Item 1. Financial Statements
Item
1. Financial Statements
Modular
Medical, Inc.
Condensed
Consolidated Balance Sheets
(In
thousands, except par value)
September 30,
2025
March 31,
(Unaudited)
2025
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 5,316
$ 13,095
Prepaid expenses and other
631
422
TOTAL CURRENT ASSETS
5,947
13,517
Property and equipment, net
6,459
4,453
Right of use asset, net
568
765
TOTAL ASSETS
$ 12,974
$ 18,735
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
$ 2,879
$ 338
Accrued expenses
715
504
Short-term lease liabilities
450
423
TOTAL CURRENT LIABILITIES
4,044
1,265
Long-term lease liabilities
161
393
TOTAL LIABILITIES
4,205
1,658
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; 61,171 and 53,706 shares issued and outstanding as of September 30, 2025 and March 31, 2025, respectively
61
54
Additional paid-in capital
107,515
101,776
Common stock issuable
438
—
Accumulated deficit
( 99,245 )
( 84,753 )
TOTAL STOCKHOLDERS’ EQUITY
8,769
17,077
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 12,974
$ 18,735
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
September 30,
Six Months Ended
September 30,
2025
2024
2025
2024
Operating expenses
Research and development
$ 5,593
$ 3,702
$ 10,727
$ 6,907
Selling, general and administrative
2,236
1,294
3,906
2,309
Total operating expenses
7,829
4,996
14,633
9,216
Loss from operations
( 7,829 )
( 4,996 )
( 14,633 )
( 9,216 )
Other income
41
42
143
125
Loss before income taxes
( 7,788 )
( 4,954 )
( 14,490 )
( 9,091 )
Provision for income taxes
2
2
2
2
Net loss
$ ( 7,790 )
$ ( 4,956 )
$ ( 14,492 )
$ ( 9,093 )
Net loss per share
Basic and diluted
$ ( 0.14 )
$ ( 0.14 )
$ ( 0.26 )
$ ( 0.27 )
Shares used in computing net loss per share
Basic and diluted
55,576
34,338
54,936
34,114
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)
Additional
Common Stock
Issuable Shares
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance as of March 31, 2025
53,706
$ 54
—
$ —
$ 101,776
$ ( 84,753 )
$ 17,077
Shares issued for services
10
—
—
—
11
—
11
At-the-market sales of stock, net
1,000
1
—
—
727
—
728
Exercise of warrants
532
—
—
—
5
—
5
Issuances under equity incentive plan
27
—
—
—
4
—
4
Stock-based compensation
—
—
—
—
720
—
720
Net loss
—
—
—
—
—
( 6,702 )
( 6,702 )
Balance as of June 30, 2025
55,275
$ 55
—
$ —
$ 103,243
$ ( 91,455 )
$ 11,843
At-the-market sales of stock, net
9
—
—
6
—
6
Issuance of common stock and warrants from warrant
inducement offering
5,860
6
644
438
3,454
—
3,898
Issuances under equity incentive plan
27
—
—
—
4
—
4
Stock-based compensation
—
—
—
—
808
—
808
Net loss
—
—
—
—
—
( 7,790 )
( 7,790 )
Balance as of September 30, 2025
61,171
$ 61
644
$ 438
$ 107,515
$ ( 99,245 )
$ 8,769
Additional
Common Stock
Issuable Shares
Paid-In
Accumulated
Stockholders’
Shares
Amount
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
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)
Six Months Ended
September 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 14,492 )
$ ( 9,093 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
1,537
1,588
Depreciation and amortization
801
456
Shares issued for services
4
26
Changes in assets and liabilities:
Prepaid expenses and other assets
( 200 )
64
Lease right-of-use asset
197
182
Accounts payable and accrued expenses
1,576
( 355 )
Lease liabilities
( 206 )
( 182 )
Net cash used in operating activities
( 10,783 )
( 7,314 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment
( 1,705 )
( 1,003 )
Net cash used in investing activities
( 1,705 )
( 1,003 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from at-the-market sales of common stock, net
732
1,923
Proceeds from exercise of common stock purchase warrants
5
1,055
Proceeds from warrant inducement offering, net
3,972
—
Net cash provided by financing activities
4,709
2,978
Net decrease in cash and cash equivalents
( 7,779 )
( 5,339 )
Cash and cash equivalents at beginning of period
13,095
9,232
Cash and cash equivalents at end of period
$ 5,316
$ 3,893
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 delivery
systems using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of innovative two-part
patch pumps, 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 its initial
product, the MODD1, and, in September 2024, the Company received FDA clearance to market and sell its MODD1 pump in the United States.
