UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the quarterly period ended December 31, 2023
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from
to
Commission
file number: 000-49671
MODULAR
MEDICAL, INC.
(Exact
Name of Registrant as Specified in its Charter)
Nevada 87-0620495
(State or Other Jurisdiction of
Incorporation or Organization) (I.R.S. Employer
Identification No.)
10740
Thornmint Road , San Diego , CA 92127
(Address
of Principal Executive Offices) (Zip Code)
(858)
800-3500
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class Trading symbol(s) Name of each exchange on
which registered
Common Stock Par Value $.001 per Share MODD The Nasdaq Stock Market, LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
☒
Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
☐
Yes ☒ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated Filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
☐
Yes ☒ No
The
number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 21,899,058 as of February 9, 2024.
MODULAR
MEDICAL, INC.
FORM
10-Q
DECEMBER
31, 2023
TABLE OF CONTENTS
PART I — FINANCIAL INFORMATION
1
Item 1.
Financial
Statements (Unaudited):
1
Condensed
Consolidated Balance Sheets as of December 31, 2023 and March 31, 2023
1
Condensed
Consolidated Statements of Operations for the three and nine months ended December 31, 2023 and 2022
2
Condensed
Consolidated Statements of Stockholders’ Equity for the three and nine months ended December 31, 2023 and 2022
3
Condensed
Consolidated Statements of Cash Flows for the nine months December 31, 2023 and 2022
4
Notes
to Condensed Consolidated Financial Statements
5
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
14
Item 4.
Controls
and Procedures
17
PART II — OTHER
INFORMATION
18
Item 1.
Legal
Proceedings
18
Item 1A.
Risk
Factors
18
Item 2.
Unregistered
Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
18
Item 3.
Defaults
Upon Senior Securities
18
Item 4.
Mine
Safety Disclosures
18
Item 5.
Other
Information
18
Item 6.
Exhibits
19
Signatures
20
i
Part
I – FINANCIAL INFORMATION
Item
1. Financial Statements
Modular
Medical, Inc.
Condensed
Consolidated Balance Sheets
(In thousands, except par value)
December 31,
2023
(Unaudited)
March
31,
2023
ASSETS
CURRENT
ASSETS
Cash
and cash equivalents
$ 2,047
$ 3,799
Prepaid
expenses and other
295
147
Security
deposit
—
100
TOTAL
CURRENT ASSETS
2,342
4,046
Property
and equipment, net
2,634
1,721
Right
of use asset, net
1,223
1,478
TOTAL
NON-CURRENT ASSETS
3,857
3,199
TOTAL
ASSETS
$ 6,199
$ 7,245
LIABILITIES
AND STOCKHOLDERS’ EQUITY
CURRENT
LIABILITIES
Accounts
payable
$ 704
$ 285
Accrued
expenses
373
339
Short-term
lease liabilities
362
355
TOTAL
CURRENT LIABILITIES
1,439
979
LONG-TERM
LIABILITIES
Long-term
lease liabilities
915
1,190
TOTAL
LIABILITIES
2,354
2,169
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, 50,000 shares authorized; 21,299 and 10,949 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively
21
11
Additional
paid-in capital
65,472
53,524
Accumulated
deficit
( 61,648 )
( 48,459 )
TOTAL
STOCKHOLDERS’ EQUITY
3,845
5,076
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 6,199
$ 7,245
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
Nine Months Ended
December 31,
December 31,
2023
2022
2023
2022
Operating expenses
Research and development
$
3,619
$
2,197
$
9,204
$
6,804
General and administrative
1,650
1,161
4,006
3,502
Total operating expenses
5,269
3,358
13,210
10,306
Loss from operations
( 5,269
)
( 3,358
)
( 13,210
)
( 10,306
)
Other income
—
—
23
—
Loss before income taxes
( 5,269
)
( 3,358
)
( 13,187
)
( 10,306
)
Provision for income taxes
—
—
2
2
Net loss
$
( 5,269
)
$
( 3,358
)
$
( 13,189
)
$
( 10,308
)
Net loss per share
Basic and diluted
$
( 0.23
)
$
( 0.27
)
$
( 0.64
)
$
( 0.86
)
Shares used in computing net loss per share
Basic and diluted
22,540
12,274
20,708
12,045
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, 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
Issuance
of common stock 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
Issuance
of common stock 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
Common Stock
Additional
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of March 31, 2022
10,462
$ 11
$ 43,406
$ ( 34,580 )
$ 8,837
Shares issued for services
—
—
1
—
1
Issuance of common stock and warrants in equity offering, net
449
—
7,372
—
7,372
Issuance of common stock under equity incentive plan
3
—
14
—
14
Stock-based compensation
—
—
725
—
725
Net loss
—
—
—
( 3,499 )
( 3,499 )
Balance as of June 30, 2022
10,914
$ 11
$ 51,518
$ ( 38,079 )
$ 13,450
Issuance of common stock under equity incentive plan
11
—
51
—
51
Stock-based compensation
—
—
692
—
692
Net loss
—
—
—
( 3,450 )
( 3,450 )
Balance as of September 30, 2022
10,925
11
52,261
( 41,529 )
10,743
Issuance of common stock under equity incentive plan
7
—
13
—
13
Stock-based compensation
—
—
626
—
626
Net loss
—
—
—
( 3,358 )
( 3,358 )
Balance as of December 31, 2022
10,932
$ 11
$ 52,900
$ ( 44,887 )
$ 8,024
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,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 13,189 )
$ ( 10,308 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
