UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended:
December
31, 2021
or
o
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.)
16772 W. Bernardo Drive , San Diego , California
92127
(Address
of principal executive offices)
(Zip
Code)
(858)
800-3500
(Registrant’s
telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
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
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.
x Yes o 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).
x Yes o 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 o
Accelerated filer o
Non-accelerated Filer x
Smaller reporting company x
Emerging growth company x
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. o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
o Yes x No
The number
of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 6,390,372 as of February 10,
2022.
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
2
Condensed Consolidated Balance Sheets as of December 31, 2021 and March 31, 2021
2
Condensed Consolidated Statements of Operations for the Three and Nine Months Ended December 31, 2021 and 2020
3
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit)
4
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2021 and 2020
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
16
Item 3. Quantitative and Qualitative Disclosures about Market Risk
19
Item 4. Controls and Procedures
19
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
20
Item 1A. Risk Factors
20
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
20
Item 3. Defaults Upon Senior Securities
21
Item 4. Mine Safety Disclosures
21
Item 5. Other Information
21
Item 6. Exhibits
21
Signatures
22
Part
I – FINANCIAL INFORMATION
Item
1. Financial Statements
Modular
Medical, Inc.
Condensed Consolidated Balance Sheets
December 31,
2021
(Unaudited)
March 31,
2021
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 204,098
$ 1,468,465
Prepaid expenses
63,607
178,158
Other current assets
946
2,466
TOTAL CURRENT ASSETS
268,651
1,649,089
Property and equipment, net
241,468
298,958
Right of use asset, net
141,720
200,124
Security deposit
100,000
100,000
TOTAL NON-CURRENT ASSETS
483,188
599,082
TOTAL ASSETS
$ 751,839
$ 2,248,171
LIABILITIES AND STOCKHOLDERS’ DEFICIT
CURRENT LIABILITIES
Accounts payable
$ 671,363
$ 169,284
Accrued expenses
1,124,499
499,948
Short-term lease liability
139,817
125,500
PPP note payable
—
368,780
Promissory note payable
1,500,000
—
Convertible notes payable
5,485,583
2,133,453
TOTAL CURRENT LIABILITIES
8,921,262
3,296,965
LONG-TERM LIABILITIES
Long-term lease liability
77,212
184,355
Bonus payable
—
42,000
TOTAL LIABILITIES
8,998,474
3,523,320
Commitments and Contingencies (Note 9)
STOCKHOLDERS’ DEFICIT
Preferred Stock, $ 0.001 par value, 5,000,000 shares authorized, none issued and outstanding
—
—
Common Stock, $ 0.001 par value, 50,000,000 shares authorized; 6,373,706 and 6,302,050 shares issued and outstanding as of December 31, 2021 and March 31, 2021, respectively
6,374
6,302
Additional paid-in capital
21,602,162
14,665,559
Common stock issuable
149,994
—
Accumulated deficit
( 30,005,165 )
( 15,947,010 )
TOTAL STOCKHOLDERS’ DEFICIT
( 8,246,635 )
( 1,275,149 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
$ 751,839
$ 2,248,171
The accompanying
notes are an integral part of these condensed consolidated financial statements.
2
Modular
Medical, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
December 31,
Nine Months Ended
December 31,
2021
2020
2021
2020
Operating expenses
Research and development
$ 1,849,399
$ 1,086,669
$ 5,742,911
$ 3,150,149
General and administrative
1,981,665
783,898
5,156,152
2,453,808
Total operating expenses
3,831,064
1,870,567
10,899,063
5,603,957
Loss from operations
( 3,831,064 )
( 1,870,567 )
( 10,899,063 )
( 5,603,957 )
Other income
4
22
368,876
126
Interest expense
( 1,010,247 )
—
( 2,204,917 )
—
Loss on debt extinguishment
—
—
( 1,321,450 )
—
Loss before income taxes
( 4,841,307 )
( 1,870,545 )
( 14,056,554 )
( 5,603,831 )
Provision for income taxes
—
—
1,600
1,600
Net loss
$ ( 4,841,307 )
$ ( 1,870,545 )
$ ( 14,058,155 )
$ ( 5,605,431 )
Net loss per share
Basic and diluted
$ ( 0.76 )
$ ( 0.30 )
$ ( 2.22 )
$ ( 0.91 )
Shares used in computing net loss per share
Basic and diluted
6,354,145
6,249,038
6,331,982
6,187,526
The accompanying
notes are an integral part of these condensed consolidated financial statements.
