NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1-Organization and description of business
operations
Hoth Therapeutics, Inc. (together with its wholly-owned
subsidiary, 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;
(ii) a treatment for mast-cell derived cancers and anaphylaxis; (iii) a treatment for traumatic brain injury and ischemic stroke; and
(iv) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory diseases. The Company also has assets being developed
for (i) atopic dermatitis (also known as eczema); (ii) a treatment for asthma and allergies using inhalational administration; and (iii)
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. 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 stockholders and future debt securities may contain covenants that limit the Company’s operations
or ability to enter into certain transactions.
The Company believes current cash is sufficient
to fund operations for at least the next 12 months from the 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.
Note 2-Significant accounting policies
Basis of Presentation
and Principles of Consolidation
The accompanying unaudited interim condensed consolidated
financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”)
for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include
all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim
condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the
fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in
the Company’s annual consolidated financial statements prepared in accordance with GAAP have been condensed or omitted. These unaudited
interim condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal
year or any future period. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction
with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed
by the Company with the Securities and Exchange Commission (the “SEC”) on March 30, 2022.
The accompanying unaudited interim condensed consolidated financial
statements include the accounts of the Company’s wholly-owned subsidiary, 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.
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Use of estimates
The preparation of condensed 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 condensed 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.
Significant Accounting Policies
There have been no material changes to the Company’s
significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2021 as filed with the SEC on March 30, 2022.
Fair Value of Financial Instruments
The fair value of the Company’s assets and
liabilities, which qualify as financial instruments under the Financial Accounting Standards Board (“FASB”) Accounting Standards
Codification (“ASC”) 820, “Fair Value Measurements,” approximates the carrying amounts represented in the
balance sheet, primarily due to their short-term nature.
Fair Value Measurement
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 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.
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. 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 venture is further described in Note of 6 these consolidated financial statements.
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Net loss per share
Net loss per share is computed by dividing net
loss by the weighted average number of shares 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:
| |
As of March 31, | |
Potentially dilutive securities | |
2022 | | |
2021 | |
Warrants | |
| 10,070,764 | | |
| 11,042,448 | |
Options | |
| 2,616,212 | | |
| 1,321,212 | |
Non-vested restricted stock awards | |
| 2,249 | | |
| 7,248 | |
Total | |
| 12,689,225 | | |
| 12,370,908 | |
Recent accounting pronouncements
Currently, management does not believe that any other recently issued,
but not yet effective accounting pronouncements, if currently adopted, would have an effect on the Company’s condensed consolidated
financial statements.
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 3-License agreements
The following summarizes the Company’s research
and development expenses for licenses acquired (including stock-based compensation) during three months ended March 31, 2022 and 2021:
| |
Three Months Ended
March 31, | |
| |
2022 | | |
2021 | |
The George Washington University | |
$ | 16,272 | | |
$ | 31,202 | |
University of Maryland and Isoprene Pharmaceuticals, Inc. | |
| - | | |
| 3,933 | |
North Carolina State University | |
| 20,000 | | |
| 48,584 | |
University of Cincinnati | |
| 5,000 | | |
| 10,028 | |
| |
$ | 41,272 | | |
$ | 93,747 | |
The George Washington University
During the three months ended March 31, 2022,
the Company recorded an expense of approximately $16,000 related to warrants granted to The George Washington University pursuant to a
patent license agreement.
North Carolina
State University
During the three months ended March 31, 2022,
the Company paid $20,000 for a license fee.
University of Cincinnati
During the three months ended March 31, 2022,
the Company paid $5,000 for the yearly minimum annual royalty fee.
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 matures
on September 10, 2022 and accrues 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 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 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 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
The realized gain or loss, unrealized gain or loss, and dividend income
related to marketable securities for the three months ended March 31, 2022 and 2021, which are recorded as a component of other income
(loss) on the condensed consolidated statements of operations and comprehensive loss, are as follows:
| |
Three Months Ended
March 31, | |
| |
2022 | | |
2021 | |
Unrealized gain (loss) | |
$ | 21,949 | | |
$ | (17,930 | ) |
Realized loss | |
| - | | |
| 33,330 | |
Dividend income | |
| 25,553 | | |
| 4,010 | |
| |
$ | 47,502 | | |
$ | 19,410 | |
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 6-Fair Value of Financial Assets and Liabilities
The following table presents the Company’s
assets and liabilities that are measured at fair value at March 31, 2022 and December 31, 2021:
| |
Fair value measured at March 31, 2022 | |
| |
Total at March 31, | | |
Quoted prices in active markets | | |
Significant other observable inputs | | |
Significant unobservable inputs | |
| |
2022 | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable securities - mutual funds | |
$ | 1,914,785 | | |
$ | 1,914,785 | | |
$ | - | | |
$ | - | |
Investment in joint venture | |
$ | 410,000 | | |
$ | - | | |
$ | - | | |
$ | 410,000 | |
Note receivable - current | |
$ | 50,000 | | |
$ | - | | |
$ | - | | |
$ | 50,000 | |
| |
Fair value measured at December 31, 2021 | |
| |
Total at December 31, | | |
Quoted prices in active markets | | |
Significant other
observable inputs | | |
Significant unobservable inputs | |
| |
2021 | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable securities - mutual funds | |
$ | 1,892,837 | | |
$ | 1,892,837 | | |
$ | - | | |
$ | - | |
Investment in joint venture | |
$ | 410,000 | | |
| - | | |
| - | | |
$ | 410,000 | |
Note receivable - current | |
$ | 50,000 | | |
| - | | |
| - | | |
$ | 50,000 | |
Investment in joint venture
The Company has elected to measure the investment
in joint venture 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.
