What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2023-03-31 compared with 2022-03-30 · 395 added, 562 removed, 504 unchanged (66% of the section changed)

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Consolidated Financial Statements

Report of Independent Registered

Public Accounting Firm (PCAOB ID:

Consolidated Balance Sheets

as of December 31, 2022 and 2021

Consolidated Statements of

Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021

Consolidated Statements of

Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021

Consolidated Statements of

Cash Flows for the years ended December 31, 2022 and 2021

Notes to Consolidated Financial

Report of Independent Registered Public Accounting Firm

Consolidated Balance Sheets as of December 31, 2021 and 2020

Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2021 and 2020

Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2021 and 2020

Consolidated Statements of Cash Flows for the years ended December 31, 2021 and 2020

Notes to Consolidated Financial Statements

Report of Independent Registered Public Accounting

To the Stockholders and the Board of Directors

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(the “Company”) as of December 31, 2022 and 2021, the related consolidated statements

of operations, changes in stockholders’ equity and cash flows, for each of the two years in the period ended December 31, 2021,

and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated

financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2021

and 2020, and the consolidated results of its operations and its cash flows for each of the two years in the period ended December 31,

2021, in conformity with accounting principles generally accepted in the United States of America.

of operations and comprehensive loss, changes in stockholders’ equity and cash flows, for each of the two years in the period ended

December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion,

the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as

of December 31, 2022 and 2021, and the consolidated results of its operations and its cash flows for each of the two years in the period

ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

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Total current assets

Note receivable

Investment in joint venture at fair value

Investment in joint ventures at fair value

LIABILITIES AND STOCKHOLDERS’ EQUITY

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Stockholders’ equity

Preferred stock, $ 0.0001 par value, 5,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2021 and 2020, respectively

Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized;

2,000,000 and - 0 - shares issued and outstanding at December 31, 2022 and 2021, respectively

Series A Convertible Preferred Stock, $ 0.0001 par value, 5,000,000 shares designated;

- 0 - shares issued and outstanding at December 31, 2022 and 2021

Common stock, $ 0.0001 par value, 75,000,000 shares authorized, 23,974,546 and 13,438,535 shares issued and outstanding at December 31, 2021 and 2020, respectively

Series B Preferred Stock, $ 0.0001 par value, 2,000,000 shares designated;

- 0 - shares issued and outstanding at December 31, 2022 and 2021

Common stock, $ 0.0001 par value, 50,000,000 shares authorized;

1,302,113 and 959,009 shares issued and outstanding at December 31, 2022 and 2021, respectively

Additional paid-in capital

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( 33,727,163 )

Accumulated other comprehensive gain (loss)

Accumulated other comprehensive income

Total stockholders’ equity

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( 14,101,440 )

Other income (expenses)

Other (expenses) income

Losses on marketable securities

Change in fair value of investments in joint ventures

Interest income

Other income (expenses), net

Total other income (expenses)

Total other expenses

$ ( 11,371,953 )

$ ( 14,313,705 )

Other comprehensive gain (loss)

Other comprehensive income

Foreign currency translation adjustment

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$ ( 14,280,768 )

Deemed dividend to Series B Preferred Stock being redeemed

Net Loss Attributable to Common Stockholders

$ ( 11,370,963 )

$ ( 14,280,768 )

Net loss per share applicable to common stockholders - basic and diluted

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Consolidated Statements of Changes in Stockholders’

Cumulative Translation

Total Stockholders’

Preferred Stock

Other Comprehensive

Stockholders’

Balance at December 31, 2020

$ ( 19,413,458 )

Issuance of common stock, common stock warrants and prefunded warrants (net of offering costs of $ 1,591,600 )

Issuance of common stock and warrants (net of offering costs of $ 572,500 )

Issuance of common stock (net of offering costs of $ 525,000 )

Cancellation of common stock

Warrant exercise

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( 33,727,163 )

Issuance of common stock, common stock warrants and prefunded warrants (net of offering costs of $ 1,591,600 )

Issuance of common stock and warrants (net of offering costs of $ 572,500 )

Warrant exercise

Stock-based compensation

Issuance of common stock (net of offering costs of $ 1,014,896 )

Issuance of Series B preferred stock

Redemption of Series B preferred stock

( 2,000,000 )

Fractional shares adjusted for reverse

Cumulative translation adjustment

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Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation expense

Research and development-acquired license, expensed

Research and development – licenses acquired

Change in fair value of investments in joint ventures

Stock-based compensation

Realized loss (gain) on marketable securities

Unrealized loss (gain) on marketable securities

Realized loss on marketable equity securities

Unrealized (gain) loss on marketable equity securities

Loss on foreign currency exchange

Changes in assets and liabilities:

Changes in operating assets and liabilities:

Prepaid expenses

Accounts payable

Accounts payable and accrued

Net cash used in operating activities

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Cash flows from investing activities

Purchase of investments in joint venture

Purchase of research and development licenses

Purchase of marketable securities

( 2,556,135 )

( 2,300,015 )

Purchase of convertible promissory note in Isoprene

Sale of marketable securities

Net cash used in investing activities

Purchase of marketable equity securities

( 2,556,135 )

Sale of marketable equity securities

Net cash provided by (used in) investing activities

Cash flows from financing activities

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Proceeds from issuance common stock, net of offering cost

Proceeds from issuance of Series B Preferred Stock

Redemption of Series B Preferred Stock

Proceeds from exercise of warrants

Proceeds from repayment of note receivable and interest received

Net cash provided by financing activities

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Net change in cash

( 2,100,066 )

Cash, beginning of period

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Non-cash investing and financing activities

Cancellation and retirement of common stock

Fractional shares adjusted for reverse split

The accompanying notes are an integral part

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The Company is focused on developing (i) a topical formulation for treating side effects from drugs used for the treatment of

(ii) a treatment for mast-cell derived cancers and anaphylaxis;

and (iii) a treatment and/or prevention for Alzheimer’s

or other neuroinflammatory diseases.

The Company also has preclinical assets being developed for (i) atopic dermatitis (also known as

(ii) a treatment for asthma and allergies using inhalational administration;

(iii) a treatment for lung diseases resulting from

bacterial infections;

and (iv) a treatment for inflammatory bowel diseases.

In addition, the Company is developing a diagnostic device

via a mobile device.

The Company also has interests in certain other assets being developed by third parties (See Note 6 for a discussion

of the Company’s agreement with Zylö Therapeutics, Inc.

cancer (HT-001);

(ii) a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT);

(iii) a treatment for traumatic brain injury

and ischemic stroke (HT-TBI);

and (iv) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ).

We also have assets being developed for (i) atopic dermatitis (also known as eczema) (BioLexa);

(ii) a treatment for asthma and allergies

using inhalational administration (HT-004);

and (iii) a treatment for acne as well as inflammatory bowel diseases (HT-003).

we are continuing to evaluate a novel peptide that may be used to slow the transmission of SARS-CoV-2.

In addition, the Company is developing

a diagnostic device via a mobile device.

The Company also has interests in certain other assets being developed by third parties (see

Note 6 for a discussion of the Company’s agreement with Zylö Therapeutics, Inc.

and Voltron Therapeutics, Inc.).

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or equity securities when needed is subject to many risks and uncertainties and, even if it were successful, future equity issuances

would result in dilution to its existing stockholders and future debt securities may contain covenants that limit the Company’s

operations or ability to enter into certain transactions.

The Company’s current cash is sufficient

to fund operations for at least the next 12 months from the date that these financial statements are available to be issued.

the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, grants

or other arrangements to develop and seek regulatory approvals for the Company’s existing and new product candidates.

If such funding

is not available, or not available on terms acceptable to the Company, the Company’s current development plan and plans for expansion

of its general and administrative infrastructure may be curtailed.

may result in dilution to its existing shareholders and future debt securities may contain covenants that limit the Company’s operations

or ability to enter into certain transactions.

The Company believes its current cash is

sufficient to fund operations for at least the next 12 months from the issuance date of these financial statements.

Company will need to raise additional funding, through strategic relationships, public or private equity or debt financings, grants

or other arrangements, to develop and seek regulatory approvals for the Company’s current and future product candidates.

such funding is not available, or not available on terms acceptable to the Company, the Company’s current development plan and

plans for expansion of its general and administrative infrastructure may be curtailed.

