Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 15, 2024 | Jun. 30, 2023 | |
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-37937 | ||
Entity Registrant Name | XENETIC BIOSCIENCES, INC. | ||
Entity Central Index Key | 0001534525 | ||
Entity Tax Identification Number | 45-2952962 | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Address, Address Line One | 945 Concord Street | ||
Entity Address, City or Town | Framingham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 01701 | ||
City Area Code | 781 | ||
Local Phone Number | 778-7720 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 5,026,928 | ||
Entity Common Stock, Shares Outstanding | 1,540,684 | ||
Documents Incorporated by Reference [Text Block] | Information required in response to Part III of Form 10-K (Items 10, 11, 12, 13 and 14) is hereby incorporated by reference to portions of the registrant's definitive proxy statement for its 2024 Annual Meeting of Stockholders, information statement or an amendment to this Annual Report on Form 10-K. The registrant intends to file a definitive proxy statement, information statement or an amendment to this Annual Report on Form 10-K with the Securities and Exchange Commission no later than 120 days after the end of the registrant's fiscal year ended December 31, 2023. | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 688 | ||
Auditor Name | Marcum LLP | ||
Auditor Location | Boston, Massachusetts | ||
Common Stock, $0.001 par value per share | |||
Title of 12(b) Security | Common Stock, $0.001 par value per share | ||
Trading Symbol | XBIO | ||
Security Exchange Name | NASDAQ | ||
Purchase Warrants | |||
Title of 12(b) Security | Purchase Warrants | ||
Trading Symbol | XBIOW | ||
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 8,983,046 | $ 13,097,265 |
Prepaid expenses and other | 603,828 | 556,094 |
Total current assets | 9,586,874 | 13,653,359 |
Other assets | 1,018,352 | 1,066,931 |
Total assets | 10,605,226 | 14,720,290 |
Current liabilities: | ||
Accounts payable | 240,832 | 287,360 |
Accrued expenses and other current liabilities | 568,753 | 785,796 |
Total current liabilities | 809,585 | 1,073,156 |
Total liabilities | 809,585 | 1,073,156 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 10,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 1,543,385 and 1,519,360 shares issued as of December 31, 2023 and December 31, 2022, respectively; 1,540,684 and 1,516,659 shares outstanding as of December 31, 2023 and December 31, 2022, respectively | 1,544 | 1,520 |
Additional paid in capital | 208,053,935 | 207,769,904 |
Accumulated deficit | (193,234,196) | (189,099,618) |
Accumulated other comprehensive income | 253,734 | 253,734 |
Treasury stock | (5,281,180) | (5,281,180) |
Total stockholders' equity | 9,795,641 | 13,647,134 |
Total liabilities and stockholders' equity | 10,605,226 | 14,720,290 |
Series B Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred stock, value | 1,804 | 1,804 |
Series A Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred stock, value | $ 0 | $ 970 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, shares, issued | 1,543,385 | 1,519,360 |
Common stock, shares, outstanding | 1,540,684 | 1,516,659 |
Series B Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares issued | 1,804,394 | 1,804,394 |
Preferred stock, shares outstanding | 1,804,394 | 1,804,394 |
Series A Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares issued | 0 | 970,000 |
Preferred stock, shares outstanding | 0 | 970,000 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue | ||
Royalty revenue | $ 2,539,986 | $ 1,706,925 |
Total revenue | 2,539,986 | 1,706,925 |
Operating costs and expenses: | ||
Research and development | (3,494,765) | (4,770,834) |
General and administrative | (3,560,936) | (3,653,999) |
Total operating costs and expenses | (7,055,701) | (8,424,833) |
Loss from operations | (4,515,715) | (6,717,908) |
Other income (expense): | ||
Other income (expense) | 25,380 | (1,597) |
Interest income, net | 355,757 | 167,152 |
Total other income, net | 381,137 | 165,555 |
Net loss | $ (4,134,578) | $ (6,552,353) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Basic net loss per share | $ (2.71) | $ (4.61) |
Diluted net loss per share | $ (2.71) | $ (4.61) |
Weighted-average shares of common stock outstanding, basic | 1,528,210 | 1,422,443 |
Weighted-average shares of common stock outstanding, diluted | 1,528,210 | 1,422,443 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Treasury Stock, Common [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 2,774 | $ 1,347 | $ 205,964,847 | $ (182,547,265) | $ 253,734 | $ (5,281,180) | $ 18,394,257 |
Beginning balance, shares at Dec. 31, 2021 | 2,774,394 | 1,346,661 | |||||
Issuance of common stock in connection with purchase of in-process research and development | 173 | 1,293,577 | 1,293,750 | ||||
Issuance of common stock in connection with purchase of in-process research and development, shares | 172,500 | ||||||
Exercise of purchase warrants | |||||||
Exercise of purchase warrants, shares | 199 | ||||||
Share-based expense | 511,480 | 511,480 | |||||
Net loss | (6,552,353) | (6,552,353) | |||||
Ending balance, value at Dec. 31, 2022 | $ 2,774 | $ 1,520 | 207,769,904 | (189,099,618) | 253,734 | (5,281,180) | 13,647,134 |
Ending balance, shares at Dec. 31, 2022 | 2,774,394 | 1,519,360 | |||||
Issuance of common stock to adjust for reverse split rounding | $ 16 | (16) | |||||
Issuance of common stock to adjust for reverse split rounding, shares | 15,941 | ||||||
Conversion of Series A preferred stock to shares of common stock | $ (970) | $ 8 | 962 | ||||
Conversion of Series A preferred stock to shares of common stock, shares | (970,000) | 8,084 | |||||
Issuance of common stock in connection with purchase of in-process research and development, shares | 15,941 | ||||||
Share-based expense | 283,085 | 283,085 | |||||
Net loss | (4,134,578) | (4,134,578) | |||||
Ending balance, value at Dec. 31, 2023 | $ 1,804 | $ 1,544 | $ 208,053,935 | $ (193,234,196) | $ 253,734 | $ (5,281,180) | $ 9,795,641 |
Ending balance, shares at Dec. 31, 2023 | 1,804,394 | 1,543,385 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (4,134,578) | $ (6,552,353) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development | 0 | 1,793,750 |
Amortization of right of use asset | 0 | 27,043 |
Share-based expense | 283,085 | 511,480 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other | (47,734) | (103,738) |
Other long-term assets | 48,579 | 25,000 |
Accounts payable, accrued expenses and other liabilities | (263,571) | (347,947) |
Net cash used in operating activities | (4,114,219) | (4,646,765) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Net cash paid to acquire in-process research and development | 0 | (500,000) |
Net cash used in investing activities | 0 | (500,000) |
Net change in cash | (4,114,219) | (5,146,765) |
Cash at beginning of period | 13,097,265 | 18,244,030 |
Cash at end of period | 8,983,046 | 13,097,265 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | 0 | 0 |
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Issuance of common stock to acquire in-process research and development | 0 | 1,293,750 |
Issuance of common stock to adjust for Reverse Stock Split | 16 | 0 |
Conversion of Series A preferred stock to common stock | $ 970 | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure [Table] | ||
Net Income (Loss) Attributable to Parent | $ (4,134,578) | $ (6,552,353) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual [Table] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
The Company
The Company | 12 Months Ended |
Dec. 31, 2023 | |
Company | |
The Company | 1. The Company Background Xenetic Biosciences, Inc. (“Xenetic” or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company’s proprietary Deoxyribonuclease (“DNase”) platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (“NETs”), which have been implicated in cancer progression and resistance to cancer treatments. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Additionally, Xenetic has partnered with biotechnology and pharmaceutical companies to develop its proprietary drug delivery platform, PolyXen ® The Company, directly or indirectly, through its wholly-owned subsidiaries, Hesperix S.A. (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and SymbioTec, GmbH (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications along with unregistered trademarks and service marks, including but not limited to XCART, OncoHist™, PolyXen, ErepoXen™, and ImuXen™, which are used throughout this Annual Report. All other company and product names may be trademarks of the respective companies with which they are associated. Going Concern and Management’s Plan Management evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company has incurred substantial losses since its inception and expects to continue to incur operating losses in the near-term. These factors raise substantial doubt about its ability to continue as a going concern. The Company believes that it has access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations, related party funding, or other means to continue as a going concern. The Company believes that its existing resources will be adequate to fund the Company’s operations for a period of at least twelve months from the date of the issuance of these financial statements. However, the Company anticipates it may need additional capital in the long-term to pursue its business initiatives. The terms, timing and extent of any future financing will depend upon several factors, including the achievement of progress in its product development programs, its ability to identify and enter into licensing or other strategic arrangements, its continued listing on the Nasdaq Stock Market (“Nasdaq”), and factors related to financial, economic, geo-political, industry and market conditions, many of which are beyond its control. The capital markets for the biotech industry can be highly volatile, which make the terms, timing and extent of any future financing uncertain. On June 3, 2022, the Company received a written notification (the “Notice”) from the Listing Qualifications Department of Nasdaq notifying the Company that the closing bid price for its common stock had been below $1.00 for 30 consecutive business days and that the Company therefore was not in compliance with the minimum bid price requirement for continued inclusion on Nasdaq under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”). The Notice had no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market. On May 15, 2023, the Company effected a reduction, on a 1-for-10 0.001 1.00 |
