What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2023-03-31 compared with 2022-03-31 · 341 added, 293 removed, 310 unchanged (67% of the section changed)

80 unchanged sentences

compliance with all laws, rules, and regulations applicable to our business.

closing of the Merger and the Contribution Transaction described below that occurred on April 16, 2021, we have been focused on developing

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.

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;

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;

is a synthetic analog of cannabidiol (“CBD”) being developed to treat various conditions, including, but not limited

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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.

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”).

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.

of the Merger and Reverse Stock Split

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”).

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”)

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.

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” or “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

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”).

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.

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).

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”)

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

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;

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.

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 its 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 its NASDAQ trading symbol to MYMD.

For additional information concerning

the Merger, please see Note 3 to the Company’s 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.

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

On March 18, 2021, the Company and the Cystron Sellers, which are also shareholders of Oravax Medical, Inc.

entered into a Termination and Release Agreement terminating the MIPA effective upon consummation of the Contribution Agreement (as defined

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 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.

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

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

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 coul d

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.

stockholders own approximately

22.95% of the outstanding equity of the Company.

as of 4:05 pm Eastern Time on April 16, 2021, we filed an amendment to its 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.

connection with the closing of the Merger, we changed our name to MyMD Pharmaceuticals, Inc.

and our trading symbol on The Nasdaq Capital

Market to MYMD.

For additional information concerning the Merger, please see Note 3 to the Company’s Consolidated Financial Statements.

of Contribution and Assignment Agreement

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.

whereby Premas granted Cystron, amongst other things, an exclusive license with respect to Premas’ genetically engineered yeast

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.

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.

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 Consolidated Financial Statements.

the Contribution Transaction, Oravax is pursuing the development of 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

Operations Overview

11 unchanged sentences

and continue research and preclinical and clinical development of potential new product candidates;

expand and protect our intellectual property as it pretains to MYMD-1 and Supera-CBD;

expand and protect our intellectual property as it pertains to MYMD-1 and Supera-CBD;

our infrastructure and facilities to accommodate our growing employee base and ongoing development activities;

11 unchanged sentences

license agreements with third parties.

operating expenses are broken into several components, research and development and general and administrative costs.

operating expenses are broken into several components, including research and development and general and administrative costs.

expect operating expenses to increase as we progress through the various clinical trials in the development of MYMD-1 and Supera-CBD.

28 unchanged sentences

functions and third-party costs for legal, accounting, insurance, investor relations, stock market and board expenses.

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.

We expect general and administrative

expenses to decline over the near-term.

We incurred significant non-recurring legal and accounting fees in 2021 associated with the Merger

with Akers Biosciences and we do not anticipate the addition of new general and administrative staff.

treated as components of general and administrative expenses, we have chosen to disclose the following significant items separately:

Expense and Accretion of Debt Discount (related party)

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.

of Intangible Assets

of our development of the MyMD.com website.

Costs for future website development and maintenance are now recorded as expenses in the

period they are incurred and included in general and administrative expenses.

expense and accretion of debt discount are the financing costs associated with the line-of-credit established between MYMD and The

Starwood Trust (the “Line of Credit”), which was terminated upon the closing of the Merger with Akers Biosciences and

paid in full along with the accumulated interest due.

Based Compensation

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of Statements of Operations for the Fiscal Years Ended December 31, 2022 and 2021

are focused on developing and commercializing two therapeutic platforms based on well-defined therapeutic targets, MYMD-1 and

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 years ended December 31, 2022 and 2021.

For the Year Ended

Operating Expenses

1 unchanged sentence

General and Administrative

Interest Expense & Accretion of Debt Discount

Amortization of Intangible Assets

Interest Expense & Accretion of Debt

Stock Based Compensation

3 unchanged sentences

(15,282,763 )

(28,809,707 )

Other Income (Expense), net

1 unchanged sentence

$ (29,889,045 )

* Not meaningful

had no revenue from operations during the years ended December 31, 2022 and 2021.

and Development Expenses

table below summarizes our research and development expenses for the year months ended December 31, 2021 and 2020 as well as the percentage

table below summarizes our research and development expenses for the years ended December 31, 2022 and 2021 as well as the percentage

of change year-over-year:

the Year Ended

Salaries and Wages

2 unchanged sentences

Regulatory Expenses

Other Research and Development

Total Research and Development

Salaries and wages increased

$537,334 for the year ended December 31, 2021.

