Item
1. Financial Statements.
MYMD
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
June
30, 2022 and December 31, 2021
(unaudited)
See
accompanying notes to the condensed consolidated financial statements
MYMD
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Comprehensive Loss
(unaudited)
See
accompanying notes to the condensed consolidated financial statements
MYMD
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed
Consolidated Statement of Changes in Shareholders’ Equity
For
the Six Months Ended June 30, 2022 and 2021
(unaudited)
| |
Shares | | |
Series D | | |
Shares | | |
No Par | | |
$0.0001 | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
Common Stock | | |
| | |
| |
| |
Series D | | |
| | |
| | |
Common | | |
| | |
| | |
| |
| |
Convertible
Preferred Stock | | |
| | |
Common
Stock | | |
Stock
Par | | |
Additional
Paid-In | | |
Accumulated | | |
Total | |
| |
Shares | | |
Series D | | |
Shares | | |
No Par | | |
$0.0001 | | |
Capital | | |
Deficit | | |
Equity | |
Balance at December 31, 2020 (restated) | |
| - | | |
$ | - | | |
| 28,553,307 | | |
| - | | |
$ | 4,004 | | |
| 43,411,487 | | |
$ | (48,672,525 | ) | |
$ | (5,257,034 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,089,704 | ) | |
| (3,089,704 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2021 | |
| - | | |
$ | - | | |
| 28,553,307 | | |
$ | - | | |
$ | 4,004 | | |
$ | 43,411,487 | | |
$ | (51,762,229 | ) | |
$ | (8,346,738 | ) |
Balance | |
| - | | |
$ | - | | |
| 28,553,307 | | |
$ | - | | |
$ | 4,004 | | |
$ | 43,411,487 | | |
$ | (51,762,229 | ) | |
$ | (8,346,738 | ) |
Reverse merger with Akers Biosciences Inc effective April 16, 2021 | |
| 72,992 | | |
| 144,524 | | |
| 8,335,627 | | |
| 85,748,325 | | |
| (4,004 | ) | |
| (43,411,487 | ) | |
| - | | |
| 42,477,358 | |
Modification of the terms of 4,188,315 pre-merger MyMD stock options per the terms of the merger agreement | |
| - | | |
| - | | |
| - | | |
| 15,036,051 | | |
| - | | |
| - | | |
| - | | |
| 15,036,051 | |
Exercise of prepaid equity forward contracts for common stock | |
| - | | |
| - | | |
| 466,716 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| | | |
| | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (18,092,336 | ) | |
| (18,092,336 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2021 | |
| 72,992 | | |
$ | 144,524 | | |
| 37,355,650 | | |
$ | 100,784,376 | | |
$ | - | | |
$ | - | | |
$ | (69,854,565 | ) | |
$ | 31,074,335 | |
Balance | |
| 72,992 | | |
$ | 144,524 | | |
| 37,355,650 | | |
$ | 100,784,376 | | |
$ | - | | |
$ | - | | |
$ | (69,854,565 | ) | |
$ | 31,074,335 | |
See
accompanying notes to the condensed consolidated financial statements
MYMD
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(unaudited)
See
accompanying notes to the condensed consolidated financial statements
MYMD
PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note
1 – Organization and Description of Business
MyMD
Pharmaceuticals, Inc., previously known as Akers Biosciences, Inc., is a New Jersey corporation (“MyMD”). These condensed
consolidated financial statements include four wholly owned subsidiaries as of June 30, 2022, MyMD Pharmaceuticals (Florida), Inc. (“MyMD
Florida”), XYZ Merger Sub, Inc. (“Merger Sub”), Akers Acquisition Sub, Inc. and Bout Time Marketing Corporation, (together,
the “Company”). All material intercompany transactions have been eliminated in consolidation.
MyMD
Florida was formed in 2014 and is a Florida-based clinical development stage biopharmaceutical company that is developing its product
candidate, MYMD-1, as an immuno regulator to treat autoimmune diseases, ageing-related diseases. Substantive operations began in 2016
and the Company’s Investigative New Drug application was filed with the U.S. Food and Drug Administration in December 2018. MyMD
Florida completed its first-in-human Phase 1 clinical trial in December 2019. A second Phase 1 dosing study was completed in December
2021. MYMD-1 is being developed to treat age-related illnesses such as frailty and sarcopenia. MYMD-1 works by regulating the release
of numerous pro-inflammatory cytokines, such as TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”).
MYMD-1 currently is being evaluated in a multicenter Phase 2 clinical trial in patients with sarcopenia and frailty (age-related muscle
loss). MyMD Florida’s intellectual property portfolio consists of 15 U.S. granted patents, 10 granted foreign patents and 23 pending
applications (3 US, 19 foreign, one international).
Supera
Pharmaceuticals, Inc. (“Supera”) was formed in September 2018 and is a Florida based development company that is developing
its product candidate “Supera-CBD” as an FDA-approved synthetic analog of naturally grown cannabidiols. Substantially all
of Supera’s research and development activities in 2020 and 2021 were related to intellectual property development and securing
patents, along with product manufacturing and planning initial pre-clinical development activities. During the year ended December 31,
2021, these activities included preclinical work on Supera-CBD confirming it effectiveness in treating anxiety. The preclinical data
was presented at the 4th Annual International Cannabinoid Summit describing the superior potency of Supera-CBD. Supera-CBD
preclinical genotoxicity studies were completed in February 2022.
On
April 16, 2021, pursuant to the previously announced Agreement and Plan of Merger and Reorganization, dated November 11, 2020 (the “Original
Merger Agreement”), as amended by Amendment No. 1 thereto, dated March 16, 2021 the Original Merger Agreement, as amended by Amendment
No. 1 (the “Merger Agreement”), by and among MyMD, Merger Sub and MyMD Florida, Merger Sub was merged with and into MyMD
Florida, with MyMD Florida continuing after the merger as the surviving entity and a wholly owned subsidiary of MyMD (the “Merger”).
At the effective time of the Merger, without any action on the part of any stockholder, each issued and outstanding share of pre-Merger
MyMD Florida’s common stock, par value $0.001 per share (the “MyMD Florida Common Stock”), including shares underlying
pre-Merger MyMD Florida’s outstanding equity awards, was converted into the right to receive (x) 0.7718 shares (the “Exchange
Ratio”) of MyMD’s common stock, no par value per share (the “Company Common Stock”), (y) an amount in cash, on
a pro rata basis, equal to the aggregate cash proceeds received by the Company from the exercise of any options to purchase shares of
MyMD Florida Common Stock outstanding at the effective time of the Merger assumed by the Company upon closing of the Merger prior to
the second-year anniversary of the closing of the Merger (the “Option Exercise Period”), such payment (the “Additional
Consideration”), and (z) potential milestone payment in shares of Company Common Stock up to the aggregate number of shares issued
by the Company to pre-Merger MyMD Florida stockholders at the closing of the Merger (the “Milestone Payments”) payable upon
the achievement of certain market capitalization milestone events during the 36-month period immediately following the closing of the
Merger (the “Milestone Period”). Immediately following the effective time of the Merger, the Company effected a 1-for-2 reverse
stock split of the issued and outstanding Company Common Stock (the “Reverse Stock Split”).
On
April 16, 2021, MyMD Florida entered into an Asset Purchase Agreement with Supera, a related company through common control, in which
Supera was acquired by MyMD Florida through the issuance of 33,937,909 shares of pre-Merger MyMD Florida’s common stock. The Supera
entity was dissolved pursuant to this transaction.
In
connection with the closing of the Merger, the Company changed its name to MyMD Pharmaceuticals, Inc. and the Company’s Common
Stock listed on The Nasdaq Capital Market, previously trading through the close of business on April 16, 2021 under the trading symbol
“AKER”, commenced trading on The Nasdaq Capital Market, on a post-Reverse Stock Split adjusted basis, under the trading symbol
“MYMD” on April 19, 2021.
Note
2 – Significant Accounting Policies
(a)
Basis of Presentation
The
Condensed Consolidated Financial Statements of the Company are prepared in U.S. Dollars and in accordance with accounting principles
generally accepted in the United States of America (US GAAP).
The
accompanying unaudited condensed financial statements have been prepared by the Company. These statements include all adjustments (consisting
only of normal recurring adjustments) which management believes necessary for a fair presentation of the statements and have been prepared
on a consistent basis using the accounting policies described in Note 2 Significant Accounting Policies included in the Notes to Financial
Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities
and Exchange Commission on March 31, 2022 (the “2021 Annual Report”). Certain financial information and footnote disclosures
normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or
omitted pursuant to such rules and regulations, although the Company believes that the accompanying disclosures are adequate to make
the information presented not misleading. The Notes to Financial Statements included in the 2021 Annual Report should be read in conjunction
with the accompanying interim financial statements. The interim operating results for the three and six months ended June 30, 2022 may
not be necessarily indicative of the operating results expected for the full year.
The
Company effected a 1-for-2 reverse stock split immediately following the effective time of the Merger. No fractional shares were issued
in connection with the Reverse Stock Split. Each stockholder who did not have a number of shares evenly divisible pursuant to the Reverse
Stock Split ratio and who would otherwise be entitled to receive a fractional share of Company Common Stock was entitled to receive an
additional share of Company Common Stock. The number of shares on equity related disclosures included in this Quarterly Report on Form
10-Q, including the condensed consolidated financial statements and accompanying notes, were retroactively adjusted to reflect the effects
of the Reverse Stock Split and the Exchange Ratio.
(b)
Use of Estimates and Judgments
The
preparation of financial statements in conformity with US GAAP requires management to make judgments, estimates and assumptions that
affect the application of accounting policies and the reported amounts of assets, liabilities and expenses. Actual results may differ
from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized
in the period in which the estimates are revised and in any future periods affected. Information about significant areas of estimation,
uncertainty and critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in
the financial statements is included in the following notes for recording research and development expenses, impairment of intangible
assets and the valuation of share-based payments.
(c)
Functional and Presentation Currency
These
condensed consolidated financial statements are presented in U.S. Dollars, which is the Company’s functional currency. All financial
information has been rounded to the nearest dollar. Foreign Currency Transaction Gains or Losses, resulting from cash balances denominated
in Foreign Currencies, are recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss.
(d)
Comprehensive Loss
The
Company follows Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 220 in reporting comprehensive
loss. Comprehensive income is a more inclusive financial reporting methodology that includes disclosure of certain financial information
that historically has not been recognized in the calculation of net income. Since the Company has no items of other comprehensive income
(loss), comprehensive loss is equal to net loss.
(e)
Cash and Cash Equivalents
The
Company considers all highly liquid investments, which include short-term bank deposits (up to three months from date of deposit) that
are not restricted as to withdrawal date or use, to be cash equivalents.
(f)
Fair Value of Financial Instruments
The
Company’s financial instruments consist of cash and cash equivalents, marketable securities, receivables and trade and other payables.
The carrying value of cash and cash equivalents, receivables and trade and other payables approximate their fair value because of their
short maturities.
The
framework for measuring fair value provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure
fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities
(Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under FASB ASC 820 are
described as follows:
|
Level
1 |
Inputs
to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company
has the ability to access. |
|
|
|
|
Level
2 |
Inputs
to the valuation methodology include: |
|
|
|
|
|
● |
quoted
prices for similar assets or liabilities in active markets; |
|
|
● |
quoted
prices for identical or similar assets or liabilities in inactive markets; |
|
|
● |
inputs
other than quoted prices that are observable for the asset or liability; |
|
|
● |
inputs
that are derived principally from or corroborated by observable market data by correlation or other means |
|
|
|
|
|
|
If
the asset or liability has a specified (contractual) term, the level 2 input must be observable for substantially the full term of
the asset or liability. |
|
|
|
|
Level
3 |
Inputs
to the valuation methodology are unobservable and significant to the fair value measurement. |
The
asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of input that is
significant to the fair value measurement. Valuation techniques maximize the use of relevant observable inputs and minimize the use of
unobservable inputs.
(f)
Fair Value of Financial Instruments, continued
The
following is a description of the valuation methodologies used for assets measured at fair value as of June 30, 2022 and December 31,
2021.
Marketable
Securities: Valued using quoted prices in active markets for identical assets.
Schedule of Marketable Securities
| |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) | | |
Quoted Prices for Similar Assets or Liabilities in Active Markets (Level 2) | | |
Significant Unobservable Inputs (Level 3) | |
Marketable securities at June 30, 2022 | |
$ | 4,505,825 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | |
Marketable securities at December 31, 2021 | |
$ | 11,003,071 | | |
$ | - | | |
$ | - | |
Marketable
securities are classified as available for sale and are valued at fair market value. Maturities of the securities are less than one year.
As
of June 30, 2022, the Company held certain mutual funds, which, under FASB ASC 321-10, were considered equity investments. As such, the
change in fair value in the three and six months ended June 30, 2022 was a gain of $2,947 and a loss of $145, respectively.
Gains
and losses resulting from the sales of marketable securities were losses of $1,999
and gains of $41,447
for the three months ended June 30, 2022 and 2021, respectively, and losses of $3,649
and gains of $41,447
for the six months ended June 30, 2022 and 2021, respectively
Proceeds
from the sales of marketable securities in the six months ended June 30, 2022 were $6,500,000. Proceeds from the sales of marketable
securities in the six months ended June 30, 2021 were $9,983,176.
(g)
Prepaid Expenses
Prepaid
expenses represent expenses paid prior to the date that the related services are rendered or used are comprised principally of prepaid
insurance and research and development expenses.
(h)
Concentrations
Financial
instruments that potentially subject the Company to concentrations of credit risk consist principally of cash on deposit with financial
institutions and accounts receivable. At times, the Company’s cash in banks is in excess of the FDIC insurance limit. The Company
has not experienced any loss as a result of these cash deposits. These cash balances are maintained with three banks as of June 30, 2022.
(i)
Risk Management of Cash and Investments
It
is the Company’s policy to minimize the Company’s capital resources to investment risks, prioritizing the preservation of
capital over investment returns. Investments are maintained in securities, primarily publicly traded, short-term money market funds based
on highly rated federal, state and corporate bonds, that minimize the risk to the Company’s capital resources and provide ready
access to funds.
The
Company’s investment portfolios are regularly monitored for risk and are held with one brokerage firm.
(j)
Investments
Investments
recorded using the cost method will be assessed for any decrease in value that has occurred that is other than temporary and the other
than temporary decrease in value shall be recognized. As and when circumstances and facts change, the Company will evaluate the Company’s
ability to significantly influence operational and financial policy to establish a basis for converting the investment accounted for
using the cost method to the equity method of valuation in accordance with FASB ASC 323.
