Modular Medical, Inc. 10-Q

Item 1. Financial Statements Modular Medical, Inc. Condensed Consolidated Balance Sheets (In thousands, except par value) December 31, 2024 (Unaudited) March 31, 2024 ASSETS CURRENT ASSETS Cash and cash equivalents $ 6,986 $ 9,232 Prepaid expenses and other 345 465 TOTAL CURRENT ASSETS 7,331 9,697 Property and equipment, net 3,958 2,975 Right of use asset, net 860 1,135 TOTAL ASSETS $ 12,149 $ 13,807 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable $ 522 $ 802 Accrued expenses 451 280 Short-term lease liabilities 410 373 TOTAL CURRENT LIABILITIES 1,383 1,455 Long-term lease liabilities 504 817 TOTAL LIABILITIES 1,887 2,272 Commitments and Contingencies (Note 7) STOCKHOLDERS’ EQUITY Preferred Stock, $ 0.001 par value, 5,000 shares authorized, none issued and outstanding — — Common Stock, $ 0.001 par value, 100,000 shares authorized; 40,665 and 32,464 shares issued and outstanding as of December 31, 2024 and March 31, 2024, respectively 41 32 Additional paid-in capital 90,047 77,432 Accumulated deficit ( 79,826 ) ( 65,929 ) TOTAL STOCKHOLDERS’ EQUITY 10,262 11,535 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 12,149 $ 13,807 The accompanying notes are an integral part of these condensed consolidated financial statements. 1 Modular Medical, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except per share data) Three Months Ended December 31, Nine Months Ended December 31, 2024 2023 2024 2023 Operating expenses Research and development $ 3,853 $ 3,838 $ 10,760 $ 9,765 General and administrative 1,001 1,431 3,310 3,445 Total operating expenses 4,854 5,269 14,070 13 210 Loss from operations ( 4,854 ) ( 5,269 ) ( 14,070 ) ( 13,210 ) Other income 50 — 175 23 Loss before income taxes ( 4,804 ) ( 5,269 ) ( 13,895 ) ( 13,187 ) Provision for income taxes — — 2 2 Net loss $ ( 4,804 ) $ ( 5,269 ) $ ( 13,897 ) $ ( 13,189 ) Net loss per share Basic and diluted $ ( 0.13 ) $ ( 0.23 ) $ ( 0.39 ) $ ( 0.64 ) Shares used in computing net loss per share Basic and diluted 37,807 22,540 35,349 20,708 The accompanying notes are an integral part of these condensed consolidated financial statements. 2 Modular Medical, Inc. Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) (In thousands) Common Stock Additional Paid-In Accumulated Stockholders’ Shares Amount Capital Deficit Equity Balance as of March 31, 2024 32,464 $ 32 $ 77,432 $ ( 65,929 ) $ 11,535 Shares issued for services 10 — 15 — 15 Exercise of warrants 55 — 68 — 68 Issuances under equity incentive plan 32 — 6 — 6 Stock-based compensation — — 529 — 529 Net loss — — — ( 4,137 ) ( 4,137 ) Balance as of June 30, 2024 32,561 $ 32 $ 78,050 $ ( 70,066 ) $ 8,016 Shares issued for services 20 — 35 — 35 Exercise of warrants 939 1 844 — 845 At-the-market sales of stock, net 825 1 1,922 — 1,923 Issuances under equity incentive plan 25 — 9 — 9 Stock-based compensation — — 1,044 — 1,044 Net loss — — — ( 4,956 ) ( 4,956 ) Balance as of September 30, 2024 34,370 $ 34 $ 81,904 $ ( 75,022 ) $ 6,916 Issuance of common stock in equity offering, net 5,451 6 7,338 — 7,344 Exercise of warrants 723 1 195 — 196 At-the-market sales of stock, net 96 — 191 — 191 Issuances under equity incentive plan 25 — 5 — 5 Stock-based compensation — — 414 — 414 Net loss — — — ( 4,804 ) ( 4,804 ) Balance as of December 31, 2024 40,665 $ 41 $ 90,047 $ ( 79,826 ) $ 10,262 Common Stock Additional Paid-In Accumulated Stockholders’ Shares Amount Capital Deficit Equity Balance as of March 31, 2023 10,949 $ 11 $ 53,524 $ ( 48,459 ) $ 5,076 Issuance of common stock and warrants in equity offering, net 10,139 10 9,723 — 9,733 Issuances under equity incentive plan 7 — 6 — 6 Stock-based compensation — — 478 — 478 Net loss — — — ( 3,737 ) ( 3,737 ) Balance as of June 30, 2023 21,095 $ 21 $ 63,731 $ ( 52,196 ) $ 11,556 Shares issued for services 2 — 1 — 1 Issuances under equity incentive plan 27 — 7 — 7 Stock-based compensation — — 557 — 557 Net loss — — — ( 4,183 ) ( 4,183 ) Balance as of September 30, 2023 21,124 $ 21 $ 64,296 $ ( 56,379 ) $ 7,938 Exercise of warrants 148 — 181 — 181 Issuance of common stock under equity incentive plan 27 — 11 — 11 Stock-based compensation — — 984 — 984 Net loss — — — ( 5,269 ) ( 5,269 ) Balance as of December 31, 2023 $ 21,299 $ 21 $ 65,472 $ ( 61,648 ) $ 3,845 The accompanying notes are an integral part of these condensed consolidated financial statements. 