On December 29, 2022, the Company entered into

a securities purchase agreement with an accredited investor pursuant to which it agreed to sell an aggregate of (i) 140,000 shares of

common stock, (ii) warrants (the “December Pre-Funded Warrants”) to purchase up to 1,860,000 shares of common stock and (iii)

warrants (the “December Common Stock Warrants”) to purchase up to 2,500,000 shares of common stock at a purchase price of

$ 5.00 per share and accompanying warrant (less $0.001 for each December Pre-Funded Warrant and accompanying warrant) in a private placement

for aggregate gross proceeds of approximately $ 10 million, exclusive of placement agent commission and fees and other offering expenses.

The closing of the offering occurred on January 3, 2023.

Each December Common Stock Warrant is exercisable for a period of five and one-half

years from the issuance date at an exercise price of $ 5.00 per share, subject to adjustment, and may, under certain circumstances, be

exercised on a cashless basis.

Each December Pre-Funded Warrant is exercisable until exercised in full at an exercise price of $ 0.001

per share and may be exercised on a cashless basis.

In addition, pursuant to the terms of the offering, the Company issued H.C.

& Co., LLC warrants (“December Wainwright Warrants”) to purchase up to 100,000 shares of the Company’s common stock.

The December Wainwright Warrants are exercisable for a period of five and one-half years from the issuance date at an exercise price of

$ 6.25 per share, subject to adjustment, and may, under certain circumstances, be exercised on a cashless basis.

Reverse Stock Split

On October 20, 2022, the Company filed a Certificate

of Change (the “Certificate of Change”) with the Secretary of State of the State of Nevada to effectuate a 1-for-25 reverse

stock split (the “Reverse Stock Split”) of the Company’s issued and outstanding and authorized shares of common stock.

The Reverse Stock Split became effective on October 26, 2022.

Shareholders who otherwise would have been entitled to receive fractional

shares of common stock had their holdings rounded up to the next whole share.

All references to common stock, convertible preferred stock

conversion ratio, warrants to purchase common stock, options to purchase common stock, restricted stock units, restricted stock awards,

share data, per share data and related information contained in the consolidated financial statements have been retrospectively adjusted

to reflect the effect of the Reverse Stock Split for all periods presented.

Note 2-Significant accounting policies

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Concentrations of credit risk and off-balance

Cash is a financial instrument that is potentially

subject to concentrations of credit risk.

The Company’s cash is deposited in accounts at large financial institutions, and amounts

may exceed federally insured limits.

The Company believes it is not exposed to significant credit risk due to the financial strength

of the depository institutions in which the cash is held.

The Company has no financial instruments with off-balance sheet risk of loss.

The Company has significant cash balances at financial institutions

which, throughout the year, regularly exceed the federally insured limit of $ 250,000 .

Any loss incurred or a lack of access to such funds

could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

Fair Value of Financial Instruments

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use in pricing an asset or a liability.

The fair value of the Company’s assets and liabilities, which

would qualify as financial instruments under ASC Topic 820, approximates the carrying amounts represented in the Company’s balance

sheet, primarily due to their short-term nature.

The accounting guidance classifies fair value

measurements in one of the following three categories for disclosure purposes:

Quoted prices

in active markets for identical assets or liabilities.

Quoted prices in active markets

for identical assets or liabilities.

Inputs other than Level 1

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Fair value option - Note receivable

The guidance in ASC 825, Financial Instruments , provides a fair

value option election that allows entities to make an irrevocable election of fair value as the initial and subsequent measurement attribute

for certain eligible financial assets and liabilities.

Unrealized gains and losses on items for which the fair value option has been elected

are reported in earnings.

The decision to elect the fair value option is determined on an instrument-by-instrument basis and must be applied

to an entire instrument and is irrevocable once elected.

Assets and liabilities measured at fair value pursuant to this guidance are required

to be reported separately in the Company’s consolidated balance sheets from those instruments using another accounting method.

Investment in joint venture

Ownership interests in entities for which

the Company has significant influence that are not consolidated are accounted for as equity method investments.

Announcement:

Accounting for Limited Partnership Investments (codified in ASC 323-30-S99-1) guidance requires the use of the equity

method unless the investor’s interest “is so minor that the limited partner may have virtually no influence over

partnership operating and financial policies.” The SEC staff’s position is that investments in limited partnerships of

greater than 3 % to 5 % are considered more than minor and, therefore, should be accounted for using the equity method or fair value

Investments accounted for using the equity method may be reported on a lag up to three months if financial statements of the

investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date.

determination of whether an investee’s results are recorded on a lag is made on an investment-by-investment basis.

investment in joint venture is further described in Note of 6 these consolidated financial statements.

The guidance in ASC 825, Financial Instruments ,

provides a fair value option election that allows entities to make an irrevocable election of fair value as the initial and subsequent

measurement attribute for certain eligible financial assets and liabilities.

Unrealized gains and losses on items for which the fair

value option has been elected are reported in earnings.

The decision to elect the fair value option is determined on an instrument-by-instrument

basis and must be applied to an entire instrument and is irrevocable once elected.

Assets and liabilities measured at fair value pursuant

to this guidance are required to be reported separately in the Company’s consolidated balance sheets from those instruments using

another accounting method.

Investment in joint ventures

Ownership interests in entities for which the

Company has significant influence that are not consolidated are accounted for as equity method investments.

SEC Staff Announcement:

for Limited Partnership Investments” (codified in ASC 323-30-S99-1) guidance requires the use of the equity method unless the investor’s

interest “is so minor that the limited partner may have virtually no influence over partnership operating and financial policies.”

The SEC staff’s position is that investments in limited partnerships of greater than 3 % to 5 % are considered more than minor and,

therefore, should be accounted for using the equity method or fair value option.

Investments accounted for using the equity method may

be reported on a lag up to three months if financial statements of the investee are not available in sufficient time for the investor

to apply the equity method as of the current reporting date.

The determination of whether an investee’s results are recorded on

a lag is made on an investment-by-investment basis.

This investment in joint ventures is further described in Note 6 of these consolidated

financial statements.

development costs

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Recent accounting pronouncements

In December 2019, FASB issued ASU No.

“Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to

simplify various aspects related to accounting for income taxes.

ASU 2019-12 removes certain exceptions to the general principles in

Topic 740 and also clarifies and amends existing guidance to improve consistent application.

This guidance is effective for fiscal years,

and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.

The Company adopted

ASU 2019-12 effective January 1, 2021, and the adoption did not have a material impact on its consolidated financial statements.

Currently, management does not believe that any

recently issued, but not yet effective accounting pronouncements, if currently adopted, would have a material impact on the Company’s

consolidated financial statements.

Note 3-License agreements

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The George Washington University

Chelexa Biosciences, Inc.

and the University of Cincinnati

University of Maryland and Isoprene Pharmaceuticals, Inc.

Isoprene Pharmaceuticals, Inc.

North Carolina State University

Virginia Commonwealth University

University of Cincinnati

Army Medical Research and Development Command

Chelexa Biosciences, Inc.

and the University of Cincinnati

Washington University

On February 1, 2020 (“GW the Effective

Date”), the Company entered into a patent license agreement with GW pursuant to which GW granted the Company a license to certain

patent rights to, among other things, make, use, offer and sell certain licensed products throughout the world with respect to HT-001.

On the GW Effective Date, the Company paid GW $2,500, and on February 27, 2020, the Company paid GW $10,000 as a license initiation fee.

Until the first commercial sale of HT-001, the Company shall pay (i) $75,000 per year for the development and commercialization of HT-001,

(ii) $2,000 for license maintenance fees on the first anniversary of the GW Effective Date and (iii) $5,000 for license maintenance fees

commencing on the second anniversary of the GW Effective Date and thereafter.

Furthermore, the Company shall be required to pay GW a

sublicense fee equal to a certain percentage of the sum of payments plus the fair market value of all other consideration of any kind

received by the Company from sublicensees during each quarter as follows:

a 40% sublicense fee until the first anniversary of the GW

Effective Date, a 30% sublicense fee until the third anniversary of the GW Effective Date and a 20% sublicense fee after the third anniversary

of the GW Effective Date;

provided, however, such sublicense fee shall exclude certain fees paid to the Company such as certain royalties,

equity investments, loan proceeds and sponsored research funding.

The Company shall also pay GW milestone payments of up to an aggregate

of $90,000 and sales-based royalties at a low single digit percentage, subject to certain minimum royalty requirements.

