Financial Statements
−Removed: Modular Medical, Inc.
−Removed: Condensed Consolidated Balance Sheets
−Removed: (In thousands, except par value)
+Added: Medical, Inc.
+Added: Consolidated Balance Sheets
+Added: thousands, except par value)
+Added: September 30,
CURRENT ASSETS
16 unchanged sentences
Common Stock, $ 0.001 par value, 100,000 shares authorized;
−Removed: 55,275 and 53,706 shares issued and outstanding as of June 30, 2025 and March 31, 2025, respectively
+Added: 61,171 and 53,706 shares issued and outstanding as of September 30, 2025 and March 31, 2025, respectively
Additional paid-in capital
+Added: Common stock issuable
Accumulated deficit
1 unchanged sentence
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
−Removed: The accompanying notes are an integral
−Removed: part of these condensed consolidated financial statements.
−Removed: Modular Medical, Inc.
+Added: accompanying notes are an integral part of these condensed consolidated financial statements.
+Added: Medical, Inc.
Condensed Consolidated Statements of Operations
−Removed: (In thousands, except per share data)
+Added: thousands, except per share data)
Three Months Ended
+Added: September 30,
+Added: Six Months Ended
+Added: September 30,
Operating expenses
3 unchanged sentences
Loss from operations
+Added: Loss before income taxes
+Added: Provision for income taxes
Net loss per share
2 unchanged sentences
Basic and diluted
−Removed: The accompanying notes are an integral part of
−Removed: these condensed consolidated financial statements.
−Removed: Modular Medical, Inc.
−Removed: Condensed Consolidated Statements of Stockholders’ Equity
−Removed: (In thousands)
+Added: accompanying notes are an integral part of these condensed consolidated financial statements.
+Added: Medical, Inc.
+Added: Consolidated Statements of Stockholders’ Equity
+Added: Issuable Shares
Stockholders’
1 unchanged sentence
Shares issued for services
−Removed: At-the-market sale of stock, net
+Added: At-the-market sales of stock, net
Exercise of warrants
2 unchanged sentences
Balance as of June 30, 2025
+Added: At-the-market sales of stock, net
+Added: Issuance of common stock and warrants from warrant
+Added: inducement offering
+Added: Issuances under equity incentive plan
+Added: Stock-based compensation
+Added: Balance as of September 30, 2025
+Added: Issuable Shares
Stockholders’
5 unchanged sentences
Balance as of June 30, 2024
−Removed: The accompanying notes are an integral part of
−Removed: these condensed consolidated financial statements.
−Removed: Modular Medical, Inc.
−Removed: Condensed Consolidated Statements of Cash Flows
−Removed: (In thousands)
−Removed: Three Months Ended
+Added: Shares issued for services
+Added: Exercise of warrants
+Added: At-the-market sales of stock, net
+Added: Issuances under equity incentive plan
+Added: Stock-based compensation
+Added: Balance as of September 30, 2024
+Added: accompanying notes are an integral part of these condensed consolidated financial statements.
+Added: Medical, Inc.
+Added: Consolidated Statements of Cash Flows
+Added: Six Months Ended
+Added: September 30,
CASH FLOWS FROM OPERATING ACTIVITIES
13 unchanged sentences
CASH FLOWS FROM FINANCING ACTIVITIES
−Removed: Proceeds from at-the-market sale of common stock, net
−Removed: Proceeds from exercise of common stock warrants
+Added: Proceeds from at-the-market sales of common stock, net
+Added: Proceeds from exercise of common stock purchase warrants
+Added: Proceeds from warrant inducement offering, net
Net cash provided by financing activities
2 unchanged sentences
Cash and cash equivalents at end of period
−Removed: The accompanying notes are an integral part of
−Removed: these unaudited condensed consolidated financial statements.
−Removed: MODULAR MEDICAL, INC.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: NOTE 1 – THE COMPANY AND SUMMARY OF SIGNIFICANT
−Removed: ACCOUNTING POLICIES
−Removed: Modular Medical, Inc.
−Removed: (the “Company”)
−Removed: was incorporated in Nevada in October 1998 under the name Bear Lake Recreation, Inc.
−Removed: The Company had no material business operations until
−Removed: approximately 2017, when it acquired all of the issued and outstanding shares of Quasuras, Inc., a Delaware corporation (“Quasuras”)
−Removed: and changed its name from Bear Lake Recreation, Inc.
+Added: accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: MEDICAL, INC.
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 1 – THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
+Added: Medical, Inc.
+Added: (the “Company”) was incorporated in Nevada in October 1998 under the name Bear Lake Recreation, Inc.
+Added: had no material business operations until approximately 2017, when it acquired all of the issued and outstanding shares of Quasuras,
+Added: Inc., a Delaware corporation (“Quasuras”) and changed its name from Bear Lake Recreation, Inc.
to Modular Medical, Inc.
−Removed: The Company is a pre-revenue, medical device company focused on the
−Removed: design, development and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes
−Removed: Through the creation of an innovative two-part patch pump, its initial product, the MODD1, the Company seeks to fundamentally
−Removed: alter the trade-offs between cost and complexity and access to the higher standards of care requiring considerable motivation that presently
−Removed: available insulin pumps provide.
−Removed: By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training
−Removed: and day-to-day use, the Company seeks to expand the wearable insulin delivery device market beyond the highly motivated “super users”
−Removed: and expand the category into the mass market.
−Removed: The product seeks to serve both the type 1 and the rapidly growing, especially in terms
−Removed: of device adoption, type 2 diabetes markets.
−Removed: In January 2024, the Company submitted a 510(k) premarket notification to the United States
−Removed: Food and Drug Administration (“FDA”) for the MODD1, and, in September 2024, the Company received FDA clearance to market and
−Removed: sell its MODD1 pump in the United States.
−Removed: The Company expects initial shipments of the MODD1 by October 2025.
−Removed: The Company is currently
−Removed: preparing a second 510(k) premarket notification application to the FDA for an updated version of the MODD1 product, called the Pivot,
−Removed: which is a tubeless version of the product that integrates the set into a true tubeless patch.
−Removed: The Company intends to replace the MODD1
−Removed: product with the Pivot product, as soon as the required regulatory approval from the FDA is received.
+Added: Company is a pre-revenue, medical device company focused on the design, development and commercialization of innovative insulin delivery
+Added: systems using modernized technology to increase pump adoption in the diabetes marketplace.
+Added: Through the creation of innovative two-part
+Added: patch pumps, the Company seeks to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of
+Added: care requiring considerable motivation that presently available insulin pumps provide.
+Added: By simplifying and streamlining the user experience
+Added: from introduction, prescription, reimbursement, training and day-to-day use, the Company seeks to expand the wearable insulin delivery
+Added: device market beyond the highly motivated “super users” and expand the category into the mass market.
+Added: The product seeks to
+Added: serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets.
+Added: In January 2024, the
+Added: Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (“FDA”) for its initial
+Added: product, the MODD1, and, in September 2024, the Company received FDA clearance to market and sell its MODD1 pump in the United States.
+Added: The Company is seeking FDA approval for an updated version of the MODD1 product, called
+Added: the Pivot, which is a tubeless version of the product that integrates the set into a true tubeless patch.
