Item 8. Financial Statements and Supplementary Data
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY
DATA
Hoth Therapeutics, Inc.
Consolidated Financial Statements
TABLE OF CONTENTS
Page No.
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID: 100)
F-2
Consolidated Balance Sheets as of December 2023 and 2022
F-3
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022
F-4
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2023 and 2022
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022
F-6
Notes to Consolidated Financial Statements
F-7
F- 1
Report
of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors
of
Hoth Therapeutics, Inc.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated
balance sheets of Hoth Therapeutics, Inc. (the “Company”) as of December 31, 2023 and 2022, 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, 2023,
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, 2023
and 2022, and the consolidated results of its operations and its cash flows for each of the two years in the period ended December 31,
2023, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
/S/ WithumSmith+Brown, PC
We have served as the Company’s auditor
since 2018.
New York, New York
March 28, 2024
PCAOB ID No. 100
F- 2
Hoth Therapeutics, Inc.
Consolidated Balance
Sheets
December 31,
2023
December 31,
2022
ASSETS
Current assets:
Cash
$ 9,292,352
$ 6,428,611
Marketable equity securities, at fair value
—
209,320
Prepaid expenses and other current assets
135,361
88,450
Total current assets
9,427,713
6,726,381
Right of use asset – operating lease
55,165
—
Investment in joint ventures at fair value
37,400
33,000
Total assets
$ 9,520,278
$ 6,759,381
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 35,592
$ 694,989
Accrued expenses
614,226
667,742
Accrued license fee - current portion
—
25,000
Lease liability, current
28,839
—
Total current liabilities
678,657
1,387,731
Lease liability, noncurrent
26,326
—
Accrued license fee - less current portion
—
250,000
Total liabilities
704,983
1,637,731
Commitments and Contingencies (See Note 7)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized; 3,000,000 shares undesignated; 0 shares issued and outstanding as of December 31, 2023 and December 31, 2022
—
—
Series A Convertible Preferred Stock, $ 0.0001 par value, 5,000,000 shares designated; 0 shares issued and outstanding at December 31, 2023 and December 31, 2022
—
—
Series B Preferred Stock, $ 0.0001 par value, 2,000,000 shares designated; 0 shares issued and outstanding as of December 31, 2023 and December 31, 2022
—
—
Common stock, $ 0.0001 par value, 50,000,000 shares authorized, 4,348,129 and 1,302,113 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
435
130
Additional paid-in capital
61,732,106
50,198,630
Accumulated deficit
( 52,944,506 )
( 45,099,116 )
Accumulated other comprehensive income
27,260
22,006
Total stockholders’ equity
8,815,295
5,121,650
Total liabilities and stockholders’ equity
$ 9,520,278
$ 6,759,381
The accompanying notes are an integral part
of these consolidated financial statements.
F- 3
Hoth Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive
Loss
For the Year Ended
December 31,
2023
2022
Operating costs and expenses
Research and development
$ 3,480,053
$ 4,931,164
General and administrative expenses
4,212,189
6,134,390
Total operating expenses
7,692,242
11,065,554
Loss from operations
( 7,692,242 )
( 11,065,554 )
Other income (expense), net
Unrealized gain (loss) on marketable securities
( 209,320 )
119,870
Realized loss on marketable securities
—
( 567,692 )
Change in fair value of investments in joint ventures
4,400
( 377,000 )
Interest income
781
6,370
Dividend income
50,991
60,913
Other income, net
—
451,140
Total other income (expense), net
( 153,148 )
( 306,399 )
Net loss
$ ( 7,845,390 )
$ ( 11,371,953 )
Deemed dividend to Series B Preferred Stock being redeemed
—
990
Net Loss Attributable to Common Stockholders
$ ( 7,845,390 )
$ ( 11,370,963 )
Net loss per share - basic and diluted
$ ( 2.30 )
$ ( 9.50 )
Weighted average number of common shares outstanding, basic and diluted
3,409,190
1,197,521
Comprehensive loss:
Net loss
$ ( 7,845,390 )
$ ( 11,371,953 )
Other comprehensive income
Foreign currency translation adjustment
5,254
4,420
Total comprehensive loss
$ ( 7,840,136 )
$ ( 11,367,533 )
The accompanying notes are an integral part
of these consolidated financial statements.
F- 4
Hoth Therapeutics, Inc.
Consolidated Statements of Changes in Stockholders’
Equity
Series B
Preferred Stock
Common Stock
Additional
Paid-in
Accumulate
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Income (Loss)
Equity
Balance as of December 31, 2021
—
$ —
959,009
$ 96
$ 43,591,773
$ ( 33,727,163 )
$ 17,586
$ 9,882,292
Stock-based compensation
—
—
10
—
620,798
—
—
620,798
Vesting of restricted stock
—
—
1,791
—
—
—
—
—
Issuance of common stock (net of offering costs of $ 1,014,896 )
—
—
329,412
33
5,985,070
—
—
5,985,103
Issuance of Series B preferred stock
2,000,000
1,000
—
—
—
—
—
1,000
Redemption of Series B preferred stock
( 2,000,000 )
( 1,000 )
—
—
990
—
—
( 10 )
Fractional shares adjusted for reverse split
—
—
11,891
1
( 1 )
—
—
—
Cumulative translation adjustment
—
—
—
—
—
—
4,420
4,420
Net loss
—
—
—
—
—
( 11,371,953 )
—
( 11,371,953 )
Balance as of December 31, 2022
—
$ —
1,302,113
$ 130
$ 50,198,630
$ ( 45,099,116 )
$ 22,006
$ 5,121,650
Exercise of warrants
—
—
2,355,050
236
2,119
—
—
2,355
Stock-based compensation
—
—
—
—
216,428
—
—
216,428
Common stock and warrants issued in private placement (net of offering costs of $ 1,575,645 )
—
—
689,275
69
11,314,929
—
—
11,314,998
Vesting of restricted stock awards
—
—
1,691
—
—
—
—
—
Cumulative translation adjustment
—
—
—
—
—
—
5,254
5,254
Net loss
—
—
—
—
—
( 7,845,390 )
—
( 7,845,390 )
Balance as of December 31, 2023
—
$ —
4,348,129
$ 435
$ 61,732,106
$ ( 52,944,506 )
$ 27,260
$ 8,815,295
The accompanying notes are an integral part
of these consolidated financial statements.
F- 5
Hoth Therapeutics, Inc.
Consolidated Statements of Cash Flows
Year Ended December 31,
2023
2022
Cash flows from operating activities
Net loss
$ ( 7,845,390 )
$ ( 11,371,953 )
Adjustments to reconcile net loss to net cash used in operating activities:
Research and development-acquired license, expensed
—
34,000
Gain on termination of license agreement
( 275,000 )
—
Change in fair value of investments in joint ventures
( 4,400 )
377,000
Stock-based compensation
216,428
620,798
Realized loss on marketable securities
—
567,692
Unrealized (gain) loss on marketable securities
209,320
( 119,870 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 47,300 )
3,847
Accounts payable and accrued expenses
( 700,752 )
590,632
Net cash used in operating activities
( 8,447,094 )
( 9,297,854 )
Cash flows from investing activities
Purchase of research and development licenses
—
( 74,000 )
Sale of marketable securities
—
1,235,695
Net cash provided by investing activities
—
1,161,695
Cash flows from financing activities
Proceeds from issuance common stock, common stock warrants and prefunded warrants, net of offering costs
11,314,998
—
Proceeds from exercise of warrants
2,355
—
Proceeds from issuance common stock, net of offering costs
—
5,985,103
Proceeds from issuance of Series B Preferred Stock
—
1,000
Redemption of Series B Preferred Stock
—
( 10 )
Proceeds from repayment of note receivable and interest received
—
50,000
Net cash provided by financing activities
11,317,353
6,036,093
Effect of exchange rate changes on cash and cash equivalents
( 6,518 )
( 9,593 )
Net change in cash
2,870,259
( 2,100,066 )
Cash, beginning of year
6,428,611
8,538,270
Cash, end of year
$ 9,292,352
$ 6,428,611
Supplemental disclosure of cash flow information:
ROU assets obtained in exchange for lease liability
$ 59,698
$ —
The accompanying notes are an integral part
of these consolidated financial statements.
F- 6
Hoth Therapeutics, Inc.
Notes to Consolidated Financial Statements
Note 1-Organization and description of business operations
Hoth Therapeutics, Inc. (together with its wholly-owned
subsidiaries, merveille.ai and Hoth Therapeutics Australia Pty Ltd, the “Company”) was incorporated under the laws of the
State of Nevada on May 16, 2017 . The Company is a clinical-stage biopharmaceutical company focused on developing new generation therapies
for unmet medical needs. The Company is focused on developing (i) a topical formulation for treating side effects from drugs used for
the treatment of 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).
The Company also has interests in certain other assets being developed by third parties (see Note 5 to the consolidated financial statements
for a discussion of the Company’s agreement with Zylö Therapeutics, Inc. and Voltron Therapeutics, Inc.).
Liquidity and capital resources
Accounting Standards Update (“ASU”)
No. 2014-15, Presentation of Financial Statements - Going Concern, requires management to evaluate the Company’s ability to continue
as a going concern one year beyond the filing date of the given financial statements. This evaluation requires management to perform two
steps. First, management must evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability
to continue as a going concern. Second, if management concludes that substantial doubt is raised, management is required to consider whether
it has plans in place to alleviate that doubt. Disclosures in the notes to the consolidated financial statements are required if management
concludes that substantial doubt exists or that its plans alleviate the substantial doubt that was raised.
The Company has funded its operations from proceeds
from the sale of equity and debt securities. The Company will require significant additional capital to make the investments it needs
to execute its longer-term business plan. The Company’s ability to successfully raise sufficient funds through the sale of debt
or equity securities when needed is subject to many risks and uncertainties and, even if it were successful, future equity issuances 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. However, 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 current and future 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.
