UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 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, 2022
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:
001-41277
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, par value $0.001 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.
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 10,932,098 as of February 8,
2023.
FORM
10-Q
December 31, 2022
TABLE OF CONTENTS
PART
I —
FINANCIAL
INFORMATION
3
Item
1.
Financial
Statements (Unaudited):
3
Condensed
Consolidated Balance Sheets as of December 31, 2022 and March 31, 2022
3
Condensed
Consolidated Statements of Operations for the three and nine months ended December 31, 2022 and 2021
4
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months ended December 31, 2022 and
2021
5
Condensed
Consolidated Statements of Cash Flows for the nine months ended December 31, 2022 and 2021
6
Notes
to Condensed Consolidated Financial Statements
7
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
16
Item
4.
Controls
and Procedures
19
PART
II —
OTHER
INFORMATION
20
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
20
Item
4.
Mine
Safety Disclosures
20
Item
5.
Other
Information
20
Item
6.
Exhibits
21
Signatures
22
2
Part I – FINANCIAL INFORMATION
Item
1. Financial Statements
Modular
Medical, Inc.
Condensed Consolidated Balance Sheets
December
31,
2022
(Unaudited)
March
31,
2022
ASSETS
CURRENT
ASSETS
Cash
and cash equivalents
$ 7,690,957
$ 9,076,372
Prepaid
expenses and other
180,164
313,422
Security
deposit
100,000
—
TOTAL
CURRENT ASSETS
7,971,121
9,389,794
Property
and equipment, net
716,409
235,959
Right
of use asset, net
51,312
120,693
Security
deposit
—
100,000
TOTAL
NON-CURRENT ASSETS
767,721
456,652
TOTAL
ASSETS
$ 8,738,842
$ 9,846,446
LIABILITIES
AND STOCKHOLDERS’ EQUITY
CURRENT
LIABILITIES
Accounts
payable
$ 382,080
$ 299,951
Accrued
expenses
255,545
524,891
Short-term
lease liability
77,672
144,857
TOTAL
CURRENT LIABILITIES
715,297
969,699
Long-term
lease liability
—
39,957
TOTAL
LIABILITIES
715,297
1,009,656
Commitments
and Contingencies (Note 8)
STOCKHOLDERS’
EQUITY
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; 10,932,098 and 10,461,898 shares issued and outstanding as of December 31, 2022 and March 31, 2022, respectively
10,932
10,462
Additional
paid-in capital
52,900,066
43,406,099
Accumulated
deficit
( 44,887,453 )
( 34,579,771 )
TOTAL
STOCKHOLDERS’ EQUITY
8,023,545
8,836,790
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 8,738,842
$ 9,846,446
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
Modular
Medical, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
Three
Months Ended
December 31,
Nine
Months Ended
December 31,
2022
2021
2022
2021
Operating
expenses
Research
and development
$ 2,196,546
$ 1,849,399
$ 6,804,069
$ 5,742,911
General
and administrative
1,161,351
1,981,665
3,502,029
5,156,152
Total
operating expenses
3,357,897
3,831,064
10,306,098
10,899,063
Loss
from operations
( 3,357,897 )
( 3,831,064 )
( 10,306,098 )
( 10,899,063 )
Other
income (expense)
( 587 )
4
16
368,876
Interest
expense
—
( 1,010,247 )
—
( 2,204,917 )
Loss
on debt extinguishment
—
—
—
( 1,321,450 )
Loss
before income taxes
( 3,358,484 )
( 4,841,307 )
( 10,306,082 )
( 14,056,554 )
Provision
for income taxes
—
—
1,600
1,600
Net
loss
$ ( 3,358,484 )
$ ( 4,841,307 )
$ ( 10,307,682 )
$ ( 14,058,154 )
Net
loss per share
Basic
and diluted
$ ( 0.31 )
$ ( 0.76 )
$ ( 0.95 )
$ ( 2.22 )
Shares
used in computing net loss per share
Basic
and diluted
10,925,862
6,354,145
10,863,082
6,331,982
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
Modular
Medical, Inc.
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited)
Common
Stock
Additional
Paid-In
Common
Stock
Accumulated
Stockholders’
Shares
Amount
Capital
Issuable
Deficit
Equity
Balance as of March 31, 2022
10,461,898
$ 10,462
$ 43,406,099
$ —
$ ( 34,579,771 )
$ 8,836,790
Shares issued for services
348
—
1,576
—
—
1,576
Issuance of common stock and warrants in equity offering, net
449,438
449
7,371,898
—
—
7,372,347
Issuance of common stock under equity incentive plan
2,664
3
13,747
—
—
13,750
Stock-based compensation
—
—
724,819
—
—
724,819
Net loss
—
—
—
—
( 3,498,791 )
( 3,498,791 )
Balance as of June 30, 2022
10,914,348
$ 10,914
$ 51,518,139
$ —
$ ( 38,078,562 )
$ 13,450,491
Issuance of common stock under equity incentive plan
11,375
12
50,368
—
—
50,380
Stock-based compensation
—
—
692,060
—
—
692,060
Net loss
—
—
—
—
( 3,450,407 )
( 3,450,407 )
Balance as of September 30, 2022
10,925,723
$ 10,926
$ 52,260,567
$ —
$ ( 41,528,969 )
$ 10,742,524
Issuance
of common stock under equity incentive plan
6,375
6
12,737
—
—
12,743
Stock-based
compensation
—
—
626,762
—
—
626,762
Net
loss
—
—
—
—
( 3,358,484 )
( 3,358,484 )
Balance
as of December 31, 2022
10,932,098
$ 10,932
$ 52,900,066
$ —
$ ( 44,887,453 )
$ 8,023,545
Common
Stock
Additional
Paid-In
Common
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
Issuance
of common stock under equity incentive plan
1,836
2
32,495
—
—
32,497
Stock-based
compensation
—
—
623,423
—
—
623,423
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 )
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
Modular
Medical, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
Nine
Months Ended
December 31,
2022
2021
Cash Flows from operating activities
Net
loss
$ ( 10,307,682 )
$ ( 14,058,154 )
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
2,120,513
2,740,086
Depreciation
and amortization
92,616
80,268
Shares
issued for services
150,412
388,021
Shares
issuable for services
—
149,994
Amortization
of lease right-of-use asset
69,381
58,404
Change
in lease liability
( 107,142 )
( 92,826 )
Amortization
of debt discount
—
1,454,762
Changes
in assets and liabilities:
Other
assets and prepaid expenses
( 15,577 )
( 25,995 )
Accounts
payable and accrued expenses
( 187,217 )
1,223,983
Net
cash used in operating activities
( 8,184,696 )
( 7,128,787 )
CASH
FLOWS FROM INVESTING ACTIVITIES
Purchase
of property and equipment
( 573,066 )
( 22,779 )
Net
cash used in investing activities
( 573,066 )
( 22,779 )
CASH
FLOWS FROM FINANCING ACTIVITIES
Proceeds
from issuance of common stock and warrants, net
7,372,347
—
Proceed
from private placement, net of issuance costs
—
250,000
Proceeds
from issuance of convertible notes, net
—
4,137,199
Proceeds
from issuance of promissory note
—
1,500,000
Net
cash provided by financing activities
7,372,347
5,887,199
Net
decrease in cash and cash equivalents
( 1,385,415 )
( 1,264,367 )
Cash
and cash equivalents at beginning of period
9,076,372
1,468,465
Cash
and cash equivalents at end of period
$ 7,690,957
$ 204,098
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.
6
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 to address shortcomings and problems represented by the relatively limited adoption of currently available
pumps for insulin-dependent people with diabetes. The Company has developed a hardware technology allowing people with insulin-dependent
diabetes to receive their daily insulin in two ways, through a continuous “basal” delivery allowing a small amount
of insulin to be in the blood at all times and a “bolus” delivery to address meal time glucose input and to address
when the blood glucose level becomes excessively high. By addressing the time and effort required to effectively treat their condition,
the Company believes it can address the less technically savvy, less motivated part of the market.
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
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 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. 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.
7
The
Company’s operating needs include the planned costs to operate its business, 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.
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
2023 refers to the fiscal year ending March 31, 2023). 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, 2022 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 three months ended December 31, 2022 are not necessarily
indicative of the results that may be expected for the year ending March 31, 2023 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 and, as applicable, multiplying the exercise
price by three, as a result of the reverse stock split. All share numbers, share prices, exercise prices and per share amounts
have been adjusted, on a retroactive basis to reflect this 1-for-3 reverse stock split.
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.
8
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 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.
Risks and Uncertainties
The
Company is subject to risks from, among other things, competition associated with the industry in general, other risks associated
with financing, liquidity requirements, rapidly changing customer requirements, limited operating history and the volatility of
public markets.
The
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 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.
Fixed
assets comprised:
Schedule
of Fixed Assets
December 31,
March 31,
2022
2022
Machinery
and equipment
$ 487,855
$ 346,358
Construction-in-process
427,670
—
Leasehold
improvements
139,197
139,197
Total
property and equipment
1,054,722
485,555
Less:
accumulated depreciation and amortization
( 338,313 )
( 249,596 )
Total
property and equipment, net
$ 716,409
$ 235,959
9
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.
Right-of-Use
Asset
The
Company’s right-of-use assets consist of leased assets recognized in accordance with FASB Accounting Standards Codification
(ASC) No. 842, Leases which requires lessees to recognize a lease liability and a corresponding lease asset for virtually all
lease contracts. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and the
lease liability represents the Company’s obligation to make lease payments arising from the lease, both of which are recognized
based on the present value of the future minimum lease payments over the lease term at the commencement date. Leases with a lease
term of 12 months or less at inception are not recorded on the condensed consolidated balance sheets and are expensed on a straight-line
basis over the lease term in the condensed 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 recognizes stock-based compensation for stock options granted to employees and non-employees on a straight-line basis
over the requisite service period, usually the vesting period, based on the grant-date fair value. The Company estimates the value
of stock options on the date of grant using the Black-Scholes pricing model. The determination of fair value of share-based payment
awards on the date of grant using an option-pricing model is affected by the option price, as well as assumptions regarding a
number of highly complex and subjective variables. These variables include, but are not limited to, the expected stock price volatility
over the term of the awards, and projected stock option exercise behaviors.
Per-Share Amounts
Basic
net loss per share is computed by dividing the net 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. Potentially dilutive common shares consist of incremental shares of common stock issuable upon the exercise of stock
options and warrants.
For
the nine months ended December 31, 2022 and 2021, 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.
Schedule of Anti-Dilutive Shares
Nine
Months Ended
December 31,
2022
2021
Options to
purchase common stock
2,174,198
1,967,188
Common
stock warrants
7,565,588
767,796
Total
9,739,786
2,734,984
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, 2022 and 2021, the Company’s comprehensive loss was the same as its net loss.
10
Recently
Issued Accounting Pronouncement
In
June 2016, the FASB issued 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 adoption of this ASU is not expected to have a material impact
on the Company’s results of operations and financial position.
NOTE
2 – LEASES
The
Company accounts for the lease of its corporate facility in San Diego, California in accordance with ASC No. 842. The 39- month
lease term commenced April 1, 2020, and the lease provides for an initial monthly rent of approximately $12,400 with 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. In addition, the Company paid a $100,000 security deposit.
Future
minimum payments under the facility operating lease, as of December 31, 2022, are listed in the table below.
Schedule of Future
minimum Lease Payment
Annual
Fiscal Years
Operating
Lease
2023
39,507
2024
40,692
Less:
Imputed
interest
( 2,527 )
Present
value of lease liabilities
$ 77,672
Cash
paid for amounts included in the measurement of lease liabilities was $ 118,521 for the nine months ended December 31, 2022. Rent expense was $ 80,698 for each of the nine-month periods ended December 31, 2022 and 2021 and $ 26,930 for each of the three-month periods ended December 31, 2022 and 2021.