2,043
2,121
Loss on asset disposal
21
—
Depreciation and amortization
283
93
Shares for services
16
150
Changes in assets and liabilities:
Other assets and prepaid expenses
( 63 )
( 15 )
Lease right-of-use asset
255
69
Accounts payable and accrued expenses
453
( 187 )
Lease liabilities
( 268 )
( 107 )
Net cash used in operating activities
( 10,449 )
( 8,184 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment
( 1,217 )
( 573 )
Net cash used in investing activities
( 1,217 )
( 573 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common stock and warrants, net
9,733
7,372
Exercise of common stock warrants
181
—
Net cash provided by financing activities
9,914
7,372
Net decrease in cash and cash equivalents
( 1,752 )
( 1,385 )
Cash and cash equivalents at beginning of period
3,799
9,076
Cash and cash equivalents at end of period
$ 2,047
$ 7,691
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 from
2002 until approximately 2017 when it acquired all of the issued and outstanding shares of Quasuras, Inc., a Delaware corporation (Quasuras).
As the major shareholder of Quasuras retained control of both the Company and Quasuras, the share exchange was accounted for as a reverse
merger. As such, the Company recognized the assets and liabilities of Quasuras, acquired in the merger, at their historical carrying amounts.
Prior to the acquisition of Quasuras and, since at least 2002, the Company was a shell company, as defined in Rule 12b-2 promulgated under
the Securities Exchange Act of 1934 (the Exchange Act). In June 2017, the Company changed its name from Bear Lake Recreation, Inc. to
Modular Medical, Inc.
The Company is a development stage
medical device company focused on the design, development and eventual commercialization of an innovative insulin pump using modernized
technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump, our MODD1 product,
or MODD1, the Company seeks to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care
that presently available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement,
training and day-to- day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users”
and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms
of device adoption, type 2 diabetes markets.
In February 2022, the Company completed
a public offering of its equity securities, and its common stock was approved to list on the Nasdaq Capital Market under the symbol “MODD”
and began trading there on February 10, 2022.
Liquidity and Going Concern
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 subsequent commercialization of its product. The Company expects that its research and development and general and administrative
expenses will continue to increase, and, as a result, it will eventually need to generate significant revenue to achieve profitability.
The Company’s expected operating losses and cash burn 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. These 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. As discussed in Note 4, in May 2023, the Company completed an offering of its common stock and warrants.
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 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 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 2024 refers to the fiscal year ending March 31,
2024). 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, 2023 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, 2023 are not necessarily indicative of the results that may be expected for
the year ending March 31, 2024 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.
General and Administrative
General and administrative expenses
consist primarily of payroll and benefit costs, rent, stock-based compensation, legal and accounting fees, and office and other administrative
expenses.
Concentration of Credit Risk
Financial instruments that potentially
subject the Company to concentration of credit risk consist primarily of cash. The Company maintains its cash at a high-credit quality
financial institution within the United States, which is insured by the Federal Deposit Insurance Corporation (FDIC) 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.
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.
Economic Disruptions
The global outbreak of the coronavirus
disease 2019 (COVID-19) was declared a pandemic by the World Health Organization and a national emergency by the U.S. government in March
2020. This negatively affected the U.S. and global economy, disrupted global supply chains, significantly restricted travel, and transportation,
resulted in mandated closures and orders to “shelter-in- place” and created significant disruption of the financial markets.
While the U.S. national emergency expired in May 2023 and substantially all closures and “shelter-in-place” orders have ended,
there can be no assurance that the COVID-19 pandemic will not impact the Company’s operational and financial performance in the
future, as the duration and spread of the pandemic and related actions taken by U.S. and foreign government agencies to prevent disease
spread are uncertain, out of our control, and cannot be predicted.