Risks and Uncertainties
Risks and Uncertainties | 12 Months Ended |
Dec. 31, 2023 | |
Risks and Uncertainties [Abstract] | |
Risks and Uncertainties | 2. Risks and Uncertainties Impact of Global Conflicts on Operations The short and long-term implications of Russia’s invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition of current and future sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Preparation of Financial Statements On May 15, 2023, the Company effected the Reverse Stock Split. On the effective date of the Reverse Stock Split, (i) every 10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number of shares of common stock into which each outstanding warrant, restricted stock unit, or option to purchase common stock was convertible into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless otherwise indicated, all of the share numbers, share prices, and exercise prices have been adjusted in this Annual Report, on a retroactive basis, to reflect this 1-for-10 Reverse Stock Split. Principles of Consolidation The consolidated financial statements of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly-owned subsidiaries: Lipoxen, Xenetic Bioscience, Incorporated, and SymbioTec. All material intercompany balances and transactions have been eliminated in consolidation. Certain prior period amounts have been reclassified in this Annual Report to conform to the presentation for the current period. Use of Estimates The consolidated financial statements and accompanying notes are prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the reported amounts of revenue, costs and expenses in the financial statements and disclosures in the accompanying notes. Actual results and outcomes may differ materially from management’s estimates, judgments and assumptions. Functional Currency Change The functional currency for the Company’s foreign subsidiaries is the U.S. dollar. The functional currency of the Company’s UK-based subsidiaries changed from the British Pound Sterling to the U.S. dollar when the Company relocated to the U.S. in 2014. The change in functional currency was applied on a prospective basis. Therefore, any gains and losses that were previously recorded in accumulated other comprehensive income remain unchanged. Foreign Currency Transactions Realized and unrealized gains and losses resulting from foreign currency transactions arising from exchange rate fluctuations on balances denominated in currencies other than the functional currencies are recognized in “Other income (expense)” in the consolidated statements of comprehensive loss. Monetary assets and liabilities that are denominated in a currency other than the functional currency are re-measured to the functional currency using the exchange rate at the balance sheet date and gains or losses are recorded in the consolidated statements of comprehensive loss. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement, Fair Value Measurements Cash and Concentrations of Credit Risk The Company considers all highly liquid investments with an original maturity of 90 days or less from the date of purchase to be cash equivalents. Investments with original maturities of greater than 90 days from the date of purchase but less than one year from the balance sheet date are classified as short-term investments, while investments with maturities of one year or beyond from the balance sheet date are classified as long-term investments. Management determines the appropriate classification of its cash equivalents and investment securities at the time of purchase and re-evaluates such determination as of each balance sheet date. The carrying amount of cash equivalents approximate their fair value due to the short-term nature of these instruments. Financial instruments that potentially subject the Company to credit risk consist primarily of cash on deposit with financial institutions, the balances of which may exceed federally insured limits. The Company has not experienced any losses on such accounts, and does not believe it is exposed to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships. The Company maintains its primary banking relationship with one large financial institution and all cash on deposit is covered under federally insured limits. Property and Equipment The Company records property and equipment at cost less accumulated depreciation. Expenditures for major renewals and improvements which extend the life or usefulness of the asset are capitalized. Items of an ordinary repair or maintenance nature are charged directly to operating expense as incurred. The Company calculates depreciation using the straight-line method over the estimated useful lives of the assets: Schedule of estimated useful life of assets Asset Classification Estimated Useful Life Office and computer equipment 3 years Leasehold improvements 5 years or the remaining term of the lease, if shorter Furniture and fixtures 5 years The Company eliminates the cost of assets retired or otherwise disposed of, along with the corresponding accumulated depreciation, from the related accounts, and the resulting gain or loss is reflected in the results of operations. Indefinite-Lived Intangible Assets Assets acquired and liabilities assumed in business combinations, licensing and other transactions are generally recognized at the date of acquisition at their respective fair values. At acquisition, the Company generally determines the fair value of intangible assets, including in-process research and development (“IPR&D”), using the “income method.” Acquired IPR&D intangible assets are considered indefinite-lived intangible assets and are not amortized until completion or abandonment of the associated research and development efforts. Substantial additional research and development may be required before the Company’s IPR&D reaches technological feasibility. Upon completion of the IPR&D project, the IPR&D assets will be amortized over their estimated useful lives. IPR&D is not amortized but is reviewed for impairment at least annually or when events or changes in the business environment indicate that it is more likely than not that the carrying value may be impaired. The Company also has the option to first assess qualitative factors to determine whether the existence of events or circumstances leads the Company to determine that it is more likely than not (that is, a likelihood of more than 50%) that the acquired IPR&D is impaired. If the Company chooses to first assess the qualitative factors and it is determined that it is not more likely than not acquired IPR&D is impaired, the Company is not required to take further action to test for impairment. The Company also has the option to bypass the qualitative assessment and perform only the quantitative impairment test, which the Company may choose to perform in some periods but not in others. The impairment loss, if any, is measured as the excess of the carrying value of the intangible asset over its fair value. Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for IPR&D. Considering the high risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges are likely to occur in future periods. Estimating the fair value of IPR&D for potential impairment is highly sensitive to changes in projections and assumptions and changes to assumptions could potentially lead to impairment. The Company believes its estimates and assumptions are reasonable and otherwise consistent with assumptions market participants would use in their estimates of fair value. However, if future results are not consistent with the Company’s estimates and assumptions, then the Company may be exposed to an impairment charge, which could be material. Use of different estimates and judgments could yield materially different results in the Company’s analysis and could result in materially different asset values or expense. Impairment of Long-Lived Assets The Company reviews long-lived assets to be held and used, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be fully recoverable. Evaluation of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. Impairment, if any, is calculated as the amount by which an asset’s carrying value exceeds its fair value, typically using discounted cash flows to determine fair value. No Revenue Recognition The Company enters into supply, license and collaboration arrangements with pharmaceutical and biotechnology partners, some of which include royalty agreements based on potential net sales of approved commercial pharmaceutical products. The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers As part of the accounting for these arrangements, the Company must use significant judgment to determine: a) the number of performance obligations based on the determination under step (ii) above; b) the transaction price under step (iii) above; and c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. In developing the stand-alone price for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the stand-alone selling price for performance obligations by evaluating whether changes in the key assumptions used to determine the stand-alone selling prices will have a significant effect on the allocation of transaction price between multiple performance obligations. The Company recognizes a contract asset or liability for the difference between the Company’s performance (i.e., the goods or services transferred to the customer) and the customer’s performance (i.e., the consideration paid by, and unconditionally due from, the customer). The terms of the Company’s license agreements may include delivery of an IP license to a collaboration partner. The Company may be compensated under license arrangements through a combination of non-refundable upfront receipts, development and regulatory objective receipts and royalty receipts on future product sales by partners. The Company anticipates recognizing non-refundable upfront license payments and development and regulatory milestone payments received by the Company in license and collaboration arrangements that include future obligations, such as supply obligations, ratably over the Company’s expected performance period under each respective arrangement. The Company makes its best estimate of the period over which the Company expects to fulfill the Company’s performance obligations, which may include technology transfer assistance, research