+Added: The Company intends to go to
+Added: market with its Pivot product, when the required regulatory approval from the FDA is received.
and Going Concern
−Removed: The Company does
−Removed: not currently have revenues to generate cash flows to cover operating expenses.
+Added: Company does not currently have revenues to generate cash flows to cover operating expenses.
Since its inception, the Company has incurred
operating losses and negative cash flows in each year due to costs incurred in connection with its operations.
−Removed: The Company expects
−Removed: to continue to incur operating losses for the foreseeable future and incur cash outflows from operations as it continues to invest
−Removed: in the development and commercialization of its products.
−Removed: The Company expects that its operating expenses will continue to increase,
−Removed: and, as a result, it will eventually need to generate significant revenue to achieve profitability.
−Removed: When considered with its current
−Removed: operating plan, these conditions raise substantial doubt about the Company’s ability to continue as a going concern within one
−Removed: year after the date that these financial statements are issued.
−Removed: In addition, the Company’s independent registered public
−Removed: accounting firm, in its report on the consolidated financial statements as of and for the year ended March 31, 2025, expressed
−Removed: substantial doubt about the Company’s ability to continue as a going concern.
−Removed: These condensed consolidated financial
−Removed: statements do not include any adjustments that might result from this uncertainty.
−Removed: Implementation of the Company’s plans and
−Removed: its ability to continue as a going concern will depend upon the Company’s ability to raise additional capital, through the
−Removed: sale of additional equity or debt securities, to support its future operations.
−Removed: There can be no assurance that such additional
−Removed: capital, whether in the form of debt or equity financing, will be sufficient or available and, if available, that such capital will
−Removed: be offered on terms and conditions acceptable to the Company.
−Removed: The Company’s operating needs include the planned costs to
−Removed: operate its business, including amounts required to fund working capital and capital expenditures.
−Removed: The Company’s future
−Removed: capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to
−Removed: successfully commercialize its pump products, competing technological and market developments, and the need to enter into
−Removed: collaborations with other companies or acquire other companies or technologies to enhance or complement its product offering.
−Removed: Company is unable to secure additional capital, it may be required to curtail its product commercialization and research and
−Removed: development initiatives and take additional measures to reduce costs in order to conserve its cash.
−Removed: From a financing perspective, in
−Removed: June 2025, the Company sold 1,000,000 shares of common stock under the at-the-market sales program for net proceeds of $ 727,500 .
−Removed: March 2025, the Company completed private placements of its common stock and warrants for net proceeds of approximately
−Removed: $ 11,367,000 .
−Removed: Basis of Presentation
−Removed: The Company’s fiscal year ends on March
−Removed: 31 of each calendar year.
−Removed: Each reference to a fiscal year in these notes to the condensed consolidated financial statements refers to
−Removed: the fiscal year ended March 31 of the calendar year indicated (for example, fiscal 2026 refers to the fiscal year ending March 31, 2026).
−Removed: The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Quasuras.
−Removed: All significant
−Removed: intercompany transactions and balances have been eliminated in consolidation.
−Removed: The accompanying condensed consolidated financial
−Removed: statements are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”)
−Removed: and with the rules and regulations of the United States Security and Exchange Commission (“SEC”) regarding interim financial
−Removed: The condensed consolidated balance sheet as of March 31, 2025 has been derived from the audited consolidated financial statements
−Removed: at that date.
−Removed: Certain information and disclosures normally included in financial statements prepared in accordance with GAAP have been
−Removed: condensed or omitted in accordance with these rules and regulations of the SEC.
−Removed: The information in this report should be read in conjunction
−Removed: with the Company’s consolidated financial statements and notes thereto included in its most recent annual report on Form 10-K filed
−Removed: with the SEC.
−Removed: In the opinion of management, the accompanying
−Removed: unaudited condensed consolidated financial statements reflect all adjustments (consisting only of normal recurring adjustments) necessary
−Removed: to summarize fairly the Company’s financial position, results of operations and cash flows for the interim periods presented.
−Removed: operating results for the three months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the
−Removed: year ending March 31, 2026 or for any other future period.
−Removed: Use of Estimates
−Removed: The preparation of the accompanying condensed
−Removed: consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
−Removed: amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial
−Removed: statements and the reported amount of revenues and expenses during the reporting period.
−Removed: Estimates may include those pertaining to accruals,
−Removed: stock-based compensation and income taxes.
−Removed: Actual results could differ from those estimates.
−Removed: Research and Development
−Removed: The Company expenses research and development
−Removed: expenditures as incurred.
−Removed: Risks and Uncertainties
−Removed: The Company is subject to risks from, among other
−Removed: things, competition associated with the industry in general, other risks associated with financing, liquidity requirements, rapidly changing
−Removed: customer requirements, limited operating history and the volatility of public markets.
−Removed: The Company may be unable to access the capital
−Removed: markets, and additional capital may only be available to the Company on terms that could be significantly detrimental to its existing
−Removed: stockholders and to its business.
−Removed: Cash and Cash Equivalents
−Removed: Cash and cash equivalents include cash held in
−Removed: demand deposit and money market accounts, certificates of deposit and all highly liquid debt instruments with original maturities of three
−Removed: months or less.
−Removed: Property and Equipment
−Removed: Property and equipment are recorded at historical
−Removed: Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally three to five years .
+Added: The Company expects to
+Added: continue to incur operating losses for the foreseeable future and incur cash outflows from operations as it continues to invest in the
+Added: development and commercialization of its products.
+Added: The Company expects that its operating expenses will continue to increase, and, as
+Added: a result, it will eventually need to generate significant revenue to achieve profitability.
+Added: When considered with its current operating
+Added: plan, these conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after
+Added: the date that these financial statements are issued.
+Added: In addition, the Company’s independent registered public accounting firm,
+Added: in its report on the consolidated financial statements as of and for the year ended March 31, 2025, expressed substantial doubt about
+Added: the Company’s ability to continue as a going concern.
+Added: These condensed consolidated financial statements do not include any adjustments
+Added: that might result from this uncertainty.
+Added: Implementation of the Company’s plans and its ability to continue as a going concern will
+Added: depend upon the Company’s ability to raise additional capital, through the sale of additional equity or debt securities, to support
+Added: its future operations.
+Added: There can be no assurance that such additional capital, whether in the form of debt or equity financing, will
+Added: be sufficient or available and, if available, that such capital will be offered on terms and conditions acceptable to the Company.
+Added: Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital
+Added: and capital expenditures.
+Added: The Company’s future capital requirements and the adequacy of its available funds will depend on many
+Added: factors, including the Company’s ability to successfully commercialize its pump products, competing technological and market developments,
+Added: and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its
+Added: product offering.
+Added: If the Company is unable to secure additional capital, it may be required to curtail its product commercialization
+Added: and research and development initiatives and take additional measures to reduce costs in order to conserve its cash.
+Added: As disclosed in
+Added: Note 4, in September 2025, the Company effected a warrant inducement offering for net proceeds of approximately $ 3.9 million, and, during
+Added: the six months ended September 30, 2025, the Company received net proceeds of approximately $ 0.7 million from sales of shares of common
+Added: stock under its at-the-market sales program.