The increase is attributed to the addition of an additional staff position and the full

year costs of two staff members added in November and December of 2020.

Development program costs

include those associated with pre-clinical development, clinical trials and other material and development programs.

Costs increased

$3,074,185 for the year ended December 31, 2021 related to the completion of pre-clinical toxicology studies, Phase I clinical trials

and the acquisition of base compounds for current and future trails.

Professional services costs

declined $76,215 for the year ended December 31, 2021.

These costs are primarily related to legal and patent related fees associated

with the protection of our intellectual property.

Regulatory expenses increased

$797,560 for the year ended December 31, 2021.

expenses include clinical research organizations (CRO) and regulatory consulting fees associated with Phase 2 clinical study designs,

protocol preparations and the maintenance of the investigator brochures.

Other research and development

expenses declined $54,684 for the year ended December 31, 2021.

These expenses include laboratory supplies, training and travel for department

personnel while working with third party trial sites.

Other Research and Development Expenses

Total Research and Development Expenses

and wages increased $279,020 during the year ended December 31, 2022.

The increase is attributed to the full year costs of a staff member

added in May 2021 and bonuses paid to three employees.

program costs include those associated with pre-clinical development, clinical trials and other material and development programs.

Costs decreased $1,087,049 during the year ended December 31, 2022 as a result of the completion of pre-clinical toxicology studies,

the completion of Phase 1 clinical trials and the acquisition of base compounds for current and future trails.

services costs increased $85,019 during the year ended December 31, 2022.

These costs are primarily related to legal and patent related

fees associated with the protection of our intellectual property.

expenses increased $3,064,146 during the year ended December 31, 2022.

Regulatory expenses include clinical research organizations (CRO)

and regulatory consulting fees associated with Phase 2 clinical study designs, protocol preparations and the maintenance of the investigator

research and development expenses declined $18,818 during the year ended December 31, 2022.

These expenses include laboratory supplies,

training and travel for department personnel while working with third-party trial sites.

Administrative

1 unchanged sentence

year-over-year:

For the Years Ended

For the Years

Personnel Costs

3 unchanged sentences

Total Administrative Expense

costs increased $784,319 for the year ended December 31, 2021.

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

increased $815,145 during the year ended December 31, 2021.

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 $805,441 during the year ended December 31, 2021.

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 increased 1,068,484 for the year ended

December 31, 2021.

These costs include Board expenses, business insurance, corporate travel and the settlement of shareholder litigation

related to the merger.

costs decreased $227,195 during the year ended December 31, 2022.

During the year ended December 31, 2021, bonuses were included

in general and administrative expenses, regardless of the employee’s primary responsibilities.

During the year ended December 31,

2022, these bonuses were allocated to the appropriate department based upon the employee’s responsibilities.

services costs decreased $115,687 during the year ended December 31, 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.

The decrease is primarily related to non-recurring legal and accounting expenses recorded during the year ended December 31, 2021 that

were related to the Merger.

market and investor relations costs increased $65,799 during the year ended December 31, 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 shareholder meetings.

administrative expenses decreased $622,859 during the year ended December 31, 2022.

These costs include Board expenses, business insurance,

corporate travel and the settlement of shareholder litigation related to the Merger.

We incurred significant decreases in costs

associated with the terminated aircraft lease, corporate travel and legal settlements which was offset by increases director’s

fees and business insurance costs.

Expense and Accretion of Debt Discount

Interest expense and the accretion

of the debt discount on the line-of-credit declined $583,399 during the year ended December 31, 2021.

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.

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 Line of Credit.

The Line of Credit also carried an annualized 5% interest rate.

line of credit was terminated on April 16, 2021 in relation to the merger and was paid in full on April 28, 2021.

of Intangible Assets

of Intangible Assets included the amortization of the website for the year ended December 31, 2020.

No amortization was

recorded for the year ended December 31, 2021 .

the year ended December 31, 2021, no stock options were issued.

Line of Credit was terminated on April 16, 2021 in connection with the Merger and was paid in full on April 28, 2021.

the year ended December 31, 2022, stock-based compensation totaled $695,191.

These expenses include stock options issued to staff and

service providers, restricted stock units and Common Stock warrants issued for services.

During the year ended December 31, 2021, we

did not incur any stock-based compensation expenses.

Option Modification Expenses

the year ended December 31, 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.

the year ended December 31, 2022, we did not incur any stock option modification expenses.

During the year ended December 31, 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.

Income and Expense

1 unchanged sentence

year-over-year:

the Years Ended

For the Years

Interest and Dividend Income

Debt Forgiveness

Loss on FMV of Equity Investments

on Investments

Uninsured Casualty Loss

Gain on Debt Forgiveness

(Gain)/Loss on FMV of Equity Investments

(Gain)/Loss on Investments

Uninsured Casualty (Gain)/Loss

Total Other (Income)/Expense

Not meaningful

expenses, net of income, totaled $1,079,338 for the year ended December 31, 2021, and other income, net of expenses, totaled $141

income, net of expenses, totaled $85,427 for the year ended December 31, 2022, and other expenses, net of income, totaled $1,079,338

for the year ended December 31, 2021.

During the year ended December 31, 2022 interest and dividend income, the

changes in fair value of our investments and realized gains from the sale of investments are primarily the result of rising interest rates.

gain on debt forgiveness totaling $180,257 resulted from (i) $109,657 from the negotiated settlement of the amounts due under the related

1 unchanged sentence

received in 2020.

For the year ended December

31, 2021, we identified an uninsured casualty loss of $1,265,306 related to wire fraud due to a compromised electronic mail account.

the year ended December 31, 2021, we identified an uninsured casualty loss of $1,265,306 related to wire fraud due to a compromised electronic

mail account.

This incident began in late August 2021 and was discovered on October 26, 2021.

The Company’s internal review of disbursements

made during the period of the incident has not identified any additional losses.

Our management continues to investigate the incident.

The Company’s internal review of

disbursements made during the period of the incident did not identify any additional losses.

third-party forensic technology company’s investigation confirmed that we were a victim of wire fraud due to a compromised electronic

mail account.

Following the incident, we have taken measures to enhance our electronic mail security and have modified our internal

procedures to ensure the authenticity of payment instructions.

Despite these prophylactic measures, the risk of such cyber-attacks against

us or our third-party providers and business partners remain a serious issue.

Cybersecurity incidents are pervasive,

and the risks of cybercrime are complex and continue to evolve.

Although we are making significant efforts to maintain the security and

integrity of our information systems and are exploring various measures to manage the risk of a security breach or disruption,

there can be no assurance that our security efforts and measures will be effective or that attempted security breaches or disruptions

would not be successful or damaging.

As of December 31, 2021, and 2020, the Company had U.S.

federal net operating

loss carry forwards of approximately $101.9 million and $100.6 million, respectively.

Following the incident, we have taken measures to enhance our electronic mail security and have modified our internal procedures

to ensure the authenticity of payment instructions.

Despite these prophylactic measures, the risk of such cyber-attacks against us or

our third-party providers and business partners remain a serious issue.

Cybersecurity incidents are pervasive, and the risks of cybercrime

are complex and continue to evolve.

Although we are making significant efforts to maintain the security and integrity of our information

systems and are exploring various measures to manage the risk of a security breach or disruption, there can be no assurance that our

security efforts and measures will be effective or that attempted security breaches or disruptions would not be successful or damaging.

the year ended December 31, 2022, we recovered $4,442 from the receiving financial institution.

of December 31, 2022, and 2021, we had U.S.

federal net operating loss carry forwards of approximately $107.1 million and $101.9 million,

respectively.

Approximately $57.7 million of the U.S.

net operating loss generated in tax years beginning before January 1, 2018 expire beginning with the year ending December 31, 2022 through

federal net operating loss generated in tax years beginning before January 1, 2018

expire beginning with the year ending December 31, 2023 through 2037.

The remaining U.S.

federal net operating loss of approximately $44.2 million does not expire, however it is limited to 80% of each

subsequent year’s net income.