In
accordance with FASB ASC 323, the Company recognizes investments in joint ventures based upon the Company’s ability to significantly
influence the operational or financial policies of the joint venture. An objective judgment of the level of influence is made at the
time of the investment based upon several factors including, but not limited to the following:
|
a) |
Representation
on the Board of Directors |
|
b) |
Participation
in policy-making processes |
|
c) |
Material
intra-entity transactions |
|
d) |
Interchange
of management personnel |
|
e) |
Technological
dependencies |
|
f) |
Extent
of ownership and the ability to influence decision making based upon the makeup of other owners when the shareholder group is small. |
The
Company follows the equity method for valuating investments in joint ventures when the existence of significant influence over operational
and financial policy has been established, as determined by management; otherwise, the Company will valuate these investments using the
cost method.
The
investment in Oravax Medical, Inc. (“Oravax”) (Note 3) is accounted for using the cost method.
(k)
Property, Plant and Equipment
Items
of property, plant and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Costs include
expenditures that are directly attributable to the acquisition of the asset.
Gains
and losses on disposal of an item of property, plant and equipment are determined by comparing the proceeds from disposal with the carrying
amount of property, plant and equipment and are recognized within “other (income)/expense” in the Condensed Consolidated
Statements of Comprehensive Loss.
Depreciation
is recognized over the estimated useful lives of the property, plant and equipment. Leased assets are depreciated over the shorter of
the lease term or their useful lives.
The
estimated useful lives for the current and comparative periods are as follows:
Schedule of Estimated Useful Lives of Property Plant and Equipment
| |
Useful Life |
| |
(in years) |
Plant and equipment | |
5-12 |
Furniture and fixtures | |
5-10 |
Computer equipment & software | |
3-5 |
Leasehold Improvements | |
Shorter of the remaining lease or estimated useful life |
Depreciation
methods, useful lives and residual values are reviewed at each reporting date.
(l)
Intangible Assets
The
Company’s long-lived intangible assets, other than goodwill, are assessed for impairment when events or circumstances indicate
there may be an impairment. These assets were initially recorded at their estimated fair value at the time of acquisition and assets
not acquired in acquisitions were recorded at historical cost. However, if their estimated fair value is less than the carrying amount,
other intangible assets with indefinite lives are reduced to their estimated fair value through an impairment charge in the Condensed
Consolidated Statements of Comprehensive Loss.
Patents
and Trade Secrets
Propriety
protection for the Company’s products, technology and process is important to its competitive position. As of August 15, 2022,
the Company has 16 issued U.S. patents, 14 foreign patents, three pending U.S. patent applications and 17 foreign patent
applications pending in such jurisdictions as Australia, Canada, China, European Union, Israel, Japan and South Korea, which if
issued are expected to expire between 2036 and 2041. Management intends to protect all other intellectual property (e.g. copyrights,
trademarks and trade secrets) using all legal remedies available to the Company.
The
Company records expenses related to the application for and maintenance of patents as a component of research and development expenses
on the Condensed Consolidated Statement of Comprehensive Loss.
Patent
Costs
Patents
may be purchased from third parties. The costs of acquiring the patent are capitalized as patent costs if it represents a future economic
benefit to the Company. Once a patent is acquired it is amortized over its remaining useful life and assessed for impairment when necessary.
Other
Intangible Assets
Other
intangible assets that are acquired by the Company, which have definite useful lives, are measured at cost less accumulated amortization
and accumulated impairment losses.
Amortization
Amortization
is recognized on a straight-line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that
they are available for use. The estimated useful lives for the current and comparative periods are as follows:
Schedule of Condensed Consolidated Balance Sheet Information Related to Operating Lease
| |
Useful Life |
| |
(in years) |
Patents and trademarks | |
12-17 |
(m)
Goodwill
Goodwill
is evaluated annually for impairment or whenever we identify certain triggering events or circumstances that would more likely than not
reduce the fair value below its carrying amount. Events or circumstances that might indicate an interim evaluation is warranted include,
among other things, unexpected adverse business conditions, economic factors (for example, the loss of key personnel), supply costs,
unanticipated competitive activities, and acts by governments and courts.
(n)
Recoverability of Long-Lived Assets
In
accordance with FASB ASC 360-10-35 “Impairment or Disposal of Long-lived Assets”, long-lived assets to be held and used are
analyzed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable
or that the useful lives of those assets are no longer appropriate. The Company evaluates at each balance sheet date whether events and
circumstances have occurred that indicate possible impairment.
The
Company determines the existence of such impairment by measuring the expected future cash flows (undiscounted and without interest charges)
and comparing such amount to the carrying amount of the assets. An impairment loss, if one exists, is then measured as the amount by
which the carrying amount of the asset exceeds the discounted estimated future cash flows. Assets to be disposed of are reported at the
lower of the carrying amount or fair value of such assets less costs to sell. Asset impairment charges are recorded to reduce the carrying
amount of the long-lived asset that will be sold or disposed of to their estimated fair values. Charges for the asset impairment reduce
the carrying amount of the long-lived assets to their estimated salvage value in connection with the decision to dispose of such assets.
(o)
Right-of-Use Assets
The
Company leased a facility in Tampa, Florida (“Hyde Park”) under an operating lease (“Hyde Park Lease”) with
annual rentals of $22,048
to $23,320
plus certain operating expenses. The Hyde Park facility housed the MyMD Florida operations. The Hyde Park Lease took effect on July
1, 2019 for a term of 36 months
to expire on June
30, 2022. The Company cancelled the Hyde Park lease in March 2022 without penalty.
The
Company leased an aircraft under an operating lease (“Supera Aviation Lease”) with annual rentals of $600,000
plus certain operating expenses. The Supera Aviation Lease took effect on October 26, 2018 for a term of 36
months to expire on September
26, 2021. The Company cancelled the Supera Aviation Lease in April 2021 without penalty.
The
Company leased a facility in Baltimore, Maryland (“2020 Wolfe St”) under an operating lease (“2020 Baltimore
Lease”) with annual rentals of $24,000
to $25,462
plus certain operating expenses. The 2020 Baltimore Lease took effect on November 9, 2020 for a term of 12
months with automatic renewals unless a sixty day notice was provided. The initial term expired on November
30, 2021. On November 17, 2021, the 2020 Baltimore Lease was cancelled without penalty.
The
Company leases a facility in Baltimore, Maryland (“2021 Wolfe St”) under an operating lease (“2021 Baltimore
Lease”) with annual rentals of $52,800 to
$56,016 plus
certain operating expenses. The 2021 Baltimore Lease took effect on November 17, 2021 for a term of 12 months
with automatic renewals unless a sixty day notice is provided. The initial term expires on November
30, 2022.
The
Company leases a facility in Tampa, Florida (“Platt St”) under an operating lease (“Platt Street Lease”) with annual
rentals of $22,030 to $23,259 plus certain operating expenses. The Platt Street Lease took effect on April 1, 2022 for a term of 36 months.
The initial term expires on March 31, 2025.
On
January 1, 2019 (“Effective Date”), the Company adopted FASB ASC, Topic 842, Leases (“ASC 842”), which increases
transparency and comparability by recognizing a lessee’s rights and obligations resulting from leases by recording them on the
balance sheet as lease assets and lease liabilities. The new guidance requires the recognition of the right-of-use (“ROU”)
assets and related operating and finance lease liabilities on the balance sheet. The Company adopted the new guidance using the modified
retrospective approach on January 1, 2019.
The
Company elected the package of practical expedients permitted within the standard, which allows an entity to forgo reassessing (i) whether
a contract contains a lease, (ii) classification of leases, and (iii) whether capitalized costs associated with a lease meet the definition
of initial direct costs. Also, the Company elected the expedient allowing an entity to use hindsight to determine the lease term and
impairment of ROU assets and the expedient to allow the Company to not have to separate lease and non-lease components. The Company has
also elected the short-term lease accounting policy under which the Company would not recognize a lease liability or ROU asset for any
lease that at the commencement date has a lease term of twelve months or less and does not include a purchase option that the Company
is more than reasonably certain to exercise.
For
contracts entered into on or after the Effective Date, at the inception of a contract, the Company will assess whether the contract is,
or contains, a lease. The Company’s assessment is based on: (i) whether the contract involves the use of a distinct identified
asset, (ii) whether the Company obtained the right to substantially all the economic benefit from the use of the asset throughout the
period, and (iii) whether the Company has the right to direct the use of the asset. Leases entered into prior to January 1, 2020, which
were accounted for under ASC 840, were not reassessed for classification.
For
operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The Company
generally uses its incremental borrowing rate as the discount rate for leases, unless an interest rate is implicitly stated in the lease.
The present value of the lease payments is calculated using the incremental borrowing rate for operating leases, which was determined
using a portfolio approach based on the rate of interest that the Company would have to pay to borrow an amount equal to the lease payments
on a collateralized basis over a similar term. The lease term for all of the Company’s leases includes the non-cancellable period
of the lease plus any additional periods covered by either a Company option to extend the lease that the Company is reasonably certain
to exercise, or an option to extend the lease controlled by the lessor. All ROU assets are reviewed for impairment.
Lease
expense for operating leases consists of the lease payments plus any initial direct costs and is recognized on a straight-line basis
over the lease term.
The
Company’s operating leases are comprised of the Supera Aviation Lease, the Hyde Park Lease, the 2020 Baltimore Lease and the 2021 Baltimore Lease and the Platt Street Lease on the Condensed Consolidated Balance Sheet. The information related to these leases are presented below:
Schedule of Condensed Consolidated Balance Sheet Information Related to Operating Lease
| |
As
of June 30, 2022 | | |
As
of December 31, 2021 | |
| |
Platt Street | | |
2021
Baltimore | | |
| | |
Hyde Park | | |
2021 Baltimore | | |
| |
Balance
Sheet Location | |
Lease | | |
Lease | | |
Total | | |
Lease | | |
Lease | | |
Total | |
Operating
Lease | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Lease
Right of Use | |
$ | 54,135 | | |
$ | 116,091 | | |
$ | 170,226 | | |
$ | 12,156 | | |
$ | 136,853 | | |
$ | 149,009 | |
Lease
Payable, current | |
| 17,537 | | |
| 43,982 | | |
| 61,519 | | |
| 12,164 | | |
| 41,076 | | |
| 53,240 | |
Lease
Payable - net of current | |
| 36,750 | | |
| 73,042 | | |
| 109,792 | | |
| - | | |
| 95,911 | | |
| 95,911 | |
The
following provides details of the Company’s lease expense:
Schedule of Lease Cost
| |
Three Months
Ended June 30, 2022 | | |
Three
Months
Ended June 30, 2021 | |
| |
Platt Street | | |
2021 Baltimore | | |
| | |
Supera Aviation | | |
Hyde Park | | |
2020 Baltimore | | |
| |
Lease Expenses | |
Lease | | |
Lease | | |
Total | | |
Lease | | |
Lease | | |
Lease | | |
Total | |
Operating Leases | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Lease Costs | |
$ | 5,660 | | |
$ | 13,600 | | |
$ | 19,260 | | |
$ | - | | |
$ | 6,257 | | |
$ | 6,182 | | |
$ | 12,439 | |
| |
Six Months Ended June 30, 2022
|
| |
Six
Months Ended
June 30, 2021 | |
| |
Hyde Park | | |
Platt Street | | |
2021 Baltimore | |
|
|
| |
Supera Aviation | | |
Hyde Park | | |
2020 Baltimore | | |
| |
Lease Expenses | |
Lease | | |
Lease | | |
Lease | |
|
Total |
| |
Lease | | |
Lease | | |
Lease | | |
Total | |
Operating Leases | |
| | | |
| | | |
| | |
|
|
|
| |
| | | |
| | | |
| | | |
| | |
Lease Costs | |
$ | 4,171 | | |
$ | 5,660 | | |
$ | 26,400 | |
|
$ |
36,231 |
| |
$ | 150,000 | | |
$ | 12,513 | | |
$ | 12,364 | | |
$ | 174,877 | |
Other
information related to leases is presented below:
Schedule of Other Information Related to Leases
| |
As of June 30, 2022 | |
| |
Hyde | | |
Platt | | |
2021 Baltimore | | |
| |
Other Information | |
Park Lease | | |
Street Lease | | |
Lease | | |
Total | |
Operating Leases | |
| | | |
| | | |
| | | |
| | |
Operating cash used | |
$ | 4,622 | | |
$ | - | | |
$ | 26,466 | | |
$ | 31,088 | |
Average remaining lease term | |
| - | | |
| 33 | | |
| 29 | | |
| 31 | |
Average discount rate | |
| 10.0 | % | |
| 10.0 | % | |
| 10.0 | % | |
| 10.0 | % |
As
of June 30, 2022, the annual minimum lease payments of the Company’s operating lease liabilities were as follows:
Schedule of Operating Lease Minimum Lease Payments
| |
As of June 30, 2022 | |
| |
Platt | | |
2021 Baltimore | | |
| |
| |
Street Lease | | |
Lease | | |
Total | |
For Years Ending December 31, | |
| | | |
| | | |
| | |
2022 (six months) | |
$ | 11,015 | | |
$ | 26,532 | | |
$ | 37,547 | |
2023 | |
| 22,485 | | |
| 54,520 | | |
| 77,005 | |
2024 | |
| 23,103 | | |
| 51,348 | | |
| - | |
2025 | |
| 5,814 | | |
| - | | |
| 5,814 | |
Total future minimum lease payments, undiscounted | |
$ | 62,417 | | |
$ | 132,400 | | |
$ | 120,366 | |
Less: Imputed interest | |
| 152 | | |
| 934 | | |
| 1,086 | |
Present value of future minimum lease payments | |
$ | 62,265 | | |
$ | 131,466 | | |
$ | 193,731 | |
(p)
Revenue Recognition
The
Company will recognize revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that
a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration
to which the company expects to be entitled in exchange for those goods or services. The Company only applies the five-step model to
contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods and services
transferred to the customer. The following five steps are applied to achieve that core principle:
|
1) |
Identify
the contract with the customer |
|
2) |
Identify
the performance obligations in the contract |
|
3) |
Determine
the transaction price |
|
4) |
Allocate
the transaction price to the performance obligations in the contract |
|
5) |
Recognize
revenue when the company satisfies a performance obligation |
(q)
Income Taxes
The
Company utilizes an asset and liability approach for financial accounting and reporting for income taxes. The provision for income taxes
is based upon income or loss after adjustment for those permanent items that are not considered in the determination of taxable income.
Deferred income taxes represent the tax effects of differences between the financial reporting and tax basis of the Company’s assets
and liabilities at the enacted tax rates in effect for the years in which the differences are expected to reverse.
The
Company evaluates the recoverability of deferred tax assets and establishes a valuation allowance when it is more likely than not that
some portion or all the deferred tax assets will not be realized. Management makes judgments as to the interpretation of the tax laws
that might be challenged upon an audit and cause changes to previous estimates of tax liability. In management’s opinion, adequate
provisions for income taxes have been made. If actual taxable income by tax jurisdiction varies from estimates, additional allowances
or reversals of reserves may be necessary.
Tax
benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The
amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement.
A liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that
do not meet these recognition and measurement standards. As of June 30, 2022, and December 31, 2021, no liability for unrecognized tax
benefits was required to be reported.
There
is no income tax benefit for the losses for the three and six months ended June 30, 2022 and 2021 since management has determined that
the realization of the net deferred assets is not assured and has created a valuation allowance for the entire amount of such tax benefits.
The
Company’s policy for recording interest and penalties associated with tax audits is to record such items as a component of general
and administrative expense. There were no amounts accrued for penalties and interest for the three and six months ended June 30, 2022
and 2021. The Company does not expect its uncertain tax position to change during the next twelve months. Management is currently unaware
of any issues under review that could result in significant payments, accruals or material deviations from its position.
(r)
Basic and Diluted Earnings per Share of Common Stock
Basic
earnings per common share is based on the weighted average number of shares outstanding during the periods presented. Diluted earnings
per share is computed using the weighted average number of common shares plus dilutive common share equivalents outstanding during the
period. Potential common shares that would have the effect of increasing diluted earnings per share are considered anti-dilutive.
Diluted
net loss per share is computed using the weighted average number of shares of common and dilutive potential common stock outstanding
during the period.
As
the Company reported a net loss for the three and six months ended June 30, 2022 and 2021, common stock equivalents were anti-dilutive.
The
following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have
been anti-dilutive:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2022 | | |
2021 | | |
2022 | | |
2021 | |
Stock Options | |
| 4,476,737 | | |
| 4,188,315 | | |
| 4,476,737 | | |
| 4,188,315 | |
Warrants to purchase common stock | |
| 5,072,432 | | |
| 5,363,547 | | |
| 5,072,432 | | |
| 5,363,547 | |
Pre-funded Warrants to purchase common stock | |
| 135,135 | | |
| 520,270 | | |
| 135,135 | | |
| 520,270 | |
Unvested Restricted Stock Units | |
| 2,795,000 | | |
| - | | |
| 2,795,000 | | |
| - | |
Series D Preferred Convertible Stock | |
| 36,496 | | |
| 36,496 | | |
| 36,496 | | |
| 36,496 | |
Warrants to purchase Series C Preferred stock | |
| 27,500 | | |
| 27,500 | | |
| 27,500 | | |
| 27,500 | |
Total potentially dilutive shares | |
| 12,543,300 | | |
| 10,136,128 | | |
| 12,543,300 | | |
| 10,136,128 | |
(s)
Stock-based Payments
The
Company accounts for stock-based compensation under the provisions of Financial Accounting Standards Board (FASB) Accounting Standards
Codification (ASC) 718, “Compensation - Stock Compensation”, which requires the measurement and recognition of compensation
expense for all stock-based awards made to employees and directors based on estimated fair values on the grant date. The Company estimates
the fair value of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is
ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method. In June 2018,
the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment
Accounting (the “2018 Update”). The amendments in the 2018 Update expand the scope of Topic 718 to include share-based payment
transactions for acquiring goods and services from nonemployees. Prior to the 2018 Update, Topic 718 applied only to share-based transactions
to employees. Consistent with the accounting requirement for employee share-based payment awards, nonemployee share-based payment awards
within the scope of Topic 718 are measured at grant-date fair value of the equity instruments that an entity is obligated to issue when
the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the
instruments have been satisfied.
The
Company has elected to account for forfeiture of stock-based awards as they occur.
(t)
Reclassifications
Certain
prior year amounts have been reclassified to conform to the current year’s presentation.
(u)
Recently Issued Accounting Pronouncements
Recently
Issued Accounting Pronouncements Adopted
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt - Modifications and Extinguishments (Subtopic 470-50),
Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40),
Issuer’s Accounting for Certain Modifications or Exchanges or Freestanding Equity - Classified Written Call Options. The amendments
in this Update clarify an issuer’s accounting for modifications or exchanges of freestanding equity - classified written call options
(for example, warrants) that remain equity classified after modification or exchange. The amendments are effective for all entities for
fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply the amendments
prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted for
all entities, including adoption in an interim period. If an entity elects to early adopt the amendments in this Update in an interim
period, the guidance should be applied as of the beginning of the fiscal year that includes the interim period. The adoption of this
ASU had no material impact on the Company’s condensed consolidated financial statements and related disclosure.
Recently
Issued Accounting Pronouncements Not Adopted
In
June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial
Instruments (“ASU-2016-13”). ASU 2016-13 affects loans, debt securities, trade receivables, and any other financial assets
that have the contractual right to receive cash. The ASU requires an entity to recognize expected credit losses rather than incurred
losses for financial assets. ASU 2016-13 is effective for the fiscal year beginning after December 15, 2022, including interim periods
within that fiscal year. The Company expects that there would be no material impact on the Company’s condensed consolidated financial
statements upon the adoption of this ASU.
Note
3 – Recent Developments, Liquidity and Management’s Plans
Acquisition
and Disposition of Cystron
The
Company acquired 100% of the membership interests of Cystron pursuant to a Membership Interest Purchase Agreement, dated March 23, 2020
(as amended by Amendment No. 1 on May 14, 2020, the “MIPA”) from certain selling parties (the “Cystron Sellers”).
The acquisition of Cystron was accounted for as a purchase of an asset. Cystron is a party to a License and Development Agreement (as
amended and restated on March 19, 2020, in connection with our entry into the MIPA, the “License Agreement”) with Premas
Biotech PVT Ltd. (“Premas”) whereby Premas granted Cystron, amongst other things, an exclusive license with respect to Premas’
vaccine platform for the development of a vaccine against COVID-19 and other coronavirus infections. Cystron was incorporated on March
10, 2020. Since its formation and through the date of its acquisition by the Company, Cystron did not have any employees and its sole
asset consisted of the exclusive license from Premas.
On
March 18, 2021, the Company and the Cystron Sellers, which are also shareholders of Oravax, entered into a Termination and Release Agreement
terminating the MIPA effective upon consummation of the Contribution Agreement. In addition, the Cystron Sellers agreed to waive any
change of control payment triggered under the MIPA as a result of the Merger.
On
April 16, 2021, pursuant to the Contribution and Assignment Agreement, dated March 18, 2021 (the “Contribution Agreement”)
by and among the Company, Cystron, Oravax and, for the limited purpose set forth therein, Premas, the parties consummated the transactions
contemplated therein. Pursuant to the Contribution Agreement, among other things, the Company caused Cystron to contribute substantially
all of the assets associated with its business of developing and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax (the
“Contribution Transaction”).
As
of December 31, 2021, all amounts due to Premas under the Contribution Agreement have been paid. (Note: Pursuant to the Contribution
Agreement, a total of $1,500,000 was owed to Premas, of which $1,200,000 was paid by pre-merger Akers Biosciences, Inc.)
Agreement
and Plan of Merger and Reorganization
On
November 11, 2020, MyMD, Merger Sub, and MyMD Florida entered into the Merger Agreement (Note 1).
Upon
completion of the Merger and the transactions contemplated in the Merger Agreement, the Company issued 28,553,307 post reverse stock
split shares of Company Common Stock to the former stakeholders of pre-Merger MyMD Florida at the Exchange Ratio. Upon completion of
the Merger and the transactions contemplated in the Merger Agreement, the former stakeholders of pre-Merger MyMD Florida held approximately
77.05% of the Company’s Common Stock outstanding on a fully diluted basis, assuming the exercise in full of the pre-funded warrants
to purchase 986,486 shares of Company Common Stock and including 4,188,315 shares of Company Common Stock underlying options to purchase
shares of pre-Merger MyMD Florida Common Stock assumed by the company at closing and after adjustments based on the Company’s net
cash at closing. Holders of pre-Merger common stock of the Company held approximately 22.95% of the outstanding equity of the Company.
Also upon completion of the Merger and the transactions contemplated by the Merger Agreement, the Company assumed 4,188,315 MyMD Florida
stock options subject to certain terms contained in the Merger Agreement (including, but not limited to, the amendment of such stock
option to extend the term of such stock option for a period expiring on April 16, 2023, the second-year anniversary of the Merger.
In
accordance with ASC 805, the Company accounted for the transaction as a reverse merger with Akers Biosciences, Inc.
(“Akers”) as the legal acquirer and pre-Merger MyMD Florida as the accounting acquirer. As a result of the transaction,
the Company recognized Goodwill totalling $10,498,539
based upon Akers’ pre-merger market capitalization of $42,477,346
less net tangible assets of $31,978,807.
Akers’
valuation was based upon 8,335,627 common shares outstanding and 263,026 vested restricted stock units (“RSU’) with a fair
market value of $4.94 per share, the closing price of Akers common shares on the NASDAQ Stock Exchange on April 16, 2021.
Schedule of Net Assets Acquired to be Allocated to Goodwill
| |
Valuation Analysis | |
| |
| |
Total Consideration | |
$ | 42,477,346 | |
Cash and Cash Equivalents | |
| 1,380,852 | |
Marketable Securities | |
| 29,480,524 | |
Other Receivables | |
| 3,026,137 | |
Prepaid Expenses | |
| 192,314 | |
Investment in Oravax, Inc. | |
| 1,500,000 | |
Trade and Other Payables | |
| (3,601,020 | ) |
Net Tangible Assets Acquired | |
$ | 31,978,807 | |
Excess of Purchase Price Over Net Assets Acquired to be Allocated to Goodwill | |
$ | 10,498,539 | |
The
holders of approximately 49.68% of outstanding shares of Company Common Stock are subject to lockup agreements pursuant to which such
stockholders have agreed, except in limited circumstances, not to transfer, grant an option with respect to, sell, exchange, pledge or
otherwise dispose of, or encumber, any shares of Company capital stock for 180 days following the effective time of the Merger. For the
subsequent 180 days after the initial 180-day lock-up period, any disposal of Company Common Stock must be only in accordance with the
volume limitations set forth in paragraph (2) of Rule 144 promulgated under the Securities Act of 1933, as amended (the “Act”).
Pursuant
to the terms and conditions of the Merger Agreement, not later than 30 days after the Option Exercise Period, the Company will pay stockholders
of MyMD Florida the Additional Consideration from the exercise of any MyMD Florida options assumed by the Company prior to the second-year
anniversary of the Merger; provided, however, the amount of such payment will not exceed the maximum amount of cash consideration that
may be received by stockholders of MyMD Florida without affecting the intended tax consequences of the Merger. As of the date of this
report, there have been no exercises of the MyMD Florida options assumed by the Company.
Under
the terms of the Merger Agreement, the Company has agreed to pay contingent consideration in combined company common stock to MYMD Florida
stockholders if the combined company meets certain market capitalization milestones, referred to as Milestone Events, during the period
commencing on the business day following the closing date of the merger and ending on the 36 month anniversary of such date, referred
to as the Milestone Period. The Milestone Events and corresponding Milestone Payments are set forth in the table below.
Summary of Milestone Events Payment
Milestone
Event |
|
Milestone
Payment |
Market
capitalization of the combined company for at least ten (10) trading days during any 20 consecutive trading day period during the
Milestone Period is equal to or greater than $500,000,000 (the “First Milestone Event”). |
|
$20,000,000 |
|
|
|
For
every $250,000,000 incremental increase in market capitalization of the combined company after the First Milestone Event to the extent
such incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone Period,
up to a $1,000,000,000 market capitalization of the combined company. |
|
$10,000,000
per each incremental increase (it being understood, however, that, if such incremental increase results in market capitalization
equal to $1,000,000,000, such $10,000,000 payment in respect of such incremental increase shall be payable without duplication of
any amount payable in respect of a Second Milestone Event, as defined below). |
|
|
|
Market
capitalization of the combined company for at least 10 trading days during any 20 consecutive trading day period during the Milestone
Period is equal to or greater than $1,000,000,000 (the “Second Milestone Event”) |
|
$25,000,000 |
|
|
|
For
every $1,000,000,000 incremental increase in market capitalization of the combined company after the Second Milestone Event to the
extent such incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone
Period. |
|
$25,000,000
per each incremental increase |
For
purposes of the table above, “market capitalization” means, with respect to any trading day, the product of (i) the total
outstanding shares of the combined company common stock and (ii) the volume weighted average trading price for the combined company common
stock for such trading day.
Liquidity
As
of June 30, 2022, the Company’s cash on hand was $1,115,174 and marketable securities were $4,505,825. The Company has incurred
a net loss from operations of $ for the six months ended June 30, 2022. As of June 30, 2022, the Company had working capital
of $4,089,352 and stockholders’ equity of $16,118,343 including an accumulated deficit of $86,319,645. During the six months ended
June 30, 2022, cash flows used in operating activities were $5,934,245, consisting primarily of a net loss of $7,758,077 offset by an
increase in trade and other payables of $1,854,909. Since its inception, the Company has met its liquidity requirements principally through
the sale of its common stock in public and private placements.
The Company evaluated the
current cash requirements for operations in conjunction with management’s strategic plan and believes that the Company’s current
financial resources as of the date of the issuance of these condensed consolidated financial statements, inclusive of the funding obtained
through the definitive agreement executed on August 15, 2022 (Note 13), are sufficient to fund its current operating budget and contractual
obligations as of June 30, 2022 as they fall due within the next twelve-month period, alleviating any substantial doubt raised by the
Company’s historical operating results and satisfying its estimated liquidity needs for twelve months from the issuance of these
condensed consolidated financial statements.
Note
4 – Trade and Other Payables
Trade
and other payables consist of the following:
Schedule of Trade and Other Payables
| |
June 30, 2022 | | |
December 31, 2021 | |
| |
| | |
| |
Accounts Payable – Trade | |
$ | 2,618,109 | | |
$ | 867,518 | |
Accrued Expenses | |
| 223,426 | | |
| 119,108 | |
Trade and other payables,
Total | |
$ | 2,841,535 | | |
$ | 986,626 | |
Note
5 – Notes Payable
Secured
Promissory Note
On
November 11, 2020, concurrently with the execution of the Merger Agreement, the Company agreed to provide a bridge loan up to an aggregate
principal amount of $3,000,000 to pre-Merger MyMD Florida pursuant to the Bridge Loan Note. Advances under the Bridge Loan Note (“Bridge
Loan Advances”) were made in the amounts and at the times as needed to fund MyMD Florida’s operating expenses. Bridge Loan
Advances accrue interest at 5% per annum, which may be increased to % per annum upon occurrence of any event of default, from the date
of such default. The principal and the accrued interest thereon are to be repaid on the earliest of (a) April 15, 2022; (b); if the Merger
was consummated, then upon demand of the Company following the consummation of the Merger; or (c) the date on which the obligations under
the Bridge Loan Note are accelerated upon event of default as set forth in the Bridge Loan Note. The payment and performance of all obligations
under the Bridge Loan Note are secured by a first priority security interest in all of MyMD Florida’s right, title and interest
in and to its assets as collateral. The outstanding principal amount and the accrued interest of the Bridge Loan Note were convertible
into shares of MyMD Florida Common Stock in accordance with the terms of the Merger Agreement.
As
of June 30, 2022 and December 31, 2021 MyMD had advanced MyMD Florida $3,000,000 under the Bridge Loan Note plus accrued interest totalling
$26,137. The balance of $3,026,137 as of June 30, 2022 and December 31, 2021, respectively, were eliminated on consolidation.
Note
6 – Stock-based Payments
Equity
incentive Plans
2013
Stock Incentive Plan
On
January 23, 2014, the Company adopted the 2013 Stock Incentive Plan (“2013 Plan”). The 2013 Plan was amended by the Board
on January 9, 2015 and September 30, 2016, and such amendments were ratified by shareholders on December 7, 2018. The 2013 Plan provides
for the issuance of up to 2,162 shares of the Company’s common stock. As of June 30, 2022, grants of restricted stock and options
to purchase 1,406 shares of Common Stock have been issued pursuant to the 2013 Plan, and 756 shares of Common Stock remain available
for issuance.
2016
Stock Incentive Plan
On
December 21, 2016, the shareholders approved, and the Company adopted the 2016 Stock Incentive Plan (“2016 Plan”). The 2016
Plan provides for the issuance of up to 50,000,000 shares of the Company’s common stock. As of June 30, 2022, grants of options
to purchase 4,188,315 shares of Common Stock have been issued pursuant to the 2016 Plan, and 0 shares of Common Stock remain available
for issuance.
2017
Stock Incentive Plan
On
August 7, 2017, the shareholders approved, and the Company adopted the 2017 Stock Incentive Plan (“2017 Plan”). The 2017
Plan provides for the issuance of up to 3,516 shares of the Company’s common stock. As of June 30, 2022, grants of restricted stock
and options to purchase 2,538 shares of Common Stock have been issued pursuant to the 2017 Plan, and 978 shares of Common Stock remain
available for issuance.
2018
Stock Incentive Plan
On
December 7, 2018, the shareholders approved, and the Company adopted the 2018 Stock Incentive Plan (“2018 Plan”). On August
27, 2020, the 2019 Plan was modified to increase the total authorized shares. The 2018 Plan, as amended, provides for the issuance of
up to 560,063 shares of the Company’s common stock. As of June 30, 2022, grants of RSUs and restricted stock to purchase 263,026
shares of Common Stock have been issued pursuant to the 2018 Plan, and 297,037 shares of Common Stock remain available for issuance.
2021
Stock Incentive Plan
On
April 15, 2021, the shareholders approved, and the Company adopted the 2021 Stock Incentive Plan (“2021 Plan”). The 2021
Plan provides for the issuance of up to 7,228,184 shares of the Company’s common stock. As of June 30, 2022, grants of RSUs and
stock options to purchase 3,099,040 shares of Common Stock have been issued pursuant to the 2021 Plan, and 4,129,144 shares of Common
Stock remain available for issuance.
Stock
Options
The
following table summarizes the activities for MyMD stock options for the six months ended June 30, 2022:
Summary of Stock Options Activity
| |
| | |
| | |
| | |
Weighted | | |
| |
| |
| | |
| | |
| | |
Average | | |
| |
| |
| | |
Weighted | | |
Weighted | | |
Remaining | | |
| |
| |
Number | | |
Average | | |
Average | | |
Contractual | | |
Aggregate | |
| |
of | | |
Exercise | | |
Grant Date | | |
Term | | |
Intrinsic | |
| |
Shares | | |
Price | | |
Fair Value | | |
(years) | | |
Value | |
Balance at December 31, 2021 | |
| 4,176,737 | | |
$ | 2.59 | | |
$ | 2.59 | | |
| 1.29 | | |
$ | 14,493,284 | |
Granted | |
| 300,000 | | |
| 3,41 | | |
| 3.41 | | |
| 6.05 | | |
| - | |
Exercised | |
| | | |
| | | |
| | | |
| | | |
| - | |
Forfeited | |
| - | | |
| - | | |
| - | | |
| | | |
| - | |
Canceled/Expired | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Balance at June 30, 2022 | |
| 4,476,737 | | |
| 2.64 | | |
| 2.64 | | |
| 1.15 | | |
| - | |
Exercisable as of June 30, 2022 | |
| 4,276,737 | | |
| 2.56 | | |
| 2.58 | | |
| 0.89 | | |
| - | |
The
aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price
of $2.17 for the Company’s common shares on June 30, 2022 and the closing stock price of $6.06 for the Company’s common shares
on December 31, 2021.
On
January 28, 2022, the Company’s Compensation Committee approved the issuance of 200,000
stock options under the 2021 Stock Incentive Plan. These shares had a grant date fair value of $3.59
per share or a cumulative fair market value of $717,660
as calculated using Black-Scholes (exercise price $3.96
per share, stock price $3.96
per share, volatility of 124.43%,
discount rate of 1.74%
and seven
year term). The grant was segmented into four vesting tranches triggered by performance achievements and expire on January
28, 2029. The Company is amortizing the expenses over the vesting cycles of the individual tranches.
On
June 21, 2022, the Company granted 100,000
stock options under the 2021 Stock Incentive Plan to a third-party consultant in consideration of services rendered. These shares
had a grant date fair value of $2.30
per share or a cumulative fair market value of $199,360
as calculated using Black-Scholes (exercise price $2.30
per share, stock price $2.30
per share, volatility of 130.51%,
discount rate of 3.24%
and five
year term). The grant vested immediately and expire on June
21, 2027. The Company is amortizing the expense over twelve months, the term of the consulting agreement.
During
the three months ended June 30, 2022 and 2021, the Company incurred stock option expenses totalling $132,246 and $15,036,051, respectively. During
the six months ended June 30, 2022 and 2021, the Company incurred stock option expenses totalling $213,248 and $15,036,051, respectively. The unamortized
stock option expenses as of June 30, 2022 and 2021 totalled $703,772 and $0, respectively.
4,276,737
shares of the Company’s outstanding stock options are fully vested and exercisable.
Assumption
of MyMD Florida Stock Options
In
2016, pre-Merger MyMD Florida adopted the MyMD Pharmaceuticals, Inc. Amended and Restated 2016 Equity Incentive Plan (the “2016
Plan”). The 2016 Plan provided for the issuance of up to 50,000,000 shares of pre-Merger MyMD Florida common stock. As of June
30, 2022, options to purchase 4,188,315 shares of common stock have been issued pursuant to the plan and 0 shares of common stock remain
available for issuance.
Pursuant
to the Merger Agreement, effective as of the effective time of the Merger, the Company assumed pre-Merger MyMD Florida’s Second
Amendment to Amended and Restated 2016 Stock Incentive Plan (the “2016 Plan”), assuming all of pre-Merger MyMD Florida’s
rights and obligations with respect to the options issued thereunder. As of the effective date of the Merger, no additional awards could
be issued under the 2016 Plan.
In
addition, under the terms of the Merger Agreement, the Company assumed all of pre-Merger MyMD Florida’s rights and obligations
under pre-Merger MyMD Florida’s stock options that were outstanding immediately prior to the effective time of the Merger, and
each such stock option, whether or not vested, was converted into a stock option representing the right to purchase shares of Company
Common Stock, on terms substantially the same as those in effect immediately prior to the effective time, except that the number of shares
of Company Common Stock issuable and the exercise price per share of such stock options was adjusted by the Exchange Ratio. Additionally,
the number of shares and exercise price per share of Company Common Stock under the assumed pre-Merger MyMD Florida stock options was
further adjusted by the Reverse Stock Split.
The
Company assumed 4,188,315 MyMD Florida stock options subject to certain terms contained in the Merger Agreement (including, but not limited
to, the amendment of such stock option to change the term of such stock option for a period expiring on April 16, 2023, the second-year
anniversary of the Merger). The Company recorded expenses of $15,036,051 for the assumption of the options and the modification of the
terms which is included on the Condensed Consolidated Statement of Comprehensive Loss for the year ended December 31, 2021. The Company
utilized Black-Scholes using an exercise price of $2.59, an issue date fair value of $4.94, a volatility index of 122.31% and a discount
rate of 0.16% to determine the fair value of the modification. The pre-Merger MyMD options were valued at $0 on April 16, 2021, as there
was no reliable method of determining the fair value given the material events that had occurred since the last arms-length trade of
common shares.
Restricted
Stock Units
On
September 11, 2020, the Compensation Committee of the Board of Directors approved grants totalling 394,680 Restricted Stock Units to the
Company’s four directors. Each RSU had a grant date fair value of $4.48 which shall be amortized on a straight-line basis over
the vesting period into administrative expenses within the Consolidated Statement of Comprehensive Loss. Such RSUs were granted under
the 2018 Plan, as amended. Fifty percent (50%) of each RSU will vest on the first anniversary date of the Grant and the remaining fifty
percent (50%) will vest on the second anniversary date; provided that the RSUs shall vest immediately upon the occurrence of (i) a change
in control, provided that the director is employed by or providing services to the Company and its affiliates on the closing date of
such change of control, or (ii) the director’s termination of employment of service by the Company was without cause.
On
April 16, 2021, concurrently with the closing of the Merger, pursuant to the terms of the RSU Agreements between the Company and four
board of directors, the 394,680 RSUs granted on September 11, 2020 under the 2018 Plan, as amended, accelerated and vested in full.
Per
the terms of the RSU agreements, the Company, at the Company’s sole discretion, may settle the RSUs in cash, or part cash and part
common stock. As there is no intention to settle the RSUs in cash, the Company accounted for these RSUs as equity.
Pre-merger
Akers Biosciences, Inc. recorded expenses totalling $979,758 for the acceleration of the vesting of 394,680 RSUs, the holders immediately
surrendered 139,457 RSUs with a fair market value of $688,913 for the withholding of federal and state income taxes, as directed by the
holders, which was recorded as Payroll Taxes Payable on the date of the Merger. The withholding obligations were paid by the Company
on June 30, 2021. As of August 12, 2022, the vested RSUs have not been converted to common shares of the Company.
On
October 14, 2021, the Compensation Committee of the Board of Directors approved grants totalling 2,795,000 Restricted Stock Units to the
Company’s six directors and seven key employees. Each RSU had a grant date fair value of $8.09 which will be amortized upon vesting
into administrative expenses within the Condensed Consolidated Statement of Comprehensive Loss. Such RSUs were granted under the 2021
Plan. Vesting of each RSU is:
|
● |
One-third
(33%) of each RSU will vest when the Company’s market capitalization is equal to or greater than $500,000,000 for at least
ten trading days during any twenty (20) consecutive trading day period ending on or after December 15, 2021 and the fair market value
of the common stock equals or exceeds $5.00 during such trading day period. |
|
● |
One-third
(33%) of each RSU will vest when the Company’s market capitalization is equal to or greater than $750,000,000 for at least
ten trading days during any twenty (20) consecutive trading day period ending on or after December 15, 2021 and the fair market value
of the common stock equals or exceeds $5.00 during such trading day period. |
|
● |
The
remaining awarded units will vest when the Company’s market capitalization is equal to or greater than $1,000,000,000 for at
least ten trading days during any twenty (20) consecutive trading day period ending on or after December 15, 2021 and the fair market
value of the common stock equals or exceeds $5.00 during such trading day period. |
|
● |
In
the event that (i) a change in control occurs or (ii) the participant incurs a termination of service by the Company without cause
or due to the participant’s death or total and permanent disability, then all unvested units shall become vested units immediately
upon the occurrence of such event. |
On
January 28, 2022, the Compensation Committee of the Board of Directors approved a grant of 4,040 RSUs to a sub-contractor with a grant
date fair value of $3.96 and vested immediately. Such RSUs were granted under the 2021 Plan. The Company recorded expenses of $15,998
which is included Stock Based Compensation on the Condensed Consolidated Statement of Comprehensive Loss.
The
following is the status of outstanding restricted stock units outstanding as of June 30, 2022 and changes for the six months ended June
30, 2022:
Summary of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average | |
| |
Number of | | |
Grant Date | |
| |
RSUs | | |
Fair Value | |
Balance at December 31, 2021 | |
| 2,795,000 | | |
$ | 8.09 | |
Granted | |
| 4,040 | | |
| 3.96 | |
Exercised | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Canceled/Expired | |
| - | | |
| - | |
Balance at June 30, 2022 | |
$ | 2,799,040 | | |
$ | 8.08 | |
Exercisable as of June 30, 2022 | |
$ | 4,040 | | |
$ | 3.96 | |
As
of June 30, 2022 and December 31, 2021, the unamortized value of the RSUs was $22,611,550.
Note
7 – Equity
Preferred
Stock
The
holders of preferred shares or preferred warrants are entitled to vote per share, as limited by the Certificate of Designation for each
class of preferred shares or warrants, at meetings of the Company. As of June 30, 2022, 50,000,000 shares of Preferred Stock were authorized
and four classes of Preferred Stock or Warrants are designated.
Series
D Convertible Preferred Stock
On
March 24, 2020, the Company designated 211,353 Series D Convertible Preferred Shares, no par value with a stated value of $0.01 per share
and filed the Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (the “Certificate
of Designation”) with the Secretary of State of the State of New Jersey. Pursuant to the Certificate of Designation, in the event
of the Company’s liquidation or winding up of its affairs, the holders of its Series D Convertible Preferred Stock (the “Preferred
Stock”) will be entitled to receive the same amount that a holder of the Company’s common stock would receive if the Preferred
Stock were fully converted (disregarding for such purposes any conversion limitations set forth in the Certificate of Designation) to
common stock which amounts shall be paid pari passu with all holders of the Company’s common stock. Each share of Preferred Stock
has a stated value equal to $0.01 (the “Stated Value”), subject to increase as set forth in Section 7 of the Certificate
of Designation.
A
holder of Preferred Stock is entitled at any time to convert any whole or partial number of shares of Preferred Stock into shares of
the Company’s common stock determined by dividing the Stated Value of the Preferred Stock being converted by the conversion price
of $0.01 per share.
A
holder of Preferred Stock will be prohibited from converting Preferred Stock into shares of the Company’s common stock if, as a
result of such conversion, the holder, together with its affiliates, would own more than 4.99% of the total number of shares of the Company’s
common stock then issued and outstanding (with such ownership restriction referred to as the “Beneficial Ownership Limitation”).
However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase
in such percentage shall not be effective until 61 days after such notice to the Company.
Subject
to the Beneficial Ownership Limitation, on any matter presented to the Company’s stockholders for their action or consideration
at any meeting of the Company’s stockholders (or by written consent of stockholders in lieu of a meeting), each holder of Preferred
Stock will be entitled to cast the number of votes equal to the number of whole shares of the Company’s common stock into which
the shares of Preferred Stock beneficially owned by such holder are convertible as of the record date for determining stockholders entitled
to vote on or consent to such matter (taking into account all Preferred Stock beneficially owned by such holder). Except as otherwise
required by law or by the other provisions of the Company’s certificate of incorporation, the holders of Preferred Stock will vote
together with the holders of the Company’s common stock and any other class or series of stock entitled to vote thereon as a single
class.
A
holder of Preferred Stock shall be entitled to receive dividends as and when paid to the holders of the Company’s common stock
on an as-converted basis.
As
of June 30, 2022, the Company had 72,992 shares of Series D Convertible Preferred Stock outstanding which represent 36,496 underlying
shares of the Company Common Stock.
Common
Stock
Pursuant
to the Merger Agreement, on April 16, 2021, the Company filed an amended and restated certificate of incorporation (the “A&R
Charter”) with the Secretary of State of the State of New Jersey, which was approved by the Company’s stockholders on April
15, 2021. Among other things, the A&R Charter (i) changed the Company’s name to MyMD Pharmaceuticals, Inc., (ii) increased
the number of shares of Company Common Stock available from 100,000,000 shares to a total of 500,000,000 shares of the Company’s
Common Stock, (iii) changed the structure of the board of directors from a classified board of three classes to a non-classified board
of a single class, and (iv) simplified and consolidated various provisions.
The
holders of common shares are entitled to one vote per share at meetings of the Company.
On
February 11, 2021, 466,216 shares of common stock issued pursuant to that certain Securities Purchase Agreement, dated November 11, 2020,
by and between the Company and certain institutional and accredited investors were cancelled and 466,216 prefunded warrants (as defined
therein) were issued at the request of a shareholder.
On
May 18, 2021, 466,216 prefunded warrants were exercised in exchange for 466,716 shares of common stock.
On
August 5, 2021, the Company issued 16,826 shares of the Company’s common stock with a fair market value of $90,002 for services.
On
December 9, 2021, holders of 11,576 common stock options were exercised for 11,576 shares of the Company’s common stock at an exercise
price of $2.59 per common share. The net proceeds of $29,982 is recorded as a non-current liability on the Condensed Consolidated Balance
Sheet as of June 30, 2022. The accumulated proceeds from the exercise of these stock options will be distributed to the former shareholders
of MyMD Florida per the terms of the Merger Agreement.
On
February 16, 2022, 385,135 prefunded warrants were exercised in exchange for 385,135 shares of common stock.
Common
Stock Warrants
The
table below summarizes the warrant activity for the six months ended June 30, 2022:
Summary of Warrant Activity
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Contractual | | |
Intrinsic | |
| |
Warrants | | |
Price | | |
Term (years) | | |
Value | |
Balance at December 31, 2021 | |
| 5,074,489 | | |
$ | 5.25 | | |
| 4.34 | | |
$ | 9,554,827 | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | | |
| - | | |
| - | |
Canceled/Expired | |
| (2,057 | ) | |
| 592.49 | | |
| - | | |
| - | |
Balance at June 30, 2022 | |
| 5,072,432 | | |
$ | 5.01 | | |
| 3.85 | | |
$ | - | |
Exercisable as of June 30, 2022 | |
| 5,072,432 | | |
$ | 5.01 | | |
| 3.85 | | |
$ | - | |
The
aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock
price of $2.17
for the Company’s common shares on June 30, 2022 and the closing stock price of $6.06 for the Company’s common shares on
December 31, 2021. All warrants were vested on date of grant.
Pre-funded
Common Stock Warrants
The
table below summarizes the pre-funded warrant activity for the six months ended June 30, 2022:
Summary of Warrant Activity
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Contractual | | |
Intrinsic | |
| |
Warrants | | |
Price | | |
Term (years) | | |
Value | |
Balance at December 31, 2021 | |
| 520,270 | | |
$ | 0.002 | | |
| - | | |
$ | 3,151,796 | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| (385,135 | ) | |
| 0.002 | | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | | |
| - | | |
| - | |
Canceled/Expired | |
| - | | |
| - | | |
| - | | |
| - | |
Balance at June 30, 2022 | |
| 135,135 | | |
$ | 0.002 | | |
| - | | |
$ | 292,973 | |
Exercisable as of June 30, 2022 | |
| 135,135 | | |
$ | 0.002 | | |
| - | | |
$ | 292,973 | |
All
pre-funded warrants were vested on date of grant and are exercisable at any time. The aggregate intrinsic value is calculated as the
difference between the exercise price of the underlying award and the closing stock price of $2.17 for the Company’s common shares
on June 30, 2022.
Series
C Convertible Preferred Stock Warrants
The
table below summarizes the warrant activity for the six months ended June 30, 2022:
Summary of Warrant Activity
| |
| | |
Weighted | | |
Average | | |
| |
| |
| | |
Average | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Exercise | | |
Contractual | | |
Intrinsic | |
| |
Warrants | | |
Price | | |
Term (years) | | |
Value | |
Balance at December 31, 2021 | |
| 27,500 | | |
$ | 8.00 | | |
| 2.94 | | |
$ | - | |
Granted | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | | |
| - | | |
| - | |
Canceled/Expired | |
| - | | |
| - | | |
| - | | |
| - | |
Balance at June 30, 2022 | |
| 27,500 | | |
$ | 8.00 | | |
| 2.45 | | |
$ | - | |
Exercisable as of June 30, 2022 | |
| 27,500 | | |
$ | 8.00 | | |
| 2.45 | | |
$ | - | |
The
aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock
price of $2.17
for the Company’s common shares on June 30, 2022 and the closing stock price of $6.06 for the Company’s common shares on December 31, 2021. All Series C Convertible Preferred Stock Warrants were vested on date of
grant.
Note
8 – Commitments and Contingencies
Scientific
Advisory Board
On
February 1, 2021, the Company formed the Scientific Advisory Board to (i) provide strategic advice and make recommendations to management
regarding current and planned research and development programs, (ii) advise management regarding the scientific merit of technology
or products involved in licensing and acquisition opportunities and (iii) provide strategic advice to management regarding emerging science
and technology issues and trends. During the three months ended June 30, 2022 and 2021, the Company incurred costs of $50,000 and $42,000,
respectively. During the six months ended June 30, 2022 and 2021, the Company incurred costs of $98,000 and $71,000, respectively. These expenses
are included in Research and Development Expenses on the Condensed Consolidated Statement of Comprehensive Loss.
COVID-19
In
December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China and has reached multiple other
countries, resulting in government-imposed quarantines, travel restrictions and other public health safety measures, including in the
United States and India. On March 12, 2020, the WHO declared COVID-19 to be a global pandemic. The various precautionary measures taken
by many governmental authorities around the world in order to limit the spread of COVID-19 have had and may continue to have an adverse
effect on the global markets and global economy. Such government-imposed precautionary measures may have been relaxed in certain countries
or states, but there is no assurance that more strict measures will not be put in place again due to a resurgence in COVID-19 cases.
The
ultimate impact of the global COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to change. We do not yet
know the full extent of potential delays or impacts on the Company’s business, vaccine development efforts, healthcare systems
or the global economy as a whole. However, the effects have had and will likely continue to have a material impact on the Company’s
operations, liquidity and capital resources, and the Company will continue to monitor the COVID-19 situation closely.
In
response to public health directives and orders, the Company has implemented and continues to maintain work-from-home policies for many
of the Company’s employees and temporarily modified the Company’s operations to comply with applicable social distancing
recommendations. The effects of the orders and the Company’s related adjustments in its business are likely to negatively impact
productivity, disrupt its business and delay the Company’s timelines, the magnitude of which will depend, in part, on the length
and severity of the restrictions and other limitations on its ability to conduct its business in the ordinary course. Similar health
directives and orders are affecting third parties with whom we do business. Further, restrictions on the Company’s ability to travel,
stay-at-home orders and other similar restrictions on its business have limited and may continue to limit its ability to support its
operations.
Severe
and/or long-term disruptions in the Company’s operations will negatively impact the Company’s business, operating results
and financial condition in other ways as well. Specifically, the Company anticipates that the stress of COVID-19 on healthcare systems
generally around the globe will negatively impact regulatory authorities and the third parties that the Company may engage in connection
with the development and testing of its product candidates.
The
anticipated economic consequences of the COVID-19 pandemic have adversely impacted financial markets, resulting in high share price volatility,
reduced market liquidity, and substantial declines in the market prices of the shares of most publicly traded companies, including MyMD.
Volatile or declining markets for equities could adversely affect the Company’s ability to raise capital when needed through the
sale of shares of common stock or other equity securities. Should these market conditions persist when the Company needs to raise capital,
and if the Company is able to sell shares of its common stock under then prevailing market conditions, it might have to accept lower
prices for its shares and issue a larger number of shares than might have been the case under better market conditions, resulting in
significant dilution of the interests of the Company’s shareholders.
Litigation
and Settlements
Raymond
Akers Actions
On
April 14, 2021, Raymond F. Akers, Jr., Ph.D. filed a lawsuit against MyMD Pharmaceuticals, Inc. (p/k/a Akers Biosciences, Inc.) in the
Superior Court of New Jersey, Law Division, Gloucester County (the “First Raymond Akers Action”). Mr. Akers asserts one common
law whistleblower retaliation claim against the Company.
On
September 23, 2021, the Court granted MyMD Pharmaceutical, Inc.’s (“MyMD’s”) Motion to Dismiss Plaintiff’s Amended
Complaint and dismissed Plaintiff’s Amended Complaint. The Court indicated that Mr. Akers is “free to file another complaint,
however, tort-based ‘Pierce’ allegations, and/or CEPA claims are barred by the statute of limitations.”
On
March 1, 2022, Mr. Akers filed a second action against MyMD in the Superior Court of New Jersey, Law Division, Gloucester County (the
“Second Raymond Akers Action”) again asserting one common law whistleblower retaliation claim against the Company. The Company
believes that the Second Raymond Akers Action is without merit and, moreover, was filed against the Court’s specific admonition
that Plaintiff does not attempt to circumvent the statute of limitations.
On May 27, 2022,
the Court granted-in-part and denied-in-part MyMD’s Motion to Dismiss Plaintiff’s Complaint. The Court reaffirmed the ruling
in the First Raymond Akers Action that any tort-based Pierce claims are time-barred. However, the Court denied the Motion as it pertained
to Plaintiff’s contract-based Pierce claim and “Repayment of Monies Owed” claim. On July 29, 2022, MyMD filed its Answer,
which included affirmative defences.
All
legal fees incurred were expensed as and when incurred.
Note
9 – Related Parties
SRQ
Patent Holdings and SRQ Patent Holdings II
MyMD
is a party to two Amended and Restated Confirmatory Patent Assignment and Royalty Agreements, both dated November 11, 2020, with SRQ
Patent Holdings and SRQ Patent Holdings II, under which MyMD (or its successor) will be obligated to pay to SRQ Patent Holdings or SRQ
Patent Holdings II (or its designees) certain royalties on product sales or other revenue received on products that incorporate or are
covered by the intellectual property that was assigned to MyMD. The royalty is equal to 8% of the net sales price on product sales and,
without duplication, 8% of milestone revenue or sublicense compensation. SRQ Patent Holdings and SRQ Patent Holdings II are affiliates
of Mr. Jonnie Williams, Sr. No revenue has been received subject to these agreements as of June 30, 2022 and 2021.
Mr.
Jonnie Williams, Sr.
The
Company recorded an obligation to Mr. Williams, a shareholder, for various expenses incurred on behalf of the Company between 2016 and
2019. The balance due of $14,577 was paid on April 28, 2021.
Supera
Aviation I, LLC
In
October 2018, the Company entered a three-year leasing agreement with Supera Aviation I, LLC, a company owned by a shareholder, for a
Gulfstream IV-SP aircraft with an annual leasing fee of $600,000. The Company incurred expenses totalling $150,000 for the six months
ended June 30, 2021.
On
April 28, 2021, the Company reached a negotiated settlement with Supera Aviation I, LLC to retire the $627,042 debt due under the leasing
agreement for $517,384.
Lines
of credit payable
In
November 2018, Supera entered into a revolving credit facility which allows for borrowings of up to $1,000,000 with a shareholder. The
facility had an initial term of 38 months, which was extended to December 31, 2022 at which time all outstanding borrowings and accrued
interest, if any, are due in full. Borrowings accrue interest at a rate of 5% per annum.
In
May 2019, the pre-Merger MyMD entered into a revolving credit facility which allows for borrowings of up to $5,000,000 with a shareholder.
The facility had an initial term of 18 months, which was extended to July 31, 2021 and further extended to December 31, 2022, at which
time all outstanding borrowings and accrued interest, if any, are due in full. Borrowings accrue interest at a rate of 5% per annum.
Pursuant to the terms of the agreement, the Company must issue a number of common stock options to the lender based on the total borrowings
under the facility, with each dollar borrowed requiring the issuance of one common stock option. Upon issuance, each common stock option
will immediately vest at an exercise price of $2.59. The Company recorded accretion of the debt discount totalling $0 and $608,460, respectively,
during the three and six months ended June 30, 2021.
On
April 28, 2021, in accordance with the Merger, the Company paid $3,208,426, inclusive of interest and net of the debt discount, to retire
the amounts due to the shareholder under the two lines of credit as of April 28, 2021.
Note
10 – Employee Benefit Plan
The
Company maintains a defined contribution benefit plan under section 401(k) of the Internal Revenue Code covering substantially all qualified
employees of the Company (the “401(k) Plan”). Under the 401(k) Plan, the Company matches 100% up to a 3% contribution, and
50% over a 3% contribution, up to a maximum of 5%.
The
Company made matching contributions to the 401(k) Plan during the three months ended June 30, 2022 and 2021 of $11,849 and $2,888, respectively.
The Company made matching contributions to the 401(k) Plan during the six months ended June 30, 2022 and 2021 of $20,598 and $2,888,
respectively.
Note
11—Paycheck Protection Program Loan
On
April 16, 2020, the Company received loan proceeds in the amount of approximately $70,600 under the Paycheck Protection Program (“PPP”).
The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to
qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. The loans and accrued
interest are forgivable as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities,
and maintains its payroll levels.
The
amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the eight-week period. The
unforgiven portion of the PPP loan is payable over two years at an annual interest rate of 1%, with a deferral of payments through the
date that the Small Business Administration remits the borrower’s loan forgiveness amount to the lender. The Company was notified
on June 1, 2021 that the loan totalling $70,600 was forgiven which was recorded as a gain on debt forgiveness on the Condensed Consolidated
Statement of Comprehensive Loss.
Note
12—Patent assignment and royalty agreement
In
November 2016, the Company entered into an agreement with the holders of certain intellectual property relating to the Company’s
current product candidate. Under the terms of the agreement, the counterparty assigned its rights and interest in certain patents to
the Company in exchange for future royalty payments based on a fixed percentage of future revenues, as defined. The agreement is effective
until the later of (1) the date of expiration of the assigned patents or (2) the date of expiration of the last strategic partnership
or licensing agreement including the assigned patents.
Note
13 – Subsequent Events
On
July 7, 2022, the Company agreed to issue 50,167 shares of restricted common stock with a fair market value of $2.99 per share or $150,000
and 38,265 common stock warrants with an exercise price of $5.48 with a fair market value of $75,000 to a vendor for marketing services.
August 2022
Offering
On
August 15, 2022, the Company entered into a definitive agreement to sell 1,411,764
shares of Common Stock in a registered direct offering and issue warrants to purchase up to 1,411,764
shares of Common Stock in a private placement for gross proceeds of approximately $6.0
million, before deducting placement agent fees and offering expenses payable by the Company. Dawson James Securities, Inc. acted as
lead placement agent for the offering and Katalyst Securities served as a financial advisor.
All
of the securities being sold in the offering were offered by MyMD. At closing, the Company expects to receive net proceeds from the offering of approximately
$5.4 million, after deducting placement agent fees and offering expenses payable by the Company. The Company intends to use
the net proceeds from this offering for working capital and to fund other general corporate purposes.
Item
2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations.
The
information set forth below should be read in conjunction with our condensed consolidated financial statements and related notes
thereto included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis contains forward-looking statements
based on our current expectations, assumptions, estimates and projections. These forward-looking statements involve risks and
uncertainties. Our actual results could differ materially from those indicated in these forward-looking statements as a result of
certain factors, including those discussed in Part II, Item 1A of this Quarterly Report on Form 10-Q, entitled “Risk
Factors.” References in this discussion and analysis to “us,” “we,” “our,” or “the
Company” refer collectively to MyMD Pharmaceuticals, Inc.
Our
financial statements are prepared in accordance with GAAP. These accounting principles require us to make certain estimates, judgments
and assumptions. We believe that the estimates, judgments and assumptions upon which we rely are reasonable based upon information available
to us at the time that these estimates, judgments and assumptions are made. These estimates, judgments and assumptions can affect the
reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of expenses during
the periods presented. Our financial statements would be affected to the extent there are material differences between these estimates
and actual results. In many cases, the accounting treatment of a particular transaction is specifically dictated by GAAP and does not
require management’s judgment in its application. There are also areas in which management’s judgment in selecting any available
alternative would not produce a materially different result. The following discussion should be read in conjunction with our financial
statements and notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q.
This
Quarterly Report on Form 10-Q and other reports filed by the Company from time to time with the Securities and Exchange Commission (the
“SEC” and such reports, collectively, the “Filings”) contain or may contain forward-looking statements and information
that are based upon beliefs of, and information currently available to, the Company’s management as well as estimates and assumptions
made by Company’s management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are
only predictions and speak only as of the date hereof. When used in the Filings, the words “anticipate,” “believe,”
“estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these
terms and similar expressions as they relate to the Company or the Company’s management identify forward-looking statements. Such
statements reflect the current view of the Company with respect to future events and are subject to risks, uncertainties, assumptions,
and other factors, including the risks relating to the Company’s business, industry, and the Company’s operations and results
of operations. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect,
actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned.
Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States,
we do not intend to update any of the forward-looking statements to conform these statements to actual results.
Important
factors that could cause actual results to differ materially from the results and events anticipated or implied by such forward-looking
statements include, but are not limited to:
|
● |
fluctuation
and volatility in market price of our common stock due to market and industry factors, as well as general economic, political and
market conditions; |
|
● |
the
impact of dilution on our shareholders; |
|
● |
our
ability to realize the intended benefits of the Merger (as defined below) and the Contribution Transaction (as defined below); |
|
● |
the
impact of our ability to realize the anticipated tax impact of the Merger; |
|
● |
the
outcome of litigation or other proceedings we may become subject to in the future; |
|
● |
delisting
of our common stock from the Nasdaq; |
|
● |
our
availability and ability to continue to obtain sufficient funding to conduct planned research and development efforts and realize
potential profits; |
|
● |
our
ability to develop and commercialize our product candidates, including MYMD-1, Supera-CBD and other future product candidates; |
|
● |
the
impact of the complexity of the regulatory landscape on our ability to seek and obtain regulatory approval for our product candidates,
both within and outside of the U.S.; |
|
● |
the
required investment of substantial time, resources and effort for successful clinical development and marketization of our product
candidates; |
|
● |
challenges
we may face with maintaining regulatory approval, if achieved; |
|
● |
the
potential impact of changes in the legal and regulatory landscape, both within and outside of the U.S.; |
|
● |
the
impact of the ongoing COVID-19 pandemic on the administration, funding and policies of regulatory authorities, both within and outside
of the U.S.; |
|
● |
our
dependence on third parties to conduct pre-clinical and clinical trials and manufacture its product candidates; |
|
● |
the
impact of the ongoing COVID-19 pandemic on our results of operations, business plan and the global economy; |
|
● |
challenges
we may face with respect to our product candidates achieving market acceptance by providers, patients, patient advocacy groups, third
party payors and the general medical community; |
|
● |
the
impact of pricing, insurance coverage and reimbursement status of our product candidates; |
|
● |
emerging
competition and rapidly advancing technology in our industry; |
|
● |
our
ability to obtain, maintain and protect our trade secrets or other proprietary rights, operate without infringing upon the proprietary
rights of others and prevent others from infringing on its proprietary rights; |
|
● |
our
ability to maintain adequate cyber security and information systems; |
|
● |
our
ability to achieve the expected benefits and costs of the transactions related to the acquisition of Supera Pharmaceuticals, Inc.
(“Supera”); |
|
● |
our
ability to effectively execute and deliver our plans related to commercialization, marketing and manufacturing capabilities and strategy; |
|
● |
emerging
competition and rapidly advancing technology in our industry; |
|
● |
our
ability to obtain adequate financing in the future on reasonable terms, as and when we need it; |
|
● |
challenges
we may face in identifying, acquiring and operating new business opportunities; |
|
● |
our
ability to retain and attract senior management and other key employees; |
|
● |
our
ability to quickly and effectively respond to new technological developments; |
|
● |
changes
in political, economic or regulatory conditions generally and in the markets in which we operate; and |
|
● |
our
compliance with all laws, rules, and regulations applicable to our business. |
Overview
Following
the closing of the Merger and the Contribution Transaction described below that occurred on April 16, 2021, we have been focused on developing
and commercializing two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and Supera-CBD:
|
● |
MYMD-1
is a clinical stage small molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited
to) multiple sclerosis, diabetes, rheumatoid arthritis, and inflammatory bowel disease. MYMD-1 is being developed to treat age-related
illnesses such as frailty and sarcopenia. MYMD-1 works by regulating the release of numerous pro-inflammatory cytokines, such as
TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”). MYMD-1 currently is being evaluated in
patients with sarcopenia (age-related muscle loss). The company has significant intellectual property coverage to protect these autoimmune
indications, as well as therapy as an anti-aging product; |
|
|
|
|
● |
Supera-CBD
is a synthetic analog of cannabidiol (“CBD”) being developed to treat various conditions, including, but not limited
to, epilepsy, pain, and anxiety/depression, through its effects on the CB2 receptor, and a monoamine oxidase enzyme (“MAO”)
type B. Supera-CBD has shown tremendous promise in treating neuroinflammatory and neurodegenerative diseases, and will be a major
focus as the Company moves forward. |
The
rights to Supera-CBD were previously owned by Supera and were acquired by MyMD Florida (as defined below) immediately prior to the closing
of the Merger.
Closing
of the Merger and Reverse Stock Split
On
April 16, 2021, pursuant to the previously announced Agreement and Plan of Merger and Reorganization, dated November 11, 2020 (the “Original
Merger Agreement”), as amended by Amendment No. 1 thereto, dated March 16, 2021 (the Original Merger Agreement, as amended by Amendment
No. 1, the “Merger Agreement”), by and among MyMD, a New Jersey corporation previously known as Akers Biosciences, Inc.,
XYZ Merger Sub, Inc. (“Merger Sub”), and MyMD Pharmaceuticals (Florida), Inc., a Florida corporation previously known as
MyMD Pharmaceuticals, Inc. (“MyMD Florida”), Merger Sub was merged with and into MyMD Florida, with MyMD Florida continuing
after the merger as the surviving entity and a wholly owned subsidiary of the Company (the “Merger”). At the effective time
of the Merger, without any action on the part of any stockholder, each issued and outstanding share of pre-Merger MyMD Florida’s
common stock, par value $0.001 per share (the “MyMD Florida Common Stock”), including shares underlying pre-Merger MyMD Florida’s
outstanding equity awards, was converted into the right to receive (x) 0.7718 shares (the “Exchange Ratio”) of the Company’s
common stock, no par value per share (the “Company Common Stock”), (y) an amount in cash, on a pro rata basis, equal to the
aggregate cash proceeds received by the Company from the exercise of any options to purchase shares of MyMD Florida Common Stock outstanding
at the effective time of the Merger assumed by the Company upon closing of the Merger prior to the second-year anniversary of the closing
of the Merger (the “Option Exercise Period”), such payment (the “Additional Consideration”), and (z) potential
milestone payment in shares of Company Common Stock up to the aggregate number of shares issued by the Company to pre-Merger MyMD Florida
stockholders at the closing of the Merger (the “Milestone Payments”) payable upon the achievement of certain market capitalization
milestone events (the “Milestone Events”) during the 36-month period immediately following the closing of the Merger (the
“Milestone Period”). The Milestone Events and corresponding Milestone Payments are set forth in the table below.
Milestone
Event |
|
Milestone
Payment |
Market
capitalization of the combined company for at least ten (10) trading days during any 20 consecutive trading day period during the
Milestone Period is equal to or greater than $500,000,000 (the “First Milestone Event”). |
|
$20,000,000 |
|
|
|
For
every $250,000,000 incremental increase in market capitalization of the combined company after the First Milestone Event to the extent
such incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone Period,
up to a $1,000,000,000 market capitalization of the combined company. |
|
$10,000,000
per each incremental increase (it being understood, however, that, if such incremental increase results in market capitalization
equal to $1,000,000,000, such $10,000,000 payment in respect of such incremental increase shall be payable without duplication of
any amount payable in respect of a Second Milestone Event, as defined below). |
|
|
|
Market
capitalization of the combined company for at least 10 trading days during any 20 consecutive trading day period during the Milestone
Period is equal to or greater than $1,000,000,000 (the “Second Milestone Event”) |
|
$25,000,000 |
|
|
|
For
every $1,000,000,000 incremental increase in market capitalization of the combined company after the Second Milestone Event to the
extent such incremental increase occurs for at least 10 trading days during any 20 consecutive trading day period during the Milestone
Period. |
|
$25,000,000
per each incremental increase |
For
purposes of the table above, “market capitalization” means, with respect to any trading day, the product of (i) the total
outstanding shares of the combined company common stock and (ii) the volume weighted average trading price for the combined company common
stock for such trading day.
Immediately
following the effective time of the Merger, the Company effected a 1-for-2 reverse stock split of the issued and outstanding Company
Common Stock (the “Reverse Stock Split”). Upon completion of the Merger and the transactions contemplated in the Merger Agreement,
(i) the former MyMD Florida equity holders owned approximately 77.05% of the outstanding equity of the Company on a fully diluted basis,
assuming the exercise in full of the pre-funded warrants to purchase 986,486 shares of Company Common stock and including 4,188,315 shares
of Company Common Stock underlying options to purchase shares of MyMD Florida Common Stock assumed by the company at closing and after
adjustments based on the Company’s net cash at closing; and (ii) former Akers Biosciences, Inc. stockholders own approximately
22.95% of the outstanding equity of the Company.
Effective
as of 4:05 pm Eastern Time on April 16, 2021, we filed an amendment to our Amended and Restated Certificate of Incorporation to effect
the Reverse Stock Split. As a result of the Reverse Stock Split, immediately following the effective time of the Merger, every two shares
of our Common Stock held by a stockholder immediately prior to the Reverse Stock Split were combined and reclassified into one share
of our Common Stock. No fractional shares were issued in connection with the Reverse Stock Split. Each stockholder who did not have a
number of shares evenly divisible pursuant to the Reverse Stock Split ratio and who would otherwise be entitled to receive a fractional
share of our Common Stock was entitled to receive an additional share of our Common Stock.
In
connection with the closing of the Merger, we changed our name to MyMD Pharmaceuticals, Inc. and our NASDAQ trading symbol to MYMD. For
additional information concerning the Merger, please see Note 3 to the Company’s Condensed Consolidated Financial Statements.
Closing
of Contribution and Assignment Agreement
We
acquired 100% of the membership interests of Cystron Biotech, LLC (“Cystron”) pursuant to a Membership Interest Purchase
Agreement, dated March 23, 2020 (as amended by Amendment No. 1 on May 14, 2020, the “MIPA”) from certain selling parties
(the “Cystron Sellers”). Cystron is a party to a License and Development Agreement (as amended and restated on March 19,
2020, in connection with our entry into the MIPA, the “License Agreement”) with Premas Biotech PVT Ltd. (“Premas”)
whereby Premas granted Cystron, amongst other things, an exclusive license with respect to Premas’ genetically engineered yeast
(S. cerevisiae)-based vaccine platform, D-Crypt™, for the development of a vaccine against COVID-19 and other coronavirus infections.
We had partnered with Premas on this initiative as we sought to advance this COVID-19 vaccine candidate through the regulatory process,
both with the U.S. Food and Drug Administration (“FDA”) and the office of the drug controller in India. Premas was primarily
responsible for the development of the COVID-19 vaccine candidate through proof of concept and was entitled to receive milestone payments
upon achievement of certain development milestones through proof of concept.
As
of May 14, 2020, Premas had successfully completed its vaccine prototype and obtained transmission electron microscopic (TEM) images
of the recombinant virus like particle (VLP) assembled in yeast. In July 2020, animal studies for the COVID-19 vaccine candidate were
initiated in India. In addition, we announced that Premas had successfully completed the manufacturing process for the VLP vaccine candidate.
On August 27, 2020, we announced with Premas positive proof of concept results from the animal studies conducted during a four-week test
of the COVID-19 vaccine candidate in mice. On March 18, 2021, the Company and the Cystron Sellers, which are also shareholders of Oravax
Medical, Inc. (“Oravax”), entered into a Termination and Release Agreement terminating the MIPA effective upon consummation
of the Contribution Agreement (as defined below). In addition, the Cystron Sellers agreed to waive any change of control payment triggered
under the MIPA as a result of the Merger.