6
Wars and acts of terrorism have led to further
economic disruptions. Mounting inflationary cost pressures and recessionary fears have negatively impacted the global economy. Since mid-2022,
the U.S. Federal Reserve has addressed elevated inflation by increasing interest rates, as inflation remains elevated. While the Company
was recently able to access the capital markets, in the future, 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 on hand and cash in demand deposits, 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 capital 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) 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.
Stock-Based Compensation
The Company issues stock awards, stock options and restricted stock
units to employees and non-employees. The Company accounts for such awards based on FASB ASC 505 and ASC 718, whereby the value of the
award is measured on the date of award. The Company recognizes stock-based compensation for equity awards on a straight-line basis over
the requisite service period, usually the vesting period, after assessing the probability of achieving the requisite performance criteria
with respect to performance-based awards. 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.
7
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. 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.
Prior to April 1, 2023, the Company excluded
pre-funded warrants from the computation of WASO. The pre-funded warrants are now included in the computation of WASO. Prior period amounts
have been conformed to the current-period presentation. The impact of the change reduced the previously reported loss per share by $ 0.04
and $ 0.09 , respectively, and increased WASO by approximately 1,348,000 and 1,182,000 shares, respectively, for the three and nine months
ended December 31, 2022. The reclassification had no impact on the Company’s net loss or cash flows for the three or nine months
ended December 31, 2022.
For the nine months ended December 31,
2023 and 2022, 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,
2023
2022
Options to purchase common stock
3,720
2,174
Unvested restricted stock units
208
—
Common stock purchase warrants
11,892
6,217
Total
15,820
8,391
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, 2023 and 2022, the Company’s comprehensive
loss was the same as its net loss.
Recently Adopted Accounting Pronouncement
In June 2016, the FASB issued Accounting
Standards Update (ASU) No. 2016-13, Financial Instruments— Credit Losses . This ASU added a new impairment model (known as
the current expected credit loss (CECL) model) that is based on expected losses rather than incurred losses. Under the new guidance, an
entity recognizes an allowance for its estimate of expected credit losses and applies to most debt instruments, trade receivables, lease
receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition
of impairment losses and entities will need to measure expected credit losses on assets that have a low risk of loss. This update is effective
for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years for smaller reporting companies.
The Company adopted ASU No. 2016-13 effective April 1, 2023, and the adoption had no impact on the Company’s results of operations
and financial position.
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. The Company is currently evaluating the impact that this ASU will have 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 is currently 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,
2023
March 31,
2023
Property and equipment, net
(in thousands)
Machinery and equipment
$ 2,509
$ 820
Computer equipment and software
66
66
Construction-in-process
499
1,003
Leasehold improvements
33
25
Office equipment
63
63
3,170
1,977
Less: accumulated depreciation and amortization
( 536 )
( 256 )
Total property and equipment, net
$ 2,634
$ 1,721
December 31,
2023
March 31,
2023
Accrued expenses
(in thousands)
Accrued wages and employee benefits
$ 304
$ 267
Other
69
72
$ 373
$ 339
NOTE 3 – LEASES
W. Bernardo Drive, San Diego, CA
The 39 -month lease term expired on June
30, 2023, and, upon expiration, the Company had a $ 100,000 security deposit receivable from the landlord, which was refunded to the Company
during the nine months ended December 31, 2023.
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 other certain 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, 2023, are listed in the table below (in thousands).
Annual Fiscal Years
Operating
Lease
2024
$ 111
2025
452
2026
470
2027
405
Total future lease payments
$ 1,438
Less: Imputed interest
( 161 )
Present value of lease liability
$ 1,277
Cash paid for amounts included in the measurement of lease
liabilities was approximately $ 365,000 and $ 119,000 for the nine months ended December 31, 2023 and 2022, respectively. Rent expense was
approximately $ 337,000 and $ 81,000 for the nine months ended December 31, 2023 and 2022, respectively and $ 112,000 and $ 27,000 for the
three months ended December 31, 2023 and 2022, respectively.
NOTE 4 – STOCKHOLDERS’ EQUITY
ATM Agreement
On November 22, 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.
As of December 31, 2023, no shares had been sold under the ATM Agreement.
9
May 2023 Public Offering
On May 15, 2023, the Company entered into an underwriting
agreement (the Underwriting Agreement) with Newbridge Securities Corporation (the Underwriter), with respect to the issuance and sale
in a firm commitment underwritten offering (the 2023 Offering) by the Company of units of its securities for aggregate gross proceeds
of approximately $ 9,390,000 , before deducting underwriting discounts and commissions and other offering expenses. The Company sold 8,816,900
shares of its common stock and warrants to purchase 4,408,450 shares of its common stock. The securities were sold as a unit, with each
unit consisting of two shares of common stock of the Company and one warrant (the 2023 Warrants) to purchase one share of common stock,
at a public offering price of $ 2.13 per unit. The 2023 Warrants were immediately separable and exercisable, had a per share exercise price
of $ 1.22 and expire five years from the date of issuance. The 2023 Offering closed on May 18, 2023.