activities, clinical development activities, and manufacturing activities from development through the commercialization of the product. Given the uncertainties of these collaboration arrangements, significant judgment is required to determine the duration of the performance period. When the Company enters into an arrangement to sublicense some of its patents, it will consider the performance obligations to determine if there is a single element or multiple elements to the arrangement as it determines the proper method and timing of revenue recognition. The Company considers the terms of the license or sublicense for such elements as price adjustments or refund clauses in addition to any performance obligations for it to provide such as services, patent defense costs, technology support, marketing or sales assistance or any other elements to the arrangement that could constitute an additional deliverable to it that could change the timing of the revenue recognition. Non-refundable upfront license and sublicense fees received, whereby continued performance or future obligations are considered inconsequential or perfunctory to the relevant licensed technology, are recognized as revenue upon delivery of the technology. The Company expects to recognize royalty revenue in the period of sale, based on the underlying contract terms, provided that the reported sales are reliably measurable, the Company has no remaining performance obligations, and all other revenue recognition criteria are met. The Company anticipates reimbursements for research and development services completed by the Company related to the collaboration agreements to be recognized in operations as revenue on a gross basis. The Company’s license and collaboration agreements with certain collaboration partners could also provide for future milestone receipts to the Company based solely upon the performance of the respective collaboration partner in consideration of deadline extensions or upon the achievement of specified sales volumes of approved drugs. For such receipts, the Company expects to recognize the receipts as revenue when earned under the applicable contract terms on a performance basis or ratably over the term of the agreement. These receipts may also be recognized as revenue when continued performance or future obligations by the Company are considered inconsequential or perfunctory. See also Note 4, Significant Strategic Collaborations Research and Development Expenses Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits, facilities expenses, overhead expenses, pre-clinical development, clinical trial and related clinical manufacturing expenses, fees paid to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”) and other outside expenses. The Company expenses research and development costs as incurred. The Company expenses upfront, non-refundable payments made for research and development services as obligations are incurred. The value ascribed to intangible assets acquired but which have not met capitalization criteria is expensed as research and development at the time of acquisition. Upfront payments under license agreements are expensed upon receipt of the license. Milestone payments under license agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable. The Company is required to estimate accrued research and development expenses at each reporting period. This process involves reviewing open contracts and purchase orders, communicating with Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice in arrears for services performed, on a pre-determined schedule or when contractual milestones are met. However, some require advanced payments. The Company makes estimates of accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at that time. The Company periodically confirms the accuracy of the estimates with the service providers and makes adjustments, if necessary. Examples of estimated accrued research and development expenses include fees paid to: · · Collaborative partners performing research and development and pre-clinical activities; Program managers in connection with overall program management of clinical trials; · CMOs in connection with cGMP manufacturing; · CROs in connection with clinical trials; and · Investigative sites in connection with clinical trials. The Company bases its expenses related to research and development, pre-clinical activities, manufacturing and clinical trials on its estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions, CMOs and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company adjusts the accrual or prepaid accordingly. Although it does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to the Company’s prior estimates of accrued research and development expenses. The Company has recorded approximately $ 0.5 million 0.3 million 0.1 million Share-based Expense The Company grants share-based payments in the form of options and restricted stock units (“RSUs”) to employees and non-employees to purchase shares of the Company’s common stock, Joint Share Ownership Plan (“JSOP”) awards to employees and agreements to issue common stock in exchange for services provided by non-employees. Share-based expense is based on the estimated fair value of the option or calculated using the Black-Scholes option pricing model. Determining the appropriate fair value model and related assumptions requires judgment, including estimating share price volatility and expected terms of the awards. The expected volatility rates are estimated based on the historical volatility of the Company. To the extent Company data is not available for the full expected term of the awards the Company uses a weighted-average of the historical volatility of the Company and of a peer group of comparable publicly traded companies over the expected term of the option. The expected term represents the time that options are expected to be outstanding. The Company accounts for forfeitures as they occur and not at the time of grant. The Company has not paid dividends and does not anticipate paying cash dividends in the foreseeable future and, accordingly, uses an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards. Upon exercise, stock options are redeemed for newly issued shares of common stock. RSUs are redeemed for newly issued shares of common stock as the vesting and settlement provisions of the grant are met. For employee options that vest based solely on service conditions, the fair value measurement date is generally on the date of grant and the related compensation expense is recognized on a straight-line basis over the requisite vesting period of the awards. For non-employee options issued in exchange for goods or services consumed in the Company’s operations, the fair value measurement date is the earlier of the date the performance of services is complete or the date the performance commitment has been reached. The Company generally determines that the fair value of the stock options is more reliably measurable than the fair value of the services received. Compensation expense related to stock options granted to non-employees is recognized on a straight-line basis over requisite vesting periods of the awards. Warrants In connection with certain financing, consulting and collaboration arrangements, the Company has issued warrants to purchase shares of its common stock. The outstanding warrants are standalone instruments that are not puttable or mandatorily redeemable by the holder and are classified as equity awards. The Company measures the fair value of the awards using the Black-Scholes option pricing model as of the measurement date. Warrants issued to collaboration partners in conjunction with the issuance of common stock are initially recorded at fair value as a reduction in additional paid-in capital of the common stock issued. All other warrants are recorded at fair value as expense on a straight-line basis over the requisite service period or at the date of issuance if there is not a service period or if service has already been rendered. Warrants granted in connection with ongoing arrangements are more fully described in Note 10, Stockholders’ Equity Income Taxes The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on temporary differences resulting from the different treatment of items for tax and financial reporting purposes. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. Additionally, the Company must assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The Company evaluates the recoverability of its deferred tax assets on a quarterly basis. Basic and Diluted Net Loss per Share The Company computes basic net loss per share by dividing net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding during the period. The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options that are outstanding during the period, except where such non-participating securities would be anti-dilutive. The Company’s JSOP awards, prior to exercise, are considered treasury shares by the Company and thus do not impact the Company’s net loss per share calculation. For the years ended December 31, 2023 and 2022, basic and diluted net loss per share are the same for each year due to the Company’s net loss position. Potentially dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would be anti-dilutive. As of December 31, 2023 and 2022, approximately 5,000 Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, who is the Company’s Chief Executive Officer, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business in one operating segment. Leases The Company leases administrative facilities under operating leases. Lease agreements may include rent holidays, rent escalation clauses and tenant improvement allowances. The Company recognizes a lease liability and a right-of-use asset for all leases, with the exception of short-term leases, at the commencement date. See Note 13, Commitments and Contingencies Acquisitions The Company has a history of engaging in acquisition transactions that require the Company to evaluate whether the transaction meets the criteria of a business combination. If the transaction does not meet the business combination requirements, the transaction is accounted for as an asset acquisition or recapitalization and no goodwill is recognized. If the acquisition meets the definition of a business combination, the Company allocates the purchase price, including any contingent consideration, to the assets acquired and the liabilities assumed at their estimated fair values as of the date of the acquisition with any excess of the purchase price paid over the estimated fair value of net assets acquired recorded as goodwill. The fair value of the assets acquired and liabilities assumed is typically determined by using either estimates of replacement costs or discounted cash flow valuation methods. When determining the fair value of tangible assets acquired, the Company estimates the cost to replace the asset with a new asset, taking into consideration such factors as age, condition and the economic useful life of the asset. When determining the fair value of intangible assets acquired, the Company uses judgment to estimate the applicable discount rate, growth rates and the timing and amount of future cash flows. The fair value of assets acquired and liabilities assumed is typically determined using the assistance of an independent third-party specialist. Business combination related costs are expensed in the period in which the costs are incurred. Asset acquisition related costs are generally capitalized as a component of cost of the assets acquired. Recent Accounting Standards In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Significant Strategic Collabora