3
Modular
Medical, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited)
Additional
Common
Common Stock
Paid-In
Stock
Accumulated
Stockholders’
Shares
Amount
Capital
Issuable
Deficit
Deficit
Balance as of March 31, 2021
6,302,050
$ 6,302
$ 14,665,559
—
$ ( 15,947,010 )
$ ( 1,275,149 )
Shares issued for services
20,000
20
172,180
—
—
172,200
Warrants issued with convertible notes
—
—
3,700,632
—
—
3,700,632
Stock-based compensation
1,836
2
655,918
—
—
655,920
Net loss
—
—
—
—
( 4,835,091 )
( 4,835,091 )
Balance as of June 30, 2021
6,323,886
$ 6,324
$ 19,194,289
$ —
$ ( 20,782,101 )
$ ( 1,581,488 )
Stock-based compensation
3,635
4
862,427
—
—
862,431
Net loss
—
—
—
—
( 4,381,757 )
( 4,381,757 )
Balance as of September 30, 2021
6,327,521
$ 6,328
$ 20,056,716
$ —
$ ( 25,163,858 )
$ ( 5,100,814 )
Private placement of common stock
30,865
31
249,969
—
—
250,000
Shares issued for services
8,334
8
73,748
—
—
73,756
Shares issuable for services
—
—
—
149,994
—
149,994
Shares issued for reverse stock split
1,211
1
—
—
—
1
Stock-based compensation
5,775
6
1,221,729
—
—
1,221,735
Net loss
—
—
—
—
( 4,841,307 )
( 4,841,307 )
Balance as of December 31, 2021
6,373,706
$ 6,374
21,602,162
149,994
( 30,005,165 )
( 8,246,635 )
Additional
Common
Stockholders’
Common Stock
Paid-In
Stock
Accumulated
Equity
Shares
Amount
Capital
Issuable
Deficit
(Deficit)
Balance as of March 31, 2020
5,956,754
$ 5,957
$ 10,517,505
$ 923,994
$ ( 8,569,034 )
$ 2,878,422
Private placement of common stock
243,299
243
2,042,385
( 923,994 )
—
1,118,634
Stock-based compensation
—
—
344,716
—
—
344,716
Net loss
—
—
—
—
( 1,874,157 )
( 1,874,157 )
Balance as of June 30, 2020
6,200,053
$ 6,200
$ 12,904,606
$ —
$ ( 10,443,191 )
$ 2,467,615
Stock-based compensation
—
—
300,604
—
—
300,604
Net loss
—
—
—
—
( 1,860,729 )
( 1,860,729 )
Balance as of September 30, 2020
6,200,053
$ 6,200
$ 13,205,210
$ —
$ ( 12,303,920 )
$ 907,490
Private placement of common stock
77,497
77
667,171
—
—
667,248
Stock-based compensation
—
—
295,054
—
—
295,054
Net loss
—
—
—
—
( 1,870,545 )
( 1,870,545 )
Balance as of December 31, 2020
6,277,550
$ 6,277
$ 14,167,435
$ —
$ ( 14,174,465 )
$ ( 753 )
The accompanying
notes are an integral part of these condensed consolidated financial statements.
4
Modular
Medical, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine Months Ended
December 31,
2021
2020
Net loss
$ ( 14,058,155 )
$ ( 5,605,431 )
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on PPP note forgiveness
( 368,780 )
—
Loss on debt extinguishment
1,321,450
—
Stock-based compensation expense
2,740,086
940,374
Depreciation and amortization
80,268
82,016
Shares issued for services
388,021
—
Shares issuable for services
149,994
—
Amortization of lease right-to-use asset
58,404
52,994
Change in lease liability
( 92,826 )
67,092
Amortization of debt discount
1,454,762
—
Changes in assets and liabilities:
Prepaid expenses and other assets
( 25,995 )
15,964
Accounts payable and accrued expenses
1,223,983
( 123,722 )
Net cash used in operating activities
( 7,128,787 )
( 4,570,713 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment
( 22,779 )
( 109,541 )
Net cash used in investing activities
( 22,779 )
( 109,541 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from private placement, net of issuance costs
250,000
1,785,882
Proceeds from issuance of convertible notes, net of placement fees
4,137,199
—
Proceeds from issuance of promissory note
1,500,000
—
Proceeds from issuance of PPP note payable
—
368,780
Net cash provided by financing activities
5,887,199
2,154,662
Net decrease in cash and cash equivalents
( 1,264,367 )
( 2,525,592 )
Cash and cash equivalents at beginning of period
1,468,465
3,122,134
Cash and cash equivalents at end of period
$ 204,098
$ 596,542
Supplemental disclosure:
Noncash investing and financing activities:
Fair value of detachable warrants issued with convertible notes
$ 3,700,632
$ —
The accompanying
notes are an integral part of these unaudited condensed consolidated financial statements.
5
MODULAR
MEDICAL, INC.
F/K/A BEAR LAKE RECREATION, 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 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 product, 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, 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 Company’s pump product
seeks to serve both the type 1 and type 2 diabetes markets.
Liquidity
Financial
Accounting Standards Board (FASB) Accounting Standard Update (ASU) No. 2014-15 (ASU 2014-15), Going Concern , requires management
to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s
ability to continue as a going concern within one year after the date that the financial statements are issued. If management
identifies conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern, management
must consider if there are plans that are probable to be implemented, and whether it is probable that the plans will mitigate
the conditions or events raising the substantial doubt about the entity’s ability to continue as a going concern. If the
substantial doubt is not alleviated after consideration of management’s plans, the entity must include a statement in the
notes to the financial statements indicating that there is substantial doubt about the entity’s ability to continue as a
going concern within one year after the date that the financial statements are issued including: 1) the principal conditions or
events that raise substantial doubt about the entity’s ability to continue as a going concern, 2) management’s evaluation
of the significance of those conditions or events in relation to the entity’s ability to meet its obligations, and 3) management’s
plans to attempt to mitigate the conditions or events causing the substantial doubt about the entity’s ability to continue
as a 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
product revenues to achieve profitability. The Company’s expected operating losses and cash burn and the need to repay the
convertible promissory notes and accrued interest in the first half of 2022 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. 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 disclosed in note 9, the
Company recently sold shares of its common stock to two of its officers, obtained access to a credit facility and filed a registration
statement to offer shares of its common stock. The Company’s operating needs include the planned costs to operate its business,
including amounts required to repay its convertible promissory notes (if not converted), 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. These condensed consolidated financial
statements do not include any adjustments that might result from this uncertainty.
6
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 2022 refers
to the fiscal year ending March 31, 2022). 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 of the Company have been prepared without audit. The condensed consolidated balance
sheet as of March 31, 2021 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 accounting principles generally accepted
in the United States (GAAP) have been condensed or omitted in accordance with these rules and regulations of the Securities and
Exchange Commission (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 three months ended December 31, 2021 are not necessarily
indicative of the results that may be expected for the year ending March 31, 2022 or for any other future period.