On September 13, 2023, the Company entered into
a securities purchase agreement with certain institutional investors pursuant to which it sold (i) 549,275 shares of common stock and
(ii) pre-funded warrants (the “September Pre-Funded Warrants”) to purchase up to 550,725 shares of common stock at
a purchase price of $ 2.63 per share of common stock and a purchase price of $ 2.629 per September Pre-Funded Warrant. Concurrently with
the sale of common stock and/or the September Pre-Funded Warrants, pursuant to the securities purchase agreement, in
a private placement, the Company issued and sold warrants (the “September Common Stock Warrants”) to purchase up to
1,100,000 shares of common stock. Proceeds from the offering were approximately $ 2.9 million, prior
to deducting placement agent’s fees and other offering expenses payable by the Company . The closing of the offering occurred
on September 15, 2023. Each September Common Stock Warrant is exercisable for a period of five years from the issuance date at an exercise
price of $ 2.505 per share, subject to adjustment, and may, under certain circumstances, be exercised on a cashless basis. Each September
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 to designees of H.C. Wainwright & Co., LLC warrants
(“September Wainwright Warrants”) to purchase up to 55,000 shares of the Company’s common stock. The September Wainwright
Warrants are exercisable for a period of five years from the commencement of sales pursuant to the offering at an exercise price of $ 3.2875
per share, subject to adjustment, and may, under certain circumstances, be exercised on a cashless basis.
F- 7
Note 2-Significant accounting policies
Basis of presentation
and principles of consolidation
The Company’s consolidated financial statements
have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
The accompanying consolidated financial statements
include the accounts of the Company’s wholly-owned subsidiaries, merveille.ai which was incorporated under the laws of Nevada on
October 4, 2023 and Hoth Therapeutics Australia Pty Ltd, which was incorporated under the laws of the State of Victoria in Australia on
June 5, 2019. All significant intercompany balances and transactions have been eliminated in consolidation.
Reclassifications
Certain line items on the statement of operations
and comprehensive loss for the year ended December 31, 2022 have been reclassified to conform to the current period presentation. Research
and development - licenses acquired (including stock-based compensation) of $ 0.1 million was reclassified to research and development.
Compensation and related expenses (including stock-based compensation) of $ 2.6 million, professional fees (including stock-based compensation)
of $ 2.5 million, rent of $ 0.1 million, and other general and administrative expense of $ 1.0 million were consolidated into one general
and administrative line item. Dividend income and realized and unrealized gains and losses have been separately presented within other
income (expense), net. These reclassifications did not change our reported net loss or comprehensive loss for the year ended December
31, 2022.
Emerging growth
company
As an emerging growth company, the Company may
take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging
growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404
of the Sarbanes-Oxley Act of 2002, as amended, reduced disclosure obligations regarding executive compensation in its periodic reports
and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder
approval of any golden parachute payments not previously approved.
Further, Section 102(b)(1) of the Jumpstart Our
Business Startups Act of 2012 (“JOBS Act”) exempts emerging growth companies from being required to comply with new or revised
financial accounting standards until private companies (that is, those that have not had a Securities Act of 1933, as amended, registration
statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended) are
required to comply with the new or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect
to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such
election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a
standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth
company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison
of the Company’s financial statement with another public company that is neither an emerging growth company nor an emerging growth
company that has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting
standards used. However, beginning December 31, 2024, we will no longer be an “emerging growth company,” and will no longer
have the ability to delay adoption of these new or revised accounting standards, or to take advantage of reduced corporate governance
disclosures.
Use of estimates
The preparation of consolidated financial statements
in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses
during the reporting periods. The most significant estimates in the Company’s consolidated financial statements relate to stock-based
compensation and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are
based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results
of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are
not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there
are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
F- 8
Cash and cash equivalents
The Company considers all highly liquid investments
purchased with original maturities of 90 days or less at acquisition to be cash equivalents. There were no cash equivalents as of December
31, 2023 and December 31, 2022, respectively. Cash held in foreign bank accounts totaled $ 0.1 million and $ 0.4 million as of December
31, 2023 and December 31, 2022, respectively.
Marketable securities
Marketable securities are classified as trading
and are carried at fair value. The Company’s marketable securities consist of a mutual fund which is valued at a quoted market price.
Concentrations of credit risk and off-balance
sheet risk
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
Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) 820, Fair Value Measurements , provides guidance on the development and disclosure
of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would
be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would
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:
Level 1:
Quoted prices in active markets for identical assets or liabilities.
Level 2:
Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level 3:
Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
In some circumstances, the inputs used to measure
fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is
categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.
During the years ended December 31, 2023 and December 31, 2022, there were no changes in valuation techniques or transfers between Level
1, Level 2, and Level 3.
Leases
The Company determines if an arrangement is a
lease at inception and classifies its leases at commencement. Operating leases are presented as right-of-use (“ROU”) assets
and the corresponding lease liabilities are included in lease liability, current and lease liability, on the Company’s balance sheets.
ROU assets represent the Company’s right to use an underlying asset, and lease liabilities represent the Company’s obligation
to make lease payments in exchange for the ability to use the asset for the duration of the lease term.
F- 9
The Company has lease agreements which contain
both lease and non-lease components, which it has elected to account for as a single lease component. As such, minimum lease payments
include fixed payments for non-lease components within a lease agreement but exclude variable lease payments not dependent on an index
or rate, such as common area maintenance, operating expenses, utilities, or other costs that are subject to fluctuation from period to
period. Certain of the leases contain an option to extend the term of the lease. The option to extend a lease is included in the lease
term only when it is reasonably certain that the Company will elect that option. Additionally, the Company does not record ROU assets
or lease liabilities for short-term leases that have a term of twelve months or less at lease commencement.
ROU assets and lease liabilities are recognized
at the commencement date and determined using the present value of the future minimum lease payments over the lease term. The Company
uses an incremental borrowing rate based on an estimated rate of interest for collateralized borrowing since the Company’s leases
do not include an implicit interest rate. The estimated incremental borrowing rate considers market data, actual lease economic environment,
and the lease term at commencement date.
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: “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 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 5 of these consolidated
financial statements.
Accounts Payable
For the year ended December 31, 2023, the Company’s
subsidiary Hoth Therapeutics Australia Pty Ltd, recorded approximately a $ 260,000 gain due to a settlement agreement on a payable balance
with Novotech, a clinical trial management vendor. The gain is recognized in the consolidated statements of operations and comprehensive
loss following a manner consistent with how the expense was originally recorded.
Research and
development costs
Research and development costs, including acquired
in-process research and development expenses for which there is no alternative future use, are expensed as incurred. Advance payments
for goods and services that will be used in future research and development activities are expensed when the activity has been performed
or when the goods have been received rather than when the payment is made.
Stock-based compensation
The Company accounts for share-based payment awards
exchanged for services at the estimated grant date fair value of the award. Stock options issued under the Company’s long-term incentive
plans are granted with an exercise price equal to no less than the market price of the Company’s stock at the date of grant and
expire up to ten years from the date of grant. Options are generally issued fully vested. The Company accounts for forfeited awards as
they occur.
F- 10
The Company estimates the fair value of stock
option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards
represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
Expected Term - The
expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the
simplified method, which is the half-life from vesting to the end of its contractual term.
Expected Volatility -
The Company computes stock price volatility over expected terms based on its historical common stock trading prices.
Risk-Free Interest Rate
- The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury zero-coupon issues with an equivalent
remaining term.
Expected Dividend -
The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in the foreseeable
future, and, therefore, uses an expected dividend yield of zero in its valuation models.
The Company grants restricted stock awards under
its equity incentive plan. Restricted stock awards are granted to employees and non-employees. The restricted stock awards are measured
based on the grant-date fair value. In general, the restricted stock awards vest over a service period of zero to three years. Stock-based
compensation expense is generally recognized based on the straight-line basis over the requisite service period and forfeitures are accounted
for as they occur.
The Company has issued warrants to non-employees.
The warrants are measured based on the grant-date fair value. In general, the warrants vest over a term of zero to ten years. Stock-based
compensation expense is generally recognized based on the straight-line basis over the vesting term.
Income taxes
Income taxes are recorded in accordance with ASC
740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes
deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial
statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement
and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.
Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the
deferred tax assets will not be realized.
The Company accounts for uncertain tax positions
in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions
to the extent that the benefit would more likely than not be realized. The determination as to whether the tax benefit will more likely
than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.
Net loss per share
Net loss per share is computed by dividing net
loss by the weighted average number of common stock outstanding during the period. Since the Company had a net loss in the periods presented,
basic and diluted net loss per common share are the same. The following were excluded from the computation of diluted shares outstanding
due to the losses for each period presented, as they would have had an anti-dilutive impact on the Company’s net loss:
Year Ended December 31,
Potentially dilutive securities
2023
2022
Warrants
4,213,515
402,840
Options
169,362
104,651
Non-vested restricted stock awards
1,693
3,384
Total
4,384,570
510,875
F- 11
Recent accounting pronouncements
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
The following summarizes the Company’s research
and development expenses for licenses acquired during the years ended December 31, 2023 and 2022:
Year Ended December 31,
2023
2022
The George Washington University
$ 66,172
$ 66,586
North Carolina State University
—
27,500
Virginia Commonwealth University
( 275,000 )
—
University of Cincinnati
7,500
7,500
Adjustment
—
( 15,000 )
$ ( 201,328 )
$ 86,586
The George Washington University
During the year ended December 31, 2023, the Company
recorded an expense of approximately $ 29,000 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 recorded an expense of $ 30,000 for a milestone
payment pursuant to GW Patent License Agreement. The Company also recorded $ 7,500 the year ended December 31, 2023 for license maintenance
fees.
During the year ended December 31, 2022, the Company
recorded an expense of approximately $ 53,000 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 license maintenance fees.
North Carolina
State University
During the year ended December 31, 2023, the Company
paid $ 0 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, 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.
Virginia Commonwealth
University
On August 16, 2023, the Company terminated its
license agreement by and between the Company and Virginia Commonwealth University dated May 18, 2020. As of December 31, 2023, the Company
reversed its prior accrual of $ 150,000 for five years of annual minimum payments and $ 125,000 for annual maintenance fees.