Significant Strategic Collaborations | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Significant Strategic Collaborations | 4. Significant Strategic Collaborations Takeda Pharmaceutical Co. Ltd. ( together with its wholly-owned subsidiaries, “Takeda”) In October 2017, the Company granted to Takeda the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen technology that were previously exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding disorders. Royalty payments of approximately $ 2.5 million 1.7 million Catalent Pharma Solutions LLC (“Catalent”) On June 30, 2022, the Company entered into a Statement of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will provide certain services to the Company to perform cGMP manufacturing of the Company’s recombinant protein, Human DNase I. The parties agreed to enter into a Master Services Agreement (“MSA”) that will contain terms and conditions to govern the project contemplated by the SOW and that will supersede the addendum to the SOW containing Catalent’s standard terms and conditions. In addition, in the event of any conflict between the project-specific terms and conditions set forth in the SOW and the MSA, the MSA terms and conditions shall govern. The estimated total cost of the project contemplated by the SOW was expected to be up to approximately $5 million (exclusive of certain fees and potential alternatives) for the manufacturing services over the course of the term of the project with each phase of the project invoiced separately in connection with the commencement of such phase. The Company has paid Catalent approximately $ 2.5 million 0.1 million 0.3 million 0.3 million Scripps Research On March 17, 2023, the Company and Scripps Research entered into a Research Funding and Option Agreement (the “Agreement”), pursuant to which the Company has agreed to provide Scripps Research an aggregate of up to $ 938,000 78,000 78,000 Unless earlier terminated, the term of the Agreement continues from the date of the Agreement for fifteen (15) months. The Agreement may be terminated by the Company with 30 days advance written notice to Scripps Research beginning six (6) months after the Effective Date (as defined in the Agreement) or by Scripps Research if the Company fails to make timely payments due under the Agreement, subject to 30 days’ written notice to cure such nonpayment. The Agreement may further be terminated by either party in the event of the other party’s uncured failure to perform any obligations under the Agreement or the bankruptcy of the other party. The Company has paid Scripps Research approximately $ 0.8 million 0.4 million University of Virginia (“UVA”) On December 21, 2023, the Company entered into a Research Funding and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic DNase program. Under the terms of the UVA Agreement, n addition to advancing our existing intellectual property, we have an option to acquire an exclusive license to any new intellectual property arising from the DNase research program. Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and will oversee the research conducted under the UVA Agreement. As a surgical oncologist and scientist, Dr. Tsung is internationally recognized for leading substantial research on the role of NETs in tumor growth, metastasis, and resistance to existing cancer therapies. PJSC Pharmsynthez In November 2009, the Company entered into a collaborative research and development license agreement with Pharmsynthez (the “Pharmsynthez Arrangement”) pursuant to which the Company granted an exclusive license to Pharmsynthez to develop, commercialize and market six product candidates based on the Company’s PolyXen and ImuXen technology in certain territories. In exchange, Pharmsynthez granted an exclusive license to the Company to use any preclinical and clinical data developed by Pharmsynthez, within the scope of the Pharmsynthez Arrangement, and to engage in further research, development and commercialization of drug candidates outside of certain territories at the Company’s own expense. Pharmsynthez directly, and indirectly through its wholly-owned subsidiary, SynBio, LLC (“SynBio”), had a share ownership in the Company of approximately 3.4 2.9 1.5 million Stockholders’ Equity. In August 2011, SynBio and the Company entered into a stock subscription and collaborative development agreement (the “Co-Development Agreement”). The Company granted an exclusive license to SynBio to develop, market and commercialize certain drug candidates utilizing molecules based on SynBio’s technology and the Company’s proprietary technologies (PolyXen, OncoHist and ImuXen) in Russia and CIS, collectively referred to herein as the SynBio Market. In return, SynBio granted an exclusive license to the Company to use the preclinical and clinical data generated by SynBio in certain agreed products and to engage in the development of commercial candidates in any territory outside of the SynBio Market. SynBio is solely responsible for funding and conducting their own research and clinical development activities. There are no milestone or other research-related payments provided for under the Co-Development Agreement other than fees for the supply of each company’s respective research supplies based on their technology, which, when provided, are due to mutual convenience and not representative of an ongoing or recurring obligation to supply research supplies. Upon successful commercialization of any resultant products, the Company is entitled to receive a 10% royalty on sales in certain territories and pay royalties to SynBio for sales outside those certain territories, subject to the terms of the Co-Development Agreement. Effective December 20, 2021, SynBio assigned the Co-Development Agreement to Pharmsynthez. Through December 31, 2023, Pharmsynthez continued to engage in research and development activities with no resultant commercial products. In December 2020, Pharmsynthez reported positive data from its Phase 3 clinical study of Epolong, a treatment for anemia in patients with chronic kidney disease leveraging the Company’s PolyXen technology. In February 2021, Pharmsynthez reported in a press release that it had started the registration phase of Epolong by filing a registration dossier to obtain approval in Russia. Pharmsynthez had reported in its press release that it expected that the Russian stage of registration activities would be completed in 2021 and that it would be able to start production of the product as early as the first quarter of 2022. Pharmsynthez has informed the Company that it has received a response letter indicating certain deficiencies in the dossier and continues to develop a gap mitigation strategy with the intent of refiling the registration upon correction. The Company did not recognize revenue in connection with the Co-Development Agreement during the years ended December 31, 2023 and 2022. Serum Institute of India Limited In August 2011, the Company entered into a collaborative research and development agreement with Serum Institute of India Limited (“Serum Institute”) providing Serum Institute an exclusive license to use the Company’s PolyXen technology to research and develop one potential commercial product, Polysialylated Erythropoietin. Serum Institute is responsible for conducting all preclinical and clinical trials required to achieve regulatory approvals within the certain predetermined territories at Serum Institute’s own expense. Royalty payments are payable by Serum Institute to the Company for net sales to certain customers in the Serum Institute sales territory. There are no milestone or other research-related payments due under the collaborative arrangement. Through December 31, 2023, no commercial products were developed and no royalty revenue or expense was recognized by the Company related to the arrangement. Serum Institute had a share ownership of less than 1% of the total outstanding common stock of the Company as of each of December 31, 2023 and 2022. |
Licensing Arrangements
Licensing Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Licensing Arrangements | |