3 Modular Medical, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) (In thousands) Nine Months Ended December 31, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES Net loss $ ( 13,897 ) $ ( 13,189 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 2,007 2,043 Loss on asset disposal — 21 Depreciation and amortization 737 283 Shares for services 48 16 Changes in assets and liabilities: Prepaid expenses and other assets ( 20 ) ( 63 ) Lease right-of-use asset 275 255 Accounts payable and accrued expenses ( 285 ) 453 Change in lease liability ( 275 ) ( 268 ) Net cash used in operating activities ( 11,410 ) ( 10,449 ) CASH FLOWS FROM INVESTING ACTIVITIES Purchases of property and equipment ( 1,545 ) ( 1,217 ) Net cash used in investing activities ( 1,545 ) ( 1,217 ) CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from at-the-market sales of stock, net 2,114 — Proceeds from exercise of common stock purchase warrants 1,251 181 Proceeds from issuance of common stock, net 7,344 — Proceeds from issuance of common stock and warrants, net — 9,733 Net cash provided by financing activities 10,709 9,914 Net decrease in cash and cash equivalents ( 2,246 ) ( 1,752 ) Cash and cash equivalents at beginning of period 9,232 3,799 Cash and cash equivalents at end of period $ 6,986 $ 2,047 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 4 MODULAR MEDICAL, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) NOTE 1 – THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Modular Medical, Inc. (the “Company”) was incorporated in Nevada in October 1998 under the name Bear Lake Recreation, Inc. The Company had no material business operations until approximately 2017 when it acquired all of the issued and outstanding shares of Quasuras, Inc., a Delaware corporation (“Quasuras”), and changed its name from Bear Lake Recreation, Inc. to Modular Medical, Inc. The Company is 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 an innovative two-part patch pump, its initial product, the MODD1, the Company seeks to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care requiring considerable motivation that presently available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, the Company seeks to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, the Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (“FDA”) for the MODD1, and, in September 2024, the Company received FDA clearance to market and sell its MODD1 pump in the United States. Liquidity and Going Concern The 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. The Company expects to continue to incur operating losses for the foreseeable future and incur cash outflows from operations as it continues to invest in the development and commercialization of its products. The Company expects that its operating expenses will continue to increase, and, as a result, it will eventually need to generate significant revenue to achieve profitability. When considered with its current operating plan, these conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued. In addition, the Company’s independent registered public accounting firm, in its report on the consolidated financial statements as of and for the year ended March 31, 2024, expressed substantial doubt about the Company’s ability to continue as a going concern. These condensed consolidated financial statements do not include any adjustments that might result from this uncertainty. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise additional capital, through the sale of additional equity or debt securities, to support its future operations. There can be no assurance that such additional capital, whether in the form of debt or equity financing, will be sufficient or available and, if available, that such capital will be offered on terms and conditions acceptable to the Company. The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its MODD1 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 its product offering. If the Company is unable to secure additional capital, it may be required to curtail its product commercialization and research and development initiatives and take additional measures to reduce costs in order to conserve its cash. 5 Basis of Presentation The Company’s fiscal year ends on March 31 of each calendar year. Each reference to a fiscal year in these notes to the condensed consolidated financial statements refers to the fiscal year ended March 31 of the calendar year indicated (for example, fiscal 2025 refers to the fiscal year ending March 31, 2025). The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Quasuras. All significant intercompany transactions and balances have been eliminated in consolidation. The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and with the rules and regulations of the United States Security and Exchange Commission (“SEC”) regarding interim financial reporting. The condensed consolidated balance sheet as of March 31, 2024 has been derived from the audited consolidated financial statements at that date. Certain information and disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted in accordance with these rules and regulations of the SEC. The information in this report should be read in conjunction with the Company’s consolidated financial statements and notes thereto included in its most recent annual report on Form 10-K filed with the SEC. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting only of normal recurring adjustments) necessary to summarize fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. The operating results for the nine months ended December 31, 2024 are not necessarily indicative of the results that may be expected for the year ending March 31, 2025 or for any other future period. Use of Estimates The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of revenues and expenses during the reporting period. Estimates may include those pertaining to accruals, stock-based compensation and income taxes. Actual results could differ from those estimates. Reportable Segment The Company operates in one business segment and uses one measurement of profitability for its business. Research and Development The Company expenses research and development expenditures as incurred. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash held in demand deposit accounts. The Company maintains a portion of its cash in demand deposit accounts at high credit quality financial institutions within the United States, which are insured by the Federal Deposit Insurance Corporation up to limits of approximately $ 250,000 . No reserve has been made in the financial statements for any possible loss due to financial institution failure. 6 Risks and Uncertainties The Company is subject to risks from, among other things, competition associated with the industry in general, other risks associated with financing, liquidity requirements, rapidly changing customer requirements, limited operating history, pandemics, wars and acts of terrorism and the volatility of public markets. The Company may be unable to access the capital markets, and additional capital may only be available to the Company on terms that could be significantly detrimental to its existing stockholders and to its business. Cash and Cash Equivalents Cash and cash equivalents include cash held in demand deposit and money market accounts, certificates of deposit and all highly liquid debt instruments with original maturities of three months or less. Property and Equipment Property and equipment are recorded at historical cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally three to five years . Depreciation is recorded in operating expenses in the consolidated statements of operations. Leasehold improvements and assets acquired through finance leases are amortized over the shorter of their estimated useful life or the lease term, and amortization is recorded in operating expenses in the consolidated statements of operations. Construction-in-process includes machinery and equipment and is stated at cost and not depreciated. Depreciation on construction-in-process commences when the assets are ready for their intended use and placed into service. Fair Value of Financial Instruments The Company measures the fair value of financial instruments using a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels: ● Level 1 inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets. ● 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. ● Level 3 inputs to the valuation methodology are unobservable and significant to the fair value measurement. Due to their short-term nature, the carrying values of cash equivalents, accounts payable and accrued expenses, approximate fair value. Leases The Company’s right-of-use assets consist of leased assets recognized in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 842, Leases , which requires lessees to recognize a lease liability and a corresponding lease asset for virtually all lease contracts. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and the lease liability represents the Company’s obligation to make lease payments arising from the lease, both of which are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. Leases with a lease term of 12 months or less at inception are not recorded on the consolidated balance sheets and are expensed on a straight-line basis over the lease term in the consolidated statement of operations and comprehensive loss. The Company determines the lease term by agreement with the lessor. In cases where the lease does not provide an implicit interest rate, the Company uses the Company’s incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. 7 Stock-Based Compensation The Company periodically issues stock options, restricted stock units and stock awards to employees and non-employees. The Company accounts 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 expense on a straight-line basis over the requisite service period, usually the vesting period. With respect to performance-based awards, the Company assesses the probability of achieving the requisite performance criteria before recognizing compensation expense. The fair value of the Company’s stock options is estimated using the Black-Scholes-Merton Option Pricing (“Black Scholes”) model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the options, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes model. The assumptions used in the Black-Scholes model could materially affect compensation expense recorded in future periods. Per-Share Amounts 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. In addition, the Company includes the number of shares of common stock issuable under pre-funded warrants as outstanding for purposes of the WASO calculation. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding during the period. Potentially dilutive common shares consist of incremental shares of common stock issuable upon the exercise of stock options and exercise of warrants. The following table sets forth securities outstanding which were excluded from the computation of diluted net loss per share as their inclusion would be anti-dilutive (in thousands). Nine Months Ended December 31, 2024 2023 Options to purchase common stock 4,633 3,720 Unvested restricted stock units 125 208 Common stock purchase warrants 10,647 11,892 Total 15,405 15,820 Reclassifications Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations or cash flows. Comprehensive Loss Comprehensive loss represents the changes in equity of an enterprise, other than those resulting from stockholder transactions. Accordingly, comprehensive loss may include certain changes in equity that are excluded from net loss. For the three and nine months ended December 31, 2024 and 2023, the Company’s comprehensive loss was the same as its net loss. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires disclosure of incremental segment information on an annual and interim basis. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and it requires retrospective application to all prior periods presented in the financial statements. As the Company has only one operating segment, the Company does not expect that the adoption of this ASU will have a material impact on the presentation of its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which expands disclosures in an entity’s income tax rate reconciliation table and disclosures regarding cash taxes paid both in the U.S. and foreign jurisdictions. The update will be effective for annual periods beginning after December 15, 2024. The Company does not expect that the adoption of this ASU will have a material impact on the presentation of its consolidated financial statements. In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses . The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The standard is effective for the Company for annual periods beginning April 1, 2027 and interim periods beginning April 1, 2028, with early adoption permitted. The standard may be applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is evaluating the impact that this ASU will have on the presentation of its consolidated financial statements. 8 NOTE 2 – CONSOLIDATED BALANCE SHEET DETAIL December 31, 2024 March 31, 2024 (in thousands) Property and equipment, net Machinery and equipment $ 4,912 $ 3,209 Computer equipment and software 66 66 Construction-in-process 300 283 Leasehold improvements 33 33 Office equipment 46 63 5,357 3,654 Less: accumulated depreciation and amortization ( 1,399 ) ( 679 ) Total $ 3,958 $ 2,975 December 31, 2024 March 31, 2024 (in thousands) Accrued expenses Accrued wages and employee benefits $ 300 $ 243 Other 151 37 Total $ 451 $ 280 NOTE 3 – LEASES Thornmint Road, San Diego, CA The 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 of approximately 4 %. In addition to the minimum lease payments, the Company is responsible for property taxes, insurance and certain other operating costs. A discount rate of 8 %, which approximated the Company’s incremental borrowing rate, was used to measure the lease asset and liability. The Company obtained a right-of-use asset of approximately $ 1,560,000 in exchange for its obligations under the operating lease. Future minimum payments under the facility operating lease, as of December 31, 2024, are listed in the table below (in thousands). Annual Fiscal Years 2025 $ 115 2026 470 2027 405 Total future lease payments $ 990 Less: Imputed interest ( 76 ) Present value of lease liability $ 914 Cash paid for amounts included in the measurement of lease liabilities was approximately $ 337,000 and $ 365,000 for the nine months ended December 31, 2024 and 2023, respectively. Rent expense was approximately $ 337,000 for each of the nine month periods ended December 31, 2024 and 2023, respectively and $ 112,000 for each of the three month periods ended December 31, 2024 and 2023. NOTE 4 – STOCKHOLDERS’ EQUITY November 2024 Public Offering In November 2024, the Company entered into an Underwriting Agreement (the “Agreement”) with Titan Partners Group LLC, a division of American Capital Partners, LLC (the “Underwriter”), relating to a firm commitment underwritten offering (the “Offering”) of 5,450,573 shares (the “Shares”) of common stock of the Company, at a public offering price of $ 1.50 per share. The Offering closed on November 25, 2024 (the “Closing Date”), resulting in gross proceeds to the Company of approximately $ 8.2 million, before deducting underwriting discounts, commissions and offering expenses. The Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-264193) previously filed with the Securities and Exchange Commission on April 8, 2022, subsequently amended on April 15, 2022, and declared effective by the SEC on April 19, 2022, and a preliminary prospectus supplement relating to the Offering dated November 21, 2024. 