3 unchanged sentences
Report of Independent Registered Public Accounting Firm (PCAOB ID:
−Removed: Report of Independent Registered Public Accounting Firm (PCAOB ID:
−Removed: Consolidated Balance Sheets as of December 31, 2023 and 2022
−Removed: Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022
−Removed: Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Years Ended December 31, 2023 and 2022
−Removed: Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022
−Removed: Notes to Consolidated Financial Statements
+Added: Balance Sheets as of December 31, 2024 and 2023
+Added: Statements of Operations for the Years Ended December 31, 2024 and 2023
+Added: Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2024 and 2023
+Added: Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
+Added: to Consolidated Financial Statements
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
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on the Financial Statements
−Removed: have audited the accompanying balance sheet of Tharimmune, Inc.
−Removed: (the Company) as of the year ended December 31, 2023, and the related
−Removed: consolidated statements of operations, stockholders’ equity, and cash flows for the year ended December 31, 2023, and the related
−Removed: notes (collectively referred to as the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present
−Removed: fairly, in all material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and
−Removed: its cash flows for the year ended December 31, 2023, in conformity with accounting principles generally accepted in the United States
−Removed: financial statements of Tharimmune, Inc.
−Removed: as of December 31, 2022, and for the year then ended were audited by other auditors.
−Removed: in Note 2, these financial statements have been revised to retrospectively apply the reverse stock split on all issued and outstanding
−Removed: common shares and per share amounts.
−Removed: We have audited the adjustments that were applied to revise the 2022 financial statements.
−Removed: opinion, such adjustments are appropriate and have been properly applied.
−Removed: However, we were not engaged to audit, review or apply procedures
−Removed: to the 2022 financial statements of the Company other than with respect to such adjustments and, accordingly, we do not express an opinion
−Removed: or any for of assurance on the 2022 financial statements taken as a whole.
+Added: have audited the accompanying balance sheets of Tharimmune, Inc.
+Added: (the Company) as of December 31, 2024 and 2023, and the related consolidated
+Added: statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31,
+Added: 2024, and the related notes (collectively referred to as the consolidated financial statements).
+Added: In our opinion, the consolidated financial
+Added: statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the
+Added: results of its operations and its cash flows for the years in the two-year period ended December 31, 2024, in conformity with accounting
+Added: principles generally accepted in the United States of America.
Doubt about the Company’s Ability to Continue as a Going Concern
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Our responsibility is to express an opinion
−Removed: on the Company’s consolidated financial statements based on our audit.
+Added: on the Company’s consolidated financial statements based on our audits.
We are a public accounting firm registered with the Public
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federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: conducted our audit in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain
+Added: conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audit,
+Added: As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
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Accordingly, we express no such opinion.
−Removed: audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
+Added: audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts of disclosures in the consolidated financial statements.
+Added: regarding the amounts and disclosures in the consolidated financial statements.
Our audits also included evaluating the accounting principles
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that our audits provide a reasonable basis for our opinion.
−Removed: We have served as the Company’s auditor since 2023.
−Removed: Rosenberg Rich Baker Berman P.A.
−Removed: February 23, 2024
−Removed: of Independent Registered Public Accounting Firm
−Removed: To the Board of Directors and
−Removed: Stockholders of Tharimmune, Inc.
−Removed: (formerly Hillstream BioPharma, Inc.):
−Removed: Opinion on the Financial Statements
−Removed: We have audited, before the effects of the adjustments
−Removed: to retrospectively apply the reverse stock split described in Note 2, the accompanying consolidated balance sheet of Tharimmune, Inc.
−Removed: (formerly Hillstream BioPharma, Inc.) (“Company”) as of December 31, 2022, and the related consolidated statements of operations,
−Removed: changes in stockholders’ equity (deficit), and cash flows for the year then ended, and the related notes (collectively referred
−Removed: to as the “financial statements”).
−Removed: The 2022 financial statements before the effects of the adjustments discussed in Note 2
−Removed: are not presented herein.
−Removed: In our opinion, the financial statements, before the effects of the adjustments to retrospectively apply the
−Removed: reverse stock split described in Note 2, present fairly, in all material respects, the financial position of the Company as of December
−Removed: 31, 2022, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally
−Removed: accepted in the United States of America.
−Removed: We were not engaged to audit, review, or apply any
−Removed: procedures to the adjustments to retrospectively apply the reverse stock split described in Note 2 and, accordingly, we do not express
−Removed: an opinion or any other form of assurance about whether such adjustments are appropriate and have been properly applied.
−Removed: Those adjustments
−Removed: were audited by Rosenberg Rich Baker Berman, P.A.
−Removed: Going Concern Uncertainty
−Removed: The accompanying financial statements have been prepared
−Removed: assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 1 to the financial statements, the Company has incurred
−Removed: recurring losses and negative cash flows from operations and is dependent on additional financing to fund operations.
−Removed: These conditions
−Removed: raise substantial doubt about its ability to continue as a going concern.
−Removed: Management’s plans regarding these matters are also described
−Removed: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
−Removed: and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable
−Removed: rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audit in accordance with the standards
−Removed: of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
−Removed: are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform,
−Removed: an audit of its internal control over financial reporting.
−Removed: As part of our audit we are required to obtain an understanding of internal
−Removed: control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
−Removed: control over financial reporting.
−Removed: Accordingly, we express no such opinion.
−Removed: Our audit included performing procedures to assess
−Removed: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
−Removed: to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
−Removed: the overall presentation of the financial statements.
−Removed: We believe that our audit provides a reasonable basis for our opinion.
−Removed: We served as the Company’s auditor from 2020 to 2023.
−Removed: /s/ Mayer Hoffman McCann P.C.
−Removed: Los Angeles, California
+Added: have served as the Company’s auditor since 2023.
+Added: /s/ Rosenberg Rich Baker
BALANCE SHEETS
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current assets
−Removed: Total current assets
+Added: offering costs
+Added: current assets
LIABILITIES AND STOCKHOLDERS’
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Accounts payable
−Removed: Accrued expenses
−Removed: Total current liabilities
−Removed: Total liabilities
+Added: current liabilities
Commitments and contingencies (see Note 6)
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( 24,703,526 )
−Removed: Treasury stock, at cost, 3,633 shares held
−Removed: in treasury as of December 31, 2023 and December 31, 2022
+Added: stock, at cost, 246 shares held in treasury as of December 31, 2024 and 2023
Total stockholders’
−Removed: Total liabilities and stockholders’
+Added: Total liabilities and
+Added: stockholders’ equity
accompanying notes are an integral part of these consolidated financial statements.
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the Years Ended December 31,
−Removed: and development
−Removed: and administrative
Operating expenses
−Removed: from operations
−Removed: ( 9,455,220 )
+Added: and administrative
+Added: Total operating expenses
+Added: Loss from operations
( 12,433,792 )
−Removed: income (expense)
( 9,455,220 )
+Added: Other income (expense)
+Added: Interest expense
other income (expense), net
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$ ( 9,319,094 )
−Removed: $ ( 8,473,182 )
Net loss per share:
−Removed: Weighted average
−Removed: number of common shares outstanding:
+Added: Weighted average number of common shares outstanding:
accompanying notes are an integral part of these consolidated financial statements.
1 unchanged sentence
THE YEARS ENDED DECEMBER 31, 2024 AND 2023
−Removed: December 31, 2021
−Removed: $ ( 6,911,250 )
+Added: Balance, December 31, 2022
$ ( 15,384,432 )
+Added: Stock issuance pursuant
+Added: Public offering, net of
+Added: issuance costs
+Added: Exercise of pre-funded
+Added: Reverse stock-split
( 9,319,094 )
( 9,319,094 )
−Removed: Exercise of stock
−Removed: based compensation
−Removed: issuance pursuant
−Removed: to services agreement
−Removed: public offering, net of issuance costs of $ 2,054,918
−Removed: of related-party
−Removed: convertible notes
−Removed: of treasury stock at cost
+Added: Stock based compensation
Balance, December 31, 2023
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( 24,703,526 )
+Added: Stock issuance pursuant to
+Added: Private investments in public
+Added: offering, net of
+Added: issuance costs
+Added: At-the-market offering, net of
+Added: Issuance costs related to
+Added: Form S-3 Registration
+Added: Cashless exercise of
+Added: pre-funded warrants,
( 12,197,568 )
( 12,197,568 )
−Removed: based compensation
−Removed: offerings, net of
−Removed: issuance costs of $ 1,925,076
−Removed: offerings, net of
−Removed: issuance costs
−Removed: Exercise of pre-funded
−Removed: stock-split adjustment
−Removed: issuance pursuant to
−Removed: service agreements
−Removed: December 31, 2023
+Added: Stock based compensation
+Added: Balance, December 31, 2024
$ ( 36,901,094 )
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the Years Ended December 31,
−Removed: flows from operating activities:
+Added: Cash flows from operating activities:
$ ( 12,197,568 )
$ ( 9,319,094 )
−Removed: to reconcile net loss to net cash used in operating activities:
−Removed: of debt discount
−Removed: based compensation
−Removed: issuance pursuant to services agreement
−Removed: and original issuance discount on promissory notes
−Removed: decrease in operating assets:
−Removed: expenses and other current assets
−Removed: (decrease) in operating liabilities:
+Added: Adjustments to reconcile
+Added: net loss to net cash used in operating activities:
+Added: Stock based compensation
+Added: Stock issuance pursuant
+Added: to services agreement
+Added: Increase in operating assets:
+Added: Prepaid expenses and other
+Added: current assets
+Added: Increase (decrease) in
+Added: operating liabilities:
+Added: Accounts payable
cash used in operating activities
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cash provided by (used in) investing activities
−Removed: flows from financing activities:
−Removed: of stock options
−Removed: of treasury stock at cost
−Removed: from issuance of common stock upon initial public offering, net of underwriting discounts and issuance costs
−Removed: from issuance of common stock upon public offering, net of underwriting discounts and issuance costs
−Removed: of deferred offering costs
−Removed: of pre-funded warrants
−Removed: from insurance premium financing liability
−Removed: of insurance premium financing liability
−Removed: from promissory notes
−Removed: on promissory notes
−Removed: cash provided by financing activities
−Removed: increase in cash
−Removed: beginning of period
−Removed: end of period
−Removed: Cash paid for interest expense
−Removed: disclosure of non-cash financing activities:
−Removed: of common stock for prepaid marketing and investor related consulting services
−Removed: of related party convertible notes:
−Removed: party convertible notes principal converted to common stock upon initial public offering
−Removed: party convertible notes accrued interest converted to common stock upon initial public offering
−Removed: liability converted to common stock upon initial public offering
+Added: Cash flows from financing activities:
+Added: Proceeds from issuance of common stock upon
+Added: private investment in public equity offerings
+Added: Proceeds from issuance of common stock upon
+Added: at-the-market offering
+Added: Proceeds from issuance of common stock upon
+Added: public offering, net of underwriting discounts and issuance costs
+Added: Payment of deferred offering costs
+Added: Exercise of pre-funded warrants
+Added: Proceeds from insurance premium financing liability
+Added: Repayment of insurance
+Added: premium financing liability
+Added: Net cash provided by financing
+Added: Net (decrease) increase
+Added: ( 7,375,991 )
+Added: Cash, beginning of period
+Added: Cash, end of period
+Added: paid for interest expense
+Added: Supplemental disclosure
+Added: of non-cash financing activities:
+Added: Issuance of common stock
+Added: for prepaid marketing and investor related consulting services
accompanying notes are an integral part of these consolidated financial statements.