Licensing Arrangements | 5. Licensing Arrangements Exclusive Sublicense Agreement On April 26, 2022, the Company entered into an Exclusive Sublicense Agreement (the “Sublicense Agreement”) with CLS Therapeutics Ltd. (“CLS”) pursuant to which the Company received an exclusive license, under certain patent rights and know-how owned or controlled by CLS, to develop and commercialize pharmaceutical products and methods incorporating DNase enzyme for use in treatment of cancer (the “Sublicensed Products”). Under the terms of the Sublicense Agreement, the Company will have sole responsibility for, and shall use commercially reasonable efforts to, among other things, research, develop and obtain marketing approval for the Sublicensed Products in the U.S. and certain European markets, and to commercialize such Sublicensed Products in the relevant market once marketing approval is obtained. In consideration for the license and other rights granted to the Company under the Sublicense Agreement, the Company issued to CLS 37,500 Exclusive License Agreement On April 26, 2022, the Company entered into an Exclusive License Agreement (the “License Agreement”) with CLS, pursuant to which the Company received an exclusive license under certain patent rights and know-how owned or controlled by CLS to develop and commercialize pharmaceutical products and methods incorporating DNase in conjunction with CAR T therapies (the “Licensed Products”). Under the terms of the License Agreement, the Company will have sole responsibility for, and shall use commercially reasonable efforts to, among other things, research, develop and obtain marketing approval for the Licensed Products in the U.S. and certain European markets, and to commercialize such Licensed Products in the relevant market once marketing approval is obtained. In consideration for the license and other rights granted to the Company under the License Agreement, the Company paid CLS a one-time fee of $ 500,000 50,000 The total consideration for the Sublicense and License Agreements was approximately $ 1.3 million 0.5 million 87,500 0.8 million 1.3 million Patent Assignment and Volition Collaboration On August 2, 2022, the Company announced a research and development collaboration with Volition to develop NETs-targeted adoptive cell therapies for the treatment of cancer. The collaboration is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q ® 0.1 million On October 4, 2022, the Company completed a patent assignment related to its collaboration with Belgian Volition SARL Limited (“Volition”) and CLS. In connection with the patent assignment, the Company entered into a Subscription Agreement with CLS Therapeutics, LLC, a Delaware limited liability company (“CLS LLC ”) on October 12, 2022, pursuant to which the Company agreed to issue to CLS LLC, and CLS LLC agreed to subscribe for, 85,000 shares of the Company’s common stock (the “Shares”) as consideration for the assignment by CLS and its affiliates to the Company of certain patent rights owned by CLS and its affiliates. The total consideration for the patent assignment was approximately $0.5 million, representing the fair value of the 85,000 common shares issued utilizing the closing market price of the Company’s stock price at the closing date. As there was no future alternative use for the patent rights, the Company recorded an expense of approximately $ 0.5 million As of December 31, 2023 and 2022, CLS owned approximately 9.6 0.4 million |
Other Assets
Other Assets | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Assets | 6. Other Assets In 2016, the Company entered into an agreement with Serum Institute for the prepayment of clinical PSA supply in exchange for the Company’s common stock 0.7 million See also Note 14, Related Party Transactions |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consist of the following: Schedule of accrued expenses December 31, December 31, Accrued payroll and benefits $ 216,547 $ 353,539 Accrued professional fees 233,950 288,808 Accrued research costs 70,000 103,500 Other 48,256 39,949 Total accrued expenses $ 568,753 $ 785,796 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 8. Fair Value Measurements ASC Topic 820, Fair Value Measurement, no |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes Deferred tax assets and liabilities are determined based on temporary differences resulting from the different treatment of items for tax and financial reporting purposes. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. Additionally, the Company must assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The Company has provided a full valuation allowance on the Company’s deferred tax assets because the Company believes it is more likely than not that its deferred tax assets will not be realized. The Company evaluates the recoverability of its deferred tax assets on a quarterly basis. There was no income tax provision (benefit) for the years ended December 31, 2023 and 2022, as the Company has incurred losses to date. The components of loss before income taxes are as follows: Schedule of components of loss before income taxes Year ended December 31, 2023 2022 Domestic (U.S.) $ (6,424,969 ) $ (7,905,676 ) Foreign (U.K.) 2,440,857 1,488,938 Foreign (Germany) (136,977 ) (124,279 ) Foreign (Switzerland) (13,489 ) (11,336 ) Loss before income taxes $ (4,134,578 ) $ (6,552,353 ) The reconciliation of income tax benefit at the U.S. corporation tax rate, being the rate applicable to the country of domicile of the Company to net income tax benefit, is as follows: Schedule of reconciliation of income tax provision Year ended December 31, 2023 2022 Federal $ (868,261 ) $ (1,375,995 ) State (373,684 ) (476,802 ) Change in valuation allowance 1,116,036 7,233,525 Permanent differences, net 271,546 197,151 Foreign rate differential 81,227 (39,041 ) Share-based expense, net 7,213 19,087 Enhanced research and development tax credits (238,631 ) (109,792 ) Rate change – (5,120,196 ) Other items 4,554 (327,937 ) Net benefit for income taxes $ – $ – Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows: Schedule of deferred tax assets and liabilities Year ended December 31, 2023 2022 Deferred tax assets: U.K. net operating loss carryforwards $ 14,664,858 $ 14,812,743 U.K. capital loss carryforwards 1,545,934 1,545,934 U.S. federal net operating loss carryforwards 6,573,614 6,085,858 Switzerland net operating loss carryforwards 23,868 22,722 IPR&D 8,066,098 8,546,593 Share-based expense 2,235,214 2,169,480 Enhanced research and development tax credits 2,038,421 1,820,269 Germany net operating loss carryforwards 693,007 627,780 Capitalized research and experimental expenditure 1,473,049 735,702 U.S. state net operating loss carryforwards 2,142,380 1,913,128 Other 250,669 288,887 Lease liability – – Total deferred tax assets before valuation allowance 39,707,112 38,569,096 Valuation allowance for deferred tax assets (39,707,112 ) (38,569,096 ) Net deferred tax assets – – Deferred tax liabilities: Right of use asset – leases – – Total deferred tax liabilities – – Net deferred liability $ – $ – For the years ended December 31, 2023 and 2022, the Company had U.K. net operating loss carryforwards of approximately $ 61.3 million 61.9 million 31.3 million 29 33.9 million 30.3 million 2.2 million 2 0.3 million 0.3 million begin to expire in 2031 2026 The Company’s ability to use its operating loss carryforwards and tax credits generated in the U.S. to offset future taxable income is subject to restrictions under Section 382 of the U.S. Internal Revenue Code (the “Code”). These restrictions may limit the future use of the operating loss carryforwards and tax credits if certain ownership changes described in the Code occur. Future changes in stock ownership may occur that would create further limitations on the Company’s use of the operating loss carryforwards and tax credits. In such a situation, the Company may be required to pay income taxes, even though significant operating loss carryforwards and tax credits exist. The Company’s ability to use its operating loss carryforwards and tax credits generated in the U.K. are subject to restrictions under U.K. tax legislation. These regulations may limit the future use of operating loss carryforwards (i) if there is a change in ownership and a change in the nature or conduct of the business carried on by the Company, and (ii) in certain circumstances where there is a change in the nature or conduct of the business only. In such cases the carryforwards would cease to be available to set against future income. The Company’s ability to use its operating loss carryforwards and tax credits generated in Germany and Switzerland are also subject to restrictions under German and Swiss tax legislation. These regulations may limit the future use of operating loss carryforwards if there is a change in ownership. In such cases the carryforwards would cease to be available to set against future income. As of December 31, 2023 and 2022, the Company did no The Company files income tax returns in the U.S. federal tax jurisdiction, Massachusetts state tax jurisdiction, and certain foreign tax jurisdictions. The Company is subject to examination by the U.S. federal, state, foreign, and local income tax authorities for calendar tax years through 2023 due to available net operating loss carryforwards and research and development tax credits arising in those years. The Company has not been notified of any examinations by the Internal Revenue Service or any other tax authorities as of December 31, 2023. The Company has no Potential 382 Limitation The Company’s net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service. The Company’s ability to utilize its net operating loss (“NOL”) and research and development credit (“R&D”) carryforwards may be substantially limited due to ownership changes that may have occurred or that could occur in the future, as required by Section 382 of the Code, as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined in Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50% of the outstanding stock of a company by certain stockholders or public groups. The Company has not completed a study to assess whether one or more ownership changes have occurred since it became a loss corporation as defined in Section 382 of the Code, but the Company believes that it is likely that an ownership change has occurred. If the Company has experienced an ownership change, utilization of the NOL and R&D credit carryforwards would be subject to an annual limitation, which is determined by first multiplying the value of the Company’s common stock at the time of the ownership change by the applicable long-term, tax-exempt rate, and then could be subject to additional adjustments, as required. Any such limitation may result in the expiration of a portion of the NOL or R&D credit carryforwards before utilization. Until a study is completed, and any limitation known, no amounts are being considered as an uncertain tax position or disclosed as an unrecognized tax benefit. Any carryforwards that expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding adjustment to the valuation allowance. Due to the existence of the valuation allowance, it is not expected that any potential limitation will have a material impact on the Company’s operating results. From time to time the Company may be assessed interest or penalties by major tax jurisdictions, namely the Commonwealth of Massachusetts. As of December 31, 2023, the Company had no material unrecognized tax benefits and no adjustments to liabilities or operations were required. No |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | 10. Stockholders’ Equity Common Stock Each share of the Company’s common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to dividends when and if declared by the Board of Directors. In the event of any voluntary or involuntary liquidation, dissolution or winding-up of the Company, the holders of common stock are entitled to share ratably in the assets of the Company available for distribution. On May 11, 2023, the Company filed a Certificate of Change to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effect the Reverse Stock Split. The Reverse Stock Split was effective at 12:01 a.m., Eastern Time, on May 15, 2023. No fractional shares were issued as a result of the Reverse Stock Split and any remaining share fractions were rounded up to the nearest whole share, resulting in 15,941 Authorized Share Increase On December 21, 2022, shareholders of the Company voted to approve an amendment to the Company’s Articles of Incorporation to increase the authorized shares of common stock to 10,000,000 At the Market (“ATM”) Offering On November 19, 2021, the Company entered into an ATM Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as the exclusive sales agent (“Wainwright”), pursuant to which the Company may offer and sell, from time to time through Wainwright, shares of its common stock, par value $ 0.001 Pursuant to the ATM Agreement, Wainwright may sell the shares in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Capital Market. If agreed to in a separate terms agreement, the Company may sell shares to Wainwright as principal, at a purchase price agreed upon by Wainwright and the Company. Wainwright may also sell shares in privately negotiated transactions with the Company’s prior approval. Sales of the shares through Wainwright, if any, will be made in amounts and at times to be determined by the Company from time to time, but the Company has no obligation to sell any of the shares and either the Company or Wainwright may at any time suspend offers under the agreement or terminate the agreement. Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock and determinations by the Company of the appropriate sources of funding for the Company. The offer and sale of the shares pursuant to the ATM Agreement will terminate upon the earlier of (a) the issuance and sale of all of the shares subject to the ATM Agreement or (b) the termination of the ATM Agreement by Wainwright or the Company pursuant to the terms thereof. No 0.2 million Series A Preferred Stock The Company has designated 1,000,000 4.80 Liquidation Dividends 5 Conversion Redemption The Series A Preferred Stock has additional terms covering stock dividends and splits, voting rights, fractional shares and fundamental transactions. As of December 31, 2022, there were approximately 1.0 million 8,084 no Series B Preferred Stock The Company has designated 2,500,000 4.00 Liquidation Dividends Conversion no Subsequent Equity Sales The Series B Preferred Stock has additional terms covering stock dividends and splits, voting rights, fractional shares and fundamental transactions. As of December 31, 2023 and 2022, there were approximately 1.8 million 60,000 Warrants Related to Financing Arrangements In connection with its July 2021 private placement, the Company issued warrants to purchase an aggregate of 462,963 33.00 February 23, 2025 No In addition, the Company has publicly traded warrants to purchase approximately 2,100 130.00 July 17, 2024 None 200 None The Company also has outstanding warrants to purchase approximately 800 29.09 July 3, 2026 None |
Share-Based Expense
Share-Based Expense | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Expense | 11. Share-Based Expense Total share-based expense related to stock options, RSUs and common stock awards was approximately $ 0.3 million 0.5 million Schedule of Share-Based Compensation Expense Year Ended December 31, 2023 2022 Research and development expenses $ 56,112 $ 86,305 General and administrative expenses 226,973 425,175 $ 283,085 $ 511,480 Stock Options The Company grants stock option awards and RSUs to employees and non-employees with varying vesting terms under the Xenetic Biosciences, Inc. Amended and Restated Equity Incentive Plan. The Company measures the fair value of stock option awards using the Black-Scholes option pricing model, which uses the assumptions noted in the tables below, including the risk-free interest rate, expected term, share price volatility, dividend yield and forfeiture rate. The risk-free interest rate is based upon the U.S. Treasury yield curve in effect at the time of grant, with a term that approximates the expected life of the option. For stock options issued in 2023 and 2022 that qualify as “plain vanilla” stock options, the expected term is based on the simplified method. The Company has a limited history of stock option exercises, which does not provide a reasonable basis for the Company to estimate the expected term of employee and non-employee stock options. For all other stock options, the Company estimates the expected life using judgment based on the anticipated research and development milestones of the Company’s clinical projects and behavior of the Company’s employees and non-employees. The expected life of non-employee options is the contractual life of the option. The expected volatility rates are estimated based on the actual volatility of the Company. To the extent Company data is not available for the full expected term of the awards the Company uses a price volatility based on a blended rate of the Company’s historical volatility with that of comparable publicly traded companies with drug candidates in similar therapeutic areas and stages of nonclinical and clinical development to the Company’s drug candidates. The Company has applied an expected dividend yield of 0% as the Company has not historically declared a dividend and does not anticipate declaring a dividend during the expected life of the options. The Company accounts for forfeitures as they occur. Employee Stock Options During the years ended December 31, 2023 and 2022, 57,500 35,000 3.49 7.29 No During the years ended December 31, 2023 and 2022, 33,333 37,503 0.3 million 0.6 million 0.3 million 2.1 Key assumptions used in the Black-Scholes option pricing model for options granted to employees during the years ending December 31, 2023 and 2022 are as follows: Schedule of assumptions used Year Ended December 31, 2023 2022 Weighted-average expected dividend yield (%) – – Weighted-average expected volatility (%) 121.50 126.51 Weighted-average risk-free interest rate (%) 4.21 2.90 Weighted-average expected life of option (years) 5.76 5.72 Weighted-average exercise price ($) 4.00 8.27 The following is a summary of employee stock option activity for the years ended December 31, 2023 and 2022: Schedule of option activity Number of Weighted- Weighted- Aggregate Outstanding as of January 1, 2022 108,888 $ 62.66 8.22 $ 23,750 Granted 35,000 8.27 Expired – – Outstanding as of December 31, 2022 143,888 $ 49.43 7.78 $ – Granted 57,500 4.00 Expired – – Outstanding as of December 31, 2023 201,388 $ 36.46 7.69 $ – Vested or expected to vest as of December 31, 2023 201,388 $ 36.46 7.69 $ – Exercisable as of December 31, 2022 100,555 $ 65.70 7.14 $ – Exercisable as of December 31, 2023 133,888 $ 52.10 6.69 $ – A summary of the status of the Company’s non-vested employee stock option shares as of December 31, 2023, and the changes during the year ended December 31, 2023, is as follows: Schedule of non-vested options Number of Weighted- Balance as of January 1, 2023 43,334 $ 10.39 Granted 57,500 3.49 Forfeited – – Vested (33,333 ) 9.86 Balance as of December 31, 2023 67,501 $ 4.77 Restricted Stock Units There are 417 253.70 No Non-Employee Stock Options Share-based expense related to stock options granted to non-employees is recognized as the services are rendered on a straight-line basis. The Company determined that the fair value of the stock options is more reliably measurable than the fair value of the services received. No stock options to purchase shares of common stock were granted by the Company to non-employees during the years ended December 31, 2023 and 2022. No No The following is a summary of non-employee stock option activity for the years ended December 31, 2023 and 2022: Schedule of option activity Number of Weighted- Weighted- Aggregate Outstanding as of January 1, 2022 2,009 $ 120.83 2.83 $ 3,255 Granted – – Expired – – Outstanding as of December 31, 2022 2,009 120.83 1.83 – Granted – – Expired (84 ) 231.60 Outstanding as of December 31, 2023 1,925 $ 115.99 0.91 $ – Vested or expected to vest as of December 31, 2023 1,925 $ 115.99 0.91 $ – Exercisable as of December 31, 2022 2,009 $ 120.83 1.83 $ – Exercisable as of December 31, 2023 1,925 $ 115.99 0.91 $ – Common Stock Awards The Company has granted common stock awards to non-employees in exchange for services provided. The Company measures the fair value of these awards using the fair value of the services provided or the fair value of the awards granted, whichever is more reliably measurable. The fair value measurement date of these awards is generally the date the performance of services is complete. The fair value of the awards is recognized as services are rendered on a straight-line basis. No Joint Share Ownership Plan As of December 31, 2023 and 2022, there were approximately 2,701 no |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 12. Employee Benefit Plans The Company has a defined contribution 401(k) savings plan (the “401(k) Plan”). The 401(k) Plan covers substantially all U.S. employees, and allows participants to defer a portion of their annual compensation on a pre-tax basis or make post-tax contributions. Company contributions to the 401(k) Plan may be made at the discretion of the Board of Directors. During the years ended December 31, 2023 and 2022, the Company made contributions of approximately $ 41,000 38,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Leases The Company determines whether an arrangement is a lease at inception. On October 1, 2020, the Company entered into a two-year lease for its corporate headquarters in Framingham, Massachusetts. 78,000 September 30, 2022 12 15,000 Supplemental cash flow information and non-cash activity related to our operating leases are as follows: Cash flow information regarding leases Year Ended December 31, Year Ended December 31, 2023 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ – $ 27,043 The Company did not apply the provisions of ASU 2016-02 to the lease of its office space in Miami, Florida. Effective November 1, 2023, the Company renewed its Miami office lease for twelve-months to November 2024. 