Effective as of June 1, 2019, the Company and

GW entered into a sponsored research agreement (the “Sponsored Research Agreement”), as amended on July 29, 2019, May 29,

2020 and September 7, 2021, with respect to the exploration of the potential use of HT-001 for topical and/or systemic therapy to counter

the dermatological related side-effects of Erlotinib therapy in cancer patients.

The Sponsored Research Agreement shall terminate on

May 31, 2022 unless terminated earlier pursuant to the terms of the agreement.

On August 7, 2020 (the “GW Second Effective

Date”), the Company entered into a second Patent License Agreement (the “GW Second Patent License Agreement”) with

GW pursuant to which GW granted the Company an exclusive, worldwide, royalty bearing license to certain intellectual property that can

be used to develop a breath based diagnostic device.

The GW Second Patent License Agreement permits the Company to make, have made, use,

import, offer for sale and sell Licensed Products (as defined in the GW Second Patent License Agreement) in the field of virus sensing

and detection.

The term of the GW Second Patent License Agreement shall continue until the later of:

(a) the expiration or abandonment

of the last patent to expire or become abandoned of the Patent Rights (as defined in the GW Second Patent License Agreement);

ten years after the first Sale (as defined in the GW Second Patent License Agreement) of the first Licensed Product if no patent has

issued from the Patent Rights, unless terminated earlier pursuant to the terms of the agreement.

Pursuant to the GW Second Patent License

Agreement, the Company shall pay GW:

(i) an upfront license initiation fee, (ii) annual maintenance fees commencing on the first anniversary

of the GW Second Effective Date, (iii) milestone payments ranging from the low to mid five figures, (iv) running royalty payments at

a middle single digit percentage of Net Sales (as defined in the GW Second Patent License Agreement), (iv) quarterly minimum payments

ranging from the low four figures for the first four quarters after the first sale to low five figures commencing three years after the

first sale and (v) an annual diligence fee of high five figures.

In addition, the Company has agreed to reimburse GW for certain past

and future patent filing and prosecution costs.

On September 17, 2020, the Company entered into

a second Sponsored Research Agreement (the “Second Agreement”) with GW effective as of September 1, 2020 (the “Second

Agreement Effective Date”).

The Second Agreement relates to the development of a diagnostic device for the detection of SARS-CoV-2

via a mobile device as an aid in the diagnosis of the COVID-19 infection.

The Second Agreement was terminated on February 26, 2021.

During the year ended December 31, 2020, the

Company paid $ 10,000 for license initiation fee, $ 10,000 for option exercise fee and approximately $ 15,000 patent related expense.

Company also recorded an expense of approximately $ 134,000 related with warrants granted to GW pursuant to the GW Patent License Agreement

and GW Second Patent License Agreement.

During the year ended December 31, 2022, the Company

recorded an expense of approximately $ 53,000 for related to warrants granted to The George Washington University (“GW”) pursuant

to the patent license agreement with GW dated February 1, 2020 (“GW Patent License Agreement”) and the patent license agreement

with GW dated August 7, 2020 (“Second GW Patent License Agreement”).

The Company also recorded $ 14,000 the year ended December

31, 2022 for a license maintenance fee.

During the year ended December 31, 2021, the

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and the Second GW Patent License Agreement.

Chelexa Biosciences, Inc.

and the University

of Cincinnati

On May 14, 2020, the Company entered into an

Assignment and Assumption Agreement (the “Assignment Agreement”) with Chelexa Biosciences, Inc.

(“Chelexa”) pursuant

to which Chelexa assigned to the Company its rights and obligations in and liabilities under its license agreement with the University

of Cincinnati dated February 27, 2013 (as amended, the “University of Cincinnati License Agreement”).

In consideration for

the assignment, the Company agreed to forgive all amounts due to it by Chelexa and to pay to Chelexa certain royalty payments.

In connection with the Assignment Agreement,

on May 14, 2020, the Company entered into a novation agreement (the “Novation Agreement”) with Chelexa and the University

of Cincinnati pursuant to which the parties agreed that the Company would be substituted in place of Chelexa with respect to the rights

and obligations of Chelexa set forth in the University of Cincinnati License Agreement.

In connection with the Assignment Agreement,

on May 14, 2020, the Company entered into a royalty agreement (the “Royalty Agreement”) with Chelexa pursuant to which the

Company shall pay Chelexa sales-based royalties at percentages which range from mid to high single digits, with high sales volumes being

subject to lower royalty rates and total milestone payments of $ 3.5 million.

Pursuant to the University of Cincinnati License

Agreement, the Company was granted an exclusive license to make, use, have made, import, offer for sale, and sell products based upon

or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit biofilm

formation (the “BioLexa Platform” or “BioLexa”).

In addition, the University of Cincinnati granted the Company

the right to issue exclusive and nonexclusive sublicenses (with the right to further sublicense to third parties) to make, use, have

made, import, offer for sale, and sell products based upon the BioLexa Platform.

The term of such agreement will expire on the later

of April 16, 2034 and the last to expire patent in the patent rights granted to the Company (the “Term”).

The Company shall,

in its sole discretion, have the first right of refusal to renew the Term.

The Company is subject to total milestone payments of $ 6,000 ,

royalty payments, annual license maintenance fees, and has agreed to pay the University of Cincinnati for certain out-of-pocket expenses

including, but not limited to, payments for patent prosecution.

During the year ended December 31, 2021, the

Company paid $ 2,500 for the annual license maintenance fee and $ 5,000 for the yearly minimum annual royalty fee.

During the year ended December 31, 2020, the

Company paid a total of $ 2,500 for the annual license maintenance fee, $ 5,000 for the yearly minimum annual royalty fee and approximately

$ 2,000 for patent expense reimbursement.

As of December 31, 2020, the Company accrued a $ 7,500 for an upfront license payment.

was made in 2021.

University of Maryland and Isoprene Pharmaceuticals,

On July 30, 2020 (the “Isoprene Effective

Date”), the Company entered into a Sublicense Agreement (the “Isoprene Sublicense Agreement”) with Isoprene Pharmaceuticals,

(“Isoprene”).

Pursuant to the Isoprene Sublicense Agreement, Isoprene granted the Company an exclusive sublicense to

certain intellectual property (i) to make, have made, use, sell, offer to sell and import certain licensed products, (ii) in connection

therewith, to use certain inventions and licensed materials and (iii) to practice the Patent Rights (as defined in the Isoprene Sublicense

Agreement) for the treatment of dermatological conditions or diseases.

The Isoprene Sublicense Agreement will continue on a country-by-country

basis until the expiration of the last to expire of the Patent Rights in such country, unless earlier terminated pursuant to the Isoprene

Sublicense Agreement (the “Isoprene Term”).

Pursuant to the Isoprene Sublicense Agreement, the Company shall pay Isoprene,

among other things, (i) a license fee, (ii) a royalty rate at a middle single digit percentage, (iii) milestone payments of up to $ 1,375,000

and (iv) revenue interest at a low single digit percentage based on the net revenue of covered products sold by Isoprene during the Isoprene

On December 2, 2020, the Company entered into

an option agreement (the “Option Agreement”) with Isoprene, pursuant to which the Company had an exclusive option, until

June 2, 2021, to negotiate an exclusive, royalty-bearing and limited term license with respect to certain previously sublicensed intellectual

property for the diagnosis and treatment of inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis, which

option was exercised on July 2, 2021.This Option Agreement is based upon and expands the fields of use in which the Company can license

certain Isoprene intellectual property that is the subject of the Company’s existing Sublicense Agreement, dated July 30, 2020,

with Isoprene, and the Master License Agreement, dated July 8, 2020, by and between Isoprene and the University of Maryland, Baltimore.

During the year ended December 31, 2020, the

Company paid $ 10,000 for the license fee and $ 20,000 for the option exercise fee.

As of December 31, 2020, the Company accrued a $ 5,000

for an upfront license payment.

During the year ended December 31, 2021, the

Company paid $ 15,000 for the license fee.

Isoprene Pharmaceuticals, Inc.

During the years ended December 31, 2022 and 2021,

the Company paid $ 0 and $ 15,000 , respectively, for the license fee associated with the sublicense agreement by and between the Company

and Isoprene Pharmaceuticals, Inc.

dated July 30, 2020.

North Carolina

State University

On February 25, 2021 (the “Effective Date”),

the Company entered into a License Agreement (the “License Agreement”) with North Carolina State University (“NC State”)

pursuant to which NC State granted the Company an exclusive, worldwide, royalty bearing license to certain intellectual property to,

among other things, discover, develop, make, have made, use and sell certain licensed products and sell, use and practice certain licensed

services with respect to cancer and anaphylaxis.

The License Agreement commenced on the Effective Date and continues until the later

of (i) the date of expiration of the last to expire patents rights licensed pursuant to such agreement, including any renewals or extensions

thereof and (ii) expiration of any market exclusivity period granted for a licensed product by the applicable regulatory agency.

During the year ended December 31, 2022, the Company

paid approximately $ 28,000 for the license fee associated with the license agreement by and between the Company and North Carolina State

University dated February 25, 2021.

During the year ended December 31, 2021, the

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Commonwealth University

On May 18, 2020 (the “VCU Effective Date”),

the Company entered into an Exclusive License Agreement (the “VCU License Agreement”) with the Virginia Commonwealth University

Intellectual Property Foundation (“VCU”).

Pursuant to the VCU License Agreement, VCU granted the Company an exclusive, royalty

bearing license to a novel peptide developed by researchers at VCU that may be used to slow the transmission of SARS-CoV-2 (the “VCU

Licensed Patent”) and a non-exclusive royalty bearing, worldwide license with respect to the Licensed Technical Information Patents

(as defined in the VCU License Agreement) to make, have made, use, offer to sell, sell and import the Licensed Products (as defined in

the VCU License Agreement) and perform the Licensed Services (as defined in the VCU License Agreement).

The VCU License Agreement commenced

on the VCU Effective Date and shall continue until the expiration of the last to expire VCU Licensed Patent unless terminated earlier

pursuant to the terms of the agreement.

Pursuant to the VCU License Agreement, the Company shall pay VCU:

(i) an upfront license issue

fee, (ii) running royalty payments at a low single digit percentage of Net Sales (as defined in the VCU License Agreement), (iii) annual

maintenance fees commencing on the first anniversary of the VCU Effective Date, (iv) annual minimum payments ranging from the mid five

figures to low six figures commencing on the second anniversary of the VCU Effective Date and (v) milestone payments ranging from the

mid five figures to low six figures.

In addition, the Company has agreed to reimburse VCU for certain patent filing and prosecution costs.

On June 29, 2020, the Company entered into a

Sponsored Project Agreement (the “VCU Sponsored Project Agreement”) with VCU for the development of a potential COVID-19

treatment using the license to a novel peptide granted to the Company by VCU.

The VCU Sponsored Project Agreement was amended on April

28, 2021 to extend the period of research and to add an additional scope of investigation to include the variants of SARS-CoV-2.

In May 2020, the Company paid the signing fee

of $ 50,000 upon execution of the VCU License Agreement.

During the year ended December 31, 2021, the

Company paid $ 30,000 for annual maintenance fees.

As of December 31, 2021 and 2020, the Company

accrued $ 285,000 for five years of annual minimum payments and $ 30,000 for annual maintenance fees.

The University of Cincinnati

On May 18, 2018, the Company entered into an

exclusive license agreement with the University of Cincinnati for a patented, novel genetic marker for food allergies.

The genetic marker

licensed by the Company from the University of Cincinnati may be used to (i) identify at risk infants in predicting food allergies, including

peanut and milk allergies, (ii) identify a person’s predisposition to an allergic reaction, thereby avoiding such reaction and

(iii) determine an individual’s propensity to develop atopic dermatitis, such as eczema.

Pursuant to the terms of the exclusive

license agreement, the Company paid the University of Cincinnati a minimum annual royalty fee of $ 5,000 and agreed to pay the University

of Cincinnati an annual license fee of $ 5,000 initially due and payable within 30 days of the one year anniversary of the exclusive license

agreement and every year thereafter and milestone payments of up to $ 120,000 .

The exclusive license agreement was terminated by the Company

on October 22, 2021.

During the year ended December 31, 2021, the

Company paid $ 5,000 for the annual license maintenance fee and $ 5,000 for the yearly minimum annual royalty fee.

During the year ended December 31, 2020, the

Company paid a total of $ 5,000 for the annual license maintenance fee, $ 5,000 for the yearly minimum annual royalty.

As of December 31,

2020, the Company accrued a $ 10,500 for an upfront license payment.

The payment was made in 2021.

Army Medical Research and Development

On December 11, 2020, the Company entered into

a commercial evaluation license agreement with U.S.

Army Medical Research and Development Command (“USAMRDC”).

This agreement

was amended on January 12, 2021 to clarify that the license entered into is with Walter Reed Army Institute of Research, a subsidiary

During the year ended December 31, 2022 and 2021,

the Company paid $ 0 and $ 30,000 , respectively, for annual maintenance fees associated with the exclusive license agreement between the

Company and Virginia Commonwealth University Intellectual Property Foundation.

As of December 31, 2022, the Company accrued

a $ 2,000 for an upfront license payment.

The payment was made in January 2021.

$ 150,000 for five years of annual minimum payments and $ 125,000 for annual maintenance fees.

As of December 31, 2021, the Company accrued

$ 285,000 for five years of annual minimum payments and $ 30,000 for annual maintenance fees.

Chelexa Biosciences, Inc.

and the University

of Cincinnati

During the year ended December 31, 2022, the Company

paid $ 2,500 for the annual license maintenance fee and $ 5,000 for the yearly minimum annual royalty fee associated with the Assignment

and Assumption Agreement by and between the Company and Chelexa Biosciences dated May 14, 2020.

Note 4-Note Receivable

Pursuant to Isoprene Sublicense Agreement dated

July 30, 2020, the Company made an investment of $ 50,000 in Isoprene in the form of a convertible promissory note (the “Isoprene

Note”) on September 10, 2020.

The Isoprene Note matures on September 10, 2022 and accrues interest at a rate equal to the lower

(i) the highest lawful rate permitted under applicable law and (ii) 6% per annum.

The Isoprene Note may not be prepaid without the

prior written consent of the Company.

In the event a Qualified Financing (as defined below) occurs before the Isoprene Note is repaid

in full or the conversion of such note pursuant to a Change of Control (as defined in the Isoprene Note) transaction, the Isoprene Note

may be converted into such number of convertible preferred stock issued in the Qualified Financing equal to the balance of such note

divided by the Capped Conversion Price (as defined below).

“Qualified Financing” means the first sale of Isoprene’s

convertible preferred in a private financing that results in gross proceeds of at least $5 million.

“Capped Conversion Price”

means the lesser of (i) the per share or unit price in the Qualified Financing and (ii) an amount determined by dividing (A) $15 million

by (B) the fully diluted capitalization Isoprene immediately prior to the conversion of the Isoprene Note.

In the event a Change of Control

occurs before the Isoprene Note is repaid in full or the conversion of such note pursuant to a Qualified Financing, the Isoprene Note

may be converted into such number of shares of Isoprene’s common stock equal to the quotient obtained by dividing (i) the balance

of the Isoprene Note by (ii) two times the fair market value of a share of Isoprene common stock as set for in the acquisition agreement

pertaining to such Change of Control.

Note 5—Investments in Marketable Securities

Pursuant to the sublicense agreement dated

July 30, 2020 by and between the Company and Isoprene Pharmaceuticals, Inc.

(“Isoprene”), the Company made an investment

of $ 50,000 in Isoprene in the form of a convertible promissory note (the “Isoprene Note”) on September 10, 2020.

Isoprene Note was due to mature on September 10, 2022 and accrued interest at a rate equal to the lower of:

(i) the highest lawful

rate permitted under applicable law and (ii) 6 % per annum.

The Isoprene Note could not be prepaid without the prior written consent

of the Company;

provided, however, that if the Isoprene Note had not been converted in connection with a Qualified Financing (as

defined herein) or a Change of Control (as defined in the Isoprene Note) by the two year anniversary of the date of the issuance of

the Isoprene Note, Isoprene could elect, in its sole discretion, to repay the Isoprene Note and any accrued interest thereon.

event a Qualified Financing occurred before the Isoprene Note was repaid in full on the maturity date or the conversion of such note

pursuant to a Change of Control, the Isoprene Note could be converted into such number of convertible preferred stock issued in the

Qualified Financing equal to the balance of such note divided by the Capped Conversion Price.