As of December 31, 2022, the Company accrued $ 150,000
for five years of annual minimum payments and $ 125,000 for annual maintenance fees.
F- 12
Chelexa Biosciences, Inc. and the University
of Cincinnati
During the year ended December 31, 2023, the Company
paid $ 2,500 for the annual license maintenance fee and $ 5,000 for the minimum royalty fee to the University of Cincinnati associated with
the Assignment and Assumption Agreement by and between the Company and Chelexa Biosciences dated May 14, 2020.
During the year ended December 31, 2022, the Company
paid $ 2,500 for the annual license maintenance fee and $ 5,000 for the minimum royalty fee associated to the University of Cincinnati with
the Assignment and Assumption Agreement by and between the Company and Chelexa Biosciences dated May 14, 2020.
Note 4-Note Receivable
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. The 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 or a Change of Control
(as defined) 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. 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-Fair Value of Financial Assets and
Liabilities
The following tables present the Company’s
assets and liabilities that are measured at fair value at December 31, 2023 and 2022:
Fair value measured at December 31, 2023
Total at
December 31,
2023
Quoted
prices in
active
markets
(Level
1)
Significant
other
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3)
Assets
Marketable securities - mutual fund
$ —
$ —
$ —
$ —
Investment in joint ventures
$ 37,400
$ —
$ —
$ 37,400
Fair value measured at December 31, 2022
Total at
December 31,
2022
Quoted
prices in
active
markets
(Level 1)
Significant
other
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3)
Assets
Marketable securities - mutual fund
$ 209,320
$ 209,320
$ —
$ —
Investment in joint ventures
$ 33,000
$ —
$ —
$ 33,000
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, 2021
$ 410,000
Change in fair value of investments in joint ventures
( 377,000 )
Investment in joint ventures at fair value at December 31, 2022
33,000
Change in fair value of investments in joint ventures
4,400
Investment in joint ventures at fair value at December 31, 2023
$ 37,400
F- 13
Investment in joint ventures
The Company has elected to measure the investment
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 income (expense), net in the consolidated statements of operations and comprehensive loss.
The value at which the Company’s investment
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.
Investment in HaloVax
On March 23, 2020, the Company entered into a
Development and Royalty Agreement (the “Development and Royalty Agreement”) with Voltron Therapeutics, Inc. (“Voltron”)
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). 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. 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 as of December 31, 2023 and 2022.
Investment in Zylö
In connection with the Company’s March 2020
underwritten public offering of shares of its common stock, on May 4, 2020, the Company purchased 120,000 shares of Zylö’s
Class B common stock for $ 60,000 . On December 8, 2021, the Company entered into a third amendment (the “Zylö Amendment”)
to the Exclusive Sublicense Agreement with Zylö originally dated August 19, 2019, pursuant to which the Company licensed its novel
cannabinoid therapeutic, HT-005 for lupus patients, back to Zylö. Pursuant to the Zylö Amendment, on December 6, 2021, Zylö
issued the Company 100,000 shares of its Class B common stock. In addition, pursuant to the Zylö Amendment, within 90 days following
a sale by Zylö of all of its assets and rights related to HT-005 to a third-party (a “Sale”), Zylö shall pay the
Company a low single digit percent of the net proceeds received by it attributable to HT-005 in the United States and Canada and their
respective territories (collectively, the “Territory”) for the purposes of therapeutic uses related to lupus in humans (the
“Field”). After the Sale, any and all rights of the Company pursuant to the Exclusive Sublicense Agreement, including all
amendments thereto, shall terminate. Furthermore, pursuant to the Zylö Amendment, following the date of the first commercial sale
of HT-005 in the Territory, in the Field, Zylö shall pay the 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).
During December 2022, 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 2022. In December 2023, Zylö conducted a 409A valuation
of their Class B common stock and valued its share price at $ 0.17 per share. This value was ratified by Zylö’s board of directors
in December 2023. The valuation reflects a probability-weighted present value of expected future investment returns considering certain
possible outcomes and the rights of each class of Zylö’s equity. The future values of the common stock under the various outcomes
are discounted back to the valuation date at a risk-adjusted discount rate and probability weighted to determine the value for the Class
B common stock. Significant unobservable inputs in the valuation include: (i) probabilities of each scenario, (ii) timing of occurrence,
(iii) future valuation; (iv) and the risk-adjusted discount rate.
During the years ended December 31, 2023 and 2022,
the Company recorded approximately $ 4,400 in unrealized gain on this investment and $ 27,000 in unrealized loss on this investment, respectively.
The investment in Zylö was valued at $ 37,400 and $ 33,000 as of December 31, 2023 and 2022, respectively.