Reverse Stock Split
On November
24, 2021, the Company filed a certificate of amendment to its amended and restated certificate of incorporation with the Secretary
of State of the State of Nevada to effect a 1-for-3 reverse stock split of the Company’s shares of common stock. Such amendment
and ratio were previously approved by a majority of the Company’s stockholders and the board of directors. As a result of
the reverse stock split, which was effective November 29, 2021, every three shares of the Company’s pre-reverse split outstanding
common stock were combined and reclassified into one share of common stock. Proportionate voting rights and other rights of common
stock holders were not affected by the reverse stock split. Any fractional shares of common stock resulting from the Reverse Split
were rounded up to the nearest whole share. All stock options outstanding and common stock reserved for issuance under the
Company’s equity incentive plans and warrants outstanding immediately prior to the reverse stock split were adjusted by
dividing the number of affected shares of common stock by three (3) and, as applicable, multiplying the exercise price by three
(3), as a result of the reverse stock split.
Use
of Estimates
The preparation
of the accompanying 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 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 balances at high-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.
7
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 technology and customer requirements, limited operating history and the volatility
of public markets.
COVID-19
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 has 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. The full extent of the COVID-19 impact on the Company’s operational
and financial performance will depend on future developments, including the duration and spread of the pandemic and related actions
taken by U.S. and foreign government agencies to prevent disease spread, all of which are uncertain, out of the Company’s
control, and cannot be predicted.
Cash
and Cash Equivalents
Cash
and cash equivalents include cash on hand and cash in demand deposits, certificates of deposit and highly liquid debt instruments
with original maturities of three months or less.
Property
& Equipment
Property
and equipment are originally recorded at 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 condensed 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 condensed consolidated
statements of operations.
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.
8
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
during the period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding during the period.
For the nine months ended December 31, 2021 and 2020, outstanding options to purchase 1,967,188 and 1,170,863 shares of common
stock, respectively, were excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive.
Reclassification
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, 2021 and 2020, the Company’s comprehensive loss was the same as its net loss.
Recently
Adopted Accounting Pronouncement
In August
2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)-Accounting For Convertible Instruments and Contracts in an
Entity’s Own Equity (ASU 2020-06) . ASU 2020-06 simplifies the accounting for convertible instruments by removing
major separation models required under current GAAP. Consequently, more convertible debt instruments will be reported as a single
liability instrument with no separate accounting for embedded conversion features. ASU 2020-06 removes certain settlement conditions
that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts
to qualify for it. ASU 2020-06 also simplifies the diluted net income per share calculation in certain areas. The new guidance
is effective for annual and interim periods beginning after December 15, 2021, and early adoption is permitted for fiscal years
beginning after December 15, 2020, and interim periods within those fiscal years. The Company early adopted ASU 2020-06 effective
April 1, 2021, and the impact of the adoption was not material to the Company’s consolidated financial statements.
NOTE
2 – LEASES
Effective April
1, 2019, the Company adopted ASU No. 2016-02, Leases (ASC 842), and related ASUs, as amended, using the alternative
transition method, which allowed the Company to initially apply the new lease standard at the adoption date (the “effective
date method”). In January 2020, the Company executed a lease for a new, larger corporate facility in San Diego, California
and paid a $100,000 security deposit. The 39 -month lease
term commenced April 1, 2020, and the lease provides for an initial monthly rent of approximately $ 12,400 annual rent increases of approximately 3 % . In addition to the minimum lease payments, the Company
is responsible for property taxes, insurance and certain other operating costs. The right-to-use asset and corresponding liability
for the facility lease have been measured at the present value of the future minimum lease payments. A discount rate of 11%, which
approximated the Company’s incremental borrowing rate, was used to measure the lease asset and liability. Lease expense
is recognized on a straight line basis over the lease term.
The Company
obtained a right-of-use asset of $ 270,950 in exchange for its obligations under the operating lease. The landlord also provided
a lease incentive of approximately $ 139,000 , which was paid to the Company in June 2020, for the Company to make improvements
to the leased space.
Future
minimum payments under the facility operating lease , as of December 31, 2021, are listed in the table below.
Annual Fiscal Years
Operating
lease
2022
38,358
2023
158,028
2024
40,692
Less:
Imputed interest
( 20,049 )
Present value of lease liabilities
$ 217,029
Cash
paid for amounts included in the measurement of lease liabilities was $ 115,073 for the nine months ended December 31, 2021. Rent
expense was $ 80,698 and $ 80,654 for the nine months ended December 31, 2021 and 2020, respectively, and $ 26,930 and $ 26,844 for
the three months ended December 31, 2021 and 2020, respectively.
9
NOTE
3 – PPP NOTE
On April
24, 2020, the Company received a $ 368,780 unsecured loan (the PPP Note) under the Paycheck Protection Program (the PPP), which
was established under the U.S. government’s Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). The PPP
Note to the Company was made through Silicon Valley Bank (the Lender), and the Company entered into a U.S. Small Business Administration
Paycheck Protection Program Note with the Lender evidencing the PPP Note. The full amount of the PPP Note was due in April 2022
and interest accrued on the outstanding principal balance of the PPP Note at a fixed rate of 1.0% per annum, which was deferred
for 10 months after the covered period during which the Company used the proceeds.
The Company
applied to the Lender for forgiveness of the PPP Note in October 2020, and, in May 2021, the Company was notified by the Lender
and the U.S. Small Business Administration that the outstanding principal and accrued interest for the PPP Note was forgiven in
full. The Company accounted for the forgiveness of the PPP Note in accordance with Accounting Standards Codification Topic 470:
Debt (ASC 470), and the amount forgiven was recorded as a gain on extinguishment and recognized in the other income line of the
condensed consolidated statement of operations.