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 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. No change in fair value occurred during the three months ended March 31, 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. No change in fair value occurred during the quarter ended March 31, 2022. 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).
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note receivable
As of March 31, 2022, 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 three months ended March 31, 2022.
Note 7-Stockholders’ Equity
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 671,926
shares effective as of January 1, 2021, such that as of January 1, 2021, the Company had an aggregate of 1,671,926 shares of common stock
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
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 3,671,926 shares to 3,921,926 shares.
Restricted Stock Awards
A summary of the Company’s restricted stock
awards granted under the 2018 Plan during the three months ended March 31, 2022 is as follows:
| |
Number of Restricted
Stock Awards | | |
Weighted Average
Grant Day Fair Value | |
Nonvested at December 31, 2021 | |
| 2,801 | | |
$ | 3.00 | |
Vested | |
| (552 | ) | |
| 3.00 | |
Nonvested at March 31, 2022 | |
| 2,249 | | |
$ | 3.00 | |
As of March 31, 2022, approximately $1,300 of
unrecognized stock-based compensation expense is related to restricted stock awards. The weighted average remaining contractual terms
of unvested restricted stock awards is approximately 0.51 years at March 31, 2022.
Stock Options
A summary of option activity under the Company’s
stock option plan for three months ended March 31, 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 | |
| 1,321,212 | | |
$ | 3.37 | | |
$ | - | | |
| 8.6 | |
Employee options issued | |
| 1,295,000 | | |
| 0.59 | | |
| 132,090 | | |
| 10.0 | |
Outstanding as of March 31, 2022 | |
| 2,616,212 | | |
$ | 1.99 | | |
$ | 132,090 | | |
| 9.0 | |
Options vested and exercisable as of March 31, 2022 | |
| 2,616,212 | | |
$ | 1.99 | | |
$ | 132,090 | | |
| 9.0 | |
Stock Based Compensation
Stock-based compensation expense for the three
months ended March 31, 2022 and 2021 was as follows:
| |
Three Months Ended March 31, | |
| |
2022 | | |
2021 | |
Employee stock option awards | |
$ | 560,375 | | |
$ | 1,092,429 | |
Non-employee stock option awards | |
| - | | |
| - | |
Employee restricted stock awards | |
| 791 | | |
| 2,407 | |
Non-employee stock warrant awards | |
| 16,272 | | |
| 31,202 | |
| |
$ | 577,438 | | |
$ | 1,126,038 | |
Employee related stock-based compensation is recognized
as “compensation and related expenses (including stock-based compensation)” and non-employee related stock-based compensation
is recognized as “professional fees (including stock-based compensation)” or “research and development - licenses acquired
(including stock-based compensation)” in the condensed consolidated statements of operations and comprehensive loss.
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Warrants
A summary of warrant activity for the three months
ended March 31, 2022 is as follows:
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Total Intrinsic Value | | |
Weighted Average
Remaining Contractual
Life (in years) | |
Outstanding as of December 31, 2021 | |
| 10,070,764 | | |
$ | 1.99 | | |
$ | - | | |
| 2.3 | |
Outstanding as of March 31, 2022 | |
| 10,070,764 | | |
$ | 1.99 | | |
$ | - | | |
| 2.1 | |
Warrants exercisable as of March 31, 2022 | |
| 10,018,093 | | |
$ | 1.99 | | |
$ | - | | |
| 2.3 | |
The Company has determined that the warrants should be accounted
as a component of stockholders’ equity.
Note 8-Commitments and contingencies
Office lease
The Company leases office space for approximately
$4,500 a month. Rent expense for the three months ended March 31, 2022 and 2021 was approximately $14,000 and $7,000, respectively. The
Company is not a party to a lease that is in excess of 12 months.
Litigation
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-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 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.
HOTH THERAPEUTICS, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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. These cost
increases may not be fully recoverable or adequately covered by insurance.
Infections and deaths related to the pandemic
may disrupt the healthcare and healthcare regulatory systems in both the United States and globally, including in Australia. Such disruptions
could divert healthcare resources away from, or materially delay review and/or approval with respect to the Company’s clinical trials
by the U.S. Food and Drug Administration and foreign regulatory authorities, including the Belberry
Human Research Ethics Committee in Australia. 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 candidates.
The Company currently utilizes third parties to,
among other things, manufacture raw materials. If any third-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 negatively impact the Company’s ability to access capital on favorable terms, if at all. 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. However,
these effects could have a material impact on the Company’s operations, and the Company will continue to monitor the situation closely.
Note 10-Subsequent events
The Company evaluates events that have occurred
after the balance sheet date through the date for which the condensed consolidated financial statements are issued. Based upon the evaluation,
the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the
condensed consolidated financial statements except as set forth herein.
On April 14, 2022, the Company closed an underwritten
public offering of 8,235,294 shares of the Company’s common stock at a price to the public of $0.85 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 1,235,294 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 $6.1 million.