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 (the Agreement) 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.
In
May 2021, the Lender and the U.S. Small Business Administration notified the Company 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 ASC
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 consolidated statement of operations.
11
NOTE
4 – CONVERTIBLE PROMISSORY NOTES
From
February through April 2021, the Company sold $ 2,310,000 of convertible promissory notes (each an Original Note 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 $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 Notes and 2021 Warrants (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 2021 Warrants). The Notes were unsecured obligations of the Company with each Note having a stated maturity
date of 12 months from its issue date and accrued interest at a rate of 12% per annum, payable on maturity. If the Company completed
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 would 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.
In
connection with the issuance of the Notes, the Company issued the 2021 Warrants to purchase in the aggregate 767,796 shares
of its common stock at an initial exercise price of $24.00 per share. The fair value of the 2021 Warrants was $3,700,632, of
which $2,379,182 was recorded as a debt discount and amortized to interest expense, 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 .
Upon
the closing of a public offering in February 2022, which was a Qualified Capital Raise, in accordance with their terms, the Notes
converted into 1,511,276 shares of common stock and the holders of the Notes received an additional 1,511,276 common stock purchase
warrants with an exercise price of $6.60 per share. In addition, as a result of the February 2022 equity offering, the exercise
price of the 767,796 outstanding 2021 Warrants was reduced to $6.00 per share.
NOTE
5 – STOCKHOLDERS’ EQUITY (DEFICIT)
Placements
of Common Stock and Warrants
On
May 2, 2022, the Company entered into a securities purchase agreement (the Purchase Agreement) with an institutional investor,
pursuant to which the Company sold, in a registered direct offering (the Registered Offering), which closed on May 5, 2022, an
aggregate of 449,438 shares (the Shares) of the Company’s common stock, par value $0.001 per share, at a purchase price
per Share of $4.45 and pre-funded warrants (the Pre-Funded Warrants) to purchase an aggregate of 1,348,314 shares of common stock
at a purchase price per Pre-Funded Warrant of $4.44. The Pre-Funded Warrants will be exercisable immediately on the date of issuance
at an exercise price of $0.01 per share and may be exercised at any time until all of the Pre-Funded Warrants are exercised in
full.
In
a concurrent private placement under the Purchase Agreement, the Company issued to the Investor warrants (the Private Placement
Warrants) to purchase an aggregate of 1,438,202 shares of common stock at an exercise price of $6.60 per share. The Private Placement
Warrants will be exercisable beginning on the six-month anniversary of the date of issuance (the Initial Exercise Date) and will
expire on the five-year anniversary of the Initial Exercise Date.
12
Warrants
As of December 31, 2022,
the Company had the following warrants outstanding:
Schedule of Warrant Outstanding
Type
Number
of
Shares
Exercise
Price
Expiration
Date
Common
stock
1,348,314
$ 0.01
—
Common
stock
767,796
$ 6.00
January
- February 2027
Common
stock
4,011,276
$ 6.60
February
2027
Common
stock
1,438,202
$ 6.60
November
2027
Total
7,565,588
Other
During
the nine months ended December 31, 2022 and 2021, the Company issued 348 and 28,334 shares of common stock, respectively, with a fair
value of approximately $ 1,576 and $ 245,956 , respectively, to service providers.
NOTE
6 – STOCK-BASED COMPENSATION
Amended 2017 Equity
Incentive Plan
In
October 2017, the Company’s board of directors (the Board) approved the 2017 Equity Incentive Plan (the Plan), as amended,
with 1,000,000 shares of common stock reserved for issuance. In January 2020 and August 2021, the Board approved increases in
the number of shares reserved for issuance 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. As of December 31, 2022, the unamortized compensation cost was $3,443,902 related
to stock options and is expected to be recognized as expense over a weighted-average period of approximately 2.07 years.