Pursuant to the Underwriting Agreement, the
Company granted the Underwriter a 30-day option to purchase up to an additional 1,322,534 shares of common stock and an additional
661,267 of the 2023 Warrants to cover over-allotments, if any. On May 25, 2023, the Underwriter exercised in full this option and
purchased the additional securities for aggregate gross proceeds to the Company of approximately $ 1,408,000 , before deducting
underwriting discounts and commissions and other offering expenses.
The Underwriter was paid a cash fee of 7.0 % of
the aggregate gross proceeds of the 2023 Offering (including the over-allotment option) and reimbursed certain out-of-pocket expenses
of approximately $ 125,000 . In addition, pursuant to the Underwriting Agreement, the Company initially issued to the Underwriter
common stock purchase warrants (the UW Warrants) for a total of 709,760 shares. Subsequently, the UW Warrants were reissued to the Underwriter
and its agents for a total of 604,623 shares. The UW warrants are exercisable six months from the respective issuance dates and have
a four- year term and a per share exercise price of $ 1.32 .
The Underwriting Agreement contains customary
representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company
and the Underwriter, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination
provisions.
Warrants
As of December 31, 2023, the Company had the following warrants
outstanding (share amounts in thousands):
Type
Number of
Shares
Exercise
Price
Expiration
Balance as of March 31, 2023
7,565
Issuance of common stock warrants
605
$ 1.32
May 2027
Issuance of common stock warrants
5,070
$ 1.22
May 2028
Balance as of June 30, 2023
13,240
Activity
—
Balance as of September 30, 2023
13,240
Warrants exercised
( 148 )
$ 1.22
May 2028
Balance as of December 31, 2023
13,092
As of March 31, 2023, 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
768
$ 6.00
January 2027 – February 2027
Common stock
4,011
$ 6.60
February 2027
Common stock
1,438
$ 6.60
November 2027
Total
7,565
Other
During the nine months ended December 31, 2023 and 2022, the Company
issued 1,429 and 348 shares of common stock with fair values of approximately $ 1,400 and $ 1,000 , respectively, to a service provider.
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 an increase in the number of shares reserved for issuance by 333,334
and 1,333,334 shares, respectively. In January 2023, the Company’s stockholders approved an increase in the number of shares reserved
for issuance under the plan by an additional 2,000,000 shares. 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
As of December 31, 2023, the unamortized compensation cost was approximately
$ 2,512,000 related to stock options and is expected to be recognized as expense over a weighted-average period of approximately 1.4 years.
During the three months ended December
31, 2023, under its Two-Part FDA Submission and Clearance Milestone Bonus Program, the Company granted stock options for 909,533 shares,
which are subject to vesting upon the achievement of certain performance milestones by the Company. As of December 31, 2023, the Company
had not commenced expense recognition of 251,567 of these option shares based on its assessment of the probability of achievement of the
applicable performance requirements.
During the three months ended December
31, 2023, the Company issued 6,375 shares to members of the Board in accordance with its outside director compensation plan and recorded
approximately $ 11,000 of stock-based compensation expense for these share awards.
The weighted-average grant date fair value of options granted was $ 0.98
and $ 3.58 per share for the nine months ended December 31, 2023 and 2022, respectively, and $ 0.97 and $ 1.86 for the three months ended
December 31, 2023 and 2022, respectively. The following assumptions were used in the fair-value method calculations:
Three Months Ended
December 31,
Nine Months Ended
December 31,
2023
2022
2023
2022
Risk-free interest rates
3.8 % - 4.7 %
3.93 % - 3.99 %
3.5 % - 4.7 %
2.82 % - 4.06 %
Volatility
123.4 % - 127.6 %
149 %
82.5 % - 152.2 %
149 % - 223 %
Expected life (years)
5.0 – 5.4
5.0 – 5.7
5.0 – 6.2
5.0 – 5.7
The fair value of options at the grant
date was 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 nine months ended December 31, 2023:
Options Outstanding
Shares
Number
Weighted
Available
of
Average
for Grant
Shares
Exercise Prices
Balance at March 31, 2023
2,132,292
2,481,090
$ 5.19
Options granted
( 373,375 )
373,375
1.27
Share awards
( 6,375 )
—
—
Options cancelled and returned to the Plan
30,272
( 30,272 )
4.29
Balance at June 30, 2023
1,782,814
2,824,193
4.68
Options granted
( 101,875 )
101,875
1.16
Share awards
( 6,265 )
—
—
RSUs granted
( 250,000 )
—
—
Options cancelled and returned to the Plan
13,404
( 13,404 )
9.05
Balance at September 30, 2023
1,438,078
2,912,664
4.54
Options granted
( 941,408 )
941,408
1.11
Share awards
( 6,375 )
—
—
Options cancelled and returned to the Plan
155,679
( 155,679 )
3.77
Balance at December 31, 2023
645,974
3,698,393
$ 3.70
11
No stock options were exercised during
the nine months ended December 31, 2023 and 2022.