The Company is seeking FDA approval for an updated version of the MODD1 product, called
the Pivot, which is a tubeless version of the product that integrates the set into a true tubeless patch. The Company intends to go to
market with its Pivot product, when the required regulatory approval from the FDA is received.
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, 2025, 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 pump products, competing technological and market developments,
and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement 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. As disclosed in
Note 4, in September 2025, the Company effected a warrant inducement offering for net proceeds of approximately $ 3.9 million, and, during
the six months ended September 30, 2025, the Company received net proceeds of approximately $ 0.7 million from sales of shares of common
stock under its at-the-market sales program.
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 2026 refers to the
fiscal year ending March 31, 2026). 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, 2025 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 six months ended September 30, 2025 are not necessarily indicative
of the results that may be expected for the year ending March 31, 2026 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.
Research
and Development
The
Company expenses research and development expenditures as incurred.
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 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.
6
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, including 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.
For
the six months ended September 30, 2025 and 2024, 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).
Six Months Ended
September 30,
2025
2024
Options to purchase common stock
7,229
4,531
Unvested restricted stock units
63
146
Common stock purchase warrants
15,100
10,430
Total
22,392
15,107
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 six months ended September 30, 2025 and
2024, the Company’s comprehensive loss was the same as its net loss.
Recently
Issued Accounting Pronouncements
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
September 30,
March 31,
2025
2025
(in thousands)
Prepaid and other current assets
Prepaid expenses
$ 606
$ 352
Other receivables
25
70
$ 631
$ 422
September 30,
March 31,
2025
2025
(in thousands)
Property and equipment, net
Machinery and equipment
$ 7,904
$ 5,311
Computer equipment and software
45
66
Construction-in-process
788
685
Leasehold improvements
33
33
Office equipment
45
45
8,815
6,140
Less: accumulated depreciation and amortization
( 2,356 )
( 1,687 )
Total
$ 6,459
$ 4,453
September 30,
2025
March 31,
2025
(in thousands)
Accrued expenses
Accrued wages and employee benefits
$ 460
$ 391
Other
255
113
Total
$ 715
$ 504
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 September 30, 2025, are listed in the table below (in thousands).
Annual Fiscal Years
2026
$ 237
2027
405
Total future lease payments
$ 642
Less: Imputed interest
( 31 )
Present value of lease liability
$ 611
Cash
paid for amounts included in the measurement of lease liabilities was approximately $ 234,000 and $ 225,000 for the six months ended September
30, 2025 and 2024, respectively. Rent expense was approximately $ 225,000 for each of the six-month periods ended September 30, 2025 and
2024, respectively, and $ 113,000 for each of the three-month periods ended September 30, 2025 and 2024.
9
NOTE
4 – STOCKHOLDERS’ EQUITY
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, for aggregate gross proceeds of up to $ 6,500,000 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 six months ended September 30, 2025, under the ATM Agreement, the Company sold 9,200 and 1,009,200 shares of common
stock for net proceeds of $ 6,286 and $ 733,786 , respectively.
Warrant
Inducement Offering
In September 2025, the Company entered into inducement
offer letter agreements (the “Inducement Letters”) with certain holders (the “Holders”) of warrants issued in
May 2023 (the “2023 Warrants”) and in March 2025 (the “March 2025 Warrants” and, collectively with the 2023 Warrants,
the “Existing Warrants”) to purchase up to an aggregate of 6,504,731 shares of the Company’s common stock. Pursuant
to the Inducement Letters, the Holders agreed to exercise for cash i) 2023 Warrants to purchase 1,901,700 shares of common stock with
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
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
placement new common stock purchase warrants to purchase an aggregate of 3,252,366 shares (the “September 2025 Warrants”).
The September 2025 Warrants have an exercise price of 0.84 per share, were exercisable upon issuance and expire on the five-year anniversary
of the date of issuance.
As of September 30, 2025, the Company had
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. As a result, as of September 30, 2025, 644,248 shares
of common stock (the “Issuable Shares”) and 322,124 September 2025 Warrants were pending issuance. The fair value of the unissued Issuable Shares has been presented separately as issuable shares on the condensed consolidated balance
sheets and statements of stockholders’ equity as of September 30, 2025. The Company accounted
for the issuance of the: i) shares of its common stock and ii) the September 2025 Warrants as a single equity transaction for gross
proceeds of approximately $ 4.4 million, which proceeds had been received in full as of September 30, 2025.