During
the three and nine months ended December 31, 2022, the Company awarded 6,375 and 20,414 shares, respectively, to members of the Board
in accordance with the compensation plan for non-employee directors. During the nine months ended December 31, 2022, the Company granted
options with 10-year terms to purchase 677,199 shares of its common stock to employees, directors and consultants. The fair value of
the options granted and shares awarded was $2,503,979. The following assumptions were used in the fair value calculations of the
options granted:
Schedule
of Fair value Assumptions of Options
Three
Months Ended
December 31,
Nine
Months Ended
December 31,
2022
2021
2022
2021
Risk-free
interest rates
3.93 %
- 3.99 %
1.26 %
- 1.36 %
2.82 %
- 4.06 %
0.8 %
- 1.36 %
Volatility
149 %
197 %
- 253 %
149 %
- 223 %
89 %
- 370 %
Expected
life (years)
5.0
- 5.7
5.0
- 6.0
5.0
- 5.7
5.0
- 6.2
The
fair values of options at the grant date were estimated utilizing the Black-Scholes valuation model, which includes simplified
methods to establish the 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.
13
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, 2022
989,466
1,650,705
$ 6.58
Options
granted
( 265,634 )
265,634
4.35
Share
awards
( 2,664 )
—
—
Options
cancelled and returned to the Plan
96,668
( 96,668 )
7.69
Balance
at June 30, 2022
817,836
1,819,671
6.19
Options
granted
( 241,023 )
241,023
4.35
Share
awards
( 11,375 )
—
—
Options
cancelled and returned to the Plan
30,444
( 30,444 )
4.67
Balance
at September 30, 2022
595,882
2,030,250
6.00
Options
granted
( 170,542 )
170,542
2.00
Share
awards
( 6,375 )
—
—
Options
cancelled and returned to the Plan
26,594
( 26,594 )
5.82
Balance
at December 31, 2022
445,559
2,174,198
$ 5.69
There were no stock options
exercised during the nine months ended December 31, 2022 and 2021.
The following table
summarizes the range of outstanding and exercisable options as of December 31, 2022:
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
2,174,198
7.94
$ 5.69
1,360,318
$ 5.87
$ 8,894
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.
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, 2022 and 2021, there were no such tax benefits associated with the exercise of stock options, as no stock options
were exercised.
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 2022 may be subject to examination by the U.S. federal and state tax authorities. As of December 31,
2022, the Company has not recorded any liability for unrecognized tax benefits related to uncertain tax positions.
14
NOTE
8 – COMMITMENTS & 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, 2022 and 2021 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.
Purchase Obligations
The
Company's primary purchase obligations include purchase orders for machinery and equipment. At December 31, 2022, the Company
had outstanding purchase orders for machinery and equipment and related expenditures of approximately $735,000.
NOTE
9 – SUBSEQUENT EVENTS
New
Lease Agreement
On
January 5, 2023, the Company entered into a lease agreement (the Thornhill Lease) with Michael Summers (the Lessor) for a new
headquarters facility pursuant to which the Company will lease approximately 24,000 square feet of a building located in San Diego,
California, commencing on or about February 1, 2023. The monthly base rent is $36,000 for the first 12 months of the lease and
will increase by 4% of the prior year’s base rent at the beginning of each 12-month period thereafter. The lease term is
48 months.
Under
the Thornhill Lease, the Company will pay the Lessor a monthly fee for its pro-rated share of specified common area charges, including
maintenance costs, property taxes and insurance, in addition to base rent. The monthly fee for the common area charges is approximately
$10,700 and will be adjusted based on actual costs incurred by the Lessor.
Amended
2017 Equity Incentive Plan
In
January 2023, the Company’s stockholders approved an increase in the number of shares
reserved for issuance under the Plan by 2,000,000 shares.
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 filed with the Securities and Exchange Commission on June 28, 2022 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, 2022. 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 the Russian/Ukraine conflict and inflationary risks,
including the risk that the cost of certain of the Company’s materials and product 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 2023 refers to the fiscal year ending March 31, 2023). 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.
