3 unchanged sentences
Consolidated Financial Statements
−Removed: Report of Independent Registered
−Removed: Public Accounting Firm
−Removed: Consolidated Balance Sheets
−Removed: as of December 31, 2020 and 2019
−Removed: Consolidated Statements
−Removed: of Operations and Comprehensive Loss for the years ended December 31, 2020 and 2019
−Removed: Consolidated Statements
−Removed: of Changes in Stockholders’
−Removed: Equity for the years ended December 31, 2020 and 2019
−Removed: Consolidated Statements
−Removed: of Cash Flows for the years ended December 31, 2020 and 2019
−Removed: Notes to Consolidated Financial
−Removed: Report of Independent Registered Public
−Removed: Accounting Firm
−Removed: To the Stockholders and the Board of Directors of
+Added: Report of Independent Registered Public Accounting Firm
+Added: Consolidated Balance Sheets as of December 31, 2021 and 2020
+Added: Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2021 and 2020
+Added: Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2021 and 2020
+Added: Consolidated Statements of Cash Flows for the years ended December 31, 2021 and 2020
+Added: Notes to Consolidated Financial Statements
+Added: Report of Independent Registered Public Accounting
+Added: To the Stockholders and the Board of Directors
Hoth Therapeutics, Inc.
−Removed: Opinion on the Consolidated Financial
+Added: Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated
balance sheets of Hoth Therapeutics, Inc.
−Removed: (the “Company”) as of December 31, 2020 and 2019, the related consolidated
−Removed: statements of operations, changes in stockholders’
−Removed: equity and cash flows, for each of the two years in the period ended
−Removed: December 31, 2020, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position
−Removed: of the Company as of December 31, 2020 and 2019, and the consolidated results of its operations and its cash flows for each of
−Removed: the two years in the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United
−Removed: States of America.
+Added: (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements
+Added: of operations, changes in stockholders’ equity and cash flows, for each of the two years in the period ended December 31, 2021,
+Added: and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated
+Added: financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2021
+Added: and 2020, and the consolidated results of its operations and its cash flows for each of the two years in the period ended December 31,
+Added: 2021, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
−Removed: Thee consolidated financial statements
−Removed: are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated
−Removed: financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight
−Removed: Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance
−Removed: with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audits to obtain reasonable assurance about
−Removed: whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is
−Removed: not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our
−Removed: audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
−Removed: an opinion on the effectiveness of the Company’s internal control over financial reporting.
−Removed: Accordingly, we express no such
−Removed: Our audits included performing procedures
−Removed: to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
−Removed: procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and
−Removed: disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant
−Removed: estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: that our audits provide a reasonable basis for our opinion.
+Added: These consolidated financial statements are the
+Added: responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial
+Added: statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
+Added: States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities
+Added: laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated
+Added: financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we
+Added: engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
+Added: internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
+Added: that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
+Added: consolidated financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by
+Added: management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide
+Added: a reasonable basis for our opinion.
/S/ WithumSmith+Brown, PC
−Removed: We have served as the Company’s auditor since 2018.
+Added: We have served as the Company's auditor since
New York, New York
5 unchanged sentences
Prepaid expenses
−Removed: Deferred offering cost
+Added: Note receivable - current
Total current assets
Note receivable
−Removed: Property and equipment, net
−Removed: Investment in joint venture
−Removed: Restricted cash
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: Investment in joint venture at fair value
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
3 unchanged sentences
Total current liabilities
−Removed: Accrued license fee
+Added: Accrued license fee - less current portion
Total liabilities
Commitments and contingencies
−Removed: Stockholders’
−Removed: Preferred stock, $0.0001 par value, 5,000,000 shares
−Removed: authorized, 0 shares issued and outstanding at December 31, 2020 and 2019, respectively
−Removed: Series A Convertible Preferred Stock, $0.0001 par
−Removed: value, 1,897,250 and 5,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2020 and 2019, respectively
−Removed: Common stock, $0.0001 par value, 75,000,000 shares
−Removed: authorized, 13,438,535 and 10,119,844 shares issued and outstanding at December 31, 2020 and 2019, respectively
+Added: Stockholders’ equity
+Added: Preferred stock, $ 0.0001 par value, 5,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2021 and 2020, respectively
+Added: Series A Convertible Preferred Stock, $ 0.0001 par value, 5,000,000 shares designated;
+Added: 0 shares issued and outstanding at December 31, 2021 and 2020
+Added: Common stock, $ 0.0001 par value, 75,000,000 shares authorized, 23,974,546 and 13,438,535 shares issued and outstanding at December 31, 2021 and 2020, respectively
Additional paid-in-capital
2 unchanged sentences
( 19,413,458 )
−Removed: Accumulated other comprehensive loss
−Removed: Total stockholders’
−Removed: Total liabilities and stockholders’
−Removed: The accompanying notes are an integral
−Removed: part of these consolidated financial statements.
+Added: Accumulated other comprehensive gain (loss)
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
+Added: The accompanying notes are an integral part
+Added: of these consolidated financial statements.
Hoth Therapeutics, Inc.
−Removed: Consolidated Statements of Operations
−Removed: and Comprehensive Loss
+Added: Consolidated Statements of Operations and Comprehensive
For the years ended
4 unchanged sentences
Professional fees (including stock-based compensation)
−Removed: Other expenses
+Added: Other general and administrative expenses
Total operating expenses
Loss from operations
−Removed: Other income, net
−Removed: Loss on foreign currency exchange
−Removed: Total other income
( 14,101,440 )
( 7,301,974 )
−Removed: Other comprehensive loss
+Added: Other income (expenses)
+Added: Other income (expenses), net
+Added: Total other income (expenses)
+Added: $ ( 14,313,705 )
+Added: $ ( 7,197,816 )
+Added: Other comprehensive gain (loss)
Foreign currency translation adjustment
4 unchanged sentences
Weighted average number of common shares outstanding, basic and diluted
−Removed: The accompanying notes are an integral
−Removed: part of these consolidated financial statements.
+Added: The accompanying notes are an integral part
+Added: of these consolidated financial statements.
Hoth Therapeutics, Inc.
−Removed: Consolidated Statements of Changes in
−Removed: Stockholders’
+Added: Consolidated Statements of Changes in Stockholders’
Cumulative Translation
−Removed: Total Stockholders’
+Added: Total Stockholders’
Balance at December 31, 2019
$ ( 12,215,642 )
−Removed: Conversion of preferred stock to common stock upon
−Removed: completion of the IPO
−Removed: Issuance of common stock in the IPO (net of offering
−Removed: costs of $1,159,833)
−Removed: Issuance of common stock and warrants (net of offering
−Removed: costs of $426,990)
−Removed: Cashless warrant exercise
+Added: Issuance of common stock and warrants (net of offering costs of $ 806,243 )
+Added: Issuance of common stock (net of offering costs of $ 525,000 )
+Added: Cancellation of common stock
Warrant exercise
Stock-based compensation
+Added: Cumulative translation adjustment
+Added: ( 7,197,816 )
+Added: ( 7,197,816 )
Balance at December 31, 2020
$ ( 19,413,458 )
−Removed: Issuance of common stock and warrants (net of offering
−Removed: costs of $806,243)
−Removed: Issuance of common stock (net of offering costs
−Removed: Cancellation of common stock
+Added: Issuance of common stock, common stock warrants and prefunded warrants (net of offering costs of $ 1,591,600 )
+Added: Issuance of common stock and warrants (net of offering costs of $ 572,500 )
Warrant exercise
1 unchanged sentence
Cumulative translation adjustment
+Added: ( 14,313,705 )
+Added: ( 14,313,705 )
Balance at December 31, 2021
$ ( 33,727,163 )
−Removed: The accompanying notes are an integral
−Removed: part of these consolidated financial statements.
+Added: The accompanying notes are an integral part
+Added: of these consolidated financial statements.
Hoth Therapeutics, Inc.
Consolidated Statements of Cash Flows
−Removed: Years Ended Ended December
+Added: For the years ended
Cash flows from operating activities
5 unchanged sentences
Stock-based compensation
−Removed: Realized loss on marketable securities
−Removed: Unrealized gain on marketable securities
+Added: Realized loss (gain) on marketable securities
+Added: Unrealized loss (gain) on marketable securities
+Added: Loss on foreign currency exchange
Changes in assets and liabilities:
2 unchanged sentences
Net cash used in operating activities
+Added: ( 12,090,129 )
+Added: ( 6,133,198 )
Cash flows from investing activities
2 unchanged sentences
Purchase of marketable securities
+Added: ( 2,556,135 )
+Added: ( 2,300,015 )
Purchase of convertible promissory note in Isoprene
1 unchanged sentence
Net cash used in investing activities
+Added: ( 1,837,653 )
Cash flows from financing activities
−Removed: Proceeds from issuance of common stock in the IPO, net of offering cost
+Added: Proceeds from issuance common stock, common stock warrants and prefunded warrants, net of offering cost
Proceeds from issuance common stock and warrants, net of offering cost
3 unchanged sentences
Effect of exchange rate changes on cash and cash equivalents
−Removed: Net increase in cash
−Removed: Cash and restricted cash, beginning of period
−Removed: Cash and restricted cash, end of period
+Added: Net change in cash
+Added: Cash, beginning of period
+Added: Cash, end of period
Non-cash investing and financing activities
−Removed: Conversion of preferred stock to common stock upon completion of the IPO
Cancellation and retirement of common stock
−Removed: Cashless warrant exercise
−Removed: Offering cost included in accrued expenses
−Removed: The accompanying notes are an integral
−Removed: part of these consolidated financial statements.
+Added: The accompanying notes are an integral part
+Added: of these consolidated financial statements.
Hoth Therapeutics, Inc.
Notes to Consolidated Financial Statements
−Removed: Note 1—Organization and description of business operations
+Added: Note 1—Organization and description of business operations
Hoth Therapeutics, Inc.
−Removed: (together with
−Removed: its wholly-owned subsidiary, Hoth Therapeutics Australia Pty Ltd., the “Company”) was incorporated under the laws
−Removed: of the State of Nevada on May 16, 2017.
−Removed: The Company is a clinical-stage biopharmaceutical company which was formed to initially
−Removed: focus on developing new generation therapies for dermatological disorders including atopic dermatitis (also known as eczema),
−Removed: chronic wounds, psoriasis, asthma and acne.
−Removed: Since its formation, the Company expanded its business to also focus on developing
−Removed: a topical formulation for treating side effects from drugs used for the treatment of cancer;
−Removed: a treatment for asthma and allergies
−Removed: using inhalational administration;
−Removed: a topical treatment for patients with lupus;
−Removed: a treatment for mast-cell derived cancers and
−Removed: and a treatment for lung diseases resulting from bacterial infections.
−Removed: The Company is focused on potentially developing
−Removed: a COVID-19 treatment as well as a diagnostic device for the detection of SARS-CoV-2 via a mobile device.
+Added: (together with its wholly-owned
+Added: subsidiary, Hoth Therapeutics Australia Pty Ltd., the “Company”) was incorporated under the laws of the State of Nevada on
+Added: May 16, 2017.
+Added: The Company is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical
+Added: The Company is focused on developing (i) a topical formulation for treating side effects from drugs used for the treatment of
+Added: (ii) a treatment for mast-cell derived cancers and anaphylaxis;
+Added: and (iii) a treatment and/or prevention for Alzheimer’s
+Added: or other neuroinflammatory diseases.
+Added: The Company also has preclinical assets being developed for (i) atopic dermatitis (also known as
+Added: (ii) a treatment for asthma and allergies using inhalational administration;
+Added: (iii) a treatment for lung diseases resulting from
+Added: bacterial infections;
+Added: and (iv) a treatment for inflammatory bowel diseases.
+Added: In addition, the Company is developing a diagnostic device
+Added: via a mobile device.
+Added: The Company also has interests in certain other assets being developed by third parties (See Note 6 for a discussion
+Added: of the Company’s agreement with Zylö Therapeutics, Inc.
+Added: and Voltron Therapeutics, Inc.).
Liquidity and capital resources
−Removed: Accounting Standards Update (“ASU”)
−Removed: 2014-15, Presentation of Financial Statements - Going Concern , requires management to evaluate the Company’s
−Removed: ability to continue as a going concern one year beyond the filing date of the given financial statements.
−Removed: This evaluation requires
−Removed: management to perform two steps.
−Removed: First, management must evaluate whether there are conditions and events that raise substantial
−Removed: doubt about the entity’s ability to continue as a going concern.
−Removed: Second, if management concludes that substantial doubt
−Removed: is raised, management is required to consider whether it has plans in place to alleviate that doubt.
−Removed: Disclosures in the notes
−Removed: to the consolidated financial statements are required if management concludes that substantial doubt exists or that its plans
−Removed: alleviate the substantial doubt that was raised.
−Removed: The Company has funded its operations
−Removed: from proceeds from the sale of equity and debt securities.
−Removed: The Company will require significant additional capital to make the
−Removed: investments it needs to execute its longer-term business plan.
−Removed: The Company’s ability to successfully raise sufficient funds
−Removed: through the sale of debt or equity securities when needed is subject to many risks and uncertainties and, even if it were successful,
−Removed: future equity issuances would result in dilution to its existing stockholders and future debt securities may contain covenants
−Removed: that limit the Company’s operations or ability to enter into certain transactions.
−Removed: The Company’s current cash is sufficient
+Added: Accounting Standards Update (“ASU”)
+Added: 2014-15, Presentation of Financial Statements - Going Concern , requires management to evaluate the Company’s ability
+Added: to continue as a going concern one year beyond the filing date of the given financial statements.
+Added: This evaluation requires management
+Added: to perform two steps.
+Added: First, management must evaluate whether there are conditions and events that raise substantial doubt about the
+Added: entity’s ability to continue as a going concern.
+Added: Second, if management concludes that substantial doubt is raised, management is
+Added: required to consider whether it has plans in place to alleviate that doubt.
+Added: Disclosures in the notes to the consolidated financial statements
+Added: are required if management concludes that substantial doubt exists or that its plans alleviate the substantial doubt that was raised.
+Added: The Company has funded its operations from proceeds
+Added: from the sale of equity and debt securities.
+Added: The Company will require significant additional capital to make the investments it needs
+Added: to execute its longer-term business plan.
+Added: The Company’s ability to successfully raise sufficient funds through the sale of debt
+Added: or equity securities when needed is subject to many risks and uncertainties and, even if it were successful, future equity issuances
+Added: would result in dilution to its existing stockholders and future debt securities may contain covenants that limit the Company’s
+Added: operations or ability to enter into certain transactions.
+Added: The Company’s current cash is sufficient
to fund operations for at least the next 12 months from the date that these financial statements are available to be issued.
−Removed: the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings,
−Removed: grants or other arrangements to develop and seek regulatory approvals for the Company’s existing and new product candidates.
−Removed: If such funding is not available, or not available on terms acceptable to the Company, the Company’s current development
−Removed: plan and plans for expansion of its general and administrative infrastructure may be curtailed.
−Removed: Note 2—Significant accounting
−Removed: of presentation and principles of consolidation
−Removed: The Company’s consolidated financial
−Removed: statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
−Removed: The accompanying consolidated financial
−Removed: statements include the accounts of the Company’s wholly-owned subsidiary, Hoth Therapeutics Australia Pty Ltd, which was
−Removed: incorporated under the laws of the State of Victoria in Australia on June 5, 2019.