A summary of RSU activity under the Plan is presented
below.
Number
Weighted
Average
Grant-
of
Shares
Date
Fair Value
Balance at June 30, 2023
—
$ —
Granted
250,000
$ 0.91
Vested
( 20,834 )
$ 0.91
Non-vested shares at September 30, 2023
229,166
$ 0.91
Vested
( 20,834 )
$ 0.91
Non-vested shares at December 31, 2023
208,332
$ 0.91
The total intrinsic value of the RSUs
outstanding as of December 31, 2023 was approximately $ 379,000 . The unamortized compensation cost at December 31, 2023 was approximately
$ 190,000 related to RSUs and is expected to be recognized as expense over a period of approximately 2.50 years.
The following table summarizes the range of outstanding and
exercisable options as of December 31, 2023:
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 - $2.00
2,246,118
8.55
$ 1.48
653,549
$ 1.83
$ 62,794
$3.95 - $7.51
943,145
7.45
$ 5.29
734,459
$ 5.59
—
$8.61 - $17.70
509,130
7.48
$ 10.53
448,562
$ 10.35
—
$0.93 - $17.70
3,698,393
8.12
$ 3.70
1,836,570
$ 5.47
$ 62,794
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
2023 may be subject to examination by the U.S. federal and state tax authorities. As of December 31, 2023, 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 nine months ended December 31, 2023 and 2022 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, 2023, the Company had outstanding purchase orders for machinery and
equipment and related expenditures of approximately $ 592,000 . In December 2023, the Company signed a device integration agreement with
a provider of connected-care and remote monitoring diabetes technology solutions for an obligation of approximately $ 575,000 over three
years for technology integration and license fees.
NOTE 8 – SUBSEQUENT EVENTS
In January 2024, under the ATM Agreement,
the Company sold 153,879 shares of common stock for net proceeds of approximately $ 278,000 .
In January 2024, the Company received
proceeds of approximately $ 550,000 from the exercise of warrants to purchase 445,744 shares of common stock.
On February 13, 2024, the Company’s stockholders approved increases in: i) the number of shares reserved for issuance under the
Plan by 3,000,000 shares and ii) the authorized shares of common stock to 100,000,000 .
13
Item 2. Management’s Discussion
and Analysis of Financial Condition and Results of Operations
This Management’s Discussion
and Analysis of Financial Condition and Results of Operations should be read in conjunction with the accompanying condensed consolidated
financial statements and notes included in this Quarterly Report on Form 10-Q (this Report). This Report contains forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which
include, without limitation, statements about the market for our technology, our strategy, competition, expected financial performance
and capital raising efforts, and other aspects of our business identified in our most recent annual report on Form 10-K filed
with the Securities and Exchange Commission on June 26, 2023 and in other reports that we file from time to time with the Securities
and Exchange Commission. Any statements about our business, financial results, financial condition and operations contained
in this Report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing,
the words “believes,” “anticipates,” “expects,” “intends,” “plans,” “projects,”
or similar expressions are intended to identify forward-looking statements. Our actual results could differ materially from those
expressed or implied by these forward-looking statements as a result of various factors, including the risk factors described under Item
1A of our Annual Report on Form 10-K for the year ended March 31, 2023. These forward-looking statements represent our intentions, plans,
expectations, assumptions, and beliefs about future events and are subject to risks, uncertainties and other factors including, without
limitation, the direct and indirect effects of coronavirus disease 2019, or COVID-19, as well as inflationary risks, including
the risk that the cost of certain of the Company’s components is increasing, and related issues that may arise therefrom. Many of
those factors are outside of our control and could cause actual results to differ materially from those expressed or implied by those
forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements
might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to
place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral
forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf
are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report. We undertake no obligation
to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions,
circumstances, or assumptions underlying such statements, or otherwise.
Our fiscal year ends on March 31
of each calendar year. Each reference to a fiscal year in this Report, refers to the fiscal year ended March 31 of the calendar
year indicated (for example, fiscal 2024 refers to the fiscal year ending March 31, 2024). Unless the context requires otherwise,
references to “we,” “us,” “our,” and the “Company” refer to Modular Medical, Inc. and
its consolidated subsidiary.