+Added: of Presentation
+Added: Company’s fiscal year ends on March 31 of each calendar year.
+Added: Each reference to a fiscal year in these notes to the condensed consolidated
+Added: financial statements refers to the fiscal year ended March 31 of the calendar year indicated (for example, fiscal 2026 refers to the
+Added: fiscal year ending March 31, 2026).
+Added: The condensed consolidated financial statements include the accounts of the Company and its wholly-owned
+Added: subsidiary, Quasuras.
+Added: All significant intercompany transactions and balances have been eliminated in consolidation.
+Added: accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with generally accepted accounting
+Added: principles in the United States (“GAAP”) and with the rules and regulations of the United States Security and Exchange Commission
+Added: (“SEC”) regarding interim financial reporting.
+Added: The condensed consolidated balance sheet as of March 31, 2025 has been derived
+Added: from the audited consolidated financial statements at that date.
+Added: Certain information and disclosures normally included in financial statements
+Added: prepared in accordance with GAAP have been condensed or omitted in accordance with these rules and regulations of the SEC.
+Added: The information
+Added: in this report should be read in conjunction with the Company’s consolidated financial statements and notes thereto included in
+Added: its most recent annual report on Form 10-K filed with the SEC.
+Added: the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting
+Added: only of normal recurring adjustments) necessary to summarize fairly the Company’s financial position, results of operations and
+Added: cash flows for the interim periods presented.
+Added: The operating results for the six months ended September 30, 2025 are not necessarily indicative
+Added: of the results that may be expected for the year ending March 31, 2026 or for any other future period.
+Added: preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates
+Added: and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
+Added: date of the condensed consolidated financial statements and the reported amount of revenues and expenses during the reporting period.
+Added: Estimates may include those pertaining to accruals, stock-based compensation and income taxes.
+Added: Actual results could differ from those
+Added: and Development
+Added: Company expenses research and development expenditures as incurred.
+Added: and Uncertainties
+Added: Company is subject to risks from, among other things, competition associated with the industry in general, other risks associated with
+Added: financing, liquidity requirements, rapidly changing customer requirements, limited operating history and the volatility of public markets.
+Added: The Company may be unable to access the capital markets, and additional capital may only be available to the Company on terms that could
+Added: be significantly detrimental to its existing stockholders and to its business.
+Added: and Cash Equivalents
+Added: and cash equivalents include cash held in demand deposit and money market accounts, certificates of deposit and all highly liquid debt
+Added: instruments with original maturities of three months or less.
+Added: and Equipment
+Added: and equipment are recorded at historical cost.
+Added: Depreciation is computed using the straight-line method over the estimated useful lives
+Added: of the assets, generally three to five years .
Depreciation is recorded in operating expenses in the consolidated statements of operations.
−Removed: Leasehold improvements and assets acquired
−Removed: through finance leases are amortized over the shorter of their estimated useful life or the lease term, and amortization is recorded in
−Removed: operating expenses in the consolidated statements of operations.
−Removed: Construction-in-process includes machinery and equipment and is stated
−Removed: at cost and not depreciated.
−Removed: Depreciation on construction-in-process commences when the assets are ready for their intended use and placed
−Removed: into service.
−Removed: Fair Value of Financial Instruments
−Removed: The Company measures the fair value of financial
−Removed: instruments using a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad
−Removed: Level 1 inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets.
−Removed: Level 2 inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument.
−Removed: Level 3 inputs to the valuation methodology are unobservable and significant to the fair value measurement.
−Removed: Due to their short-term nature, the carrying values
−Removed: of cash equivalents, accounts payable and accrued expenses, approximate fair value.
−Removed: The Company’s right-of-use assets consist
−Removed: of leased assets recognized in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification
−Removed: 842, Leases , which requires lessees to recognize a lease liability and a corresponding lease asset for
−Removed: virtually all lease contracts.
−Removed: Right-of-use assets represent the Company’s right to use an underlying asset for the lease term
−Removed: and the lease liability represents the Company’s obligation to make lease payments arising from the lease, both of which are recognized
−Removed: based on the present value of the future minimum lease payments over the lease term at the commencement date.
−Removed: Leases with a lease term
−Removed: of 12 months or less at inception are not recorded on the consolidated balance sheets and are expensed on a straight-line basis over
−Removed: the lease term in the consolidated statement of operations and comprehensive loss.
−Removed: The Company determines the lease term by agreement
−Removed: with the lessor.
−Removed: In cases where the lease does not provide an implicit interest rate, the Company uses the Company’s incremental
−Removed: borrowing rate based on the information available at commencement date in determining the present value of future payments.
−Removed: Stock-Based Compensation
−Removed: The Company periodically issues stock options,
−Removed: restricted stock units and stock awards to employees and non-employees.
−Removed: The Company accounts for such awards based on FASB ASC Topic 718,
−Removed: whereby the value of the award is measured on the date of grant and recognized as compensation expense on a straight-line basis over the
−Removed: requisite service period, usually the vesting period.
−Removed: With respect to performance-based awards, the Company assesses the probability of
−Removed: achieving the requisite performance criteria before recognizing compensation expense.
−Removed: The fair value of the Company’s stock options
−Removed: is estimated using the Black-Scholes-Merton Option Pricing (“Black Scholes”) model, which uses certain assumptions related
−Removed: to risk-free interest rates, expected volatility, expected life of the options, and future dividends.
−Removed: Compensation expense is recorded
−Removed: based upon the value derived from the Black-Scholes model.
−Removed: The assumptions used in the Black-Scholes model could materially affect compensation
−Removed: expense recorded in future periods.
−Removed: Per-Share Amounts
+Added: Leasehold improvements and assets acquired through finance leases are amortized over the shorter of their estimated useful life or the
+Added: lease term, and amortization is recorded in operating expenses in the consolidated statements of operations.
+Added: Construction-in-process
+Added: includes machinery and equipment and is stated at cost and not depreciated.
+Added: Depreciation on construction-in-process commences when the
+Added: assets are ready for their intended use and placed into service.
+Added: Value of Financial Instruments
+Added: Company measures the fair value of financial instruments using a fair value hierarchy that prioritizes the inputs to valuation techniques
+Added: used to measure fair value into three broad levels:
+Added: 1 inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets.
+Added: 2 inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are
+Added: observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument.
+Added: 3 inputs to the valuation methodology are unobservable and significant to the fair value measurement.
+Added: to their short-term nature, the carrying values of cash equivalents, accounts payable and accrued expenses, approximate fair value.
+Added: Company’s right-of-use assets consist of leased assets recognized in accordance with Financial Accounting Standards Board (“FASB”)
+Added: Accounting Standards Codification (“ASC”) No.
+Added: 842, Leases , which requires lessees to recognize a lease liability and
+Added: a corresponding lease asset for virtually all lease contracts.
+Added: Right-of-use assets represent the Company’s right to use an underlying
+Added: asset for the lease term and the lease liability represents the Company’s obligation to make lease payments arising from the lease,
+Added: both of which are recognized based on the present value of the future minimum lease payments over the lease term at the commencement
+Added: Leases with a lease term of 12 months or less at inception are not recorded on the consolidated balance sheets and are expensed
+Added: on a straight-line basis over the lease term in the consolidated statement of operations and comprehensive loss.