9 Pursuant to the Agreement, as partial compensation for its services, the Company issued to the Underwriter on the Closing Date, warrants (the “Underwriter Warrants”) to purchase an aggregate of 381,540 shares of common stock, representing 7 % of the Shares issued on the Closing Date. The Underwriter Warrants will be exercisable, in whole or in part, commencing on May 21, 2025 and expiring on November 25, 2029 , at an exercise price per share of $ 1.875 . Pursuant to the Agreement, each of the Company’s directors and executive officers entered into “lock-up” agreements with the Underwriter that, subject to certain exceptions, prohibit, without the prior written consent of the Underwriter, the sale, transfer or other disposition of securities of the Company for a period of 60 days after the Closing Date (the “Lock-Up Period”). In addition, pursuant to the Agreement, except with respect to certain exempt issuances, the Company is prohibited from issuing common stock or common stock equivalents during the Lock-Up Period and from engaging in certain variable rate transactions for a period of one year from the Closing Date. ATM Offering In November 2023, the Company entered into a Sales Agreement (the “ATM Agreement”) with Leerink Partners LLC (“Leerink”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock through an “at the market offering” program under which Leerink will act as sales agent or principal. The ATM Agreement provides that Leerink will 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 Agreement. The Company has no obligation to sell any shares under the ATM Agreement and may, at any time, suspend solicitation and offers under the ATM Agreement. During the three and nine months ended December 31, 2024, under the ATM Agreement, the Company sold 95,685 and 920,199 shares of common stock, respectively, for gross proceeds of $ 218,449 and $ 2,224,440 . During the three and nine months ended December 31, 2024, the Company incurred commissions and legal fees of $ 27,760 and $ 110,440 , respectively. Common Stock Purchase Warrants As of December 31, 2024, the Company had the following warrants outstanding (share amounts in thousands): Number of Shares Exercise Price ($) Expiration Balance as of March 31, 2024 12,521 Warrants exercised ( 55 ) 1.22 May 2028 Balance as of June 30, 2024 12,466 Warrants exercised ( 252 ) 0.01 — Warrants exercised ( 649 ) 1.22 May 2028 Warrants exercised ( 39 ) 1.32 May 2027 Balance as of September 30, 2024 11,526 Issuance of warrants 382 1.875 Nov 2029 Warrants exercised ( 565 ) 0.01 — Warrants exercised ( 152 ) 1.22 May 2028 Warrants exercised ( 12 ) 1.32 May 2027 Balance as of December 31, 2024 11,179 As of March 31, 2024, the Company had the following warrants outstanding (share amounts in thousands): Type Number of Shares Exercise Price ($) Expiration Common stock 1,348 0.01 — Common stock 4,421 1.22 May 2028 Common stock 535 1.32 May 2027 Common stock 768 6.00 January 2027 - February 2027 Common stock 4,011 6.60 February 2027 Common stock 1,438 6.60 November 2027 Total 12,521 The outstanding pre-funded warrants with an exercise price of $ 0.01 per share were included in the weighted average shares outstanding calculation for each of the three and nine month periods ended December 31, 2024 and 2023. At March 31, 2024, the Company had a receivable from its transfer agent for approximately $ 142,000 for the proceeds from warrants exercised prior to March 31, 2024. The receivable was recorded in the prepaid and other line in the consolidated balance sheet at March 31, 2024 and was collected during the three months ended June 30, 2024. Other During the nine months ended December 31, 2024 and 2023, the Company issued 30,000 and 1,429 shares of common stock with fair values of approximately $ 51,000 and $ 1,400 , respectively, to service providers. 