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Item 2. Management’s Discussion and Analysis

2025-05-14 compared with 2024-11-14 · 248 added, 307 removed, 2 unchanged (100% of the section changed)

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, 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.

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.

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

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.

Company is currently developing an Implantable CBGM for use by Type 1 diabetes patients as well as insulin-dependent Type 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

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.

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

Recently we announced a 3-year longevity is feasible leveraging both in-vitro and in-silico test results.

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

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.

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

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.

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.

Klonoff, world renowned endocrinologist and diabetes technology thought leader.

continue to invest in our talent and to expand and strengthen all areas within the Company.

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.

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.

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.

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

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

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.

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

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

On October 15, 2024, we issued 254,226 shares of common stock for the June 27 Investor in respect of the Debt converted.

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

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.

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.

have been no material changes to the critical accounting policies and estimates as filed in such report.

and Capital Resources

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

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.

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

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.

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.

of Operations

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.

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

and development expenses

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.

and development expenses consist primarily of salaries and other personnel-related expenses, materials, animal trials, production labor

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.

The February 2025 offering closed on February

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 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.

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.

and administrative expenses

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.

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 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.

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.

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

and development expenses

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.

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.

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.

and administrative expenses

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.

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.

(income) expenses, net

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.

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.

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

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.

cash used in investing activities was $0.1 million and $0 for the nine-month periods ended September 30, 2024 and 2023, respectively.

cash used in investing activities primarily reflects the purchasing of fixed assets.

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.

Sheet Arrangements

of September 30, 2024, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.

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.

Concern Uncertainty

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.

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’

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.

Quantitative and Qualitative Disclosures About Market Risk.

required for smaller reporting companies.

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.

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.

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