On
April 16, 2021, pursuant to the Contribution and Assignment Agreement, dated March 18, 2021 (the “Contribution Agreement”)
by and among the Company, Cystron, Oravax and, for the limited purpose set forth therein, Premas, the parties consummated the transactions
contemplated therein. Pursuant to the Contribution Agreement, effective upon the closing of the Merger, the Company agreed (i) to contribute
an amount in cash equal to $1,500,000 to Oravax and (ii) cause Cystron to contribute substantially all of the assets associated with
its business or developing and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax (the “Contribution Transaction”).
In consideration for the Company’s commitment to consummate the Contribution Transaction, Oravax issued to the Company 390,000
shares of its capital stock (equivalent to 13% of Oravax’s outstanding capital stock on a fully diluted basis) and assumed all
of the obligations or liabilities in respect of the assets of Cystron (excluding certain amounts due to Premas), including the obligations
under the license agreement with Premas. In addition, Oravax agreed to pay future royalties to the Company equal to 2.5% of all net sales
of products (or combination products) manufactured, tested, distributed and/or marketed by Oravax or its subsidiaries. For additional
information concerning the Contribution Transaction, please see Note 3 to the Company’s Condensed Consolidated Financial Statements.
Following
the Contribution Transaction, Oravax is expected to pursue the COVID-19 vaccine candidate. MyMD is currently evaluating several options
with respect to its interest in Oravax, including a potential distribution of Oravax shares to the MyMD shareholders. This would make
Oravax a publicly held company. MyMD’s interest in Oravax consists of 13% of Oravax’s outstanding shares of capital stock
and the rights to a 2.5% royalty on all future net sales. In addition, MyMD currently has the right to designate a member of the board
of directors of Oravax, pursuant to which Mr. Joshua Silverman, our Chairman of the Board, has been designated to serve as a director
of Oravax.
Impact
of the COVID-19 Pandemic on Our Business and Company Operations
The
ultimate impact of the ongoing global COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to future developments.
These include but are not limited to the duration of the COVID-19 pandemic, new information which may emerge concerning the severity
of the COVID-19 pandemic, and any additional preventative and protective actions that regulators, or our board of directors or management
of the Company, may determine are needed. We do not yet know the full extent of potential delays or impacts on our business, healthcare
systems or the global economy. We will continue to monitor the COVID-19 situation closely.
In
response to public health directives and orders, we have implemented work-from-home policies for many of our employees and temporarily
modified our operations to comply with applicable social distancing recommendations. The effects of the orders and our related adjustments
in our business have in the past and may continue to negatively impact productivity, disrupt our business and delay our timelines, the
magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct
our business in the ordinary course. Similar health directives and orders are affecting third parties with whom we do business. Further,
restrictions on our ability to travel, stay-at-home orders and other similar restrictions on our business have limited our ability to
support our operations.
Severe
and/or long-term disruptions in our operations will negatively impact our business, operating results and financial condition in other
ways, as well. Specifically, we anticipate that the stress of COVID-19 on healthcare systems generally around the globe will negatively
impact regulatory authorities and the third parties that we may engage in connection with the development and testing of our therapeutic
targets.
To
date, we have encountered delays in receiving critical clinical supplies from our manufacturer in India, which has impacted our ability
to execute our development plan and the studies needed to advance product development have been delayed by the Company’s difficulty
recruiting patients for the required clinical trials.
In
addition, while the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, it has
significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future negatively affect
our liquidity. A recession or market correction resulting from the continuation of the COVID-19 pandemic could materially affect our
business and the value of our common stock.
Recent Developments
August 2022
Offering
On August 15, 2022, the Company
entered into a securities purchase agreement (the “Purchase Agreement”) with certain accredited and institutional investors
(the “Purchasers”). Pursuant to the Purchase Agreement, the Company agreed to sell in a registered direct offering (the “Registered
Direct Offering”) 1,411,764 shares (the “Shares”) of the Company’s Common Stock to the Purchasers at an offering
price of $4.25 per share and associated Investor Warrant (as defined below). Pursuant to the Purchase Agreement, in a concurrent private
placement (together with the Registered Direct Offering, the “Offering”), the Company is also selling to the Purchasers unregistered
warrants (the “Investor Warrants”) to purchase up to an aggregate of 1,411,764 shares of Common Stock, representing 100% of
the shares of Common Stock that may be purchased in the Registered Direct Offering (the “Warrant Shares”). The Investor Warrants
are exercisable at an exercise price of $5.25 per share, are exercisable six months following the date of issuance and have a term of
exercise equal to five years from the initial exercise date.
The
Company expects to receive net proceeds from the sale of the Shares, after deducting fees and other estimated offering expenses payable
by the Company, of approximately $5.4 million. The Company intends to use the net proceeds for working capital and general
corporate purposes.
The
Offering is expected to close on August 17, 2022, subject to satisfaction of customary closing conditions.
Financial
Operations Overview
We
will not generate revenue from product sales unless and until we successfully complete clinical development, obtain regulatory approval
for, and successfully commercialize our MYMD-1 and Supera-CBD product candidates. The lengthy process of securing marketing approvals
for new drugs requires the expenditure of substantial resources. Any significant delay or failure to obtain regulatory approvals would
materially adversely affect our product candidate’s development efforts and our business overall. In addition, if we obtain regulatory
approval for MYMD-1 and/or Supera-CBD, we expect to incur significant expenses related to developing our commercialization capability
to support product sales, marketing, manufacturing and distribution activities.
We
anticipate that our expenses will increase significantly as we:
|
● |
advance
the development of our MYMD-1 and Supera-CBD; |
|
● |
initiate
and continue research and preclinical and clinical development of potential new product candidates; |
|
● |
maintain,
expand and protect our intellectual property as it pertains to MYMD-1 and Supera-CBD; |
|
● |
expand
our infrastructure and facilities to accommodate our growing employee base and ongoing development activities; |
|
● |
establish
agreements with contract research organizations, or CROs, and third-party contract manufacturing organizations, or CMOs, in connection
with our Supera-CBD preclinical studies, MYMD-1 ongoing and planned clinical trials, Supera-CBD clinical trials and the development
of our manufacturing capabilities for MYMD-1 and Supera-CBD; |
|
● |
develop
the large-scale manufacturing processes and capabilities for the commercialization of our MYMD-1 and Supera-CBD drug products; |
|
● |
seek
marketing approvals for our MYMD-1 and Supera-CBD product candidates that successfully complete clinical trials and |
|
● |
establish
a sales, marketing and distribution infrastructure to commercialize MYMD-1 and Supera-CBD should we obtain marketing approval |
As
a result of these anticipated expenditures, we will need substantial additional funding to support our continuing operations and pursue
our growth strategy.
Components
of our Results of Operations
Revenue
We
have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future.
If our research and development efforts with MYMD-1 and Supera-CBD are successful, we may generate revenue from product sales or through
license agreements with third parties.
Operating
Expenses
Our
operating expenses are broken into several components, research and development and general and administrative costs.
We
expect operating expenses to increase as we progress through the various clinical trials in the development of MYMD-1 and Supera-CBD.
Research
and development
Our
research and development expenses primarily consist of costs associated with the development of MYMD-1 and Supera-CBD. These costs include,
but are not limited to:
● |
Salaries,
wages and benefits of the research and development staff; |
● |
Contractual
agreements with third parties including contract research organizations, preclinical activities and clinical trials. |
● |
Outside
consultants including fees and expenses |
● |
Laboratory
supplies and equipment |
● |
Regulatory
compliance |
● |
Patent
application and maintenance costs to protect our intellectual property. |
Six
of our nine employees are principally involved in research and development activities for either MYMD-1 or Supera-CBD. Their salaries,
wages and benefits are captured as a component of research and development but not allocated to specific projects.
We
utilize third party contractors and consultants with expertise in specific research or development activities to perform work under the
supervision of our researchers. We believe this allows us to control costs and to progress through the development cycle and to utilize
our staff more efficiently.
It
is difficult to project with absolute accuracy the duration or final cost of the development of MYMD-1 and Super-CBD or if revenue will
be generated from the commercialization of these components. The process of achieving regulatory approval is very costly and time consuming.
A few of the many factors that contribute to costs of duration include:
● |
Size
and scope of pre-clinical trials |
● |
The
phases of clinical development and the stage of our product candidates in the cycle |
● |
Per
subject trial costs |
● |
The
number of sites required for the trials and the availability of appropriate sites to perform the trials |
● |
The
time that is required to enroll the appropriate number of trial participants |
● |
The
time required to achieve the approval of regulatory agencies. |
General
and Administrative
General
and administrative expenses primarily consist of salaries, wages and benefits for our employees in the executive, legal and accounting
functions and third party costs for legal, accounting, insurance, investor relations, stock market and board expenses.
We
expect general and administrative expenses to decline over the near-term. We incurred significant non-recurring legal and accounting
fees associated with our merger with Akers Biosciences and we do not anticipate the addition of new general and administrative staff.
Although
treated as components of general and administrative expenses, we have chosen to disclose the following significant items separately:
Interest
Expense and Accretion of Debt Discount (related party)
Interest
expense and accretion of debt discount are the financing costs associated with the Starwood line-of credit which was terminated upon
the closing of the merger with Akers Biosciences and the related line-of-credit plus the accumulated interest due was paid in full.
Stock
Based Compensation
Stock
based compensation includes the fair market value, as determined by Black-Scholes, of stock options issued to key staff and consultants.
Other
Income (Expense), net
Other
income (expense), net consists of interest and dividends earned on our cash, cash equivalents, and investments, losses on the sale of
marketable securities, losses on equity investments, gains on the forgiveness of debt and an uninsured casualty loss.
RESULTS
OF OPERATIONS
Summary
of Statements of Operations for the Three Months Ended June 30, 2022 and 2021
We
are focused on developing and commercializing two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and Supera-CBD.
The following table summarized the results of operations for the three months ended June 30, 2022 and 2021.
| |
For the Three Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
Operating Expenses | |
| | | |
| | | |
| | |
General and Administrative | |
$ | 1,346,763 | | |
$ | 1,540,392 | | |
| (12.6 | ) |
Research and Development | |
| 2,163,968 | | |
| 1,661,265 | | |
| 30.3 | |
Interest Expense & Accretion of Debt Discount | |
| - | | |
| 40,526 | | |
| (100.0 | ) |
Stock Based Compensation | |
| 132,246 | | |
| 15,036,051 | | |
| (99.1 | ) |
Total Operating Expenses | |
$ | 3,642,977 | | |
$ | 18,278,234 | | |
| (80.1 | ) |
Loss from Operations | |
| (3,642,977 | ) | |
| (18,278,234 | ) | |
| (80.9 | ) |
Other Income | |
| (6,934 | ) | |
| (185,898 | ) | |
| (96.3 | ) |
Net Loss | |
$ | (3,636,043 | ) | |
$ | (18,092,336 | ) | |
| (79.9 | ) |
Revenue
We
had no revenue during the three months ended June 30, 2022 and June 30, 2021.
Research
and Development Expenses
Research
and development expenses for the three months ended June 30, 2022 totalled $2,163,968 as compared to $1,661,265 for the three months ended
June 30, 2021.
The
table below summarizes our research and development expenses for the three months ended June 30, 2022 and 2021 as well as the percentage
of change year-over-year:
| |
For the Three Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
Salaries and Wages | |
$ | 215,774 | | |
$ | 175,112 | | |
| 23.2 | |
Development Programs | |
| 746,620 | | |
| 1,339,624 | | |
| (44.3 | ) |
Professional Services | |
| 11,426 | | |
| 13,730 | | |
| (16.8 | ) |
Regulatory Expenses | |
| 1,186,611 | | |
| 150,325 | | |
| 689.4 | |
Other Research and Development Expenses | |
| 3,337 | | |
| (17,526 | ) | |
| (119.0 | ) |
Total Research and Development Expenses | |
$ | 2,163,968 | | |
$ | 1,661,265 | | |
| 30.3 | |
Salaries
and wages increased $40,662 for the three months ended June 30, 2022. The increase is attributed to the addition of an additional staff
position.
Development
program costs include those associated with pre-clinical development, clinical trials and other manufacturing and development
programs. Costs decreased $592,804 for the three months ended June 30, 2022 related to the completion of a 10 month dog toxicology and a 6 month rat toxicology study. Both studies were required by
the FDA under the current Investigational New Drug Applications (“IND”). The Company completed a Phase 1 clinical trial that
was submitted to the FDA and justified further testing of the Phase 2 studies.
Professional
services costs declined $2,304 for the three months ended June 30, 2022. These costs are primarily related to legal and patent related
fees associated with the protection of our intellectual property.
Regulatory
expenses increased $1,036,286 for the three months ended June 30, 2022. These expenses include the submission of an IND to the FDA to investigate sarcopenia and frailty in patients. We started a Phase 2 multi-center
double blind placebo controlled randomized study to investigate efficacy and tolerability of MYMD-1 in the treatment of chronic inflammation
associated with sarcopenia and frailty. A clinical research organizations (“CRO”) is managing the study with two central laboratories
and a Pharmacokinetic testing site.
Other
research and development expenses increased $20,863 for the three months ended June 30, 2022. These expenses include laboratory supplies,
training and travel for department personnel while working with third party trial sites.
Administrative
Expenses
Administrative
expenses for the three months ended June 30, 2022, totalled $1,346,763, as compared to $1,540,392 for the three months ended June 30,
2021.
The
table below summarizes our administrative expenses for the three months ended June 30, 2022 and 2021 as well as the percentage of change
year-over-year:
| |
For the Three Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
Personnel Costs | |
$ | 307,919 | | |
$ | 246,184 | | |
| 25.1 | |
Professional Service Costs | |
| 335,768 | | |
| 458,488 | | |
| (26.8 | ) |
Stock Market & Investor Relations Costs | |
| 247,946 | | |
| 294,076 | | |
| (15.7 | ) |
Other Administrative Costs | |
| 455,130 | | |
| 541,644 | | |
| (16.0 | ) |
Total Administrative Expense | |
$ | 1,346,763 | | |
$ | 1,540,392 | | |
| (12.6 | ) |
Personnel
costs increased $61,735 for the three months ended June 30, 2022. Two additional staff members were acquired during the merger with Akers
Biosciences and a 20% allocation for two research and development staff members has been made to account for their administrative duties.
Professional
services costs declined $122,720 during the three months ended June 30, 2022. These costs included legal and accounting and specialized
consulting services related to the merger as well as other legal and accounting services regularly incurred in the course of business.
Stock
market and investor relations costs decreased $46,130 during the three months ended June 30, 2022. These costs include the annual NASDAQ
listing fees, activities related to keeping the shareholder base informed through press releases, presentations and other communication
efforts and the costs of annual and special shareholder meetings.