Company Overview
We are a development-stage medical device
company focused on the design, development and commercialization of an innovative insulin pump using modernized technology to increase
pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump, our MODD1 product, we seek to fundamentally
alter the trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps
provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use,
we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category
into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type
2 diabetes markets. In January 2024, we made the premarket submission of our MODD1 next-generation insulin pump to the U.S. Food and Drug
Administration (the FDA) for 510(k) clearance. We expect the FDA to provide initial feedback on our submission during the quarter ending
June 30, 2024.
Historically, we have financed
our operations principally through private placements and public offerings of our common stock and sales of convertible promissory
notes. Based on our current operating plan, substantial doubt about our ability to continue as a going concern for a period of at least
one year from the date that the financial statements included in this Report are issued exists. Our ability to continue as a going
concern depends on our ability to raise additional capital, likely through the sale of equity or debt securities, to support our future
operations. If we are unable to secure additional capital, we will be required to curtail our research and development initiatives and
take additional measures to reduce costs. We have provided additional disclosure in Note 1 to the consolidated financial statements
in Item 1 of this Report and under Liquidity below.
14
Economic Disruptions
The global outbreak of the coronavirus
disease 2019 (COVID-19) was declared a pandemic by the World Health Organization and a national emergency by the U.S. government in March
2020. This negatively affected the U.S. and global economy, disrupted global supply chains, significantly restricted travel
and transportation, resulted in mandated closures and orders to “shelter-in- place” and created significant disruption
of the financial markets. While the U.S. national emergency expired in May 2023 and substantially all closures and “shelter-in-place”
orders have ended, there can be no assurance that the COVID-19 pandemic will not impact our operational and financial performance
in the future, as the duration and spread of the pandemic and related actions taken by U.S. and foreign government agencies to prevent
disease spread are uncertain, out of our control, and cannot be predicted.
Wars and acts of terrorism have led
to further economic disruptions. Mounting inflationary cost pressures and recessionary fears have negatively impacted the global
economy. Since mid-2022, the U.S. Federal Reserve has addressed elevated inflation by increasing interest rates, as inflation
remains elevated. While we were able to access the capital markets in May 2023 and 2022, in the future, we may be unable to access the
capital markets, and additional capital may only be available to us on terms that could be significantly detrimental to our existing
stockholders and to our business.
For additional information on risks
that could impact our future results, please refer to “Risk Factors” in Part I, Item 1A of this Report.
Critical Accounting Policies and
Estimates
The discussion and analysis of our financial
condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance
with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make certain estimates and judgments
that affect the reported amounts of assets, liabilities, and expenses. On an ongoing basis, we make these estimates based on our
historical experience and on assumptions that we consider reasonable under the circumstances. Actual results may differ from these
estimates and reported results could differ under different assumptions or conditions. Our significant accounting policies
and estimates are disclosed in Note 1 of the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year
ended March 31, 2023. As of December 31, 2023, there have been no material changes to our significant accounting policies and estimates.
Results of Operations
Research and Development
December 31,
Change
(dollar amounts in thousands)
2023
2022
2022 to 2023
Research and development – Three months ended
$
3,619
$
2,197
$
1,422
64.7
%
Research and development – Nine months ended
$
9,204
$
6,804
2,400
35.3
%
Our research and development expenses
include personnel and related costs, materials and other costs associated with the development and initial production of our insulin pump
products. We expense research and development costs as they are incurred.
Research and development, or R&D, expenses increased for the three
months ended December 31, 2023 compared with the same period of 2022, primarily due to increases in employee-related costs of approximately
$348,000, stock-based compensation of approximately $324,000 and consulting costs of approximately $766,000. The increase in consulting
costs was primarily attributable to pre-submission testing and related activities performed during the third quarter of fiscal 2024 in
preparation for our 510(k) submission to the FDA, which was completed in January 2024.
R&D expenses increased for the nine months ended December 31, 2023
compared with the same period of 2022, primarily due to increases in employee-related costs of approximately $1,134,000, consulting costs
of $580,000, stock-based compensation expense of $385,000 and materials costs of approximately $300,000. The increase in material costs
was primarily attributable to pre-submission activities, as we began producing units of our MODD1 pump product during fiscal 2024 in anticipation
of our 510(k) submission to the FDA. The increase in consulting costs was primarily attributable to third-party testing costs incurred
in fiscal 2024 in anticipation of our 510(k) submission to the FDA, which was completed in January 2024.
