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

of Operations

following discussion of our operating results explains material changes in our results of operations for the three and six months ended

June 30, 2025 compared with the same periods ended June 30, 2024.

The discussion should be read in conjunction with the financial statements

and related notes included elsewhere in this report.

Results of Operations for the Three Months ended June 30, 2025 and 2024

All information below is stated in thousands of U.S.

and administrative expenses

and administrative expenses were approximately $1,464 for the three-month period ended June 30, 2025, as compared to approximately $802,

for the prior-year period.

The increase is primarily attributable to increased legal and professional fees, and personnel costs.

and development expenses

and development expenses were approximately $3,150 for the three-month period ended June 30, 2025, as compared to approximately $3,589

for the prior-year period.

The decrease is attributable to a reduction in product and manufacturing costs we accrued during the period

related to the development of the Glucotrack CBGM model.

expenses were approximately $182 for the three-month period ended June 30, 2025, as compared to $100 for the prior-year period.

increase is primarily attributable to increased market research fees.

in derivative liability

in derivative liability for the three months ended June 30, 2025, was a decrease of $107.

The change is primarily due to adjustments

of the estimated fair value of the remaining 4,368 Series A and Series B Warrants.

(income) expense, net

expense was $96 for the three-month period ended June 30, 2025.

The increase was due to the $95 loss from the Series A Warrant repurchase.

income (expenses), net

income, net was approximately $29 for the three-month period ended June 30, 2025, as compared to financing income of approximately $2

for the prior-year period.

The increase is attributable to interest income received during the period.

loss was $4,756 for the three-month period ended June 30, 2025, as compared to $4,489 for the prior-year period.

in net loss is primarily attributed to the increase in general and administrative expenses and the loss from the Series A Warrant repurchase,

as described above.

Results of Operations for the Six Months ended June 30, 2025 and 2024

and administrative expenses

and administrative expenses were approximately $2,963 for the six-month period ended June 30, 2025, as compared to approximately $1,535,

for the prior-year period.

The increase is primarily attributable to increased legal and professional fees, personnel costs.

and development expenses

and development expenses were approximately $5,021 for the six-month period ended June 30, 2025, as compared to approximately $5,737

for the prior-year period.

The decrease is attributable to a reduction in product and manufacturing costs we accrued during the period

related to the development of the Glucotrack CBGM model.

expenses were approximately $310 for the six-month period ended June 30, 2025, as compared to $170 for the prior-year period.

This increase

is primarily attributable to increased market research fees and personnel costs.

in derivative liability

in derivative liability for the six months ended June 30, 2025, was a decrease of $3,269.

The change is primarily due to adjustments

of the estimated fair value of the remaining 4,368 Series A and Series B Warrants.

(income) expense, net

expense was $92 for the six-month period ended June 30, 2025.

The increase was primarily due to the $95 loss from the Series A Warrant

income (expenses), net

income, net was $66 for the six-month period ended June 30, 2025, as compared to financing income of $29 for the prior-year period.

increase is attributable to interest income received during the period.

loss was $11,589 for the six-month period ended June 30, 2025, as compared to $7,416 for the prior-year period.

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.

and Going Concern

of June 30, 2025, we had $9,555 in cash and cash equivalents compared with $5,627 in cash, cash equivalents and restricted cash as

of December 31, 2024.

The net increase in cash and cash equivalents was attributable to the $10,555 of net proceeds received from

financing activities offset by cash used in operating and investing activities of $6,693.

have a history of recurring losses, and as of June 30, 2025, we have an accumulated deficit of $144,039.

During the six months ended

June 30, 2025, we recorded a net loss of $11,589.

Our primary requirements for liquidity have been to fund product and clinical development

activities and to satisfy our general corporate and working capital needs.

on our operating plans, we do not expect that our current cash and cash equivalents as of June 30, 2025, will be sufficient to fund our

operating 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

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.

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.

Going Concern Uncertainty

To date, we have not yet commercialized the Glucotrack

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.

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

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.

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.

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

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.

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.

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

Off Balance Sheet Arrangements

We do not have any off balance sheet agreements.

Quantitative and Qualitative Disclosures

About Market Risk.

As a smaller reporting company, we are not required

to provide the information required by this Item.

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.

Accounting Policies

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.

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.

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.

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

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.

Balance Sheet Arrangements

do not have any off balance sheet agreements.

Quantitative and Qualitative Disclosures About Market Risk.

a smaller reporting company, we are not required to provide the information required by this Item.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis