Canton Strategic Holdings, Inc. 10-K

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA THARIMMUNE, INC. INDEX TO FINANCIAL STATEMENTS Page AUDITED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 89 ) F-2 Consolidated Balance Sheets as of December 31, 2024 and 2023 F-3 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023 F-4 Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2024 and 2023 F-5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023 F-6 Notes to Consolidated Financial Statements F-7 F- 1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of Tharimmune, Inc. Opinion on the Financial Statements We have audited the accompanying balance sheets of Tharimmune, Inc. (the Company) as of December 31, 2024 and 2023, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2024, and the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America. Substantial Doubt about the Company’s Ability to Continue as a Going Concern The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company’s limited operating history, recurring negative cash flows from operations and the Company’s need for substantial additional funding to support future operating activities raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. We have served as the Company’s auditor since 2023. /s/ Rosenberg Rich Baker Berman P.A. Somerset, New Jersey March 25, 2025 F- 2 THARIMMUNE, INC. CONSOLIDATED BALANCE SHEETS December 31, December 31, 2024 2023 ASSETS Current assets Cash $ 3,559,361 $ 10,935,352 Prepaid expenses and other current assets 45,263 11,041 Deferred offering costs 117,000 - Total current assets 3,721,624 10,946,393 Total assets $ 3,721,624 $ 10,946,393 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 1,089,666 $ 908,577 Accrued expenses 1,324,316 906,469 Total current liabilities 2,413,982 1,815,046 Total liabilities 2,413,982 1,815,046 Commitments and contingencies (see Note 6) - - Stockholders’ equity Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of December 31, 2024 and December 31, 2023 - - Common stock, $ 0.0001 par value, 250,000,000 shares authorized, 1,973,999 shares and 884,720 shares issued and 1,973,753 shares and 884,474 shares outstanding as of December 31, 2024 and December 31, 2023, respectively 198 89 Additional paid-in capital 38,278,503 33,904,749 Accumulated deficit ( 36,901,094 ) ( 24,703,526 ) Treasury stock, at cost, 246 shares held in treasury as of December 31, 2024 and 2023 ( 69,965 ) ( 69,965 ) Total stockholders’ equity 1,307,642 9,131,347 Total liabilities and stockholders’ equity $ 3,721,624 $ 10,946,393 The accompanying notes are an integral part of these consolidated financial statements. F- 3 THARIMMUNE, INC. CONSOLIDATED STATEMENTS OF OPERATIONS 2024 2023 For the Years Ended December 31, 2024 2023 Operating expenses Research and development $ 6,392,097 $ 3,559,635 General and administrative 6,041,695 5,895,585 Total operating expenses 12,433,792 9,455,220 Loss from operations ( 12,433,792 ) ( 9,455,220 ) Other income (expense) Interest expense ( 13,684 ) ( 16,505 ) Interest income 249,908 152,631 Total other income (expense), net 236,224 136,126 Net loss $ ( 12,197,568 ) $ ( 9,319,094 ) Net loss per share: Basic and diluted $ ( 9.41 ) $ ( 107.02 ) Weighted average number of common shares outstanding: Basic and diluted 1,296,290 87,079 The accompanying notes are an integral part of these consolidated financial statements. F- 4 THARIMMUNE, INC. CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED DECEMBER 31, 2024 AND 2023 Shares Amount Paid-in Capital Deficit Shares Amount Total Common Stock Additional Accumulated Treasury Stock Shares Amount Paid-in Capital Deficit Shares Amount Total Balance, December 31, 2022 31,001 $ 3 $ 20,998,049 $ ( 15,384,432 ) 246 $ ( 69,965 ) $ 5,543,655 Stock issuance pursuant to services agreement 1,861 - 350,000 - - - 350,000 Public offering, net of issuance costs 135,801 14 11,715,735 - - - 11,715,749 Exercise of pre-funded warrants 614,280 62 9,113 - - - 9,175 Reverse stock-split adjustments 101,777 10 ( 10 ) - - - - Net loss - - - ( 9,319,094 ) - - ( 9,319,094 ) Stock based compensation - - 831,862 - - - 831,862 Balance, December 31, 2023 884,720 89 33,904,749 ( 24,703,526 ) 246 ( 69,965 ) 9,131,347 Balance 884,720 89 33,904,749 ( 24,703,526 ) 246 ( 69,965 ) 9,131,347 Stock issuance pursuant to services agreement 3,334 1 20,549 - - - 20,550 Private investments in public equity offering, net of issuance costs 677,581 68 3,642,193 - - - 3,642,261 At-the-market offering, net of issuance costs 40,000 4 73,185 - - - 73,189 Issuance costs related to Form S-3 Registration Statement - - ( 72,450 ) - - - ( 72,450 ) Cashless exercise of pre-funded warrants, net of cancellation 368,364 36 ( 36 ) - - - - Net loss - - - ( 12,197,568 ) - - ( 12,197,568 ) Stock based compensation - - 710,313 - - - 710,313 Balance, December 31, 2024 1,973,999 $ 198 $ 38,278,503 $ ( 36,901,094 ) 246 $ ( 69,965 ) $ 1,307,642 Balance 1,973,999 $ 198 $ 38,278,503 $ ( 36,901,094 ) 246 $ ( 69,965 ) $ 1,307,642 The accompanying notes are an integral part of these consolidated financial statements. F- 5 THARIMMUNE, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS 2024 2023 For the Years Ended December 31, 2024 2023 Cash flows from operating activities: Net loss $ ( 12,197,568 ) $ ( 9,319,094 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock based compensation 710,313 831,862 Stock issuance pursuant to services agreement 20,550 350,000 Increase in operating assets: Prepaid expenses and other current assets ( 34,222 ) 167,053 Increase (decrease) in operating liabilities: Accounts payable 181,089 ( 45,928 ) Accrued expenses 417,847 716,001 Net cash used in operating activities ( 10,901,991 ) ( 7,300,106 ) Net cash provided by (used in) investing activities - - Cash flows from financing activities: Proceeds from issuance of common stock upon private investment in public equity offerings 4,104,161 - Proceeds from issuance of common stock upon at-the-market offering 83,568 - Proceeds from issuance of common stock upon public offering, net of underwriting discounts and issuance costs - 12,234,929 Payment of deferred offering costs ( 661,729 ) ( 519,180 ) Exercise of pre-funded warrants - 9,175 Proceeds from insurance premium financing liability 393,960 716,775 Repayment of insurance premium financing liability ( 393,960 ) ( 716,775 ) Net cash provided by financing activities 3,526,000 11,724,924 Net (decrease) increase in cash ( 7,375,991 ) 4,424,818 Cash, beginning of period 10,935,352 6,510,534 Cash, end of period $ 3,559,361 $ 10,935,352 Cash paid for interest expense $ 13,684 $ 16,505 Supplemental disclosure of non-cash financing activities: Issuance of common stock for prepaid marketing and investor related consulting services $ - $ 100,000 The accompanying notes are an integral part of these consolidated financial statements. F- 6 THARIMMUNE, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1 – Description of Business and Liquidity Nature of Operations Tharimmune, Inc. (formerly, Hillstream BioPharma, Inc.) (“Tharimmune” or the “Company”) was incorporated on March 28, 2017, as a Delaware C-corporation. At December 31, 2024, Tharimmune had one wholly-owned subsidiary: Hillstream Oncology, Inc. (“Hillstream Oncology”), formerly, HB Pharma Corp. Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in rare, inflammatory, and oncologic conditions with high unmet need. On November 3, 2023, the Company entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which it received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103) and to practice the Licensed Technology in connection with the foregoing, throughout the world (each as defined in the Avior License Agreement. In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational new drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching.” With respect to TH104, the Company intends to first seek approval for the treatment of moderate to severe chronic pruritis in patients with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritis, and with respect to TH103, it intends to develop the product candidate and potentially file an IND. On September 11, 2024, Tharimmune entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”), pursuant to which, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor TNF-α. Under the terms of the Agreement, the Company licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. The Company is also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”) targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”) and programmed cell death protein 1 (“PD-1”). The Company is developing antibodies including bispecific antibodies, antibody drug conjugates (“ADCs”) and small molecular weight bovine-derived Picobodies™ or antibody “knob” domains which have the potential to target and bind more tightly to “undruggable” epitopes better than full sized antibodies. The 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. 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. Name Change On September 21, 2023, Hillstream BioPharma, Inc. filed a Certificate of Amendment (the “Amendment”) to its Certificate of Incorporation, as amended (the “Certificate of Incorporation”), with the Secretary of State of the State of Delaware pursuant to which it changed its name to Tharimmune, Inc. effective as of September 25, 2023. The name change became effective with The Nasdaq Capital Market on September 25, 2023 and the Company’s common stock has since traded on The Nasdaq Capital Market under the new name and new ticker symbol, “THAR.” F- 7 In addition, on May 23, 2024, HB Pharma Corp. filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware pursuant to which it changed its name to Hillstream Oncology, Inc. effective as of May 23, 2024. Liquidity and Going Concern The accompanying consolidated financial statements have been prepared on the basis that the Company will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2024, the Company incurred operating losses in the amount of approximately $ 12.4 million, expended approximately $ 10.9 million in net cash used in operating activities, and had an accumulated deficit of approximately $ 36.9 million as of December 31, 2024. Through December 31, 2024, the Company has primarily financed its operations through public and private offerings of its equity securities. The Company received net proceeds from its initial public offering (“IPO”) on January 14, 2022 of approximately $ 12.5 million. Additionally, the Company received net proceeds of approximately $ 2.1 million from a public offering (the “May 2023 Offering”) of its common stock on May 2, 2023. The Company closed an additional public offering (the “November 2023 Offering”) of its common stock on November 30, 2023 with net proceeds of approximately $ 8.7 million. In addition, on June 7, 2024, the Company filed a Registration Statement on Form S-3 with the SEC using a “shelf” registration process pursuant to which, under an at-the-market offering agreement (the “ATM Agreement”), the Company may sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar amount of $ 1.65 million. Under the ATM Agreement, the Company sold 40,000 shares of it’s common stock for gross proceeds of $ 83,688 (the “ATM Sale”). Net proceeds from the ATM Sale after deducting commissions of $ 2,507 and other fees of $ 7,992 were $ 73,189 . Further, on June 17, 2024 and December 9, 2024, the Company closed private placement offerings (the “June 2024 PIPE Offering” and “December 2024 PIPE Offering”) with certain accredited investors, of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the Company’s common stock and warrants to acquire shares of the Company’s common stock, with combined net proceeds to the Company of approximately $ 3.6 million. See Note 3 to the consolidated financial statements for details regarding the various offerings. The shares of the Company’s common stock began trading on The Nasdaq Capital Market on January 12, 2022 under the ticker symbol “HILS” and effective as of September 25, 2023, are traded under the ticker symbol “THAR.” Based on the Company’s limited operating history, recurring negative cash flows from operations, current plans and available resources, the Company will need substantial additional funding to support future operating activities. The Company has concluded that the prevailing conditions and ongoing liquidity risks faced raise substantial doubt about the Company’s ability to continue as a going concern for at least one year following the date these consolidated financial statements are issued. The accompanying consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern. The Company may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships, grants, or other arrangements or a combination of the foregoing to support its future operations, however, there can be no assurance that the Company will be able to obtain additional capital on terms acceptable to the Company, on a timely basis or at all. The failure to obtain sufficient additional funding could adversely affect the Company’s ability to achieve its business objectives and product development timelines and may result in the Company delaying or terminating clinical trial activities which could have a material adverse effect on the Company’s results of operations. Other Risks and Uncertainties There can be no assurance that the Company’s products, if approved, will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed, if at all. The Company is subject to risks common to biopharmaceutical companies including, but not limited to, the development of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, product liability, uncertainty of market acceptance of products and the need to obtain additional financing. The Company is dependent on third party suppliers. The Company’s products require approval or clearance from the FDA prior to commencing commercial sales in the United States. Approvals or clearances are also required in foreign jurisdictions in which the Company may license or sell its products. There can be no assurance that the Company’s products will receive all of the required approvals or clearances. F- 8 Note 2 – Summary of Significant Accounting Policies Basis of Presentation These accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company operates in one segment. Reverse Stock Splits On November 17, 2023, the Company effectuated a reverse split of shares of its common stock at a ratio of 1-for-25 pursuant to an amendment to the Company’s Certificate of Incorporation, as amended, filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders. On May 24, 2024, the Company effectuated an 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 of Incorporation, as amended, filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders. The par value of the Company’s common stock was not adjusted as a result of either reverse split. All issued and outstanding common stock share and per share amounts contained in the consolidated financial statements have been retroactively adjusted to reflect these reverse splits for all periods presented. Principles of Consolidation The consolidated financial statements include the accounts of Tharimmune and its wholly-owned subsidiaries, HB and Farrington Therapeutics LLC. All significant intercompany balances and transactions have been eliminated in consolidation. On February 27, 2023, the Company filed a Certificate of Cancellation with the Delaware Secretary of State with respect to Farrington Therapeutics LLC. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Areas of the consolidated financial statements where estimates may have the most significant effect include research and development expense recognition, valuation of common shares and share-based compensation, allowances of deferred tax assets, valuation of debt related instruments, and cash flow assumptions regarding going concern considerations. Although management believes the estimates that have been used are reasonable, actual results could vary from the estimates that were used. Concentration of Credit Risk The Company maintains cash balances with various financial institutions. Account balances at these institutions are insured by the Federal Deposit Insurance Corporation up to $ 250,000 per depositor. At various times during the year, bank account balances may have been in excess of federally insured limits. The Company has not experienced losses in such accounts. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash equivalents, if any, are stated at cost and consist primarily of money market accounts. F- 9 Research and Development Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, conduct clinical trials, and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the services completed. Stock-Based Compensation The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees, and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock-based award. The fair value of each option grant to employees, non-employees, and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on the straight-line basis over the requisite service period of the awards, which is generally the vesting period. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to January 12, 2022, the Company was a private company and the Company’s common stock has only been publicly traded since that date. As a result, the Company has lacked company-specific historical and implied volatility information. Therefore, it has estimated its expected stock volatility based on the historical data regarding the volatility of a publicly traded set of peer companies. The expected term of stock options granted was between five and seven years. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Fair Value Measurements The Company applies Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances. The carrying value of the Company’s cash, prepaid expenses, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: Level 1 Inputs: Observable inputs such as quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Level 2 Inputs: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for assets or liabilities recently traded in active markets, with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals, as well as quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3 Inputs: Unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities, that reflect the reporting entity’s own assumptions. F- 10 Deferred Offering Costs Deferred offering costs consists primarily of legal, accounting, underwriters’ fees, printing, and filing fees that are incurred prior to an offering of the Company’s common stock and are initially capitalized and then subsequently reclassified to additional paid-in capital upon completion of the offering. If an offering is not completed, any associated offering costs will be expensed immediately upon termination of the offering. At December 31, 2024, there are $ 117,000 in deferred offering costs associated with the ATM Agreement. Insurance Premium Financing Liability In January 2023, the Company entered into an insurance premium financing agreement for $ 955,700 , with a term of nine months and an annual interest rate of 5.25 %. The Company made a down payment of $ 238,925 and was required to make monthly principal and interest payments of $ 81,394 over the term of the agreement, which was repaid in full in October 2023. In January 2024, the Company entered into an insurance premium financing agreement for $ 492,450 , with a term of 10 months and an annual interest rate of 7.5 %. The Company made a down payment of $ 98,490 and is required to make monthly principal and interest payments of $ 40,763 over the term of the agreement, which was repaid in full in November 2024. Retirement Plan The Company has a 401(k) defined contribution plan which covers all employees that meet the plan’s eligibility requirements. Eligible employees may contribute a percentage of their salary subject to certain limitations. The Company makes a discretionary match which is currently equal to 3% of employee contributions. Total company contributions to the plan were $ 6,793 and $ 19,336 for the years ended December 31, 2024 and 2023, respectively. Income Taxes The Company accounts for income taxes using the asset-and-liability method in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred income taxes are recognized for the tax effect of temporary differences between the financial statement carrying amount of assets and liabilities and the amounts used for income tax purposes and for certain changes in valuation allowances. Valuation allowances are recorded to reduce certain deferred tax assets when, in management’s estimation, it is more-likely-than-not that a tax benefit will not be realized. A full valuation allowance has been recognized for all periods since it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized in future periods. The Company follows the guidance in FASB ASC Subtopic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely-than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more-likely-than-not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense. At December 31, 2024 and 2023, the Company had no unrecognized uncertain income tax positions, and therefore no amounts have been recognized in the consolidated financial statements. F- 11 Net Loss per Share The Company reports loss per share in accordance with FASB ASC Subtopic 260-10, Earnings Per Share , which provides for calculation of basic and diluted earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available to common stockholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives effect to common stock equivalents; however, potential common shares are excluded if their effect is anti-dilutive. Potentially dilutive securities not included in the computation of loss per share for the years ended December 31, 2024 and 2023 included options to purchase 108,955 and 6,102 shares of common stock, respectively. Other potentially dilutive securities not included in the computation of loss per share for the years ended December 31, 2024 and 2023 included warrants to purchase 500 shares of the Company’s common 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 May 2023 and November 2023 Offerings, respectively, warrants to purchase an additional 480,721 shares and 329,771 shares of the Company’s common stock issued in the December 2024 and June 2024 PIPE Offerings, respectively, and warrants to purchase 19,786 shares of the Company’s common stock issued to the placement agents in the June 2024 PIPE Offering. All common share amounts as of December 31, 2024 and 2023 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 split of the Company’s common stock effectuated on November 17, 2023 and a 1-for-15 reverse stock split of the Company’s common stock effectuated on May 24, 2024. Recently Adopted Accounting Pronouncements The Company has evaluated all recent accounting pronouncements that were required to be adopted and believes that other than the following, none of them will have a material effect on the Company’s financial position, results of operations, or cash flows. The FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), to reduce complexity in applying U.S. GAAP to certain financial instruments with characteristics of liabilities and equity. The guidance in ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by removing the existing guidance that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock. The guidance in ASC Subtopic 470-20 applies to convertible instruments for which the embedded conversion features are not required to be bifurcated from the host contract and accounted for as derivatives. In addition, the amendments revise the scope exception from derivative accounting in ASC Subtopic 815-40 for freestanding financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the host contract. The amendments in ASU 2020-06 further revise the guidance in FASB ASC Topic 260, Earnings Per Share , to require entities to calculate diluted earnings per share (“EPS”) for convertible instruments by using the if-converted method. In addition, entities must presume share settlement for purposes of calculating diluted EPS when an instrument may be settled in cash or shares. The amendments in ASU 2020-06 are effective for public entities that meet the definition of an SEC filer, excluding smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2021. For all other entities, including the Company, the amendments are effective for fiscal years beginning after December 15, 2023. The Company adopted this guidance effective January 1, 2024 and the adoption of ASU 2020-06 did not have a material impact on its consolidated financial statements. F- 12 Note 3 – Common Stock Pursuant to an amendment to the Company’s Certificate of Incorporation filed in April 2019, the Company increased the number of authorized shares of common stock to 250,000,000 shares. On November 17, 2023, the Company effectuated a reverse split of shares of its common stock at a ratio of 1-for-25 pursuant to an amendment to the Company’s Certificate of Incorporation filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders. Further, on May 24, 2024, the Company effectuated an 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 of Incorporation filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders. The par value of the Company’s common stock was not adjusted as a result of either reverse stock split. On February 16, 2022, the Company entered into an agreement for marketing and investor related consulting services. Pursuant to the agreement, compensation includes a monthly fee and an upfront issuance of shares of the Company’s common stock. On the effective date of February 16, 2022, the Company issued 85 shares of its common stock with a per share value of $ 1,176.47 and a total value of $ 100,000 as compensation expense. The agreement automatically renews annually and upon renewal, a payment of $ 100,000 of shares of the Company’s common stock is issued. On February 16, 2023, the agreement was renewed and on the effective date of August 22, 2023, an additional 187 shares of the Company’s common stock were issued with a per share value of $ 534.76 (as calculated based on the trailing 10-day average closing value of the Company’s common stock prior to the renewal date) representing compensation expense of $ 100,000 . On March 17, 2023, the Company filed a Registration Statement on Form S-3 with the SEC using a “shelf” registration process pursuant to which, the Company may sell, from time to time in one or more offerings, shares of common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either individually or as units comprised of a combination of one or more of the other securities in one or more offerings up to a total dollar amount of $ 75 million. On May 2, 2023, the Company closed a public offering pursuant to which it issued 14,134 shares of its common stock at a public offering price of $ 188.00 per share. 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 to the Company from the May Offering were approximately $ 2.1 million. The Company granted the underwriters a 45-day option to purchase up to an additional 53,000 shares of common stock at the public offering price less discounts and commissions, to cover over-allotments; however, this option expired unexercised. On July 26, 2023, pursuant to the research and development collaboration and license agreement with Applied Biomedical Science Institute (“ABSI”), further described in Note 5 to the consolidated financial statements, the Company issued 1,674 shares of its common stock with a per share value of $ 149.34 , representing total compensation expense of $ 250,000 (as calculated based on the trailing 10-day average closing value of the Company’s common stock prior to the agreement date). On 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 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 an exercise price of $ 0.015 per share, to those purchasers whose purchase of common stock in the offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of the Company’s outstanding common stock immediately following the consummation of the offering. The gross proceeds to the Company from the November Offering were approximately $ 10.0 million, prior to deducting underwriting discounts, commissions, and other expenses of approximately $ 1.3 million. 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. The underwriter exercised the option to purchase 66,667 pre-funded warrants to purchase shares of the Company’s common stock for gross proceeds of $ 1.0 million, prior to deducting underwriting discounts and commissions of approximately $ 70,000 . On January 24, 2024, pursuant to a corporate advisory consulting agreement, the Company issued 3,334 shares of its common stock with a per share value of $ 6.16 , representing total compensation expense of $ 20,550 (as calculated based on the closing value of the Company’s common stock at the effective transfer date). F- 13 On June 7, 2024, the Company entered into the ATM Agreement with Rodman & Renshaw LLC (the “ATM Sales Manager”) under which 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 dollar amount of $ 1.65 million. Sales of shares of the Company’s common stock through the ATM Sales Manager, if any, will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”), including without limitation sales made directly on the Nasdaq Stock Market LLC or any other existing trading market for the common shares. The Company’s common stock is being offered and sold pursuant to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on March 24, 2023, and pursuant to a prospectus supplement dated June 7, 2024. On June 21, 2024, the Company closed a private placement offering with certain accredited investors of $ 2.08 million of the Company’s securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the Company’s common stock and warrants to acquire shares of the Company’s common stock. Pursuant to the June 2024 PIPE Offering, the Company 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 of the Company’s common stock (the “June 2024 Pre-Funded Warrants”), exercisable at $ 0.001 per share, and warrants to purchase up to 329,771 shares of the Company’s common stock, exercisable at $ 3.09 (the “June 2024 PIPE Warrants”). Net proceeds to the Company from the PIPE Offering were approximately $ 1.8 million, after a deduction of approximately $ 268,000 in offering costs. In addition, the Company issued placement agent warrants to purchase up to 19,786 shares of the Company’s common stock, exercisable at $ 3.09 per share (the “June 2024 Placement Agent Warrants”). On December 9, 2024, the Company closed an additional private placement offering with certain accredited investors of $ 2.02 million of the Company’s securities consisting of shares of the Company’s common stock and/or pre-funded warrants to acquire shares of the Company’s common stock and warrants to acquire shares of the Company’s common stock. Pursuant to the December 2024 PIPE Offering, 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 491,157 shares of the Company’s common stock (the “December 2024 Pre-Funded Warrants”), exercisable at $ 0.001 per share, and warrants to purchase up to 480,721 shares of the Company’s common stock, exercisable at $ 2.031 (the “December 2024 PIPE Warrants”). Net proceeds to the Company from the PIPE Offering were approximately $ 1.8 million, after a deduction of approximately $ 0.2 million in offering costs. On December 20, 2024, the Company sold 40,000 shares of its common stock under the ATM Agreement at an offering price of $ 2.0892 per share (the “ATM Sale”). Net proceeds from the ATM Sale were $ 73,189 , after deducting fees and other offering costs. Note 4 – Stock Based Compensation Incentive Plans and Options Under the Company’s 2017 Stock Incentive Plan (the “2017 Plan”) the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates. Up to 261 shares of the Company’s common stock may be issued pursuant to the 2017 Plan. The 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 of common stock remain available for issuance. As of December 31, 2024 and 2023, there were options outstanding to acquire 255 shares of common stock. As of December 31, 2024 and 2023, all such options were fully vested, and the weighted average remaining contractual life for such options was approximately 3.2 and 4.2 years, respectively. In July 2019, the Company authorized an additional plan, the 2019 Stock Incentive Plan (the “2019 Plan”). Under the 2019 Plan, the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates. At both December 31, 2024 and December 31, 2023, a total of 10,452 shares were authorized for issuance under the 2019 Plan. F- 14 As 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 of common stock remain available for issuance under the 2019 Plan. There are stock options outstanding to acquire 5,512 shares of common 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 31, 2024 and 2023, respectively. On August 17, 2023, the Company authorized a new plan, the Tharimmune, Inc. 2023 Omnibus Incentive Plan (the “2023 Plan”). Under the 2023 Plan, the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates. Initially, options to purchase up to 6,934 shares of the Company’s common stock were available to be issued pursuant to the 2023 Plan. 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 options to purchase shares of the Company’s common stock may be issued pursuant to the 2023 Plan. In addition, under the amendment, an “evergreen” provision was added to automatically increase the number of shares available under the 2023 Plan on January 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 (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 Common Stock as determined by the Board of Directors. Effective January 1, 2025, an additional 98,688 options to purchase shares of the Company’s common stock were added to the 2023 Plan. During the year ended December 31, 2024, the Company granted 102,853 options to acquire shares of common stock under the 2023 Plan. At December 31, 2024 and 2023, 70,412 and 6,934 shares of common stock remain available for issuance under the 2023 Plan, respectively. There are 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 and weighted-average contractual terms of 9.6 years and 9.9 years at December 31, 2024 and 2023, respectively. The following table summarizes stock-based activities under the 2017, 2019, and 2023 Stock Incentive Plans: Schedule of Stock Option Activity Weighted Weighted Shares Average Average Underlying Exercise Contractual Options Price Terms Outstanding at December 31, 2022 4,393 $ 1,628.69 7.2 years Granted 1,709 $ 129.17 9.2 years Outstanding at December 31, 2023 6,102 $ 1,208.72 7.8 years Granted 102,853 $ 2.925 9.6 years Outstanding at December 31, 2024 108,955 $ 70.46 9.5 years Exercisable options at December 31, 2024 48,435 $ 138.56 9.2 years Vested and expected to vest at December 31, 2024 108,955 $ 70.46 9.5 years The fair value of stock option awards is estimated at the date of grant using the Black-Scholes option-pricing model. The estimated fair value of each stock option is then expensed over the requisite service period, which is generally the vesting period (ranging between immediate vesting and four years). The determination of fair value using the Black-Scholes model is affected by the Company’s share price as well as assumptions regarding a number of complex and subjective variables, including expected price volatility, expected life, risk-free interest rate and forfeitures. Forfeitures are accounted for as they occur. F- 15 Stock options granted during the years ended December 31, 2024 and 2023 were valued using the Black-Scholes option-pricing model with the following weighted-average assumptions: Schedule of Options Weighted Average Assumptions For the years ended December 31, 2024 2023 Expected volatility 100.8 % 95.10 % - 103.3 % Risk-free interest rate 3.80 % 3.99 % - 4.53 % Expected dividend yield 0 % 0 % Expected life of options in years 5.0 5.0 Estimated fair value of options granted $ 2.23 $ 46.05 - $ 108.22 The 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. The weighted-average fair value of stock options vested during the years ended December 31, 2024 and 2023 was approximately $ 16.38 and $ 95.97 , respectively. Total stock-based compensation expense included in the accompanying consolidated statements of operations was as follows: Schedule of Stock-Based Compensation Expense 2024 2023 For the years ended December 31, 2024 2023 Research and development $ 338,022 $ 404,895 General and administrative 372,291 426,967 Total stock-based compensation $ 710,313 $ 831,862 As of December 31, 2024, the total unrecognized compensation expense related to non-vested options was approximately $ 0.8 million and is expected to be recognized over the remaining weighted-average service period of approximately 0.59 years. Warrants In connection with the IPO, the Company issued warrants to purchase such number of shares of the Company’s common stock equal to 5% of the total shares of common stock issued in the IPO, or 500 warrants. The warrants are exercisable at $ 1,875.00 per share, were not exercisable within the first six months after issuance, and may, under certain circumstances, be exercised on a cashless basis. The exercise price of the warrants is subject to standard antidilutive provision adjustments for stock splits, stock combinations, or similar events affecting the Company’s common stock. The Company has determined that these warrants should be classified as equity instruments since they do not require the Company to repurchase the underlying common stock and do not require the Company to issue a variable amount of common stock. In addition, these warrants are indexed to common stock and do not have any unusual antidilution rights. In connection with the May 2023 Offering as described in Note 3 to the consolidated financial statements, the Company issued warrants to designees of the underwriter (the “Representative’s Warrants”) to purchase 424 shares of the Company’s common 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, subject to adjustment. The Representative’s Warrants are exercisable at any time and from time to time, in whole or in part, during 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. In connection with the November 2023 Offering as described in Note 3 to the consolidated financial statements, the Company issued pre-funded warrants to purchase 545,000 shares of the Company’s common stock at an exercise price of $ 0.015 (the “November 2023 Pre-Funded Warrants”). The November 2023 Pre-Funded Warrants were issued to those purchasers whose purchase of common stock in the November 2023 Offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of outstanding common stock immediately following the consummation of the offering . The November 2023 Pre-Funded Warrants were immediately exercisable and could be exercised at any time until exercised in full. 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 warrants. The underwriters exercised the option to purchase 66,667 pre-funded warrants at an initial exercise price of $ 0.015 per share, subject to adjustment (the “November 2023 Underwriters Pre-Funded Warrants”). These pre-funded warrants were immediately exercisable and could be exercised at any time until exercised in full. The underwriters received warrants to purchase 20,000 shares of common stock with an initial exercise price of $ 18.75 , exercisable beginning May 27, 2024 , and expiring May 2, 2028 (the “November 2023 Underwriters Warrants”). As of December 31, 2024 and 2023, all of the November 2023 Pre-Funded Warrants and the November 2023 Underwriters Pre-Funded Warrants have been exercised and the additional warrants to purchase 20,000 shares of common stock have not yet been exercised. F- 16 In connection with the June 2024 PIPE Offering as described in Note 3 to the consolidated financial statements, the Company issued the June 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 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 Agent Warrants to purchase up to 19,786 shares of the Company’s common stock, exercisable at $ 3.09 per share. The June 2024 Pre-Funded Warrants were immediately exercisable and are able to be exercised at any time until exercised in full. The June 2024 PIPE Warrants and June 2024 Placement Agent Warrants were immediately exercisable and are able to be exercised until five and a half years from the effective date, or December 21, 2029. As of December 31, 2024, 368,533 of the June 2024 Pre-Funded Warrants have been exercised and none of the June 2024 PIPE Warrants or June 2024 Placement Agent Warrants have been exercised. In connection with the December 2024 PIPE Offering as described in Note 3 to the consolidated financial statements, the Company issued the 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 December 2024 PIPE Warrants to purchase 480,721 shares of the Company’s common stock at an exercise price of $ 2.031 . The December 2024 Pre-Funded Warrants were immediately exercisable and are able to be exercised at any time until exercised in full. The December 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 the effective date, or December 9, 2030. As of December 31, 2024, none of the December 2024 Pre-Funded Warrants and December 2024 PIPE Warrants have been exercised. Terms of the warrants outstanding at December 31, 2024 are as follows: Schedule of Warrants Initial Expiration Exercise Warrants Warrants Warrants Issuance Date Exercise Date Date Price Issued Exercised Outstanding January 14, 2022 July 10, 2022 January 11, 2027 $ 1,875.00 500 - 500 May 2, 2023 November 2, 2023 May 2, 2028 $ 234.375 424 - 424 November 30, 2023 November 30, 2023 N/A $ 0.015 545,000 545,000 - November 30, 2023 November 30, 2023 N/A $ 0.015 66,667 66,667 - November 30, 2023 May 27, 2024 May 2, 2028 $ 18.75 20,000 - 20,000 June 21, 2024 June 21, 2024 N/A $ 0.001 452,253 368,533 83,720 June 21, 2024 June 21, 2024 December 21, 2029 $ 3.09 329,771 - 329,771 December 9, 2024 June 9, 2025 December 9, 2030 $ 2.031 480,721 - 480,721 December 9, 2024 December 9, 2024 N/A $ 0.001 491,157 - 491,157 F- 17 Note 5 – Income Taxes The Company does not have any significant current income taxes due because of the losses generated in each year. Deferred income taxes represent the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and income tax purposes. The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences. In accordance with FASB ASC 740, the Company recorded a valuation allowance to fully offset the gross deferred tax asset because it is not more likely than not that the Company will realize future benefits associated with these deferred tax assets at December 31, 2024 and 2023. The valuation allowance increased by approximately $ 3.5 million and $ 2.8 million for the years ended December 31, 2024 and 2023, respectively. The 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 Deferred tax asset (liabilities) related to: 2024 2023 December 31, Deferred tax asset (liabilities) related to: 2024 2023 Federal net operating loss carryforward $ 4,264,000 $ 3,017,000 State net operating loss carryforward 1,444,000 1,021,000 Capitalized costs 1,957,000 1,261,000 Acquired in-process research and development 1,027,000 319,000 Research and development credit 382,000 243,000 Stock compensation 904,000 733,000 Accrued expenses and other 211,000 84,000 Total deferred tax assets 10,189,000 6,678,000 Valuation allowance ( 10,189,000 ) ( 6,678,000 ) Deferred tax asset, net of valuation allowance $ - $ - The income tax benefit for the years ended December 31, 2024 and 2023 differ from the amounts computed by applying the U.S. federal income tax rate of 21 % to loss before income tax benefit as a result of non-deductible expenses, tax credits generated, and increases in the Company’s valuation allowance. Schedule of Effective Income Tax Expense 2024 2023 For the years ended December 31, 2024 2023 Income tax benefit at the federal statutory rate $ ( 2,550,000 ) $ ( 1,957,000 ) Permanent differences and other 30,000 34,000 State income taxes ( 853,000 ) ( 661,000 ) Research and development credit ( 216,000 ) ( 238,000 ) Other 78,000 45,000 Change in valuation allowance 3,511,000 2,777,000 Effective income tax expense $ - $ - A valuation allowance is required to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of the available evidence, both positive and negative, the Company determined that valuation allowances of approximately $ 10.2 million and $ 6.7 million at December 31, 2024 and 2023, respectively, were necessary to reduce the deferred tax assets to the amount that will more likely than not be realized. At 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. At December 31, 2024 and 2023, the Company had approximately $ 382,000 and $ 243,000 of federal research and development (“R&D”) tax credit carryforwards. If not utilized, the federal R&D credits will begin to expire in 2038. The Company also had $ 20.3 million and $ 14.9 million of state net operating losses that will begin to expire in 2037. F- 18 Sections 382 and 383 of the Internal Revenue Code, and similar state regulations, contain provisions that may limit the NOL carryforwards available to be used to offset income in any given year upon the occurrence of certain events, including changes in the ownership interests of significant stockholders. In the event of a cumulative change in ownership in excess of 50% over a three-year period, the amount of the NOL carryforwards that the Company may utilize in any one year may be limited. Although the Company has not undertaken a formal analysis, it is likely that such an ownership change occurred during 2021. The Tax Cuts and Jobs Act of 2017 (“TCJA”) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize over five years for U.S. activities and 15 years for non-U.S. activities using a mid-year convention. Therefore, the capitalization of research and development costs in accordance with IRC 174 results in a gross deferred tax asset of $ 6,961,000 . Note 6 – Commitments and Contingencies Small Molecule Analogues On December 30, 2019, the Company acquired a series of small molecule analogues pursuant to an Asset Purchase Agreement (“APA”). Pursuant to the APA, the Company is required to make a payment of $50,000 upon raising of at least $2.0 million in funding, and up to approximately $1.75 million based upon successfully meeting clinical and sales milestones. The Company included, in accounts payable at both December 31, 2024 and 2023, the $ 50,000 required initial payment. Milestone based payments, if any, will be expensed as incurred. Research Collaboration and Product License Agreement with Minotaur Therapeutics, Inc. (“Minotaur”) and Commercial License Agreement with Taurus Biosciences, LLC (“Taurus”) The Company has entered into a research collaboration and product license agreement with Minotaur (as amended, the “Minotaur Agreement”) and a commercial license agreement with Taurus (the “Taurus Agreement”) for use of certain technology, including OmniAb antibodies, to advance Picobodies against novel, unreachable, and undruggable epitopes in high-value validated targets starting with PD-1. The Minotaur Agreement and Taurus Agreement are for the development of proprietary targeted biologics, including TH 1940, against PD-1. It is anticipated that the Company will collaborate with Minotaur under the license from Taurus to discover, develop, and advance biotherapeutics against high-value validated IO targets starting with PD-1. The Minotaur Agreement included an up-front payment of $ 150,000 , which was paid in January 2023. In addition, the Company shall fund the discovery and characterization study performed by Minotaur as set forth in the Minotaur Agreement. Pursuant to the Minotaur Agreement, the Company shall pay Minotaur a milestone payment of $ 1,000,000 for each first Product (as defined in the Minotaur Agreement) directed against a target and first regulatory approval in the U.S. In addition, the Company shall pay a low single digit royalty on net sales until the later of (i) ten years after the First Commercial Sale (as defined in the Minotaur Agreement) of such Product in such country and (ii) the expiration of the last-to-expire Valid Claim (as defined in the Minotaur Agreement) of a Collaboration Patent (as defined in the Minotaur Agreement) or MINT Patent (as defined in the Minotaur Agreement) covering the manufacture, use, or sale of such Product. The Taurus Agreement contains single digit payments on net product sales and certain development milestone payments tied to the advancement through clinical trials and final regulatory approval. Research and Development Collaboration and License Agreement with Applied Biomedical Science Institute On July 5, 2023 (the “ABSI Effective Date”), the Company entered into a Research and Development Collaboration and License Agreement (the “ABSI Agreement”) with ABSI pursuant to which ABSI granted the Company an exclusive royalty-bearing, sublicensable license to the ABSI Patents (as defined in the ABSI Agreement) and a non-exclusive, royalty-bearing, sublicensable license to the ABSI Know-How (as defined in the ABSI Agreement) to Exploit (as defined in the ABSI Agreement) the ABSI Products (as defined in the ABSI Agreement) for the treatment, diagnosis, prediction, detection or prevention of disease in humans and animals worldwide (the “Territory”). F- 19 Pursuant to the ABSI Agreement, the parties shall form a committee to manage the preclinical, investigational new drug enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product. The parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target (as defined below) with a view to identifying or generating suitable Products (as defined in the ABSI Agreement) for the Company to Exploit. “Target” means ErB2 (Her2) and ErbB3. Upon completion of the Discovery Timeline (as defined in the ABSI Agreement) for a Target, subject to the terms and conditions of ABSI Agreement, the Company shall exclusively own any ABSI Products against such Target. In the event the committee determines that the discovery activities are unsuccessful with respect to a Target, the Company may propose an additional target, which, upon approval by ABSI, shall replace a failed Target. Pursuant to the ABSI Agreement: (i) the Company issued ABSI 25,107 shares of its common stock which is equal to $ 250,000 based on the ten day trailing volume weighted-average price of the Company’s common stock prior to the date of issuance (see Note 3 to the consolidated financial statements for details of the July 27, 2023 issuance of the Company’s common stock to ABSI); (ii) in the event the Company closes a financing pursuant to which it receives more than $ 10 million in Net Proceeds (as defined in the ABSI Agreement), the Company paid ABSI an up front license fee of $ 250,000 ; (iii) upon the achievement of certain milestones as set forth in the ABSI Agreement, the Company shall pay ABSI up to an aggregate of $ 8,250,000 ; (iv) after the second anniversary of the ABSI Effective Date, the Company shall pay 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 Agreement); and (v) during the Royalty Term for each Product, the Company shall pay ABSI a quarterly royalty on the Net Sales (as defined in the ABSI Agreement) with royalties at percentages which range from the low to mid-single digits, with high Net Sales being subject to lower royalty rates, subject to adjustment as set forth in the ABSI Agreement. In addition, in the event the Company transfers all 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 to the transfer of the Product. Specifically, the Company shall pay ABSI amounts at percentages which range from the mid-single digit to low double digits depending on the Company Expenses (as defined in the ABSI Agreement), with higher Company Expenses being subject to lower rates. On a Product-by-Product basis, upon the expiration of the last Royalty Term of such Product in the Territory, licenses granted to the Company with respect to such Product shall be deemed non-exclusive, fully paid, royalty-free, perpetual and irrevocable. The ABSI Agreement shall expire upon the expiration of the last Royalty Term of the last Product, unless such agreement is terminated earlier pursuant to its terms. The ABSI Agreement may also be terminated (i) by either the Company or ABSI for (A) a material breach of the ABSI Agreement or (B) bankruptcy, (ii) ABSI may terminate the ABSI Agreement upon the commencement of a Challenge Proceeding (as defined in the ABSI Agreement) or (iii) the Company may terminate the ABSI Agreement at any time upon 90 days prior written notice to ABSI. Upon termination or expiration of the ABSI Agreement other than as a result of a bankruptcy or Challenge Proceeding, all licenses granted to the Company pursuant to such agreement will terminate and all rights under such licenses shall revert to ABSI. On March 11, 2024, the Company entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $ 50,000 beginning March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter. During the year ended December 31, 2024, the Company made payments of $ 200,000 to ABSI. During the year ended December 31, 2023, the Company paid milestone fees of $ 500,000 to ABSI in accordance with the terms of the agreement, which included a non-cash common stock equity grant of $ 250,000 . F- 20 Avior Patent License Agreement On November 3, 2023 (the “Avior Effective Date”), the Company entered into the Avior Patent License Agreement with Avior pursuant to which the Company received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world. Pursuant to the Avior Patent License Agreement, the Company shall paid Avior an up front license fee of $ 400,000 within ten days of the Avior Effective Date and an additional mid six-digit license fee which shall be paid in four equal installments within ten days of the end of each fiscal quarter following the Avior Effective Date. 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 of any sublicenses with respect to TH104. The Company shall also pay Avior milestone payments in the aggregate amount of $ 24,250,000 upon the occurrence of various development milestones (the “Development Milestone Payments”). Furthermore, the Company shall pay Avior certain fees based upon sales milestones. The payments for such sales milestones range from the low seven digits to the low eight digits with higher sales being subject to higher fees. Finally, the Company shall pay Avior royalties based on net sales. Such royalties range from low single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages. The Avior Patent License Agreement shall expire upon the expiration of the final payment obligation due to Avior as set forth in such agreement. Upon the expiration of the Avior Patent License Agreement, the Company shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have commercialized any and all Licensed Products and to practice the Licensed Technology worldwide. Pursuant to the Avior Patent License Agreement, the Company may terminate the agreement at any time without cause, upon 30 days’ prior written notice to Avior along with payment of the next unpaid Development Milestone Payment, if any. Furthermore, either the Company or Avior may terminate the Avior Patent License Agreement (i) on written notice to the other party if the other party materially breaches any provision of the Avior Patent License Agreement and fails to cure such breach within 30 days after the breaching party receives written notice thereof or (ii) on written notice in the event that either party (A) becomes insolvent or admits its inability to pay its debts generally as they become due; (B) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within 60 days; (C) is dissolved or liquidated or takes any corporate action for such purpose; (D) makes a general assignment for the benefit of creditors; or (E) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business. Upon termination of the Avior Patent License Agreement, the license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed Products shall revert back to Avior. During the year ended December 31, 2024, the Company paid license fees of $ 600,000 to Avior in accordance with the terms of the agreement. In addition, during the years ended December 31, 2024 and 2023, the Company incurred milestone fees of $ 750,000 and $ 380,000 , respectively. Enkefalos License Agreement On June 17, 2024 (the “Enkefalos Effective Date”), the Company signed a letter of intent to enter into the Enkefalos License Agreement with Enkefalos Biosciences Inc. pursuant to which the Company is licensing the global rights in all fields of use for the products related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier and all associated know-how, technology, intellectual property and related information and constructs, and any associated authorized generic rights and all related assets (collectively, the “Products” referred to in this letter as ENBI-01) from Enkefalos Biosciences, Inc. Pursuant to the Enkefalos License Agreement, the Company shall pay Enkefalos an up-front license fee of $ 150,000 within ten days of the Enkefalos Effective Date 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 . The Company shall also pay Enkefalos milestone payments in the aggregate amount of up to $ 8,500,000 upon the occurrence of various development milestones (the “Enkefalos Development Milestone Payments”). Furthermore, the Company shall pay Enkefalos royalties based on net sales ranging from low single-digit percentages to mid-single digit percentages with higher sales being subject to lower percentages. The Enkefalos License Agreement shall expire upon the expiration of the final payment obligation due to Enkefalos as set forth in such agreement and upon expiration, the Company shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have commercialized any and all Licensed Products and to practice the Licensed Technology worldwide. Pursuant to the Enkefalos License Agreement, either the Company or Enkefalos may terminate the Enkefalos License Agreement on written notice to the other party. Upon termination of the Enkefalos License Agreement, the license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed Products shall revert back to Enkefalos. F- 21 During the year ended December 31, 2024, the Company incurred license fees of $ 150,000 to Enkefalos in accordance with the terms of the agreement. Intract Patent License Agreement On September 11, 2024, the Company entered into a patent license agreement (the “Intract Agreement”) with Intract. Pursuant to the Intract Agreement, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Intract Agreement, the Company licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Pursuant to the Intract Agreement, the Company paid Intract an up-front license fee of $ 400,000 and Intract is eligible to receive additional payments upon an equity financing of the Company and additional payments for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. The Agreement retains a right of first refusal to continue development and commercialization after a Phase 2 clinical trial. In addition, the Company has the option to exercise the license to Intract’s platform for up to four additional targets. The term of the Intract Agreement expires upon the final payment obligation of Tharimmune and may be terminated by Tharimmune at any time upon 90 days written notice to Intract. Either party may terminate the Intract Agreement if the other party materially breaches any provision of the Intract Agreement and fails to cure such breach within thirty (30) days after the breaching party receives written notice thereof. In addition, either party may terminate the Intract Agreement on written notice in the event that either party declare: (a) becomes insolvent or admits inability to pay its debts generally as they become due; (b) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within sixty (60) days; (c) is dissolved or liquidated or takes any corporate action for such purpose; (d) makes a general assignment for the benefit of creditors; or (e) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business. During the year ended December 31, 2024, the Company incurred fees of $ 400,000 to Intract in accordance with the terms of the agreement. Employment Agreements On June 1, 2021, the Company entered into an Amended and Restated Employment Agreement with the Company’s CEO, as amended periodically (the “Amended and Restated Employment Agreement”). The term of the Amended and Restated Employment Agreement commenced upon the closing of the Company’s IPO in January 2022 and continues for a period of five years and automatically renews for successive one-year periods at the end of each term unless either party provides written notice of their intent not to renew at least 60 days prior to the expiration of the then effective term. Pursuant to the Amended and Restated Employment Agreement, the CEO will receive an annual base salary of $ 485,000 , which may be increased from time to time, and shall be eligible to receive an annual cash bonus equal to 55 % of his then base salary based upon the achievement of Company and individual performance targets established by the Company’s board of directors. In addition, in the first year in which the Company’s market capitalization (as defined in the Amended and Restated Employment Agreement) equals or exceeds (i) $250 million, the CEO shall receive a cash payment of $150,000; (ii) $500 million, the CEO shall receive a cash payment of $350,000; and (iii) $1.0 billion, the CEO shall receive a cash payment of $750,000 . Furthermore, following the date of the Company’s IPO, the CEO was issued an option to purchase 2,021 shares of the Company’s common stock at an 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. This shall be in addition to any additional equity-based compensation awards the Company may grant the CEO from time to time. On 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 common stock at an exercise price of $ 146.25 per share, which options vested immediately on the date of grant. F- 22 On July 6, 2023, the Company entered into an amended and restated employment agreement (the “CEO Employment Agreement”) with the CEO. The Employment Agreement has the same terms as the COO Employment Agreement (as defined below) except, the CEO shall (i) receive a base salary of $ 500,000 per year, which may be increased by the Board; and (ii) be eligible to receive an annual bonus equal 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 discretion. 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 other than for Cause, or if the CEO terminates his employment for Good Reason, then, in addition to the Accrued Compensation, the Company shall continue to pay the CEO’s base salary and provide health benefits for a period of 18 months following the termination date (each as defined in the CEO Employment Agreement). In addition, all Restricted Shares and Stock Options that have not vested as of the date of termination shall be forfeited and outstanding unvested time-based equity awards shall be accelerated in accordance with the applicable vesting schedule as if the CEO had been in service for an additional 12 months as of the termination date. In connection with the appointment of the Company’s Chief Operating Officer, on July 11, 2023 (the “Effective Date”), the Company entered into an employment agreement (the “COO Employment Agreement”) with the COO. The COO Employment Agreement shall continue for a period of five years and, thereafter, shall automatically renew for successive one-year terms unless either party provides the other party with written notice of non-renewal at least 60 days prior to the last day of the then-current term. Pursuant to the COO Employment Agreement, the COO shall: (i) receive a base salary of $ 400,000 per year, which may be increased by the Board; (ii) be eligible to receive an annual bonus equal to 50 % of his then base salary based upon the achievement of Company and individual targets to be established by the Board, in its sole discretion; (iii) shall be eligible to receive equity-based compensation awards as determined by the Company; (iv) receive reimbursement of reasonable business expenses; and (v) receive such other benefits that the Company may make available to its senior executives from time to time along with vacation, sick and holiday pay in accordance with the Company’s policies established and in effect from time to time. In accordance with the employment agreements, the compensation committee approved a bonus of 50 % in equity compensation and 50 % in cash on January 13, 2025, based on corporate performance objectives earned during the year ended December 31, 2024. The total bonus earned 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 common stock. 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 purchase up to 52,875 shares of the Company’s common stock. The total cash bonus of $ 258,300 and total equity compensation bonus of $ 202,122 are recorded within accrued expenses on the accompanying consolidated balance sheet at December 31, 2024. The equity compensation is valued at the grant and effective date of the options, which is January 13, 2025. Note 7 – Subsequent Events Except as noted below, there were no material subsequent events that required recognition or additional disclosure in these consolidated financial statements. Insurance Financing Agreement In January 2025, the Company entered into an insurance premium financing agreement for $ 386,280 , with a term of 10 months and an annual interest rate of 7.15 %. The Company made a down payment of $ 77,356 and is required to make monthly principal and interest payments of $ 31,914 over the term of the agreement, which matures in November 2025. Settlement Agreement In March 2025, the Company entered into an agreement with its previous attorney to reduce the outstanding balance of legal fees to $ 240,000 (the “Settlement Agreement”) for amounts owed related to services performed prior to the year ended December 31, 2024. The Company will adjusts its accounts payable by $ 54,240 in the first quarter of 2025. In accordance with the terms of the Settlement Agreement, 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 be satisfied. If payments are not made timely or the Company becomes insolvent (defined as event of default in the Settlement Agreement), interest will begin to accrue at a rate of 3.7 % per annum until all past due amounts have been paid in full. No interest will accrue if no event of default occurs. F- 23 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None.