NOTE
4 – CONVERTIBLE PROMISSORY NOTES
From
February through April 2021, the Company sold $2,310,000 of convertible promissory notes (each an Original Notes and, collectively,
the Original Notes), at par in a private placement transaction effected pursuant to an exemption from the registration requirements
under the Securities Act of 1933, as amended. Effective April 30, 2021, pursuant to a revocation and replacement agreement between
each holder of an Original Note and the Company (the Revocation Agreement), the $2,310,000 of Original Notes and accrued interest
thereon as of April 30, 2021 were replaced with $2,360,550 aggregate principal amount of new Notes (as defined below). The Company
accounted for the replacement of the Original Notes in accordance with ASC 470 and recorded a loss on extinguishment of $ 1,321,450
and interest expense of $ 70,647 for unamortized debt issuance costs as of April 30, 2021.
In April
and May 2021, pursuant to a Securities Purchase Agreement by and between the Company and each investor (the SPA), the Company
sold to investors $ 4,250,000 aggregate principal amount of convertible promissory notes (the Notes) and warrants to purchase shares
of its common stock (the Warrants). The Notes are unsecured obligations of the Company with each Note having a stated maturity
date of 12 months from its issue date (the Issue Date). The Notes bear interest at a rate of 12% per annum, payable on maturity,
provided that, if the Company fails to pay any amounts when due under a Note, the interest rate increases to the greater of 16%
or the maximum amount permitted by law. Each Note may be prepaid at the Company’s option during the first 270 calendar days
following its Issue Date (the 270 th day, the Trigger Date), subject to a 110% prepayment penalty on outstanding principal
and accrued interest then outstanding. No Note may be prepaid in whole or in part after the Trigger Date.
Notes
outstanding after the Trigger Date may be converted into shares of the Company’s common stock at an initial conversion price
of $8.61 per share; provided that a Note holder may not convert any portion of its Note that would cause it to beneficially own
in excess of 4.99% of the Company’s outstanding common stock. The conversion price and number of shares of Company common
stock issuable upon conversion of the Notes are subject to adjustment from time to time for subdivisions and consolidations of
shares and other standard dilutive and corporate events, as provided in the Notes. Subject to certain Exempt Issuances (as defined
in the Notes), if while a Note is outstanding, the Company sells, issues or grants any shares of its common stock or other securities
to acquire shares of common stock at a price per share less than the then conversion price, such conversion price shall be reduced
to such lesser price, and the number of conversion shares issuable upon conversion of the Notes shall be increased, as provided
in the Notes.
If the
Company completes an offering of its common stock or other securities in excess of $12,000,000 of gross proceeds (a Qualified
Capital Raise, as defined in the Notes), each Note holder will be required to convert its Adjusted Note Amount (as defined below)
into the securities of such Qualified Capital Raise. Adjusted Note Amount equals the product of (i) the sum of all outstanding
principal plus accrued interest on a Note, multiplied by (ii) 1.25.
The Notes
contain a number of Company events of default (Events of Default) including, without limitation (i) failure to pay any principal
or interest thereon when due, (ii) failure to timely deliver shares upon conversions, (iii) failure to comply with SEC reporting
requirements under the Exchange Act, (iv) certain breaches of the SPA, the Notes, the Warrants, and the Registration Rights Agreement,
(v) material restatements of the Company’s consolidated financial statements filed with the SEC, (vi) a holder’s inability
to rely on Rule 144 for sales of shares underlying the Notes, (vii) the Company’s common stock is suspended or halted from
trading and/or fails to be quoted or listed (as applicable) on the OTCQB, OTCQX, any tier of the NASDAQ Stock Market, the New
York Stock Exchange, or the NYSE American within 10 days thereafter, (viii) failure to file with the SEC a registration statement
covering the resale of shares of common stock underlying the Notes and Warrants within 60 calendar days following the Issue Date,
(ix) failure to cause such registration statement to become effective within 120 calendar days following the Issue Date, or (x)
certain mergers consolidations, business combinations and sales of all or substantially all of the Company’s assets in the
event the Company is not the survivor of such transaction.
10
Upon
an Event of Default, a Note holder may declare all amounts under its Note(s) due and payable, in which event the Company will
be required to pay such Note holder the sum of (i) the product of (a) all then outstanding principal amount and accrued interest
thereon, multiplied by (b) 125%; and (ii) all collection costs including legal fees and expenses in connection therewith. At the
option of a Note holder, in the event the Company receives cash proceeds as a result of certain events, including, but not limited
to, payments from customers, issuances of debt or equity securities, exercise of warrants or asset sales, the Company will be
required to use such proceeds to repay all or any lesser outstanding amounts due under such holder’s Note.
The Notes
include covenants, representations, warranties, other payment obligations and agreements by the Company including, without limitation,
most-favored nation rights, rights of participation and first refusal and exchange rights.
In connection
with the issuance of the Notes, the Company issued Warrants to purchase in the aggregate 767,796 shares of its common stock at
an initial exercise price of $24.00 per share. The Warrants may be exercised for a period of five years from the Trigger Date,
provided that, if prior to the Trigger Date, the Company (i) completes a Qualified Capital Raise, the outstanding Warrants shall
be cancelled or (ii) prepays a holder’s Note(s) in whole or in part, such holder’s pro-rata number of Warrants shall
be cancelled. The fair value of the Warrants was $3,700,632, of which $2,379,182 was recorded as a debt discount, which is being
amortized to interest expense over the term of the Warrants, and $1,321,450 was recorded as a loss on debt extinguishment. The
Company calculated the fair value of the Warrants utilizing the Black-Scholes valuation model with the following assumptions:
volatility of 88.98 % , risk-free interest rate of 0.86 % , a term of 5.75 years and a dividend yield of zero .
In connection
with the April and May 2021 sales of the $4,250,000 aggregate principal amount of the Notes, the Company incurred debt issuance
costs of $116,000, which were recorded as a debt discount and are being amortized to interest expense over the term of the Notes
using the effective interest rate method. The interest expense attributable to the debt discount, comprising the debt issuance
costs and Warrants, during the three and nine months ended December 31, 2021 was $630,323 and $1,454,762, respectively.