“Qualified Financing”

means the first sale of Isoprene’s convertible preferred stock in a private financing that results in gross proceeds of at

least $ 5 million.

“Capped Conversion Price” means the lesser of (i) the per share or unit price in the Qualified

Financing and (ii) an amount determined by dividing (A) $ 15 million by (B) the fully diluted capitalization of Isoprene immediately

prior to the conversion of the Isoprene Note.

In the event a Change of Control occurred before the Isoprene Note was repaid in full

on the maturity date or the conversion of such note pursuant to a Qualified Financing, the Isoprene Note could be converted into

such number of shares of Isoprene’s common stock equal to the quotient obtained by dividing (i) the balance of the Isoprene

Note by (ii) two times the fair market value of a share of Isoprene common stock as set for in the acquisition agreement pertaining

to such Change of Control.

As of the maturity date of the Isoprene Note, neither a Qualified Financing nor a Change of Control had

occurred, and the Isoprene Note of $ 50,000 and accrued interest of approximately $ 6,000 was paid off on October 21, 2022.

Note 5-Investments in Marketable Equity Securities

The realized gain or loss, unrealized gain or

loss, and dividend income related to marketable securities for the years ended December 31, 2021 and 2020, which are recorded as a component

of other income (expenses) on the consolidated statements of operations, are as follows:

loss, and dividend income related to marketable equity securities for the years ended December 31, 2022 and 2021, which are recorded

as a component of other income (expenses) on the consolidated statements of operations and comprehensive loss, are as follows:

For the Years Ended

Unrealized gain

Unrealized gain (loss)

$ ( 176,974 )

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Dividend income

Interest income

$ ( 386,909 )

Note 6—Fair Value of Financial Assets

and Liabilities

The following table presents the Company’s

$ ( 152,682 )

Note 6-Fair Value of Financial Assets and

The following tables present the Company’s

assets and liabilities that are measured at fair value at December 31, 2022 and 2021:

Fair value measured at December 31, 2022

Quoted prices

Significant other

observable inputs

Marketable securities - mutual funds

Investment in joint venture

Investment in joint ventures

Note receivable - current

Fair value measured at December 31, 2021

Quoted prices

Significant other

observable inputs

Marketable securities - mutual funds

Investment in joint venture

Note receivable

Investment in joint venture

Investment in joint ventures

Note receivable - current

Level 3 Measurement

The following table sets forth a summary of the

changes in the fair value of the Company’s Level 3 financial assets that are measured at fair value on a recurring basis:

Investment in joint ventures at fair value at December 31, 2020

Investment in joint ventures at fair value at December 31, 2021

Change in fair value of investments in joint ventures

Investment in joint ventures at fair value at December 31, 2022

Investment in joint ventures

The Company has elected to measure the investment

in joint venture using the fair value option at each reporting date.

in joint ventures using the fair value option at each reporting date.

Under the fair value option, bifurcation of an embedded derivative

is not necessary, and all related gains and losses on the host contract and derivative due to change in the fair value will be reflected

in interest income and other, net in the consolidated statements of operations.

in interest income and other income (expense), net in the consolidated statements of operations and comprehensive loss.

The value at which the Company’s investment

in joint venture is carried on its books is adjusted to estimated fair value at the end of each quarter, taking into account general

in joint ventures is carried on its books is adjusted to estimated fair value at the end of each quarter, taking into account general

economic and stock market conditions and those characteristics specific to the underlying investments.

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to form a joint venture entity named HaloVax, LLC (“HaloVax”) to jointly develop potential product candidates for the prevention

of COVID-19 based upon certain technology that had been exclusively licensed by Voltron from The General Hospital Corporation (d/b/a

Massachusetts General Hospital).

of COVID-19 based upon certain technology that had been exclusively licensed by Voltron from The General Hospital Corporation (d/b/a Massachusetts

General Hospital).

Pursuant to the Development and Royalty Agreement, the Company is entitled to receive sales-based royalties.

In addition, pursuant to the terms of the Development and Royalty Agreement, on March 23, 2020, the Company and HaloVax entered into

a Membership Interest Purchase Agreement pursuant to which the Company purchased 5% of HaloVax’s outstanding membership interests

for $250,000 on March 27, 2020 (the “Initial Closing Date”) and had the option to purchase up to an additional 25% of HaloVax’s

membership interests (for $3,000,000 (inclusive of the $250,000)), which option expired 30 days after the Initial Closing Date.

28, 2020, the Company entered into a membership interest purchase agreement to purchase 1% of HaloVax’s outstanding membership

interest for a purchase price of $100,000.

No change in fair value occurred during the year ended December 31, 2021 and 2020.

pursuant to the terms of the Development and Royalty Agreement, on March 23, 2020, the Company and HaloVax entered into a Membership Interest

Purchase Agreement pursuant to which the Company purchased 5 % of HaloVax’s outstanding membership interests for $ 250,000 on March

27, 2020 (the “Initial Closing Date”) and had the option to purchase up to an additional 25 % of HaloVax’s membership

interests (for $ 3,000,000 (inclusive of the $ 250,000 )), which option expired 30 days after the Initial Closing Date.

On May 28, 2020,

the Company entered into a Membership Interest Purchase Agreement to purchase 1 % of HaloVax’s outstanding membership interest for

a purchase price of $ 100,000 .

During the fourth quarter of 2022, the Company identified indicators

of impairment for the HaloVax investment as a result of adverse changes in HaloVax’s business operations, including liquidity concerns.

As a result, the Company recorded an impairment charge of approximately $ 0.4 million in the fourth quarter of 2022.

The investment

in HaloVax was valued at $ 0 and $ 350,000 as of December 31, 2022 and 2021.

Investment in Zylö

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Class B common stock for $ 60,000 .

No change in fair value occurred during the year ended December 31, 2021 and 2020.

No change in fair value occurred during the nine months ended September 30, 2022.

On December 8, 2021,

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Company (i) a low single digit percent of the Net Sales (as defined in the Exclusive Sublicense Agreement) of HT-005 in the event HT-005

is sold in the Territory and (ii) a low double digit percent of any royalty that Zylö receives through the sublicense to a third

party based on Net Sales of HT-005 in the Territory which payments shall continue in each country in the Territory until expiration of

the last-to-expire Valid Claim (as defined in the Exclusive Sublicense Agreement).

Note receivable

As of December 31, 2021, the fair value of the

Isoprene Note was measured at $ 50,000 , taking into consideration cost of the investment, market participant inputs, market conditions,

liquidity, operating results and other qualitative and quantitative factors.

No change in fair value was recorded during the year ended

December 31, 2021.

is sold in the Territory and (ii) a low double digit percent of any royalty that Zylö receives through the sublicense to a third-party

based on Net Sales of HT-005 in the Territory which payments shall continue in each country in the Territory until expiration of the

last-to-expire Valid Claim (as defined in the Exclusive Sublicense Agreement).

Zylö conducted a 409A valuation of their Class B

common stock and valued its share price at $ 0.15 per share.

This value was ratified by Zylö’s board of directors in December

Therefore, the Company recorded approximate $ 27,000 in unrealized loss on this investment during the second quarter of 2022.

investment in Zylö was valued at $ 33,000 and $ 60,000 as of December 31, 2022 and 2021, respectively.

Note 7-Stockholders’ Equity

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As of December

31, 2021, 5,000,000 shares of the Company’s preferred stock has been designated as Series A Convertible Preferred Stock.

31, 2022, 5,000,000 shares of the Company’s preferred stock has been designated as Series A Convertible Preferred Stock and 2,000,000

shares of the Company’s preferred stock has been designated as Series B Preferred Stock.

Series A Convertible Preferred Stock

The shares of Series A Convertible Preferred

Stock are not mandatorily redeemable and do not embody an unconditional obligation to settle in a variable number of equity shares.

such, the shares of Series A Convertible Preferred Stock are classified as permanent equity on the balance sheets.

such, the shares of Series A Convertible Preferred Stock are classified as permanent equity on the consolidated balance sheets.

contingent redemption right in the event of certain deemed liquidation events does not preclude permanent equity classification.

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preferred stock host instrument and therefore was not bifurcated from the equity host.