10 NOTE 5 – STOCK-BASED COMPENSATION Amended 2017 Equity Incentive Plan In October 2017, the Company’s board of directors (the “Board”) approved the 2017 Equity Incentive Plan (the “Plan”), as amended, with 1,000,000 shares of common stock reserved for issuance. In January 2020 and August 2021, the Board approved increases in the number of shares reserved for issuance by 333,334 and 1,333,334 shares, respectively. In January 2023 and February 2024, the Company’s stockholders approved increases in the number of shares reserved for issuance under the Plan by an additional 2,000,000 and 3,000,000 shares, respectively. Under the Plan, eligible employees, directors and consultants may be granted a broad range of awards, including stock options, stock appreciation rights, restricted stock, performance-based awards and restricted stock units. The Plan is administered by the Board or, in the alternative, a committee designated by the Board. Stock-Based Compensation Expense Stock options granted by the Company generally vest over 36 months and have a 10 -year term. As of December 31, 2024, the unamortized compensation cost related to stock options was approximately $ 1,486,000 and is expected to be recognized as expense over a weighted-average period of approximately 1.9 years. In October 2023, under its Two-Part FDA Submission and Clearance Milestone Bonus Program (the “Bonus Program”), the Company granted stock options to purchase 909,533 shares of common stock, which were subject to vesting based upon the achievement of certain performance milestones by the Company and continued service by the optionees. In January 2024, options to purchase 625,326 shares (net of forfeitures), which were granted under part one of the Bonus Program, vested upon the Company’s submission to the FDA. In August 2024, options to purchase 242,307 shares (net of forfeitures), which were granted under part two of the Bonus Program, were canceled, as the Company did not receive clearance from the FDA for its MODD1 product by August 1, 2024. In August 2024, the Company granted new options to purchase 339,298 shares (the “Clearance Options”), which were subject to vesting based upon the Company’s receipt of clearance from the FDA for its MODD1 product by December 31, 2024 and continued service by the optionees. The Clearance Options vested in full in September 2024 upon the Company’s receipt of clearance from the FDA for its MODD1 product. The weighted-average grant date fair value of options granted was $ 1.42 and $ 0.98 per share for the nine months ended December 31, 2024 and 2023, respectively, and $ 1.56 and $ 0.97 for the three months ended December 31, 2024 and 2023, respectively. The following assumptions were used in the fair-value method calculations: Three Months Ended December 31, Nine Months Ended December 31, 2024 2023 2024 2023 Risk-free interest rates 3.9 % - 4.4 % 3.8 % - 4.7 % 3.5 % - 4.4 % 3.5 % - 4.7 % Volatility 110 % - 113 % 123.4 % - 127.6 % 110 % - 123 % 82.5 % - 152.2 % Expected life (years) 5.0 – 5.7 5.0 – 5.4 5.0 – 5.7 5.0 – 6.2 The fair values of options at the grant date were estimated utilizing the Black-Scholes valuation model, which includes simplified methods to establish the expected life of options, as well as average volatility. The risk-free interest rate was derived from the Daily Treasury Yield Curve Rates, as published by the U.S. Department of the Treasury as of the grant date for terms equal to the expected terms of the options. A dividend yield of zero was applied because the Company has never paid dividends and has no intention to pay dividends in the foreseeable future. The Company accounts for forfeitures as they occur. The following table summarizes the activity in the shares available for grant under the Plan during the nine months ended December 31, 2024: Options Outstanding Weighted Shares Average Available Number of Exercise for Grant Shares Price ($) Balance at March 31, 2024 3,648,651 3,689,341 3.70 Share awards ( 3,875 ) — 1.56 Options granted ( 682,375 ) 682,375 1.52 Options exercised — ( 7,530 ) 1.08 Options cancelled and returned to the Plan 42,230 ( 42,230 ) 2.62 Balance at June 30, 2024 3,004,631 4,321,956 3.36 Share awards ( 3,875 ) — 2.28 Options granted ( 483,673 ) 483,673 1.81 Options cancelled and returned to the Plan 274,901 ( 274,901 ) 1.51 Balance at September 30, 2024 2,791,984 4,530,728 3.33 Share awards ( 3,875 ) — 1.37 Options granted ( 129,375 ) 129,375 1.88 Options cancelled and returned to the Plan 27,388 ( 27,388 ) 1.30 Balance at December 31, 2024 2,686,122 4,632,715 3.30 11 A stock option was exercised on a cashless basis for a net issuance of 7,530 shares of common stock during the nine months ended December 31, 2024. There were no stock options exercised during the nine months ended December 31, 2023. During the nine months ended December 31, 2024 and 2023, the Company awarded 11,625 and 19,015 shares, respectively, and for the three months ended December 31, 2024 and 2023, the Company awarded 3,875 and 6,375 shares, respectively, to its non-employee directors under the Company’s outside director compensation plan. For the nine months ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense for these share awards of approximately $ 20,000 and $ 25,000 , respectively, and for the three months ended December 31, 2024 and 2023, the Company recorded stock-based compensation expense for these share awards of approximately $ 5,000 and $ 11,000 , respectively. A