−Removed: All significant intercompany balances and transactions
−Removed: have been eliminated in consolidation.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: The preparation of consolidated financial
−Removed: statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
−Removed: and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the
−Removed: reported amounts of expenses during the reporting periods.
−Removed: The most significant estimates in the Company’s consolidated
−Removed: financial statements relate to stock-based compensation and the valuation allowance of deferred tax assets resulting from net
−Removed: operating losses.
−Removed: These estimates and assumptions are based on current facts, historical experience and various other factors
−Removed: believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
−Removed: values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.
−Removed: Actual results
−Removed: may differ materially and adversely from these estimates.
−Removed: To the extent there are material differences between the estimates and
−Removed: actual results, the Company’s future results of operations will be affected.
+Added: the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, grants
+Added: or other arrangements to develop and seek regulatory approvals for the Company’s existing and new product candidates.
+Added: If such funding
+Added: is not available, or not available on terms acceptable to the Company, the Company’s current development plan and plans for expansion
+Added: of its general and administrative infrastructure may be curtailed.
+Added: Note 2—Significant accounting policies
+Added: Basis of presentation
+Added: and principles of consolidation
+Added: The Company’s consolidated financial statements
+Added: have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
+Added: The accompanying consolidated financial statements
+Added: include the accounts of the Company’s wholly-owned subsidiary, Hoth Therapeutics Australia Pty Ltd, which was incorporated under
+Added: the laws of the State of Victoria in Australia on June 5, 2019.
+Added: All significant intercompany balances and transactions have been eliminated
+Added: in consolidation.
+Added: Emerging growth
+Added: As an emerging growth company, the Company may
+Added: take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging
+Added: growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404
+Added: of the Sarbanes-Oxley Act of 2002, as amended, reduced disclosure obligations regarding executive compensation in its periodic reports
+Added: and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder
+Added: approval of any golden parachute payments not previously approved.
+Added: Further, Section 102(b)(1) of the Jumpstart Our
+Added: Business Startups Act of 2012 (“JOBS Act”) exempts emerging growth companies from being required to comply with new or revised
+Added: financial accounting standards until private companies (that is, those that have not had a Securities Act of 1933, as amended, registration
+Added: statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended) are
+Added: required to comply with the new or revised financial accounting standards.
+Added: The JOBS Act provides that an emerging growth company can
+Added: elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any
+Added: such election to opt out is irrevocable.
+Added: The Company has elected not to opt out of such extended transition period which means that when
+Added: a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth
+Added: company, can adopt the new or revised standard at the time private companies adopt the new or revised standard.
+Added: This may make comparison
+Added: of the Company’s financial statement with another public company that is neither an emerging growth company nor an emerging growth
+Added: company that has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting
+Added: standards used.
+Added: Use of estimates
+Added: The preparation of consolidated financial statements
+Added: in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
+Added: and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of
+Added: expenses during the reporting periods.
+Added: The most significant estimates in the Company’s consolidated financial statements relate
+Added: to stock-based compensation and the valuation allowance of deferred tax assets resulting from net operating losses.
+Added: These estimates and
+Added: assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances,
+Added: the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses
+Added: that are not readily apparent from other sources.
+Added: Actual results may differ materially and adversely from these estimates.
+Added: To the extent
+Added: there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Cash and cash equivalents
−Removed: The Company considers all highly liquid
−Removed: investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents.
−Removed: There were no cash equivalents
−Removed: as of December 31, 2020 and 2019.
−Removed: Restricted cash
−Removed: In November 2016, the Financial Accounting
−Removed: Standards Board (“FASB”) issued ASU No.
−Removed: 2016-18 , Statement of Cash Flows (Topic 230):
−Removed: Restricted Cash (“ASU
−Removed: 2016-18”) , which clarifies the presentation of restricted cash in the statements of cash flows.
−Removed: Under ASU 2016-18,
−Removed: restricted cash is included with cash when reconciling the beginning-of-period and end-of-period total amounts shown on the statements
−Removed: of cash flows.
−Removed: The Company adopted ASU 2016-18 during the year ended December 31, 2019 on a retrospective basis.
−Removed: The following
−Removed: is a summary of the Company’s cash and restricted cash total as presented in the consolidated statements of cash flows for
−Removed: the years ended December 31, 2020 and 2019:
−Removed: Restricted cash
−Removed: Total cash and restricted cash
−Removed: The $0.2 million restricted cash was deposited
−Removed: into a third-party escrow account in order to provide a source of funding for certain indemnification obligations the Company
−Removed: has pursuant to its Qualified Independent Underwriter Engagement Agreement.
−Removed: On May 29, 2020, the $0.2 million restricted cash
−Removed: in the escrow account was returned to the Company.
+Added: The Company considers all highly liquid investments
+Added: purchased with original maturities of 90 days or less at acquisition to be cash equivalents.
+Added: There were no cash equivalents as of December
+Added: 31, 2021 and 2020.
Marketable securities
−Removed: Marketable securities are classified as
−Removed: trading and are carried at fair value.
−Removed: The Company’s marketable securities consist of a mutual fund which is valued at a
−Removed: quoted market price.
−Removed: Concentrations of credit risk and
−Removed: off-balance sheet risk
−Removed: Cash is a financial instrument that is
−Removed: potentially subject to concentrations of credit risk.
−Removed: The Company’s cash is deposited in accounts at large financial institutions,
−Removed: and amounts may exceed federally insured limits.
−Removed: The Company believes it is not exposed to significant credit risk due to the
−Removed: financial strength of the depository institutions in which the cash is held.
−Removed: The Company has no financial instruments with off-balance
−Removed: sheet risk of loss.
−Removed: offering costs
−Removed: Deferred offering costs, which primarily
−Removed: consist of direct, incremental professional fees incurred in connection with the Company’s initial public offering (“IPO”)
−Removed: as well as other private equity offerings are capitalized as current assets on the consolidated balance sheet.
−Removed: Upon the closing
−Removed: of the offerings, the deferred offering costs are offset against the offering proceeds.
−Removed: Approximately $0 and $30,000 of such offering
−Removed: costs were accrued but unpaid at December 31, 2020 and 2019, respectively.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
+Added: Marketable securities are classified as trading
+Added: and are carried at fair value.
+Added: The Company’s marketable securities consist of a mutual fund which is valued at a quoted market
+Added: Concentrations of credit risk and off-balance
+Added: Cash is a financial instrument that is potentially
+Added: subject to concentrations of credit risk.
+Added: The Company’s cash is deposited in accounts at large financial institutions, and amounts
+Added: may exceed federally insured limits.
+Added: The Company believes it is not exposed to significant credit risk due to the financial strength
+Added: of the depository institutions in which the cash is held.
+Added: The Company has no financial instruments with off-balance sheet risk of loss.
+Added: Fair Value of Financial Instruments
+Added: Financial Accounting Standards Board (“FASB”)
+Added: Accounting Standards Codification (“ASC”) 820, Fair Value Measurements , provides guidance on the development and disclosure
+Added: of fair value measurements.
+Added: Under this accounting guidance, fair value is defined as an exit price, representing the amount that would
+Added: be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
+Added: As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would
+Added: use in pricing an asset or a liability.
+Added: The accounting guidance classifies fair value
+Added: measurements in one of the following three categories for disclosure purposes:
+Added: Quoted prices
+Added: in active markets for identical assets or liabilities.
+Added: Inputs other than Level
+Added: 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
+Added: Unobservable inputs which
+Added: are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or
+Added: similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
+Added: In some circumstances, the inputs used to measure
+Added: fair value might be categorized within different levels of the fair value hierarchy.
+Added: In those instances, the fair value measurement is
+Added: categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.
+Added: Fair value option – Note receivable
+Added: The guidance in ASC 825, Financial Instruments , provides a fair
+Added: value option election that allows entities to make an irrevocable election of fair value as the initial and subsequent measurement attribute
+Added: for certain eligible financial assets and liabilities.
+Added: Unrealized gains and losses on items for which the fair value option has been elected
+Added: are reported in earnings.
+Added: The decision to elect the fair value option is determined on an instrument-by-instrument basis and must be applied
+Added: to an entire instrument and is irrevocable once elected.
+Added: Assets and liabilities measured at fair value pursuant to this guidance are required
+Added: to be reported separately in the Company’s consolidated balance sheets from those instruments using another accounting method.
Investment in joint venture
1 unchanged sentence
the Company has significant influence that are not consolidated are accounted for as equity method investments.
−Removed: SEC Staff Announcement:
−Removed: Accounting for Limited Partnership Investments (codified in Accounting Standards Codification (“ASC”) 323-30-S99-1)
−Removed: guidance requires the use of the equity method unless the investor’s interest “is so minor that the limited partner
−Removed: may have virtually no influence over partnership operating and financial policies.”
−Removed: The SEC staff’s position is that
−Removed: investments in limited partnerships of greater than 3% to 5% are considered more than minor and, therefore, should be accounted
−Removed: for using the equity method or fair value option.
−Removed: Investments accounted for using the equity method may be reported on a lag up
−Removed: to three months if financial statements of the investee are not available in sufficient time for the investor to apply the equity
−Removed: method as of the current reporting date.
−Removed: The determination of whether an investee’s results are recorded on a lag is made
−Removed: on an investment-by-investment basis.
−Removed: This investment in joint venture is further described in Note of 7 these consolidated financial
−Removed: and development costs
−Removed: Research and development costs, including
−Removed: acquired in-process research and development expenses for which there is no alternative future use, are expensed as incurred.
−Removed: Advance payments for goods and services that will be used in future research and development activities are expensed when the
−Removed: activity has been performed or when the goods have been received rather than when the payment is made.
−Removed: value measurement
−Removed: FASB ASC 820, Fair Value Measurements ,
−Removed: provides guidance on the development and disclosure of fair value measurements.
−Removed: Under this accounting guidance, fair value is
−Removed: defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an
−Removed: orderly transaction between market participants at the measurement date.
−Removed: As such, fair value is a market-based measurement that
−Removed: should be determined based on assumptions that market participants would use in pricing an asset or a liability.
−Removed: The accounting guidance classifies fair
−Removed: value measurements in one of the following three categories for disclosure purposes:
−Removed: Quoted prices in active markets for
−Removed: identical assets or liabilities.
−Removed: Inputs other than Level 1 prices for similar assets
−Removed: or liabilities that are directly or indirectly observable in the marketplace.
−Removed: Unobservable inputs which are supported by little
−Removed: or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques,
−Removed: as well as instruments for which the determination of fair value requires significant judgment or estimation.
−Removed: In some circumstances, the inputs used
−Removed: to measure fair value might be categorized within different levels of the fair value hierarchy.
−Removed: In those instances, the fair value
−Removed: measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to
−Removed: the fair value measurement.
−Removed: The following table presents the Company’s
−Removed: assets and liabilities that are measured at fair value at December 31, 2020 and 2019:
−Removed: Fair value measured at December
−Removed: Total at December 31,
−Removed: Quoted prices in active markets
−Removed: other observable inputs
−Removed: Significant unobservable inputs
−Removed: Marketable securities - mutual funds
−Removed: Fair value measured at December
−Removed: Total at December 31,
−Removed: Quoted prices in active markets
−Removed: other observable inputs
−Removed: Significant unobservable inputs
−Removed: Marketable securities - mutual funds
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
+Added: Announcement:
+Added: Accounting for Limited Partnership Investments (codified in ASC 323-30-S99-1) guidance requires the use of the equity
+Added: method unless the investor’s interest “is so minor that the limited partner may have virtually no influence over
+Added: partnership operating and financial policies.” The SEC staff’s position is that investments in limited partnerships of
+Added: greater than 3 % to 5 % are considered more than minor and, therefore, should be accounted for using the equity method or fair value
+Added: Investments accounted for using the equity method may be reported on a lag up to three months if financial statements of the
+Added: investee are not available in sufficient time for the investor to apply the equity method as of the current reporting date.
+Added: determination of whether an investee’s results are recorded on a lag is made on an investment-by-investment basis.
+Added: investment in joint venture is further described in Note of 6 these consolidated financial statements.
+Added: development costs
+Added: Research and development costs, including acquired
+Added: in-process research and development expenses for which there is no alternative future use, are expensed as incurred.
+Added: Advance payments
+Added: for goods and services that will be used in future research and development activities are expensed when the activity has been performed
+Added: or when the goods have been received rather than when the payment is made.
Stock-based compensation
1 unchanged sentence
awards exchanged for services at the estimated grant date fair value of the award.
−Removed: Stock options issued under the Company’s
−Removed: long-term incentive plans are granted with an exercise price equal to no less than the market price of the Company’s stock
−Removed: at the date of grant and expire up to ten years from the date of grant.
+Added: Stock options issued under the Company’s long-term
+Added: 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
+Added: grant and expire up to ten years from the date of grant.
These options generally vest over a one to five year period .
−Removed: The Company estimates the fair value of
−Removed: stock option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based
−Removed: awards represent management’s best estimates and involve inherent uncertainties and the application of management’s
−Removed: Expected Term
−Removed: - The expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding
−Removed: based on the simplified method, which is the half-life from vesting to the end of its contractual term.
+Added: The Company accounts
+Added: for forfeited awards as they occur.
+Added: The Company estimates the fair value of stock
+Added: option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards
+Added: represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
+Added: Expected Term - The
+Added: expected term of options represents the period that the Company’s stock-based awards are expected to be outstanding based on the
+Added: 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.
−Removed: Risk-Free Interest
−Removed: Rate - The Company bases the risk-free interest rate on the implied yield available on U.
−Removed: Treasury zero-coupon issues with
−Removed: an equivalent remaining term.
+Added: Risk-Free Interest Rate
+Added: - The Company bases the risk-free interest rate on the implied yield available on U.S.
+Added: Treasury zero-coupon issues with an equivalent
+Added: remaining term.
Expected Dividend -
−Removed: - The Company has never declared or paid any cash dividends on its common shares and does not plan to pay cash dividends in
−Removed: the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models.
−Removed: Effective January 1, 2017, the Company
−Removed: elected to account for forfeited awards as they occur, as permitted by ASU 2016-09.
−Removed: Ultimately, the actual expenses recognized
−Removed: over the vesting period will be for those shares that vested.
−Removed: Prior to making this election, the Company estimated a forfeiture
−Removed: rate for awards at 0%, as the Company did not have a significant history of forfeitures.
−Removed: Income taxes are recorded in accordance
−Removed: with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach.
−Removed: The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included
−Removed: in the consolidated financial statements or tax returns.
−Removed: Deferred tax assets and liabilities are determined based on the difference
−Removed: between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which
−Removed: the differences are expected to reverse.
−Removed: Valuation allowances are provided, if based upon the weight of available evidence, it
−Removed: is more likely than not that some or all of the deferred tax assets will not be realized.
−Removed: The Company accounts for uncertain tax
−Removed: positions in accordance with the provisions of ASC 740.
−Removed: When uncertain tax positions exist, the Company recognizes the tax benefit
−Removed: of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority.
−Removed: The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the
−Removed: tax position as well as consideration of the available facts and circumstances.
+Added: 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
+Added: future, and, therefore, uses an expected dividend yield of zero in its valuation models.
+Added: Income taxes are recorded in accordance with
+Added: ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach.
+Added: recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated
+Added: financial statements or tax returns.
+Added: Deferred tax assets and liabilities are determined based on the difference between the financial
+Added: statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected
+Added: Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or
+Added: all of the deferred tax assets will not be realized.
+Added: The Company accounts for uncertain tax positions
+Added: in accordance with the provisions of ASC 740.
+Added: When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions
+Added: to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority.
+Added: The determination
+Added: 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
+Added: consideration of the available facts and circumstances.
Net loss per share
−Removed: Net loss per share is computed by dividing
−Removed: net loss by the weighted average number of common stock outstanding during the period.
−Removed: Since the Company had a net loss in the
−Removed: periods presented, basic and diluted net loss per common share are the same.
−Removed: The following were excluded from the computation
−Removed: of diluted shares outstanding due to the losses for each period presented, as they would have had an anti-dilutive impact on the
−Removed: Company’s net loss:
+Added: Net loss per share is computed by dividing net
+Added: loss by the weighted average number of common stock outstanding during the period.
+Added: Since the Company had a net loss in the periods presented,
+Added: basic and diluted net loss per common share are the same.
+Added: The following were excluded from the computation of diluted shares outstanding
+Added: 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 December 31,
1 unchanged sentence
Non-vested restricted stock awards
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
Recent accounting pronouncements
−Removed: In February 2016, the FASB issued ASU
−Removed: 2016-02, Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles
−Removed: for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors.
−Removed: The new standard requires
−Removed: lessees to apply a dual approach, classifying virtually all leases as either finance or operating leases based on the principle
−Removed: of whether or not the lease is effectively a financed purchase by the lessee.
−Removed: This classification will determine whether lease
−Removed: expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease.
−Removed: also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless
−Removed: of classification.
−Removed: Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating
−Removed: The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted
−Removed: upon issuance.
−Removed: On January 1, 2019, the Company adopted ASU No.
−Removed: 2016-02, and the adoption did not have a material impact on its
−Removed: consolidated financial statements and related disclosures due to the short-term nature of its operating leases.
−Removed: In June 2018, the FASB issued ASU 2018-07,
−Removed: Compensation—Stock Compensation (Topic 718):
−Removed: Improvements to Nonemployee Share-Based Payment Accounting (“ASU
−Removed: 2018-07”).
−Removed: ASU 2018-07 simplifies several aspects of the accounting for nonemployee share-based payment transactions resulting
−Removed: from expanding the scope of Topic 718, Compensation—Stock Compensation, to include share-based payment transactions for
−Removed: acquiring goods and services from non-employees.
−Removed: ASU 2018-07 is effective for public business entities for fiscal years beginning
−Removed: after December 15, 2018, including interim periods within that fiscal year.
−Removed: On January 1, 2019, the Company adopted ASU 2018-07,
−Removed: and the adoption did not have a material impact on its consolidated financial statements.
−Removed: In December 2019, the FASB issued ASU
−Removed: 2019-12, “Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income Taxes (“ASU 2019-12”),
−Removed: which is intended to simplify various aspects related to accounting for income taxes.
−Removed: ASU 2019-12 removes certain exceptions to
−Removed: the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
−Removed: This guidance
−Removed: is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption
−Removed: The Company adopted ASU No.
−Removed: 2019-12 effective January 1, 2021, and the adoption did not have a material impact on its
−Removed: consolidated financial statements.
−Removed: Note 3—License agreements
−Removed: The following summarizes the Company’s
+Added: In December 2019, FASB issued ASU No.
+Added: “Income Taxes (Topic 740):
+Added: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to
+Added: simplify various aspects related to accounting for income taxes.
+Added: ASU 2019-12 removes certain exceptions to the general principles in
+Added: Topic 740 and also clarifies and amends existing guidance to improve consistent application.
+Added: This guidance is effective for fiscal years,
+Added: and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
+Added: The Company adopted
+Added: ASU 2019-12 effective January 1, 2021, and the adoption did not have a material impact on its consolidated financial statements.
+Added: Note 3—License agreements
+Added: The following summarizes the Company’s
research and development expenses for licenses acquired during the years ended December 31, 2021 and 2020:
−Removed: For the years ended December 31,
+Added: For the years ended
+Added: The George Washington University
Chelexa Biosciences, Inc.
and the University of Cincinnati
−Removed: The George Washington University
University of Maryland and Isoprene Pharmaceuticals, Inc.
North Carolina State University
+Added: Virginia Commonwealth University
University of Cincinnati
Army Medical Research and Development Command
−Removed: Virginia Commonwealth University
−Removed: Therapeutics, Inc.
+Added: Washington University
+Added: On February 1, 2020 (“GW the Effective
+Added: Date”), the Company entered into a patent license agreement with GW pursuant to which GW granted the Company a license to certain
+Added: patent rights to, among other things, make, use, offer and sell certain licensed products throughout the world with respect to HT-001.
+Added: On the GW Effective Date, the Company paid GW $2,500, and on February 27, 2020, the Company paid GW $10,000 as a license initiation fee.
+Added: Until the first commercial sale of HT-001, the Company shall pay (i) $75,000 per year for the development and commercialization of HT-001,
+Added: (ii) $2,000 for license maintenance fees on the first anniversary of the GW Effective Date and (iii) $5,000 for license maintenance fees
+Added: commencing on the second anniversary of the GW Effective Date and thereafter.
+Added: Furthermore, the Company shall be required to pay GW a
+Added: sublicense fee equal to a certain percentage of the sum of payments plus the fair market value of all other consideration of any kind
+Added: received by the Company from sublicensees during each quarter as follows:
+Added: a 40% sublicense fee until the first anniversary of the GW
+Added: Effective Date, a 30% sublicense fee until the third anniversary of the GW Effective Date and a 20% sublicense fee after the third anniversary
+Added: of the GW Effective Date;
+Added: provided, however, such sublicense fee shall exclude certain fees paid to the Company such as certain royalties,
+Added: equity investments, loan proceeds and sponsored research funding.
+Added: The Company shall also pay GW milestone payments of up to an aggregate
+Added: of $90,000 and sales-based royalties at a low single digit percentage, subject to certain minimum royalty requirements.
+Added: Effective as of June 1, 2019, the Company and
+Added: GW entered into a sponsored research agreement (the “Sponsored Research Agreement”), as amended on July 29, 2019, May 29,
+Added: 2020 and September 7, 2021, with respect to the exploration of the potential use of HT-001 for topical and/or systemic therapy to counter
+Added: the dermatological related side-effects of Erlotinib therapy in cancer patients.
+Added: The Sponsored Research Agreement shall terminate on
+Added: May 31, 2022 unless terminated earlier pursuant to the terms of the agreement.
+Added: On August 7, 2020 (the “GW Second Effective
+Added: Date”), the Company entered into a second Patent License Agreement (the “GW Second Patent License Agreement”) with
+Added: GW pursuant to which GW granted the Company an exclusive, worldwide, royalty bearing license to certain intellectual property that can
+Added: be used to develop a breath based diagnostic device.
+Added: The GW Second Patent License Agreement permits the Company to make, have made, use,
+Added: import, offer for sale and sell Licensed Products (as defined in the GW Second Patent License Agreement) in the field of virus sensing
+Added: and detection.
+Added: The term of the GW Second Patent License Agreement shall continue until the later of:
+Added: (a) the expiration or abandonment
+Added: of the last patent to expire or become abandoned of the Patent Rights (as defined in the GW Second Patent License Agreement);
+Added: ten years after the first Sale (as defined in the GW Second Patent License Agreement) of the first Licensed Product if no patent has
+Added: issued from the Patent Rights, unless terminated earlier pursuant to the terms of the agreement.
+Added: Pursuant to the GW Second Patent License
+Added: Agreement, the Company shall pay GW:
+Added: (i) an upfront license initiation fee, (ii) annual maintenance fees commencing on the first anniversary
+Added: of the GW Second Effective Date, (iii) milestone payments ranging from the low to mid five figures, (iv) running royalty payments at
+Added: a middle single digit percentage of Net Sales (as defined in the GW Second Patent License Agreement), (iv) quarterly minimum payments
+Added: ranging from the low four figures for the first four quarters after the first sale to low five figures commencing three years after the
+Added: first sale and (v) an annual diligence fee of high five figures.
+Added: In addition, the Company has agreed to reimburse GW for certain past
+Added: and future patent filing and prosecution costs.
+Added: On September 17, 2020, the Company entered into
+Added: a second Sponsored Research Agreement (the “Second Agreement”) with GW effective as of September 1, 2020 (the “Second
+Added: Agreement Effective Date”).
+Added: The Second Agreement relates to the development of a diagnostic device for the detection of SARS-CoV-2
+Added: via a mobile device as an aid in the diagnosis of the COVID-19 infection.
+Added: The Second Agreement was terminated on February 26, 2021.
+Added: During the year ended December 31, 2020, the
+Added: Company paid $ 10,000 for license initiation fee, $ 10,000 for option exercise fee and approximately $ 15,000 patent related expense.
+Added: Company also recorded an expense of approximately $ 134,000 related with warrants granted to GW pursuant to the GW Patent License Agreement
+Added: and GW Second Patent License Agreement.
+Added: During the year ended December 31, 2021, the
+Added: Company recorded an expense of approximately $ 0.1 million for related to warrants granted to GW pursuant to the GW Patent License Agreement
+Added: and the Second GW Patent License Agreement.
Chelexa Biosciences, Inc.
1 unchanged sentence
of Cincinnati
−Removed: On May 14, 2020, the Company entered into
−Removed: an Assignment and Assumption Agreement (the “Assignment Agreement”) with Chelexa Biosciences, Inc.
−Removed: (“Chelexa”)
−Removed: pursuant to which Chelexa assigned to the Company its rights and obligations in and liabilities under its license agreement with
−Removed: the University of Cincinnati dated February 27, 2013, as amended (the “University of Cincinnati License Agreement”).
−Removed: In consideration for the assignment, the Company agreed to forgive all amounts due to it by Chelexa and to pay to Chelexa certain
−Removed: royalty payments.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
+Added: On May 14, 2020, the Company entered into an
+Added: Assignment and Assumption Agreement (the “Assignment Agreement”) with Chelexa Biosciences, Inc.
+Added: (“Chelexa”) pursuant
+Added: to which Chelexa assigned to the Company its rights and obligations in and liabilities under its license agreement with the University
+Added: of Cincinnati dated February 27, 2013 (as amended, the “University of Cincinnati License Agreement”).
+Added: In consideration for
+Added: the assignment, the Company agreed to forgive all amounts due to it by Chelexa and to pay to Chelexa certain royalty payments.
In connection with the Assignment Agreement,
−Removed: on May 14, 2020, the Company entered into a novation agreement (the “Novation Agreement”) with Chelexa and the University
−Removed: of Cincinnati pursuant to which the parties agreed that the Company would be substituted in place of Chelexa with respect to the
−Removed: rights and obligations of Chelexa set forth in the University of Cincinnati License Agreement.
+Added: on May 14, 2020, the Company entered into a novation agreement (the “Novation Agreement”) with Chelexa and the University
+Added: of Cincinnati pursuant to which the parties agreed that the Company would be substituted in place of Chelexa with respect to the rights
+Added: and obligations of Chelexa set forth in the University of Cincinnati License Agreement.
In connection with the Assignment Agreement,
−Removed: on May 14, 2020, the Company entered into a royalty agreement (the “Royalty Agreement”) with Chelexa pursuant to which
−Removed: the Company shall pay Chelexa sales-based royalties at percentages which range from mid to high single digits, with high sales
−Removed: volumes being subject to lower royalty rates and total milestone payments of $3.5 million.
−Removed: Pursuant to the University of Cincinnati
−Removed: License Agreement, the Company was granted an exclusive license to make, use, have made, import, offer for sale, and sell products
−Removed: based upon or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators
−Removed: to inhibit biofilm formation (the “BioLexa Platform”
−Removed: or “BioLexa”).
−Removed: In addition, the University of Cincinnati
−Removed: granted the Company the right to issue exclusive and nonexclusive sublicenses (with the right to further sublicense to third parties)
−Removed: to make, use, have made, import, offer for sale, and sell products based upon the BioLexa Platform.
−Removed: The term of such agreement
−Removed: will expire on the later of April 16, 2034 and the last to expire patent in the patent rights granted to the Company (the “Term”).
−Removed: The Company shall, in its sole discretion, have the first right of refusal to renew the Term.
−Removed: The Company is subject to total
−Removed: milestone payments of $6,000, royalty payments, annual license maintenance fees, and has agreed to pay the University of Cincinnati
−Removed: for certain out-of-pocket expenses including, but not limited to, payments for patent prosecution.
−Removed: During the year ended December 31, 2020
−Removed: the Company paid $5,000 for the annual license maintenance fee and $5,000 for the yearly minimum annual royalty fee.
−Removed: George Washington University
−Removed: Effective as of June 1, 2019, the Company
−Removed: and The George Washington University (“GW”) entered into a sponsored research agreement (the “Sponsored Research
−Removed: Agreement”), as amended on July 29, 2019 and May 29, 2020, with respect to the exploration of the potential use of HT-001
−Removed: for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients.
−Removed: Pursuant to the terms of the Sponsored Research Agreement, GW granted the Company a non-exclusive license to certain of GW’s
−Removed: intellectual property.
−Removed: The Company has agreed to pay GW for all costs incurred in connection with the research;
−Removed: provided, however,
−Removed: such costs shall not exceed approximately $0.5 million.
−Removed: The Sponsored Research Agreement shall terminate on June 30, 2021.
−Removed: Sponsored Research Agreement may be terminated by either party upon 30 days written notice.
−Removed: On June 28, 2019 (the “Effective
−Removed: Date”), the Company and GW entered into a research option agreement (the “Research Option Agreement”) pursuant
−Removed: to which GW granted the Company an option (the “Option”) until April 30, 2020 to acquire an exclusive license to certain
−Removed: products made or used by the Company (the “GW Licensed Product”) that involve certain patents owned by GW (the “Licensed
−Removed: Patents”).
−Removed: On February 1, 2020, the Company exercised the Option and entered into a patent license agreement (the “Patent
−Removed: License Agreement”) with GW.
−Removed: On the Effective Date, the Company paid GW $2,500, and on February 27, 2020, the Company paid
−Removed: GW $10,000 as a license initiation fee.
−Removed: Until the first commercial sale of the GW Licensed Product, the Company shall pay (i)
−Removed: $75,000 per year for the development and commercialization of the GW Licensed Product, (ii) $2,000 for license maintenance fees
−Removed: on the first anniversary of the Effective Date and (iii) $5,000 for license maintenance fees commencing on the second anniversary
−Removed: of the Effective Date and thereafter.
−Removed: Furthermore, the Company shall be required to pay GW a sublicense fee equal to a certain
−Removed: percentage of the sum of payments plus the fair market value of all other consideration of any kind received by the Company from
−Removed: sublicensees during each quarter as follows:
−Removed: a 40% sublicense fee until the first anniversary of the Effective Date, a 30% sublicense
−Removed: fee until the third anniversary of the Effective Date and a 20% sublicense fee after the third anniversary of the Effective Date;
−Removed: provided, however, such sublicense fee shall exclude certain fees paid to the Company such as certain royalties, equity investments,
−Removed: loan proceeds and sponsored research funding.
−Removed: The Company shall also pay GW milestone payments of up to an aggregate of $90,000
−Removed: and sales-based royalties at a low single digit percentage, subject to certain minimum royalty requirements.
−Removed: In addition, during
−Removed: each Option Exercise Period and Renewal Period (as defined in the Research Option Agreement) the Company shall pay GW, on a quarterly
−Removed: basis, for all costs and expenses related to the Licensed Patents.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: On August 7, 2020 (the “GW Effective
−Removed: Date”), the Company entered into a Patent License Agreement (the “GW Patent License Agreement”) with the GW.
−Removed: Pursuant to the GW Patent License Agreement, GW granted the Company an exclusive, worldwide, royalty bearing license to certain
−Removed: intellectual property that can be used to develop a device designed to detect the presence of SARS-CoV-2.
−Removed: Specifically, the GW
−Removed: Patent License Agreement permits the Company to make, have made, use, import, offer for sale and sell Licensed Products (as defined
−Removed: in the GW Patent License Agreement) in the field of virus sensing and detection.
−Removed: The GW Patent License Agreement shall commence
−Removed: on the GW Effective Date and shall continue until the later of:
−Removed: (a) the expiration or abandonment of the last patent to expire
−Removed: or become abandoned of the Patent Rights (as defined in the GW Patent License Agreement);
−Removed: or (b) ten years after the first Sale
−Removed: (as defined in the GW Patent License Agreement) of the first Licensed Product if no patent has issued from the Patent Rights,
−Removed: unless terminated earlier pursuant to the terms of the agreement.
−Removed: Pursuant to the GW Patent License Agreement, the Company shall
−Removed: (i) an upfront license initiation fee, (ii) annual maintenance fees commencing on the first anniversary of the GW Effective
−Removed: Date, (iii) milestone payments ranging from the low to mid five figures, (iv) running royalty payments at a middle single digit
−Removed: percentage of Net Sales (as defined in the GW License Agreement), (iv) quarterly minimum payments ranging from the low four figures
−Removed: for the first four quarters after the first sale to low five figures commencing three years after the first sale and (v) an annual
−Removed: diligence fee of high five figures.
−Removed: In addition, the Company has agreed to reimburse GW for certain past and future patent filing
−Removed: and prosecution costs.
−Removed: On September 17, 2020, the Company entered
−Removed: into a Sponsored Research Agreement (the “Agreement”) with GW effective as of September 1, 2020 (the “Agreement
−Removed: Effective Date”).
−Removed: The Agreement relates to the development of a diagnostic device for the detection of SARS-CoV-2 via a
−Removed: mobile device as an aid in the diagnosis of the COVID-19 infection.
−Removed: The Agreement commences on the Agreement Effective Date and
−Removed: terminates on July 31, 2021 unless such term is extended or terminated by the parties.
−Removed: Pursuant to the Agreement, the Company
−Removed: shall pay GW up to a mid-six figure fee for all research costs.
−Removed: During the year ended December 31, 2020
−Removed: the Company paid $10,000 for license initiation fee, $10,000 for option exercise fee and approximately $15,000 patent related
−Removed: The Company also recorded an expense of approximately $134,000 related with warrants granted to GW pursuant to Patent
−Removed: License Agreement.
−Removed: University of Maryland and Isoprene
−Removed: Pharmaceuticals, Inc.
−Removed: On March 8, 2019, the Company entered
−Removed: into a commercial evaluation sublicense and option agreement (the “Commercial Evaluation Sublicense and Option Agreement”)
−Removed: with the University of Maryland, Baltimore (“UMB”) and Isoprene Pharmaceuticals, Inc.
−Removed: (“Isoprene”).
−Removed: to the agreement, the Company paid an initial option and material access fee of $5,000 to UMB and $5,000 to Isoprene.
−Removed: that Isoprene enters into a master license agreement with UMB (the “MLA”), UMB shall permit Isoprene to grant an exclusive
−Removed: option to the Company to negotiate and obtain an exclusive sublicensable, worldwide royalty-bearing license to the subject technology
−Removed: (the “Isoprene-Hoth Option”);
−Removed: provided, however, in the event Isoprene does not enter into the MLA, UMB may grant
−Removed: the Company an option to negotiate and obtain an exclusive sublicensable, worldwide royalty-bearing license to the subject technology
−Removed: (the “UMB-Hoth Option”).
−Removed: If the Company exercises the Isoprene-Hoth Option, it shall pay Isoprene an option exercise
−Removed: fee of $20,000.
−Removed: If the Company exercises the UMB-Hoth Option, it shall pay UMB an option exercise fee of $20,000.
−Removed: On July 30, 2020 (the “Isoprene
−Removed: Effective Date”), the Company entered into a Sublicense Agreement (the “Isoprene Sublicense Agreement”) with
−Removed: Isoprene pursuant to the Commercial Evaluation Sublicense and Option Agreement.
−Removed: Pursuant to the Isoprene Sublicense Agreement,
−Removed: Isoprene granted the Company an exclusive sublicense to certain intellectual property (i) to make, have made, use, sell, offer
−Removed: to sell and import certain licensed products, (ii) in connection therewith, to use certain inventions and licensed materials and
−Removed: (iii) to practice the Patent Rights (as defined in the Isoprene Sublicense Agreement) for the treatment of dermatological conditions
−Removed: The Isoprene Sublicense Agreement will continue on a country-by-country basis until the expiration of the last to
−Removed: expire of the Patent Rights in such country, unless earlier terminated pursuant to the Isoprene Sublicense Agreement (the “Isoprene
−Removed: Term”).
−Removed: Pursuant to the Isoprene Sublicense Agreement, the Company shall pay Isoprene, among other things, (i) a license
−Removed: fee, (ii) a royalty rate at a middle single digit percentage, (iii) milestone payments of up to $1,375,000 and (iv) revenue interest
−Removed: at a low single digit percentage based on the net revenue of covered products sold by Isoprene during the Isoprene Term.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: In March 2019, the Company recorded an
−Removed: expense of an aggregate of $10,000 for the initial option and materials access fee.
−Removed: During the year ended 2020, the Company paid
−Removed: a total of $30,000 for the license fee.
−Removed: At December 31, 2020, the Company accrued a $5,000 for an upfront license payment.
−Removed: On December 2, 2020, Hoth Therapeutics,
−Removed: (the “Company”) entered into an option agreement (the “Option Agreement”) with Isoprene Pharmaceutics,
−Removed: (“Isoprene”), pursuant to which the Company will have an exclusive option, until June 2, 2021, to negotiate an
−Removed: exclusive, royalty-bearing and limited term license with respect to certain previously sublicensed intellectual property for the
−Removed: diagnosis and treatment of inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.
−Removed: This Option Agreement
−Removed: is based upon, and potentially expands, the fields of use in which the Company can license certain Isoprene intellectual property
−Removed: that is the subject of the Company’s existing Sublicense Agreement, dated July 30, 2020, with Isoprene, and the Master License
−Removed: Agreement, dated July 8, 2020, by and between Isoprene and the University of Maryland, Baltimore.
−Removed: During the year ended December 31, 2020
−Removed: the Company paid $10,000 for license fee and $20,000 for the option exercise fee.
−Removed: As of December 31, 2020, the Company accrued
−Removed: a $5,000 for an upfront license payment.
−Removed: Carolina State University
−Removed: On November 20, 2019 (the “NC State
−Removed: Effective Date”), the Company entered into a license agreement with North Carolina State University (“NC State”)
−Removed: pursuant to which NC State granted the Company an exclusive license to, among other things, develop, make, use, offer and sell
−Removed: certain licensed products throughout the world with respect to HT-004 for treating allergic diseases.
−Removed: The term of the license
−Removed: agreement shall commence on the NC State Effective Date and shall continue until the date of the expiration of the last to expire
−Removed: patent right granted pursuant to the license agreement unless terminated earlier pursuant to the terms of the agreement.
−Removed: to the terms of the license agreement, the Company paid NC State a one-time license fee $25,000 and is also required to pay (i)
−Removed: sales-based royalties at a low single digit percentage, (ii) minimum royalties ranging from $0 to $50,000 and (iii) milestone
−Removed: payments of up to $585,000.
−Removed: University of Cincinnati
−Removed: On May 18, 2018, the Company entered into
−Removed: an exclusive license agreement with the University of Cincinnati for a patented, novel genetic marker for food allergies.
−Removed: genetic marker licensed by the Company from the University of Cincinnati may be used to (i) identify at risk infants in predicting
−Removed: food allergies, including peanut and milk allergies, (ii) identify a person’s predisposition to an allergic reaction, thereby
−Removed: avoiding such reaction and (iii) determine an individual’s propensity to develop atopic dermatitis, such as eczema.
−Removed: Company intends to utilize the genetic marker for purposes of determining an individual’s propensity to develop eczema as
−Removed: well as to identify and treat allergies in at-risk infants.
+Added: on May 14, 2020, the Company entered into a royalty agreement (the “Royalty Agreement”) with Chelexa pursuant to which the
+Added: Company shall pay Chelexa sales-based royalties at percentages which range from mid to high single digits, with high sales volumes being
+Added: subject to lower royalty rates and total milestone payments of $ 3.5 million.
+Added: Pursuant to the University of Cincinnati License
+Added: Agreement, the Company was granted an exclusive license to make, use, have made, import, offer for sale, and sell products based upon
+Added: or involving the use of (i) topical compositions comprising a zinc chelator and gentamicin and (ii) zinc chelators to inhibit biofilm
+Added: formation (the “BioLexa Platform” or “BioLexa”).
+Added: In addition, the University of Cincinnati granted the Company
+Added: the right to issue exclusive and nonexclusive sublicenses (with the right to further sublicense to third parties) to make, use, have
+Added: made, import, offer for sale, and sell products based upon the BioLexa Platform.
+Added: The term of such agreement will expire on the later
+Added: of April 16, 2034 and the last to expire patent in the patent rights granted to the Company (the “Term”).
+Added: The Company shall,
+Added: in its sole discretion, have the first right of refusal to renew the Term.
+Added: The Company is subject to total milestone payments of $ 6,000 ,
+Added: royalty payments, annual license maintenance fees, and has agreed to pay the University of Cincinnati for certain out-of-pocket expenses
+Added: including, but not limited to, payments for patent prosecution.
+Added: During the year ended December 31, 2021, the
+Added: Company paid $ 2,500 for the annual license maintenance fee and $ 5,000 for the yearly minimum annual royalty fee.
+Added: During the year ended December 31, 2020, the
+Added: Company paid a total of $ 2,500 for the annual license maintenance fee, $ 5,000 for the yearly minimum annual royalty fee and approximately
+Added: $ 2,000 for patent expense reimbursement.
+Added: As of December 31, 2020, the Company accrued a $ 7,500 for an upfront license payment.
+Added: was made in 2021.
+Added: University of Maryland and Isoprene Pharmaceuticals,
+Added: On July 30, 2020 (the “Isoprene Effective
+Added: Date”), the Company entered into a Sublicense Agreement (the “Isoprene Sublicense Agreement”) with Isoprene Pharmaceuticals,
+Added: (“Isoprene”).
+Added: Pursuant to the Isoprene Sublicense Agreement, Isoprene granted the Company an exclusive sublicense to
+Added: certain intellectual property (i) to make, have made, use, sell, offer to sell and import certain licensed products, (ii) in connection
+Added: therewith, to use certain inventions and licensed materials and (iii) to practice the Patent Rights (as defined in the Isoprene Sublicense
+Added: Agreement) for the treatment of dermatological conditions or diseases.
+Added: The Isoprene Sublicense Agreement will continue on a country-by-country
+Added: basis until the expiration of the last to expire of the Patent Rights in such country, unless earlier terminated pursuant to the Isoprene
+Added: Sublicense Agreement (the “Isoprene Term”).
+Added: Pursuant to the Isoprene Sublicense Agreement, the Company shall pay Isoprene,
+Added: among other things, (i) a license fee, (ii) a royalty rate at a middle single digit percentage, (iii) milestone payments of up to $ 1,375,000
+Added: and (iv) revenue interest at a low single digit percentage based on the net revenue of covered products sold by Isoprene during the Isoprene
+Added: On December 2, 2020, the Company entered into
+Added: an option agreement (the “Option Agreement”) with Isoprene, pursuant to which the Company had an exclusive option, until
+Added: June 2, 2021, to negotiate an exclusive, royalty-bearing and limited term license with respect to certain previously sublicensed intellectual
+Added: property for the diagnosis and treatment of inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis, which
+Added: option was exercised on July 2, 2021.This Option Agreement is based upon and expands the fields of use in which the Company can license
+Added: certain Isoprene intellectual property that is the subject of the Company’s existing Sublicense Agreement, dated July 30, 2020,
+Added: with Isoprene, and the Master License Agreement, dated July 8, 2020, by and between Isoprene and the University of Maryland, Baltimore.
+Added: During the year ended December 31, 2020, the
+Added: Company paid $ 10,000 for the license fee and $ 20,000 for the option exercise fee.
+Added: As of December 31, 2020, the Company accrued a $ 5,000
+Added: for an upfront license payment.
+Added: During the year ended December 31, 2021, the
+Added: Company paid $ 15,000 for the license fee.
+Added: North Carolina
+Added: State University
+Added: On February 25, 2021 (the “Effective Date”),
+Added: the Company entered into a License Agreement (the “License Agreement”) with North Carolina State University (“NC State”)
+Added: pursuant to which NC State granted the Company an exclusive, worldwide, royalty bearing license to certain intellectual property to,
+Added: among other things, discover, develop, make, have made, use and sell certain licensed products and sell, use and practice certain licensed
+Added: services with respect to cancer and anaphylaxis.
+Added: The License Agreement commenced on the Effective Date and continues until the later
+Added: of (i) the date of expiration of the last to expire patents rights licensed pursuant to such agreement, including any renewals or extensions
+Added: thereof and (ii) expiration of any market exclusivity period granted for a licensed product by the applicable regulatory agency.
+Added: During the year ended December 31, 2021, the
+Added: Company paid $ 30,000 for the license fee.
+Added: Commonwealth University
+Added: On May 18, 2020 (the “VCU Effective Date”),
+Added: the Company entered into an Exclusive License Agreement (the “VCU License Agreement”) with the Virginia Commonwealth University
+Added: Intellectual Property Foundation (“VCU”).
+Added: Pursuant to the VCU License Agreement, VCU granted the Company an exclusive, royalty
+Added: bearing license to a novel peptide developed by researchers at VCU that may be used to slow the transmission of SARS-CoV-2 (the “VCU
+Added: Licensed Patent”) and a non-exclusive royalty bearing, worldwide license with respect to the Licensed Technical Information Patents
+Added: (as defined in the VCU License Agreement) to make, have made, use, offer to sell, sell and import the Licensed Products (as defined in
+Added: the VCU License Agreement) and perform the Licensed Services (as defined in the VCU License Agreement).
+Added: The VCU License Agreement commenced
+Added: on the VCU Effective Date and shall continue until the expiration of the last to expire VCU Licensed Patent unless terminated earlier
+Added: pursuant to the terms of the agreement.
+Added: Pursuant to the VCU License Agreement, the Company shall pay VCU:
+Added: (i) an upfront license issue
+Added: fee, (ii) running royalty payments at a low single digit percentage of Net Sales (as defined in the VCU License Agreement), (iii) annual
+Added: maintenance fees commencing on the first anniversary of the VCU Effective Date, (iv) annual minimum payments ranging from the mid five
+Added: figures to low six figures commencing on the second anniversary of the VCU Effective Date and (v) milestone payments ranging from the
+Added: mid five figures to low six figures.
+Added: In addition, the Company has agreed to reimburse VCU for certain patent filing and prosecution costs.
+Added: On June 29, 2020, the Company entered into a
+Added: Sponsored Project Agreement (the “VCU Sponsored Project Agreement”) with VCU for the development of a potential COVID-19
+Added: treatment using the license to a novel peptide granted to the Company by VCU.
+Added: The VCU Sponsored Project Agreement was amended on April
+Added: 28, 2021 to extend the period of research and to add an additional scope of investigation to include the variants of SARS-CoV-2.
+Added: In May 2020, the Company paid the signing fee
+Added: of $ 50,000 upon execution of the VCU License Agreement.
+Added: During the year ended December 31, 2021, the
+Added: Company paid $ 30,000 for annual maintenance fees.
+Added: As of December 31, 2021 and 2020, the Company
+Added: accrued $ 285,000 for five years of annual minimum payments and $ 30,000 for annual maintenance fees.
+Added: The University of Cincinnati
+Added: On May 18, 2018, the Company entered into an
+Added: exclusive license agreement with the University of Cincinnati for a patented, novel genetic marker for food allergies.
+Added: The genetic marker
+Added: licensed by the Company from the University of Cincinnati may be used to (i) identify at risk infants in predicting food allergies, including
+Added: peanut and milk allergies, (ii) identify a person’s predisposition to an allergic reaction, thereby avoiding such reaction and
+Added: (iii) determine an individual’s propensity to develop atopic dermatitis, such as eczema.
Pursuant to the terms of the exclusive
−Removed: license agreement, the Company paid the University of Cincinnati a minimum annual royalty fee of $5,000 and has agreed to pay
−Removed: the University of Cincinnati an annual license fee of $5,000 initially due and payable within 30 days of the one year anniversary
−Removed: of the exclusive license agreement and every year thereafter and milestone payments of up to $120,000.
−Removed: The exclusive license agreement
−Removed: will continue until the later of (i) the date upon which a valid claim pursuant to the terms of the exclusive license agreement
−Removed: expires or (ii) ten years after the first commercial sale or unless earlier terminated pursuant to the terms of the exclusive
−Removed: license agreement.
−Removed: During the year ended December 31, 2020,
−Removed: the Company paid a total of $2,500 for the annual license maintenance fee, $5,000 for the yearly minimum annual royalty fee and
−Removed: approximately $2,000 for patent expense reimbursement.
−Removed: As of December 31, 2020, the Company accrued a $17,500 for an upfront license
+Added: license agreement, the Company paid the University of Cincinnati a minimum annual royalty fee of $ 5,000 and agreed to pay the University
+Added: of Cincinnati an annual license fee of $ 5,000 initially due and payable within 30 days of the one year anniversary of the exclusive license
+Added: agreement and every year thereafter and milestone payments of up to $ 120,000 .
+Added: The exclusive license agreement was terminated by the Company
+Added: on October 22, 2021.
+Added: During the year ended December 31, 2021, the
+Added: Company paid $ 5,000 for the annual license maintenance fee and $ 5,000 for the yearly minimum annual royalty fee.
+Added: During the year ended December 31, 2020, the
+Added: Company paid a total of $ 5,000 for the annual license maintenance fee, $ 5,000 for the yearly minimum annual royalty.
+Added: As of December 31,
+Added: 2020, the Company accrued a $ 10,500 for an upfront license payment.
+Added: The payment was made in 2021.
Army Medical Research and Development
−Removed: On December 11, 2020, the Company entered
−Removed: into a commercial evaluation license agreement with U.S.
−Removed: Army Medical Research and Development Command (“USAMRDC”).
−Removed: This agreement was amended on January 12, 2021 to clarify that the license entered into is with Walter Reed Army Institute of
−Removed: Research, a subsidiary of USAMRDC.
+Added: On December 11, 2020, the Company entered into
+Added: a commercial evaluation license agreement with U.S.
+Added: Army Medical Research and Development Command (“USAMRDC”).
+Added: This agreement
+Added: was amended on January 12, 2021 to clarify that the license entered into is with Walter Reed Army Institute of Research, a subsidiary
As of December 31, 2020, the Company accrued
a $ 2,000 for an upfront license payment.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: Commonwealth University
−Removed: On May 18, 2020 (the “VCU Effective
−Removed: Date”), the Company entered into an Exclusive License Agreement (the “VCU License Agreement”) with the Virginia
−Removed: Commonwealth University Intellectual Property Foundation (“VCU”).
−Removed: Pursuant to the VCU License Agreement, VCU granted
−Removed: the Company an exclusive, royalty bearing license to a novel peptide developed by researchers at VCU that may be used to slow
−Removed: the transmission of SARS-CoV-2 (the “VCU Licensed Patent”) and a non-exclusive royalty bearing, worldwide license
−Removed: with respect to the Licensed Technical Information Patents (as defined in the VCU License Agreement) to make, have made, use,
−Removed: offer to sell, sell and import the Licensed Products (as defined in the VCU License Agreement) and perform the Licensed Services
−Removed: (as defined in the VCU License Agreement).
−Removed: The VCU License Agreement commenced on the VCU Effective Date and shall continue until
−Removed: the expiration of the last to expire VCU Licensed Patent unless terminated earlier pursuant to the terms of the agreement.
−Removed: to the VCU License Agreement, the Company shall pay VCU:
−Removed: (i) an upfront license issue fee, (ii) running royalty payments at a
−Removed: low single digit percentage of Net Sales (as defined in the VCU License Agreement), (iii) annual maintenance fees commencing on
−Removed: the first anniversary of the VCU Effective Date, (iv) annual minimum payments ranging from the mid five figures to low six figures
−Removed: commencing on the second anniversary of the VCU Effective Date and (v) milestone payments ranging from the mid five figures to
−Removed: low six figures.
−Removed: In addition, the Company has agreed to reimburse VCU for certain patent filing and prosecution costs.
−Removed: On June 29, 2020, the Company entered
−Removed: into a Sponsored Project Agreement (the “VCU Sponsored Project Agreement”) with VCU for the development of a potential
−Removed: COVID-19 treatment using the license to a novel peptide granted to the Company by VCU.
−Removed: The VCU Sponsored Project Agreement shall
−Removed: terminate on January 9, 2021, unless earlier terminated pursuant to the terms thereof.
−Removed: In May 2020, the Company paid the signing
−Removed: fee of $50,000 upon execution of the VCU License Agreement.
−Removed: The Company also accrued $285,000 for five years of annual minimum
−Removed: payments and $30,000 for annual maintenance fees.
−Removed: Therapeutics Inc.
−Removed: On August 19, 2019 (the “Zylö
−Removed: Effective Date”), the Company entered into an exclusive sublicense agreement (the “Sublicense Agreement”) with
−Removed: Therapeutics, Inc.
−Removed: (“Zylö”) pursuant to which Zylö
−Removed: granted to the Company an exclusive sublicense
−Removed: to the Licensed Patent Rights (as defined in the Sublicense Agreement) and the Licensed Technology (as defined in the Sublicense
−Removed: Agreement) to, among other things, develop, make and sell the Licensed Products (as defined in the Sublicense Agreement) and to
−Removed: practice the Licensed Technology in the United States and Canada for any and all uses within the Field.
−Removed: “Field”
−Removed: all therapeutic uses related to lupus in human beings, subject to the Field Expansion Rights (as defined in the Sublicense Agreement).
−Removed: The term of the Sublicense Agreement shall commence on the Zylö
−Removed: Effective Date and shall continue until the latest of (i)
−Removed: ten years from the date of First Commercial Sale (as defined in the Sublicense Agreement) of the Licensed Product in such country
−Removed: and (ii) expiration of the last to expire Valid Claim (as defined in the Sublicense Agreement) of the Licensed Patent Rights that
−Removed: would be infringed by the composition, use or sale of such Licensed Product in such country.
−Removed: Pursuant to the terms of the Sublicense
−Removed: Agreement, the Company and Zylö
−Removed: shall establish a joint development committee to plan, review, coordinate and oversee the
−Removed: Company’s development activities with respect to the Licensed Products in the Field.
−Removed: Pursuant to the Sublicense Agreement,
−Removed: the Company paid Zylö
−Removed: an upfront license fee of $50,000 and is required to pay Zylö
−Removed: (i) sales-based royalties at percentages
−Removed: which range from high single digits to low double digits, with low sales volumes being subject to lower royalty rates;
−Removed: total milestone payments of up to $13.5 million.
−Removed: In addition, in connection with the Company’s March 2020 underwritten public
−Removed: offering of shares of its common stock, on May 4, 2020, the Company purchased 30,000 shares of Zylö’s Class B common
−Removed: stock for $60,000.
−Removed: Effective January 1, 2018, the Company adopted ASU 2016-01 concerning recognition and measurement of financial
−Removed: assets and financial liabilities.
−Removed: In adopting this new guidance, the Company has made an accounting policy election to adopt an
−Removed: adjusted cost method measurement alternative for its investment in Zylö.
−Removed: Note 4—Note Receivable
−Removed: Pursuant to Isoprene Sublicense Agreement
−Removed: dated July 30, 2020, the Company made an investment of $50,000 in Isoprene in the form of a convertible promissory note (the “Isoprene
−Removed: Note”) on September 10, 2020.
−Removed: The Isoprene Note matures on September 10, 2022 and accrues interest at a rate equal to the
+Added: The payment was made in January 2021.
+Added: Note 4—Note Receivable
+Added: Pursuant to Isoprene Sublicense Agreement dated
+Added: July 30, 2020, the Company made an investment of $ 50,000 in Isoprene in the form of a convertible promissory note (the “Isoprene
+Added: Note”) on September 10, 2020.
+Added: The Isoprene Note matures on September 10, 2022 and accrues interest at a rate equal to the lower
(i) the highest lawful rate permitted under applicable law and (ii) 6% per annum.
−Removed: The Isoprene Note may not be prepaid
−Removed: without the prior written consent of the Company.
−Removed: In the event a Qualified Financing (as defined below) occurs before the Isoprene
−Removed: Note is repaid in full or the conversion of such note pursuant to a Change of Control (as defined in the Isoprene Note) transaction,
−Removed: the Isoprene Note may be converted into such number of convertible preferred stock issued in the Qualified Financing equal to
−Removed: the balance of such note divided by the Capped Conversion Price (as defined below).
−Removed: “Qualified Financing”
−Removed: first sale of Isoprene’s convertible preferred in a private financing that results in gross proceeds of at least $5 million.
−Removed: “Capped Conversion Price”
−Removed: means the lesser of (i) the per share or unit price in the Qualified Financing and (ii)
−Removed: an amount determined by dividing (A) $15 million by (B) the fully diluted capitalization Isoprene immediately prior to the conversion
−Removed: of the Isoprene Note.
−Removed: In the event a Change of Control occurs before the Isoprene Note is repaid in full or the conversion of
−Removed: such note pursuant to a Qualified Financing, the Isoprene Note may be converted into such number of shares of Isoprene’s
−Removed: common stock equal to the quotient obtained by dividing (i) the balance of the Isoprene Note by (ii) two times the fair market
−Removed: value of a share of Isoprene common stock as set for in the acquisition agreement pertaining to such Change of Control.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: Note 5—Related Party
−Removed: A former director of the Company, is also
−Removed: the Executive Chairman of Chelexa.
−Removed: During the year ended December 31, 2020, that director received $22,500 in cash compensation
−Removed: for services provided as a member of the Company’s board of directors.
−Removed: On September 30, 2020, this director resigned as
−Removed: a member of the Company’s board of directors.
−Removed: Options issued to him expired on December 30, 2020.
−Removed: During the year ended
−Removed: December 31, 2019, that director received $30,000 in cash compensation for services provided as a board member and $5,000 cash
−Removed: compensation for his services as a member of the Company’s Scientific Advisory Board.
−Removed: The Company also granted him options
−Removed: to purchase up to 35,000 of the Company’s common stock pursuant to the Company’s 2018 Equity Incentive Plan.
−Removed: A former director of the Company, is also
−Removed: the Chief Executive Officer, Principal Accounting and Financial Officer and a member of the board of directors of AIkido Pharma
−Removed: During the year ended December 31, 2020, that director received $8,736 in cash compensation for services provided as a member
−Removed: of the Company’s board of directors.
−Removed: On April 15, 2020, this director resigned as a member of the Company’s board
−Removed: of directors.
−Removed: Options issued to him expired on July 15, 2020.
−Removed: During the year ended December 31, 2019, that director received
−Removed: $30,000 in cash compensation for services provided as a board member.
−Removed: The Company also granted such director options to purchase
−Removed: up to 35,000 shares of the Company’s common stock pursuant to the Company’s 2018 Equity Incentive Plan.
−Removed: Note 6—Investments in Marketable
−Removed: The realized gain or loss, unrealized
−Removed: gain or loss, and dividend income related to marketable securities for the years ended December 31, 2020 and 2019, which are recorded
−Removed: as a component of other income (expenses) on the consolidated statements of operations, are as follows:
−Removed: For the years ended December 31,
+Added: The Isoprene Note may not be prepaid without the
+Added: prior written consent of the Company.
+Added: In the event a Qualified Financing (as defined below) occurs before the Isoprene Note is repaid
+Added: in full or the conversion of such note pursuant to a Change of Control (as defined in the Isoprene Note) transaction, the Isoprene Note
+Added: may be converted into such number of convertible preferred stock issued in the Qualified Financing equal to the balance of such note
+Added: divided by the Capped Conversion Price (as defined below).
+Added: “Qualified Financing” means the first sale of Isoprene’s
+Added: convertible preferred in a private financing that results in gross proceeds of at least $5 million.
+Added: “Capped Conversion Price”
+Added: 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
+Added: by (B) the fully diluted capitalization Isoprene immediately prior to the conversion of the Isoprene Note.
+Added: In the event a Change of Control
+Added: occurs before the Isoprene Note is repaid in full or the conversion of such note pursuant to a Qualified Financing, the Isoprene Note
+Added: may be converted into such number of shares of Isoprene’s common stock equal to the quotient obtained by dividing (i) the balance
+Added: 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
+Added: pertaining to such Change of Control.
+Added: Note 5—Investments in Marketable Securities
+Added: The realized gain or loss, unrealized gain or
+Added: loss, and dividend income related to marketable securities for the years ended December 31, 2021 and 2020, which are recorded as a component
+Added: of other income (expenses) on the consolidated statements of operations, are as follows:
+Added: For the years ended
Unrealized gain
+Added: $ ( 176,974 )
Realized loss
1 unchanged sentence
Interest income
−Removed: Note 7—Investment in HaloVax
−Removed: On March 23, 2020, the Company entered
−Removed: into a Development and Royalty Agreement (the “Development and Royalty Agreement”) with Voltron Therapeutics, Inc.
−Removed: (“Voltron”) to form a joint venture entity named HaloVax, LLC (“HaloVax”) to jointly develop potential
−Removed: product candidates for the prevention of COVID-19 based upon certain technology that had been exclusively licensed by Voltron
−Removed: from The General Hospital Corporation (d/b/a Massachusetts General Hospital).
−Removed: Pursuant to the Development and Royalty Agreement,
−Removed: the Company is entitled to receive sales-based royalties.
−Removed: In addition, pursuant to the terms of the Development and Royalty Agreement,
−Removed: on March 23, 2020, the Company and HaloVax entered into a Membership Interest Purchase Agreement pursuant to which the Company
−Removed: purchased 5% of HaloVax’s outstanding membership interests for $250,000 on March 27, 2020 (the “Initial Closing Date”)
−Removed: and had the option to purchase up to an additional 25% of HaloVax’s membership interests (for $3,000,000 (inclusive of the
−Removed: $250,000)), which option expired 30 days after the Initial Closing Date.
−Removed: On May 28, 2020, the Company entered into a membership
−Removed: interest purchase agreement to purchase 1% of HaloVax’s outstanding membership interest for a purchase price of $100,000.
−Removed: The Company accounts for the foregoing investments under the equity method.
−Removed: There was no significant change in HaloVax’s
−Removed: operations from March 23, 2020 to December 31, 2020.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: Note 8—Stockholders’
+Added: $ ( 152,683 )
+Added: Note 6—Fair Value of Financial Assets
+Added: and Liabilities
+Added: The following table presents the Company’s
+Added: assets and liabilities that are measured at fair value at December 31, 2021 and 2020:
+Added: Fair value measured at December
+Added: Quoted prices
+Added: Significant other
+Added: observable inputs
+Added: Marketable securities - mutual funds
+Added: Investment in joint venture
+Added: Note receivable - current
+Added: Fair value measured at December
+Added: Quoted prices
+Added: Significant other
+Added: observable inputs
+Added: Marketable securities - mutual funds
+Added: Investment in joint venture
+Added: Note receivable
+Added: Investment in joint venture
+Added: The Company has elected to measure the investment
+Added: in joint venture using the fair value option at each reporting date.
+Added: Under the fair value option, bifurcation of an embedded derivative
+Added: 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
+Added: in interest income and other, net in the consolidated statements of operations.
+Added: The value at which the Company’s investment
+Added: in joint venture is carried on its books is adjusted to estimated fair value at the end of each quarter, taking into account general
+Added: economic and stock market conditions and those characteristics specific to the underlying investments.
+Added: Investment in HaloVax
+Added: On March 23, 2020, the Company entered into a
+Added: Development and Royalty Agreement (the “Development and Royalty Agreement”) with Voltron Therapeutics, Inc.
+Added: to form a joint venture entity named HaloVax, LLC (“HaloVax”) to jointly develop potential product candidates for the prevention
+Added: of COVID-19 based upon certain technology that had been exclusively licensed by Voltron from The General Hospital Corporation (d/b/a
+Added: Massachusetts General Hospital).
+Added: Pursuant to the Development and Royalty Agreement, the Company is entitled to receive sales-based royalties.
+Added: In addition, pursuant to the terms of the Development and Royalty Agreement, on March 23, 2020, the Company and HaloVax entered into
+Added: a Membership Interest Purchase Agreement pursuant to which the Company purchased 5% of HaloVax’s outstanding membership interests
+Added: 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
+Added: membership interests (for $3,000,000 (inclusive of the $250,000)), which option expired 30 days after the Initial Closing Date.
+Added: 28, 2020, the Company entered into a membership interest purchase agreement to purchase 1% of HaloVax’s outstanding membership
+Added: interest for a purchase price of $100,000.
+Added: No change in fair value occurred during the year ended December 31, 2021 and 2020.
+Added: Investment in Zylö
+Added: In connection with the Company’s March
+Added: 2020 underwritten public offering of shares of its common stock, on May 4, 2020, the Company purchased 120,000 shares of Zylö’s
+Added: Class B common stock for $ 60,000 .
+Added: No change in fair value occurred during the year ended December 31, 2021 and 2020.
+Added: On December 8, 2021,
+Added: the Company entered into a third amendment (the “Zylö Amendment”) to the Exclusive Sublicense Agreement with Zylö
+Added: originally dated August 19, 2019 pursuant to which the Company licensed its novel cannabinoid therapeutic, HT-005 for lupus patients,
+Added: back to Zylö.
+Added: Pursuant to the Zylö Amendment, on December 6, 2021 Zylö issued the Company 100,000 shares of its Class
+Added: B common stock.
+Added: In addition, pursuant to the Zylö Amendment, within 90 days following a sale by Zylö of all of its assets and
+Added: rights related to HT-005 to a third party (a “Sale”), Zylö shall pay the Company a low single digit percent of the net
+Added: proceeds received by it attributable to HT-005 in the United States and Canada and their respective territories (collectively, the “Territory”)
+Added: for the purposes of therapeutic uses related to lupus in humans (the “Field”).
+Added: After the Sale, any and all rights of the
+Added: Company pursuant to the Exclusive Sublicense Agreement, including all amendments thereto, shall terminate.
+Added: Furthermore, pursuant to the
+Added: Zylö Amendment, following the date of the first commercial sale of HT-005 in the Territory, in the Field, Zylö shall pay the
+Added: 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
+Added: is sold in the Territory and (ii) a low double digit percent of any royalty that Zylö receives through the sublicense to a third
+Added: party based on Net Sales of HT-005 in the Territory which payments shall continue in each country in the Territory until expiration of
+Added: the last-to-expire Valid Claim (as defined in the Exclusive Sublicense Agreement).
+Added: Note receivable
+Added: As of December 31, 2021, the fair value of the
+Added: Isoprene Note was measured at $ 50,000 , taking into consideration cost of the investment, market participant inputs, market conditions,
+Added: liquidity, operating results and other qualitative and quantitative factors.
+Added: No change in fair value was recorded during the year ended
+Added: December 31, 2021.
+Added: Note 7—Stockholders’ Equity
Preferred Stock
−Removed: The Company is authorized to issue up
−Removed: to 10,000,000 shares of preferred stock.
−Removed: This preferred stock may be issued in one or more series, and shall have such designations,
−Removed: preferences and relative, participating, optional or other special rights and qualifications, limitations or restrictions thereof
−Removed: as shall be determined at the time of issuance by the Company’s board of directors without further action by the Company’s
−Removed: shareholders.
−Removed: As of December 31, 2020, 5,000,000 shares of the Company’s preferred stock has been designated as Series A
−Removed: Convertible Preferred Stock of which 3,102,480 shares which were previously issued were converted into common stock at the time
−Removed: of the Company’s IPO.
+Added: The Company is authorized to issue up to 10,000,000
+Added: shares of preferred stock.
+Added: This preferred stock may be issued in one or more series, and shall have such designations, preferences and
+Added: relative, participating, optional or other special rights and qualifications, limitations or restrictions thereof as shall be determined
+Added: at the time of issuance by the Company’s board of directors without further action by the Company’s shareholders.
+Added: As of December
+Added: 31, 2021, 5,000,000 shares of the Company’s preferred stock has been designated as Series A Convertible Preferred Stock.
The shares of Series A Convertible Preferred
Stock are not mandatorily redeemable and do not embody an unconditional obligation to settle in a variable number of equity shares.
−Removed: As such, the shares of Series A Convertible Preferred Stock are classified as permanent equity on the balance sheets.
−Removed: The holders’
+Added: such, the shares of Series A Convertible Preferred Stock are classified as permanent equity on the balance sheets.
contingent redemption right in the event of certain deemed liquidation events does not preclude permanent equity classification.
−Removed: Further, the shares of Series A Convertible Preferred Stock are considered an equity-like host for purposes of assessing embedded
−Removed: derivative features for potential bifurcation.
−Removed: The embedded conversion feature is considered to be clearly and closely related
−Removed: to the associated convertible preferred stock host instrument and therefore was not bifurcated from the equity host.
+Added: the shares of Series A Convertible Preferred Stock are considered an equity-like host for purposes of assessing embedded derivative features
+Added: for potential bifurcation.
+Added: The embedded conversion feature is considered to be clearly and closely related to the associated convertible
+Added: preferred stock host instrument and therefore was not bifurcated from the equity host.
Common Shares
−Removed: On February 15, 2019, the Company announced
−Removed: the pricing of its IPO of 1,250,000 shares of its common stock at an initial offering price to the public of $5.60 per share.
−Removed: The Company issued an aggregate of 1,250,000 shares of common stock and received net proceeds of $5.8 million from the IPO.
−Removed: On January 15, 2020, pursuant to the termination
−Removed: and general release agreement between the Company and FON Consulting LLC dated January 7, 2020, 15,000 of the shares of common
−Removed: stock originally issued to FON Consulting LLC were cancelled.
On February 5, 2020, the Company issued 12,500
−Removed: 12,500 shares of common stock upon exercise of warrants issued to an investor on January 19, 2018, which resulted in gross proceeds
−Removed: On March 6, 2020, the Company issued 25,000
−Removed: shares of common stock upon exercise of warrants issued to an investor on December 14, 2017, which resulted in gross proceeds
−Removed: On May 18, 2020, the Company issued 6,250
−Removed: shares of common stock upon exercise of warrants issued to an investor on February 2, 2018, which resulted in gross proceeds of
−Removed: On June 3, 2020, the Company issued 12,500
−Removed: shares of common stock upon exercise of warrants issued to an investor on November 20, 2017, which resulted in gross proceeds
−Removed: During the year ended December 31, 2020,
−Removed: the Company issued an aggregate of 9,984 shares of the Company’s common stock to members of the Company’s Board for
−Removed: services rendered.
+Added: shares of common stock upon exercise of warrants issued to an investor on January 19, 2018, which resulted in gross proceeds of $ 12,500 .
+Added: On March 6, 2020, the Company issued 25,000 shares
+Added: of common stock upon exercise of warrants issued to an investor on December 14, 2017, which resulted in gross proceeds of $ 25,000 .
+Added: On May 18, 2020, the Company issued 6,250 shares
+Added: of common stock upon exercise of warrants issued to an investor on February 2, 2018, which resulted in gross proceeds of $ 6,250 .
+Added: On June 3, 2020, the Company issued 12,500 shares
+Added: of common stock upon exercise of warrants issued to an investor on November 20, 2017, which resulted in gross proceeds of $ 12,500 .
+Added: During the year ended December 31, 2020, the
+Added: Company issued an aggregate of 9,984 shares of the Company’s common stock to members of the Company’s Board for services
Public Offering of Securities
−Removed: On March 24, 2020 (the “UA Effective
−Removed: Date”), the Company entered into an underwriting agreement with Laidlaw & Company (UK) Ltd.
−Removed: (“Laidlaw”),
−Removed: the representative of the underwriters, relating to a best efforts underwritten public offering of 1,449,275 shares (the “Shares”)
−Removed: of the Company’s common stock at a public offering price of $3.45 per Share.
−Removed: The Company received net proceeds of approximately
−Removed: $4.2 million, after deducting the underwriting discount and offering expenses.
+Added: On March 24, 2020 (the “UA Effective Date”),
+Added: the Company entered into an underwriting agreement with Laidlaw & Company (UK) Ltd.
+Added: (“Laidlaw”), the representative
+Added: of the underwriters, relating to a best efforts underwritten public offering of 1,449,275 shares (the “Shares”) of the Company’s
+Added: common stock at a public offering price of $ 3.45 per Share.
+Added: The Company received net proceeds of approximately $ 4.2 million, after deducting
+Added: the underwriting discount and offering expenses.
In connection with the offering, on March 26,
−Removed: 26, 2020, the Company issued Laidlaw warrants to purchase up to 72,464 shares of the Company’s common stock.
−Removed: are exercisable for a period of five years from the UA Effective Date at a price per share equal to $4.14, subject to adjustment,
−Removed: and may be exercised on a cashless basis.
−Removed: The Company reimbursed Laidlaw for certain of its out-of-pocket expenses incurred in
−Removed: connection with the offering.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: On May 21, 2020, the Company entered into
−Removed: an underwriting agreement with The Benchmark Company, LLC (“Benchmark”), as representative of the several underwriters,
−Removed: relating to the public offering of 1,818,182 shares of the Company’s common stock at a price to the public of $2.75 per
−Removed: The Company received net proceeds of approximately $4.5 million, after deducting the underwriting discount and offering
+Added: 2020, the Company issued Laidlaw warrants to purchase up to 72,464 shares of the Company’s common stock.
+Added: The warrants are exercisable
+Added: for a period of five years from the UA Effective Date at a price per share equal to $4.14, subject to adjustment, and may be exercised
+Added: on a cashless basis.
+Added: The Company reimbursed Laidlaw for certain of its out-of-pocket expenses incurred in connection with the offering.
+Added: On May 21, 2020, the Company entered into an
+Added: underwriting agreement with The Benchmark Company, LLC (“Benchmark”), as representative of the several underwriters, relating
+Added: to the public offering of 1,818,182 shares of the Company’s common stock at a price to the public of $ 2.75 per share.
+Added: received net proceeds of approximately $ 4.5 million, after deducting the underwriting discount and offering expenses.
In connection with the offering, on May 27, 2020
−Removed: 27, 2020 (the “Benchmark Issue Date”), the Company issued Benchmark warrants to purchase up to 90,909 shares of the
−Removed: Company’s common stock.
−Removed: The warrants are exercisable for a period of five years commencing six months from the Benchmark
−Removed: Issue Date at a price per share equal to $2.75, subject to adjustment, and may be exercised on a cashless basis.
−Removed: Private Placement of Securities
−Removed: On August 16, 2019 (the “Closing
−Removed: Date”), the Company entered into subscription agreements (the “Subscription Agreements”) and unit purchase agreements
−Removed: (the “Purchase Agreements”) with certain accredited investors (the “Investors”) pursuant to which it sold
−Removed: units (the “Units”) for aggregate gross proceeds of $2,037,120, exclusive of placement agent commission
−Removed: and fees and offering and transaction expenses (the “Offering”).
−Removed: Each Unit was sold at an offering price of $5.00
−Removed: per Unit and consisted of (i) one share of the Company’s common stock and (ii) a warrant (the “2019 Warrant”)
−Removed: to purchase one-half share of common stock.
−Removed: Each Warrant is exercisable for a period
−Removed: of two years beginning six months from the Closing Date at an exercise price of $8.00 per whole share, subject to adjustment.
−Removed: The Company is prohibited from effecting an exercise of the Warrant to the extent that, as a result of such exercise, the holder
−Removed: together with the holder’s affiliates, would beneficially own more than 4.99% of the number of shares of common stock outstanding
−Removed: immediately after giving effect to the issuance of shares of common stock upon exercise of the Warrant, which beneficial ownership
−Removed: limitation may be increased by the holder up to, but not exceeding, 9.99%.
−Removed: In addition, pursuant to the terms of
−Removed: the Offering, the Company issued Laidlaw warrants (the “Placement Agent Warrants”) to purchase up to 61,113 shares
−Removed: of the Company’s common stock.
−Removed: The Placement Agent Warrants are exercisable for a period of five years from the Closing
−Removed: Date (the “Initial Exercise Date”) at an exercise price of $5.00 per share, subject to adjustment.
−Removed: The Warrants may
−Removed: be exercised at any time after the Initial Exercise Date on a cashless basis and contain piggy-back registration rights.
−Removed: Pursuant to the Offering, the Company
−Removed: received $1.6 million in net proceeds from the issuance of 407,424 Units.
−Removed: The Company has determined that the 2019
−Removed: Warrants should be accounted as a component of stockholders’
−Removed: For the 2019 Warrants issued on August 16, 2019, the
−Removed: Company estimated the relative fair value of the warrants at $0.8 million using the Black-Scholes option pricing model using the
−Removed: following primary assumptions:
−Removed: fair value of common stock underlying the warrants ranges from $2.55 to $4.33, expected life ranges
−Removed: from 2.0 to 5.0 years, volatility rate ranges from 107.30% to 110.08%, risk-free interest rate ranges from 1.42% to 1.48% and
−Removed: expected dividend rate of 0%.
+Added: (the “Benchmark Issue Date”), the Company issued Benchmark warrants to purchase up to 90,909 shares of the Company’s
+Added: common stock.
+Added: The warrants are exercisable for a period of five years commencing six months from the Benchmark Issue Date at a price
+Added: per share equal to $ 2.75 , subject to adjustment, and may be exercised on a cashless basis.
+Added: Securities Purchase Agreements
+Added: On January 5, 2021, the Company entered into
+Added: a securities purchase agreement with certain accredited investors pursuant to which the Company offered and sold to the investors an
+Added: aggregate of 2,475,248 shares of its common stock and warrants to purchase up to 1,237,624 shares of common stock in a private placement
+Added: for aggregate net proceeds to the Company of $ 4.6 million, after deducting estimated offering expenses payable by the Company.
+Added: purchase price for each share of common stock and accompanying warrant to purchase one half of a share of common stock was $ 2.02 .
+Added: closing of the offering occurred on January 7, 2021.
+Added: Each warrant is exercisable for a period of five years from the issuance date at
+Added: an exercise price of $ 2.25 per share, subject to adjustment, and may be exercised on a cashless basis.
+Added: In addition, pursuant to the terms
+Added: of the offering, the Company issued The Benchmark Company, LLC (“Benchmark”) warrants to purchase up to 185,644 shares of
+Added: the Company’s common stock.
+Added: Benchmark’s warrants are exercisable for a period of five years from the closing date of the
+Added: offering at an exercise price of $ 2.25 per share, subject to adjustment, and may be exercised on a cashless basis.
+Added: On March 8, 2021, the Company entered into a
+Added: securities purchase agreement with certain institutional and accredited investors pursuant to which it offered and sold to the investors
+Added: 6,826,962 shares of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 767,975 shares of common
+Added: stock and warrants (the “Common Stock Warrants”) to purchase up to 7,594,937 shares of common stock in a private placement
+Added: for aggregate net proceeds to the Company of $ 13.5 million, after deducting estimated offering expenses payable by the Company.
+Added: purchase price for each share of common stock and accompanying warrant was $ 1.975 .
+Added: The closing of the offering occurred on March 10,
+Added: Each Common Stock Warrant is exercisable for a period of three years from the issuance date at an exercise price of $ 1.86 per share,
+Added: subject to adjustment, and may be exercised on a cashless basis.
+Added: Each Pre-Funded Warrant is exercisable until exercised in full at an
+Added: exercise price of $ 0.001 per share and may be exercised by means of a cashless exercise.
+Added: In addition, pursuant to the terms of the offering,
+Added: the Company issued H.C.
+Added: Wainwright & Co., LLC warrants (“Wainwright Warrants”) to purchase up to 379,747 shares of the
+Added: Company’s common stock.
+Added: The Wainwright Warrants are exercisable for a period of three years from the issuance date at an exercise
+Added: price of $ 2.4688 per share, subject to adjustment, and may be exercised by on a cashless basis.
2018 Equity Incentive Plan
−Removed: The Company’s 2018 Equity Incentive
−Removed: Plan (the “2018 Plan”) was adopted by the Company’s board of directors on May 4, 2018 and by its shareholders
−Removed: on May 4, 2018.
−Removed: The Company has reserved 1,000,000 shares of common stock for issuance pursuant to the 2018 Plan.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
+Added: The compensation committee of the board of directors
+Added: increased the number of shares reserved pursuant to the Company’s 2018 Equity Incentive Plan (“2018 Plan”) by 671,926
+Added: 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
+Added: reserved for issuance pursuant to the 2018 Plan.
+Added: On June 24, 2021, at the annual shareholder meeting, shareholders of the Company approved
+Added: 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
Restricted Stock Awards
−Removed: A summary of the Company’s restricted
−Removed: stock awards granted under the 2018 Plan during the years ended December 31, 2020 and 2019 is as follows:
−Removed: Number of Restricted Stock
−Removed: Weighted Average Grant Day
+Added: A summary of the Company’s restricted stock
+Added: awards granted under the 2018 Plan during the years ended December 31, 2021 and 2020 is as follows:
+Added: Number of Restricted Stock Awards
+Added: Weighted Average Grant Day Fair Value
Nonvested at December 31, 2019
1 unchanged sentence
Nonvested at December 31, 2021
−Removed: As of December 31, 2020, approximately
+Added: As of December 31, 2021, there is approximately
$ 2,000 of unrecognized stock-based compensation expense related to restricted stock awards.
2 unchanged sentences
Stock Options
−Removed: The fair value of options granted in 2020
−Removed: and 2019 was estimated using the following assumptions:
−Removed: the years ended December 31,
+Added: During the year ended December 31, 2021, pursuant
+Added: to and subject to the available number of shares reserved under the 2018 Plan, the Company issued an aggregate of 632,000 options to
+Added: the Company’s directors.
+Added: The aggregate grant date fair value of these options was approximately $ 1.1 million.
+Added: During the year ended December 31, 2020, pursuant
+Added: to and subject to the available number of shares reserved under the 2018 Plan, the Company issued an aggregate of 200,000 options to
+Added: the Company’s directors.
+Added: The aggregate grant date fair value of these options was approximately $ 0.5 million.
+Added: The Company also
+Added: issued 49,212 options to purchase common stock of the Company to a third party for consulting services.
+Added: The aggregate grant date fair
+Added: value of these options was approximately $ 0.1 million.
+Added: The fair value of options granted in 2021 and
+Added: 2020 was estimated using the following assumptions:
+Added: For the years ended
Exercise price
−Removed: Expected stock price volatility
$ 2.54 - 3.05
+Added: Expected stock price volatility
114.2 % - 114.5 %
Risk-free rate of interest
−Removed: A summary of option activity under the
−Removed: Company’s stock option plan for years ended December 31, 2020 and 2019 is presented below:
+Added: A summary of option activity under the Company’s
+Added: stock option plan for the years ended December 31, 2021 and 2020 is presented below:
Number of Shares
−Removed: Weighted Average Exercise
+Added: Weighted Average Exercise Price
Total Intrinsic Value
−Removed: Weighted Average Remaining
−Removed: Contractual Life (in years)
+Added: Weighted Average Remaining Contractual
+Added: Life (in years)
Outstanding as of December 31, 2019
2 unchanged sentences
Outstanding as of December 31, 2020
−Removed: Options vested and exercisable
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
+Added: Employee options issued
+Added: Outstanding as of December 31, 2021
+Added: Options vested and exercisable as of December 31, 2021
+Added: Stock-based compensation associated with the
+Added: amortization of stock option expense was approximately $ 1.1 million and $ 0.6 for the year ended December 31, 2021 and 2020,
+Added: respectively.
+Added: All stock compensation associated with the amortization of employee stock option expense was recorded as a component of
+Added: compensation and related expense in the statement of operations.
+Added: All stock compensation associated with the amortization of nonemployee
+Added: stock option expense was recorded as a component of professional fees in the statement of operations.
+Added: Estimated future stock-based compensation expense
+Added: relating to unvested stock options is approximately $ 0 .
Stock Based Compensation
−Removed: Stock-based compensation expense for the
−Removed: years ended December 31, 2020 and 2019 was approximately $0.7 million and $2.5 million, respectively, and comprised of the following:
−Removed: For the years ended December 31,
+Added: Stock-based compensation expense for the years
+Added: ended December 31, 2021 and 2020 was as follows:
+Added: For the years ended
Employee stock option awards
3 unchanged sentences
Non-employee stock warrant awards
−Removed: Employee and director related stock-based
−Removed: compensation was included in compensation and related expenses, and non-employee related stock-based compensation was included
−Removed: in professional fees on the consolidated statements of operations.
−Removed: Pursuant to the Patent License Agreement
−Removed: between the Company and GW dated February 1, 2020, on February 27, 2020 (the “February Warrant Date of Issuance”),
−Removed: the Company issued GW ten year warrants (the “February Warrants”) to purchase up to 22,988 shares of the Company’s
−Removed: common stock at an exercise price of $4.35 per share.
+Added: Employee and director related stock-based compensation
+Added: was included in compensation and related expenses, and non-employee related stock-based compensation was included in professional fees
+Added: and research and development related with licenses acquisition in the consolidated statements of operations and comprehensive loss.
+Added: Pursuant to the Patent License Agreement between
+Added: the Company and GW dated February 1, 2020, on February 27, 2020 (the “February Warrant Date of Issuance”), the Company issued
+Added: GW ten year warrants (the “February Warrants”) to purchase up to 22,988 shares of the Company’s common stock at an
+Added: exercise price of $ 4.35 per share.
The February Warrants vest as follows:
−Removed: 20% on the February Warrant Date
−Removed: of Issuance and the balance, or 80% of the February Warrants, vest in four equal annual installments of 20% on each anniversary
−Removed: of the February Warrant Date of Issuance.
+Added: 20% on the February Warrant Date of Issuance and the balance,
+Added: or 80% of the February Warrants, vest in four equal annual installments of 20% on each anniversary of the February Warrant Date of Issuance.
Pursuant to the GW Patent License Agreement,
−Removed: between the Company and GW dated August 7, 2020, on August 10, 2020 (the “August Warrant Date of Issuance”), the Company
−Removed: issued GW ten year warrants (the “August Warrants”) to purchase up to 72,463 shares of the Company’s common
−Removed: stock at an exercise price of $2.76 per share.
−Removed: The August Warrants vest as follows:
−Removed: 20% on the August Warrant Date of Issuance
−Removed: and the balance, or 80% of the August Warrants, shall vest in four equal annual installments of 20% on each anniversary of the
−Removed: August Warrant Date of Issuance.
−Removed: In connection with the public offering
−Removed: of securities discussed above, the Company granted to Laidlaw and Benchmark warrants to purchase up to 72,464 and 90,909 shares
−Removed: of the Company’s common stock, respectively.
−Removed: A summary of warrant activity for the
−Removed: years ended December 31, 2020 and 2019 is presented below:
+Added: on August 10, 2020 (the “August Warrant Date of Issuance”), the Company issued GW ten year warrants (the “August Warrants”)
+Added: to purchase up to 72,463 shares of the Company’s common stock at an exercise price of $ 2.76 per share.
+Added: The August Warrants vest
+Added: 20% on the August Warrant Date of Issuance and the balance, or 80% of the August Warrants, shall vest in four equal annual
+Added: installments of 20% on each anniversary of the August Warrant Date of Issuance.
+Added: In connection with the public offering of securities
+Added: discussed above, the Company granted to Laidlaw and Benchmark warrants to purchase up to 72,464 and 90,909 shares of the Company’s
+Added: common stock, respectively.
+Added: A summary of warrant activity for the years ended
+Added: December 31, 2021 and 2020 is presented below:
Number of Warrants
Weighted Average
+Added: Exercise Price
Total Intrinsic Value
−Removed: Weighted Average Remaining
−Removed: Contractual Life (in years)
+Added: Weighted Average
+Added: Remaining Contractual
+Added: Life (in years)
Outstanding as of December 31, 2019
Outstanding as of December 31, 2020
+Added: ( 1,126,720 )
Outstanding as of December 31, 2021
Warrants exercisable as of December 31, 2021
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: Note 9—Commitments and contingencies
+Added: The Company has determined that the warrants
+Added: should be accounted as a component of stockholders’ equity.
+Added: Note 8—Commitments and contingencies
The Company leases office space for approximately
1 unchanged sentence
Rent expense for the years ended December 31, 2021 and 2020 was approximately $ 47,000 and $ 25,000 , respectively.
−Removed: The Company is not a party to a lease that is in excess of 12 months.
−Removed: The Company is not a party to any material
−Removed: legal proceedings and is not aware of any pending or threatened claims.
−Removed: From time to time, the Company may be subject to various
−Removed: legal proceedings and claims that arise in the ordinary course of its business activities.
−Removed: Note 10—Income taxes
−Removed: The table below presents the components
−Removed: of the provision for taxes:
−Removed: As of December 31,
+Added: Company is not a party to a lease that is in excess of 12 months.
+Added: The Company is not a party to any material legal
+Added: proceedings and is not aware of any pending or threatened claims.
+Added: From time to time, the Company may be subject to various legal proceedings
+Added: and claims that arise in the ordinary course of its business activities.
+Added: Note 9—Income taxes
+Added: The table below presents the components of the
+Added: provision for taxes:
+Added: The Company’s provision is driven by refundable tax credits generated
+Added: by its subsidiary in Australia.
Total current provision
2 unchanged sentences
Total provision for income taxes
−Removed: At December 31, 2020 and 2019, the tax
−Removed: effects of the temporary differences and carryforwards that give rise to deferred tax assets consist of the following:
+Added: At December 31, 2021 and 2020, the tax effects
+Added: of the temporary differences and carryforwards that give rise to deferred tax assets consist of the following:
As of December 31,
−Removed: Deferred tax assets:
−Removed: Net operating loss carryforward
−Removed: License acquired
−Removed: Stock Compensation
−Removed: Total deferred income tax assets
−Removed: Deferred income tax assets liabilities:
−Removed: Depreciation fixed assets
−Removed: Total deferred income tax liabilities
−Removed: Net deferred income tax assets
−Removed: Valuation allowance
−Removed: Deferred tax asset, net of allowance
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
−Removed: A reconciliation of the statutory income
−Removed: tax rates and the Company’s effective tax rate for the year ended December 31, 2020 and 2019 is as follows:
+Added: Net operating loss carryforwards
+Added: Research and development credits
+Added: Equity based compensation
+Added: Licenses acquired
+Added: Accruals and other temporary differences
+Added: Gross deferred tax assets
+Added: Accruals and other temporary differences
+Added: Less valuation allowance
+Added: ( 8,284,693 )
+Added: ( 4,025,205 )
+Added: Net deferred taxes
+Added: A reconciliation of the statutory income tax
+Added: rates and the Company’s effective tax rate for the year ended December 31, 2021 and 2020 is as follows:
Years Ended December 31,
−Removed: Statutory federal income tax rate
−Removed: State taxes, net of federal tax benefit
−Removed: Return to Provison
−Removed: Change in valuation allowance
−Removed: Income taxes provision (benefit)
−Removed: The Company has determined, based upon
−Removed: available evidence, that it is more likely than not that the net deferred tax assets will not be realized and, accordingly, has
−Removed: provided a full valuation allowance against its net deferred tax assets.
−Removed: As of December 31, 2020, the Company has
−Removed: net operating loss carryforwards of approximately $15.9 million available to reduce future taxable income, if any, for Federal
−Removed: and state income tax purposes.
−Removed: Approximately $1.5 million of Federal net operating losses can be carried forward to future tax
−Removed: years and expire in 2037.
−Removed: The Federal net operating loss generated during the years ended December 31, 2018 and 2019 of approximately
−Removed: $14.4 million can be carried forward indefinitely.
−Removed: However, the deduction for net operating losses incurred in tax years beginning
−Removed: after January 1, 2018 is limited to 80% of annual taxable income.
−Removed: At December 31, 2020 and 2019, the Company
−Removed: did not have any significant uncertain tax positions.
−Removed: The Company will recognize interest and penalties related to uncertain tax
−Removed: positions in income tax expense.
−Removed: As of December 31, 2020 and 2019, the Company had no accrued interest or penalties related to
−Removed: uncertain tax positions and no amounts have been recognized in the Company’s statement of operations.
−Removed: The Company does not
−Removed: anticipate a material change to unrecognized tax benefits in the next twelve months.
−Removed: All of the Company’s tax years will
−Removed: remain open for examination by the Federal and state tax authorities from the date of utilization of the net operating loss.
−Removed: Note 10—Risk and Uncertainties
−Removed: The outbreak of the novel Coronavirus
−Removed: (COVID-19) evolved into a global pandemic.
+Added: Tax provision at statutory rate
+Added: State taxes, net of federal benefit
+Added: Permanent items
+Added: Equity compensation
+Added: Foreign rate differential
+Added: Increase/(decrease) in valuation reserve
+Added: The Company has determined, based upon available
+Added: evidence, that it is more likely than not that the net deferred tax assets will not be realized and, accordingly, has provided a full
+Added: valuation allowance against its net deferred tax assets.
+Added: As of December 31, 2021, the Company has net operating loss carryforwards
+Added: of approximately $ 26.7 million and 22.4 million available to reduce future taxable income, if any, for Federal and state income tax purposes,
+Added: respectively.
+Added: Approximately $ 1.5 million of Federal net operating losses can be carried forward to future tax years and expire in 2037.
+Added: The Federal net operating loss generated during the years ended after December 31, 2017 of approximately $ 25.2 million can be carried
+Added: forward indefinitely;
+Added: however, the deduction for net operating losses incurred in tax years beginning after December 31, 2017 is limited
+Added: to 80 % of annual taxable income.
+Added: As of December 31, 2021, the Company has research
+Added: and development credits of approximately $ 0.4 million and $ 0 available to reduce future income taxes, if any, for Federal and state income
+Added: tax purposes, respectively.
+Added: The Federal credits expire if not utilized by 2041.
+Added: The utilization of the Company’s net operating
+Added: loss carryforwards and research tax credit carryovers could be subject to annual limitations under Section 382 and 383 of the Internal
+Added: Revenue Code of 1986, as amended (the “Code”), and similar state tax provisions, due to ownership change limitations that
+Added: may have occurred previously or that could occur in the future.
+Added: These ownership changes limit the amount of net operating loss carryforwards
+Added: and other deferred tax assets that can be utilized to offset future taxable income and tax, respectively.
+Added: In general, an ownership change,
+Added: as defined by Section 382 and 383 of the Code, results from transactions increasing ownership of certain stockholders or public groups
+Added: in the stock of the corporation by more than 50 percent points over a three-year period.
+Added: The Company has not conducted an analysis of
+Added: an ownership change under Section 382 of the Code.
+Added: To the extent that a study is completed and an ownership change is deemed to occur,
+Added: the Company’s net operating losses and tax credits could be limited.
+Added: The following table summarizes the activity related
+Added: to the Company’s gross unrecognized tax benefits at the beginning and end of the years ended December 31, 2021 and December 31,
+Added: 2020, respectively (in thousands):
+Added: As of December 31,
+Added: Gross unrecognized tax benefits at the beginning of the year
+Added: Increases related to current year positions
+Added: Increases related to prior year positions
+Added: Decreases related to prior year positions
+Added: Expiration of unrecognized tax benefits
+Added: Gross unrecognized tax benefits at the end of the year
+Added: At December 31, 2021 and 2020, the Company did
+Added: not have any significant uncertain tax positions.
+Added: The Company will recognize interest and penalties related to uncertain tax positions
+Added: in income tax expense.
+Added: As of December 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions
+Added: and no amounts have been recognized in the Company’s statement of operations.
+Added: The Company does not anticipate a material change
+Added: to unrecognized tax benefits in the next twelve months.
+Added: All of the Company’s tax years will remain
+Added: open for examination by the Federal and state tax authorities from the date of utilization of the net operating loss.
+Added: Note 10—Risk and Uncertainties
+Added: The outbreak of the novel Coronavirus (COVID-19)
+Added: evolved into a global pandemic.
The Coronavirus has spread to many regions of the world.
−Removed: The extent to which the Coronavirus
−Removed: impacts the Company’s business and operating results will depend on future developments that are highly uncertain and cannot
−Removed: be accurately predicted, including new information that may emerge concerning the Coronavirus and the actions to contain the Coronavirus
+Added: The extent to which the Coronavirus impacts
+Added: the Company’s business and operating results will depend on future developments that are highly uncertain and cannot be accurately
+Added: predicted, including new information that may emerge concerning the Coronavirus, including variants, and the actions to contain the Coronavirus
or treat its impact, among others.
−Removed: As a result of the continuing spread of
−Removed: the Coronavirus, certain aspects of the Company’s business operations have been delayed, and the Company may be subject
−Removed: to additional delays or interruptions.
−Removed: Specifically, as a result of the shelter-in-place orders and other mandated local travel
−Removed: restrictions, among other things, the research and development activities of certain of the Company’s partners may be affected,
−Removed: which may result in delays to the Company’s clinical trials, and the Company can provide no assurance as to when such trials,
−Removed: if delayed, will resume at this time or the revised timeline to complete trials once resumed.
−Removed: Furthermore, site initiation, participant
−Removed: recruitment and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may
−Removed: be paused or delayed due to changes in hospital or university policies, federal, state or local regulations, prioritization of
−Removed: hospital resources toward pandemic efforts, or other reasons related to the pandemic.
−Removed: If the Coronavirus continues to spread,
−Removed: some participants and clinical investigators may not be able to comply with clinical trial protocols.
−Removed: For example, quarantines
−Removed: or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study sites,
−Removed: or interrupt healthcare services, and the Company may be unable to conduct its clinical trials.
−Removed: Further, if the spread of the
−Removed: Coronavirus pandemic continues and the Company’s operations are adversely impacted, the Company risks a delay, default and/or
−Removed: nonperformance under existing agreements which may increase its costs.
−Removed: These cost increases may not be fully recoverable or adequately
−Removed: covered by insurance.
−Removed: Hoth Therapeutics, Inc.
−Removed: Notes to Consolidated Financial Statements
+Added: As a result of the continuing spread of the Coronavirus,
+Added: certain aspects of the Company’s business operations have been delayed, and the Company may be subject to additional delays or
+Added: interruptions.
+Added: Specifically, as a result of the shelter-in-place orders and other mandated local travel restrictions, among other things,
+Added: the research and development activities of certain of the Company’s partners may be affected, which may result in delays to the
+Added: Company’s clinical trials, and the Company can provide no assurance as to when such trials, if delayed, will resume at this time
+Added: or the revised timeline to complete trials once resumed.
+Added: Furthermore, site initiation, participant recruitment
+Added: and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed
+Added: due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic
+Added: efforts, or other reasons related to the pandemic.
+Added: If the Coronavirus continues to spread, some participants and clinical investigators
+Added: may not be able to comply with clinical trial protocols.
+Added: For example, quarantines or other travel limitations (whether voluntary or required)
+Added: may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and the Company may be unable
+Added: to conduct its clinical trials.
+Added: Further, if the spread of the Coronavirus pandemic continues and the Company’s operations are adversely
+Added: impacted, the Company risks a delay, default and/or nonperformance under existing agreements which may increase its costs.
+Added: increases may not be fully recoverable or adequately covered by insurance.
Infections and deaths related to the pandemic
−Removed: may disrupt the United States’
−Removed: healthcare and healthcare regulatory systems.
+Added: may disrupt the United States’ healthcare and healthcare regulatory systems.
Such disruptions could divert healthcare resources
−Removed: away from, or materially delay FDA review and/or approval with respect to, the Company’s clinical trials.
−Removed: It is unknown
−Removed: how long these disruptions could continue, were they to occur.
−Removed: Any elongation or de-prioritization of the Company’s clinical
−Removed: trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of the
−Removed: Company’s product candidates.
+Added: away from, or materially delay FDA review and/or approval with respect to, the Company’s clinical trials.
+Added: It is unknown how long
+Added: these disruptions could continue, were they to occur.
+Added: Any elongation or de-prioritization of the Company’s clinical trials or delay
+Added: in regulatory review resulting from such disruptions could materially affect the development and study of the Company’s product
The Company currently utilizes third parties
1 unchanged sentence
If any third-party party in the supply chain for materials used in the production
−Removed: of the Company’s product candidates are adversely impacted by restrictions resulting from the Coronavirus outbreak, the
−Removed: Company’s supply chain may be disrupted, limiting the Company’s ability to manufacture its product candidates for
−Removed: its clinical trials and research and development.
−Removed: The spread of the Coronavirus, which has
−Removed: caused a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments,
−Removed: may have a material economic effect on the Company’s business.
−Removed: While the potential economic impact brought by and the duration
−Removed: of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant
−Removed: disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms.
−Removed: addition, a recession, depression or other sustained adverse market event resulting from the spread of the Coronavirus could materially
−Removed: and adversely affect the Company’s business and the value of its common stock.
+Added: of the Company’s product candidates are adversely impacted by restrictions resulting from the Coronavirus outbreak, the Company’s
+Added: supply chain may be disrupted, limiting the Company’s ability to manufacture its product candidates for its clinical trials and
+Added: research and development.
+Added: The spread of the Coronavirus, which has caused
+Added: a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have
+Added: a material economic effect on the Company’s business.
+Added: While the potential economic impact brought by and the duration of the pandemic
+Added: may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial
+Added: markets, which may reduce our ability to access capital either at all or on favorable terms.
+Added: In addition, a recession, depression or
+Added: other sustained adverse market event resulting from the spread of the Coronavirus could materially and adversely affect the Company’s
+Added: 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.
−Removed: The Company does not yet know the full extent of potential
−Removed: delays or impacts on its business, its clinical trials, its research programs, healthcare systems or the global economy as a whole.
−Removed: However, these effects could have a material impact on the Company’s operations, and the Company will continue to monitor
−Removed: the situation closely.
−Removed: Note 12—Subsequent Events
−Removed: The compensation committee of the board
−Removed: of directors increased the number of shares reserved pursuant to the Company’s 2018 Plan by 671,926 shares effective as
−Removed: 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
−Removed: for issuance pursuant to the 2018 Plan.
−Removed: On January 5, 2021, the Company entered
−Removed: into a Securities Purchase Agreement with certain accredited investors identified on the signature pages thereto (the “Purchasers”)
−Removed: pursuant to which the Company offered and sold to the Purchasers an aggregate of 2,475,248 shares of its common stock and warrants
−Removed: to purchase up to 1,237,624 shares of common stock in a private placement for aggregate gross proceeds to the Company of $5 million,
−Removed: before deducting estimated offering expenses payable by the Company.
−Removed: The combined purchase price for each share of common stock
−Removed: and accompanying warrant to purchase 0.5 of a share of common stock was $2.02.
−Removed: The closing of the offering occurred on January
−Removed: 7, 2021.Each warrant is immediately exercisable for a period of five years at an exercise price of $2.25 per Warrant Share, subject
−Removed: to adjustment, and may be exercised on a cashless basis.
−Removed: In addition, pursuant to the terms of the offering, the Company issued
−Removed: Benchmark Company, LLC warrants to purchase up to 185,644 shares of common stock.
−Removed: Benchmark’s warrants are exercisable for
−Removed: a period of five years from the closing date of the offering at an exercise price of $2.25 per share, subject to adjustment.
−Removed: On February 25, 2021, the Company entered
−Removed: into an exclusive, worldwide, royalty bearing license with NC State pursuant to which NC State granted the Company an exclusive,
−Removed: worldwide, royalty bearing license to certain intellectual property to, among other things, discover, develop, make, have made,
−Removed: use and sell certain licensed products and sell, use and practice certain licensed services with respect to cancer and anaphylaxis.
−Removed: On March 8, 2021, the Company entered into
−Removed: a securities purchase agreement with certain institutional and accredited investors pursuant to which it offered and sold to the
−Removed: purchaser 6,826,962 shares of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 767,975
−Removed: shares of common stock and warrants (the “Common Stock Warrants”) to purchase up to 7,594,937 shares
−Removed: of common stock.
−Removed: in a private placement for aggregate gross proceeds to the Company of $15 million, before deducting estimated
−Removed: offering expenses payable by the Company.
−Removed: The combined purchase price for each share of common stock and accompanying warrant was
−Removed: The closing of the offering occurred on March 10, 2021.
−Removed: Each warrant is immediately exercisable for a period of five years
−Removed: at an exercise price of $2.25 per warrant share, subject to adjustment, and may be exercised on a cashless basis.
−Removed: Each Pre-Funded
−Removed: Warrant is exercisable until exercised in full at an exercise price of $0.001 per share and may be exercised by means of a cashless
−Removed: In addition, pursuant to the terms of the offering, the Company issued H.C.
−Removed: Wainwright & Co., LLC warrants
−Removed: to purchase up to 379,747 shares of common stock.
−Removed: The warrants are exercisable for a period of three years from the issuance date
−Removed: at an exercise price of $2.4688 per share, subject to adjustment and may be exercised by means of a cashless exercise.
−Removed: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS AND
−Removed: FINANCIAL DISCLOSURE
+Added: The Company does not yet know the full extent of potential delays
+Added: or impacts on its business, its clinical trials, its research programs, healthcare systems or the global economy as a whole.
+Added: these effects could have a material impact on the Company’s operations, and the Company will continue to monitor the situation
+Added: Nasdaq Delisting Notice
+Added: On December 30,
+Added: 2021, the Company received a written notice from the Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that the bid
+Added: price of its common stock, par value $0.0001 per share, failed to comply with the $1.00 minimum bid price required for continued
+Added: listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).
+Added: Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company
+Added: was granted an initial 180 calendar day compliance period, or until June 28, 2022, to regain compliance with the minimum bid price requirement.
+Added: To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least
+Added: 10 consecutive business days during the initial 180 calendar day compliance period.
+Added: In the event the Company does not regain compliance
+Added: by June 28, 2022, the Company may be eligible for an additional 180 calendar day grace period if the Company meets the continued listing
+Added: standards for The Nasdaq Capital Market, with the exception of bid price, and the Company provides written notice to Nasdaq of its intention
+Added: to cure the deficiency during the second compliance period.
+Added: Note 11—Subsequent Events
+Added: On February 2, 2022, the compensation committee
+Added: of the Board of Directors of the Company approved an increase in the number of shares of common stock reserved for issuance under the
+Added: 2018 Plan by 250,000 shares from 3,671,926 shares to 3,921,926 shares.
+Added: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS AND FINANCIAL
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.