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utr:D
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended:
June 30,
2022
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from __________ to __________
Commission
File No.
001-36268
MyMD Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
New Jersey |
|
22-2983783 |
(State
or other jurisdiction
of
incorporation)
|
|
(IRS
Employer
Identification
No.)
|
855 N. Wolfe Street,
Suite 601
Baltimore,
MD
21205
(Address
of principal executive offices and zip code)
(856)
848-8698
(Registrant’s
telephone number, including area code)
Securities registered pursuant to Section 12(b) of the
Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of exchange on which registered |
Common Stock, no par value per share |
|
MYMD |
|
The
NASDAQ Capital Market |
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by section 13 or 15(d) of the Securities
Exchange Act of 1934 during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90
days.
Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
|
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
Non-accelerated filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
Emerging
growth company |
☐ |
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As of
August 12, 2022, there were
38,058,245 shares outstanding of the registrant’s common
stock.
EXPLANATORY
NOTE
This
report is the Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022 of MyMD Pharmaceuticals, Inc., which was formerly
known as Akers Biosciences, Inc. prior to the consummation on April
16, 2021 of the merger described below.
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 Pharmaceuticals, Inc., a New Jersey corporation previously
known as Akers Biosciences, Inc. (the “Company”), XYZ Merger Sub
Inc., a Florida corporation and a wholly owned subsidiary of the
Company (“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 payments 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
payable upon the achievement of certain market capitalization
milestone events during the 36-month period immediately following
the closing of the Merger. 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 owned approximately
22.95% of the outstanding equity of the Company.
The
Merger is being treated as a reverse recapitalization effected by a
share exchange for financial accounting and reporting purposes.
MyMD Florida is being treated as the accounting acquirer, as its
stockholders control the Company after the Merger, even though
Akers Biosciences, Inc. was the legal acquirer.
See
Note 1 of the Unaudited Condensed Consolidated Financial Statements
for additional information.
TABLE
OF CONTENTS
PART
I - Financial
Information
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.
Item 3. Quantitative and Qualitative Disclosures About
Market Risk.
Not
applicable.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer, after
evaluating the effectiveness of our disclosure controls and
procedures (as defined in the Securities Exchange Act of 1934, as
amended (the “Exchange Act”) Rule 13a-15(e) and 15d-15(e)) as of
the end of the period covered by this Quarterly Report on Form
10-Q, have concluded that, based on such evaluation, our disclosure
controls and procedures were effective to ensure that information
required to be disclosed by us in the reports that we file or
submit under the Exchange Act is recorded, processed, summarized
and reported, within the time periods specified in the SEC’s rules
and forms, and is accumulated and communicated to our management,
including our principal executive officer and principal financial
officer as appropriate to allow timely decisions regarding required
disclosure.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting
that occurred during our last fiscal quarter ended June 30, 2022
that have materially affected, or are reasonably likely to affect,
our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From
time to time we are a party to litigation and subject to claims
incident to the ordinary course of business. Future litigation may
be necessary to defend ourselves and our customers by determining
the scope, enforceability, and validity of third-party proprietary
rights or to establish our proprietary rights. For a description of
certain legal proceedings, please read Note 8 to the interim
condensed consolidated financial statements, which information is
incorporated herein by reference.
Item 1A. Risk Factors
The
following description of risk factors includes any material changes
to, and supersedes the description of, risk factors associated with
our business, financial condition and results of operations
previously disclosed in “Item 1A. Risk Factors” of our Annual
Report for the year ended December 31, 2021 on Form 10-K, as filed
with the SEC on March 31, 2022. Our business, financial condition
and operating results can be affected by a number of factors,
whether currently known or unknown, including but not limited to
those described below, any one or more of which could, directly or
indirectly, cause our actual financial condition and operating
results to vary materially from past, or from anticipated future,
financial condition and operating results. Any of these factors, in
whole or in part, could materially and adversely affect our
business, financial condition, operating results and stock
price.
The
following discussion of risk factors contains forward-looking
statements. These risk factors may be important to understanding
other statements in this Form 10-Q. The following information
should be read in conjunction with the condensed consolidated
financial statements and related notes in Part I, Item 1,
“Financial Statements” and Part I, Item 2, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” of
this Form 10-Q.
We may not be able to adequately protect or enforce our
intellectual property rights, which could harm our competitive
position.
Our
success and future revenue growth will depend, in part, on our
ability to protect our intellectual property. We will primarily
rely on patent, copyright, trademark and trade secret laws, as well
as nondisclosure agreements and other methods, to protect our
proprietary technologies or processes. It is possible that
competitors or other unauthorized third parties may obtain, copy,
use or disclose proprietary technologies and processes, despite
efforts by the us to protect our proprietary technologies and
processes. While we hold rights in several patents, there can be no
assurances that any additional patents will be issued, or
additional rights will be granted, to us. Even if new patents are
issued, the claims allowed may not be sufficiently broad to
adequately protect our technology and processes. Our competitors
may also be able to develop similar technology independently or
design around the patents to which we have rights.
Currently,
MyMD 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. Although we expect to obtain
additional patents and in-licenses in the future, there is no
guarantee that we will be able to successfully obtain such patents
or in-licenses in a timely manner or at all. Further, any of our
rights to existing patents, and any future patents issued to us,
may be challenged, invalidated or circumvented. As such, any rights
granted under these patents may not provide us with meaningful
protection. Even if foreign patents are granted, effective
enforcement in foreign countries may not be available. If our
patents or rights to patents do not adequately protect our
technology or processes, competitors may be able to offer products
similar to our products.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
There
were no unregistered sales of the Company’s equity securities
during the three months ended June 30, 2022, other than those
previously reported in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities
There
has been no default in the payment of principal, interest, sinking
or purchase fund installment, or any other material default, with
respect to any indebtedness of the Company.