Our R&D employee headcount increased to 36 at December 31, 2023
from 32 at December 31, 2022. R&D expenses included stock-based compensation expenses of approximately $681,000 and $357,000 for the
three-months ended December 31, 2023 and 2022, respectively, and $1,420,000 and $1,035,000 for the nine months ended December 31, 2023
and 2022, respectively. We expect research and development expenses to decrease for the remainder of fiscal 2024, as we made our 510(k)
submission of our MODD-1 insulin pump to the FDA in January 2024.
15
General and Administrative
December 31,
Change
(dollar amounts in thousands)
2023
2022
2022 to 2023
General and administrative – Three months ended
$ 1,650
$ 1,161
$ 489
42.1 %
General and administrative – Nine months ended
$ 4,006
$ 3,502
$ 504
14.4 %
General and administrative expenses
consist primarily of costs for personnel, finance, human resources, marketing, and general management.
General and administrative, or G&A, expenses
increased for the three months ended December 31, 2023 compared with the same period of the prior year, primarily as a result of increases
in legal and other professional services fees of $143,000, rent and other facility-related expenses of approximately $130,000, marketing-related
expenses of approximately $113,000, employee-related costs of approximately $112,000, depreciation and amortization expense of approximately
$97,000, stock-based compensation of approximately $30,000, accounting costs of approximately $22,000 and other expense increases, as
partially offset by a decrease in consulting expenses of approximately $169,000.
G&A expenses increased for the nine months
ended December 31, 2023 compared with the same period of the prior year, primarily as a result of increases in facility-related costs
of approximately $383,000, employee-related costs of approximately $272,000, depreciation expense of approximately $190,000, marketing-related
expenses of approximately $193,000, legal and other professional services fees of $147,000, and other expenses, as partially offset by
decreases in stock-based compensation expenses of approximately $464,000 and consulting services expenses of approximately $415,000.
Our G&A employee headcount increased to four
at December 31, 2023 from three at December 31, 2022. G&A expenses included stock-based compensation expenses of approximately $313,000
and $283,000 for the three months ended December 31, 2023 and 2022, respectively, and approximately $622,000 and $1,086,000 for the nine
months ended December 31, 2023 and 2022, respectively. We expect G&A expenses to decrease for the remainder of fiscal 2024.
Liquidity and Going Concern
As a development-stage enterprise, we do not currently
have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses and negative
cash flows from operations in each year due to costs incurred in connection with R&D activities and G&A expenses associated with
our operations. For the nine months ended December 31, 2023 and year ended March 31, 2023, we incurred net losses of $13.2 million and
$13.9 million, respectively. At December 31, 2023, we had a cash balance of approximately $2.0 million and an accumulated deficit of $61.4
million. When considered with our current operating plan, these conditions raise substantial doubt about our ability to continue as a
going concern for a period of at least one year from the date that the financial statements included in this Report are issued. Our financial
statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable
to continue as a going concern. Our operating needs include the planned costs to operate our business, including amounts required to fund
research and development activities, including clinical studies, working capital and capital expenditures. Our ability to continue as
a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities to support our future
operations. In May 2023, we completed a public offering of units, comprising shares of our common stock and warrants to purchase shares
of our common stock, for net proceeds of $9.7 million. On November 22, 2023, we entered into a Sales Agreement (the ATM Agreement) with
Leerink Partners LLC (Leerink) under which we may offer and sell, from time to time at our sole discretion, shares of our common stock,
for aggregate gross proceeds of up to $6,500,000 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. In January 2024, we sold 153,879 shares of common
stock for net proceeds of approximately $278,000 under the ATM Agreement. In addition, in January 2024, we received a total of approximately
$550,000 of proceeds from the exercise of warrants to purchase 445,744 shares of our common stock.
Our future capital requirements and
the adequacy of our available funds will depend on many factors, including, without limitation, our ability to successfully commercialize
our product, competing technological and market developments, and the need to enter into collaborations with other companies or acquire
other companies or technologies to enhance or complement our product o ff erings.
If we are unable to secure additional capital timely, we may be required to curtail R&D initiatives, reduce headcount and take additional
measures to reduce costs in order to conserve our cash.
16
For the nine months ended December 31, 2023, we used approximately
$10.5 million in operating activities, which primarily resulted from our net loss of approximately $13.2 million, as adjusted for net
changes in operating assets and liabilities of approximately $0.4 million and non-cash items, including stock-based compensation expenses
of approximately $2.0 million, depreciation and amortization expenses of approximately $0.3 million and other immaterial adjustments.
For the nine months ended December 31, 2022, we used approximately $8.2 million in operating activities, which primarily resulted from
our net loss of $10.3 million, as adjusted for changes to operating assets and liabilities of approximately $0.2 million and non-cash
items, including stock-based compensation expenses of approximately $2.1 million, issuances of shares of common stock in exchange for
services of approximately $0.1 million and depreciation and amortization expenses of approximately $0.1 million.