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At December 31, 2024, Tharimmune had one wholly-owned subsidiary:
−Removed: HB Pharma Corp.
−Removed: Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in rare, inflammatory, and oncologic conditions
−Removed: with high unmet need.
−Removed: On November 3, 2023, the Company entered into a patent license agreement (the “Avior License Agreement”)
−Removed: with Avior Inc.
−Removed: d/b/a Avior Bio, LLC (“Avior”) pursuant to which it received an exclusive sublicensable right and license
−Removed: to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import,
−Removed: export and commercialize TH104 and TH10) and to practice the Licensed Technology in connection with the foregoing, throughout the world
−Removed: (each as defined in the Avior License Agreement.
+Added: Hillstream Oncology, Inc.
+Added: Oncology”), formerly, HB Pharma Corp.
+Added: is a clinical-stage biotechnology company developing therapeutic candidates in rare, inflammatory, and oncologic conditions with high
+Added: On November 3, 2023, the Company entered into a patent license agreement (the “Avior License Agreement”) with
+Added: d/b/a Avior Bio, LLC (“Avior”) pursuant to which it received an exclusive sublicensable right and license to Licensed
+Added: Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and
+Added: commercialize TH104 and TH103) and to practice the Licensed Technology in connection with the foregoing, throughout the world (each as
+Added: defined in the Avior License Agreement.
In February 2023, the U.S.
−Removed: Food and Drug Administration (“FDA”) approved
−Removed: an investigational new drug (“IND”) application for TH104.
−Removed: TH104 has a dual mechanism of action by affecting multiple receptors,
−Removed: known to suppress chronic, debilitating pruritis or “uncontrollable itching.” With respect to TH104, the Company intends
−Removed: to first seek approval for the treatment of moderate to severe chronic pruritis in patients with primary biliary cholangitis (“PBC”),
−Removed: an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritis,
−Removed: and with respect to TH103, it intends to develop the product candidate and potentially file an IND.
+Added: Food and Drug Administration (“FDA”) approved an investigational
+Added: new drug (“IND”) application for TH104.
+Added: TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress
+Added: chronic, debilitating pruritis or “uncontrollable itching.” With respect to TH104, the Company intends to first seek approval
+Added: for the treatment of moderate to severe chronic pruritis in patients with primary biliary cholangitis (“PBC”), an orphan
+Added: rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritis, and with
+Added: respect to TH103, it intends to develop the product candidate and potentially file an IND.
+Added: September 11, 2024, Tharimmune entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited
+Added: (“Intract”), pursuant to which, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha
+Added: (TNF-α) monoclonal antibody infliximab.
+Added: Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein
+Added: that contains both murine and human components that inhibit tumor TNF-α.
+Added: Under the terms of the Agreement, the Company licensed
+Added: global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform
+Added: along with an existing supply agreement for infliximab to be used in the oral product development program.
Company is also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”)
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which have the potential to target and bind more tightly to “undruggable” epitopes better than full sized antibodies.
−Removed: Company is advancing TH3215, a bispecific against both HER2 and HER3 antibody which targets a novel “bridging epitope” encompassing
+Added: Company is advancing HS3215, a bispecific against both HER2 and HER3 antibody which targets a novel “bridging epitope” encompassing
multiple domains of the HER2 extracellular domain (“ECD”) as well as ligand-dependent and independent blocking of the ECD
of HER3 into IND-enabling studies in 2024.
−Removed: In addition, the Company anticipates that TH0059, a HER2/HER3 bispecific ADC (“bsADC”),
+Added: In addition, the Company anticipates that HS0059, a HER2/HER3 bispecific ADC (“bsADC”),
and TH1940, a PD-1 Picobody, will progress to enter IND-enabling studies in 2025.
−Removed: Company has deprioritized its previous preclinical candidate, HSB-1216, due to a strategic reprioritization of its vision to focus on
−Removed: therapeutics in high unmet need cancers focused on novel epitopes of certain antitumor drug targets.
September 21, 2023, Hillstream BioPharma, Inc.
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symbol, “THAR.”
+Added: addition, on May 23, 2024, HB Pharma Corp.
+Added: filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the
+Added: Secretary of State of the State of Delaware pursuant to which it changed its name to Hillstream Oncology, Inc.
+Added: effective as of May 23,
and Going Concern
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$ 10.9 million in net cash used in operating activities, and had an accumulated deficit of approximately $ 36.9 million as of December
−Removed: Through December 31, 2023, the Company has primarily financed its operations through public and private offerings of equity securities.
−Removed: The Company received net proceeds from its initial public offering (“IPO”) on January 14, 2022 of approximately $ 12.5 million.
−Removed: Additionally, the Company closed a public offering (the “May Offering”) of its common stock on May 2, 2023.
−Removed: to the Company from the offering were approximately $ 2.1 million.
−Removed: The Company recently closed an additional public offering (the “November
−Removed: Offering”) of its common stock on November 30, 2023.
−Removed: Net proceeds to the Company from the offering were approximately $ 8.7 million.
−Removed: Also see Note 5 to the consolidated financial statements for details regarding the May and November Offerings.
−Removed: The shares of the Company’s
−Removed: common stock began trading on The Nasdaq Capital Market on January 12, 2022 under the ticker symbol “HILS” and effective
−Removed: as of September 25, 2023, are traded under the ticker symbol “THAR.”
+Added: Through December 31, 2024, the Company has primarily financed its operations through public and private offerings of its equity
+Added: The Company received net proceeds from its initial public offering (“IPO”) on January 14, 2022 of approximately
+Added: $ 12.5 million.
+Added: Additionally, the Company received net proceeds of approximately $ 2.1 million from a public offering (the “May 2023
+Added: Offering”) of its common stock on May 2, 2023.
+Added: The Company closed an additional public offering (the “November 2023 Offering”)
+Added: of its common stock on November 30, 2023 with net proceeds of approximately $ 8.7 million.
+Added: addition, on June 7, 2024, the Company filed a Registration Statement on Form S-3 with the SEC using a “shelf”
+Added: registration process pursuant to which, under an at-the-market offering agreement (the “ATM Agreement”), the Company may
+Added: sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar
+Added: amount of $ 1.65
+Added: Under the ATM Agreement, the Company sold 40,000 shares of it’s common stock for gross proceeds of $ 83,688 (the
+Added: Net proceeds from the ATM Sale after deducting commissions of $ 2,507 and other fees of $ 7,992 were $ 73,189 .
+Added: Further, on June 17, 2024 and December 9, 2024, the Company closed private placement offerings (the “June 2024 PIPE
+Added: Offering” and “December 2024 PIPE Offering”) with certain accredited investors, of shares of the Company’s
+Added: common stock and/or pre-funded warrants to acquire shares of the Company’s common stock and warrants to acquire shares of the
+Added: Company’s common stock, with combined net proceeds to the Company of approximately $ 3.6
+Added: See Note 3 to the consolidated financial statements for details regarding the various offerings.
+Added: The shares of the
+Added: Company’s common stock began trading on The Nasdaq Capital Market on January 12, 2022 under the ticker symbol
+Added: “HILS” and effective as of September 25, 2023, are traded under the ticker symbol “THAR.”
on the Company’s limited operating history, recurring negative cash flows from operations, current plans and available resources,
33 unchanged sentences
board of directors and stockholders.
−Removed: The par value of the Company’s common stock was not adjusted as a result of the reverse split.
−Removed: All issued and outstanding common stock share and per share amounts contained in the consolidated financial statements have been retroactively
−Removed: adjusted to reflect this reverse split for all periods presented.
+Added: On May 24, 2024, the Company effectuated an additional reverse split of shares of its common stock
+Added: at a ratio of 1-for-15 pursuant to an amendment to the Company’s Certificate of Incorporation, as amended, filed with the Delaware
+Added: Secretary of State and approved by the Company’s board of directors and stockholders.
+Added: The par value of the Company’s common
+Added: stock was not adjusted as a result of either reverse split.
+Added: All issued and outstanding common stock share and per share amounts contained
+Added: in the consolidated financial statements have been retroactively adjusted to reflect these reverse splits for all periods presented.
of Consolidation
39 unchanged sentences
services completed.
−Removed: Approximately $ 61,000 of prepaid expenses at December 31, 2022 related to a manufacturing services agreement.
Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees, and directors as
15 unchanged sentences
yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.
−Removed: Company’s board of directors authorized the repurchase of up to $ 1 million of shares of the Company’s common stock, from
−Removed: time to time, until December 31, 2022, in the open market or through privately-negotiated transactions, at such times and at such prices
−Removed: as the Company’s management may decide.
−Removed: Treasury stock purchases are accounted for under the cost method whereby the entire cost
−Removed: of the acquired common stock is recorded as treasury stock.
−Removed: Discount and Derivative Instruments
−Removed: initial fair value of the redemption feature relating to the convertible debt instruments was treated as a debt discount and was amortized
−Removed: over the term of the related debt using the straight-line method, which approximates the interest method.
−Removed: Amortization of debt discount
−Removed: was recorded as a component of interest expense.
−Removed: If a loan is paid in full, any unamortized debt discounts will be removed from the related
−Removed: accounts and charged to operations.
−Removed: As the convertible debt was converted into common stock at the date of the IPO, the unamortized debt
−Removed: discount of $ 1,569,003 was charged to interest expense during the year ended December 31, 2022.
−Removed: Company accounts for derivative instruments in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards
−Removed: Codification (“ASC”) Topic 815, Derivative and Hedging , which establishes accounting and reporting standards for derivative
−Removed: instruments, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of
−Removed: all derivatives on the balance sheet at fair value.
−Removed: The Company’s derivative financial instrument consisted of an embedded feature
−Removed: contained in the Company’s convertible debt that was bifurcated and accounted for separately.
−Removed: See Note 3 to the consolidated financial
−Removed: statements for further details.
Value Measurements
−Removed: Company applies FASB ASC Topic 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring
−Removed: fair value and clarifies the definition of fair value within that framework.
−Removed: ASC 820 defines fair value as an exit price, which is the
−Removed: price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market
−Removed: in an orderly transaction between market participants on the measurement date.
−Removed: The fair value hierarchy established in ASC 820 generally
−Removed: requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
−Removed: inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market
−Removed: data obtained from sources independent of the reporting entity.
−Removed: Unobservable inputs reflect the entity’s own assumptions based
−Removed: on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability
−Removed: and are to be developed based on the best information available in the circumstances.
+Added: Company applies Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic
+Added: 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the
+Added: definition of fair value within that framework.
+Added: ASC 820 defines fair value as an exit price, which is the price that would be received
+Added: for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between
+Added: market participants on the measurement date.
+Added: The fair value hierarchy established in ASC 820 generally requires an entity to maximize
+Added: the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
+Added: Observable inputs reflect the assumptions
+Added: that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent
+Added: of the reporting entity.
+Added: Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments
+Added: about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best
+Added: information available in the circumstances.
carrying value of the Company’s cash, prepaid expenses, accounts payable, and accrued expenses approximate fair value because of
−Removed: the short-term maturity of these consolidated financial instruments.
−Removed: The redemption feature of the debt instruments is recorded at fair
−Removed: See Note 4 to the consolidated financial statements for further details.
+Added: the short-term maturity of these financial instruments.
valuation hierarchy is composed of three levels.
2 unchanged sentences
The levels within the valuation hierarchy are described below:
−Removed: Observable inputs such as quoted prices (unadjusted) in active markets that are accessible at the measurement date for
−Removed: identical, unrestricted assets or liabilities.
+Added: Observable inputs such as quoted prices (unadjusted) in active markets that are accessible at the measurement date
+Added: for identical, unrestricted assets or liabilities.
Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly.
−Removed: These include
−Removed: quoted prices for assets or liabilities recently traded in active markets, with similar underlying terms, as well as direct or indirect
−Removed: observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals, as well as quoted prices
−Removed: for identical or similar assets or liabilities in markets that are not active.
−Removed: Unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for
−Removed: the assets or liabilities, that reflect the reporting entity’s own assumptions.
+Added: include quoted prices for assets or liabilities recently traded in active markets, with similar underlying terms, as well as direct
+Added: or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals, as well
+Added: as quoted prices for identical or similar assets or liabilities in markets that are not active.
+Added: Unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists
+Added: for the assets or liabilities, that reflect the reporting entity’s own assumptions.
Offering Costs
4 unchanged sentences
upon termination of the offering.
+Added: At December 31, 2024, there are $ 117,000 in deferred offering costs associated with the ATM Agreement.
Premium Financing Liability
−Removed: January 2022, the Company entered into an insurance premium financing agreement for $ 1,207,200 , with a term of 10 months and an annual
−Removed: interest rate of 3.5 %.
−Removed: The Company made a down payment of $ 289,728 and was required to make monthly principal and interest payments of
−Removed: $ 93,225 over the term of the agreement, which was repaid in full in November 2022.
January 2023, the Company entered into an insurance premium financing agreement for $ 955,700 , with a term of nine months and an annual
2 unchanged sentences
of $ 81,394 over the term of the agreement, which was repaid in full in October 2023.
+Added: January 2024, the Company entered into an insurance premium financing agreement for $ 492,450 , with a term of 10 months and an annual
+Added: interest rate of 7.5 %.
+Added: The Company made a down payment of $ 98,490 and is required to make monthly principal and interest payments of
+Added: $ 40,763 over the term of the agreement, which was repaid in full in November 2024.
Company has a 401(k) defined contribution plan which covers all employees that meet the plan’s eligibility requirements.
35 unchanged sentences
the potential dilution of securities that could share in the earnings of an entity.
−Removed: The calculation of diluted net loss per share gives
−Removed: effect to common stock equivalents;
+Added: The calculation of diluted net earnings (loss) per
+Added: share gives effect to common stock equivalents;
however, potential common shares are excluded if their effect is anti-dilutive.
−Removed: dilutive securities not included in the computation of loss per share for the years ended December 31, 2023 and 2022 included
−Removed: options to purchase 90,758
−Removed: shares of common stock, respectively.
−Removed: Other potentially dilutive securities also not included in the computation of loss per share
−Removed: for the years ended December 31, 2023 and 2022 included warrants to purchase 7,500
−Removed: shares of the Company’s common stock related to the IPO and for the year ended December 31, 2023, warrants to purchase an
−Removed: additional 6,360
−Removed: shares of the Company’s common stock related to the public offering which closed on May 2, 2023.
−Removed: All common share amounts as
−Removed: of December 31, 2023 and 2022 and per share amounts for the years ended December 31, 2023 and 2022 have been retroactively adjusted
−Removed: to reflect a 1-for-25
−Removed: reverse stock split of the Company’s common stock effectuated on November 17, 2023.
+Added: dilutive securities not included in the computation of loss per share for the years ended December 31, 2024 and 2023 included options
+Added: to purchase 108,955 and 6,102 shares of common stock, respectively.
+Added: Other potentially dilutive securities not included in the computation
+Added: of loss per share for the years ended December 31, 2024 and 2023 included warrants to purchase 500 shares of the Company’s common
+Added: stock related to the IPO and warrants to purchase an additional 424 and 20,000 shares of the Company’s common stock issued in the
+Added: May 2023 and November 2023 Offerings, respectively, warrants to purchase an additional 480,721 shares and 329,771 shares of the Company’s
+Added: common stock issued in the December 2024 and June 2024 PIPE Offerings, respectively, and warrants to purchase 19,786 shares of the Company’s
+Added: common stock issued to the placement agents in the June 2024 PIPE Offering.
+Added: All common share amounts as of December 31, 2024 and 2023
+Added: and per share amounts for the years ended December 31, 2024 and 2023 have been retroactively adjusted to reflect a 1-for-25 reverse stock
+Added: split of the Company’s common stock effectuated on November 17, 2023 and a 1-for-15 reverse stock split of the Company’s
+Added: common stock effectuated on May 24, 2024.
Adopted Accounting Pronouncements
−Removed: Company has evaluated all recent accounting pronouncements that were required to be adopted and believes that none of them will have
−Removed: a material effect on the Company’s financial position, results of operations, or cash flows.
−Removed: Accounting Pronouncements Not Yet Adopted
+Added: Company has evaluated all recent accounting pronouncements that were required to be adopted and believes that other than the following,
+Added: none of them will have a material effect on the Company’s financial position, results of operations, or cash flows.
FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20)
26 unchanged sentences
financial statements.
−Removed: 3 – Convertible Notes - Related Parties
−Removed: in May 2017, the Company entered into Subordinated Convertible Promissory Note Agreements (the “Agreements”) with certain
−Removed: lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued Subordinated
−Removed: Convertible Promissory Notes (individually the “Note” or together, the “Notes”) to the Holders, principally all
−Removed: to the Chief Executive Officer (“CEO”) and founder of the Company, a member of the Company’s board of directors and
−Removed: third parties that are family members of the founder and CEO.
−Removed: Interest on the unpaid principal balance accrued at a rate of 5 % per annum,
−Removed: computed on the basis of the actual number of days elapsed and a year of 365 days.
−Removed: Unless earlier converted into shares of the Company’s
−Removed: common stock or preferred stock (collectively, the “Equity Securities”), the principal and accrued interest was to be due
−Removed: and payable by the Company on demand by the Holders at any time after the earlier of (i) the Maturity Date (as defined in each Agreement)
−Removed: and (ii) the closing of the Next Equity Financing.
−Removed: “Next Equity Financing” means the next sale, or series of related sales,
−Removed: by the Company of its Equity Securities pursuant to which the Company received gross proceeds of not less than $ 5.0 million for Notes
−Removed: issued in 2017 and through November 2020 and $ 7.5 million for Notes issued after November 2020 (including the aggregate amount of debt
−Removed: securities converted into Equity Securities upon conversion or cancellation of the Notes).
−Removed: The Company’s IPO qualified as a Next
−Removed: Equity Financing.
−Removed: general, the stated maturity date was two years from the date of issuance, except for the Notes issued in December 2020 and thereafter
−Removed: (in the aggregate principal amount of approximately $ 2.1 million) which had a stated maturity date of three years .
−Removed: For Notes issued in
−Removed: 2017 and through September 2018, the default interest rate of 20 % was added to the Notes for the period after the stated maturity date.
−Removed: Notes were to automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing.
−Removed: The number of
−Removed: shares of such Equity Securities to be issued was equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
−Removed: interest due on the Note on the date of conversion by the lesser of (i) 80% of the price paid per share for Equity Securities by the
−Removed: investors in the Next Equity Financing, or (ii) an equity valuation of $ 25 million ($ 50 million for Notes issued after December 2020) .
−Removed: On January 14, 2022, all outstanding Notes and accrued interest were converted into an aggregate of 49,015 shares of the Company’s
−Removed: common stock as the IPO qualified as a Next Equity Financing.
−Removed: embedded features contained in the Notes in the aggregate were embedded derivative instruments, which were recorded as a debt discount
−Removed: and derivative liability at the issuance date at their estimated fair value for all Notes of approximately $ 2.4 million.
−Removed: of debt discount for the Notes recorded as interest expense was approximately $ 1.6 million for the year ended December 31, 2022.
−Removed: amount contains amortization charged to interest expense of approximately $ 34,000 up to the date of the IPO and the full amount of the
−Removed: unamortized debt discount of approximately $ 1.5 million charged to interest expense on the date of the IPO.
−Removed: interest expense associated with the Notes at the date of the IPO was approximately $ 187,000 and was converted into common stock upon
−Removed: completion of the IPO.