+Added: The Company determines
+Added: the lease term by agreement with the lessor.
+Added: In cases where the lease does not provide an implicit interest rate, the Company uses the
+Added: Company’s incremental borrowing rate based on the information available at commencement date in determining the present value of
+Added: future payments.
+Added: Company periodically issues stock options, restricted stock units and stock awards to employees and non-employees.
+Added: The Company accounts
+Added: for such awards based on FASB ASC Topic 718, whereby the value of the award is measured on the date of grant and recognized as compensation
+Added: expense on a straight-line basis over the requisite service period, usually the vesting period.
+Added: With respect to performance-based awards,
+Added: the Company assesses the probability of achieving the requisite performance criteria before recognizing compensation expense.
+Added: value of the Company’s stock options is estimated using the Black-Scholes-Merton Option Pricing (“Black Scholes”) model,
+Added: which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the options, and future dividends.
+Added: Compensation expense is recorded based upon the value derived from the Black-Scholes model.
+Added: The assumptions used in the Black-Scholes
+Added: model could materially affect compensation expense recorded in future periods.
Basic net loss per share is computed by dividing
loss for the period by the weighted-average number of shares of common stock outstanding (“WASO”) during the period.
−Removed: the Company includes the number of shares of common stock issuable under pre-funded warrants as outstanding for purposes of the WASO calculation.
+Added: the Company includes the number of shares of common stock issuable, including under pre-funded warrants, as outstanding for purposes
+Added: of the WASO calculation.
Diluted net loss per share gives effect to all potentially dilutive common shares outstanding during the period.
−Removed: Potentially dilutive
−Removed: common shares consist of incremental shares of common stock issuable upon the exercise of stock options and exercise of warrants.
−Removed: For the three months ended June 30, 2025 and 2024,
−Removed: the following table sets forth securities outstanding which were excluded from the computation of diluted net loss per share as their
−Removed: inclusion would be anti-dilutive (in thousands).
−Removed: Three Months Ended
+Added: Potentially dilutive common shares consist of incremental shares of common stock issuable upon the exercise of stock options and exercise
+Added: the six months ended September 30, 2025 and 2024, the following table sets forth securities outstanding which were excluded from the
+Added: computation of diluted net loss per share as their inclusion would be anti-dilutive (in thousands).
+Added: Six Months Ended
+Added: September 30,
Options to purchase common stock
2 unchanged sentences
Reclassifications
−Removed: Certain prior year amounts have been reclassified
−Removed: for consistency with the current period presentation.
−Removed: These reclassifications had no effect on the reported results of operations or cash
−Removed: Comprehensive Loss
−Removed: Comprehensive loss represents the changes in equity
−Removed: of an enterprise, other than those resulting from stockholder transactions.
−Removed: Accordingly, comprehensive loss may include certain changes
−Removed: in equity that are excluded from net loss.
−Removed: For the three months ended June 30, 2025 and 2024, the Company’s comprehensive loss was
−Removed: the same as its net loss.
−Removed: Recently Issued Accounting Pronouncements
−Removed: In November 2024, the FASB issued ASU No.
−Removed: Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40):
−Removed: Disaggregation
−Removed: of Income Statement Expenses .
−Removed: The new standard requires disclosures about specific types of expenses included in the expense captions
−Removed: presented on the face of the income statement as well as disclosures about selling expenses.
−Removed: The standard is effective for the Company
−Removed: for annual periods beginning April 1, 2027 and interim periods beginning April 1, 2028, with early adoption permitted.
−Removed: The standard may
−Removed: be applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any
−Removed: or all prior periods presented in the financial statements.
−Removed: The Company is evaluating the impact that this ASU will have on the presentation
−Removed: of its consolidated financial statements.
+Added: prior year amounts have been reclassified for consistency with the current period presentation.
+Added: These reclassifications had no effect
+Added: on the reported results of operations or cash flows.
+Added: Comprehensive
+Added: Comprehensive
+Added: loss represents the changes in equity of an enterprise, other than those resulting from stockholder transactions.
+Added: Accordingly, comprehensive
+Added: loss may include certain changes in equity that are excluded from net loss.
+Added: For the three and six months ended September 30, 2025 and
+Added: 2024, the Company’s comprehensive loss was the same as its net loss.
+Added: Issued Accounting Pronouncements
+Added: November 2024, the FASB issued ASU No.
+Added: 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation
+Added: Disclosures (Subtopic 220-40):
+Added: Disaggregation of Income Statement Expenses .
+Added: The new standard requires disclosures about specific
+Added: types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling
+Added: The standard is effective for the Company for annual periods beginning April 1, 2027 and interim periods beginning April 1,
+Added: 2028, with early adoption permitted.
+Added: The standard may be applied either prospectively to financial statements issued for reporting periods
+Added: after the effective date or retrospectively to any or all prior periods presented in the financial statements.
+Added: The Company is evaluating
+Added: the impact that this ASU will have on the presentation of its consolidated financial statements.
NOTE 2 – CONSOLIDATED BALANCE SHEET DETAIL
+Added: September 30,
(in thousands)
2 unchanged sentences
Other receivables
+Added: September 30,
(in thousands)
6 unchanged sentences
accumulated depreciation and amortization
+Added: September 30,
(in thousands)
1 unchanged sentence
Accrued wages and employee benefits
−Removed: NOTE 3 – LEASES
−Removed: Thornmint Road, San Diego, CA
−Removed: The 48 -month lease term commenced February 1,
−Removed: 2023, and the lease provides for an initial base monthly rent of $ 36,000 with annual rent increases of approximately 4 %.
−Removed: In addition to
−Removed: the minimum lease payments, the Company is responsible for property taxes, insurance and certain other operating costs.
−Removed: A discount rate
−Removed: of 8 %, which approximated the Company’s incremental borrowing rate, was used to measure the lease asset and liability.
−Removed: obtained a right-of-use asset of approximately $ 1,560,000 in exchange for its obligations under the operating lease.
−Removed: Future minimum payments under the facility operating
−Removed: lease, as of June 30, 2025, are listed in the table below (in thousands).
+Added: Road, San Diego, CA
+Added: 48 -month lease term commenced February 1, 2023, and the lease provides for an initial base monthly rent of $ 36,000 with annual rent increases
+Added: of approximately 4 %.
+Added: In addition to the minimum lease payments, the Company is responsible for property taxes, insurance and certain
+Added: other operating costs.
+Added: A discount rate of 8 %, which approximated the Company’s incremental borrowing rate, was used to measure
+Added: the lease asset and liability.
+Added: The Company obtained a right-of-use asset of approximately $ 1,560,000 in exchange for its obligations
+Added: under the operating lease.
+Added: minimum payments under the facility operating lease, as of September 30, 2025, are listed in the table below (in thousands).
Annual Fiscal Years
2 unchanged sentences
Present value of lease liability
−Removed: Cash paid for amounts included in the measurement
−Removed: of lease liabilities was approximately $ 117,000 and $ 112,000 for the three months ended June 30, 2025 and 2024, respectively.
