HCW Biologics Inc. 10-K

Item 8 Financial Statements and Supplementary Data. HCW Biologics Inc. Index to Financial Statements Years ended December 31, 2022 and 2023 Audited Financial Statements Page Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248 ) 88 Balance Sheets 89 Statements of Operations 90 Statements of Changes in Stockholders’ Equity 91 Statements of Cash Flows 92 87 RE PORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Board of Directors and Stockholders HCW Biologics Inc. Opinion on the financial statements We have audited the accompanying balance sheets of HCW Biologics Inc. (the “Company”) as of December 31, 2023 and 2022, the related statements of operations, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and itscash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America. Liquidity and going concern As discussed in Note 1 to the financial statements, the Company is not profitable, has recorded negative cash flows from operations, and will need substantial capital to support its ongoing operations. Management's evaluation of the events and conditions and management’s plans to mitigate these matters are also described in Note 1. Basis for opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s 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 audit 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 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 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. /s/ GRANT THORNTON LLP We have served as the Company’s auditor since 2019. Miami, FL April 1, 2024 88 HCW Biologics Inc. Bal ance Sheets December 31, December 31, 2022 2023 ASSETS Current assets: Cash and cash equivalents $ 22,326,356 $ 3,595,101 Short-term investments 9,735,930 — Accounts receivable, net 417,695 1,535,757 Prepaid expenses 1,394,923 1,042,413 Other current assets 196,015 230,916 Total current assets 34,070,919 6,404,187 Investments 1,599,751 1,599,751 Property, plant and equipment, net 10,804,610 20,453,184 Other assets 333,875 56,538 Total assets $ 46,809,155 $ 28,513,660 LIABILITIES AND STOCKHOLDERS’ EQUITY Liabilities Current liabilities: Accounts payable $ 1,226,156 $ 6,167,223 Accrued liabilities and other current liabilities 1,730,325 2,580,402 Total current liabilities 2,956,481 8,747,625 Debt, net 6,409,893 6,304,318 Other liabilities 14,275 — Total liabilities 9,380,649 15,051,943 Commitments and contingencies (Note 15) Stockholders’ equity: Common stock: Common, $ 0.0001 par value; 250,000,000 shares authorized and 35,876,440 shares issued at December 31, 2022; 250,000,000 shares authorized and 36,025,104 shares issued at December 31, 2023 3,588 3,603 Additional paid-in capital 82,962,964 83,990,437 Accumulated deficit ( 45,538,046 ) ( 70,532,323 ) Total stockholders’ equity 37,428,506 13,461,717 Total liabilities and stockholders’ equity $ 46,809,155 $ 28,513,660 The accompanying notes are an integral part of these financial statements. 89 HCW Biologics Inc. State ments of Operations Years Ended December 31, 2022 2023 Revenues: Revenues $ 6,722,090 $ 2,841,794 Cost of revenues ( 4,135,712 ) ( 2,281,434 ) Net revenues 2,586,378 560,360 Operating expenses: Research and development 9,338,365 7,676,316 General and administrative 8,326,791 13,351,204 Reserve for credit losses — 5,250,000 Total operating expenses 17,665,156 26,277,520 Loss from operations ( 15,078,778 ) ( 25,717,160 ) Interest expense ( 126,660 ) ( 283,042 ) Other (expense) income, net 304,735 1,005,925 Net loss $ ( 14,900,703 ) $ ( 24,994,277 ) Net loss per share, basic and diluted $ ( 0.42 ) $ ( 0.70 ) Weighted average shares outstanding, basic and diluted 35,822,249 35,929,446 The accompanying notes are an integral part of these financial statements. 90 HCW Biologics Inc. Statem ents of Changes in Stockholders’ Equity Stockholders’ Equity Common Stock Additional Paid-In Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, December 31, 2021 35,768,264 $ 3,577 81,827,006 $ ( 30,637,343 ) $ 51,193,240 Issuance of Common Stock upon exercise of stock options 108,176 11 15,767 — 15,778 Stock-based compensation — — 1,120,191 — 1,120,191 Net loss — — — ( 14,900,703 ) ( 14,900,703 ) Balance, December 31, 2022 35,876,440 $ 3,588 $ 82,962,964 $ ( 45,538,046 ) $ 37,428,506 Issuance of Common Stock upon exercise of stock options 148,664 15 23,724 — 23,739 Stock-based compensation — — 1,003,749 — 1,003,749 Net loss — — — ( 24,994,277 ) ( 24,994,277 ) Balance, December 31, 2023 36,025,104 $ 3,603 $ 83,990,437 $ ( 70,532,323 ) $ 13,461,717 The accompanying notes are an integral part of these financial statements. 91 HCW Biologics Inc. State ments of Cash Flows Years Ended December 31, 2022 2023 Cash flows from operating activities: Net loss $ ( 14,900,703 ) $ ( 24,994,277 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 717,854 1,135,184 Stock-based compensation 1,120,191 1,003,749 Unrealized loss (gain) on investments, net 186,370 ( 248,445 ) Realized (gain) on investments — ( 15,625 ) Changes in the carrying amount of right-of-use asset 2,089 ( 1,671 ) Reserve for credit losses — 5,250,000 Changes in operating assets and liabilities: Accounts receivable ( 284,695 ) ( 1,118,061 ) Deposit for interest reserve — ( 5,250,000 ) Prepaid expenses and other assets 2,482,822 432,410 Accounts payable and other liabilities 418,208 1,619,357 Operating lease liability ( 128,246 ) ( 326,742 ) Net cash used in operating activities ( 10,386,110 ) ( 22,514,121 ) Cash flows from investing activities: Purchases of property and equipment ( 10,275,128 ) ( 6,202,600 ) Proceeds for sale or maturities of short-term investments 24,983,520 10,000,000 Net cash provided by investing activities 14,708,392 3,797,400 Cash flows from financing activities: Proceeds from issuance of common stock 15,778 23,739 Proceeds from issuance of debt, net 6,448,166 — Offering costs ( 190,547 ) — Debt repayment — ( 38,273 ) Net cash provided by (used in) financing activities 6,273,397 ( 14,534 ) Net increase (decrease) in cash and cash equivalents 10,595,679 ( 18,731,255 ) Cash and cash equivalents at the beginning of the period 11,730,677 22,326,356 Cash and cash equivalents at the end of the period $ 22,326,356 $ 3,595,101 Supplemental disclosure of cash flow information: Cash paid for interest, net of capitalized interest $ 126,660 $ 283,042 Noncash operating, investing and financing activities: Operating lease liabilities arising from obtaining right-of-use assets $ 192,686 $ — Capital expenditures accrued, but not yet paid $ — $ 4,240,593 Reserve for credit losses $ — $ 5,250,000 The accompanying notes are an integral part of these financial statements. 92 HCW Biologics Inc. Notes to the Financial Statements December 31, 2022 and 2023 1. Organization and Summary of Significant Accounting Policies Organization HCW Biologics Inc. (the “Company”) is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases. The Company believes age-related low-grade chronic inflammation, or “inflammaging,” is a significant contributing factor to several chronic diseases and conditions, such as cancer, cardiovascular disease, diabetes, neurodegenerative diseases, and autoimmune diseases. The Company is located in Miramar, Florida and was incorporated in the state of Delaware in April 2018. Liquidity and Going Concern  In accordance with ASC 205-40, Presentation of Financial Statements – Going Concern (“Topic 205-40”), we are required to evaluate whether there are conditions and events, considered in the aggregate that raise substantial doubt about our ability to continue as a going concern for at least 12 months from the issuance date of our financial statements. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. As of December 31, 2023, the Company had not generated any revenue from commercial product sales of its internally-developed immunotherapeutic products for the treatment of cancer and other age-related diseases. In the course of its development activities, the Company has sustained operating losses and expects to continue to incur operating losses for the foreseeable future. Since inception to December 31, 2023, the Company incurred cumulative net losses of $ 67.8 million. As of December 31, 2023, the Company had $ 3.6 million in cash and cash equivalents, compared to $ 22.3 million as of December 31, 2022. Management expects to incur additional losses in the future to conduct product research and development and recognizes the need to raise additional capital to fully implement its business plan. As a result of these conditions substantial doubt about the Company’s ability to continue as a going concern was raised. To date, we have funded operations primarily through the sale of stock and revenues generated from the Company’s exclusive worldwide license with Wugen, Inc. (“Wugen”), pursuant to which Wugen licensed limited rights to develop, manufacture, and commercialize cell therapy treatments for cancer based on two of the Company’s internally-developed multi-cytokine fusion protein molecules, and its manufacturing and supply arrangement with Wugen. In the year ended December 31, 2022 and 2023, the Company recognized revenues of $ 6.7 million and $ 2.8 million, respectively, generated from the supply of clinical and research grade material to Wugen. Under the Company’s policy for its going concern assessment under Topic 205-40, future receipt of potential funding from partnerships, equity or debt issuances or other transactions is considered probable if a transaction is approved by the Board of Directors and the Company has entered into legally binding agreements. As of March 31, 2024, the Company has closed or entered into binding legal agreements for additional financings of $ 12.5 million. On February 20, 2024, in a $ 2.5 million private placement of common stock, the Company sold an aggregate of 1,785,718 shares to certain officers and directors. As of March 31, 2024, the Company entered into an agreement to issue $ 10.0 million of secured notes (the “Secured Notes”), of which $ 2.0 million funded prior to the issuance date of the accompanying financial statements. The Secured Notes were sold to certain officers and directors of the Company as well as other investors. 93 Management plans to pursue additional sources of capital. Future financings may be from non-dilutive funding sources such as bank or debt financing, out-licensing rights to technology or markets, cooperative agreements for clinical trials, or other business development transactions, which may include the issuance of additional equity financing and/or third-party collaboration funding. If the Company is not successful in raising additional capital, management has the intent and ability to streamline its business plan and reduce costs. The Company believes that, as a result of these plans, it has sufficient liquidity and probable financing to meet the Company’s funding requirements for at least 12 months from the issuance date of the accompanying financial statements. In implementing a streamlined business plan the Company may be forced to delay, reduce, or eliminate some of its product development programs, efforts to establish manufacturing capacity, headcount and other operating costs, as well as commercialization efforts. Projections are based on assumptions, including the Company’s existing commitments and contingencies, that may prove to be incorrect, and the Company may use available capital sooner than expected. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. Summary of Significant Accounting Policies Basis of Presentation The accompanying audited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) 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 in the financial statements and accompanying notes. Management must apply significant judgment in this process. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from estimates. Cash and Cash Equivalents Cash and cash equivalents consist of demand deposits at financial institutions, money market funds, and highly liquid investments with original maturities of three months or less. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement (“Topic 820”), establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between fair value measurements based on market data (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require a reporting entity to develop its own assumptions. Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values, as disclosed in Note 3, takes into account the market for the Company’s financial assets and liabilities, the associated credit risk, and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis. 94 Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents, accounts receivable, and investments. The Company’s cash and cash equivalents are deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. For the year ended December 31, 2023, the Company recognized revenues of $ 2.8 million. A ll of the Company's revenues were derived from the supply of clinical grade material to Wugen under the supply agreement between Wugen and the Company, as contemplated in the Wugen License. As of December 31, 2023, there was a balance of $ 1.5 million in accounts receivable related to sales to Wugen on the accompanying audited balance sheet, and the Company believes that collection of these amounts are probable. Since December 24, 2020, the Company holds 2,174,311 shares of Wugen common stock, which were received as consideration for the Wugen License on December 24, 2020. Currently, these shares represent a 5.6 % equity ownership interest of Wugen, based on fully diluted, issued and outstanding shares as of December 31, 2023. The Company has not been able to realize any benefit from the sale of these shares, as they are not currently traded on any public market and thus have limited marketability. The Company is highly dependent on a third-party manufacturer to supply drug products for its research and development activities of its programs, including clinical and non-clinical studies. These programs could be adversely affected by a significant interruption in the supply of such drug products. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements. Property, Plant and Equipment, Net Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation expense is calculated using the straight-line method over the estimated useful lives of the assets, which range from 3 to 39 years. Land is not subjected to the recording of depreciation expense because it has an infinite life. Leasehold improvements are amortized on a straight-line method over the shorter of the useful life of the leasehold improvement or the term of the lease. Construction-in-progress represents property and buildings under construction and consists of construction expenditures, equipment procurement, and other direct costs attributable to the construction. Construction-in-progress is not depreciated. Upon completion and ready for intended use, construction-in-progress is reclassified to the appropriate category within property, plant and equipment. Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the balance sheet in the period in which the retirement or sale occurred, and the resulting gain or loss is recognized in the statements of operations. Repairs and maintenance are expensed as incurred. Depreciation of property, plant and equipment is calculated using the straight-line method over the estimated useful lives of the assets, as follows: Estimated Useful Lives Building 39 years Property 5 - 15 years Laboratory equipment 5 years Office equipment 3 years Furniture and fixtures 7 years Leasehold improvements The lesser of the lease term or life of the asset Impairment of Long-Lived Assets Long-lived assets are reviewed for indications of possible impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amounts to the future undiscounted cash flows attributable to these assets. An impairment loss is recognized to the extent an asset group is not recoverable, and the carrying amount exceeds the projected discounted future cash flows arising from these assets. Impairment losses, if any, are recognized in earnings. There were no impairment losses for any of the periods presented. 95 Collaborative Arrangements When the Company enters into collaboration arrangements, it assesses whether the arrangements fall within the scope of FASB issued ASC 808, Collaborative Arrangements, based on whether the arrangements involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. If the payments from the collaboration partner to the Company represent consideration from a customer, such as license fees and contract research and development activities, the Company accounts for those payments within the scope of FASB issued ASC 606, Revenue from Contracts with Customers (“Topic 606”). However, if the Company concludes that the payments are not from a customer, for certain activities and associated payments, such as for certain collaborative research, development, manufacturing, and commercial activities, these payments are presented as a reduction of research and development expense or general and administrative expense, based on where the Company presents the underlying expense. Revenue Recognition The Company accounts for revenues in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“Topic 606”). To determine revenue recognition for arrangements that fall within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services transferred to the customer. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To date, the Company's revenues have been generated exclusively from the Wugen License, which consists of licenses of intellectual property, cost reimbursements, upfront signing fees, milestone payments and royalties on future licensee’s product sales. In addition, the Company and Wugen have an agreement for the supply of clinical and research grade materials under which the Company also recognized revenues. License Grants: For out-licensing arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement. Milestone and Contingent Payments: At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s licensees will generally pay milestones payments subsequent to achievement of the triggering event. 96 Materials Supply: The Company provides clinical and research grade materials so that licensees may develop products based on the licensed molecules. The amounts billed are recognized as revenue as the performance obligations are satisfied by the Company, once the Company determines that a contract exists. On June 18, 2021, the Company entered into a master services agreement (“MSA”) with Wugen for the supply of materials for clinical development of licensed products. The terms set forth in the MSA were not sufficient to meet all the requirements for the Company to determine that a contract existed for a transaction. In order for a contract to exist, additional terms for each transaction require the Company to enter into a statement-of-work (“SOW”) for each purchase. Each of these transactions represents a single performance obligation that is satisfied over time. The Company recognizes revenue using an input method based on the costs incurred relative to the total expected cost, which determines the extent of the Company’s progress toward completion. As part of the accounting for these arrangements, the Company must develop estimates and assumptions that require judgement to determine the progress towards completion. The Company reviews its estimate of the progress toward completion based on the best information available to recognize the cumulative progress toward completion as of the end of each reporting period, and makes revisions to such estimates, if facts and circumstances change during each reporting period. Any such revisions are recorded on a cumulative catch-up basis, noting no material revisions during the year ended December 31, 2023. For each in process SOW, amounts are billed in the same quarter the costs are incurred. On March 14, 2022, the Company entered into SOWs with Wugen for each of the then-current and historical purchases of clinical and research grade materials under the MSA. As a result, the Company determined that all requirements were met to qualify as contracts under Topic 606 for the related transactions covered by these SOWs. For the years ended December 31, 2022 and 2023, the Company recognized revenues related to sale of development supply materials to Wugen of $ 6.7 million and $ 2.8 million, respectively. Accounts Receivable, Net Accounts receivable is presented in accordance the current expected credit losses (“CECL”) impairment model as required under Topic 326. The Company estimates a reserve for expected credit losses based on existing contractual payment terms, actual payment patterns of its customers, current and future economic and market conditions and individual customer circumstances. As of December 31, 2022 or December 31, 2023 , the Company determined that a reserve for expected credit losses was not required. No accounts were written off during the periods presented.. Deferred Revenue Deferred revenue represents amounts billed, or in certain cases, yet to be billed to the Company’s customer for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying performance obligations. In the year ended December 31, 2021, there was a balance of $ 1.8 million in deferred revenues in the Company's balance sheet, all of which were recognized as revenue in the year ended December 31, 2022. There were no deferred revenue balances as of December 31, 2022 or 2023. Investments The Company holds a minority interest in Wugen. The underlying shares of common stock are not traded on any public market and thus have limited marketability. The Company does not have significant influence over the operating and financial policies of Wugen. As a result, the Company has accounted for this investment using the measurement alternative whereby the investment is recorded at cost less impairment, adjusted for observable price changes in orderly transactions for an identical or similar investment of the same investee. No impairment was recognized during the years ended December 31, 2022 and 2023. The Company invested net proceeds of its IPO in bills and notes issued by the U.S. Treasury which are classified as trading securities. As of December 31, 2022, the Company held $ 9.7 million in U.S. Treasury bills included in Short-term investments in the balance sheet included in the audited financial statements. As of December 31, 2023, the Company had no Short-term investments. 97 Operating Leases The Company determines if an arrangement is a lease at inception. Operating leases right of use (“ROU”) assets are included in Other assets, and operating liabilities are included in Accrued liabilities and other current liabilities, and Other liabilities on the balance sheets included in the audited financial statements. ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company has a lease agreement with lease and non-lease components, which are accounted for separately. For short-term leases with a term of one year or less, the Company uses the practical expedient and does not record an ROU asset for such short-term leases. Research and Development Expenses Research and development costs are expensed as incurred and include salaries, benefits, and other operating costs such as outside services, supplies and allocated overhead expenses. The Company may perform research and development for its own proprietary drug candidates and technology development or for certain third parties under collaborative arrangements. For its proprietary drug candidates and its own internal technology development programs, the Company invests its own funds without reimbursement from a third party. Where the Company performs research and development activities under a clinical joint development collaboration, it records the partner’s share of collaboration expenses as a reduction to research and development expense when reimbursement amounts are due under the agreement. The Company records an accrued expense for the estimated costs of its contract manufacturing activities performed by third parties if there is no invoice. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to vendors. Payments under the contracts include upfront payments and milestone payments, which depend on factors such as the achievement of the completion of certain stages of the manufacturing process. For purposes of recognizing expense, the Company assesses whether the production process is sufficiently defined to be considered the delivery of a good, as evidenced by predictive or contractually required yields in the production process, or the delivery of a service, where processes and yields are developing and less certain. If the Company considers the process to be the delivery of a good, the Company recognizes the expense when the drug product is delivered, or otherwise bears risk of loss. If the Company considers the process to be the delivery of a service, the expense is recognized based on its best estimates of the contract manufacturer’s progress towards completion of the stages in the contracts. The Company recognizes and amortizes upfront payments and accrues for liabilities based on the specific terms of each arrangement. Arrangements may provide upfront payments for certain stages of the arrangement and milestone payments for the completion of certain stages, and, accordingly, may result in advance payments for services that have not been completed or goods not delivered and liabilities for stages where the contract manufacturer is entitled to a milestone payment. Advance payments for goods or services that will be used or rendered for future research and development activities are capitalized as prepaid expenses and recognized as expense as the related goods are delivered or the related services are performed. The Company bases its estimates on the best information available at the time. However, additional information may become available to the Company which may allow it to make a more accurate estimate in future periods. In this event, the Company may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain. Such increases or decreases in cost are generally considered to be changes in estimates and will be reflected in research and development expenses in the period identified. Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expenses in the statement of operations and expensed as incurred, since recoverability of such expenditures is uncertain. Stock-based Compensation The Company measures its stock-based awards granted to employees and directors based on the estimated fair value of the option on the date of grant (grant date fair value) and recognizes compensation expense over the vesting period. Compensation expense is recorded as either research and development or general and administrative expenses in the statement of operations based on the function to which the related services are provided. Forfeitures are accounted for as they occur. The Company has granted options with service-based and performance-based vesting conditions. 98 The Company uses the Black-Scholes option pricing model for the respective grant to determine the grant date fair value. The Black-Scholes option pricing model requires the input of highly subjective assumptions. These variables include, but are not limited to, its stock price volatility over the term of the awards and actual and projected employee stock option exercise behaviors. Management will continue to assess the assumptions and methodologies used to calculate the estimated grant date fair value of stock-based compensation. Circumstances may change and additional data may become available over time, which could result in changes to these assumptions and methodologies and materially impact the Company’s grant date fair value determination. For stock option grants with service-based vesting, stock-based compensation expense represents the portion of the grant date fair value of employee stock option grants recognized over the requisite service period of the awards on a straight-line basis, net of estimated forfeitures. For options that vest upon the achievement of performance milestones, the Company estimates fair value at the date of grant and compensation expense is recognized using the accelerated attribution method when it is determined that the performance criteria are probable of being met. Debt Issuance Costs Debt issuance costs are presented in the balance sheet as a direct deduction from the carrying amount of the related debt and are amortized, using the effective interest method, as interest expense over the contractual life of the related debt. Deferred Offering Costs The Company defers offering costs consisting of legal, accounting and other fees and costs directly attributable to offering costs. For offerings expected to occur within 90 days, the deferred offering costs will be offset against the proceeds received upon the completion of the offering. Deferred offering costs will be recorded under Other noncurrent assets on the balance sheet. In the event an offering is terminated or the timing for completing the offering is uncertain, all of the deferred offering costs will be expensed within the Company’s statement of operations in the period in which the determination is made. In the year ended December 31, 2022, the Company expensed $ 190,547 of deferred offering costs in connection with its $ 100.0 million shelf registration statement on Form S-3, including a prospectus for the issuance and sale of up to $ 15.5 million shares of the Company's common stock through an at-the-market program, which was declared effective by the SEC on August 26, 2022. Income Taxes The Company accounts for income taxes using an asset and liability approach in accordance with applicable guidance prescribed by FASB issued ASC 740, Income Taxes (“Topic 740”). Topic 740 requires that the deferred tax consequences of temporary differences between the amounts recorded in the financial statements and the amounts included in the federal and state income tax returns to be recognized in the balance sheet. The Company makes judgments regarding the realizability of its deferred tax assets. The balance sheet carrying value of its deferred tax assets is based on whether the Company believes it is more likely than not that the Company will generate sufficient future taxable income to realize these deferred tax assets after consideration of all available evidence. The Company regularly reviews its deferred tax assets for recoverability considering historical profitability, projected future taxable income, the expected timing of the reversals of existing temporary differences and tax planning strategies. In assessing the need for a valuation allowance, the Company considers both positive and negative evidence related to the likelihood of realization of the deferred tax assets. The weight given to the positive and negative evidence is commensurate with the extent to which the evidence may be objectively verified. As such, it is generally difficult for positive evidence regarding projected future taxable income exclusive of reversing taxable temporary differences to outweigh objective negative evidence of recent financial reporting losses. Generally, cumulative loss in recent years is a significant piece of negative evidence that is difficult to overcome in determining that a valuation allowance is not needed. The Company’s tax positions may be subject to income tax audits. The Company recognizes the tax benefit of an uncertain tax position only if it is more likely than not that the position is sustainable upon examination by the taxing authority, based on the technical merits. The tax benefit recognized is measured as the largest amount of benefit which is more likely than not to be realized upon settlement with the taxing authority. The Company recognizes interest accrued and penalties related to unrecognized tax benefits in its tax provision. The Company evaluates uncertain tax positions on a regular basis. The evaluations are based on a number of factors, including changes in facts and circumstances, changes in tax law, correspondence with tax authorities during the course of the audit, and effective settlement of audit issues. The provision for income taxes includes the effects of any accruals that the Company believes are appropriate, as well as the related net interest and penalties. The Company had no accrual for interest or penalties on its balance sheets as of December 31, 2022 and 2023, and has no t recognized interest or penalties in its statements of operations for the years ended December 31, 2022 and 2023. 99 Tax Credit Receivable The Company may be eligible for research and development credits for its research and development activities, in accordance with Internal Revenue Code (“I.R.C.”) § 41(c). The credits are generally available to offset income tax liabilities. As of December 31, 2022 and 2023 , the outstanding payroll tax receivables is included in Other current assets in the balance sheet. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is anti-dilutive. The Company’s potentially dilutive securities, which include convertible redeemable preferred stock and outstanding stock options under the 2019 Equity Incentive Plan (“2019 Plan”) and the 2021 Equity Incentive Plan (“2021 Plan”), have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. Recently Issued Accounting Pronouncements In June 2016 the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326). It requires the use of the current expected credit losses (CECL) impairment model for a broad scope of financial instruments, including financial assets measured at amortized cost (which includes loans, held-to-maturity debt securities and trade receivables), net investments in leases, and certain off-balance sheet credit exposures. The CECL model requires the immediate recognition of estimated expected credit losses over the life of the financial instrument. The estimate of expected credit losses considers not only historical information, but also current and future economic conditions and events. For accounts receivable, the Company estimates a reserve for expected credit losses based on existing contractual payment terms, actual payment patterns of its customers, current and future economic and market conditions and individual customer circumstances. For other asses, the measurement approach used by the Company may be based on the probability-of-default method, under which expected credit losses are determined by multiplying the probability of default (i.e., the probability the asset will default within the given time frame) by the loss given default (the percentage of the asset not expected to be collected because of default). The Company adopted CECL on January 1, 2023 on a prospective basis and it had no impact on the Company’s financial statements. In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures (ASU 2023-07) which is intended to improve reportable segment disclosures primarily through enhanced disclosure of reportable segment expenses and requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. The new guidance is required to be applied retrospectively to all prior periods presented in the financial statements and is effective for the Company for fiscal periods beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The Company has one reportable segment and is evaluating the impact of the standard on the Company’s financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures which requires significant disclosures about income taxes, primarily focused on the disclosure of income taxes paid and the rate reconciliation table. The new guidance will be applied prospectively and is effective for the Company for fiscal periods beginning after December 15, 2024. The Company is evaluating the impact of the standard on the Company’s financial statements. 100 2. Property, Plant and Equipment, Net Property, plant and equipment, net consists of the following: At December 31, 2022 2023 Land $ 2,150,038 $ 2,150,038 Building 6,105,570 6,105,570 Property 1,767,231 1,767,231 Laboratory equipment 2,115,153 2,146,637 Office equipment 209,405 225,369 Furniture and fixtures 292,045 292,045 Leasehold improvements 349,976 354,276 Construction in progress 52,414 10,443,859 $ 13,041,832 $ 23,485,025 Less: Accumulated depreciation and amortization ( 2,237,222 ) ( 3,031,841 ) Property, plant and equipment, net $ 10,804,610 $ 20,453,184 Construction in progress of $ 10.4 million represents direct costs of construction and equipment incurred for the Company’s new research lab and manufacturing facilities, that are not ready for their intended use. Depreciation and amortization expense for the year ended December 31, 2022 was $ 589,608 , of which $ 441,698 is included in research and development expenses. Depreciation and amortization expense for the year ended December 31, 2023 was $ 794,619 , of which $ 541,679 is included in research and development expenses. During the year ended December 31, 2023, the Company capitalized interest expense of $ 95,627 , into Construction in progress. 3. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, U.S. government backed securities with maturity dates up to one year, accounts payable and accrued liabilities, are measured at approximate fair value due to their short-term maturities. Money market funds included in cash and cash equivalents and U.S. government-backed securities are measured at fair value based on quoted prices in active markets, which are considered Level 1 inputs. No transfers between levels occurred during the periods presented. The following table presents the Company’s assets which were measured at fair value at December 31, 2022 and 2023: At December 31, 2022: Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,458,020 $ — $ — $ 19,458,020 Treasury notes 9,735,930 — — 9,735,930 Total $ 29,193,950 $ — $ — $ 29,193,950 At December 31, 2023: Level 1 Level 2 Level 3 Total Assets: Money market funds $ 1,626,129 $ — $ — $ 1,626,129 Total $ 1,626,129 $ — $ — $ 1,626,129 101 4. Investments In December 2020, the Company entered into the Wugen License for limited rights to develop, manufacture and commercialize cellular therapy products based on two of the Company’s fusion protein molecules. As part of the consideration received for the Wugen License, the Company received shares of Wugen common stock, which were recognized at $ 1.6 million, the fair value of the securities as of December 24, 2020, the effective date for the Wugen License. Initial recognition was at fair value based on level 3 inputs, since there was no public market on which to trade these shares at the time they were received. The fair value was determined based primarily on the pricing and terms of a third-party financing completed by Wugen in 2020. So long as there continues to be no public market for these securities, the Company will classify this asset as a cost method investment, recorded at cost less impairment adjusted for observable market changes. As of December 31, 2022 and 2023, Investments had a balance of $ 1.6 million, reflecting the investment in Wugen, whic h the Company continues to carry at cost since no public market exists for these securities and no impairment adjustments have been necessary since the acquisition date. 5. Accrued Liabilities and Other Current Liabilities As of December 31, 2022, the Company had a bala nce of $ 1.7 million included in Accrued liabilities and other current liabilities in the balance sheet included in the audited financial statements, consisting of $ 416,000 for legal expenses, $ 277,500 for clinical expenses, $ 524,000 in bonus expenses, $ 134,000 in salary expenses, and $ 178,000 in lease liability. As of December 31, 2023, the Company had a balance of $ 2.6 million included in Accrued liabilities and other current liabilities in the balance sheet included in the audited financing statements, consisting of $ 392,000 for construction expenses, $ 105,000 for manufacturing expenses, $ 1.1 million for legal expenses, $ 262,000 for clinical expenses, $ 365,000 in bonus expense, $ 160,000 for salary expenses, $ 119,000 for the current portion of long-term debt, $ 28,500 in lease liability and $ 68,500 of other liabilities. 6. Debt, Net On August 15, 2022, the Company entered into a loan and security agreement (the “2022 Loan Agreement”) with Cogent Bank (“Cogent”), pursuant to which it received $ 6.5 million in gross proceeds to purchase a building that will become the Company's new headquarters. The loan is secured by a first priority lien on the building. The Company is in compliance with all covenants as of December 31, 2023. As of December 31, 2022, the Company had $ 6.5 million in gross principal outstanding in a loan under the 2022 Loan Agreement. An interest-only period is one year followed by 48 months of equal payments of principal and interest beginning on September 15, 2023 based on a 25-year amortization rate. The unamortized balance is due on August 15, 2027 (the “Maturity Date”), and bears interest at a fixed per annum rate equal to 5.75 %. Upon the Maturity Date, a final payment of unamortized principal will be due. The Company has the op tion to prepay the outstanding balance of the loan prior to the Maturity Date without penalty. As of December 31, 2023 , the current portion of $ 119,398 is included in Accrued liabilities and other current liabilities, and the noncurrent portion of $ 6.3 million is included in Debt, net in the balance sheet included in the audited financial statements. The Company classifies the total undiscounted contractual payments that are due in the next 12 months as current. The loan was initially measured on a present value basis. An amortization schedule is used to determine how much of each payment is applied to interest and principal each period. The payment is first applied to interest, and the remainder reduces the principal balance. The table below shows the amount of maturities for each of the five years following the date of the latest balance sheet: Maturities per Year 2024 $ 119,398 2025 127,623 2026 135,266 2027 6,079,440 Total Debt $ 6,461,727 102 7. License Agreement On December 24, 2020, the Company entered into the Wugen License transferring rights to Wugen to develop, manufacture, and commercialize certain cellular therapy products based on two of the Company’s fusion protein molecules. The term of the agreement will expire on a product-by-product and country-by-country basis, upon the later of (i) ten years from the first commercial sale of the product or (ii) the expiration of the last-to-expire valid patent claim of such product. The Company concluded that Wugen is a customer and the Wugen License is a functional license under the provisions of Topic 606. In addition to upfront fees and revenues from other transactions that took place upon entering the Wugen License, the Wugen License includes milestone payments and royalties. The Company uses judgment to determine whether milestones or other variable consideration should be included in the transaction price. For revenue-based royalties, including milestone payments based on the level of sales, the Company will include royalties in the transaction price at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalties are allocated has been satisfied (or partially satisfied). As part of management’s evaluation of the transaction price, the Company considers numerous factors, including whether the achievement of the milestones is outside of its control, contingent upon the efforts of others or subject to scientific risks of success. If the Company concludes it is probable that a significant revenue reversal would not occur, the associated milestone payment is included in the transaction price. Milestone payments that are not within its control, such as regulatory approvals, are generally not considered probable until those milestones are achieved. The Company reevaluates the transaction price, including estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur. 8. Preferred Stock At December 31, 2022 and December 31, 2023, the Company had 10,000,000 shares of preferred stock authorized and no shares issued. 9. Net Loss Per Share The following table summarizes the computation of the basic and diluted net loss per share: Years Ended December 31, 2022 2023 Numerator: Net loss $ ( 14,900,703 ) $ ( 24,994,277 ) Denominator: Weighted-average common shares outstanding 35,822,249 35,929,446 Net loss per share, basic and diluted $ ( 0.42 ) $ ( 0.70 ) The following table summarizes the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive: At December 31, 2022 2023 Common stock options 1,867,458 1,779,338 Potentially dilutive securities 1,867,458 1,779,338 10. Stock-based Compensation On June 21, 2021, the 2021 Plan was adopted by the Company’s board of directors and approved by the Company’s stockholders. As of the adoption date, the 2019 Plan was terminated. No terms were changed for grants previously awarded under the 2019 Plan, and the Company concluded a modification did not occur. Under the 2019 Plan, the Company primarily granted employees incentive stock options, which had a maximum term of ten years from the date of the grant. Generally, the incentive stock options granted under the 2019 Plan have a four-year , service-based vesting period. All of the options granted under the 2019 Plan had an exercise price equal to the fair value of a share of common stock on the date of the grant, according to Company policy. 103 The 2021 Plan permits the grant of incentive stock options, nonstatutory stock options, stock a ppreciation rights, restricted stock, restricted stock units, and stock bonus awards. The 2021 Plan initially reserved 3,444,343 shares of Common Stock, including the transfer of remaining shares reserved under the 2019 Plan. In addition, the number of shares reserved for issuance under the 2021 Plan will increase automatically on the first day of each fiscal year beginning with the 2022 fiscal year. Under the 2021 Plan, the term of each stock option must be stated in the stock award agreement. In the case of an incentive stock option, the term will be ten years from the date of grant, or such shorter term as may be provided in the stock award agreement. Moreover, in the case of an incentive stock option granted to a participant who owns stock representing more than 10 % of the total combined voting power of all classes of our stock or the stock of any of our affiliates, the term of the incentive stock option will be five years from the date of grant or such shorter term as may be provided in the stock award agreement. Under the 2021 Plan, the Company continues to have a policy to grant options with an exercise price equal to the fair value of a share of common stock, as determined by the closing price on NASDAQ on the grant date. The following summarizes the Company’s stock option activity for the years ended December 31, 2022 and 2023: Shares Weighted Weighted Average Issuable Average Remaining Aggregate under Exercise Contract Intrinsic Options Price Term Value Outstanding at December 31, 2021 1,770,739 2.96 9.0 years $ 1,124,215 Granted 237,364 2.33 Exercised ( 108,176 ) 0.15 Forfeited or cancelled ( 31,441 ) 0.41 Expired ( 1,028 ) 0.21 Outstanding at December 31, 2022 1,867,458 3.11 8.5 years $ 671,878 Exercisable at December 31, 2022 473,686 3.06 8.3 years $ 198,258 Outstanding at December 31, 2022 1,867,458 3.11 8.5 years $ 671,878 Granted 91,000 1.88 Exercised ( 148,664 ) 0.16 Forfeited or cancelled ( 26,342 ) 1.86 Expired ( 4,114 ) 3.40 Outstanding at December 31, 2023 1,779,338 3.31 7.7 years $ 238,210 Exercisable at December 31, 2023 942,998 3.07 7.6 years $ 173,385 The exercise price of the underlying stock options and the fair value of the Company’s common stock for stock options as of the reporting date. The intrinsic value of stock options exercised during the years ended December 31, 2022 and 2023 was $ 231,301 and $ 202,917 , respectively. The weighted-average fair value of options granted during the years ended December 31, 2022 and 2023 was $ 1.71 and $ 1.42 per share, respectively. For stock option grants with service-based vesting, stock-based compensation expense represents the portion of the grant date fair value of employee stock option grants recognized over the requisite service period of the awards on a straight-line basis, net of estimated forfeitures. For options that vest upon the achievement of performance milestones, the Company estimates fair value at the date of grant and compensation expense is recognized using the accelerated attribution method when it is determined that the performance criteria are probable of being met. In determining the grant date fair value of the stock-based awards, the Company uses the Black-Scholes option-pricing model and assumptions discussed below. Each of these inputs is subjective and its determination generally requires significant judgment. Fair Value of Common Stock —Since the completion of our initial public offering on July 19, 2021, the fair value of each share of common stock underlying stock option grants is based the quoted market price on the primary stock exchange on which our common stock is traded on the day the stock award or option is granted. Expected term —The expected term of stock options is determined using the “simplified” method, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. 104 Expected volatility —The expected volatility was derived from the historical stock volatilities of comparable peer public companies within our industry. Risk-free interest rate —The risk-free interest rate is based on the U.S. Treasury Bond in effect at the time of grant for periods corresponding with the expected term. Dividend yield —The expected dividend yield is 0 % because the Company has not historically paid, and does not expect, for the foreseeable future, to pay a dividend on its common stock. For the years ended December 31, 2022 and 2023, the fair value of employee and director stock option awards was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Years Ended December 31, 2022 2023 Expected term (years) 5.73 5.71 Expected volatility 88.05 % 89.90 % Risk-free interest rate 3.29 % 3.99 % Dividend yield — — Fair value underlying common stock $ 1.71 $ 1.42 For the year ended December 31, 2022 , for options with service-based vesting conditions, the Company recognized $ 62,473 of employee stock-based compensation expense in research and development expenses and $ 1,057,718 of employee stock-based compensation in general and administrative expenses in the statement of operations included in the audited financial statements. For the year ended December 31, 2023 , for options with service-based vesting conditions, the Company recognized $ 65,941 of employee stock-based compensation expense in research and development expenses and $ 937,808 of employee stock-based compensation in general and administrative expenses in the statement of operations included in the audited financial statements. As of December 31, 2023 , the Company had an aggregate of $ 1.8 million of unrecognized employee stock-based compensation cost for options with service-based vesting, which is expected to be recognized over a weighted average vesting period of 1.62 years. 11. Employee Benefit Plan The Company offers a defined contribution savings plan (the “Benefit Plan”) under Section 401 of the Internal Revenue Code for all eligible employees. The Benefit Plan allows for discretionary contributions which are limited to the maximum allowable for federal tax purposes. The total expense related to the discretionary payments made by the Company to the Benefit Plan for the years ended December 31, 2022 and 2023 was $ 171,215 and $ 184,214 , respectively. 12. Collaborative Arrangements The Company has certain contract research agreements with contractors that were entered during the two years ended December 31, 2023 for the (i) hybridoma development, (ii) cell line improvement, and (iii) research to support pre-clinical studies. We own all rights to the resulting intellectual property, including the antibodies, sequences, and data. For certain contractors, the Company is obligated to pay one future milestone payment upon filing and acceptance of an IND for each respective human antibody or protein from cell line; however no additional future development or financial obligations are due under these contract research agreements as of December 31, 2022 or 2023. 105 13. Income Taxes The Company di d no t have a provision for income taxes (current or deferred tax expense) for tax years ended December 31, 2022 and 2023. The following table summarizes the differences between the statutory federal income tax rate and the Company's effective income tax rate (percent data): Rate Reconciliation 2022 2023 Net Loss Before Taxes $ ( 14,900,703 ) $ ( 24,994,277 ) Benefit at statutory rate ( 3,129,148 ) 21.00 % ( 5,248,798 ) 21.00 % State tax benefit net of federal benefit ( 655,142 ) 4.40 % ( 1,027,320 ) 4.11 % Permanent book/tax differences 64,106 ( 0.43 %) 31,046 ( 0.12 %) Other adjustments 8,545 ( 0.06 %) — 0.00 % R&D credit carryforward ( 512,967 ) 3.44 % ( 540,777 ) 2.16 % Change in valuation allowance 4,224,606 ( 28.35 %) 6,785,849 ( 27.15 %) Income tax expense/(benefit) $ — 0.00 % $ — 0.00 % The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2022 and 2023 are presented below: 2022 2023 Deferred tax assets: Federal net operating loss carryforward $ 6,569,874 $ 8,403,928 State net operating loss carryforward 1,411,041 1,738,257 Capitalized section 174 R&D expenses 2,121,015 3,872,297 Reserve for credit losses - 1,330,613 R&D credit 720,165 1,260,942 Accrued expenses 151,255 123,408 Capitalized legal fees for patents 177,405 1,235,488 Stock-based compensation 341,038 566,396 Charitable contributions 65 65 Unrealized gain/loss 59,314 — ROA asset 530 106 Depreciable assets 47,037 — Total deferred tax assets 11,598,739 18,531,500 Deferred tax Liabilities: Unrealized gain/loss $ — $ ( 5,238 ) Depreciable assets — ( 127,474 ) Deferred revenue/costs — ( 14,202 ) Total deferred tax liability — ( 146,914 ) Net deferred tax asset 11,598,739 18,384,586 Less: valuation allowance ( 11,598,739 ) ( 18,384,586 ) Net deferred tax asset (after valuation allowance) $ — $ — A valuation allowance is recorded to reduce the deferred tax asset if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax asset will not be realized. As of December 31, 2023 , after consideration of all the evidence, both positive and negative, management has determined that a valuation allowance of $ 18.4 million is necessary to reduce the deferred tax asset to the amount that will more likely than not be realized. During the year ended December 31, 2023 , the valuation allowance increased by $ 6.8 million. As of December 31, 2022 and 2023 , the Company had available federal NOL carryforwards of $ 31.3 million and $ 40.0 million, respectively. The Company also has available state NOLs carryforwards of approximately $ 32.5 million and $ 40.0 million, as of December 31, 2022 and 2023 , respectively. The federal and state NOLs will carryforward indefinitely. The Federal NOLs are available to offset 80 % of taxable income. In addition, the Company had federal research and development credits carryforwards of $ 720,165 and $ 1.3 million, as of December 31, 2022 and 2023 , respectively, to reduce future federal income taxes, if any. These carryforwards expire from 2038 through 2043 and are subject to review and possible adjustment. 106 Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, (the Code), substantial changes in the Company’s ownership may limit the amount of net operating loss and research and development credit carryforwards that could be used annually in the future to offset taxable income. A formal Section 382 study has not been completed to determine if an ownership change has occurred and if its net operating losses are subject to an annual limitation. Such annual limitations could affect the utilization of NOL and tax credit carryforwards in the future. Effective for tax years beginning after December 31, 2021, Section 174 requires that research and experimental expenses (“R&E”) be capitalized and amortized. The amortization period is five years for domestic expenses and 15 years for foreign expenses. Since the Company has a significant amount of expenses that fall under the definition of R&E expenses, the change can materially affect the Company's tax provision. During the year ended December 31, 2022 and 2023, the Company analyzed its expenses and determined that expenses of $ 9.2 million and $ 9.8 million, respectively, fell within the definition of Section 174. Accordingly, these expenditures were capitalized and amortized for tax purposes. As of December 31, 2022 and 2023, the Company had $ 864,179 and $ 2.6 million, respectively, of amortization expense related to Section 174 capitalized R&E costs. The Company’s tax returns remain subject to examination by tax authorities beginning with the tax year ended December 31, 2020. However, due to NOLs and credits carried forward from prior tax years, substantially all tax years may also be subject to examination. The Company recognizes the tax benefit of an uncertain tax position only if it is more likely than not that the position is sustainable upon review by the taxing authorities based on the technical merits. The Company recognizes interest accrued and penalties for unrecognized tax benefits in its tax provision. As of December 31, 2022 and 2023 , the Company had no t recognized any expense related to uncertain tax position in its statement of operations. 