What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-13 compared with 2025-08-14 · 128 added, 118 removed, 143 unchanged (63% of the section changed)

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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.

Quarterly Report on Form 10-Q (the “Quarterly Report”) 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,

including statements regarding our future activities, events or developments, including such things as future revenues, capital raising

and financing, product development, clinical trials, regulatory approval, market acceptance, responses from competitors, capital expenditures

(including the amount and nature thereof), business strategy and measures to implement strategy, competitive strengths, goals, expansion

and growth of our business and operations, plans, references to future success, projected performance and trends, and other such matters,

are forward-looking statements.

The words “believe,” “expect,” “anticipate,” “intend,”

“estimate,” “plan,” “may,” “will,” “could,” “would,” “should”

and other similar words and phrases, are intended to identify forward-looking statements.

The forward-looking statements made in this

Quarterly Report 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

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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.

All of the forward-looking statements made in this Quarterly Report 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 “Annual Report”).

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.

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.

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.

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.

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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.

We have initiated a long-term

clinical study outside the United States to evaluate the CBGM product performance and safety over an initial period of one (1) year.

The first phase of the clinical study provided early product learnings about how the complexity of certain health conditions may

impact study eligibility.

Consequently, we are undertaking certain protocol amendments to refine participant selection criteria

before enrolling additional participants.

In parallel, we intend to implement certain product improvements.

committed to advancing our clinical program and intend to proceed swiftly with the relevant protocol amendments and product

enhancements, subject to approval by the institutional review board.

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

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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.

We remain in active review with the FDA to accommodate

their requirements and expects to file the IDE submission to the FDA during the Spring of 2026.

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

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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”).

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,

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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.

As of September 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

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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 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.

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agent for the offerings pursuant to a placement agency agreement, dated February 4, 2025, by and between us and Dawson James.

September 12, 2025, we entered into a Note Purchase Agreement, with an investor, pursuant to which we issued a Promissory Note to the

Investor in the principal amount of $3,600,000 for a purchase price of $3,000,000.

on January 6, 2025, through March 15, 2025, we received exchange notices from certain holders of the Series B Warrants, with respect

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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.

the nine months ended September 30, 2025, we repurchased 51,529 of its Series A Warrants form existing warrant holders for $166.

fair value of the Series A Warrants on the date of exercise was $67, resulting in a loss on repurchase of $99.

Wulff as Chief Financial Officer

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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.

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

September 30, 2025 compared with the same periods ended September 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 September 30, 2025 and 2024

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 administrative expenses were approximately $1,024 for the three-month period ended September 30, 2025, as compared to

approximately $1,063, for the prior-year period.

The decrease is primarily attributable to reduced board of director and legal fees,

offset by increased 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

and development expenses were approximately $3,165 for the three-month period ended September 30, 2025, as compared to approximately

$2,063 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.

The increase is attributable to product and manufacturing development costs we accrued during the

period related to the development of the Glucotrack CBGM Product.

expenses were approximately $120 for the three-month period ended September 30, 2025, as compared to $125 for the prior-year period.

The decrease is primarily attributable to a reduction in 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.

in derivative liability for the three months ended September 30, 2025, was less than $1.0.

(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 was $136 for the three-month period ended September 30, 2025, as compared to $12 for the prior-year period.

The increase was due

to the receipt of a non-recurring research grant.

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

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

$1,848 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

This increase was primarily due to $1,505 in revaluation expenses incurred from settlement of financial

liabilities and $330 in discount amortization and interest expenses recognized in the prior-year period.

loss was $4,171 for the three-month period ended September 30, 2025, as compared to $5,087 for the prior-year period.

The reduction in

net loss is primarily attributed to the prior year revaluation expenses, discussed above, offset by the current year increase in research

and development expense.

Results of Operations for the Nine Months ended September 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 administrative expenses were approximately $3,987 for the nine-month period ended September 30, 2025, as compared to

approximately $2,598, 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 $5,021 for the six-month period ended June 30, 2025, as compared to approximately $5,737

and development expenses were approximately $8,186 for the nine-month period ended September 30, 2025, as compared to approximately $7,800

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.

The increase is attributable to product and manufacturing development costs we accrued during the period related

to the development of the Glucotrack CBGM Product.

expenses were approximately $430 for the nine-month period ended September 30, 2025, as compared to $295 for the prior-year period.

increase is primarily attributable to increased market research fees.

in derivative liability

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

in derivative liability for the nine-month period ended September 30, 2025, was a $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.

of the estimated fair value of the exchanged and repurchased warrants, as well as the outstanding 2,518 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 was $44 for the nine-month period ended September 30, 2025, as compared to $12 for the prior-year period.

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.

income, net was approximately $68 for the nine-month period ended September 30, 2025, as compared to financing expense of approximately

$1,822 for the prior-year period.

This increase was primarily due to $1,505 in revaluation expenses incurred from settlement of financial

liabilities and $330 in discount amortization and interest expenses recognized in the prior-year period.

loss was $15,760 for the nine-month period ended September 30, 2025, as compared to $12,503 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.

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.

of September 30, 2025, we had $7,869 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 $13,549 of net proceeds received from

financing activities offset by cash used in operating and investing activities of $11,380.

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.

have a history of recurring losses, and as of September 30, 2025, we have an accumulated deficit of $148,210.

During the nine-months

ended September 30, 2025, we recorded a net loss of $15,760.

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 September 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.

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.

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.

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.

Accounting Policies

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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.

Condition and Results of Operations of our Annual Report.

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

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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