−Removed: was approximately $ 112,000 for each of the three-month periods ended June 30, 2025 and 2024.
−Removed: NOTE 4 – STOCKHOLDERS’ EQUITY
−Removed: In November 2023, the Company entered into a Sales
−Removed: Agreement (the “ATM Agreement”) with Leerink Partners LLC (Leerink) under which the Company may offer and sell, from time
−Removed: to time at its sole discretion, shares of its common stock, for aggregate gross proceeds of up to $ 6,500,000 through an “at the
−Removed: market offering” program under which Leerink will act as sales agent or principal.
−Removed: The ATM Agreement provides that Leerink will
−Removed: be entitled to compensation for its services equal to 3.0 % of the gross proceeds from sales of any shares of common stock under the ATM
−Removed: The Company has no obligation to sell any shares under the ATM Agreement and may, at any time, suspend solicitation and offers
−Removed: under the ATM Agreement.
−Removed: During the three months ended June 30, 2025, under the ATM Agreement, the Company sold 1,000,000 shares of common
−Removed: stock for net proceeds of $ 727,500 .
−Removed: 30, 2025, the Company had the following common stock purchase warrants outstanding (share amounts in thousands):
+Added: paid for amounts included in the measurement of lease liabilities was approximately $ 234,000 and $ 225,000 for the six months ended September
+Added: 30, 2025 and 2024, respectively.
+Added: Rent expense was approximately $ 225,000 for each of the six-month periods ended September 30, 2025 and
+Added: 2024, respectively, and $ 113,000 for each of the three-month periods ended September 30, 2025 and 2024.
+Added: 4 – STOCKHOLDERS’ EQUITY
+Added: In November 2023, the Company entered into a Sales Agreement (the “ATM
+Added: Agreement”) with Leerink Partners LLC (“Leerink”) under which the Company may offer and sell, from time to time at its
+Added: sole discretion, shares of its common stock, for aggregate gross proceeds of up to $ 6,500,000 through an “at the market offering”
+Added: program under which Leerink will act as sales agent or principal.
+Added: The ATM Agreement provides that Leerink will be entitled to compensation
+Added: for its services equal to 3.0 % of the gross proceeds from sales of any shares of common stock under the ATM Agreement.
+Added: The Company has
+Added: no obligation to sell any shares under the ATM Agreement and may, at any time, suspend solicitation and offers under the ATM Agreement.
+Added: During the three and six months ended September 30, 2025, under the ATM Agreement, the Company sold 9,200 and 1,009,200 shares of common
+Added: stock for net proceeds of $ 6,286 and $ 733,786 , respectively.
+Added: Inducement Offering
+Added: In September 2025, the Company entered into inducement
+Added: offer letter agreements (the “Inducement Letters”) with certain holders (the “Holders”) of warrants issued in
+Added: May 2023 (the “2023 Warrants”) and in March 2025 (the “March 2025 Warrants” and, collectively with the 2023 Warrants,
+Added: the “Existing Warrants”) to purchase up to an aggregate of 6,504,731 shares of the Company’s common stock.
+Added: to the Inducement Letters, the Holders agreed to exercise for cash i) 2023 Warrants to purchase 1,901,700 shares of common stock with
+Added: an original exercise price of $ 1.22 per share and ii) March 2025 Warrants to purchase 4,603,031 shares with an original exercise price
+Added: of $ 1.12 per share at a reduced exercise price of $ 0.68 per share in consideration for the Company’s agreement to issue in a private
+Added: placement new common stock purchase warrants to purchase an aggregate of 3,252,366 shares (the “September 2025 Warrants”).
+Added: The September 2025 Warrants have an exercise price of 0.84 per share, were exercisable upon issuance and expire on the five-year anniversary
+Added: of the date of issuance.
+Added: As of September 30, 2025, the Company had
+Added: issued 5,860,483 shares of common stock and 2,930,242 September 2025 Warrants, and the processing of the exercise of 175,500 2023 Warrants and 468,748 2025 Warrants was pending.
+Added: As a result, as of September 30, 2025, 644,248 shares
+Added: of common stock (the “Issuable Shares”) and 322,124 September 2025 Warrants were pending issuance.
+Added: The fair value of the unissued Issuable Shares has been presented separately as issuable shares on the condensed consolidated balance
+Added: sheets and statements of stockholders’ equity as of September 30, 2025.
+Added: The Company accounted
+Added: for the issuance of the:
+Added: i) shares of its common stock and ii) the September 2025 Warrants as a single equity transaction for gross
+Added: proceeds of approximately $ 4.4 million, which proceeds had been received in full as of September 30, 2025.
+Added: relation to the above warrant inducement offering, the Company engaged Newbridge Securities Corporation as the servicing agent and paid
+Added: a fee of $ 400,000 and expense reimbursement of $ 50,000 .
+Added: Equity-Classified
+Added: following table sets forth changes in the number of common stock purchase warrants outstanding during fiscal 2026 (share amounts in thousands):
+Added: Number of Exercise
+Added: Shares Price ($) Expiration
Balance as of March 31, 2025 18,561
1 unchanged sentence
Balance as of June 30, 2025 18,030
−Removed: As of March 31, 2025, the Company had the following warrants outstanding
−Removed: (share amounts in thousands):
−Removed: Type Number of
−Removed: Shares Exercise
−Removed: Price Expiration
−Removed: Common stock 531 $ 0.01 —
+Added: Warrants issued 2,930 0.84 September 2030
+Added: Warrants exercised ( 1,726 ) 0.68 May 2028
+Added: Warrants exercised ( 4,134 ) 0.68 March 2029
+Added: Balance as of September 30, 2025 15,100
+Added: of September 30, 2025, the Company had the following warrants outstanding (share amounts in thousands):
+Added: Number of Exercise
+Added: Type Shares Price ($) Expiration
+Added: Common stock 2,930 0.84 September 2030
Common stock 2,374 1.12 March 2029
6 unchanged sentences
Common stock 1,438 6.60 November 2027
−Removed: During the three months ended June 30, 2025,
−Removed: the Company issued 10,000 shares of common stock with a fair value of approximately $ 11,000 to a service provider.
−Removed: NOTE 5 – STOCK-BASED COMPENSATION
−Removed: Amended and Restated 2017 Equity Incentive
−Removed: In October 2017, the Company’s board of
−Removed: directors (the “Board”) approved the 2017 Equity Incentive Plan (the “Plan”) with 1,000,000 shares of common stock
−Removed: reserved for issuance.
−Removed: In January 2020 and August 2021, the Board approved increases in the number of shares reserved for issuance under
−Removed: the Plan by 333,334 and 1,333,334 shares, respectively.
−Removed: In January 2023, February 2024 and February 2025, the Company’s stockholders
−Removed: approved increases in the number of shares reserved for issuance under the Plan by an additional 2,000,000 , 3,000,000 and 3,000,000 shares,
−Removed: respectively.
−Removed: Under the Plan, eligible employees, directors and consultants may be granted a broad range of awards, including stock options,
−Removed: stock appreciation rights, restricted stock, performance-based awards and restricted stock units (“RSUs”).