F- 14
Note 6-Stockholder’s Equity
Preferred Stock
The Company is authorized to issue up to 10,000,000
shares of preferred stock. This preferred stock may be issued in one or more series, and shall have such designations, preferences and
relative, participating, optional or other special rights and qualifications, limitations or restrictions thereof as shall be determined
at the time of issuance by the Company’s board of directors without further action by the Company’s shareholders. As of December
31, 2023, 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,
par value $ 0.0001 per share, are not mandatorily redeemable and do not embody an unconditional obligation to settle in a variable number
of equity shares. As such, the shares of Series A Convertible Preferred Stock are classified as permanent equity on the consolidated balance
sheets. The holders’ contingent redemption right in the event of certain deemed liquidation events does not preclude permanent equity
classification. Further, the shares of Series A Convertible Preferred Stock are considered an equity-like host for purposes of assessing
embedded derivative features for potential bifurcation. The embedded conversion feature is considered to be clearly and closely related
to the associated convertible 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.
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 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 outstanding shares of Series B Preferred Stock were redeemed in whole for an aggregate
price of $ 10 automatically and effective immediately after the effectiveness of the Authorized Stock Increase.
Common Shares
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
increase.
F- 15
Securities Purchase Agreements
On September 13, 2023, the Company entered into
a securities purchase agreement with certain institutional investors pursuant to which it sold (i) 549,275 shares of common stock and
(ii) pre-funded warrants (the “September Pre-Funded Warrants”) to purchase up to 550,725 shares of common stock at
a purchase price of $ 2.63 per share of common stock and a purchase price of $ 2.629 per September Pre-Funded Warrant. Concurrently with
the sale of common stock and/or the September Pre-Funded Warrants, pursuant to the securities purchase agreement, in
a private placement, the Company issued and sold warrants (the “September Common Stock Warrants”) to purchase up to
1,100,000 shares of common stock. Proceeds from the offering were approximately $ 2.9 million, prior
to deducting placement agent’s fees and other offering expenses payable by the Company . The closing of the offering occurred
on September 15, 2023. Each September Common Stock Warrant is exercisable for a period of five years from the issuance date at an exercise
price of $ 2.505 per share, subject to adjustment, and may, under certain circumstances, be exercised on a cashless basis. Each September
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 to designees of H.C. Wainwright & Co., LLC warrants
(“September Wainwright Warrants”) to purchase up to 55,000 shares of the Company’s common stock. The September Wainwright
Warrants are exercisable for a period of five years from the commencement of sales pursuant to the offering at an exercise price of $ 3.2875
per share, subject to adjustment, and may, under certain circumstances, 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 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
Price”). 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
The compensation committee of the board of directors
increased the number of shares reserved pursuant to the Company’s 2018 Equity Incentive Plan (“2018 Plan”) by 26,878
shares effective as of January 1, 2021, such that as of January 1, 2021, the Company had an aggregate of 66,878 shares of common stock
reserved for issuance pursuant to the 2018 Plan. 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. On January
4, 2024, the compensation committee of the board of directors further increased the number of shares reserved for issuance under the 2018
Plan from 166,878 shares to 176,878 shares.
F- 16
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. On June 2, 2023, the Company’s
board of directors approved the Hoth Therapeutics, Inc. Amended and Restated 2022 Omnibus Equity Incentive Plan (the “Amended and
Restated 2022 Plan”) which was approved by stockholders on August 18, 2023. Under the Amended and Restated 2022 Plan there are 591,317
shares of Company common stock available for grant.
Restricted Stock Awards
A summary of the Company’s restricted stock
awards granted under the equity incentive plans during the years ended December 31, 2023 and 2022 is as follows:
Number of
Restricted Stock
Awards
Weighted
Average
Grant Day
Fair Value
Nonvested at December 31, 2021
100
$ 75.00
Granted
5,075
3.16
Vested
( 1,791 )
7.17
Nonvested at December 31, 2022
3,384
$ 3.16
Vested
( 1,691 )
3.16
Nonvested at December 31, 2023
1,693
$ 3.16
As of December 31, 2023, approximately $ 3,000
of unrecognized stock-based compensation expense was related to restricted stock awards. The weighted average remaining contractual term
of unvested restricted stock awards was approximately 1.0 year at December 31, 2023.
Stock Options
During the year ended December 31, 2023, pursuant
to and subject to the available number of shares reserved under the 2022 Plan, the Company issued an aggregate of 90,000 options to the
Company’s employees and directors. The aggregate grant date fair value of these options was approximately $ 0.2 million.
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 51,800 options to the
Company’s directors. The aggregate grant date fair value of these options was approximately $ 0.6 million.
The fair value of options granted in 2023 and
2022 was estimated using the following assumptions:
Year Ended December 31,
2023
2022
Exercise price
$ 2.59
$ 14.75
Term (years)
10
10
Expected stock price volatility
105.00 %
96.10 %
Risk-free rate of interest
4.02 %
2.10 %
F- 17
A summary of option activity under the Company’s
stock option plan for the years ended December 31, 2023 and 2022 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, 2021
52,851
84.15
—
8.6
Options issued
51,800
14.75
—
9.2
Outstanding as of December 31, 2022
104,651
49.80
—
8.3
Options expired
( 25,289 )
46.10
—
—
Options issued
90,000
2.59
—
9.5
Outstanding as of December 31, 2023
169,362
26.78
—
8.4
Options vested and exercisable as of December 31, 2023
169,362
26.78
—
8.4
All outstanding stock options are fully vested.