−Removed: 4 – Redemption Liability
−Removed: fair value of the redemption liability is calculated under Level 3 of the fair value hierarchy, determined based upon a probability-weighted
−Removed: expected returns method (“PWERM”).
−Removed: This PWERM was determined to be the most appropriate method of estimating the value of
−Removed: possible redemption or conversion outcomes over time, since the Company had not entered into a priced equity round through December 31,
−Removed: The significant assumptions utilized in these calculations are the possible exit scenarios (either a conversion of the principal
−Removed: and accrued interest of the Notes in the event of a Next Equity Financing, further described in Note 3 to the consolidated financial
−Removed: statements, a repayment of the Notes and accrued interest in the event of a corporate transaction (as defined in the Notes) or a repayment
−Removed: of the Notes and accrued interest at maturity, the pre-money valuation of the Company’s common stock, the probabilities of such
−Removed: exit events occurring, and discounts/premiums available to the Holders at such measurement dates.
−Removed: The calculation of the redemption liability
−Removed: prior to the IPO was based upon the actual incremental value derived by the Holders at the IPO date.
−Removed: The balance of approximately $ 980,000
−Removed: as of the date of the IPO was converted into common stock in connection with the related-party convertible debt to which it related.
3 – Common Stock
4 unchanged sentences
of State and approved by the Company’s board of directors and stockholders.
−Removed: The par value of the Company’s common stock was
−Removed: not adjusted as a result of the reverse stock split.
−Removed: January 14, 2022, the Company closed the IPO pursuant to which it issued 150,000 shares of its common stock at a public offering price
−Removed: of $ 100.00 per share.
−Removed: The gross proceeds to the Company from the IPO were $ 15.0 million, prior to deducting underwriting discounts of
−Removed: approximately $ 1.1 million and commissions and other offering expenses of approximately $ 1.0 million.
−Removed: Other offering expenses include
−Removed: deferred offering costs of approximately $ 547,000 that were capitalized and additional costs incurred prior to the date of the IPO.
−Removed: net proceeds to the Company from the IPO were approximately $ 12.5 million.
−Removed: The Company granted the underwriters a 45-day option to purchase
−Removed: up to an additional 22,500 shares of common stock at the public offering price less discounts and commissions, to cover over-allotments;
−Removed: however, this option expired unexercised.
−Removed: Additionally, and as a result of the completion of the IPO, all of the Company’s convertible
−Removed: debt and accrued interest was converted into an aggregate of 49,015 shares of the Company’s common stock pursuant to the terms
−Removed: of the Notes.
−Removed: Outstanding principal of approximately $ 3.7 million, accrued interest of approximately $ 187,000 , and a redemption liability
−Removed: of approximately $ 980,000 were converted to common stock as the IPO qualified as a Next Equity Financing.
−Removed: In addition, the Company issued
−Removed: warrants in connection with the IPO.
−Removed: See Note 6 to the consolidated financial statements for a discussion of the warrants issued.
+Added: Further, on May 24, 2024, the Company effectuated an
+Added: additional reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an amendment to the Company’s Certificate
+Added: of Incorporation filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders.
+Added: The par value of the Company’s common stock was not adjusted as a result of either reverse stock split.
February 16, 2022, the Company entered into an agreement for marketing and investor related consulting services.
8 unchanged sentences
closing value of the Company’s common stock prior to the renewal date) representing compensation expense of $ 100,000 .
−Removed: June 9, 2022, the Company’s Board of Directors authorized the repurchase of up to $ 1,000,000 shares of the Company’s common
−Removed: stock until December 31, 2022.
−Removed: On June 10, 2022, the Company entered into a Repurchase Agreement (the “Repurchase Agreement”)
−Removed: with a financial institution pursuant to which such financial institution was able to purchase shares of the Company’s common stock
−Removed: upon the terms and conditions set forth in such agreement, including in accordance with the guidelines specified in Rules 10b5-1 and
−Removed: 10b-8 under the Securities Exchange Act of 1934, as amended.
−Removed: Shares of the Company’s common stock could be repurchased in open
−Removed: market or through privately-negotiated transactions.
−Removed: Pursuant to the Repurchase Agreement, the financial institution was to cease purchasing
−Removed: shares of the Company’s common stock upon the earlier of (i) the close of trading on December 31, 2022, (ii) the completion of
−Removed: repurchases up to the approved amount and (iii) the date upon which the Company gave notice of termination of the Repurchase Agreement
−Removed: to the financial institution.
−Removed: The Company determined the timing and amount of any repurchases based upon its evaluation of market conditions,
−Removed: applicable SEC guidelines and regulations, and other factors.
−Removed: the year ended December 31, 2022, the Company purchased 3,633 shares of its common stock, respectively, for a total purchase cost of
−Removed: approximately $ 70,000 .
March 17, 2023, the Company filed a Registration Statement on Form S-3 with the SEC using a “shelf” registration process
4 unchanged sentences
price of $ 188.00 per share.
−Removed: The gross proceeds to the Company from the public offering were approximately $ 2.7 million, prior to deducting
+Added: The gross proceeds to the Company from the May Offering were approximately $ 2.7 million, prior to deducting
underwriting discounts and commissions of approximately $ 186,000 and other offering expenses of approximately $ 417,000 .
The net proceeds
−Removed: to the Company from the public offering were approximately $ 2.1 million.
+Added: to the Company from the May Offering were approximately $ 2.1 million.
The Company granted the underwriters a 45-day option to purchase
5 unchanged sentences
average closing value of the Company’s common stock prior to the agreement date).
−Removed: November 30, 2023, the Company closed a public offering pursuant to which it issued 1,825,000 shares of its common stock at a public
−Removed: offering price of $ 1.00 per share and pre-funded warrants to purchase up to 8,175,000 shares of the Company’s common stock, exercisable
−Removed: at an exercise price of $ 0.001 per share, to those purchasers whose purchase of common stock in the offering would otherwise result in
−Removed: the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99 % (or, at the election of
−Removed: the purchaser, 9.99 %) of the Company’s outstanding common stock immediately following the consummation of the offering.
−Removed: proceeds to the Company from the public offering were approximately $ 10 million, prior to deducting underwriting discounts, commissions,
−Removed: and other expenses of approximately $ 1.3 million.
−Removed: The net proceeds to the Company from the public offering were approximately $ 8.7 million.
+Added: November 30, 2023, the Company closed a public offering pursuant to which it issued 121,667 shares of its common stock at a public offering
+Added: price of $ 15.00 per share and pre-funded warrants to purchase up to 545,000 shares of the Company’s common stock, exercisable at
+Added: an exercise price of $ 0.015 per share, to those purchasers whose purchase of common stock in the offering would otherwise result in the
+Added: purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the
+Added: purchaser, 9.99%) of the Company’s outstanding common stock immediately following the consummation of the offering.
+Added: The gross proceeds
+Added: to the Company from the November Offering were approximately $ 10.0 million, prior to deducting underwriting discounts, commissions, and
+Added: other expenses of approximately $ 1.3 million.
+Added: The net proceeds to the Company from the November Offering were approximately $ 8.7 million.
The Company granted the underwriters a 45-day option to purchase up to an additional 100,000 shares of common stock and/or pre-funded
warrants, to cover over-allotments.
−Removed: The underwriter exercised the option to purchase 1,000,000 pre-funded warrants to purchase shares
−Removed: of the Company’s common stock for gross proceeds of $ 1 million, prior to deducting underwriting discounts and commissions of approximately
+Added: The underwriter exercised the option to purchase 66,667 pre-funded warrants to purchase shares of
+Added: the Company’s common stock for gross proceeds of $ 1.0 million, prior to deducting underwriting discounts and commissions of approximately
+Added: January 24, 2024, pursuant to a corporate advisory consulting agreement, the Company issued 3,334 shares of its common stock with a per
+Added: share value of $ 6.16 , representing total compensation expense of $ 20,550 (as calculated based on the closing value of the Company’s
+Added: common stock at the effective transfer date).
+Added: June 7, 2024, the Company entered into the ATM Agreement with Rodman & Renshaw LLC (the “ATM Sales Manager”) under which
+Added: the Company may sell, from time to time through the ATM Sales Manager, shares of common stock in one or more offerings up to a total
+Added: dollar amount of $ 1.65 million.
+Added: Sales of shares of the Company’s common stock through the ATM Sales Manager, if any, will be made
+Added: by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities
+Added: Act of 1933, as amended (the “Securities Act”), including without limitation sales made directly on the Nasdaq Stock Market
+Added: LLC or any other existing trading market for the common shares.
+Added: The Company’s common stock is being offered and sold pursuant to
+Added: the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus declared effective by the U.S.
+Added: Securities and Exchange Commission (the “SEC”) on March 24, 2023, and pursuant to a prospectus supplement dated June 7, 2024.
+Added: June 21, 2024, the Company closed a private placement offering with certain accredited investors of $ 2.08 million of the Company’s
+Added: securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the Company’s
+Added: common stock and warrants to acquire shares of the Company’s common stock.
+Added: Pursuant to the June 2024 PIPE Offering, the Company
+Added: issued 207,292 shares of its common stock at an offering price of $ 3.16 per share, pre-funded warrants to purchase up to 452,253 shares
+Added: of the Company’s common stock (the “June 2024 Pre-Funded Warrants”), exercisable at $ 0.001 per share, and warrants
+Added: to purchase up to 329,771 shares of the Company’s common stock, exercisable at $ 3.09 (the “June 2024 PIPE Warrants”).
+Added: Net proceeds to the Company from the PIPE Offering were approximately $ 1.8 million, after a deduction of approximately $ 268,000 in offering
+Added: In addition, the Company issued placement agent warrants to purchase up to 19,786 shares of the Company’s common stock,
+Added: exercisable at $ 3.09 per share (the “June 2024 Placement Agent Warrants”).
+Added: December 9, 2024, the Company closed an additional private placement offering with certain accredited investors of $ 2.02 million of the
+Added: Company’s securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the
+Added: Company’s common stock and warrants to acquire shares of the Company’s common stock.
+Added: Pursuant to the December 2024 PIPE Offering,
+Added: the Company issued 470,289 shares of its common stock at an offering price of $ 2.101 per share, pre-funded warrants to purchase up to
+Added: 491,157 shares of the Company’s common stock (the “December 2024 Pre-Funded Warrants”), exercisable at $ 0.001 per share,
+Added: and warrants to purchase up to 480,721 shares of the Company’s common stock, exercisable at $ 2.031 (the “December 2024 PIPE
+Added: Net proceeds to the Company from the PIPE Offering were approximately $ 1.8 million, after a deduction of approximately
+Added: $ 0.2 million in offering costs.
+Added: December 20, 2024, the Company sold 40,000
+Added: shares of its common stock under the ATM Agreement at an offering price of $ 2.0892
+Added: per share (the “ATM Sale”).
+Added: Net proceeds from the ATM Sale were $ 73,189 ,
+Added: after deducting fees and other offering costs.
4 – Stock Based Compensation
5 unchanged sentences
be issued pursuant to the 2017 Plan.
−Removed: Company has granted options to acquire 3,712 shares of common stock at $ 330 per share under the 2017 Plan, and 76 shares remain available
−Removed: for issuance.
−Removed: As of December 31, 2023 and 2022, there were options outstanding to acquire 3,712 shares of common stock.
−Removed: As of December
−Removed: 31, 2023 and 2022, all such options were fully vested, and the weighted average remaining contractual life for such options was approximately
−Removed: 4.2 and 5.2 years, respectively.
+Added: Company has granted options to acquire 255 shares of common stock at $ 4,950 per share under the 2017 Plan, and 6 options to acquire shares
+Added: of common stock remain available for issuance.
+Added: As of December 31, 2024 and 2023, there were options outstanding to acquire 255 shares
+Added: of common stock.
+Added: As of December 31, 2024 and 2023, all such options were fully vested, and the weighted average remaining contractual
+Added: life for such options was approximately 3.2 and 4.2 years, respectively.
July 2019, the Company authorized an additional plan, the 2019 Stock Incentive Plan (the “2019 Plan”).
−Removed: The Company initially
−Removed: reserved 11,363 shares of its common stock for issuance pursuant to the 2019 Plan in the form of incentive stock options, non-statutory
−Removed: stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units
−Removed: to employees, directors, and consultants of the Company and its affiliates.
−Removed: On August 30, 2019, the Company approved an increase in the
−Removed: number of shares authorized for issuance under the 2019 Plan by 22,980 shares.
−Removed: In January 2021, the Company approved an increase in the
−Removed: number of shares reserved for issuance under the 2019 Plan by 22,980 shares.
−Removed: On May 31, 2021, the Company approved an increase in the
−Removed: number of shares reserved for issuance under the 2019 Plan by 18,687 shares.
−Removed: As of December 31, 2023 and 2022, a total of 156,060 shares
−Removed: were authorized for issuance under the 2019 Plan.
−Removed: of December 31, 2023 and 2022, the Company has granted options to acquire 156,060 and 135,455 shares of common stock under the 2019 Plan,
−Removed: respectively, and had 0 and 20,605 shares of common stock remain available for issuance under the 2019 Plan, respectively.
−Removed: stock options outstanding to acquire 82,046 and 61,440 shares of common stock with weighted-average exercise prices of $ 73.66 and $ 95.09
−Removed: and weighted average contractual terms of 7.8 years and 8.4 years at December 31, 2023 and 2022, respectively.
+Added: Under the 2019 Plan,
+Added: the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation rights,
+Added: restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates.
+Added: At both December 31, 2024 and December 31, 2023, a total of 10,452 shares were authorized for issuance under the 2019 Plan.
+Added: of December 31, 2024 and 2023, the Company has granted options to acquire 10,452 shares of common stock under the 2019 Plan and 0 shares
+Added: of common stock remain available for issuance under the 2019 Plan.
+Added: There are stock options outstanding to acquire 5,512 shares of common
+Added: stock with a weighted-average exercise price of $ 1,105.50 and weighted average contractual terms of 6.8 years and 7.8 years at December
+Added: 31, 2024 and 2023, respectively.
August 17, 2023, the Company authorized a new plan, the Tharimmune, Inc.
2023 Omnibus Incentive Plan (the “2023 Plan”).
−Removed: the Company’s 2023 Plan, the Company may grant incentive stock options, non-statutory stock options, rights to purchase common
−Removed: stock, stock appreciation rights, restricted stock, performance shares, and performance units to employees, directors, and consultants
−Removed: of the Company and its affiliates.
−Removed: Up to 2,600,000 shares of the Company’s common stock may initially be issued pursuant to the
−Removed: the year ended December 31, 2023, the Company granted options to acquire 5,000 shares of common stock under the 2023 Plan, and 2,595,000
−Removed: shares of common stock remain available for issuance under the 2023 Plan at December 31, 2023.
−Removed: There are stock options outstanding to
−Removed: acquire 5,000 shares of common stock with a weighted-average exercise price of $ 3.94 and a weighted-average contractual term of 9.9 years
−Removed: at December 31, 2023.
+Added: the 2023 Plan, the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation
+Added: rights, restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates.
+Added: Initially, options to purchase up to 6,934 shares of the Company’s common stock were available to be issued pursuant to the 2023
+Added: Under an amendment to the 2023 Plan by vote of the Company’s stockholders on May 14, 2024, an amended total of up to 173,600
+Added: options to purchase shares of the Company’s common stock may be issued pursuant to the 2023 Plan.
+Added: In addition, under the amendment,
+Added: an “evergreen” provision was added to automatically increase the number of shares available under the 2023 Plan on January
+Added: 1 annually, beginning January 1, 2025 and ending January 1, 2033, equal to the lesser of five percent of the shares of Common Stock outstanding
+Added: (on an as-converted basis) on the final day of the immediately preceding calendar year or such lesser number of shares of the Company’s
+Added: Common Stock as determined by the Board of Directors.
+Added: Effective January 1, 2025, an additional 98,688 options to purchase shares of the
+Added: Company’s common stock were added to the 2023 Plan.
+Added: the year ended December 31, 2024, the Company granted 102,853 options to acquire shares of common stock under the 2023 Plan.
+Added: 31, 2024 and 2023, 70,412 and 6,934 shares of common stock remain available for issuance under the 2023 Plan, respectively.
+Added: stock options outstanding to acquire 103,188 and 335 shares of common stock with a weighted-average exercise price of $ 3.11 and $ 59.14
+Added: and weighted-average contractual terms of 9.6 years and 9.9 years at December 31, 2024 and 2023, respectively.
following table summarizes stock-based activities under the 2017, 2019, and 2023 Stock Incentive Plans:
Schedule of Stock Option Activity
−Removed: at December 31, 2021
−Removed: Forfeited/cancelled
Outstanding at December 31, 2022
−Removed: at December 31, 2023
−Removed: options at December 31, 2023
−Removed: and expected to vest at December 31, 2023
+Added: Outstanding at December 31, 2023
+Added: Outstanding at December 31, 2024
+Added: Exercisable options at December 31, 2024
+Added: Vested and expected
+Added: to vest at December 31, 2024
fair value of stock option awards is estimated at the date of grant using the Black-Scholes option-pricing model.
10 unchanged sentences
the years ended December 31,
−Removed: interest rate
−Removed: dividend yield
−Removed: life of options in years
−Removed: fair value of options granted
−Removed: weighted-average grant date fair value of stock options granted during the years ended December 31, 2023 and 2022 was approximately $ 6.41
+Added: Expected volatility
+Added: Risk-free interest rate
+Added: Expected dividend yield
+Added: Expected life of options in years
+Added: Estimated fair value of options granted
+Added: weighted-average grant date fair value of stock options granted during years ended December 31, 2024 and 2023 was approximately $ 2.23
and $ 96.04 , respectively.
1 unchanged sentence
approximately $ 16.38 and $ 95.97 , respectively.
−Removed: in the above table are performance-based stock options granted in 2019 to purchase 9,242 shares of the Company’s common stock at
−Removed: an exercise price of $ 1.98 per share, which vested upon completion of the Company’s IPO in 2022.
stock-based compensation expense included in the accompanying consolidated statements of operations was as follows:
1 unchanged sentence
the years ended December 31,
−Removed: and development
−Removed: and administrative
−Removed: stock-based compensation
+Added: Research and development
+Added: General and administrative
+Added: Total stock-based compensation
of December 31, 2024, the total unrecognized compensation expense related to non-vested options was approximately $ 0.8 million and is
1 unchanged sentence
connection with the IPO, the Company issued warrants to purchase such number of shares of the Company’s common stock equal to 5%
−Removed: of the total shares of common stock issued in the IPO.
−Removed: The warrants are exercisable at $ 125.00 per share, were not exercisable within
−Removed: the first six months after issuance, and may, under certain circumstances, be exercised on a cashless basis.
−Removed: The exercise price of the
−Removed: warrants is subject to standard antidilutive provision adjustments for stock splits, stock combinations, or similar events affecting
−Removed: the Company’s common stock.
−Removed: The Company has determined that these warrants should be classified as equity instruments since they
−Removed: do not require the Company to repurchase the underlying common stock and do not require the Company to issue a variable amount of common
+Added: of the total shares of common stock issued in the IPO, or 500 warrants.
+Added: The warrants are exercisable at $ 1,875.00 per share, were not
+Added: exercisable within the first six months after issuance, and may, under certain circumstances, be exercised on a cashless basis.
+Added: price of the warrants is subject to standard antidilutive provision adjustments for stock splits, stock combinations, or similar events
+Added: affecting the Company’s common stock.
+Added: The Company has determined that these warrants should be classified as equity instruments
+Added: since they do not require the Company to repurchase the underlying common stock and do not require the Company to issue a variable amount
+Added: of common stock.
In addition, these warrants are indexed to common stock and do not have any unusual antidilution rights.
−Removed: connection with the May 2, 2023 public offering as described in Note 5 to the consolidated financial statements, the Company issued warrants
−Removed: to designees of the underwriter (the “Representative’s Warrants”) to purchase 6,360 shares of the Company’s common
−Removed: stock (which is equal to 3 % of the number of shares sold in the public offering) at an initial exercise price of $ 15.625 per share, subject
−Removed: to adjustment.
−Removed: The Representative’s Warrants are exercisable at any time and from time to time, in whole or in part, during the
−Removed: four and one half year period commencing 180 days from the commencement of sales of the shares of common stock in the public offering.
−Removed: connection with the November 30, 2023 public offering as described in Note 5 to the consolidated financial statements, the Company issued
−Removed: pre-funded warrants to purchase 8,175,000 shares of the Company’s common stock at an exercise price of $ 0.001 (the “Pre-Funded
−Removed: The Pre-Funded Warrants were issued to those purchasers whose purchase of common stock in the November Offering would
−Removed: otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99 % (or,
−Removed: at the election of the purchaser, 9.99 %) of outstanding common stock immediately following the consummation of the offering.
−Removed: The Pre-Funded
−Removed: Warrants were immediately exercisable and could be exercised at any time until exercised in full.
−Removed: The Company also granted the underwriters
−Removed: a 45-day option to purchase up to an additional 1,500,000 shares of common stock and/or prefunded warrants.
−Removed: The underwriters exercised
−Removed: the option to purchase 1,000,000 pre-funded warrants at an initial exercise price of $ 0.001 per share, subject to adjustment (the “Underwriters
−Removed: Pre-Funded Warrants”).
−Removed: These pre-funded warrants were immediately exercisable and could be exercised at any time until exercised
−Removed: The underwriters received warrants to purchase 300,000 shares of common stock with an initial exercise price of $ 1.25 , exercisable
−Removed: beginning May 27, 2024, and expiring May 2, 2028 (the “Underwriters Warrants”).
−Removed: As of December 31, 2023, all of the Pre-Funded
−Removed: Warrants and the Underwriters Pre-Funded Warrants have been exercised.
+Added: connection with the May 2023 Offering as described in Note 3 to the consolidated financial statements, the Company issued warrants to
+Added: designees of the underwriter (the “Representative’s Warrants”) to purchase 424 shares of the Company’s common
+Added: stock (which is equal to 3% of the number of shares sold in the public offering) at an initial exercise price of $ 234.375 per share,
+Added: subject to adjustment.
+Added: The Representative’s Warrants are exercisable at any time and from time to time, in whole or in part, during
+Added: the four- and one-half year period commencing 180 days from the commencement of sales of the shares of common stock in the public offering.
+Added: connection with the November 2023 Offering as described in Note 3 to the consolidated financial statements, the Company issued pre-funded
+Added: warrants to purchase 545,000 shares of the Company’s common stock at an exercise price of $ 0.015 (the “November 2023 Pre-Funded
+Added: The November 2023 Pre-Funded Warrants were issued to those purchasers whose purchase of common stock in the November
+Added: 2023 Offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning
+Added: more than 4.99% (or, at the election of the purchaser, 9.99%) of outstanding common stock immediately following the consummation of the
+Added: The November 2023 Pre-Funded Warrants were immediately exercisable and could be exercised at any time until exercised in full.
+Added: The Company also granted the underwriters a 45-day option to purchase up to an additional 100,000 shares of common stock and/or prefunded
+Added: The underwriters exercised the option to purchase 66,667 pre-funded warrants at an initial exercise price of $ 0.015 per share,
+Added: subject to adjustment (the “November 2023 Underwriters Pre-Funded Warrants”).
+Added: These pre-funded warrants were immediately
+Added: exercisable and could be exercised at any time until exercised in full.
+Added: The underwriters received warrants to purchase 20,000 shares
+Added: of common stock with an initial exercise price of $ 18.75 , exercisable beginning May 27, 2024 , and expiring May 2, 2028 (the “November
+Added: 2023 Underwriters Warrants”).
+Added: As of December 31, 2024 and 2023, all of the November 2023 Pre-Funded Warrants and the November 2023
+Added: Underwriters Pre-Funded Warrants have been exercised and the additional warrants to purchase 20,000 shares of common stock have not yet
+Added: been exercised.
+Added: connection with the June 2024 PIPE Offering as described in Note 3 to the consolidated financial statements, the Company issued the June
+Added: 2024 Pre-Funded Warrants to purchase 452,253 shares of the Company’s common stock at an exercise price of $ 0.001 , the June 2024
+Added: PIPE Warrants to purchase 329,771 shares of the Company’s common stock at an exercise price of $ 3.09 , and the June 2024 Placement
+Added: Agent Warrants to purchase up to 19,786 shares of the Company’s common stock, exercisable at $ 3.09 per share.
+Added: The June 2024 Pre-Funded
+Added: Warrants were immediately exercisable and are able to be exercised at any time until exercised in full.
+Added: The June 2024 PIPE Warrants and
+Added: June 2024 Placement Agent Warrants were immediately exercisable and are able to be exercised until five and a half years from the effective
+Added: date, or December 21, 2029.
+Added: As of December 31, 2024, 368,533 of the June 2024 Pre-Funded Warrants have been exercised and none of the
+Added: June 2024 PIPE Warrants or June 2024 Placement Agent Warrants have been exercised.
+Added: connection with the December 2024 PIPE Offering as described in Note 3 to the consolidated financial statements, the Company issued the
+Added: December 2024 Pre-Funded Warrants to purchase 491,157 shares of the Company’s common stock at an exercise price of $ 0.001 and the
+Added: December 2024 PIPE Warrants to purchase 480,721 shares of the Company’s common stock at an exercise price of $ 2.031 .
+Added: 2024 Pre-Funded Warrants were immediately exercisable and are able to be exercised at any time until exercised in full.
+Added: 2024 PIPE Warrants are exercisable six months from the date of issuance and are able to be exercised until five and a half years from
+Added: the effective date, or December 9, 2030.
+Added: As of December 31, 2024, none of the December 2024 Pre-Funded Warrants and December 2024 PIPE
+Added: Warrants have been exercised.
of the warrants outstanding at December 31, 2024 are as follows:
Schedule of Warrants
+Added: November 2, 2023
+Added: November 30, 2023
+Added: November 30, 2023
+Added: November 30, 2023
+Added: November 30, 2023
+Added: November 30, 2023
+Added: June 21, 2024
+Added: June 21, 2024
+Added: June 21, 2024
+Added: June 21, 2024
+Added: December 21, 2029
+Added: December 9, 2024
+Added: December 9, 2030
+Added: December 9, 2024
+Added: December 9, 2024
5 – Income Taxes
9 unchanged sentences
the years ended December 31, 2024 and 2023, respectively.
−Removed: significant components of the Company’s deferred tax assets and liabilities as of December
−Removed: 31, 2023 and 2022 were as follows:
+Added: significant components of the Company’s deferred tax assets and liabilities as of December 31, 2023 and 2022 were as follows:
Schedule of Significant Components of Company’s Deferred Tax Assets
−Removed: tax asset (liabilities) related to:
−Removed: tax asset (liabilities) related to:
−Removed: net operating loss carryforward
−Removed: net operating loss carryforward
−Removed: in-process research and development
−Removed: and development credit
+Added: Deferred tax asset (liabilities) related to:
+Added: Deferred tax asset (liabilities) related to:
+Added: operating loss carryforward
+Added: State net operating loss
+Added: Capitalized costs
+Added: Acquired in-process research
+Added: and development
+Added: Research and development
+Added: Stock compensation
expenses and other
−Removed: deferred tax assets
+Added: Total deferred tax assets
( 10,189,000 )
7 unchanged sentences
the years ended December 31,
−Removed: tax benefit at the federal statutory rate
+Added: Income tax benefit at the federal
+Added: statutory rate
$ ( 2,550,000 )
$ ( 1,957,000 )
−Removed: differences and other
−Removed: and development credit
−Removed: in valuation allowance
−Removed: income tax expense
+Added: Permanent differences and other
+Added: State income taxes
+Added: Research and development credit
+Added: Change in valuation allowance
+Added: Effective income tax
valuation allowance is required to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely
3 unchanged sentences
2024 and 2023, respectively, were necessary to reduce the deferred tax assets to the amount that will more likely than not be realized.
−Removed: December 31, 2023 and 2022, the Company had available net operating loss carryforwards of approximately $ 14.4
−Removed: million and $ 9.3
+Added: December 31, 2024 and 2023, the Company had available net operating loss carryforwards of approximately $ 20.3 million and $ 14.4 million,
respectively, for federal income tax purposes, all of which were generated after 2017 and can be carried forward indefinitely under the
Tax Cuts and Jobs Act.
−Removed: At December 31, 2023 and 2022, the Company had approximately $ 243,000
−Removed: federal research and development (“R&D”) tax credit carryforwards.
−Removed: If not utilized, the federal R&D credits will
−Removed: begin to expire in 2038.
−Removed: The Company also had $ 14.9
−Removed: of state net operating losses that will begin to expire in 2037.
+Added: At December 31, 2024 and 2023, the Company had approximately $ 382,000 and $ 243,000 of federal research and development
+Added: (“R&D”) tax credit carryforwards.
+Added: If not utilized, the federal R&D credits will begin to expire in 2038.
+Added: also had $ 20.3 million and $ 14.9 million of state net operating losses that will begin to expire in 2037.
382 and 383 of the Internal Revenue Code, and similar state regulations, contain provisions that may limit the NOL carryforwards available
5 unchanged sentences
it is likely that such an ownership change occurred during 2021.
−Removed: The Tax Cuts and Jobs Act
−Removed: of 2017 (“TCJA”) has modified the IRC 174 expenses related to research and development for the tax years beginning after December
−Removed: Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize
−Removed: over five years for U.S.
+Added: Tax Cuts and Jobs Act of 2017 (“TCJA”) has modified the IRC 174 expenses related to research and development for the tax
+Added: years beginning after December 31, 2021.
+Added: Under the TCJA, the Company must now capitalize the expenditures related to research and development
+Added: activities and amortize over five years for U.S.
activities and 15 years for non-U.S.
activities using a mid-year convention.
−Removed: Therefore, the capitalization of
−Removed: research and development costs in accordance with IRC 174 results in a gross deferred tax asset of $ 4,487,000 .
−Removed: 8 – Related-Party Transactions
−Removed: described in Note 3 to the consolidated financial statements, the Company entered into the Notes with the Holders commencing in May 2017.
−Removed: The Holders of substantially all of the Notes were the Company’s founder and CEO, a member of the Company’s board of directors,
−Removed: and third parties that are family members of the founder and CEO.
−Removed: The Notes were converted into shares of the Company’s common
−Removed: stock on January 14, 2022 in connection with the closing of the IPO.
−Removed: addition to the above Notes, the Company had amounts due to the founder and CEO that totaled $ 200,000 at December 31, 2021 for accrued
−Removed: compensation, which was paid in full in April 1, 2022.
−Removed: January 4, 2022 and January 6, 2022, the Company issued unsecured promissory notes in the aggregate principal amount of approximately
−Removed: $ 139,000 (including an original issuance discount of an aggregate of approximately $ 14,000 ) to three related-party investors.
−Removed: were to accrue interest at a rate of 12 % per annum and mature upon the earlier of (i) June 30, 2022, and (ii) the closing of a subsequent
−Removed: equity financing.
−Removed: “Subsequent equity financing” means the next sale (or series of related sales) by the Company of its equity
−Removed: securities following the date of the notes pursuant to which the Company receives gross proceeds of not less than $ 5.0 million.
−Removed: were repaid in full on January 21, 2022 following the Company’s IPO on January 14, 2022 as the IPO was considered a subsequent
−Removed: Equity Financing.
−Removed: Additionally,
−Removed: on April 18, 2022, the founder and CEO exercised options to purchase up to 9,621 shares of the Company’s common stock at a weighted-average
−Removed: exercise price of $ 2.53 per share for a total of approximately $ 24,000 .
+Added: the capitalization of research and development costs in accordance with IRC 174 results in a gross deferred tax asset of $ 6,961,000 .
6 – Commitments and Contingencies
46 unchanged sentences
to the ABSI Agreement:
−Removed: (i) the Company issued ABSI 25,107 shares of its common stock which is equal to $ 250,000 based on the ten day
−Removed: trailing volume weighted-average price of the Company’s common stock prior to the date of issuance (see Note 5 to the consolidated
−Removed: financial statements for details of the July 27, 2023 issuance of the Company’s common stock to ABSI);
−Removed: (ii) in the event the Company
−Removed: closes a financing pursuant to which it receives more than $ 10 million in Net Proceeds (as defined in the ABSI Agreement), the Company
−Removed: shall pay ABSI a mid six digit amount;
−Removed: (iii) upon the achievement of certain milestones as set forth in the ABSI Agreement, the Company
−Removed: shall pay ABSI up to an aggregate of $ 8,250,000 ;
−Removed: (iv) after the second anniversary of the ABSI Effective Date, the Company shall pay
−Removed: ABSI a low five digit amount for the first year and a mid five digit amount thereafter during the Royalty Term (as defined in the ABSI
−Removed: and (v) during the Royalty Term for each Product, the Company shall pay ABSI a quarterly royalty on the Net Sales (as defined
−Removed: in the ABSI Agreement) with royalties at percentages which range from the low to mid single digits, with high Net Sales being subject
−Removed: to lower royalty rates, subject to adjustment as set forth in the ABSI Agreement.
−Removed: In addition, in the event the Company transfers all
−Removed: or substantially all of its rights to a Product to a third party, the Company shall pay to ABSI the percentage of Net Proceeds attributable
−Removed: to the transfer of the Product.
−Removed: Specifically, the Company shall pay ABSI amounts at percentages which range from the mid single digit
−Removed: to low double digits depending on the Company Expenses (as defined in the ABSI Agreement), with higher Company Expenses being subject
−Removed: to lower rates.
+Added: (i) the Company issued ABSI 25,107
+Added: shares of its common stock which is equal to $ 250,000
+Added: based on the ten day trailing volume weighted-average price of the Company’s common stock prior to the date of issuance (see
+Added: Note 3 to the consolidated financial statements for details of the July 27, 2023 issuance of the Company’s common stock to
+Added: (ii) in the event the Company closes a financing pursuant to which it receives more than $ 10
+Added: million in Net Proceeds (as defined in the ABSI Agreement), the Company paid ABSI an up front license fee of $ 250,000 ;
+Added: (iii) upon the achievement
+Added: of certain milestones as set forth in the ABSI Agreement, the Company shall pay ABSI up to an aggregate of $ 8,250,000 ;
+Added: (iv) after the second anniversary of the ABSI Effective Date, the Company shall pay ABSI a low five digit amount for the first year
+Added: and a mid-five digit amount thereafter during the Royalty Term (as defined in the ABSI Agreement);
+Added: and (v) during the Royalty Term
+Added: for each Product, the Company shall pay ABSI a quarterly royalty on the Net Sales (as defined in the ABSI Agreement) with royalties
+Added: at percentages which range from the low to mid-single digits, with high Net Sales being subject to lower royalty rates, subject to
+Added: adjustment as set forth in the ABSI Agreement.
+Added: In addition, in the event the Company transfers all or substantially all of its
+Added: rights to a Product to a third party, the Company shall pay to ABSI the percentage of Net Proceeds attributable to the transfer of
+Added: Specifically, the Company shall pay ABSI amounts at percentages which range from the mid-single digit to low double
+Added: digits depending on the Company Expenses (as defined in the ABSI Agreement), with higher Company Expenses being subject to lower
a Product-by-Product basis, upon the expiration of the last Royalty Term of such Product in the Territory, licenses granted to the Company
8 unchanged sentences
such agreement will terminate and all rights under such licenses shall revert to ABSI.
+Added: March 11, 2024, the Company entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $ 50,000
+Added: beginning March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter.
+Added: During the year ended December
+Added: 31, 2024, the Company made payments of $ 200,000 to ABSI.
the year ended December 31, 2023, the Company paid milestone fees of $ 500,000 to ABSI in accordance with the terms of the agreement,
1 unchanged sentence
Patent License Agreement
−Removed: November 3, 2023 (the “Avior Effective Date”), the Company entered into the Avior Patent License Agreement with Avior pursuant
−Removed: to which the Company received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among
−Removed: other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the
−Removed: Licensed Technology in connection with the foregoing, throughout the world.
−Removed: Pursuant to the Avior Patent License Agreement, the Company
−Removed: shall pay Avior a mid six digit up front license fee within ten days of the Avior Effective Date and an additional mid six digit license
−Removed: fee which shall be paid in four equal installments within ten days of the end of each fiscal quarter following the Avior Effective Date.
−Removed: In addition, the Company shall pay Avior a high single digit percentage of any upfront payments received by it as a result of the grant
−Removed: of any sublicenses with respect to TH104.
−Removed: The Company shall also pay Avior milestone payments in the aggregate amount of $ 24,250,000
+Added: November 3, 2023 (the “Avior Effective Date”), the Company entered into the Avior Patent License Agreement with Avior
+Added: pursuant to which the Company received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed
+Added: Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and
+Added: TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world.
+Added: Pursuant to the Avior Patent
+Added: License Agreement, the Company shall paid Avior an up front license fee of $ 400,000 within ten days of the Avior Effective Date and
+Added: an additional mid six-digit license fee which shall be paid in four equal installments within ten days of the end of each fiscal
+Added: quarter following the Avior Effective Date.
+Added: In addition, the Company shall pay Avior a high single digit percentage of any upfront
+Added: payments received by it as a result of the grant of any sublicenses with respect to TH104.
+Added: The Company shall also pay Avior
+Added: milestone payments in the aggregate amount of $ 24,250,000
upon the occurrence of various development milestones (the “Development Milestone Payments”).
−Removed: Furthermore, the Company shall
−Removed: pay Avior certain fees based upon sales milestones.
−Removed: The payments for such sales milestones range from the low seven digits to the low
−Removed: eight digits with higher sales being subject to higher fees.
−Removed: Finally, the Company shall pay Avior royalties based on net sales.
−Removed: royalties range from low single digit percentages to mid single digit percentages with higher sales being subject to lower percentages.
−Removed: The Avior Patent License Agreement shall expire upon the expiration of the final payment obligation due to Avior as set forth in such
−Removed: Upon the expiration of the Avior Patent License Agreement, the Company shall have a fully paid, irrevocable, freely transferable
−Removed: and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made,
−Removed: use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have commercialized any
−Removed: and all Licensed Products and to practice the Licensed Technology worldwide.
−Removed: Pursuant to the Avior Patent License Agreement, the Company
−Removed: may terminate the agreement at any time without cause, upon 30 days’ prior written notice to Avior along with payment of the next
−Removed: unpaid Development Milestone Payment, if any.
−Removed: Furthermore, either the Company or Avior may terminate the Avior Patent License Agreement
−Removed: (i) on written notice to the other party if the other party materially breaches any provision of the Avior Patent License Agreement and
−Removed: fails to cure such breach within 30 days after the breaching party receives written notice thereof or (ii) on written notice in the event
−Removed: that either party (A) becomes insolvent or admits its inability to pay its debts generally as they become due;
−Removed: (B) becomes subject, voluntarily
−Removed: or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated
−Removed: within 60 days;
−Removed: (C) is dissolved or liquidated or takes any corporate action for such purpose;
−Removed: (D) makes a general assignment for the
−Removed: benefit of creditors;
−Removed: or (E) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction
−Removed: to take charge of or sell any material portion of its property or business.
+Added: Furthermore, the Company
+Added: shall pay Avior certain fees based upon sales milestones.
+Added: The payments for such sales milestones range from the low seven digits to
+Added: the low eight digits with higher sales being subject to higher fees.
+Added: Finally, the Company shall pay Avior royalties based on net
+Added: Such royalties range from low single digit percentages to mid-single digit percentages with higher sales being subject to
+Added: lower percentages.
+Added: The Avior Patent License Agreement shall expire upon the expiration of the final payment obligation due to Avior
+Added: as set forth in such agreement.
+Added: Upon the expiration of the Avior Patent License Agreement, the Company shall have a fully paid,
+Added: irrevocable, freely transferable and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to
+Added: Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have
+Added: exported, commercialize or have commercialized any and all Licensed Products and to practice the Licensed Technology worldwide.
+Added: Pursuant to the Avior Patent License Agreement, the Company may terminate the agreement at any time without cause, upon 30
+Added: days’ prior written notice to Avior along with payment of the next unpaid Development Milestone Payment, if any.
+Added: either the Company or Avior may terminate the Avior Patent License Agreement (i) on written notice to the other party if the other
+Added: party materially breaches any provision of the Avior Patent License Agreement and fails to cure such breach within 30 days after the
+Added: breaching party receives written notice thereof or (ii) on written notice in the event that either party (A) becomes insolvent or
+Added: admits its inability to pay its debts generally as they become due;
+Added: (B) becomes subject, voluntarily or involuntarily, to any
+Added: proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within 60 days;
+Added: is dissolved or liquidated or takes any corporate action for such purpose;
+Added: (D) makes a general assignment for the benefit of
+Added: or (E) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to
+Added: take charge of or sell any material portion of its property or business.
Upon termination of the Avior Patent License Agreement, the
−Removed: license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed Products shall revert
−Removed: back to Avior.
−Removed: the year ended December 31, 2023, the Company paid milestone fees of $ 380,000 to Avior in accordance with the terms of the agreement.
+Added: license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed Products shall
+Added: revert back to Avior.
+Added: the year ended December 31, 2024, the Company paid license fees of $ 600,000 to Avior in accordance with the terms of the agreement.
+Added: addition, during the years ended December 31, 2024 and 2023, the Company incurred milestone fees of $ 750,000 and $ 380,000 , respectively.
+Added: License Agreement
+Added: June 17, 2024 (the “Enkefalos Effective Date”), the Company signed a letter of intent to enter into the Enkefalos License
+Added: Agreement with Enkefalos Biosciences Inc.
+Added: pursuant to which the Company is licensing the global rights in all fields of use for the products
+Added: related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier and all associated know-how, technology,
+Added: intellectual property and related information and constructs, and any associated authorized generic rights and all related assets (collectively,
+Added: the “Products” referred to in this letter as ENBI-01) from Enkefalos Biosciences, Inc.
+Added: Pursuant to the Enkefalos License
+Added: Agreement, the Company shall pay Enkefalos an up-front license
+Added: fee of $ 150,000 within ten days of the Enkefalos Effective Date
+Added: and an additional license fee of $150,000 to be paid 6 months after the Enkefalos Effective Date and an annual license fee of $ 50,000 .
+Added: The Company shall also pay Enkefalos milestone payments in the aggregate amount of up to $ 8,500,000 upon the occurrence of various development
+Added: milestones (the “Enkefalos Development Milestone Payments”).
+Added: Furthermore, the Company shall pay Enkefalos royalties based
+Added: on net sales ranging from low single-digit percentages to mid-single digit percentages with higher sales being subject to lower percentages.
+Added: The Enkefalos License Agreement shall expire upon the expiration of the final payment obligation due to Enkefalos as set forth in such
+Added: agreement and upon expiration, the Company shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license
+Added: to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for sale,
+Added: have sold, import, have imported, export, have exported, commercialize or have commercialized any and all Licensed Products and to practice
+Added: the Licensed Technology worldwide.
+Added: Pursuant to the Enkefalos License Agreement, either the Company or Enkefalos may terminate the Enkefalos
+Added: License Agreement on written notice to the other party.
+Added: Upon termination of the Enkefalos License Agreement, the license granted pursuant
+Added: to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed Products shall revert back to Enkefalos.
+Added: the year ended December 31, 2024, the Company incurred license fees of $ 150,000 to Enkefalos in accordance with the terms of the agreement.
+Added: Patent License Agreement
+Added: September 11, 2024, the Company entered into a patent license agreement (the “Intract Agreement”) with Intract.
+Added: to the Intract Agreement, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal
+Added: antibody infliximab.
+Added: Under the terms of the Intract Agreement, the Company licensed global development and commercialization rights (outside
+Added: of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab
+Added: to be used in the oral product development program.
+Added: Pursuant to the Intract Agreement, the Company paid Intract an up-front license fee
+Added: of $ 400,000 and Intract is eligible to receive additional payments upon an equity financing of the Company and additional payments for
+Added: future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales.
+Added: The Agreement
+Added: retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial.
+Added: In addition, the Company
+Added: has the option to exercise the license to Intract’s platform for up to four additional targets.
+Added: The term of the Intract Agreement
+Added: expires upon the final payment obligation of Tharimmune and may be terminated by Tharimmune at any time upon 90 days written notice to
+Added: Either party may terminate the Intract Agreement if the other party materially breaches any provision of the Intract Agreement
+Added: and fails to cure such breach within thirty (30) days after the breaching party receives written notice thereof.
+Added: In addition, either
+Added: party may terminate the Intract Agreement on written notice in the event that either party declare:
+Added: (a) becomes insolvent or admits inability
+Added: to pay its debts generally as they become due;
+Added: (b) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic
+Added: or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within sixty (60) days;
+Added: (c) is dissolved or liquidated
+Added: or takes any corporate action for such purpose;
+Added: (d) makes a general assignment for the benefit of creditors;
+Added: or (e) has a receiver, trustee,
+Added: custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of
+Added: its property or business.
+Added: the year ended December 31, 2024, the Company incurred fees of $ 400,000 to Intract in accordance with the terms of the agreement.
June 1, 2021, the Company entered into an Amended and Restated Employment Agreement with the Company’s CEO, as amended periodically
16 unchanged sentences
exercise price of $ 1,500.00 per share, which options shall vest over a 48-month period commencing 12 months after the date of grant.
−Removed: shall be in addition to any additional equity-based compensation awards the Company may grant the CEO from time to time.
+Added: This shall be in addition to any additional equity-based compensation awards the Company may grant the CEO from time to time.
January 1, 2023, in lieu of half of his 2023 salary, the CEO was issued options to purchase up to 1,374 shares of the Company’s
1 unchanged sentence
July 6, 2023, the Company entered into an amended and restated employment agreement (the “CEO Employment Agreement”) with
−Removed: The Employment Agreement has the same terms as of the COO Employment Agreement (as defined below) except, the CEO shall (i)
−Removed: receive a base salary of $ 500,000 per year, which may be increased by the Board;
−Removed: and (ii) be eligible to receive an annual bonus equal
−Removed: to 60 % of his then base salary based upon the achievement of Company and individual targets to be established by the Board, in its sole
−Removed: In addition, in the event the CEO’s employment is terminated by the Company other than as a result of his death or
−Removed: Disability and other than for Cause, or if the CEO terminates his employment for Good Reason, then, in addition to the Accrued Compensation,
−Removed: the Company shall continue to pay the CEO’s base salary and provide health benefits for a period of 18 months following the termination
−Removed: date (each as defined in the CEO Employment Agreement).
−Removed: In addition, all Restricted Shares and Stock Options that have not vested as
−Removed: of the date of termination shall be forfeited and outstanding unvested time-based equity awards shall be accelerated in accordance with
−Removed: the applicable vesting schedule as if the CEO had been in service for an additional 12 months as of the termination date.
+Added: The Employment Agreement has the same terms as the COO Employment Agreement (as defined below) except, the CEO shall (i) receive
+Added: a base salary of $ 500,000 per year, which may be increased by the Board;
+Added: and (ii) be eligible to receive an annual bonus equal to 60 %
+Added: of his then base salary based upon the achievement of Company and individual targets to be established by the Board, in its sole discretion.
+Added: In addition, in the event the CEO’s employment is terminated by the Company other than as a result of his death or Disability and
+Added: other than for Cause, or if the CEO terminates his employment for Good Reason, then, in addition to the Accrued Compensation, the Company
+Added: shall continue to pay the CEO’s base salary and provide health benefits for a period of 18 months following the termination date
+Added: (each as defined in the CEO Employment Agreement).
+Added: In addition, all Restricted Shares and Stock Options that have not vested as of the
+Added: date of termination shall be forfeited and outstanding unvested time-based equity awards shall be accelerated in accordance with the
+Added: applicable vesting schedule as if the CEO had been in service for an additional 12 months as of the termination date.
connection with the appointment of the Company’s Chief Operating Officer, on July 11, 2023 (the “Effective Date”),
4 unchanged sentences
to the COO Employment Agreement, the COO shall:
−Removed: (i) receive a base salary of $ 400,000
−Removed: per year, which may be increased by the Board;
−Removed: (ii) be eligible to receive an annual bonus equal to 50 %
−Removed: of his then base salary based upon the achievement of Company and individual targets to be established by the Board, in its sole discretion;
−Removed: (iii) shall be eligible to receive equity-based compensation awards as determined by the Company;
−Removed: (iv) receive reimbursement of reasonable
−Removed: business expenses;
−Removed: and (v) receive such other benefits that the Company may make available to its senior executives from time to time
−Removed: along with vacation, sick and holiday pay in accordance with the Company’s policies established and in effect from time to time.
+Added: (i) receive a base salary of $ 400,000 per year, which may be increased by the Board;
+Added: (ii) be eligible to receive an annual bonus equal to 50 % of his then base salary based upon the achievement of Company and individual
+Added: targets to be established by the Board, in its sole discretion;
+Added: (iii) shall be eligible to receive equity-based compensation awards as
+Added: determined by the Company;
+Added: (iv) receive reimbursement of reasonable business expenses;
+Added: and (v) receive such other benefits that the Company
+Added: may make available to its senior executives from time to time along with vacation, sick and holiday pay in accordance with the Company’s
+Added: policies established and in effect from time to time.
+Added: accordance with the employment agreements, the compensation committee approved a bonus of 50 % in equity compensation and 50 % in cash
+Added: on January 13, 2025, based on corporate performance objectives earned during the year ended December 31, 2024.
+Added: The total bonus earned
+Added: for the CEO for the year ended December 31, 2024 was made up of cash of $ 156,250 and options to purchase up to 80,958 shares of the Company’s
+Added: common stock.
+Added: The total bonus earned for the COO for the year ended December 31, 2024 was made up of cash of $ 102,050 and options to
+Added: purchase up to 52,875 shares of the Company’s common stock.
+Added: The total cash bonus of $ 258,300 and total equity compensation bonus
+Added: of $ 202,122 are recorded within accrued expenses on the accompanying consolidated balance sheet at December 31, 2024.
+Added: The equity compensation
+Added: is valued at the grant and effective date of the options, which is January 13, 2025.
7 – Subsequent Events
as noted below, there were no material subsequent events that required recognition or additional disclosure in these consolidated financial
+Added: Financing Agreement
January 2025, the Company entered into an insurance premium financing agreement for $ 386,280 , with a term of 10 months and an annual
2 unchanged sentences
$ 31,914 over the term of the agreement, which matures in November 2025.
+Added: Settlement Agreement
+Added: In March 2025, the Company entered into an agreement
+Added: with its previous attorney to reduce the outstanding balance of legal fees to $ 240,000
+Added: (the “Settlement Agreement”) for amounts owed related to services performed prior to the year ended December 31, 2024.
+Added: Company will adjusts its accounts payable by $ 54,240
+Added: in the first quarter of 2025.
+Added: In accordance with the terms of the Settlement Agreement,
+Added: payments of $ 24,000 are due each month beginning in March 2025 through December 2025, at which time the full balance of $ 240,000 will
+Added: be satisfied.
+Added: If payments are not made timely or the Company becomes insolvent (defined as event of default in the Settlement Agreement),
+Added: interest will begin to accrue at a rate of 3.7 % per annum until all past due amounts have been paid in full.
+Added: No interest will accrue if
+Added: no event of default occurs.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
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.