−Removed: The Plan is administered
−Removed: by the Board or, in the alternative, a committee designated by the Board.
−Removed: Stock-Based Compensation Expense
−Removed: Stock options granted by the Company generally vest over 36 months
−Removed: and have a 10 -year term.
−Removed: As of June 30, 2025, the unamortized compensation cost related to stock options was approximately $ 2,369,550
−Removed: and is expected to be recognized as expense over a weighted-average period of approximately 1.21 years.
−Removed: In April 2025, under its Two-Part FDA Submission and Product Milestone
−Removed: Bonus Program, the Company granted stock options for 1,941,000 shares, which are subject to vesting based upon achievement of certain
−Removed: performance milestones by the Company and continued service by the optionee.
−Removed: As of June 30, 2025, the Company had commenced expense recognition
−Removed: for all 1,941,000 of these option shares based on its assessment of the probability of achievement of the applicable performance requirements,
−Removed: including (i) submission of the 510(k) to the FDA for the Pivot pump product on or before October 31, 2025 and (ii) validation of the
−Removed: manufacturing line validated for the Pivot pump product with capacity to serve 6,000 patents by March 15, 2026.
−Removed: The weighted-average grant date fair value of
−Removed: options granted was $ 0.75 and $ 1.33 per share for the three months ended June 30, 2025 and 2024, respectively.
+Added: Issuances to Service Providers
+Added: During the six months ended September 30, 2025
+Added: and 2024, the Company issued 10,000 and 30,000 shares of common stock, respectively, with fair values of approximately $ 11,000 and $ 51,000 , respectively,
+Added: to service providers.
+Added: 5 – STOCK-BASED COMPENSATION
+Added: and Restated 2017 Equity Incentive Plan
+Added: October 2017, the Company’s board of directors (the “Board”) approved the 2017 Equity Incentive Plan (the “Plan”)
+Added: with 1,000,000 shares of common stock reserved for issuance.
+Added: In January 2020 and August 2021, the Board approved increases in the number
+Added: of shares reserved for issuance under the Plan by 333,334 and 1,333,334 shares, respectively.
+Added: In January 2023, February 2024 and February
+Added: 2025, the Company’s stockholders approved increases in the number of shares reserved for issuance under the Plan by an additional
+Added: 2,000,000 , 3,000,000 and 3,000,000 shares, respectively.
+Added: Under the Plan, eligible employees, directors and consultants may be granted
+Added: a broad range of awards, including stock options, stock appreciation rights, restricted stock, performance-based awards and restricted
+Added: stock units (“RSUs”).
+Added: The Plan is administered by the Board or, in the alternative, a committee designated by the Board.
+Added: Compensation Expense
+Added: options granted by the Company generally vest over 36 months and have a 10 -year term.
+Added: As of September 30, 2025, the unamortized compensation
+Added: cost related to stock options was approximately $ 1,526,736 and is expected to be recognized as expense over a weighted-average period
+Added: of approximately 1.12 years.
+Added: April 2025, under its Two-Part FDA Submission and Product Milestone Bonus Program, the Company granted stock options for 1,941,000 shares,
+Added: which are subject to vesting based upon achievement of certain performance milestones by the Company and continued service by the optionee.
+Added: As of June 30, 2025, the Company had commenced expense recognition for all 1,941,000 of these option shares based on its assessment of
+Added: the probability of achievement of the applicable performance requirements, including (i) submission of the 510(k) to the FDA for the
+Added: Pivot pump product on or before October 31, 2025 and (ii) validation of the manufacturing line validated for the Pivot pump product with
+Added: capacity to serve 6,000 patents by March 15, 2026.
+Added: weighted-average grant date fair value of options granted was $ 0.74 and $ 1.41 per share for the six months ended September 30, 2025
+Added: and 2024, respectively, and $ 0.56 and $ 1.51 for the three months ended September 30, 2025 and 2024, respectively.
The following assumptions
1 unchanged sentence
Three Months Ended
+Added: September 30,
+Added: Six Months Ended
+Added: September 30,
Risk-free interest rates
3 unchanged sentences
3.5 % - 4.4 %
+Added: 102 % - 106 %
+Added: 114 % - 117 %
+Added: 102 % - 107 %
+Added: 114 % - 123 %
Expected life (years)
−Removed: The fair values of options at the grant date were
−Removed: estimated utilizing the Black-Scholes valuation model, which includes simplified methods to establish the fair term of options, as well
−Removed: as average volatility.
−Removed: The risk-free interest rate was derived from the Daily Treasury Yield Curve Rates, as published by the U.S.
−Removed: of the Treasury as of the grant date for terms equal to the expected terms of the options.
−Removed: A dividend yield of zero was applied because
−Removed: the Company has never paid dividends and has no intention to pay dividends in the foreseeable future.
−Removed: The Company accounts for forfeitures
−Removed: as they occur.
−Removed: The following table summarizes the activity in
−Removed: the shares available for grant under the Plan during the three months ended June 30, 2025:
+Added: Expected dividend %
+Added: fair values of options at the grant date were estimated utilizing the Black-Scholes valuation model, which includes simplified methods
+Added: to establish the fair term of options, as well as average volatility.
+Added: The risk-free interest rate was derived from the Daily Treasury
+Added: Yield Curve Rates, as published by the U.S.
+Added: Department of the Treasury as of the grant date for terms equal to the expected terms of
+Added: A dividend yield of zero was applied because the Company has never paid dividends and has no intention to pay dividends
+Added: in the foreseeable future.
+Added: The Company accounts for forfeitures as they occur.
+Added: following table summarizes the activity in the shares available for grant under the Plan during the six months ended September 30, 2025:
Options Outstanding
4 unchanged sentences
Balance at June 30, 2025
−Removed: There were no stock options exercised during the
−Removed: three months ended June 30, 2025.
−Removed: A stock option was exercised on a cashless basis for 7,530 shares of common stock during the three months
−Removed: ended June 30, 2024.
−Removed: During the three months ended June 30, 2025 and 2024, the Company awarded 6,375 and 3,875 shares, respectively, to
−Removed: its non-employee directors under the Company’s outside director compensation plan.
−Removed: For the three months ended June 30, 2025 and
−Removed: 2024, the Company recorded stock-based compensation expense for these share awards of approximately $ 4,000 and $ 6,000 , respectively.
−Removed: A summary of restricted stock unit (RSU) activity
−Removed: under the Plan is presented below.
−Removed: Balance at March 31, 2025
+Added: Options granted
+Added: Options cancelled and returned to the Plan
+Added: Balance at September 30, 2025
+Added: were no stock options exercised during the six months ended September 30, 2025.
+Added: A stock option was exercised on a cashless basis for
+Added: 7,530 shares of common stock during the six months ended September 30, 2024.
+Added: During the six months ended September 30, 2025 and 2024,
+Added: the Company awarded 12,750 and 7,750 shares, respectively, and for the three months ended September 30, 2025 and 2024, the Company awarded
+Added: 6,375 and 3,875 shares, respectively, to its non-employee directors under the Company’s outside director compensation plan.