The $6,610,550
aggregate principal amount of Notes are due and payable in full in the first quarter of fiscal 2023. Subsequent to the Trigger
Date, the Notes can be converted into 767,783 shares of common stock at a conversion price of $8.61 per share.
NOTE
5 – PROMISSORY NOTE
On
October 28, 2021, the Company issued a secured promissory note (the Bridge Note) to Manchester Explorer, L.P. (“Manchester”)
that provides the Company with a $ 3,000,000 revolving credit facility with all amounts being drawn down by the Company thereunder
being due and payable, subject to acceleration in the event of a default, on March 15, 2022 (the “Maturity Date”).
Interest at the rate of 12 % is payable on each drawn down without regard to the draw down date or the date when interest is paid.
The
principal amount of the Bridge Note and interest due thereon is payable to Manchester no later than the earlier of: (i) the Maturity
Date and (ii) the date on which the Company has received proceeds in excess of $12,000,000 from a transaction or series of related
transactions occurring prior to the Maturity Date, which such transactions constitute equity financings or other issuances of
the Company’s equity securities. Provided that no Event of Default (as such term is defined in the Bridge Note) has occurred,
on any date prior to the Maturity Date, upon no less than three days written notice by the Company specifying the draw amount,
Manchester will advance the draw amount to the Company. No draw amount can be in an amount less than $100,000 or exceed an amount
equal to $3,000,000 minus the aggregate principal amount outstanding under the Bridge Note at the time of such draw request. If
an Event of Default occurs and is continuing, Manchester may declare all of the Bridge Note, including any interest and other
amounts due, to be due and payable immediately.
11
In
connection with the issuance of the Note, on October 28, 2021, the Company entered into a Security Agreement with Manchester (the
“Security Agreement”) under which the Company granted Manchester a continuing and unconditional first priority security
interest in and to any and all of the Company’s property of any kind or description, tangible or intangible, wheresoever
located and whether now existing or hereafter arising or acquired.
During
the quarter ended December 31, 2021, the Company made draws on the Bridge Note of $ 1,500,000 and incurred interest charges of
$ 180,000 .
NOTE
6 – STOCKHOLDERS’ DEFICIT AND STOCK-BASED COMPENSATION
During
the three months ended December 31, 2021, the Company sold 30,865 shares of common stock to its chief executive officer and its
chairman of the board of directors, president, chief financial officer and treasurer, issued 8,334 shares of common stock to a
service provider and issued 5,775 shares to its non-employee directors under the Company’s outside director compensation
plan. At December 31, 2021, the Company had an obligation to issue 16,666 shares of common stock to service providers, and the
value of these shares was recorded as common stock issuable in the condensed consolidated balance sheet.
Amended
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. Under the Plan, eligible employees, directors and consultants
may be granted a broad range of awards, including stock options, stock appreciation rights, restricted stock, performance-based
awards and restricted stock units. The Plan is administered by the Board or, in the alternative, a committee designated by the
Board.
Stock-Based
Compensation Expense
The expense
relating to stock options is recognized on a straight-line basis over the requisite service period, usually the vesting period,
based on the grant date fair value. The unamortized compensation cost, as of December 31, 2021, was $ 7,419,022 related to stock
options and is expected to be recognized as expense over a weighted-average period of approximately two years.
During
the nine months ended December 31, 2021, the Company granted options to purchase 723,269 shares of its common stock to employees,
directors and consultants. The options had 10-year terms, and 85,484 options vested immediately when granted. The fair value of
the options was determined to be $ 8,108,043 of which $ 1,769,805 was recorded as stock-based compensation expense and included
in the condensed consolidated statement of operations for the nine months ended December 31, 2021.
The following
assumptions were used in the fair value method calculations:
Schedule of Fair Value Assumptions
Three
Months Ended
December 31,
Nine
Months Ended
December 31,
2021
2020
2021
2020
Risk-free
interest rates
1.26 % - 1.36 %
0.38 %
0.8 % - 1.36 %
0.28 % - 0.38 %
Volatility
197 %
- 253 %
87 %
89 %
- 370 %
87 %
- 127 %
Expected life (years)
5.0
– 6.0
5.2
– 5.7
5.0
- 6.2
5.0
- 6.0
Dividend yield
—
—
—
—
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 of three comparable organizations. 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. In accordance with ASU No. 2016-09, the Company
accounts for forfeitures as they occur.
12
A summary
of stock option activity under the Plan is presented below:
Schedule of Stock Option activity
Options Outstanding
Shares
Available
for Grant
Number of
Shares
Weighted
Average
Exercise
Prices
Balance at March 31, 2021
136,082
1,197,252
$ 5.25
Options granted
( 60,774 )
60,774
12.69
Share awards
( 1,836 )
—
—
Options cancelled and returned to the Plan
7,547
( 7,547 )
8.61
Balance at June 30, 2021
81,089
1,250,479
5.58
Additional shares authorized under the Plan
1,333,334
—
—
Options granted
( 396,384 )
396,384
12.15
Share awards
( 3,636 )
—
—
Options cancelled and returned to the Plan
49,213
( 49,213 )
7.02
Balance at September 30, 2021
1,063,546
1,597,650
7.17
Options granted
( 266,112 )
259,559
9.99
Share awards
( 5,775 )
—
Options cancelled and returned to the Plan
29,073
( 11,256 )
7.24
Balance at December 31, 2021
820,732
1,845,953
7.57
There
were no stock options exercised during the nine months ended December 31, 2021 and 2020.
13
The following
table summarizes the range of outstanding and exercisable options as of December 31, 2021:
Schedule of
Outstanding and Exercisable Option, Range
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
$ 1.98 - $ 17.70
1,845,953
8.13
$ 7.57
1,011,586
$ 5.10
$ 3,564,268
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 at December 31, 2021.
The Company
is required to present the tax benefits resulting from tax deductions in excess of the compensation cost recognized from the exercise
of stock options as financing cash flows in the consolidated statements of cash flows. For the nine months ended December 31,
2021 and 2020, there were no such tax benefits associated with the exercise of stock options.