14. Related Party Transactions See Note 16 for disclosure of related party transactions which occurred after the balance sheet reporting date. 15. Commitments and Contingencies Operating Leases The Company has operating leases for approximately 12,250 square feet of space located in Miramar, Florida. The leases have a two-year term which commenced on March 1, 2022 and terminated on February 29, 2024 . Upon the commencement of the leases, the Company used its incremental borrowing rate of 6.0 % to determine the amounts to recognize for a ROU asset and a lease liability. There are no obligations under finance leases. The components of the lease expense for the year ended December 31, 2023 were as follows: For the Year Ended December 31, 2023 Operating lease cost $ 169,651 Supplemental cash flow information related to lease for the twelve months ended December 31, 2023 was as follows: For the Year Ended December 31, 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 171,822 Right-of-use assets obtained in exchange for lease obligations: Operating lease $ 162,535 As of December 31, 2023, the supplemental balance sheet information related to leases was as follows: As of December 31, 2023 Operating lease right-of-use assets $ 28,061 Operating lease liabilities, current $ 28,061 107 As of December 31, 2023, the remaining lease payments were as follows: 2024 $ 28,693 Total future minimum lease payments $ 28,693 For the years ended December 31, 2022 and 2023 , rent expense recognized by the Company was $ 187,600 and $ 169,700 , respectively, of which $ 86,000 and $ 88,800 , respectively, is included in Research and development in the statements of operations included in the audited financial statements. Contractual Commitments The Company has commitments with a third-party manufacturing organization to supply us with clinical grade materials. As of December 31, 2023, we are under contract for obligations of $ 1.2 million that we expect to pay during the year ending December 31, 2024. As of December 31, 2023, the Company had commitments to fund $ 6.9 million in construction costs, related to the buildout of its new headquarters and manufacturing facility. Project Financing On January 10, 2024, the Company exercised its right to terminate its credit agreement (the “Credit Agreement”), dated April 21, 2023, with Prime Capital Ventures, LLC (the "Lender"), as permitted under the terms of the Credit Agreement. The termination followed repeated delays in funding and related concerns. There are no borrowings under the Credit Agreement, and the Company will not incur any penalties as a result of such termination under the terms of the Agreement. Upon exercising its right to terminate the Agreement, the Company was entitled to receive the return of the $ 5.3 million that the Company placed on deposit to establish an interest reserve account with the Lender. Subsequent to the year ended December 31, 2023, the Lender defaulted on its obligation to return the interest reserve deposit. Given the uncertainty of when or if funds will be recovered from the Lender, the Company recognized a reserve for a credit loss for $ 5.3 million as of December 31, 2023. The Company intends to pursue all available remedies to recover these funds, including legal actions, receivership and insurance. Legal Matters From time to time, the Company is a party to or otherwise involved in legal proceedings, including suits, assessments, regulatory actions and investigations generally arising out of the normal course of business. In addition, the Company enters into agreements that may include indemnification provisions, pursuant to which the Company agrees to indemnify, hold harmless and defend the indemnified parties for losses suffered or incurred by the indemnified party. When the Company believes that the outcome of such a matter will result in a liability that is probable to be incurred and result in a potential loss, or range of loss, that can be reasonably estimated, the Company will accrue a liability and make the appropriate disclosure in the footnotes to the financial statements. On December 23, 2022, Altor BioScience, LLC and NantCell, Inc. (“Altor/NantCell”) initiated an arbitration against Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in California alleging breach of contract and fiduciary duty, among other claims. On that same date, Altor/NantCell filed a lawsuit against the Company in federal court alleging misappropriation of trade secrets, inducement of breach of contract and breach of fiduciary duty, among other claims against the Company. On January 31, 2023, the Company filed a motion to compel arbitration, a motion for the stay of the litigation, and a motion to dismiss the complaint (“motion to compel”). On April 18, 2023, the U.S. District Court for the Southern District of Florida (the “Court”) heard oral argument on the Company’s motion to compel and ordered the parties to provide supplemental briefing by April 28, 2023. Before the Court ruled on the Company’s motion to compel, on April 26, 2023, the parties stipulated that Altor/NantCell’s action against the Company would be consolidated with the Altor/NantCell arbitration demand against Dr. Wong. On April 27, 2023, the Court approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS, with an arbitration hearing scheduled for May 20, 2024. In addition, on March 26, 2024, Altor/NantCell gave notice that they are filing a complaint (the “Complaint”) against the Company in the Chancery Court of the State of Delaware for the contribution of legal fees and expenses advanced to Dr. Wong, our founder and chief executive officer, in connection with the arbitration discussed above. Prior to the filing of the Complaint, Altor/NantCell had previously sought advancement from the Company and the Company agreed to advance 50 % of Dr. Wong’s legal 108 fees going forward from December 2023. On January 8, 2024, Altor/NantCell reserved their right to pursue contribution against the Company for 50 % of the amount Altor/NantCell sent for advancement of expenses for Dr. Wong. In the Complaint, Altor/NantCell seek 50 % of the fees they have already advanced to Dr. Wong, a declaration that the Company has an obligation to contribute 50 % of the advancement of Dr. Wong’s expenses including 50 % of Dr. Wong’s expenses incurred in connection with the arbitration through final resolution of the matter, and costs and fees in bringing this action. Inflationary Cost Environment, Geopolitical Risks and Other Macroeconomic Factors The Company’s operations have been affected by many headwinds, including inflationary pressures, rising interest rates, ongoing global supply chain disruptions resulting from increased geopolitical tensions such as the war in the Middle East, the conflict between Russia and Ukraine, China-Taiwan relations, financial market volatility and currency movements. The Company has been impacted by inflation, and may continue to be so, when procuring materials required for the buildout of our new headquarters, the costs for recruiting and retaining employees and other employee-related costs. Management employs a number of strategies to effectively navigate these issues, including product redesign, alternate sourcing, and establishing contingencies in budgeting and timelines. Future developments in these and other areas present material uncertainty and risk with respect to the Company's clinical trials, IND-enabling activities, buildout of the new headquarters, as well as the Company's financial condition and results of operations. The extent and duration of such events and conditions, and resulting disruptions to our operations, are highly unpredictable. 16. Subsequent Events Subsequent events have been evaluated through the date the financial statements were available to be issued. In addition to the required recognition or disclosure disclosed in the footnotes herein, there were also the following subsequent events after the reporting date: On February 29, 2024, the lease on the Company's current location reached the end of its term. The Company entered a new one-year lease for the same location which commenced on March 1, 2024 and terminates on February 28, 2025. As a lease of 12 months or less in duration and qualifies for a short-term lease exemption under ASC 842-20-25-2. The Company elects to account for this lease on a straight-line basis over the lease term and will not recognize a ROU asset and a lease liability as a result. The remaining lease payments under the new short-term lease are $ 274,823 . On February 20, 2024, the Company completed a $ 2.5 million private placement of shares of common stock with certain of its officers and directors at a price of $ 1.40 per share. The Company issued 1,785,718 shares of common stock in connection with the offering. The shares have not been registered and will not be sold or transferred except as permitted under law and pursuant to registration or exemption therefrom. The Board of Directors and Audit Committee of the Board of Directors reviewed the transaction under the policy for Related Party Transactions and determined that the transaction was in compliance with the Company's policy. As of March 31, 2024, the Company agreed to issue $ 10.0 million in secured notes to investors, including certain officers and directors. The Board of Directors and Audit Committee of the Board of Directors reviewed the transaction under the policy for Related Party Transactions and determined that the transaction was in compliance with the Company's policy. 109 Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure . None.