What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-02-13 · 160 added, 163 removed, 47 unchanged (87% of the section changed)

1 unchanged sentence

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 21, 2024 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

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.

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.

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.

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, 2024.

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.

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.

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

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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, our initial product, the MODD1, 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.

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

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

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

We are actively working to commercialize our MODD1 product and commence initial shipments in the first half of fiscal 2026, obtain regulatory

clearance to market and sell our MODD1 product in foreign jurisdictions, improve the manufacturability and usability of our MODD1 product

and develop new pump products.

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, our initial product, the MODD1, 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 MODD1 insulin

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

We are actively working

to i) commercialize our MODD1 product and commence initial shipments by October 2025, ii) obtain regulatory clearance to market and sell

our Pivot product during the first half of 2026, iii) obtain regulatory clearance to market and sell our pump products in foreign jurisdictions,

iv) improve the manufacturability and usability of our pump products and v) develop new pump products.

We believe the Pivot product will

provide us with cost and usability improvements and improved manufacturability, allowing our marketing to be focused on low cost and ease

of use and learnability.

We intend to replace the MODD1 product with the Pivot product, as soon as the required regulatory approval from

the FDA is received.

From a financing perspective, in June 2025, we

sold 1,000,000 shares of common stock under our ATM sales program for proceeds of approximately $0.7 million, and, in March 2025, we completed

private placements of our common stock and common stock purchase warrants for net proceeds of approximately $11.4 million.

Historically, we have financed our operations

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

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.

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.

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.

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.

Recent Developments

Compliance with Nasdaq Continued Listing Requirements

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 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.

The 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.

Critical Accounting

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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, 2024, there have been no material changes to our significant accounting policies and estimates.

June 30, 2025, there have been no material changes to our significant accounting policies and estimates.

Results of Operations

Research and Development

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Research and development – Three months ended

Research and development – Nine months ended

Research and development

Our research and development, or R&D, expenses

include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with

the pre-commercialization development and production of our insulin pump products.

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 remained relatively flat for

the three months ended December 31, 2024 compared with the same period of 2023, as employee-related costs increased approximately $0.5

million, depreciation expense increased by approximately $0.2 million, materials and supplies costs increased by approximately $0.2 million,

and other R&D-related expenses increased $0.1 million.

These increases were substantially offset by decreases of $0.6 million in consulting

expenses, which were significant in fiscal 2024 in support of our submission to the FDA in January 2024, and $0.4 million in stock-based

compensation expense.

R&D expenses increased for the nine months

ended December 31, 2024 compared with the same period of 2023, primarily due to increased employee-related costs of approximately $0.9

million, an increase in depreciation expense of approximately $0.5 million, an increase in travel-related and other costs of approximately

$0.2 million and an increase in stock-based compensation costs of approximately $0.1 million.

These increases were partially offset by

decreases of approximately $0.6 million in consulting expenses and $0.1 million in material and supplies costs.

R&D expenses increased for fiscal 2026 compared

with the same period of fiscal 2025, primarily due to increased personnel costs of approximately $0.9 million, an increase in material

costs of approximately $0.3 million, an increase in stock-based compensation expense of approximately $0.2 million, an increase of approximately

$0.2 million in consulting costs, an increase in depreciation expense of approximately $0.2 million and an increase in shipping and related

expenses of approximately $0.1 million.

Our full-time R&D employee headcount increased

to 44 at December 31, 2024 from 36 at December 31, 2023.

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

$0.3 million and $0.7 million for the three-months ended December 31, 2024 and 2023, respectively, and $1.5 million and $1.4 million for

the nine-month periods ended December 31, 2024 and 2023, respectively.

We expect research and development expenses to increase for the

remainder of fiscal 2025 due to testing activities in support of commercialization of our MODD1 product and to advance development of

new pump products.

General and Administrative

to 55 at June 30, 2025 from 36 at June 30, 2024.

R&D expenses included stock-based compensation expenses of approximately $0.6 million

and $0.4 million for the three-month periods ended June 30, 2025 and June 30, 2024, respectively.

We expect research and development

expenses to remain consistent in fiscal 2026.

Selling, General and Administrative

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General and administrative – Three months ended

General and administrative – Nine months ended

General and administrative, or G&A, expenses

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

and general management.

G&A expenses decreased for the three months

ended December 31, 2024 compared with the same period of 2023, primarily as a result of decreased stock-based compensation expense of

approximately $0.2 million, decreased legal and other professional service expenses of approximately $0.1 million, decreased marketing

expenses of approximately $0.1 million and a decrease in other G&A expenses of approximately $0.1 million.

The decreases were partially

offset by an increase in consulting expenses of approximately $0.1 million.

G&A expenses decreased for the nine months

ended December 31, 2024 compared with the same period of 2023, primarily as a result of a decrease in stock-based compensation expense

of approximately $0.1 million, a decrease in marketing expenses of approximately $0.1 million, and a decrease in travel-related and other

costs of approximately $0.2 million.

The decreases were partially offset by an increase in legal and other professional service expenses

of approximately $0.3 million.

G&A expenses included stock-based compensation

expenses of approximately $0.1 million and $0.3 million for the three-month periods ended December 31, 2024 and 2023, respectively and

$0.5 million and $0.6 million for the nine months ended December 31, 2024 and 2023, respectively.

We expect G&A expenses to increase

for the remainder of fiscal 2025, as we expect to incur additional expenses in support of commercialization of our MODD1 product.