For the nine months ended December 31, 2023 and 2022, cash
used in investing activities of approximately $1.2 million and $0.6 million, respectively, was for the purchase of property and equipment.
Cash provided by financing activities
for the nine months ended December 31, 2023 was attributable to $9.7 million of net proceeds from the issuance of common stock and warrants
in a public offering, which closed in May 2023, and approximately $0.2 million of proceeds from the exercise of common stock warrants.
Cash provided by financing activities of $7.4 million for the nine months ended December 31, 2022 was attributable to net proceeds
from the issuance of common stock and warrants in a registered direct offering, which closed in May 2022.
Purchase Obligations
Our primary purchase obligations include purchase
orders for machinery and equipment and software. At December 31, 2023, we had outstanding purchase orders for machinery and equipment
and related expenditures of approximately $0.6 million. In December 2023, we signed a device integration agreement with a provider of
connected-care and remote monitoring diabetes technology solutions for an obligation of approximately $0.6 million for technology integration
and license fees over three years.
Recently Adopted and Issued
Accounting Pronouncements
Recently Adopted and Issued
Accounting Pronouncements are detailed in Note 1 in the Notes to the Condensed Consolidated Financial Statements included in Item 1
of this Report.
Item 3. Quantitative and Qualitative
Disclosures about Market Risk
As a smaller reporting company, we are
not required to provide the information required by this item.
Item 4. Controls and Procedures
Disclosure Controls and Procedures.
Our management is responsible for establishing
and maintaining adequate internal control over our financial reporting. Because of inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject
to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or
procedures may deteriorate.
Under the supervision and with the participation of our management,
including our Chief Executive Officer, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls
and procedures, as defined in Rules 13a-1I) and 15I5(e) under the Securities Exchange Act of 1934. Based on this evaluation, our management
concluded that, as of December 31, 2023, our disclosure controls and procedures were effective.
Changes in Internal Control over
Financial Reporting.
During the three months ended December
31, 2023, there was no change in our internal control over financial reporting that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
17
Part II - OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently involved in any
litigation that we believe could have a material adverse effect on our financial condition or results of operations. To our
knowledge, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory
organization or body pending or, to the knowledge of the executive officers of us or our subsidiary, threatened against or affecting
us, our common stock, our subsidiary or our subsidiary’s officers or directors in their capacities as such, in which an adverse
decision could have a material adverse effect.
Item 1A. Risk Factors
We face many significant risks
in our business, some of which are unknown to us and not presently foreseen. These risks could have a material adverse impact on our business,
financial condition and results of operations in the future. There are no material changes to the risk factors set forth under Item
1A of our Annual Report on Form 10-K for the year ended March 31, 2023, which we filed with the SEC on June 26, 2023.
Item 2. Unregistered Sales of Equity
Securities, Use of Proceeds, and Issuer Repurchases of Equity Securities
Recent Sales of Unregistered Securities
On December 29, 2023, we issued the following shares of unregistered
common stock: (i) a total of 6,375 shares to four of our non-employee directors in accordance with our Outside Director Compensation Plan
and (ii) 20,834 shares to one of our non-employee directors upon vesting of a restricted stock unit award granted under our Amended 2017
Equity Incentive Plan. The aforementioned issuances were made pursuant to exemptions from registration pursuant to Section 4(2) and/or
Rule 506 of Regulation D of the Securities Act.
Item 3. Defaults Upon Senior Securities
There has been no default in the payment
of principal, interest, or a sinking or purchase fund installment, or any other material default, with respect to any indebtedness of
ours.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
18
Item 6. Exhibits
Exhibit
Reference
Filed
or
Furnished
Number
Exhibit
Description
Form Exhibit
Filing Date
Herewith
1.1
Sales
Agreement, dated as of November 22, 2023, between Modular Medical, Inc. and Leerink Partners LLC
8-K
11/22/2023
10.1
Modular
Medical, Inc. Two-Part FDA Submission and Clearance Milestone Bonus Program
8-K
10/05/2023
31.1
Certification
of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
31.2
Certification
of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
32.1
Certification
of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002
X
101.INS
Inline
XBRL Instance Document
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
X
19
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
MODULAR MEDICAL, INC.
Date: February 13, 2024
By:
/s/
James E. Besser
James E. Besser
Chief Executive Officer
(Principal Executive Officer)
By:
/s/ Paul
DiPerna
Paul DiPerna
Chairman, President, Chief Financial
Officer and
Treasurer
(Principal Financial Officer)
20
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.