As of December 31, 2021, and 2020, the Company had U.S.

state net operating loss carry forwards of

approximately $38.2 million and $7.5 million, respectively, some of which expire beginning with the year ending December 31, 2022 through

federal net operating loss of approximately

$49.4 million does not expire, however it is limited to 80% of each subsequent year’s net income.

As of December 31, 2022, and

2021, we had U.S.

state net operating loss carry forwards of approximately $41.0 million and $38.2 million, respectively, some of which

expire beginning with the year ending December 31, 2023 through 2042.

Section 382 of the Code, use of our net operating loss carryforwards is limited if we experience a cumulative change in ownership of

5 unchanged sentences

is expected that the Merger caused our net operating loss carryforwards to be limited.

However, the limitation had no immediate impact

on our financial statements since we recorded a full valuation allowance for our deferred tax assets as of December 31, 2021 and 2020.

(See Note 8 to the Consolidated Financial Statements)

However, the limitation had no impact on our financial

statements since we recorded a full valuation allowance for our deferred tax assets as of December 31, 2022 and 2021.

(See Note 8 to

the Consolidated Financial Statements)

and Capital Resources

As of December 31, 2021, the

Company’s cash and cash equivalents on hand was $555,967 and marketable securities were $11,003,071.

The Company has incurred net

losses of $29,889,045 and $9,487,824 for the years ended December 31, 2021 and 2020, respectfully.

of December 31, 2022, the Company’s cash and cash equivalents on hand was $749,090 and marketable securities were $4,086,902.

Company has incurred net losses of $15,197,336 and $29,889,045 for the years ended December 31, 2022 and 2021, respectfully.

As of December

the Company had working capital of $11,625,519 and a stockholders’ deficit of $78,561,568.

During the year ended

December 31, 2021, cash flows used in operating activities were $19,516,475, consisting primarily of a net loss from operations of $29,889,045

and a decrease in trade and other payables of $4,268,961 offset by non-cash stock option modification expenses of $15,036,051.

Since inception, the Company has met its liquidity requirements principally through the sale of its common stock in public and private

31, 2022, the Company had working capital of $2,632,796 and a stockholders’ equity of $14,695,056 including an accumulated deficit

of $93,758,904.

During the year ended December 31, 2022, cash flows used in operating activities were $12,270,068, consisting primarily

of a net loss from operations of $15,197,336 offset by an increase in trade and other payables of $1,686,595, a decrease in prepaid expenses

of $540,560 and non-cash stock compensation expenses of $695,191.

Since inception, the Company has met its liquidity requirements principally

through the sale of its Common Stock in public and private placements.

See also “Recent Developments” below.

has evaluated the Company’s 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

believes that the Company’s current financial resources as of the date of the issuance of these consolidated financial

statements, are sufficient to fund its current operating budget and contractual obligations as of December 31, 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.

has created an alternative plan providing that, in the event no financing consummated by September 30, 2022, management will slow down

clinical efforts in order to maintain adequate cash reserves to maintain operations for an additional six months, providing additional

time for the Company to complete a financing.

Management believes a financing will occur prior to September 30, 2022.

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 consolidated financial statements.

net cash used by operating activities totaled $12,270,068 during the year ended December 31, 2022.

Net cash used consisted principally

of the net losses from operations of $29,889,045 and a decrease in trade and other payables of $4,268,961 partially offset

by non-cash option modification expenses of $15,036,051.

of the net loss from operations of $15,197,336 partially offset by an increase in trade and other payables of $1,686,595, a decrease

in prepaid expenses of $540,560 and non-cash stock compensation expenses of $695,191.

net cash used by operating activities totaled $19,516,475 during the year ended December 31, 2021.

Net cash used consisted principally

of the net loss from continuing operations of $9,487,24 partially offset by non-cash amortization of the debt discount of $1,191,859

and stock option expenses of $2,009,145.

cash provided by investing activities totaled $19,850,625 for the year ended December 31, 2021 as compared to cash provided by investing

of the net losses from operations of $29,889,045 and a decrease in trade and other payables of $4,268,961 partially offset by non-cash

option modification expenses of $15,036,051.

net cash provided by investing activities totaled $6,913,163 for the year ended December 31, 2022 as compared to cash provided by investing

activities totaling $19,850,625 during the year ended December 31, 2021.