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 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
COVID-19
and Macroeconomic Factors
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.
Since
March 2020, the jurisdiction in which we operate has issued “shelter-in-place” orders from time to time. We have
complied with these orders, and, when such orders were in place, minimized business activities at our facility. We have implemented
a teleworking policy for our employees and contractors to reduce on-site activity, as necessary. 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 U.S. Food
and Drug Administration (FDA) for approval to commercialize our pump product. 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.
We
believe that as the COVID-19 pandemic evolves, the direct and indirect impacts of the pandemic on global macroeconomic conditions,
as well as conditions specific to us, are becoming more difficult to isolate or quantify. In addition, these direct and indirect
factors can make it difficult to isolate and quantify the portion of our costs that are a direct result of the pandemic and costs
arising from factors that may have been influenced by the pandemic, such as supply chain constraints, rising inflation, and recessionary
fears. We expect these factors and their effects on our operations may persist for a longer period, even after the COVID-19 pandemic
has subsided. The continued spread of COVID-19 has also led to disruption and volatility in the global capital markets.
The Russian invasion of
Ukraine in February 2022 has led to further economic disruptions. Mounting inflationary costs pressures and recessionary fears
have negatively impacted the global economy. During the third quarter of 2022, the U.S. Federal Reserve continued to aggressively
address elevated inflation by increasing interest rates. The U.S. Federal reserve increased interest rates by 75 basis points
in each of its meetings held in July, September and November 2022, 50 basis points in its meeting held in December 2022, and 25
basis points in its meeting held in February 2023, as inflation remains elevated. We were able to raise additional capital through
equity offerings in February 2022 and May 2022, however, we will need to raise additional capital to commercialize our pump product
candidate and 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.
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, 2022. As of December 31, 2022, there have been no material
changes to our significant accounting policies and estimates.
17
Results of Operations
Research and Development
December
31,
Change
2022
2021
Fiscal 2022 to
Fiscal 2023
Research
and development – Three months ended
$ 2,196,546
$ 1,849,399
$ 347,147
18.8 %
Research
and development – Nine months ended
$ 6,804,069
$ 5,742,911
$ 1,061,158
18.5 %
Our
research and development expenses include personnel, consulting, product prototyping and other costs associated with the development
and initial production 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 and nine months ended December 31, 2022 compared with the same period
of fiscal 2021, primarily due to increased engineering and operations personnel costs, prototype and production component and
material costs and higher stock-based compensation expenses. The increases in R&D expenses were partially offset by a decrease
in consulting costs, as we reduced our utilization of consultants, as we increased our employee headcount and the consultants
completed development of aspects of our pump design and features. Our full-time R&D employee headcount increased to 32 at
December 31, 2022 from 18 at December 31, 2021. R&D expenses included stock-based compensation expenses of $356,752 and $204,962
for the three months ended December 31, 2022 and 2021, respectively, and $1,034,674 and $459,989 for the nine months ended December
31, 2022 and 2021, respectively. We expect research and development expenses to remain comparable for the remainder of fiscal
2023, as we continue to advance the development of our pump product and develop our manufacturing
process.
General
and Administrative
December
31,
Change
2022
2021
Fiscal 2022 to
Fiscal 2023
General and administrative
– Three months ended
$ 1,161,351
$ 1,981,665
$ (820,314 )
(41.4 )%
General and administrative – Nine
months ended
$ 3,502,029
$ 5,156,152
$ (1,654,123 )
(32.1 )%
General
and administrative expenses consist primarily of personnel and related overhead costs for finance, human resources, legal, marketing
and general management.
General
and administrative, or G&A, expenses decreased for the three months ended December 31, 2022 compared with the same period
of 2021, primarily as a result of decreased stock-based compensation, personnel and benefit costs and legal fees, which in fiscal
2022 related to our public offering and listing on the Nasdaq that was completed in February 2022. These decreases were partially
offset by increased consulting and professional services fees.
G&A
expenses decreased for the nine months ended December 31, 2022 compared with the same period of 2021, primarily as a result of
decreased stock-based compensation, personnel and benefit costs, consulting and legal fees and marketing costs. These decreases
were partially offset by increased accounting fees, travel costs and office-related expenses. Our full-time G&A employee headcount
increased to 3 at December 31, 2022 from 2 at December 31, 2021. G&A expenses included stock-based compensation expenses of
$282,753 and $1,016,774 for the three months ended December 31, 2022 and 2021, respectively and $1,085,839 and $2,280,098 for
the nine months ended December 31, 2022 and 2021, respectively. We expect G&A expenses to remain flat for the remainder of
fiscal 2023.
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, 2022, we incurred a net
loss of approximately $10.3 million. For the years ended March 31, 2022 and 2021, we incurred net losses of approximately $18.6
million and $7.4 million, respectively. At December 31, 2022, we had a cash balance of approximately $7.7 million and an accumulated
deficit of approximately $44.9 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 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. In
May 2022, we completed a registered direct offering of securities for net proceeds of approximately $7.4 million.
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. During the nine months ended December 31, we
made capital expenditures of approximately $574,000, as we have begun procuring equipment to develop a low-volume manufacturing
production line to build our pump product to demonstrate and develop our manufacturing process. We expect to incur increased capital
expenditures for the remainder of fiscal 2023. At December 31, 2022, we had outstanding, non-cancelable purchase orders for production
equipment totaling $735,000, and we expect to receive and pay for this equipment over the following six months. 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 offerings. If we are unable
to secure additional capital timely, 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 31, 2022, we used $8,184,696 in operating activities, which primarily resulted from our net loss of $10,307,682,
as adjusted for stock-based compensation expenses of $2,120,513, $150,412 for issuances of shares of common stock in exchange for services
and depreciation and amortization expenses of $92,616, and increased by net changes in operating lease assets and liabilities of $37,761
and operating assets and liabilities $202,794 and other immaterial adjustments. For the nine months ended December 31, 2021, we used
$7,128,787 in operating activities, which primarily resulted from our net loss of $14,058,154, 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 $1,197,988, 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, 2022 and 2021, cash used in investing activities of $573,066 and $22,779, respectively, was
for the purchase of property and equipment.
Cash
provided by financing activities of $7,372,347 for the nine months ended December 31, 2022 was attributable to net proceeds from
the issuance of common stock upon completion of an equity offering, net of underwriting fees and issuance costs. Cash provided
by financing activities of $5,887,199 for the nine months ended December 31, 2021 was primarily attributable to $4,137,199 of
net proceeds from the issuance of our convertible promissory notes, $250,000 from the sale of shares of common stock to officers
of the Company and $1,500,000 from the issuance of a promissory bride note.
Recently Issued Accounting
Pronouncements
Recently
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
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,
2022, our disclosure controls and procedures were effective.
Changes in Internal
Control over Financial Reporting.
During
the three months ended December 31, 2022, 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
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, 2022, which we filed with the SEC on June 28,
2022, and of our Quarterly Report on Form 10Q for the three months ended September 30, 2022, which we filed with the SEC on November
14, 2022, as amended on November 17, 2022.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Securities
On December 30, 2022,
we issued 6,375 shares of our common stock to four of our non-employee directors in accordance with our Outside Director Compensation
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. We made such determinations based upon representations by the purchasers of such securities including,
without limitation, that such purchasers were “accredited investors” as defined in 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.
20
Item 6. Exhibits
Exhibit
No.
Description
of Document
31.1*
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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
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
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
* Filed herewith
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
13, 2023
By:
/s/ James E. Besser
James E. Besser
Chief Executive Officer
(Principal Executive Officer)
Date: February 13,
2023
By:
/s/ Paul M. DiPerna
Paul M. DiPerna
Chairman, President, Chief Financial Officer and
Treasurer
(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.