In
relation to the above warrant inducement offering, the Company engaged Newbridge Securities Corporation as the servicing agent and paid
a fee of $ 400,000 and expense reimbursement of $ 50,000 .
Equity-Classified
Warrants
The
following table sets forth changes in the number of common stock purchase warrants outstanding during fiscal 2026 (share amounts in thousands):
Number of Exercise
Shares Price ($) Expiration
Balance as of March 31, 2025 18,561
Warrants exercised ( 531 ) 0.01 —
Balance as of June 30, 2025 18,030
Warrants issued 2,930 0.84 September 2030
Warrants exercised ( 1,726 ) 0.68 May 2028
Warrants exercised ( 4,134 ) 0.68 March 2029
Balance as of September 30, 2025 15,100
As
of September 30, 2025, the Company had the following warrants outstanding (share amounts in thousands):
Number of Exercise
Type Shares Price ($) Expiration
Common stock 2,930 0.84 September 2030
Common stock 2,374 1.12 March 2029
Common stock 1,839 1.22 May 2028
Common stock 484 1.32 May 2027
Common stock 875 1.40 March 2029
Common stock 381 1.875 November 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 15,100
10
Share
Issuances to Service Providers
During the six months ended September 30, 2025
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,
to service providers.
NOTE
5 – STOCK-BASED COMPENSATION
Amended
and Restated 2017 Equity Incentive Plan
In
October 2017, the Company’s board of directors (the “Board”) approved the 2017 Equity Incentive Plan (the “Plan”)
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 under the Plan by 333,334 and 1,333,334 shares, respectively. In January 2023, February 2024 and February
2025, the Company’s stockholders 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, 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 (“RSUs”). 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 September 30, 2025, the unamortized compensation
cost related to stock options was approximately $ 1,526,736 and is expected to be recognized as expense over a weighted-average period
of approximately 1.12 years.
In
April 2025, under its Two-Part FDA Submission and Product Milestone Bonus Program, the Company granted stock options for 1,941,000 shares,
which are subject to vesting based upon achievement of certain performance milestones by the Company and continued service by the optionee.
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
the probability of achievement of the applicable performance requirements, 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 manufacturing line validated for the Pivot pump product with
capacity to serve 6,000 patents by March 15, 2026.
The
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
and 2024, respectively, and $ 0.56 and $ 1.51 for the three months ended September 30, 2025 and 2024, respectively. The following assumptions
were used in the fair-value method calculations:
Three Months Ended
September 30,
Six Months Ended
September 30,
2025
2024
2025
2024
Risk-free interest rates
3.7 % - 4.1 %
3.4 % - 4.1 %
3.7 % - 4.1 %
3.5 % - 4.4 %
Volatility
102 % - 106 %
114 % - 117 %
102 % - 107 %
114 % - 123 %
Expected life (years)
5.0 – 5.7
5.0 – 5.7
5.0 – 5.7
5.0 – 5.7
Expected dividend %
—
—
—
—
The
fair values of options at the grant date were estimated utilizing the Black-Scholes valuation model, which includes simplified methods
to establish the fair term 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 six months ended September 30, 2025:
Options Outstanding
Weighted
Shares
Average
Available
Number of
Exercise
for Grant
Shares
Prices
Balance at March 31, 2025
5,397,872
4,917,090
$ 3.17
Share awards
( 6,375 )
—
0.68
Options granted
( 2,291,172 )
2,291,172
0.93
Options cancelled and returned to the Plan
8,056
( 8,056 )
1.52
Balance at June 30, 2025
3,108,381
7,200,206
$ 2.46
Share awards
( 6,375 )
—
0.70
Options granted
( 139,375 )
139,375
0.71
Options cancelled and returned to the Plan
110,555
( 110,555 )
1.13
Balance at September 30, 2025
3,073,186
7,229,026
$ 2.44
11
There
were no stock options exercised during the six months ended September 30, 2025. A stock option was exercised on a cashless basis for
7,530 shares of common stock during the six months ended September 30, 2024. During the six months ended September 30, 2025 and 2024,
the Company awarded 12,750 and 7,750 shares, respectively, and for the three months ended September 30, 2025 and 2024, the Company awarded
6,375 and 3,875 shares, respectively, to its non-employee directors under the Company’s outside director compensation plan. For
the six months ended September 30, 2025 and 2024, the Company recorded stock-based compensation expense for these share awards of approximately
$ 9,000 and $ 15,000 , respectively, and for the three months ended September 30, 2025 and 2024, the Company recorded stock-based compensation
expense for these share awards of approximately $ 4,000 and $ 9,000 , 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, 2025
104,168
$ 0.91
Vested
( 20,833 )
$ 0.91
Non-vested shares at June 30, 2025
83,335
$ 0.91
Vested
( 20,834 )
$ 0.91
Non-vested shares at September 30, 2025
62,501
$ 0.91
The
total intrinsic value of RSUs outstanding as of September 30, 2025 was approximately $ 44,000 . The unamortized compensation cost at September
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.