During the year ended December 31, 2022 we purchased securities

totaling $4,836,837 and sold securities totaling $11,750,000.

During the year ended December 31, 2021 we purchased securities totaling

$13,403, sold securities totaling $18,483,176 and received $1,380,852 from the merger.

cash provided by financing activities during the year ended December 31, 2021 was $73,533 which consisted of the payoff of our

lines of credit totaling $3,062,444 offset by proceeds of $120,000 from the line of credit and $1,826,137 from the Promissory Note and

net proceeds of $1,189,840 from the exercise of warrants for common stock.

Net cash provided by financing activities totaled $4,677,331

during the year ended December 31, 2020 which consisted of proceeds from the line of credit of $1,426,731, $1,200,000 from the Promissory

Note, $1,980,000 from the issuance of common stock and $70,600 from the Payroll Protection Program.

cash provided by financing activities during the year ended December 31, 2022 was $5,550,028 which consisted of the net proceeds

from the sale of Common Stock.

Net cash provided by financing activities during the year ended December 31, 2021 was $73,533 which

consisted of the payoff of our Line of Credit totaling $3,062,444 offset by proceeds of $120,000 from the Line of Credit and

$1,826,137 from a Secured Promissory Note made to us by pre-Merger MyMD Florida which was paid off at the time of the Merger and net

proceeds of $1,189,840 from the exercise of warrants for Common Stock.

August 15, 2022, we entered into a securities purchase agreement (the “August 2022 SPA”) with certain

accredited and institutional investors pursuant to which we agreed to issue 1,411,764 shares of Common Stock (the

“August 2022 Shares”) in a registered direct offering and unregistered warrants to purchase up to an aggregate of

1,411,764 shares of Common Stock in a concurrent private placement (the “August 2022 Warrants”).

August 2022 Warrants have an exercise price of $5.25 per share, became exercisable six months following the date of issuance

and have a term of exercise equal to five years from the initial exercise date.

We received net proceeds from the sale of the

August 2022 Shares and the August 2022 Warrants, after deducting fees and other estimated offering expenses payable by the

Company, of approximately $5.5 million.

As of March 29, 2023, none of the August 2022 Warrants have been exercised and

1,411,764 of the August 2022 Warrants remain outstanding.

Accounting Policies

66 unchanged sentences

To calculate the fair

value of the options, certain assumptions are made regarding components of the model, including the fair value of the underlying common

stock, risk-free interest rate, volatility, expected dividend yield and expected option life.

value of the options, certain assumptions are made regarding components of the model, including the fair value of the underlying Common Stock, risk-free interest rate, volatility, expected dividend yield and expected option life.

Changes to the assumptions could cause

17 unchanged sentences

have no significant known off balance sheet arrangements.

2023 Offering

February 21, 2023, we entered into a Securities Purchase Agreement (the “February 2023 SPA”) with certain accredited

investors, pursuant to which we agreed to sell in a registered direct offering (the “February 2023 Offering”) (i) an

aggregate of 15,000 shares (the “Series F Preferred Shares”) of our newly-designated Series F Convertible Preferred

Stock, with a stated value of $1,000 per Preferred Share and without par value (the “Series F Preferred Stock”), convertible

into shares of Common Stock (the “Series F Conversion Shares”) pursuant to the terms of the Certificate of Designations

of the Series F Preferred Stock (the “Certificate of Designation”), and (ii) 6,651,885 warrants (the “February 2023

Warrants”) to acquire up to an aggregate of 6,651,885 shares of Common Stock, subject to adjustment (the “February 2023

Warrant Shares”).

The Conversion Price (as defined below) is subject to customary adjustments for stock dividends, stock splits,

reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible,

exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions).

closing, we received net proceeds from the February 2023 Offering of approximately $14.1 million, after deducting various fees

and expenses.

We intend to use the net proceeds from this offering for general corporate purposes.

Preferred Shares

terms of the Series F Preferred Shares are as set forth in the form of Certificate of Designation.