Series B Preferred Stock

On November 2, 2022, the Company filed a Certificate

of Designation of the Series B Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State

of Nevada to create a new class of Series B Preferred Stock, par value $ 0.0001 per share (the “Series B Preferred Stock”).

The Certificate of Designation designated 2,000,000 shares of authorized preferred stock as Series B Preferred Stock.

The Series B Preferred

Stock were not entitled to receive dividends or any other distributions.

The Series B Preferred Stock were entitled to ten votes per

share and voted together with the Company’s issued and outstanding shares of common stock as a single class exclusively with respect

to the Authorized Stock Increase (as defined herein).

The Series B Preferred Stock had no rights as to any distribution or assets of

the Company upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company.

outstanding shares of Series B Preferred Stock were redeemed in whole an aggregate price of $10automatically and effective immediately

after the effectiveness of the Authorized Stock Increase.

On November 2, 2022, the Company entered into

a Subscription and Investment Representation Agreement with an investor pursuant to which the Company issued and sold 2,000,000 shares

of its newly designated Series B Preferred Stock to such purchaser for an aggregate purchase price of $ 1,000 .

On December 12, 2022, the Company’s shareholders

approved the an increase to the number of authorized shares of the Company’s common stock from 3,000,000 to 50,000,000 shares (the

“Authorized Stock Increase”).

On December 13, 2022, upon filing a Certificate of Amendment to its Articles of Incorporation,

as amended, to increase its authorized shares of common stock, the Series B Preferred Stock was automatically redeemed for an aggregate

Common Shares

On February 5, 2020, the Company issued 12,500

shares of common stock upon exercise of warrants issued to an investor on January 19, 2018, which resulted in gross proceeds of $ 12,500 .

On March 6, 2020, the Company issued 25,000 shares

of common stock upon exercise of warrants issued to an investor on December 14, 2017, which resulted in gross proceeds of $ 25,000 .

On May 18, 2020, the Company issued 6,250 shares

of common stock upon exercise of warrants issued to an investor on February 2, 2018, which resulted in gross proceeds of $ 6,250 .

On June 3, 2020, the Company issued 12,500 shares

of common stock upon exercise of warrants issued to an investor on November 20, 2017, which resulted in gross proceeds of $ 12,500 .

During the year ended December 31, 2020, the

Company issued an aggregate of 9,984 shares of the Company’s common stock to members of the Company’s Board for services

Public Offering of Securities

On March 24, 2020 (the “UA Effective Date”),

the Company entered into an underwriting agreement with Laidlaw & Company (UK) Ltd.

(“Laidlaw”), the representative

of the underwriters, relating to a best efforts underwritten public offering of 1,449,275 shares (the “Shares”) of the Company’s

common stock at a public offering price of $ 3.45 per Share.

The Company received net proceeds of approximately $ 4.2 million, after deducting

the underwriting discount and offering expenses.

In connection with the offering, on March 26,

2020, the Company issued Laidlaw warrants to purchase up to 72,464 shares of the Company’s common stock.

The warrants are exercisable

for a period of five years from the UA Effective Date at a price per share equal to $4.14, subject to adjustment, and may be exercised

on a cashless basis.

The Company reimbursed Laidlaw for certain of its out-of-pocket expenses incurred in connection with the offering.

On May 21, 2020, the Company entered into an

underwriting agreement with The Benchmark Company, LLC (“Benchmark”), as representative of the several underwriters, relating

to the public offering of 1,818,182 shares of the Company’s common stock at a price to the public of $ 2.75 per share.

received net proceeds of approximately $ 4.5 million, after deducting the underwriting discount and offering expenses.

In connection with the offering, on May 27, 2020

(the “Benchmark Issue Date”), the Company issued Benchmark warrants to purchase up to 90,909 shares of the Company’s

common stock.

The warrants are exercisable for a period of five years commencing six months from the Benchmark Issue Date at a price

per share equal to $ 2.75 , subject to adjustment, and may be exercised on a cashless basis.

On December 12, 2022, shareholders of the Company

approved an increase to the number of authorized shares of the Company’s common stock from 3,000,000 shares to 50,000,000 shares,

and on December 13, 2022, the Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, to effectuate such

Securities Purchase Agreements

1 unchanged sentence

a securities purchase agreement with certain accredited investors pursuant to which the Company offered and sold to the investors an

aggregate of 2,475,248 shares of its common stock and warrants to purchase up to 1,237,624 shares of common stock in a private placement

for aggregate net proceeds to the Company of $ 4.6 million, after deducting estimated offering expenses payable by the Company.

aggregate of 99,010 shares of its common stock and warrants to purchase up to 49,505 shares of common stock in a private placement for

aggregate net proceeds to the Company of $ 4.6 million, after deducting estimated offering expenses payable by the Company.

purchase price for each share of common stock and accompanying warrant to purchase one half of a share of common stock was $ 50.50 .

2 unchanged sentences

an exercise price of $ 56.25 per share, subject to adjustment, and may be exercised on a cashless basis.

In addition, pursuant to the terms

of the offering, the Company issued The Benchmark Company, LLC (“Benchmark”) warrants to purchase up to 185,644 shares of

the Company’s common stock.

In addition, pursuant to the

terms of the offering, the Company issued The Benchmark Company, LLC (“Benchmark”) warrants to purchase up to 7,426 shares

of the Company’s common stock.

Benchmark’s warrants are exercisable for a period of five years from the closing date of the

offering at an exercise price of $ 56.25 per share, subject to adjustment, and may be exercised on a cashless basis.

On March 8, 2021, the Company entered into a

securities purchase agreement with certain institutional and accredited investors pursuant to which it offered and sold to the investors

6,826,962 shares of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 767,975 shares of common

stock and warrants (the “Common Stock Warrants”) to purchase up to 7,594,937 shares of common stock in a private placement

for aggregate net proceeds to the Company of $ 13.5 million, after deducting estimated offering expenses payable by the Company.

purchase price for each share of common stock and accompanying warrant was $ 1.975 .

On March 8, 2021, the Company entered into a securities purchase agreement

with certain institutional and accredited investors pursuant to which it offered and sold to the investors 273,079 shares of common stock,

pre-funded warrants (the “March Pre-Funded Warrants”) to purchase up to 30,719 shares of common stock and warrants (the “March

Common Stock Warrants”) to purchase up to 303,798 shares of common stock in a private placement for aggregate net proceeds to the

Company of $ 13.5 million, after deducting estimated offering expenses payable by the Company.

The combined purchase price for each share

of common stock and accompanying warrant was $ 49.375 .

The closing of the offering occurred on March 10, 2021.

Each Common Stock Warrant is exercisable for a period of three years from the issuance date at an exercise price of $ 1.86 per share,

subject to adjustment, and may be exercised on a cashless basis.

Each Pre-Funded Warrant is exercisable until exercised in full at an

exercise price of $ 0.001 per share and may be exercised by means of a cashless exercise.

Each March Common Stock

Warrant is exercisable for a period of three years from the issuance date at an exercise price of $ 46.50 per share, subject to adjustment,

and may be exercised on a cashless basis.

Each March Pre-Funded Warrant is exercisable until exercised in full at an exercise price of

$ 0.025 per share and may be exercised on a cashless basis.

In addition, pursuant to the terms of the offering, the Company issued H.C.

Wainwright & Co., LLC warrants (“March Wainwright Warrants”) to purchase up to 15,190 shares of the Company’s common

The March Wainwright Warrants are exercisable for a period of three years from the issuance date at an exercise price of $ 61.72

per share, subject to adjustment, and may be exercised on a cashless basis.

On December 29, 2022, the Company entered into a securities purchase

agreement with an accredited investor pursuant to which it agreed to sell an aggregate of (i) 140,000 shares of common stock, (ii) December

Pre-Funded Warrants to purchase up to 1,860,000 shares of common stock and (iii) December Common Stock Warrants to purchase up to 2,500,000

shares of common stock at a purchase price of $ 5.00 per share and accompanying warrant (less $ 0.001 for each December Pre-Funded Warrant

and accompanying warrant) in a private placement for aggregate gross proceeds of approximately $ 10 million, exclusive of placement agent

commission and fees and other offering expenses.

The closing of the offering occurred on January 3, 2023.

Each December Common Stock Warrant

is exercisable for a period of five and one-half years from the issuance date at an exercise price of $ 5.00 per share, subject to adjustment,

and may, under certain circumstances, be exercised on a cashless basis.