The
following table summarizes the range of outstanding and exercisable options as of September 30, 2025:
Options Outstanding Options Exercisable
Weighted
Average
Remaining Weighted Weighted
Contractual Average Average Aggregate
Number Life Exercise Number Exercise Intrinsic
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
$3.95 - $7.51 933,145 5.69 $ 5.30 933,145 $ 5.30 —
$8.61 - $17.70 499,129 5.73 $ 10.56 499,129 $ 10.56 —
$0.68 - $17.70 7,229,026 7.88 $ 2.44 4,145,183 $ 3.47 $ 795
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
2018 to fiscal 2025 may be subject to examination by the U.S. federal and state tax authorities. As of September 30, 2025, 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 six months ended September 30, 2025 and 2024 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 September 30, 2025, the Company
had outstanding purchase orders for machinery and equipment and related expenditures of approximately $ 1,719,000 .
NOTE
8 – BUSINESS SEGMENT AND CONCENTRATIONS
Segment
Information
The
Company determines its reporting units in accordance with ASC No. 280, Segment Reporting (“ASC 280”), as amended by
ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which the Company adopted effective
March 31, 2025. Management evaluates a reporting unit by first identifying its operating segments under ASC 280. The Company then evaluates
each operating segment to determine if it includes one or more components that constitute a business. If there are components within
an operating segment that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated
into one or more reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the
Company determines if the segments are economically similar and, if so, the operating segments are aggregated.
The
Company’s chief executive officer is the chief operating decision maker (the “CODM”), and the CODM evaluates financial
performance and makes operating decisions about allocating resources based on financial data presented on a consolidated basis, including
consolidated net income (loss). Because the CODM evaluates financial performance on a consolidated basis, the Company operates and manages
its business as one reportable and operating segment as a medical device company focused on the design, development and eventual commercialization
of innovative insulin pumps using modernized technology. The measure of segment assets is reported on the balance sheet as total consolidated
assets. The Company’s reporting segment meets the definition of an operating segment and does not include the aggregation of multiple
operating segments.
13
Significant
segment expenses include research and development expenditures, salaries and benefits, and stock-based compensation. Operating expenses
include all remaining costs necessary to operate the Company’s business, which primarily include facilities, external professional
services and other administrative expenses. The following table presents the significant segment expenses and other segment items regularly
reviewed by the CODM:
September 30,
2025
2024
(in thousands)
Research and development
$ 3,134
$ 1,912
Compensation
6,202
3,497
Stock-based compensation
1,537
1,587
Other operating expenses
3,760
2,220
Other income
( 141 )
( 123 )
Net loss
$ 14,492
$ 9,093
Concentrations
Financial
instruments that potentially subject the Company to concentration of credit risk consist primarily of cash held in demand deposit accounts.
The Company maintains its cash 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.
The
following table lists significant vendors that represented more than 10% of the Company’s total accounts payable balance at each
respective balance sheet date:
September 30,
March 31,
2025
2025
Vendor A
30 %
13 %
Vendor B
12 %
*
Vendor C
*
12 %
Vendor D
*
10 %
* Represents
less than 10%
NOTE
9 – 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 September
30, 2025 and 2024, the Company paid the family member approximately $ 33,760 and $ 43,365 , 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 six months
ended September 30, 2025 and 2024, the Company paid the family member approximately $ 86,460 and $ 100,625 , 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.
A second family member of one of the Company’s
executive officers consulted with and became an employee of the Company during 2025. During the three months ended September 30, 2025,
the Company paid the family member approximately $ 16,000 , 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 six months ended September 30, 2025, the Company paid
the family member approximately $ 34,600 , which includes the aggregate grant date fair values, as determined pursuant to FASB ASC Topic
718, of any stock options granted during each period.
NOTE 10 – SUBSEQUENT EVENTS
Subsequent to September 30, 2025, under the ATM
Agreement, the Company sold 1,793,064 shares of common stock for net proceeds of approximately $ 1.1 million.
14
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.