Other
administrative expenses decreased $86,514 for the three months ended June 30, 2022. These costs include Board expenses, business insurance,
corporate travel and other general operating expenses.
Interest
Expense and Accretion of Debt Discount
Interest
expense and the accretion of the debt discount on the line-of-credit declined $40,526 during the three months ended June 30, 2022. The
line-of-credit included a requirement to issue one share of stock for each dollar borrowed. The fair market value, as determined using
Black-Scholes, was amortized over the remaining life of the credit line. The line of credit also carried an annualized 5% interest rate.
The
line of credit was terminated on April 16, 2021 in relation to the merger and was paid in full on April 28, 2021.
Stock-Based
Compensation
During
the three months ended March 31, 2022, we issued 200,000 stock options to an employee with an issue date fair value of $3.59 per option.
The options expire January 28, 2029 and are subject to a variable vesting schedule. For the three months ended June 30, 2022, we recognized
expenses of $127,330.
During
the three months ended June 30, 2022, we issued 100,000 stock options to a consultant with an issue date fair value of $2.30 per option.
The options expire June 21, 2027 and vested immediately. The fair market value of the shares are being amortized over the twelve month
term of the agreement. For the three months ended June 30, 2022, we recognized expenses of $4,916.
During the three months ended June 30, 2021, we recorded $15,036,051 in stock option modification expenses related
to the 4,188,315 pre-Merger MyMD Florida options that were assumed by MyMD upon the consummation of the merger.
Other
Income and Expense
Other
income, net of expense, for the three months ended June 30, 2022, totalled $6,934. Other income, net of expense, for the three months
ended June 30, 2021 totalled $185,898.
The
table below summarizes our other income and expenses for the three months ended June 30, 2022 and 2021, as well as the percentage of
change year-over-year:
| |
For the Three Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
| |
| | |
| | |
| |
Realized (Gains)/Losses on Investments | |
$ | 1,999 | | |
$ | (41,447 | ) | |
| (104.8 | ) |
Equity Investments (Gains)/Losses | |
| (2,947 | ) | |
| 41,447 | | |
| 107.1 | |
Interest and Dividend Income | |
| (5,986 | ) | |
| (5,641 | ) | |
| 6.1 | |
Gain on Forgiveness of Debt | |
| - | | |
| (180,257 | ) | |
| (100.0 | ) |
Total Other Expense, Net of Income | |
$ | (6,934 | ) | |
$ | (185,898 | ) | |
| (96.3 | ) |
Realized
losses on investments were $1,999 for the three months ended June 30, 2022 as compared to gains of $41,447 for the same period in
2021. The decline is principally due to the overall decline in the financial markets and our cash reserves available for
investment.
Equity
investment gains were $2,947 for the three months ended June 30, 2022 as compared to losses of $41,447 for the same period in 2021 and
reflect the changes in the fair market value of the equity investments.
Interest
and dividend income increased to $5,986 for the three months ended June 30, 2022 compared to $5,641 for the three months ended June 30,
2021.
The
gain on debt forgiveness is associated with the negotiated settlement of an outstanding debt on a lease totalling $109,657 and the forgiveness
of our Payroll Protection Program loans totalling $70,600.
Summary
of Statements of Operations for the Six Months Ended June 30, 2022 and 2021
We
are focused on developing and commercializing two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and Supera-CBD.
The following table summarized the results of operations for the six months ended June 30, 2022 and 2021.
| |
For the six Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
Operating Expenses | |
| | | |
| | | |
| | |
General and Administrative | |
$ | 2,741,875 | | |
$ | 2,618,555 | | |
| 4.7 | |
Research and Development | |
| 4,793,711 | | |
| 3,012,242 | | |
| 59.1 | |
Interest Expense & Accretion of Debt Discount | |
| - | | |
| 701,090 | | |
| (100.0 | ) |
Stock Based Compensation | |
| 229,245 | | |
| 15,036,051 | | |
| (98.5 | ) |
Total Operating Expenses | |
$ | 7,764,831 | | |
$ | 21,367,938 | | |
| (63.7 | ) |
Loss from Operations | |
| (7,764,831 | ) | |
| (21,367,938 | ) | |
| (63.7 | ) |
Other Income | |
| (6,754 | ) | |
| (185,898 | ) | |
| (96.4 | ) |
Net Loss | |
$ | (7,758,077 | ) | |
$ | (21,182,040 | ) | |
| (63.4 | ) |
Revenue
We
had no revenue during the six months ended June 30, 2022 and June 30, 2021.
Research
and Development Expenses
Research
and development expenses for the six months ended June 30, 2022 totalled $4,793,710 as compared to $3,012,242 for the six months
ended June 30, 2021.
The
table below summarizes our research and development expenses for the six months ended June 30, 2022 and 2021 as well as the percentage
of change year-over-year:
| |
For the Six Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
Salaries and Wages | |
$ | 427,194 | | |
$ | 350,261 | | |
| 22.0 | |
Development Programs | |
| 2,226,294 | | |
| 2,271,497 | | |
| (2.0 | ) |
Professional Services | |
| 11,426 | | |
| 24,265 | | |
| (52.9 | ) |
Regulatory Expenses | |
| 2,119,174 | | |
| 343,315 | | |
| 517.3 | |
Other Research and Development Expenses | |
| 9,623 | | |
| 22,904 | | |
| (58.0 | ) |
Total Research and Development Expenses | |
$ | 4,793,711 | | |
$ | 3,012,242 | | |
| 59.1 | |
Salaries
and wages increased $76,933 for the six months ended June 30, 2022. The increase is attributed to the addition of an additional staff
position.
Development
program costs include those associated with pre-clinical development, clinical trials and other manufacturing and development programs.
Costs decreased $45,203 for the six months ended June 30, 2022 related to the completion of a 10 month dog toxicology and a 6 month rat toxicology study. Both studies were required by
the FDA under the current IND. The Company completed a Phase 1 clinical trial that was submitted to the FDA and justified further testing
of the Phase 2 studies.
Professional
services costs declined $12,839 for the six months ended June 30, 2022. These costs are primarily related to legal and patent related
fees associated with the protection of our intellectual property.
Regulatory
expenses increased $1,775,859 for the six months ended June 30, 2022. These expenses include the submission of an IND to the FDA to investigate sarcopenia and frailty in patients. We started a Phase 2 multi-center
double blind placebo controlled randomized study to investigate efficacy and tolerability of MYMD-1 in the treatment of chronic inflammation
associated with sarcopenia and frailty. A CRO is managing the study with two central laboratories and a Pharmacokinetic testing site.
Other
research and development expenses declined $13,281 for the six months ended June 30, 2022. These expenses include laboratory supplies,
training and travel for department personnel while working with third party trial sites.
Administrative
Expenses
Administrative
expenses for the six months ended June 30, 2022, totalled $2,741,875, as compared to $2,618,555 for the six months ended June 30,
2021.
The
table below summarizes our administrative expenses for the six months ended June 30, 2022 and 2021 as well as the percentage of
change year-over-year:
| |
For the Six Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
Personnel Costs | |
$ | 662,572 | | |
$ | 408,999 | | |
| 62.0 | |
Professional Service Costs | |
| 683,382 | | |
| 922,002 | | |
| (25.9 | ) |
Stock Market & Investor Relations Costs | |
| 518,016 | | |
| 339,971 | | |
| 52.4 | |
Other Administrative Costs | |
| 877,905 | | |
| 947,583 | | |
| (7.4 | ) |
Total Administrative Expense | |
$ | 2,741,875 | | |
$ | 2,618,555 | | |
| 4.7 | |
Personnel
costs increased $253,573 for the six months ended June 30, 2022. Two additional staff members were acquired during the merger with Akers
Biosciences and a 20% allocation for two research and development staff members has been made to account for their administrative duties.
Professional
services costs declined $238,620 during the six months ended June 30, 2022. These costs included legal and accounting and specialized
consulting services related to the merger as well as other legal and accounting services regularly incurred in the course of business.
Stock
market and investor relations costs increased $178,045 during the six months ended June 30, 2022. These costs include the annual NASDAQ
listing fees, activities related to keeping the shareholder base informed through press releases, presentations and other communication
efforts and the costs of annual and special shareholder meetings. Prior to the Merger, MyMD Florida was not a reporting company and did
not experience the costs associated with a publicly reporting entity.
Other
administrative expenses decreased $69,678 for the six months ended June 30, 2022. These costs include Board expenses, business insurance,
corporate travel, the settlement of shareholder litigation related to the merger and other general operating expenses.
Interest
Expense and Accretion of Debt Discount
Interest
expense and the accretion of the debt discount on the line-of-credit declined $701,090 during the six months ended June 30, 2022. The
line-of-credit included a requirement to issue one share of stock for each dollar borrowed. The fair market value, as determined using
Black-Scholes, was amortized over the remaining life of the credit line. The line of credit also carried an annualized 5% interest rate.
The
line of credit was terminated on April 16, 2021 in relation to the merger and was paid in full on April 28, 2021.
Stock-Based
Compensation
During
the three months ended March 31, 2022, we issued 200,000 stock options to an employee with an issue date fair value of $3.59 per option.
The options expire January 28, 2029 and are subject to a variable vesting schedule. For the six months ended June 30, 2022, we recognized
expenses of $208,332.
During
the three months ended June 30, 2022, we issued 100,000 stock options to a consultant with an issue date fair value of $2.30 per option.
The options expire June 21, 2027 and vested immediately. The fair market value of the shares are being amortized over the twelve month
term of the agreement. For the six months ended June 30, 2022, we recognized expenses of $4,916.
We
issued 4,040 restricted stock units with an issue date fair value of $3.96 per RSU. These units vested upon issue. For the six months
ended June 30, 2022, we recognized expenses of $15,998.
During the six months ended June 30, 2021, we recorded $15,036,051 in stock option modification expenses related
to the 4,188,315 pre-Merger MyMD Florida options that were assumed by MyMD upon the consummation of the merger.
Other
Income and Expense
Other
income, net of expense, for the six months ended June 30, 2022, totalled $6,754. Other income, net of expense, for the six months ended
June 30, 2021 totalled $185,898.
The
table below summarizes our other income and expenses for the six months ended June 30, 2022 and 2021, as well as the percentage of change
year-over-year:
| |
For the Six Months Ended June 30, | | |
Percent | |
Description | |
2022 | | |
2021 | | |
Change | |
| |
| | |
| | |
| |
Realized (Gains)/Losses on Investments | |
$ | 3,649 | | |
$ | (41,447 | ) | |
| (108.8 | ) |
Equity Investments Losses | |
| 145 | | |
| 41,447 | | |
| (99.7 | ) |
Interest and Dividend Income | |
| (6,106 | ) | |
| (5,641 | ) | |
| 8.2 | |
Gain on Forgiveness of Debt | |
| - | | |
| (180,257 | ) | |
| (100.0 | ) |
Gain on Recovery of Casualty Loss | |
| (4,442 | ) | |
| - | | |
| 100.0 | |
Total Other Expense, Net of Income | |
$ | (6,754 | ) | |
$ | (185,898 | ) | |
| (96.4 | ) |
Realized
losses on investments were $3,649 for the six months ended June 30, 2022 as compared to gains of $41,447 for the same period in
2021. The decline is principally due to the overall decline in the financial markets and our cash reserves available for
investment.
Equity
investment losses were $145 for the six months ended June 30, 2022 as compared $41,447 for the same period in 2021. The losses were due
to a decrease in the fair market value of the equity investments.
Interest
and dividend income increased to $6,106 for the six months ended June 30, 2022 compared to $5,641 for the three months ended June 30,
2021.
The
gain on debt forgiveness is associated with the negotiated settlement of an outstanding debt on a lease totalling $109,657 and the forgiveness
of our Payroll Protection Program loans totalling $70,600.
We recovered $4,442 of the uninsured casualty losses identified in October
2021.
Liquidity
and Capital Resources
As
of June 30, 2022, our cash on hand totalled $1,115,174 and marketable securities totalling $4,505,825. We incurred a net loss of $7,758,077
for the six months ended June 30, 2022. As of June 30, 2022, we had working capital of $4,089,352, shareholders’ equity of $16,118,343
and an accumulated deficit of $86,319,645. During the six months ended June 30, 2022, cash flows used in operating activities were $5,934,245
consisting primarily of a net loss of $7,758,077 offset by an increase in trade and other payables of $1,854,909. Since the Company’s
inception, we have met our liquidity requirements principally through the sale of our common stock in public offerings and private placements.
We evaluated the current cash
requirements for operations in conjunction with management’s strategic plan and believe that our current financial resources
as of the date of the issuance of these condensed consolidated financial statements, inclusive of the funding obtained through the definitive
agreement executed on August 15, 2022, are sufficient to fund our current operating budget and contractual obligations as of June 30,
2022 as they fall due within the next twelve-month period, alleviating any substantial doubt raised by our historical operating results
and satisfying our estimated liquidity needs for twelve months from the issuance of these condensed consolidated financial statements.
Operating
Activities
Our
net cash used by operating activities totalled $5,934,245 during the six months ended June 30, 2022. Net cash used consisted principally
of the net loss of $7,758,077 partially offset by an increase in trade and other payables of $1,854,909.
Our
net cash used by operating activities totalled $8,258,496 during the six months ended June 30, 2021. Net cash used consisted principally
of the net losses from operations of $21,182,040 and a decrease in trade and other payables of $1,988,204 partially offset by non-cash
option modification expenses of $15,036,051.
Investing
Activities
Our
net cash provided by investing activities totalled $6,493,452 for the six months ended June 31, 2022 as compared to cash provided by investing
activities total $11,353,891 during the six months ended June 31, 2021. During the six months ended June 30, 2022 we purchased securities
totalling $6,548 and sold securities totalling $6,500,000. During the six months ended June 30, 2021, we purchased securities totalling
$10,137 and sold securities totalling $9,983,176 and received $1,380,852 from the merger.
Financing
Activities
Net
cash consumed by financing activities during the six months ended June 30, 2022 was $0 as compared to cash consumed by financing activities
totalling $1,116,307 during the six months ended June 30, 2021 which consisted of the payoff of the Company’s lines of credit totalling
$3,062,444 offset by proceeds of $120,000 from the line of credit and $1,826,137 from the Promissory Note.
Critical
Accounting Policies
Our
management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated
financial statements, which have been prepared in accordance with US GAAP. The preparation of our condensed consolidated financial statements
and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities,
costs and expenses and related disclosures. We base our assumptions, estimates and judgments on historical experience, current trends
and other factors that management believes to be relevant at the time our consolidated financial statements are prepared. Accordingly,
we evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions
and conditions.
Our
critical accounting estimates have not changed materially from those previously reported in our Annual Report for the year ended
December 31, 2021 on Form 10-K.