+Added: the six months ended September 30, 2025 and 2024, the Company recorded stock-based compensation expense for these share awards of approximately
+Added: $ 9,000 and $ 15,000 , respectively, and for the three months ended September 30, 2025 and 2024, the Company recorded stock-based compensation
+Added: expense for these share awards of approximately $ 4,000 and $ 9,000 , respectively.
+Added: summary of restricted stock unit (RSU) activity under the Plan is presented below.
+Added: Non-vested shares at March 31, 2025
Non-vested shares at June 30, 2025
−Removed: The total intrinsic value of RSUs outstanding
−Removed: as of June 30, 2025 was approximately $ 63,000 .
−Removed: The unamortized compensation cost at June 30, 2025 was approximately $ 77,000 related to
−Removed: RSUs and is expected to be recognized as expense over a period of approximately one year .
−Removed: The following table summarizes the range of outstanding
−Removed: and exercisable options as of June 30, 2025:
+Added: Non-vested shares at September 30, 2025
+Added: total intrinsic value of RSUs outstanding as of September 30, 2025 was approximately $ 44,000 .
+Added: The unamortized compensation cost at September
+Added: 30, 2025 was approximately $ 58,000 related to RSUs and is expected to be recognized as expense over a period of approximately 0.75 years.
+Added: following table summarizes the range of outstanding and exercisable options as of September 30, 2025:
Options Outstanding Options Exercisable
−Removed: Range of Exercise Price Number
−Removed: Outstanding Weighted
−Removed: (in Years) Weighted
−Removed: Exercisable Weighted
−Removed: Price Aggregate
+Added: Remaining Weighted Weighted
+Added: Contractual Average Average Aggregate
+Added: Number Life Exercise Number Exercise Intrinsic
+Added: Range of Exercise Price Outstanding (in Years) Price Exercisable Price value
$0.68 - $2.28 5,796,752 8.42 $ 1.27 2,712,909 $ 1.53 $ 795
2 unchanged sentences
$0.68 - $17.70 7,229,026 7.88 $ 2.44 4,145,183 $ 3.47 $ 795
−Removed: The common stock on the Company’s principal trading market over the exercise price of the option.
−Removed: NOTE 6 – INCOME TAXES
−Removed: The Company determines deferred tax assets and
−Removed: liabilities based upon the differences between the financial statement and tax bases of the Company’s assets and liabilities using
−Removed: tax rates in effect for the year in which the Company expects the differences to affect taxable income.
−Removed: A valuation allowance is established
−Removed: for any deferred tax assets for which it is more likely than not that all or a portion of the deferred tax assets will not be realized.
−Removed: Based on the available information and other factors, management believes it is more likely than not that its federal and state net deferred
−Removed: tax assets will not be fully realized, and the Company has recorded a full valuation allowance.
−Removed: The Company files U.S.
−Removed: federal and state income
−Removed: tax returns in jurisdictions with varying statutes of limitations.
−Removed: All tax returns for fiscal 2018 to fiscal 2025 may be subject to examination
+Added: intrinsic value per share is calculated as the excess of the closing price of the common stock on the Company’s principal trading
+Added: market over the exercise price of the option.
+Added: 6 – INCOME TAXES
+Added: Company determines deferred tax assets and liabilities based upon the differences between the financial statement and tax bases of the
+Added: Company’s assets and liabilities using tax rates in effect for the year in which the Company expects the differences to affect
+Added: taxable income.
+Added: A valuation allowance is established for any deferred tax assets for which it is more likely than not that all or a portion
+Added: of the deferred tax assets will not be realized.
+Added: Based on the available information and other factors, management believes it is more
+Added: likely than not that its federal and state net deferred tax assets will not be fully realized, and the Company has recorded a full valuation
+Added: Company files U.S.
+Added: federal and state income tax returns in jurisdictions with varying statutes of limitations.
+Added: All tax returns for fiscal
+Added: 2018 to fiscal 2025 may be subject to examination by the U.S.
federal and state tax authorities.
−Removed: As of June 30, 2025, the Company has not recorded any liability for unrecognized tax benefits
−Removed: related to uncertain tax positions.
−Removed: NOTE 7 – COMMITMENTS AND CONTINGENCIES
−Removed: Litigations, Claims and Assessments
−Removed: In the normal course of business, the Company
−Removed: may be involved in legal proceedings, claims and assessments arising in the ordinary course of business.
−Removed: The Company records legal costs
−Removed: associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
+Added: As of September 30, 2025, the Company
+Added: has not recorded any liability for unrecognized tax benefits related to uncertain tax positions.
+Added: 7 – COMMITMENTS AND CONTINGENCIES
+Added: Claims and Assessments
+Added: the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary
+Added: course of business.
+Added: The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and
+Added: estimable settlements.
Indemnification
−Removed: In the ordinary course of business, the Company
−Removed: enters into contractual arrangements under which it may agree to indemnify the counterparties from any losses incurred relating to breach
−Removed: of representations and warranties, failure to perform certain covenants, or claims and losses arising from certain events as outlined
−Removed: within the particular contract, which may include, for example, losses arising from litigation or claims relating to past performance.
+Added: the ordinary course of business, the Company enters into contractual arrangements under which it may agree to indemnify the counterparties
+Added: from any losses incurred relating to breach of representations and warranties, failure to perform certain covenants, or claims and losses
+Added: arising from certain events as outlined within the particular contract, which may include, for example, losses arising from litigation
+Added: or claims relating to past performance.
Such indemnification clauses may not be subject to maximum loss clauses.
−Removed: The Company has also entered into indemnification agreements
−Removed: with its officers and directors.
−Removed: No amounts were reflected in the Company’s consolidated financial statements for the three months
−Removed: ended June 30, 2025 and 2024 related to these indemnifications.
−Removed: The Company has not estimated the maximum potential amount of indemnification
−Removed: liability under these agreements due to the limited history of prior claims and the unique facts and circumstances applicable to each
−Removed: particular agreement.
−Removed: To date, the Company has not made any payments related to these indemnification agreements.
−Removed: Purchase Obligations
−Removed: The Company’s primary purchase obligations
−Removed: include purchase orders for machinery and equipment.
−Removed: At June 30, 2025, the Company had outstanding purchase orders for machinery and equipment
−Removed: and related expenditures of approximately $ 2,431,000 .
−Removed: In addition, at June 30, 2025, the Company
−Removed: had purchase commitments of approximately $ 900,000 over the next three years for technology related to its pump
−Removed: NOTE 8 – BUSINESS SEGMENT AND CONCENTRATIONS
−Removed: Segment Information
−Removed: The Company determines its reporting units in
−Removed: accordance with ASC No.
−Removed: 280, Segment Reporting (“ASC 280”), as amended by ASU No.
−Removed: 2023-07, Segment
−Removed: Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures , which the Company adopted effective March 31, 2025.
−Removed: evaluates a reporting unit by first identifying its operating segments under ASC 280.
−Removed: The Company then evaluates each operating segment
−Removed: to determine if it includes one or more components that constitute a business.
−Removed: If there are components within an operating segment that
−Removed: meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more reporting
−Removed: If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines if the segments
−Removed: are economically similar and, if so, the operating segments are aggregated.