12 15,000 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions The Company has entered into various research, development, license and supply agreements with Serum Institute and Pharmsynthez, each a related party whose relationship, ownership, and nature of transactions is disclosed within other sections of these footnotes. Please refer to Note 4, Significant Strategic Collaborations, Other Assets During the fourth quarter of 2019, the Company entered into a loan agreement with Pharmsynthez (the “Pharmsynthez Loan”), pursuant to which the Company advanced Pharmsynthez an aggregate principal amount of up to $ 500,000 10 Pharmsynthez paid all obligations due under the Pharmsynthez Loan in May 2023, and no further amounts are due under the Pharmsynthez Loan. As a result, the Company recognized approximately $ 65,000 40,000 9,000 0.4 million In April 2022, the Company entered into certain agreements with CLS as described in Note 5. One of the Company’s directors, Roger Kornberg, is a member of the scientific advisory board of CLS. However, Mr. Kornberg does not own any equity of CLS and is not receiving any economic benefit as a result of the transactions contemplated by such agreements. Mr. Adam Logal, one of our directors, is Senior Vice President, Chief Financial Officer, Chief Accounting Officer and Treasurer of OPKO. Dr. Dmitry Genkin is a significant shareholder of CLS. Dr. Genkin was elected to our board of directors on December 6, 2023. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events The Company performed a review of events subsequent to the balance sheet date through the date the financial statements were issued and determined that there were no such events requiring recognition or disclosure in the financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Preparation of Financial Statements | Preparation of Financial Statements On May 15, 2023, the Company effected the Reverse Stock Split. On the effective date of the Reverse Stock Split, (i) every 10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number of shares of common stock into which each outstanding warrant, restricted stock unit, or option to purchase common stock was convertible into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless otherwise indicated, all of the share numbers, share prices, and exercise prices have been adjusted in this Annual Report, on a retroactive basis, to reflect this 1-for-10 Reverse Stock Split. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly-owned subsidiaries: Lipoxen, Xenetic Bioscience, Incorporated, and SymbioTec. All material intercompany balances and transactions have been eliminated in consolidation. Certain prior period amounts have been reclassified in this Annual Report to conform to the presentation for the current period. |
Use of Estimates | Use of Estimates The consolidated financial statements and accompanying notes are prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the reported amounts of revenue, costs and expenses in the financial statements and disclosures in the accompanying notes. Actual results and outcomes may differ materially from management’s estimates, judgments and assumptions. |
Functional Currency Change | Functional Currency Change The functional currency for the Company’s foreign subsidiaries is the U.S. dollar. The functional currency of the Company’s UK-based subsidiaries changed from the British Pound Sterling to the U.S. dollar when the Company relocated to the U.S. in 2014. The change in functional currency was applied on a prospective basis. Therefore, any gains and losses that were previously recorded in accumulated other comprehensive income remain unchanged. |
Foreign Currency Transactions | Foreign Currency Transactions Realized and unrealized gains and losses resulting from foreign currency transactions arising from exchange rate fluctuations on balances denominated in currencies other than the functional currencies are recognized in “Other income (expense)” in the consolidated statements of comprehensive loss. Monetary assets and liabilities that are denominated in a currency other than the functional currency are re-measured to the functional currency using the exchange rate at the balance sheet date and gains or losses are recorded in the consolidated statements of comprehensive loss. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement, Fair Value Measurements |
Cash and Concentrations of Credit Risk | Cash and Concentrations of Credit Risk The Company considers all highly liquid investments with an original maturity of 90 days or less from the date of purchase to be cash equivalents. Investments with original maturities of greater than 90 days from the date of purchase but less than one year from the balance sheet date are classified as short-term investments, while investments with maturities of one year or beyond from the balance sheet date are classified as long-term investments. Management determines the appropriate classification of its cash equivalents and investment securities at the time of purchase and re-evaluates such determination as of each balance sheet date. The carrying amount of cash equivalents approximate their fair value due to the short-term nature of these instruments. Financial instruments that potentially subject the Company to credit risk consist primarily of cash on deposit with financial institutions, the balances of which may exceed federally insured limits. The Company has not experienced any losses on such accounts, and does not believe it is exposed to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships. The Company maintains its primary banking relationship with one large financial institution and all cash on deposit is covered under federally insured limits. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost less accumulated depreciation. Expenditures for major renewals and improvements which extend the life or usefulness of the asset are capitalized. Items of an ordinary repair or maintenance nature are charged directly to operating expense as incurred. The Company calculates depreciation using the straight-line method over the estimated useful lives of the assets: Schedule of estimated useful life of assets Asset Classification Estimated Useful Life Office and computer equipment 3 years Leasehold improvements 5 years or the remaining term of the lease, if shorter Furniture and fixtures 5 years The Company eliminates the cost of assets retired or otherwise disposed of, along with the corresponding accumulated depreciation, from the related accounts, and the resulting gain or loss is reflected in the results of operations. |
Indefinite-Lived Intangible Assets | Indefinite-Lived Intangible Assets Assets acquired and liabilities assumed in business combinations, licensing and other transactions are generally recognized at the date of acquisition at their respective fair values. At acquisition, the Company generally determines the fair value of intangible assets, including in-process research and development (“IPR&D”), using the “income method.” Acquired IPR&D intangible assets are considered indefinite-lived intangible assets and are not amortized until completion or abandonment of the associated research and development efforts. Substantial additional research and development may be required before the Company’s IPR&D reaches technological feasibility. Upon completion of the IPR&D project, the IPR&D assets will be amortized over their estimated useful lives. IPR&D is not amortized but is reviewed for impairment at least annually or when events or changes in the business environment indicate that it is more likely than not that the carrying value may be impaired. The Company also has the option to first assess qualitative factors to determine whether the existence of events or circumstances leads the Company to determine that it is more likely than not (that is, a likelihood of more than 50%) that the acquired IPR&D is impaired. If the Company chooses to first assess the qualitative factors and it is determined that it is not more likely than not acquired IPR&D is impaired, the Company is not required to take further action to test for impairment. The Company also has the option to bypass the qualitative assessment and perform only the quantitative impairment test, which the Company may choose to perform in some periods but not in others. The impairment loss, if any, is measured as the excess of the carrying value of the intangible asset over its fair value. Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for IPR&D. Considering the high risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D impairment charges are likely to occur in future periods. Estimating the fair value of IPR&D for potential impairment is highly sensitive to changes in projections and assumptions and changes to assumptions could potentially lead to impairment. The Company believes its estimates and assumptions are reasonable and otherwise consistent with assumptions market participants would use in their estimates of fair value. However, if future results are not consistent with the Company’s estimates and assumptions, then the Company may be exposed to an impairment charge, which could be material. Use of different estimates and judgments could yield materially different results in the Company’s analysis and could result in materially different asset values or expense. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets to be held and used, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be fully recoverable. Evaluation of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset or asset group and its eventual disposition. Impairment, if any, is calculated as the amount by which an asset’s carrying value exceeds its fair value, typically using discounted cash flows to determine fair value. No |