The Series F Preferred

Shares will be convertible into the Conversion Shares at the election of the holder at any time at an initial conversion price of $2.255

(the “Conversion Price”).

The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications

and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable

or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions).

will be required to redeem the Series F Preferred Shares in 12 equal monthly installments, commencing on July 1, 2023.

The amortization

payments due upon such redemption are payable, at the company’s election, in cash, or subject to certain limitations, in shares

of Common Stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) 80% of the average of the

three lowest closing prices of the Company’s Common Stock during the thirty trading day period immediately prior to the date the

amortization payment is due or (B) the Floor Price (as defined below).

For purposes of the Certificate of Designation, the “Floor

Price” means the lower of (x) $0.4014 and (y) 20% of the “Minimum Price” (as defined in Rule 5635 of the Rules of the

Nasdaq Stock Market) on the date of the Nasdaq Stockholder Approval (as defined below) (subject to adjustment for stock splits, stock

dividends, stock combinations, recapitalizations or other similar events) or, in any case, such lower amount as permitted, from time

to time, by the Nasdaq Stock Market.

The Company may require holders to convert their Series F Preferred Shares into Conversion

Shares if the closing price of the Common Stock exceeds $6.765 per share (subject to adjustment for stock splits, stock dividends, stock

combinations, recapitalizations or other similar events) for 20 consecutive trading days and the daily dollar trading volume of the Common

Stock exceeds $3,000,000 per day during the same period and certain equity conditions described in the Certificate of Designation are

holders of the Series F Preferred Shares will be entitled to dividends of 10% per annum, compounded monthly, which will be payable

in cash or shares of Common Stock at the Company’s option, in accordance with the terms of the Certificate of Designation.

the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designation), the Series F Preferred

Shares will accrue dividends at the rate of 15% per annum.

In connection with a Triggering Event, each holder of Series F Preferred

Shares will be able to require the Company to redeem in cash any or all of the holder’s Series F Preferred Shares at a premium

set forth in the Certificate of Designation.

Upon conversion or redemption, the holders of the Series F Preferred Shares are also

entitled to receive a dividend make-whole payment.

The holders of Series F Preferred Shares have no voting rights on account of

the Series F Preferred Shares, other than with respect to certain matters affecting the rights of the Series F Preferred Shares.

Company will be subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment

transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends

pursuant to the Certificate of Designation), distributions or redemptions, and the transfer of assets, among other matters.

no established public trading market for the Series F Preferred Shares and the Company does not intend to list the Series F

Preferred Shares on any national securities exchange or nationally recognized trading system.

2023 Warrants

February 2023 Warrants are exercisable immediately upon issuance at an exercise price of $2.255 per share (the “Exercise Price”)

and expire five years from the date of issuance.

The Exercise Price is subject to customary adjustments for stock dividends, stock splits,

reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances

of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise

Price (subject to certain exceptions).

There is no established public trading market for the February 2023 Warrants and the Company

does not intend to list the February 2023 Warrants on any national securities exchange or nationally recognized trading system

Stockholder Approval

ability to issue Series F Conversion Shares and February 2023 Warrant Shares using shares of Common Stock is subject to

certain limitations set forth in the Certificate of Designation, including a limit on the number of shares that may be issued until

the time, if any, that our stockholders have approved the issuance of more than 19.9% of our outstanding shares of Common Stock in

accordance with the Nasdaq Listing Rules (the “Nasdaq Stockholder Approval”).

In the February 2023 SPA we agreed to

seek the Nasdaq Stockholder Approval at a meeting of stockholders.

Certain stockholders, who beneficially held approximately 44% of

our outstanding Common Stock as of the date of the February 2023 SPA, are party to a voting agreement pursuant to which, among other

things, each such stockholder agreed, solely in their capacity as a stockholder, to vote all of their shares of Common Stock in

favor of the approval of the Nasdaq Stockholder Approval and against any actions that could adversely affect our ability to perform

our obligations under the February 2023 SPA.

The voting agreement also places certain restrictions on the transfer of the

shares of Common Stock held by the signatories thereto.

Quantitative and Qualitative Disclosures About Market Risk.

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis