What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-02-17 compared with 2025-11-14 · 266 added, 202 removed, 12 unchanged (98% of the section changed)

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

Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the accompanying

condensed consolidated financial statements and notes included in this Quarterly Report on Form 10-Q (this Report).

This Report contains

forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange

Act of 1934, which include, without limitation, statements about the market for our technology, our strategy, competition, expected financial

performance and capital raising efforts, and other aspects of our business identified in our most recent annual report on Form 10-K filed

with the Securities and Exchange Commission on June 20, 2025 and in other reports that we file from time to time with the Securities

and Exchange Commission.

Any statements about our business, financial results, financial condition and operations contained in this Report

that are not statements of historical fact may be deemed to be forward-looking statements.

Without limiting the foregoing, the words

“believes,” “anticipates,” “expects,” “intends,” “plans,” “projects,”

or similar expressions are intended to identify forward-looking statements.

Our actual results could differ materially from those expressed

or implied by these forward-looking statements as a result of various factors, including the risk factors described under Item 1A of

our Annual Report on Form 10-K for the year ended March 31, 2025.

These forward-looking statements represent our intentions, plans, expectations,

assumptions and beliefs about future events and are subject to risks, uncertainties and other factors including, without limitation,

inflationary risks, including the risk of increasing costs for certain of the Company’s components and related issues that may

arise therefrom.

Many of those factors are outside of our control and could cause actual results to differ materially from those expressed

or implied by those forward-looking statements.

In light of these risks, uncertainties and assumptions, the events described in the forward-looking

statements might not occur or might occur to a different extent or at a different time than we have described.

You are cautioned not

to place undue reliance on these forward-looking statements, which speak only as of the date of this Report.

All subsequent written and

oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our

behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.

We undertake no

obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events,

conditions, circumstances or assumptions underlying such statements, or otherwise.

fiscal year ends on March 31 of each calendar year.

Each reference to a fiscal year in this Report, refers to the fiscal year ended March

31 of the calendar year indicated (for example, fiscal 2026 refers to the fiscal year ending March 31, 2026).

Unless the context requires

otherwise, references to “we,” “us,” “our,” and the “Company” refer to Modular Medical,

Management’s Discussion and Analysis of Financial

Condition and Results of Operations

This Management’s Discussion and Analysis

of Financial Condition and Results of Operations should be read in conjunction with the accompanying condensed consolidated financial

statements and notes included in this Quarterly Report on Form 10-Q (this Report).

This Report contains forward-looking statements within

the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which include, without

limitation, statements about the market for our technology, our strategy, competition, expected financial performance and capital raising

efforts, and other aspects of our business identified in our most recent annual report on Form 10-K filed with the Securities and Exchange

Commission on June 20, 2025 and in other reports that we file from time to time with the Securities and Exchange Commission.

Any statements

about our business, financial results, financial condition and operations contained in this Report that are not statements of historical

fact may be deemed to be forward-looking statements.

Without limiting the foregoing, the words “believes,” “anticipates,”

“expects,” “intends,” “plans,” “projects,” or similar expressions are intended to identify

forward-looking statements.

Our actual results could differ materially from those expressed or implied by these forward-looking statements

as a result of various factors, including the risk factors described under Item 1A of our Annual Report on Form 10-K for the year ended

March 31, 2025.

These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events

and are subject to risks, uncertainties and other factors including, without limitation, inflationary risks, including the risk of increasing

costs for certain of the Company’s components and related issues that may arise therefrom.

Many of those factors are outside of

our control and could cause actual results to differ materially from those expressed or implied by those forward-looking statements.

light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur

to a different extent or at a different time than we have described.

You are cautioned not to place undue reliance on these forward-looking

statements, which speak only as of the date of this Report.

All subsequent written and oral forward-looking statements concerning other

matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by

the cautionary statements contained or referred to in this Report.

We undertake no obligation to update or revise any forward-looking

statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying

such statements, or otherwise.

Our fiscal year ends on March 31 of each calendar

Each reference to a fiscal year in this Report, refers to the fiscal year ended March 31 of the calendar year indicated (for example,

fiscal 2026 refers to the fiscal year ending March 31, 2026).

Unless the context requires otherwise, references to “we,” “us,”

“our,” and the “Company” refer to Modular Medical, Inc.

and its consolidated subsidiary .

We are a pre-revenue medical device company

focused on the design, development and commercialization of innovative insulin pumps using modernized technology to increase pump

adoption in the diabetes marketplace.

Through the creation of a novel two-part patch pump, we seek to fundamentally alter the

trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps provide.

simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we

seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the

category into the mass market.

The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device

adoption, type 2 diabetes markets.

In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug

Administration (the “FDA”) for our initial product, our MODD1, and, in September 2024, we received FDA clearance to

market and sell our MODD1 pump in the United States.

In August 2025, we announced the first human use of our MODD1 pump delivering

insulin to a human patient.

In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot.

a 510(k) premarket notification to the FDA for our Pivot product on November 13, 2025, when the United States government shutdown

We intend to initiate our commercial launch with the Pivot product, when the required regulatory approval from the FDA

is received, which is expected in the first quarter of 2026.

We are actively working to i) obtain regulatory clearance and prepare to commence commercialization of our Pivot product, ii) obtain regulatory clearance to market and sell our Pivot product in

foreign jurisdictions, iii) improve the manufacturability and usability of our Pivot product and iv) develop new pump products.

Historically, we have financed our operations

principally through private placements and public offerings of our common stock and warrants and sales of convertible promissory notes.

Based on our current operating plan, substantial doubt about our ability to continue as a going concern for a period of at least one

year from the date that the financial statements included in Item 1 of this Report are issued exists.

Our ability to continue as a going

concern depends on our ability to raise additional capital, through the sale of equity or debt securities, to support our future operations.

If we are unable to secure additional capital, we will be required to curtail our research and development initiatives and take additional

measures to reduce costs.

We have provided additional disclosure in Note 1 to the consolidated financial statements in Item 1 of this

Report and under Liquidity below.

Company Overview

We are a pre-revenue medical device company focused

on the design, development and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in

the diabetes marketplace.

Through the creation of a novel two-part patch pump, we seek to fundamentally alter the trade-offs between cost

and complexity and access to the higher standards of care that presently-available insulin pumps provide.

By simplifying and streamlining

the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin

delivery device market beyond the highly motivated “super users” and expand the category into the mass market.

seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets.

In January 2024,

we submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for our initial

product, our MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States.

2025, we announced the first human use of our MODD1 pump delivering insulin to a human patient.

In addition, in August 2025, we announced

our next-generation patch pump, branded as Pivot.

We intend to commercialize our Pivot product, and will not commercialize our

MODD1 product.

We submitted a 510(k) premarket notification to the FDA for our Pivot product on November 13, 2025, when the United States

government shutdown ended.

We intend to initiate our commercial launch with the Pivot product, when the required regulatory approval from

the FDA is received, which we believe may occur by March 31, 2026 or shortly thereafter.

We are actively working to i) obtain regulatory clearance and prepare

to commence commercialization of our Pivot product, ii) obtain regulatory clearance to market and sell our Pivot product in foreign jurisdictions,

iii) improve the manufacturability and usability of our Pivot product and iv) develop new pump products.

Historically, we have financed our

operations principally through private placements and public offerings of our common stock and warrants and sales of convertible

promissory notes.

Based on our current operating plan, substantial doubt about our ability to continue as a going concern for a

period of at least one year from the date that the financial statements included in Item 1 of this Report are issued exists.

ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt

securities, to support our future operations.

If we are unable to secure additional capital, we will be required to curtail our

research and development initiatives and take additional measures to reduce costs.

We have provided additional disclosure in Note 1

to the condensed consolidated financial statements in Item 1 of this Report and under Liquidity below.

Recent Developments

As disclosed in Note 4 to the condensed consolidated

financial statements in this Report, in September 2025, we effected a warrant inducement offering for net proceeds of approximately $3.9

million, after deducting servicing agent fees and other offering expenses payable by us, and, during the six months ended September 30,

2025, we received net proceeds of approximately $0.7 million from sales of shares of our common stock under our at-the-market sales program.

financial statements in this Report, in December 2025, the Company entered into a firm commitment underwritten offering for net proceeds

of approximately $4.8 million.

Compliance with Nasdaq Continued Listing Requirements

June 30, 2025, we received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating

that, based upon the closing bid price of our common stock for the 30 consecutive business days ending on June 27, 2025, we no longer

met the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2).

accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided a period of 180 calendar days, or until December 29, 2025, in

which to regain compliance.

In order to regain compliance with the minimum bid price requirement, the closing bid price of our common

stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period.

In the event we do not

regain compliance within this 180-day period, we may be eligible to seek an additional compliance period of 180 calendar days provided

we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq

Capital Market, with the exception of the bid price requirement, and if we provide written notice to Nasdaq of our intent to cure the

deficiency during this second compliance period by effecting a reverse stock split, if necessary.

However, if it appears to the Nasdaq

staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will provide notice to us that our

common stock will be subject to delisting.

above mentioned letter does not result in the immediate delisting of our common stock from the Nasdaq Capital Market.

We are monitoring

the closing bid price of our common stock and considering our available options in the event the closing bid price of our common stock

remains below $1 per share.

Accounting Policies and Estimates

discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements,

which have been prepared in accordance with U.S.

The preparation of these condensed consolidated financial statements requires

us to make certain estimates and judgments that affect the reported amounts of assets, liabilities, and expenses.

On an ongoing basis,

we make these estimates based on our historical experience and on assumptions that we consider reasonable under the circumstances.

results may differ from these estimates and reported results could differ under different assumptions or conditions.

Our significant

accounting policies and estimates are disclosed in Note 1 of the Notes to Consolidated Financial Statements in our Annual Report on Form

10-K for the year ended March 31, 2025.

As of September 30, 2025, there have been no material changes to our significant accounting policies

and estimates.

of Operations

and Development

September 30,

On June 30, 2025, we received a letter from the

Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of

our common stock for the 30 consecutive business days ending on June 27, 2025, we no longer met the requirement to maintain a minimum

bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were

provided a period of 180 calendar days, or until December 29, 2025, in which to regain compliance.

On December 23, 2025, we submitted a request to

Nasdaq for an additional 180-day period (the “Second Compliance Period”) to provide additional time for us to demonstrate

compliance with the minimum bid price requirement.

In such request, we communicated that we intend to regain compliance during the Second

Compliance Period by effecting a reverse stock split.

On December 30, 2025, we received written notification from the Listing Qualifications

Department of Nasdaq, granting our request for a 180-day extension to regain compliance with the minimum bid price requirement.

have until June 29, 2026 to meet the requirement.

If at any time prior to June 29, 2026, the bid price of our common stock closes at $1

per share or more for a minimum of 10 consecutive business days, we will regain compliance with the minimum bid price requirement.

the event we do not regain compliance with the minimum bid price requirement during the additional 180-day extension, Nasdaq will provide

written notification to us that our Common Stock will be delisted.

At that time, we may appeal the relevant delisting determination to

a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.

However, there can be no assurance that,

if we do appeal the delisting determination by Nasdaq to the hearings panel, that such appeal would be successful.

On January 23, 2026,

at our annual meeting of shareholders, our shareholders authorized our board of directors to effect a reverse split, as necessary, to

regain compliance.

We will continue to monitor the closing bid price of our common stock and evaluate available options to regain compliance

with the minimum bid price requirement.

Nasdaq’s extension notice has no immediate effect on the listing or trading of our common

stock, which continues to trade on the Nasdaq Capital Market under the ticker symbol, “MODD.”

Increase in Authorized Shares

On January 23, 2026, we filed a certificate of

amendment to our Amended and Restated Articles of Incorporation with the secretary of state of the state of Nevada to increase our number

of authorized shares of common stock to 250,000,000.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition

and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with

The preparation of these condensed consolidated financial statements requires us to make certain estimates and judgments that

affect the reported amounts of assets, liabilities, and expenses.

On an ongoing basis, we make these estimates based on our historical

experience and on assumptions that we consider reasonable under the circumstances.

Actual results may differ from these estimates and

reported results could differ under different assumptions or conditions.

Our significant accounting policies and estimates are disclosed

in Note 1 of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended March 31, 2025.

December 31, 2025, there have been no material changes to our significant accounting policies and estimates.

Results of Operations

Research and Development

(dollar amounts in thousands)

Research and development – Three months ended

Research and development – Six months ended

research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization

and other non-capitalizable operational costs associated with the production of our insulin pump product.

We expense R&D costs as

they are incurred.

R&D expenses increased for the three

months ended September 30, 2025 compared with the same period of 2024, primarily due to increased personnel-related costs of

approximately $1.0 million, an increase in depreciation expense of approximately $0.1 million, an increase in consulting costs of

$0.4 million and an increase in materials and supplies costs of $0.4 million.

R&D expenses increased for the six

months ended September 30, 2025 compared with the same period of 2024, primarily due to increased personnel-related costs of

approximately $1.9 million, an increase in depreciation expense of approximately $0.3 million, an increase in consulting costs of

$0.5 million, an increase in materials and supplies costs of $0.7 million, an increase in shipping costs of approximately $0.2

million and increases in other costs of approximately $0.2 million.

Our full-time R&D employee headcount increased to 56 at

September 30, 2025 from 42 at September 30, 2024.

Research and development – Nine months ended

Our research and development, or R&D, expenses

include personnel, consulting, testing, materials and supplies, depreciation and amortization and other non-capitalizable operational

costs associated with the production of our insulin pump product.

We expense R&D costs as they are incurred.

R&D expenses increased for the three months

ended December 31, 2025 compared with the same period of 2024, primarily due to an increase in personnel-related costs of approximately

$0.5 million, an increase in consulting and outside services costs of $0.6 million, an increase in shipping and freight costs of approximately

$0.2 million, an increase in depreciation expense of approximately $0.1 million and a $0.1 million increase in stock-based compensation

R&D expenses increased for the nine months

ended December 31, 2025 compared with the same period of 2024, primarily due to increased personnel-related costs of approximately $2.4

million, an increase in consulting and outside services costs of $1.2 million, an increase in materials and supplies costs of $0.6 million,

an increase in depreciation expense of approximately $0.5 million, and an increase in shipping and freight costs of approximately $0.5

million and increases and a $0.2 million increase in stock-based compensation expenses.

Our full-time R&D employee headcount increased

to 58 at December 31, 2025 from 44 at December 31, 2024.

R&D expenses included stock-based compensation expenses of approximately

million and $0.8 million for the three-months ended September 30, 2025 and 2024, respectively, and $1.2 million for each of the

six-month periods ended September 30, 2025 and 2024.

We expect research and development expenses to increase in the second half of

fiscal 2026, as we have commenced activities in support of commercialization of our Pivot product, which we expect to occur in the first half of calendar year 2026.

General and Administrative

September 30,

$0.4 million and $0.3 million for the three-months ended December 31, 2025 and 2024, respectively, and $1.7 million and $1.5 million for

the nine-month periods ended December 31, 2025 and 2024, respectively.

We expect research and development expenses to remain flat to decrease in the last quarter of fiscal 2026, as we manage expenses in anticipation of expected FDA clearance and the commercialization of our Pivot pump product.

Selling, General and Administrative

(dollar amounts in thousands)

Selling, general and administrative – Three months ended

Selling, general and administrative – Six months ended

general and administrative, or SG&A, expenses consist primarily of personnel and related overhead costs for facilities, finance,

human resources, legal, sales, marketing and general management.

Selling, general and administrative – Nine months ended

Selling, general and administrative, or SG&A,

expenses consist primarily of personnel and related overhead costs for facilities, finance, human resources, legal, sales, marketing and

general management.