summary of restricted stock unit (“RSU”) activity under the Plan is presented below. Weighted Average Number of Shares Grant-Date Fair Value ($) Non-vested shares at March 31, 2024 187,499 0.91 Vested ( 20,832 ) 0.91 Non-vested shares at June 30, 2024 166,667 0.91 Vested ( 20,833 ) 0.91 Non-vested shares at September 30, 2024 145,834 0.91 Vested ( 20,833 ) 0.91 Non-vested shares at December 31, 2024 125,001 0.91 The total intrinsic value of RSUs outstanding as of December 31, 2024 was approximately $ 171,000 . The unamortized compensation cost at December 31, 2024 was approximately $ 115,000 related to RSUs and is expected to be recognized as expense over a period of approximately 1.5 years. The following table summarizes the range of outstanding and exercisable options as of December 31, 2024: Options Outstanding Options Exercisable Range of Exercise Price Number Outstanding Weighted Average Remaining Contractual Life (in Years) Weighted Average Exercise Price ($) Number Exercisable Weighted Average Exercise Price ($) Aggregate Intrinsic value ($) $0.93 - $2.28 3,200,441 8.22 1.59 2,095,570 1.57 213,512 $3.95 - $7.51 933,145 6.43 5.30 873,089 5.37 — $8.61 - $17.70 499,129 6.48 10.56 499,129 10.56 — $0.93 - $17.70 4,632,715 7.67 3.30 3,467,788 3.82 213,512 The intrinsic value per share is calculated as the excess of the closing price of the common stock on the Company’s principal trading market over the exercise price of the option. NOTE 6 – INCOME TAXES The Company determines deferred tax assets and liabilities based upon the differences between the financial statement and tax bases of the Company’s assets and liabilities using tax rates in effect for the year in which the Company expects the differences to affect taxable income. A valuation allowance is established 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. Based on the available information and other factors, management believes it is more 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 allowance. The Company files U.S. federal and state income tax returns in jurisdictions with varying statutes of limitations. All tax returns for fiscal 2016 to fiscal 2024 may be subject to examination by the U.S. federal and state tax authorities. As of December 31, 2024, the Company has not recorded any liability for unrecognized tax benefits related to uncertain tax positions. 12 NOTE 7 – COMMITMENTS AND CONTINGENCIES Litigations, Claims and Assessments In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. Indemnification In the ordinary course of business, the Company enters into contractual arrangements under which it may agree to indemnify the counterparties from any losses incurred relating to breach of representations and warranties, failure to perform certain covenants, or claims and losses arising from certain events as outlined within the particular contract, which may include, for example, losses arising from litigation or claims relating to past performance. Such indemnification clauses may not be subject to maximum loss clauses. The Company has also entered into indemnification agreements with its officers and directors. No amounts were reflected in the Company’s consolidated financial statements for the three and nine months ended December 31, 2024 and 2023 related to these indemnifications. The Company has not estimated the maximum potential amount of indemnification liability under these agreements due to the limited history of prior claims and the unique facts and circumstances applicable to each particular agreement. To date, the Company has not made any payments related to these indemnification agreements. Purchase Obligations The Company’s primary purchase obligations include purchase orders for machinery and equipment. At December 31, 2024, the Company had outstanding purchase orders for machinery and equipment and related expenditures of approximately $ 1,061,000 . In December 2023, the Company signed a device integration agreement with a provider of connected-care and remote monitoring diabetes technology solutions. As of December 31, 2024, the Company had a remaining obligation under the device integration agreement of approximately $ 400,000 over three years for technology license and maintenance fees. NOTE 8 – RELATED PARTY TRANSACTIONS A family member of one of the Company’s executive officers is an employee of the Company. During the three months ended December 31, 2024 and 2023, the Company paid the family member $ 38,191 and $ 44,095 , respectively, which includes the aggregate grant date fair values, as determined pursuant to FASB ASC Topic 718, of any stock options granted during each period. During the nine months ended December 31, 2024 and 2023, the Company paid the family member $ 138,510 and $ 107,849 , respectively, which includes the aggregate grant date fair values, as determined pursuant to FASB ASC Topic 718, of any stock options granted during each period. 13