Stock Based Compensation
Stock-based compensation expense for the years
ended December 31, 2023 and 2022 was as follows:
Year Ended December 31,
2023
2022
Employee and director stock option awards
$ 182,522
$ 560,376
Employee and director restricted stock awards
7,734
7,836
Non-employee stock warrant awards
26,173
52,586
$ 216,428
$ 620,798
For the years ended December 31, 2023 and 2022,
the amount of stock-based compensation expense included within research and development and general and administrative expenses was as
follows:
Year Ended December 31,
2023
2022
Research and development
$ 26,172
$ 52,586
General and administrative
190,256
568,212
$ 216,428
$ 620,798
Warrants
A summary of warrant activity for the years ended
December 31, 2023 and 2022 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, 2021
402,840
49.83
—
2.3
Outstanding as of December 31, 2022
402,840
49.83
—
1.4
Issued
6,165,725
2.61
—
4.5
Exercised
( 2,355,050 )
0.00
—
—
Outstanding as of December 31, 2023
4,213,515
7.01
—
4.5
Warrants exercisable as of December 31, 2023
4,212,751
6.99
—
4.5
The Company has determined that the warrants should
be accounted as a component of stockholders’ equity.
F- 18
Note 7-Commitments and Contingencies
Office lease
Effective November 2023, the Company leased office
space for a two year term. The Company’s office lease contains a renewal option. The Company has evaluated several factors in assessing
whether there is reasonable certainty that the Company will exercise its contractual renewal option concluding that it is not reasonably
certain to exercise such option. As it is not reasonably certain to be exercised, the Company excluded the renewal term in determining
the lease term used in calculating the right-of-use asset and lease liability. Prior to entering into this lease, the Company has not
entered into any lease arrangements in excess of 12 months.
The table below presents certain information related
to the Company’s lease cost:
Year Ended December 31,
2023
2022
Operating lease expense
$ 5,464
$ —
Short term lease expense
$ 33,351
$ 66,834
Total lease cost
$ 38,815
$ 66,834
Right-of-use asset and lease liability for operating
leases were recorded in the consolidated balance sheets as follows:
As of
December 31,
2023
Assets
Lease right of use assets
$ 55,165
Total lease assets
$ 55,165
Liabilities
Current liabilities:
Lease liability - current portion
$ 28,839
Noncurrent liabilities:
Lease liability, net of current portion
$ 26,326
Total lease liability
$ 55,165
Supplemental cash flow information related to the Company’s leases
for the year ended December 31, 2023 were as follows:
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows for operating leases
$ 5,464
The weighted-average remaining lease term for
the operating lease is 1.8 years and the weighted-average incremental borrowing rate is 10 % as of December 31, 2023.
F- 19
As of December 31, 2023, future minimum lease
payments required under operating leases are as follows:
2024
$ 32,784
2025
27,320
Total minimum lease payments
$ 60,104
Less: effects of discounting
( 4,939 )
Present value of future minimum lease payments
$ 55,165
Litigation
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 8-Income taxes
The table below presents the components of the
provision for taxes:
The Company’s provision is primarily driven
by the full valuation allowance in 2023 and 2022.
As of December 31,
2023
2022
Current
U.S. Federal
$ -
$ -
U.S. State
-
-
U.S. Foreign
-
-
Total current provision
Deferred
-
-
U.S. Federal
-
-
U.S. State
-
-
U.S. Foreign
-
-
Total deferred benefit
-
Change in valuation allowance
-
-
Total provision for income taxes
$ -
$ -
At December 31, 2023 and 2022, the tax effects
of the temporary differences and carryforwards that give rise to deferred tax assets consist of the following:
As of December 31,
2023
2022
Deferred tax assets
Net operating loss carryforwards
$ 11,926,158
$ 10,378,471
Research and development credits
-
-
Capitalized research costs
2,272,029
1,211,477
Equity based compensation
549,587
670,035
Licenses acquired
266,091
338,239
Depreciation
-
-
Accruals and other temporary differences
297,949
215,152
Total deferred tax assets
15,311,814
12,813,374
Less valuation allowance
( 15,311,814 )
( 12,813,374 )
Deferred tax assets, net of allowance
$ -
$ -
F- 20
A reconciliation of the statutory income tax rates
and the Company’s effective tax rate for the years ended December 31, 2023 and 2022 is as follows:
Years Ended
December 31,
2023
2022
Statutory federal income tax rate
21.0 %
21.0 %
State taxes, net of federal benefit
10.3 %
9.5 %
Impact of non-U.S. earnings
0.0 %
0.0 %
Permanent items
0.0 %
( 0.9 )%
Credits
0.8 %
0.0 %
Equity compensation
0.0 %
( 0.1 )%
Rate changes
0.0 %
0.0 %
Foreign rate differential
0.1 %
0.0 %
Previous tax year adjustment
( 0.2 )%
10.0 %
Other
0.0 %
0.0 %
Change in valuation allowance
( 32.0 )%
( 39.6 )%
Total
0.0 %
0.0 %
The Company has determined, based upon available
evidence, that it is more likely than not that the net deferred tax assets will not be realized and, accordingly, has provided a full
valuation allowance against its net deferred tax assets.