Each December Pre-Funded Warrant is exercisable until exercised

in full at an exercise price of $ 0.001 per share and may be exercised on a cashless basis.

In addition, pursuant to the terms of the offering,

the Company issued H.C.

Wainwright & Co., LLC warrants (“Wainwright Warrants”) to purchase up to 379,747 shares of the

Company’s common stock.

The Wainwright Warrants are exercisable for a period of three years from the issuance date at an exercise

price of $ 2.4688 per share, subject to adjustment, and may be exercised by on a cashless basis.

Wainwright & Co., LLC the December Wainwright Warrants to purchase up to 100,000 shares of the Company’s

common stock.

The December Wainwright Warrants are exercisable for a period of five and one-half years from the issuance date at an exercise

price of $6.25 per share, subject to adjustment, and may, under certain circumstances, be exercised on a cashless basis.

Public Offering of Securities

On April 14, 2022, the Company closed an underwritten

public offering of 329,412 shares of the Company’s common stock at a price to the public of $ 21.25 per share (the “Offering

Pursuant to the terms of an underwriting agreement dated April 11, 2022 between the Company and EF Hutton, division of

Benchmark Investments, LLC, as representative of the several underwriters (the “Underwriters”), the Company granted the Underwriters

a 45-day option to purchase up to an additional 49,412 shares of the Company’s common stock to cover over-allotments, if any, at

the Offering Price less the underwriting discounts and commissions.

The net proceeds to the Company from the sale of the shares, after

deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company, were $ 6.0 million.

The Underwriters did not exercise their over-allotment option.

2018 Equity Incentive Plan

3 unchanged sentences

reserved for issuance pursuant to the 2018 Plan.

On June 24, 2021, at the annual shareholder meeting, shareholders of the Company approved

an amendment to the 2018 Plan to further increase the number of shares reserved for issuance thereunder from 1,671,926 shares to 3,671,926

On June 24, 2021, at the annual meeting of shareholders, shareholders of the Company

approved an amendment to the 2018 Plan to further increase the number of shares reserved for issuance thereunder from 66,878 shares to

146,878 shares.

On February 2, 2022, the compensation committee of the board of directors further increased the number of shares reserved

for issuance under the 2018 Plan from 146,878 shares to 156,878 shares.

On January 11, 2023, the compensation committee of the board

of directors further increased the number of shares reserved for issuance under the 2018 Plan from 156,878 shares to 166,878 shares.

2022 Equity Incentive Plan

On March 24, 2022, the Company’s board

of directors adopted the Hoth Therapeutics, Inc.

2022 Omnibus Equity Incentive Plan (the “2022 Plan”) initially reserving

96,000 shares of the Company’s common stock for issuance thereunder.

The 2022 Plan became effective on June 23, 2022 upon approval

of the 2022 Plan by the Company’s shareholders at the Company’s annual meeting of shareholders.

Restricted Stock Awards

A summary of the Company’s restricted stock

awards granted under the 2018 Plan during the years ended December 31, 2021 and 2020 is as follows:

Number of Restricted Stock Awards

Weighted Average Grant Day Fair Value

awards granted under the equity incentive plans during the years ended December 31, 2022 and 2021 is as follows:

Nonvested at December 31, 2020

7 unchanged sentences

During the year ended December 31, 2022, pursuant

to and subject to the available number of shares reserved under the 2018 Plan, the Company issued an aggregate of 632,000 options to

the Company’s directors.

to and subject to the available number of shares reserved under the 2018 Plan, the Company issued an aggregate of 51,800 options to the

Company’s directors.

The aggregate grant date fair value of these options was approximately $ 0.6 million.

During the year ended December 31, 2021, pursuant

to and subject to the available number of shares reserved under the 2018 Plan, the Company issued an aggregate of 200,000 options to

the Company’s directors.

to and subject to the available number of shares reserved under the 2018 Plan, the Company issued an aggregate of 25,280 options to the

Company’s directors.

The aggregate grant date fair value of these options was approximately $ 1.1 million.

The Company also

issued 49,212 options to purchase common stock of the Company to a third party for consulting services.

The aggregate grant date fair

value of these options was approximately $ 0.1 million.

The fair value of options granted in 2022 and

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Exercise price

$ 2.54 - 3.05

Expected stock price volatility

114.2 % - 114.5 %

Risk-free rate of interest

1 unchanged sentence

stock option plan for the years ended December 31, 2022 and 2021 is presented below:

Number of Shares

Weighted Average Exercise Price

Total Intrinsic Value

Weighted Average Remaining Contractual

Life (in years)

Outstanding as of December 31, 2020

Employee options issued

Non - employee options issued

Outstanding as of December 31, 2021

2 unchanged sentences

Options vested and exercisable as of December 31, 2022

Stock-based compensation associated with the

amortization of stock option expense was approximately $ 1.1 million and $ 0.6 for the year ended December 31, 2021 and 2020,

respectively.

All stock compensation associated with the amortization of employee stock option expense was recorded as a component of

compensation and related expense in the statement of operations.

All stock compensation associated with the amortization of nonemployee

stock option expense was recorded as a component of professional fees in the statement of operations.

All stock compensation associated with the amortization of employee stock option expense was recorded as a component of compensation

and related expense in the consolidated statements of operations and comprehensive loss.

All stock compensation associated with the amortization

of nonemployee stock option expense was recorded as a component of professional fees in the consolidated statements of operations and

comprehensive loss.

Estimated future stock-based compensation expense

5 unchanged sentences

Employee stock option awards

Non-employee stock option awards

Employee restricted stock awards

4 unchanged sentences

and research and development related with licenses acquisition in the consolidated statements of operations and comprehensive loss.

Pursuant to the Patent License Agreement between

the Company and GW dated February 1, 2020, on February 27, 2020 (the “February Warrant Date of Issuance”), the Company issued

GW ten year warrants (the “February Warrants”) to purchase up to 22,988 shares of the Company’s common stock at an

exercise price of $ 4.35 per share.

The February Warrants vest as follows:

20% on the February Warrant Date of Issuance and the balance,

or 80% of the February Warrants, vest in four equal annual installments of 20% on each anniversary of the February Warrant Date of Issuance.

Pursuant to the GW Patent License Agreement,

on August 10, 2020 (the “August Warrant Date of Issuance”), the Company issued GW ten year warrants (the “August Warrants”)

to purchase up to 72,463 shares of the Company’s common stock at an exercise price of $ 2.76 per share.

The August Warrants vest

20% on the August Warrant Date of Issuance and the balance, or 80% of the August Warrants, shall vest in four equal annual

installments of 20% on each anniversary of the August Warrant Date of Issuance.

In connection with the public offering of securities

discussed above, the Company granted to Laidlaw and Benchmark warrants to purchase up to 72,464 and 90,909 shares of the Company’s

common stock, respectively.

A summary of warrant activity for the years ended

December 31, 2022 and 2021 is presented below:

Number of Warrants

Weighted Average

Exercise Price

Total Intrinsic Value

Weighted Average

Remaining Contractual

Life (in years)

Outstanding as of December 31, 2020

Outstanding as of December 31, 2021

( 1,126,720 )

Outstanding as of December 31, 2022

7 unchanged sentences

Company is not a party to a lease that is in excess of 12 months.

The Company is not a party to any material legal

proceedings and is not aware of any pending or threatened claims.

From time to time, the Company may be subject to various legal proceedings

and claims that arise in the ordinary course of its business activities.

Note 9—Income taxes

The Company is not currently a party to any

material legal proceedings and is not aware of any pending or threatened claims.

From time to time, the Company may be subject to

various legal proceedings and claims that arise in the ordinary course of its business activities.

Note 9-Income

The table below presents the components of the

provision for taxes:

The Company’s provision is driven by refundable tax credits generated

by its subsidiary in Australia.

The Company's provision is primarily driven by the full valuation allowance in 2022 and 2021.

As of December 31,

Total current provision

2 unchanged sentences

Total provision for income taxes

At December 31, 2021 and 2020, the tax effects

of the temporary differences and carryforwards that give rise to deferred tax assets consist of the following:

At December 31, 2022 and 2021, the tax effects of the temporary differences

and carryforwards that give rise to deferred tax assets consist of the following:

As of December 31,

1 unchanged sentence

Research and development credits

Capitalized research costs

Equity based compensation

7 unchanged sentences

Net deferred taxes

A reconciliation of the statutory income tax

rates and the Company’s effective tax rate for the year ended December 31, 2021 and 2020 is as follows:

Years Ended December 31,

A reconciliation of the statutory income tax rates and the Company’s

effective tax rate for the years ended December 31, 2022 and 2021 is as follows:

Tax provision at statutory rate

State taxes, net of federal benefit

Impact of non-U.S.