NOTE
7 – 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 2021 may be subject to examination by the U.S. federal and state tax authorities. As of December 31, 2021, the
Company has not recorded any liability for unrecognized tax benefits related to uncertain tax positions.
NOTE
8 – RELATED PARTY TRANSACTIONS
In
February 2021, the Company’s chairman of the board of directors and president and an existing investor, who is represented by
a member of the Company’s board of directors, purchased $100,000 and $1,000,000, aggregate principal amount of the Original
Notes, respectively. Effective April 30, 2021, the related party holders entered into revocation agreements with the Company
pursuant to which their collective $ 1,100,000
aggregate principal amount of Original Notes and accrued interest of $ 50,091
were replaced with Notes. At December 31, 2021, the investor and executive officer held Notes in an aggregate principal amount of
$ 1,026,630 and
$ 102,663 ,
respectively, with $ 82,693 and
$ 8,269 of
interest payable thereon. For the three months ended December 31, 2021, the Company incurred interest expense of approximately
$ 31,052
and $ 3,105 ,
respectively, and for the nine months ended December 31, 2021, the Company incurred interest expense of approximately $ 82,693
and $ 8 ,269,
respectively, on the related party holder Notes.
In May
2021, a member of the Board purchased $ 200,000 aggregate principal amount of Notes (the Director Note). For the three and nine
months ended December 31, 2021, the Company incurred expense of approximately $ 6,049 and $ 16,110 , respectively, on the Director
Note. At December 31, 2021, approximately $ 16,110 of interest was payable by the Company on the Director Note.
In
October 2021, the Company entered into purchase agreements with Ellen O’Connor (Lynn) Vos , the Company’s chief executive
officer, and Paul DiPerna , the chairman of the Company’s board of directors and its president, chief financial officer and
treasurer, providing for the sale and issuance by the Company of 30,864 shares of the Company’s common stock, par value
$0.001 per share at the closing market price on October 28, 2021 of $8.10 per share. The Company received proceeds of approximately
$250,000 from the sale of the shares, comprising $ 150,000 from Ms. Vos and $ 100,000 from Mr. DiPerna.
14
NOTE
9 – 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, 2021 and 2020 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, and no claims for payment have been made under such agreements.
NOTE
10 – SUBSEQUENT EVENTS
Bridge
Note
Subsequent
to December 31, 2021, the Company made additional draws totaling $ 600,000 under the Bridge Note.
Public
Offering
On February
9, 2022, the Company entered into an underwriting agreement (the Underwriting Agreement), with Oppenheimer & Co. Inc.,
which acted as the representative of the several underwriters (the “Representative”), in a firm commitment underwritten
public offering (the Offering) pursuant to which the Company agreed to sell to the Representative an aggregate of 2,500,000 shares
of the Company’s common stock, par value $0.001 per share (the Common Stock), and 2,500,000 warrants (Warrants and, collectively
with the Common Stock, the Units), each to purchase one share of Common Stock, at a public offering price of $6.00 per Unit. The
Warrants included in the Units are exercisable immediately, have an exercise price of $6.60 per share and expire five years from
the date of issuance. The Common Stock was approved to list on the Nasdaq Capital Market under the symbol “MODD” and
began trading there on February 10, 2022. The gross proceeds from the Offering were $ 15 million , before deducting underwriting
discounts and commissions and other offering expenses.
The Units were
offered and sold to the public pursuant to the Company’s registration statement on Form S-1 (File No. 333-260682), initially
filed by the Company with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the Securities
Act), on November 2, 2021, and declared effective on February 9, 2022.
The Underwriting
Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification
obligations of the Company and the Representative, including for liabilities under the Securities Act of 1933, as amended,
other obligations of the parties and termination provisions. In addition, pursuant to the terms of the Underwriting Agreement and
related “lock-up” agreements, the Company, each director and executive officer of the Company, and certain stockholders
have agreed with the Representative not to offer for sale, issue, sell, contract to
sell, pledge or otherwise dispose of any of our Common Stock or securities convertible into Common Stock for a period of 180 days
after February 9, 2022, the date of the final prospectus.
15
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 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, 2021. 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, 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 2022 refers to the fiscal year ending March 31, 2022). 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, 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.
Historically,
we have financed our operations principally through private placements of our common stock and convertible promissory notes. Based
on our current operating plan, substantial doubt about our ability to continue as a going concern for a period of at least one
year from the date that the financial statements included in Item 1 of this Report are issued exists. Our ability to continue
as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities, to support
our future operations. 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 condensed consolidated
financial statements in Item 1 of this Report and under Liquidity below.
16
Impacts
of COVID-19
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 has 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. The full extent of the COVID-19 impact on our operational and financial
performance will depend on future developments, including, without limitation, the duration and spread of the pandemic and related
actions taken by U.S. and foreign government agencies to prevent disease spread, all of which are uncertain, out of our control,
and cannot be predicted.
In March
2020, Santa Diego County in California, where we are based, and the state of California issued “shelter-in-place”
orders (the Orders). We complied with the Orders and minimized business activities at our San Diego facility from March 2020 until
May 2021. During that time, we implemented a teleworking policy for our employees and contractors to reduce on-site activity at
our facility. In May 2021, our employees and certain contractors returned to work in our office. We have and continue to experience
longer lead times for certain components used to manufacture initial quantities of our products for our submission to the FDA.
We remain diligent in continuing to identify and manage risks to our business given the changing uncertainties related to COVID-19.
While we believe that our operations personnel are currently in a position to build an adequate supply of products for our FDA
submission, we recognize that unpredictable events could create difficulties in the months ahead. We may not be able to address
these difficulties in a timely manner, which could delay our submission to the FDA and negatively impact our business, results
of operations, financial condition and cash flows.