Selling, general and administrative

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 June 30, 2025 compared with the same period of 2024, primarily as a result of increases in personnel costs of approximately $0.3

million, consulting fees of approximately $0.1 million, legal and professional services expenses of approximately $0.1 million, and sales

and marketing expenses of approximately $0.1 million.

Our full-time SG&A employee headcount increased

to 12 at June 30, 2025 from 4 at June 30, 2024.

SG&A expenses included stock-based compensation expenses of approximately $0.2 million

for each of the three-month periods ended June 30, 2025 and June 30, 2024, respectively.

We expect SG&A expenses to increase in 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 pump products during fiscal 2026.

Liquidity and Capital Resources;

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 our operations.

For the nine months ended December 31, 2024 and year ended March 31, 2024, we incurred

net losses of approximately $13.9 million and $17.5 million, respectively.

At December 31, 2024, we had a cash balance of $7.0 million

and an accumulated deficit of approximately $80 million.

We expect to continue to incur operating

losses for the foreseeable future and incur cash outflows from operations, as we continue to invest in the development and commercialization

of our pump products.

We expect that our expenses will continue to increase, and, as a result, we will eventually need to generate significant

revenue to achieve profitability.

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 acts as sales agent or principal.

During the three months ended December 31, 2024,

we sold 95,685 shares of common stock for net proceeds of approximately $0.2 million under the ATM Agreement.

Subject to market conditions,

we may resume sales under the ATM during the remainder of fiscal 2025, however, the potential net proceeds from such future sales,

if any, are unknown.

In November 2024, in a firm commitment underwritten offering, we sold 5,450,573 shares of our common stock at a public

offering price of $1.50 per share for net proceeds to us of approximately $7.3 million, after deducting underwriting discounts, commissions

and offering expenses.

In addition, during the three months ended December 31, 2024, we received a total of approximately $0.2 million

of proceeds from the exercise of common stock purchase warrants issued in a public offering we completed in May 2023.

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 MODD1 product and future pump products, 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.

unable to secure additional capital timely, we may be required to curtail product commercialization

and R&D initiatives, reduce headcount and take additional measures to reduce costs in order to conserve our cash.

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

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.

the three months ended June 30, 2025 and year ended March 31, 2025, we incurred net losses of approximately $6.7 million and $18.8 million,

respectively.

At June 30, 2025, we had a cash balance of $7.5 million and an accumulated deficit of approximately $91 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, for aggregate gross proceeds of up to $6.5 million

(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 three months ended June 30, 2025, we sold 1,000,000 shares of common stock under the

at-the-market agreement for proceeds of approximately $0.7 million.

In addition, in March 2025, the Company completed private placements

of its common stock and warrants for net proceeds of approximately $11.4 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.

For the three months ended June 30, 2025, we used

approximately $5.4 million of cash in operating activities, which primarily resulted from our net loss of approximately $6.7 million,

as adjusted for net changes in operating assets and liabilities of approximately $0.2 million, stock-based

compensation expenses of approximately $0.7 million, depreciation and amortization expenses of approximately $0.4 million and other

immaterial adjustments.

For the nine months ended December 31, 2023, we used approximately $10.5 million in operating activities, which

primarily resulted from our net loss of approximately $13.2 million and net changes in operating assets and liabilities of approximately

For the three months ended June 30, 2024, we used approximately $3.5 million of cash in operating activities,

which primarily resulted from our net loss of approximately $4.1 million and net changes in operating assets and liabilities of approximately

$0.1 million, as adjusted for stock-based compensation expenses of approximately $0.5 million and

depreciation and amortization expenses of approximately $0.2 million and other immaterial adjustments.

nine months ended December 31, 2024 and 2023, cash used in investing activities of approximately $1.5 million and $1.2 million ,

three months ended June 30, 2025 and 2024, cash used in investing activities of approximately $0.9 million and $0.8 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, 2024 was attributable to $7.3 million of proceeds from the issuance of common stock

in a public offering, net of underwriting fees and issuance costs, which closed in November 2024, $2.1 million of proceeds from sales

of our common stock under an at-the-market offering and $1.3 million of proceeds from exercises of common stock purchase warrants.

provided by financing activities for the nine months ended December 31, 2023 was attributable to $9.7 million of net proceeds from the

issuance of common stock and warrants in a public offering, which closed in May 2023, and approximately $0.2 million of proceeds from

the exercise of common stock purchase warrants.

$0.7 million for the three months ended June 30, 2025 was attributable to proceeds from sales of common stock under the ATM agreement.

Cash provided by financing activities of $0.2 million for the three months ended June 30, 2024 was attributable to proceeds from the exercise

of common stock purchase warrants.

Purchase Obligations

1 unchanged sentence

obligations include purchase orders for machinery and equipment.

At December 31, 2024, we had outstanding purchase orders for machinery

and equipment and related expenditures of approximately $1.1 million.

In December 2023, we

signed a device integration agreement with a provider of connected-care and remote monitoring diabetes technology solutions.

As of December

31, 2024, we had a remaining obligation under the device integration agreement of approximately $0.4 million over three years for

technology license and maintenance fees.

At June 30, 2025, we had outstanding purchase orders for machinery and

equipment and related expenditures of approximately $2.4 million.

In addition, at June 30, 2025, we had purchase commitments of approximately $0.9 million over the next three years for technology related

to our pump products.

Recently Issued Accounting Pronouncements

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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