Permanent items

1 unchanged sentence

Foreign rate differential

RTP and other

Increase/(decrease) in valuation reserve

8 unchanged sentences

forward indefinitely;

however, the deduction for net operating losses incurred in tax years beginning after December 31, 2017 is limited

however, the deduction for net operating losses incurred in tax years beginning after January 1, 2018 is limited

to 80 % of annual taxable income.

As of December 31, 2021, the Company has research

and development credits of approximately $ 0.4 million and $ 0 available to reduce future income taxes, if any, for Federal and state income

tax purposes, respectively.

In addition, the Company had approximately $ 0.3 million of net operating losses at its subsidiary located

in Australia, as of December 31, 2022.

As required by the 2017 Tax

Cuts and Jobs Act and effective in 2022, the deferred tax asset as of December 31, 2022 included $ 1.2 million related to the

mandatory capitalization of research and development expenses.

As of December 31, 2022, the Company does

not have any research and development credits available to reduce future income taxes for Federal and state income tax purposes.

The Federal credits expire if not utilized by 2042.

12 unchanged sentences

the Company’s net operating losses and tax credits could be limited.

The following table summarizes the activity related

to the Company’s gross unrecognized tax benefits at the beginning and end of the years ended December 31, 2021 and December 31,

2020, respectively (in thousands):

As of December 31,

Gross unrecognized tax benefits at the beginning of the year

Increases related to current year positions

Increases related to prior year positions

Decreases related to prior year positions

Expiration of unrecognized tax benefits

Gross unrecognized tax benefits at the end of the year

At December 31, 2022 and 2021, the Company did

1 unchanged sentence

The Company will recognize interest and penalties related to uncertain tax positions,

in income tax expense.

As of December 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions

and no amounts have been recognized in the Company’s statement of operations.

The Company does not anticipate a material change

to unrecognized tax benefits in the next twelve months.

as applicable, in income tax expense.

As of December 31, 2022 and 2021, the Company had no accrued interest or penalties related to uncertain

tax positions and no amounts have been recognized in the Company’s statements of operations.

The Company does not anticipate a material

change to unrecognized tax benefits in the next twelve months.

All of the Company’s tax years will remain

open for examination by the Federal and state tax authorities from the date of utilization of the net operating loss.

Note 10—Risk and Uncertainties

The outbreak of the novel Coronavirus (COVID-19)

evolved into a global pandemic.

The Coronavirus has spread to many regions of the world.

The extent to which the Coronavirus impacts

the Company’s business and operating results will depend on future developments that are highly uncertain and cannot be accurately

predicted, including new information that may emerge concerning the Coronavirus, including variants, and the actions to contain the Coronavirus

or treat its impact, among others.

As a result of the continuing spread of the Coronavirus,

certain aspects of the Company’s business operations have been delayed, and the Company may be subject to additional delays or

interruptions.

Specifically, as a result of the shelter-in-place orders and other mandated local travel restrictions, among other things,

the research and development activities of certain of the Company’s partners may be affected, which may result in delays to the

Company’s clinical trials, and the Company can provide no assurance as to when such trials, if delayed, will resume at this time

or the revised timeline to complete trials once resumed.

Furthermore, site initiation, participant recruitment

and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed

due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic

efforts, or other reasons related to the pandemic.

If the Coronavirus continues to spread, some participants and clinical investigators

may not be able to comply with clinical trial protocols.

For example, quarantines or other travel limitations (whether voluntary or required)

may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and the Company may be unable

to conduct its clinical trials.

Further, if the spread of the Coronavirus pandemic continues and the Company’s operations are adversely

impacted, the Company risks a delay, default and/or nonperformance under existing agreements which may increase its costs.

increases may not be fully recoverable or adequately covered by insurance.

Infections and deaths related to the pandemic

may disrupt the United States’ healthcare and healthcare regulatory systems.

Such disruptions could divert healthcare resources

away from, or materially delay FDA review and/or approval with respect to, the Company’s clinical trials.

It is unknown how long

these disruptions could continue, were they to occur.

Any elongation or de-prioritization of the Company’s clinical trials or delay

in regulatory review resulting from such disruptions could materially affect the development and study of the Company’s product

The Company currently utilizes third parties

to, among other things, manufacture raw materials.

If any third-party party in the supply chain for materials used in the production

of the Company’s product candidates are adversely impacted by restrictions resulting from the Coronavirus outbreak, the Company’s

supply chain may be disrupted, limiting the Company’s ability to manufacture its product candidates for its clinical trials and

research and development.

The spread of the Coronavirus, which has caused

a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have

a material economic effect on the Company’s business.

While the potential economic impact brought by and the duration of the pandemic

may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial

markets, which may reduce our ability to access capital either at all or on favorable terms.

In addition, a recession, depression or

other sustained adverse market event resulting from the spread of the Coronavirus could materially and adversely affect the Company’s

business and the value of its common stock.

The ultimate impact of the current pandemic,

or any other health epidemic, is highly uncertain and subject to change.

The Company does not yet know the full extent of potential delays

or impacts on its business, its clinical trials, its research programs, healthcare systems or the global economy as a whole.

these effects could have a material impact on the Company’s operations, and the Company will continue to monitor the situation

Nasdaq Delisting Notice

On December 30,

2021, the Company received a written notice from the Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that the bid

price of its common stock, par value $0.0001 per share, failed to comply with the $1.00 minimum bid price required for continued

listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company

was granted an initial 180 calendar day compliance period, or until June 28, 2022, to regain compliance with the minimum bid price requirement.

To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least

10 consecutive business days during the initial 180 calendar day compliance period.

In the event the Company does not regain compliance

by June 28, 2022, the Company may be eligible for an additional 180 calendar day grace period if the Company meets the continued listing

standards for The Nasdaq Capital Market, with the exception of bid price, and the Company provides written notice to Nasdaq of its intention

to cure the deficiency during the second compliance period.

Note 10-Subsequent Events

On February 2, 2022, the compensation committee

of the Board of Directors of the Company approved an increase in the number of shares of common stock reserved for issuance under the

2018 Plan by 250,000 shares from 3,671,926 shares to 3,921,926 shares.

The Company has evaluated subsequent events and

transactions that occurred up to the date the consolidated financial statements were issued.

Based upon this review, except for as noted

below, the Company did not identify any subsequent events that would have required adjustment or disclosure in the consolidated financial

On December 29, 2022, the Company entered into a securities purchase

agreement with certain institutional and accredited investors pursuant to which it agreed to sell an aggregate of (i) 140,000 shares of

common stock, (ii) December Pre-Funded Warrants to purchase up to 1,860,000 shares of common stock and (iii) December Common Stock Warrants

to purchase up to 2,500,000 shares of common stock at a purchase price of $5.00 per share and accompanying warrant (less $0.001 for each

December Pre-Funded Warrant and accompanying warrant) in a private placement for aggregate gross proceeds of approximately $10 million,

exclusive of placement agent commission and fees and other offering expenses.

The closing of the Offering occurred on January 3, 2023.

Each December Common Stock Warrant is exercisable for a period of five and one-half years from the issuance date at an exercise price

of $ 5.00 per share, subject to adjustment, and may be exercised on a cashless basis.

Each December Pre-Funded Warrant is exercisable until

exercised in full at an exercise price of $ 0.001 per share and may be exercised on a cashless basis.

In addition, pursuant to the terms

of the offering, the Company issued H.C.

Wainwright & Co., LLC the December Wainwright Warrants to purchase up to 100,000 shares of

the Company’s common stock.

The December Wainwright Warrants are exercisable for a period of five and one-half years from the issuance

date at an exercise price of $ 6.25 per share, subject to adjustment, and may be exercised on a cashless basis.

On January 11, 2023, the compensation committee

of the board of directors increased the number of shares reserved for issuance under the 2018 Plan from 156,878 shares to 166,878 shares.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS AND FINANCIAL

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 8. Financial Statements and Supplementary Data