SG&A expenses increased for the three months

ended September 30, 2025 compared with the same period of 2024, primarily as a result of increases in personnel costs of approximately

$0.5 million, consulting fees of approximately $0.3 million, and marketing expenses of approximately $0.1 million.

SG&A expenses increased for the six months

ended September 30, 2025 compared with the same period of 2024, primarily as a result of increases in personnel costs of approximately

$0.8 million, increases in consulting expenses of approximately $0.5 million, and increased marketing expenses of approximately $0.3 million.

Our full-time SG&A employee headcount increased to 13 at September 30, 2025 from 4 at September 30, 2024.

SG&A expenses included

stock-based compensation expenses of approximately $0.2 million for each of the three-month periods ended September 30, 2025 and 2024,

and $0.3 million and $0.4 million for the six months ended September 30, 2025 and 2024, respectively.

We expect SG&A expenses to increase

in the second half of fiscal 2026 as compared with fiscal 2025, as we continue to expand our sales and marketing organization and increase

our general and administrative headcount to support the commercialization of our Pivot pump product during fiscal 2026.

and Capital Resources;

ended December 31, 2025 compared with the same period of 2024, primarily as a result of increases in personnel costs of approximately

$0.4 million, increases in consulting expenses of approximately $0.6 million, which was partially offset by a decrease in legal and professional

services of $0.2 million.

SG&A expenses increased for the nine months

ended December 31, 2025 compared with the same period of 2024, primarily as a result of increases in personnel costs of approximately

$1.0 million, increases in consulting expenses of approximately $1.2 million, and a $0.3 million increase in marketing costs, which was

partially offset by a $0.1 million decrease in stock-based compensation expenses.

Our full-time SG&A employee headcount

increased to 11 at December 31, 2025 from 4 at December 31, 2024.

SG&A expenses included stock-based compensation expenses of

approximately $0.1 million for the three-month periods ended December 31, 2025 and 2024, and $0.4 million and $0.5 million for the

nine months ended December 31, 2025 and 2024, respectively.

We expect SG&A expenses to remain flat to decrease in the last

quarter of fiscal 2026, as we manage expenses in anticipation of expected FDA clearance and the

commercialization of our Pivot pump product.

Liquidity and Capital Resources;

Changes in Financial Condition

We do not currently have revenues to

generate cash flows to cover operating expenses.

Since our inception, we have incurred operating losses and negative cash flows in

each year due to costs incurred in connection with R&D activities and SG&A expenses associated with our operations.

six months ended September 30, 2025 and year ended March 31, 2025, we incurred net losses of approximately $14.5 million and $18.8

million, respectively.

At September 30, 2025, we had a cash balance of $5.3 million and an accumulated deficit of approximately

$99.2 million.

When considered with our current operating plan, these conditions raise substantial doubt about our ability to

continue as a going concern for a period of at least one year from the date that the financial statements included in Item 1 of this

Report are issued.

Our financial statements do not include adjustments to the amounts and classification of assets and liabilities

that may be necessary should we be unable to continue as a going concern.

Our operating needs include the planned costs to operate

our business, including amounts required to fund continued research and development activities, working capital and capital

expenditures.

Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of

equity or debt securities to support our future operations.

In November 2023, we entered into a Sales Agreement (the “ATM

Agreement”) with Leerink Partners LLC (“Leerink”) under which we may offer and sell, from time to time at our sole

discretion, shares of our common stock (subject to availability on our shelf registration statement) through an “at the market

offering” program under which Leerink will act as sales agent or principal.

During the six months ended September 30, 2025, we

received net proceeds of approximately $0.7 million from sales of common stock under the ATM Agreement.

During the six months ended

September 30, 2025, we effected a warrant inducement offering of warrants issued in May 2023 and March 2025 for net proceeds of

approximately $3.9 million, after deducting servicing agent fees and other offering expenses.

Subsequent to September 30, 2025, under the ATM Agreement, we sold 1.8 million shares of common stock for net proceeds of approximately

$1.1 million.

Our future capital requirements and

the adequacy of our available funds will depend on many factors, including, without limitation, our ability to successfully

commercialize our product, competing technological and market developments, and the need to enter into collaborations with other

companies or acquire other companies or technologies to enhance or complement our product offerings.

If we are unable to secure

additional capital timely, we may be required to curtail R&D initiatives, reduce headcount and take additional measures to

reduce costs in order to conserve our cash.

the six months ended September 30, 2025, we used approximately $10.8 million of cash in operating activities, which primarily

resulted from our net loss of approximately $14.5 million, as adjusted for net changes in operating assets and liabilities of

approximately $1.4 million, stock-based compensation expenses of approximately $1.5 million and depreciation and amortization

expenses of approximately $0.8 million.

For the six months ended September 30, 2024, we used

approximately $7.3 million of cash in operating activities, which primarily resulted from our net loss of approximately $9.1 million

and net changes in operating assets and liabilities of approximately $0.3 million, as adjusted for stock-based compensation expenses

of approximately $1.6 million, depreciation and amortization expenses of approximately $0.5 million and other immaterial

the six months ended September 30, 2025 and 2024, cash used in investing activities of approximately $1.7 million and $1.0 million, respectively,

was for the purchase of property and equipment.

provided by financing activities of approximately $4.7 million for the six months ended September 30, 2025 was attributable to $4.0 million

of proceeds from a warrant inducement offering completed in September 2025 and $0.7 million of proceeds from sales of common stock under

the ATM Agreement.

Cash provided by financing activities of approximately $3.0 million for the six months ended September 30, 2024 was

attributable to proceeds from the at-the-market sales of stock and exercise of common stock purchase warrants.

primary purchase obligations include purchase orders for machinery and equipment.

At September 30, 2025, we had outstanding purchase

orders for machinery and equipment and related expenditures of approximately $1.7 million.

Issued Accounting Pronouncements

issued accounting pronouncements are detailed in Note 1 in the Notes to the Condensed Consolidated Financial Statements included in Item

1 of this Report.

For the nine months ended December 31, 2025, we

used approximately $17.9 million of cash in operating activities, which primarily resulted from our net loss of approximately $21.9 million,

as adjusted for net changes in operating assets and liabilities of approximately $0.5 million, stock-based compensation expenses of approximately

$2.1 million, an approximately $0.1 million change in fair value of warrant liabilities and depreciation and amortization expenses of

approximately $1.2 million.

For the nine months ended December 31, 2024, we used approximately $11.4 million of cash in operating activities,

which primarily resulted from our net loss of approximately $13.9 million and net changes in operating assets and liabilities of approximately

$0.3 million, as adjusted for stock-based compensation expenses of approximately $2.0 million, depreciation and amortization expenses

of approximately $0.7 million and other immaterial adjustments.

For the nine months ended December 31, 2025 and

2024, cash used in investing activities of approximately $2.9 million and $1.5 million, respectively, was for the purchase of property

and equipment.

Cash provided by financing activities of approximately

$10.7 million for the nine months ended December 31, 2025 was attributable to $4.8 million of net proceeds from a public offering of our

common stock and warrants completed in December 2025, $4.0 million of net proceeds from a warrant inducement offering completed in September

2025 and $1.9 million of net proceeds from sales of common stock under the ATM Agreement.

Cash provided by financing activities of approximately

$10.7 million for the nine months ended December 31, 2024 was attributable to $7.3 million of net proceeds from the issuance of common

stock in a public offering, $2.1 million of net proceeds from sales of our common stock under the ATM Agreement and $1.3 million of proceeds

from exercises of common stock purchase warrants.

Purchase Obligations

Our primary purchase obligations include purchase

orders for machinery and equipment.

At December 31, 2025, we had outstanding purchase orders for machinery and equipment and related expenditures

of approximately $2.0 million.

Going Concern - Working Capital

We do not currently have revenues to generate

cash flows to cover operating expenses.

Since our inception, we have incurred operating losses and negative cash flows in each year due

to costs incurred in connection with R&D activities and SG&A expenses associated with our operations.

For the nine months ended

December 31, 2025 and year ended March 31, 2025, we incurred net losses of approximately $21.9 million and $18.8 million, respectively.

At December 31, 2025, we had a cash balance of $2.9 million and an accumulated deficit of $106.6 million.

When considered with our current

operating plan, these conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one

year from the date that the financial statements included in Item 1 of this Report are issued.

We currently lack sufficient liquidity

to fund our operations for the next 30 days.

If we do not obtain additional financing, we will be unable to meet our upcoming obligations,

including employee compensation and vendor payments.

In addition, our independent registered public accounting firm, in its report on

our consolidated financial statements for the year ended March 31, 2025, expressed substantial doubt about our ability to continue as

a going concern.

The condensed consolidated financial statements presented in Part I, Item 1 of this Report have been prepared assuming

that we will continue as a going concern, and do not include any adjustments that might result from the outcome of this uncertainty.

Our operating needs include the planned costs to operate our business, including amounts required to fund continued research and development

activities, working capital and capital expenditures.

Our ability to continue as a going concern depends on our ability to raise additional

capital, through the sale of equity or debt securities to support our future operations.

There can be no assurance that such additional

capital, whether in the form of debt or equity financing, will be sufficient or available and, if available, that such capital will be

offered on terms and conditions acceptable to us.

We are currently seeking additional financing in order to meet our cash requirements

for the foreseeable future.

If we are unable to obtain adequate capital to fund our operations, we would not be able to continue to operate

our business pursuant to our current business plan, which would require us to modify our operations to reduce spending to a sustainable

level by, among other things, delaying, scaling back or eliminating some or all of our ongoing or planned investments in our product,

including but not limited to research and development and other activities, which would have a material impact on our operations or force

us to discontinue our operations entirely.

In November 2023, we entered into a Sales Agreement

(the “ATM Agreement”) with Leerink Partners LLC (“Leerink”) under which we may offer and sell, from time to time

at our sole discretion, shares of our common stock (subject to availability on our shelf registration statement) through an “at

the market offering” program under which Leerink will act as sales agent or principal.

During the nine months ended December 31,

2025, we received net proceeds of approximately $1.9 million from sales of common stock under the ATM Agreement.

In December 2025, we

completed a public offering of our common stock and warrants for net proceeds of approximately $4.8 million.

If we were to raise additional capital through

sales of our equity securities, our shareholders would suffer dilution of their equity ownership.

If we engage in debt financing, we may

be required to accept terms that restrict our ability to incur additional indebtedness, prohibit us from paying dividends, repurchasing

our stock or making investments, and force us to maintain specified liquidity or other ratios, any of which could harm our business, operating

results and financial condition.

If we need additional capital and cannot raise it on acceptable terms, we may not be able to, among other

● continue to seek regulatory approvals for our Pivot insulin

delivery system in the United States and other jurisdictions;

● commercialize our Pivot insulin delivery system;

or enhance our products;

to expand our product development and sales and marketing organizations;

operations, in the United States or internationally;

train and retain employees;

to competitive pressures or unanticipated working capital requirements.

Our failure to do any of these

things could seriously harm our ability to execute our business strategy and may force us to curtail our existing operations.

Off-Balance Sheet Arrangements

We do not maintain any off-balance sheet arrangements

or obligations that are reasonably likely to have a material current or future effect on our financial condition, results of operations,

liquidity or capital resources.

Indemnifications

In the ordinary course of business, we enter into

contractual arrangements under which we may agree to indemnify the counter-party from losses relating to a breach of representations and

warranties, a failure to perform certain covenants, or claims and losses arising from certain external events as outlined within the contract,

which may include, for example, losses arising from litigation or claims relating to past performance.

Such indemnification clauses may

not be subject to maximum loss clauses.

We have also entered into indemnification agreements with our officers and directors.

amounts related to these indemnifications are reflected in our condensed consolidated financial statements for the three and nine months

ended December 31, 2025.

Recently Issued Accounting Pronouncements

Recently issued accounting pronouncements are

detailed in Note 1 in the Notes to the Condensed Consolidated Financial Statements included in Item 1 of this Report.

Quantitative and Qualitative Disclosures about Market Risk

Not required.

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