Item 4. Mine Safety Disclosures
Not
applicable.
Item 5. Other Information.
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.
Certain existing stockholders of the Company led and participated
in the Offering.
The Offering is expected to close on August 17, 2022, subject
to satisfaction of customary closing conditions.
Dawson
James Securities, Inc. (the “Placement Agent”) acted as the lead
placement agent for the Offering pursuant to the engagement letter
with the Company dated as of August 14, 2022. Upon closing of the
Offering, the Company will pay to the Placement Agent a commission
of 4% and reimbursement of certain expenses. In addition, the
Company agreed to pay to the Placement Agent a cash fee equal to
4.0% of the proceeds from the exercise of the Investor Warrants
that were solicited by the Placement Agent. In addition, Katalyst
Securities, Inc. acted as a financial advisory in connection with
the Offering and will receive a cash fee of $200,000.
Neither
the Investor Warrants nor the Warrant Shares are registered under
the Securities Act of 1933, as amended (the “Securities Act”). The
Investor Warrants and Warrant Shares will be issued in reliance on
the exemptions from registration provided by Section 4(a)(2)
under the Securities Act and Regulation D promulgated
thereunder for transactions not involving a public
offering.
The
sale of the Shares will be made pursuant to the Company’s effective
Registration Statement on Form S-3 (Registration No. 333-254698),
including a prospectus contained therein dated May 11, 2021,
as supplemented by a prospectus supplement, dated August 15, 2022,
relating to the Registered Direct Offering.
The
Purchase Agreement contains customary representations, warranties,
and covenants of the Company and also provides for customary
indemnification by the Company against certain liabilities of the
Purchasers.
The
foregoing descriptions of the terms and conditions of the Purchase
Agreement and the Investor Warrants are qualified in their entirety
by reference to the full text of the form of Purchase Agreement and
the form of Investor Warrant, copies of which are attached hereto
as Exhibits 10.1 and 4.1, respectively, and which are
incorporated herein by reference.
Item 6. Exhibits.
Exhibit
Number |
|
Exhibit
Description |
|
|
|
2.1** |
|
Agreement and Plan of Merger and
Reorganization, dated November 11, 2020, by and among Akers
Biosciences, Inc., XYZ Merger Sub Inc., and MYMD Pharmaceuticals,
Inc. (incorporated herein by reference to Exhibit 2.1 to the
Company’s Current Report on Form 8-K filed with the Securities and
Exchange Commission on November 12, 2020). |
|
|
|
2.2 |
|
Amendment No.1 to Agreement and Plan
of Merger and Reorganization, dated March 16, 2021, by and among
Akers Biosciences, Inc., XYZ Merger Sub Inc., and MyMD
Pharmaceuticals, Inc. (incorporated by reference to Exhibit 2.2 to
the Company’s Registration Statement on Form S-4/A filed with the
Securities and Exchange Commission on March 19,
2021). |
|
|
|
3.1 |
|
Amended and Restated Certificate of
Incorporation, effective April 16, 2021 (incorporated herein by
reference to Exhibit 3.1 to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on April 22,
2021). |
|
|
|
3.2 |
|
Certificate of Amendment to Amended
and Restated Certificate of Incorporation, effective April 16, 2021
(incorporated herein by reference to Exhibit 3.2 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange
Commission on April 22, 2021). |
|
|
|
3.3 |
|
Amended and Restated Bylaws of MyMD
Pharmaceuticals, Inc., effective April 16, 2021 (incorporated
herein by reference to Exhibit 3.3 to the Company’s Current Report
on Form 8-K filed with the Securities and Exchange Commission on
April 22, 2021). |
|
|
|
4.1* |
|
Form of Warrant. |
|
|
|
10.1* |
|
Form of Securities Purchase
Agreement. |
|
|
|
31.1* |
|
Certification
of Principal Executive Officer required by Rule 13a-14(a) or Rule
15d-14(a). |
|
|
|
31.2* |
|
Certification
of Principal Financial Officer required by Rule 13a-14(a) or Rule
15d-14(a). |
|
|
|
32.1* |
|
Certification
of Principal Executive Officer pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
|
|
|
32.2* |
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
|
|
|
101* |
|
Interactive
Data Files of Financial Statements and Notes. |
|
|
|
104* |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained
in Exhibit 101). |
*
Filed herewith.
**
The schedules and exhibits to the Agreement and Plan of Merger and
Reorganization have been omitted pursuant to Item 601(b)(2) of
Regulation S-K. A copy of any omitted schedule and/or exhibit will
be furnished to the SEC upon request.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
MYMD
PHARMACEUTICALS, INC. |
|
|
Date:
August 15, 2022 |
By: |
/s/
Chris Chapman |
|
Name: |
Chris
Chapman |
|
Title: |
President,
Chief Medical Officer, and Director |
|
|
(Principal
Executive Officer) |
|
|
|
Date:
August 15, 2022 |
By: |
/s/
Ian Rhodes |
|
Name: |
Ian
Rhodes |
|
Title: |
Chief
Financial Officer |
|
|
(Principal
Financial Officer) |
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