The continued
spread of COVID-19 has also led to disruption and volatility in the global capital markets. We were recently able to raise additional
capital in a private placement of convertible promissory notes (see discussion below under Liquidity ). However, we need
to raise additional capital to support our operations in the future. We may be unable to access the capital markets or additional
capital may only be available to us on terms that could be significantly detrimental to our existing stockholders and holders
of the convertible promissory notes and to our business.
For additional
information on risks that could impact our future results, please refer to “Risk Factors” in Part II, 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, 2021. As of December 31, 2021, there have been no material changes to
our significant accounting policies and estimates.
Results
of Operations
Research
and Development
December 31,
Change
2021
2020
2020 to 2021
Research and development – Three months ended
$ 1,849,399
$ 1,086,669
$ 762,730
70.2 %
Research and development – Nine months ended
$ 5,742,911
$ 3,150,149
$ 2,592,762
82.3 %
Our research
and development expenses include personnel, consulting, materials and other costs associated with the development of our insulin
pump product. 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, 2021 as compared with the prior period
of fiscal 2021 primarily due to increased engineering and manufacturing consulting costs, as we have increased our development
and manufacturing activities. R&D expenses increased for the nine months ended December 31, 2021 as compared with the prior
period of fiscal 2021 primarily due to increased engineering and manufacturing personnel and consulting costs, protype and production
component and material costs and stock-based compensation expenses. R&D expenses included non-cash, stock-based compensation
expenses of $204,962 and $96,127 for the three months ended December 31, 2021 and 2020, respectively, and $459,989 and $301,767
for the nine months ended December 31, 2021 and 2020, respectively. We expect R&D expenses to remain flat for the remainder
of fiscal 2022, as we continue to advance the development of our pump product and develop an initial low-volume manufacturing
process.
17
General
and Administrative
December 31,
Change
2021
2020
2020 to 2021
General and administrative – Three months ended
$ 1,981,665
$ 783,898
$ 1,197,767
152.8 %
General and administrative – Nine months ended
$ 5,156,152
$ 2,453,808
$ 2,702,344
110.1 %
General
and administrative expenses consist primarily of personnel and related overhead costs for facilities, marketing, finance, human
resources and general management.
General
and administrative, or G&A, expenses, increased for the three and nine months ended December 31, 2021 as compared with the
prior periods of fiscal 2021 primarily as a result of increased stock-based compensation expense and increased consulting and
legal fees. G&A expenses included stock-based compensation expenses of $1,016,774 and $198,926 for the three months ended
December 31, 2021 and 2020, respectively, and $2,280,098 and $638,607 for the nine months ended December 31, 2021 and 2020, respectively.
We expect G&A expenses to increase for the remainder of fiscal 2022, as we pursue a public offering of our common stock.
Interest
Expense
December 30,
Change
2021
2020
2020 to 2021
Interest expense – Three months ended
$ 1,010,247
$ —
$ (1,010,225 )
—
Interest expense – Nine months ended
$ 2,204,917
$ —
$ (2,204,791 )
—
Interest
expense consisted of interest expense incurred from our convertible promissory notes, including amortization of debt issuance
costs, and our promissory (bridge) note. See Notes 4 and 5 to the condensed consolidated financial statements included in Item
1 of this Report for additional disclosure.
Liquidity
and Capital Resources
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 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, 2021, we incurred a net loss of approximately
$14.1 million. For the years ended March 31, 2021 and 2020, we incurred net losses of approximately $7.4 million and $5.3
million, respectively. At December 31, 2021, we had a cash balance of approximately $0.2 million and an accumulated deficit of
approximately $29.9 million. When considered with our current operating plan and the requirement to repay the Notes (as defined
below) and the draws under the Bridge Note (as defined below) by May 2022, 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 of issuance of the consolidated financial
statements included in Item 1 of this Report. Our consolidated 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 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, and we are currently seeking such additional financing. As discussed in Note 3 to our condensed
consolidated financial statements in Item 1 of this Report, we obtained forgiveness of the $368,000 principal balance and interest
on the PPP Note we received from Silicon Valley Bank in April 2020 under the U.S. Small Business Administration Paycheck Protection
Program. As discussed in Note 4 to our condensed consolidated financial statements in Item 1 of this Report, in May 2021, we completed
a private placement of $6,610,500 aggregate principal amount of our convertible promissory notes (the Notes). The Notes are unsecured
obligations of ours with each Note having a stated maturity date of 12 months from its issue date (the Issue Date). The Notes
bear interest at a rate of 12% per annum, payable on maturity, provided that, if we fail to pay any amounts when due under a Note,
the interest rate increases to the greater of 16% or the maximum amount permitted by law. Each Note may be prepaid at our option
during the first 270 calendar days following its Issue Date (the 270 th day, the Trigger Date), subject to a 110% prepayment
penalty on all principal and accrued interest then outstanding. No Notes may be prepaid in whole or in part after the Trigger
Date. As discussed in Note 9 to our condensed consolidated financial statements in Item 1 of this Report, on October 28, 2021,
we sold $250,000 of shares of our common stock to officers, and we issued a secured promissory note (the Bridge Note) to an investor.
The Bridge Note provides us with a $3,000,000 revolving credit facility with all amounts being drawn down by the Company thereunder
being due and payable, subject to acceleration in the event of a default, on March 15, 2022. For the three months ended December
31, 2021, we drew down $1,500,000 under the Bridge Note.
18
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 future capital requirements and the adequacy of our
available funds will depend on many factors, including 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 offering. 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 in order to conserve our cash.