−Removed: The Company’s chief executive officer is
−Removed: the chief operating decision maker (the “CODM”), and the CODM evaluates financial performance and makes operating decisions
−Removed: about allocating resources based on financial data presented on a consolidated basis, including consolidated net income (loss).
−Removed: the CODM evaluates financial performance on a consolidated basis, the Company operates and manages its business as one reportable
−Removed: and operating segment as a medical device company focused on the design, development and eventual commercialization of innovative insulin
−Removed: pumps using modernized technology.
−Removed: The measure of segment assets is reported on the balance sheet as total consolidated assets.
−Removed: The Company’s
−Removed: reporting segment meets the definition of an operating segment and does not include the aggregation of multiple operating segments.
−Removed: Significant segment expenses include research
−Removed: and development expenditures, salaries and benefits, and stock-based compensation.
−Removed: Operating expenses include all remaining costs necessary
−Removed: to operate the Company’s business, which primarily include facilities, external professional services and other administrative expenses.
−Removed: following table presents the significant segment expenses and other segment items regularly reviewed by the CODM:
+Added: The Company has also
+Added: entered into indemnification agreements with its officers and directors.
+Added: No amounts were reflected in the Company’s consolidated
+Added: financial statements for the three and six months ended September 30, 2025 and 2024 related to these indemnifications.
+Added: The Company has
+Added: not estimated the maximum potential amount of indemnification liability under these agreements due to the limited history of prior claims
+Added: and the unique facts and circumstances applicable to each particular agreement.
+Added: To date, the Company has not made any payments related
+Added: to these indemnification agreements.
+Added: Company’s primary purchase obligations include purchase orders for machinery and equipment.
+Added: At September 30, 2025, the Company
+Added: had outstanding purchase orders for machinery and equipment and related expenditures of approximately $ 1,719,000 .
+Added: 8 – BUSINESS SEGMENT AND CONCENTRATIONS
+Added: Company determines its reporting units in accordance with ASC No.
+Added: 280, Segment Reporting (“ASC 280”), as amended by
+Added: 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures , which the Company adopted effective
+Added: March 31, 2025.
+Added: Management evaluates a reporting unit by first identifying its operating segments under ASC 280.
+Added: The Company then evaluates
+Added: each operating segment to determine if it includes one or more components that constitute a business.
+Added: If there are components within
+Added: an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated
+Added: into one or more reporting units.
+Added: If applicable, when determining if it is appropriate to aggregate different operating segments, the
+Added: Company determines if the segments are economically similar and, if so, the operating segments are aggregated.
+Added: Company’s chief executive officer is the chief operating decision maker (the “CODM”), and the CODM evaluates financial
+Added: performance and makes operating decisions about allocating resources based on financial data presented on a consolidated basis, including
+Added: consolidated net income (loss).
+Added: Because the CODM evaluates financial performance on a consolidated basis, the Company operates and manages
+Added: its business as one reportable and operating segment as a medical device company focused on the design, development and eventual commercialization
+Added: of innovative insulin pumps using modernized technology.
+Added: The measure of segment assets is reported on the balance sheet as total consolidated
+Added: The Company’s reporting segment meets the definition of an operating segment and does not include the aggregation of multiple
+Added: operating segments.
+Added: segment expenses include research and development expenditures, salaries and benefits, and stock-based compensation.
+Added: Operating expenses
+Added: include all remaining costs necessary to operate the Company’s business, which primarily include facilities, external professional
+Added: services and other administrative expenses.
+Added: The following table presents the significant segment expenses and other segment items regularly
+Added: reviewed by the CODM:
+Added: September 30,
(in thousands)
2 unchanged sentences
Other operating expenses
−Removed: Other income and expense
Concentrations
−Removed: Financial instruments that potentially subject
−Removed: the Company to concentration of credit risk consist primarily of cash held in demand deposit accounts.
−Removed: The Company maintains its cash
−Removed: at high credit quality financial institutions within the United States, which are insured by the Federal Deposit Insurance Corporation
−Removed: (“FDIC”) up to limits of approximately $ 250,000 .
−Removed: No reserve has been made in the financial statements for any possible loss
−Removed: due to financial institution failure.
−Removed: The following table lists significant vendors
−Removed: that represented more than 10% of the Company’s total accounts payable balance at each respective balance sheet date:
+Added: instruments that potentially subject the Company to concentration of credit risk consist primarily of cash held in demand deposit accounts.
+Added: The Company maintains its cash at high credit quality financial institutions within the United States, which are insured by the Federal
+Added: Deposit Insurance Corporation up to limits of approximately $ 250,000 .
+Added: No reserve has been made in the financial
+Added: statements for any possible loss due to financial institution failure.
+Added: following table lists significant vendors that represented more than 10% of the Company’s total accounts payable balance at each
+Added: respective balance sheet date:
+Added: September 30,
less than 10%
−Removed: NOTE 9 – RELATED PARTY TRANSACTIONS
−Removed: A family member of one of the Company’s
−Removed: executive officers is an employee of the Company.
−Removed: During the three months ended June 30, 2025 and 2024, the Company paid the family member
−Removed: approximately $ 52,700 and $ 57,300 , respectively, which includes the aggregate grant date fair values, as determined pursuant to FASB ASC
−Removed: Topic 718, of stock options granted during each period.
−Removed: A second family member of one of the
−Removed: Company’s executive officers consulted with and became an employee of the Company during the three months ended June 30, 2025.
−Removed: During the three months ended June 30,
−Removed: 2025, the Company paid the family member approximately $ 18,600 which includes the aggregate grant date fair values, as determined
−Removed: pursuant to FASB ASC Topic 718, of stock options granted during the period.
+Added: 9 – RELATED PARTY TRANSACTIONS
+Added: family member of one of the Company’s executive officers is an employee of the Company.
+Added: During the three months ended September
+Added: 30, 2025 and 2024, the Company paid the family member approximately $ 33,760 and $ 43,365 , respectively, which includes the aggregate grant
+Added: date fair values, as determined pursuant to FASB ASC Topic 718, of any stock options granted during each period.
+Added: During the six months
+Added: ended September 30, 2025 and 2024, the Company paid the family member approximately $ 86,460 and $ 100,625 , respectively, which includes
+Added: the aggregate grant date fair values, as determined pursuant to FASB ASC Topic 718, of any stock options granted during each period.
+Added: A second family member of one of the Company’s
+Added: executive officers consulted with and became an employee of the Company during 2025.
+Added: During the three months ended September 30, 2025,
+Added: the Company paid the family member approximately $ 16,000 , which includes the aggregate grant date fair values, as determined pursuant
+Added: to FASB ASC Topic 718, of any stock options granted during each period.
+Added: During the six months ended September 30, 2025, the Company paid
+Added: the family member approximately $ 34,600 , which includes the aggregate grant date fair values, as determined pursuant to FASB ASC Topic
+Added: 718, of any stock options granted during each period.
+Added: NOTE 10 – SUBSEQUENT EVENTS
+Added: Subsequent to September 30, 2025, under the ATM
+Added: Agreement, the Company sold 1,793,064 shares of common stock for net proceeds of approximately $ 1.1 million.
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.