As of December 31, 2023 and December 31, 2022,
the Company has Federal net operating loss carryforwards of approximately $ 37.7 million and $ 32.9 million available to reduce future taxable
income, if any, for Federal tax purposes. Approximately $ 1.5 million of Federal net operating losses can be carried forward to future
tax years and expire in 2037. The Federal net operating loss generated during the years ended after December 31, 2017 of approximately
$ 36.0 million can be carried forward indefinitely; however, the deduction for net operating losses incurred in tax years beginning
after January 1, 2018 is limited to 80 % of annual taxable income. In addition, the Company had approximately $ 0.5 million and $ 0.3 million
of net operating losses at its subsidiary located in Australia, as of December 31, 2023 and December 31, 2022, respectively.
As required by the 2017 Tax Cuts and Jobs Act
and effective in 2022, the deferred tax asset as of December 31, 2023 and December 31, 20222, included $ 2.3 million and $ 1.2 million related
to the mandatory capitalization of research and development expenses.
On August 16, 2022, the Inflation Reduction Act
of 2022 (“IRA”) was signed into law. The IRA increased and modified the qualified small business (“QSB”) payroll
tax credit for increasing research activities. Provision 13902 of the IRA of 2022 increased the maximum amount of payroll tax research
credit that a QSB can elect to apply against payroll tax liability from $ 250,000 to $ 500,000 for tax years beginning after December 31,
2022. This payroll tax credit is a creditable tax credit against the employer’s portion of social security taxes, and the IRA also
modified IRC 3111(f) to allow a portion of the payroll tax credit to apply against the employer’s portion of Medicare tax. For the
year ended December 31, 2023, the Company recorded $ 0.1 million of other income for the payroll tax credit and $ 0.2 million is still outstanding.
The remaining research credit carryforward of $ 0.2 million will be utilized in the future as an offset against payroll taxes at the time
the payroll tax is incurred.
The utilization of the Company’s net operating
loss carryforwards and research tax credit carryovers could be subject to annual limitations under Section 382 and 383 of the Internal
Revenue Code of 1986, as amended (the “Code”), and similar state tax provisions, due to ownership change limitations that
may have occurred previously or that could occur in the future. These ownership changes limit the amount of net operating loss carryforwards
and other deferred tax assets that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change,
as defined by Section 382 and 383 of the Code, results from transactions increasing ownership of certain stockholders or public groups
in the stock of the corporation by more than 50 percent points over a three-year period. The Company has not conducted an analysis of
an ownership change under Section 382 of the Code. To the extent that a study is completed and an ownership change is deemed to occur,
the Company’s net operating losses and tax credits could be limited.
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At December 31, 2023 and 2022, the Company did
not have any significant uncertain tax positions. The Company will recognize interest and penalties related to uncertain tax positions,
as applicable, in income tax expense. As of December 31, 2023 and 2022, 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.
Management asserts that its foreign earnings are
permanently reinvested, and therefore, have not provided deferred taxes on foreign cash. Additionally, no additional income taxes have
been provided for any remaining undistributed foreign earnings not subject to the transition tax, or any additional outside basis differences
inherent in our foreign subsidiaries, as these amounts continue to be indefinitely reinvested in foreign operations. The company will
continue to monitor the foreign cash position as they maintain the assertion that foreign earnings are permanently reinvested.
Note 9-Subsequent Events
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
statements.
On January 4, 2024, the compensation committee
of the board of directors increased the number of shares reserved for issuance under the 2018 Plan from 166,878 shares to 176,878 shares.
On January 26, 2024, the Company provided 60 days
notice to the George Washington University of its termination of the license agreement for its breath based diagnostic device. The license
agreement terminated on March 26, 2024.
On February 6, 2024, the Company received notice
that its office lease was to be terminated. The Company and its landlord agreed to relocate its office space to another location under
substantially the same terms and conditions as its existing lease. Monthly payments for the new office lease are unchanged and term of
the lease expires in February 2026.
On March 27, 2024, the Company entered into a
warrant inducement agreement with a holder of certain of its existing warrants to immediately exercise for cash an aggregate 2,500,000
warrants to purchase shares of the Company’s common stock at a reduced exercise price of $ 1.6675 per share for gross proceeds to
the Company of approximately $ 4.2 million. The exercised warrants were issued pursuant to a securities purchase agreement dated December
29, 2022, by and between the Company and a certain accredited investor. Each warrant was exercisable for a period of five and one-half
years from the issuance date at an original exercise price of $ 5.00 per share. As an inducement to such exercise, the Company agreed to
issue new unregistered warrants to purchase up to 3,750,000 shares of the Company’s common stock at an exercise price of $ 1.50 per
share. The warrants are exercisable immediately upon issuance and will expire on July 3, 2028.
F- 22
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS AND FINANCIAL
DISCLOSURE
None.