For the
nine months ended December 30, 2021, we used $7,128,787 in operating activities, which primarily
resulted from our net loss of $14,058,155 increased for a non-cash gain on the PPP Note extinguishment of $368,780 and
net changes in operating lease assets and liabilities of $34,422, as adjusted for changes to operating assets and liabilities
of $1,197,989, a loss on debt extinguishment of $1,321,450 stock-based compensation expenses of $2,740,086, $388,021
for issuances of shares of common stock in exchange for services, $149,994 for issuable shares of common stock in exchange
for services, depreciation and amortization expenses of $80,268, and interest expense of $1,454,762 for amortization of
debt discount. For the nine months ended December 31, 2020, we used $4,570,713 in operating
activities, which primarily resulted from our net loss of $5,605,431 and changes to operating assets and liabilities of $107,758,
as adjusted for stock-based compensation expenses of $940,374, depreciation and amortization expenses of $82,016, net changes
in lease assets and liabilities of $120,085.
For the
nine months ended December 31, 2021 and 2020, cash used in investing activities of $22,779 and $109,541, respectively was due
to the purchase of property and equipment.
Cash
provided by financing activities of $6,037,199 for the nine months ended December 31, 2021 primarily attributable to net proceeds
from the issuance of our Notes of $5,637,199 and net proceeds of $250,000 from the sale of shares of common stock to officers
of the Company. Cash provided by financing activities of $2,154,662 for the nine months ended
December 31, 2020 was attributable to net proceeds of $1,785,882 from the sale of shares of our common stock in a private placement
that was initiated in March 2020 and $368,780 in proceeds from the PPP Note.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not required.
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-15(e) and
15d-15(e) under the Securities Exchange Act of 1934. Based on this evaluation, our management concluded that, as of December 31,
2021, our disclosure controls and procedures were effective.
Changes
in Internal Control over Financial Reporting.
During
the nine months ended December 31, 2021, 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.
19
Part
II - OTHER INFORMATION
Item
1. Legal Proceedings
None.
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. We disclosed a number of material
risks under Item 1A of our Annual Report on Form 10-K for the year ended March 31, 2021, which we filed with the SEC on June 29,
2021.
The
full effects of COVID-19 and other potential future public health crises, epidemics, pandemics or similar events are uncertain
and could have a material and adverse effect on our business, financial condition, operating results and cash flows.
The global
outbreak of the coronavirus disease 2019, or COVID-19, was declared a pandemic by the World Health Organization and a national
emergency by the U.S. government in March 2020. This has negatively affected the world 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. The extent of the impact on our operational and financial performance
will depend on future developments, including the duration and spread of the pandemic and related actions taken by U.S. and foreign
government agencies to prevent disease spread, all of which are uncertain, out of our control and cannot be predicted.
We have
been complying with county and state orders and, until May 2021, had implemented a teleworking policy for our employees and contractors
and significantly minimized the number of employees who visit our office. However, a facility closure, work slowdowns or temporary
stoppage at one of our manufacturing suppliers could occur, which could have a longer-term impact and could delay our prototype
production and ability to conduct business. If our workforce is unable to work effectively, including because of illness, quarantines,
absenteeism, government actions, facility closures, travel restrictions or other restrictions in connection with the COVID-19
pandemic, our operations will be negatively impacted. We may be unable to develop our product, and our costs may increase as a
result of the COVID-19 outbreak. The impacts could worsen if there is an extended duration of any COVID-19 outbreak or a resurgence
of COVID-19 infection in affected regions after they have begun to experience improvement.
We rely
on other companies to provide components and to perform services for us. An extended period of supply chain disruption caused
by the response to COVID-19 could impact our ability to produce our initial product quantities, and, if we are not able to implement
alternatives or other mitigations, product deliveries would be adversely impacted and negatively impact our business, financial
condition, operating results and cash flows. Limitations on government operations can also impact regulatory approvals that are
necessary for us to operate our business.
The continued
spread of COVID-19 has also led to disruption and volatility in the global capital markets. We were recently able to raise additional
capital in a private placement of convertible promissory notes, however, we will need to raise additional capital to support our
operations 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.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent
Sales of Unregistered Securities
On
December 31, 2021, we issued a total of 5,775 shares of our common stock to three of our non-employee directors in accordance
with our outside director compensation plan.
On
October 22, 2021 we issued 8,834 shares of our common stock to service providers.
20
On
October 28, 2021, we sold to two of our executive officers a total of 30,864 shares of our common stock at a purchase price of
$8.10 per share, which resulted in gross proceeds to us of $250,000.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not applicable.
Item
5. Other Information
None.
Item
6. Exhibits
Exhibit
No.
Description
of Document
3.1(1)
Certificate of Amendment and Second Amended and Restated Articles of Incorporation, as filed with the Secretary of State of Nevada on June 27, 2017
3.2(2)
Certificate of Amendment to the Amended and Restated Articles of Incorporation of Modular Medical, Inc., filed with the Secretary of the State of Nevada on November 24, 2021
10.27(3)
Promissory Note dated October 28, 2021
10.28(3)
Security Agreement dated October 28, 2021
10.29(3)
Form of Common Stock Purchase Agreement dated October 28, 2021
31.1
Certification of Ellen O’Connor Vos pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Paul M. DiPerna pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Ellen O’Connor Vos and Paul M. DiPerna pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema
101.CAL
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
XBRL Taxonomy Extension Definition Linkbase
101.LAB
XBRL Taxonomy Extension Label Linkbase
101.PRE
XBRL Taxonomy Extension Presentation Linkbase
(1) As filed with the Registrant’s Current Report on Form 8-K filed June 29, 2017, and incorporated herein by reference.
(2) As filed with the Registrant’s Current Report on Form 8-K filed December 1, 2021, and incorporated herein by reference.
(3) As filed with the Registrant’s Current Report on Form 8-K filed October 29, 2021, and incorporated herein by reference.
21
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 14, 2022
By:
/s/ Ellen O’Connor Vos
Ellen O’Connor Vos
Chief Executive Officer
(principal executive officer)
By:
/s/ Paul M. DiPerna
Paul M. DiPerna
Chief Financial Officer
(principal financial officer)
22
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.