Revenue Recognition | Revenue Recognition The Company enters into supply, license and collaboration arrangements with pharmaceutical and biotechnology partners, some of which include royalty agreements based on potential net sales of approved commercial pharmaceutical products. The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers As part of the accounting for these arrangements, the Company must use significant judgment to determine: a) the number of performance obligations based on the determination under step (ii) above; b) the transaction price under step (iii) above; and c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. In developing the stand-alone price for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the stand-alone selling price for performance obligations by evaluating whether changes in the key assumptions used to determine the stand-alone selling prices will have a significant effect on the allocation of transaction price between multiple performance obligations. The Company recognizes a contract asset or liability for the difference between the Company’s performance (i.e., the goods or services transferred to the customer) and the customer’s performance (i.e., the consideration paid by, and unconditionally due from, the customer). The terms of the Company’s license agreements may include delivery of an IP license to a collaboration partner. The Company may be compensated under license arrangements through a combination of non-refundable upfront receipts, development and regulatory objective receipts and royalty receipts on future product sales by partners. The Company anticipates recognizing non-refundable upfront license payments and development and regulatory milestone payments received by the Company in license and collaboration arrangements that include future obligations, such as supply obligations, ratably over the Company’s expected performance period under each respective arrangement. The Company makes its best estimate of the period over which the Company expects to fulfill the Company’s performance obligations, which may include technology transfer assistance, research activities, clinical development activities, and manufacturing activities from development through the commercialization of the product. Given the uncertainties of these collaboration arrangements, significant judgment is required to determine the duration of the performance period. When the Company enters into an arrangement to sublicense some of its patents, it will consider the performance obligations to determine if there is a single element or multiple elements to the arrangement as it determines the proper method and timing of revenue recognition. The Company considers the terms of the license or sublicense for such elements as price adjustments or refund clauses in addition to any performance obligations for it to provide such as services, patent defense costs, technology support, marketing or sales assistance or any other elements to the arrangement that could constitute an additional deliverable to it that could change the timing of the revenue recognition. Non-refundable upfront license and sublicense fees received, whereby continued performance or future obligations are considered inconsequential or perfunctory to the relevant licensed technology, are recognized as revenue upon delivery of the technology. The Company expects to recognize royalty revenue in the period of sale, based on the underlying contract terms, provided that the reported sales are reliably measurable, the Company has no remaining performance obligations, and all other revenue recognition criteria are met. The Company anticipates reimbursements for research and development services completed by the Company related to the collaboration agreements to be recognized in operations as revenue on a gross basis. The Company’s license and collaboration agreements with certain collaboration partners could also provide for future milestone receipts to the Company based solely upon the performance of the respective collaboration partner in consideration of deadline extensions or upon the achievement of specified sales volumes of approved drugs. For such receipts, the Company expects to recognize the receipts as revenue when earned under the applicable contract terms on a performance basis or ratably over the term of the agreement. These receipts may also be recognized as revenue when continued performance or future obligations by the Company are considered inconsequential or perfunctory. See also Note 4, Significant Strategic Collaborations |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits, facilities expenses, overhead expenses, pre-clinical development, clinical trial and related clinical manufacturing expenses, fees paid to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”) and other outside expenses. The Company expenses research and development costs as incurred. The Company expenses upfront, non-refundable payments made for research and development services as obligations are incurred. The value ascribed to intangible assets acquired but which have not met capitalization criteria is expensed as research and development at the time of acquisition. Upfront payments under license agreements are expensed upon receipt of the license. Milestone payments under license agreements are accrued, with a corresponding expense being recognized, in the period in which the milestone is determined to be probable of achievement and the related amount is reasonably estimable. The Company is required to estimate accrued research and development expenses at each reporting period. This process involves reviewing open contracts and purchase orders, communicating with Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice in arrears for services performed, on a pre-determined schedule or when contractual milestones are met. However, some require advanced payments. The Company makes estimates of accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at that time. The Company periodically confirms the accuracy of the estimates with the service providers and makes adjustments, if necessary. Examples of estimated accrued research and development expenses include fees paid to: · · Collaborative partners performing research and development and pre-clinical activities; Program managers in connection with overall program management of clinical trials; · CMOs in connection with cGMP manufacturing; · CROs in connection with clinical trials; and · Investigative sites in connection with clinical trials. The Company bases its expenses related to research and development, pre-clinical activities, manufacturing and clinical trials on its estimates of the services received and efforts expended pursuant to quotes and contracts with multiple research institutions, CMOs and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company adjusts the accrual or prepaid accordingly. Although it does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to the Company’s prior estimates of accrued research and development expenses. The Company has recorded approximately $ 0.5 million 0.3 million 0.1 million |
Share-based Expense | Share-based Expense The Company grants share-based payments in the form of options and restricted stock units (“RSUs”) to employees and non-employees to purchase shares of the Company’s common stock, Joint Share Ownership Plan (“JSOP”) awards to employees and agreements to issue common stock in exchange for services provided by non-employees. Share-based expense is based on the estimated fair value of the option or calculated using the Black-Scholes option pricing model. Determining the appropriate fair value model and related assumptions requires judgment, including estimating share price volatility and expected terms of the awards. The expected volatility rates are estimated based on the historical volatility of the Company. To the extent Company data is not available for the full expected term of the awards the Company uses a weighted-average of the historical volatility of the Company and of a peer group of comparable publicly traded companies over the expected term of the option. The expected term represents the time that options are expected to be outstanding. The Company accounts for forfeitures as they occur and not at the time of grant. The Company has not paid dividends and does not anticipate paying cash dividends in the foreseeable future and, accordingly, uses an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards. Upon exercise, stock options are redeemed for newly issued shares of common stock. RSUs are redeemed for newly issued shares of common stock as the vesting and settlement provisions of the grant are met. For employee options that vest based solely on service conditions, the fair value measurement date is generally on the date of grant and the related compensation expense is recognized on a straight-line basis over the requisite vesting period of the awards. For non-employee options issued in exchange for goods or services consumed in the Company’s operations, the fair value measurement date is the earlier of the date the performance of services is complete or the date the performance commitment has been reached. The Company generally determines that the fair value of the stock options is more reliably measurable than the fair value of the services received. Compensation expense related to stock options granted to non-employees is recognized on a straight-line basis over requisite vesting periods of the awards. |
Warrants | Warrants In connection with certain financing, consulting and collaboration arrangements, the Company has issued warrants to purchase shares of its common stock. The outstanding warrants are standalone instruments that are not puttable or mandatorily redeemable by the holder and are classified as equity awards. The Company measures the fair value of the awards using the Black-Scholes option pricing model as of the measurement date. Warrants issued to collaboration partners in conjunction with the issuance of common stock are initially recorded at fair value as a reduction in additional paid-in capital of the common stock issued. All other warrants are recorded at fair value as expense on a straight-line basis over the requisite service period or at the date of issuance if there is not a service period or if service has already been rendered. Warrants granted in connection with ongoing arrangements are more fully described in Note 10, Stockholders’ Equity |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on temporary differences resulting from the different treatment of items for tax and financial reporting purposes. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. Additionally, the Company must assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The Company evaluates the recoverability of its deferred tax assets on a quarterly basis. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per Share The Company computes basic net loss per share by dividing net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding during the period. The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options that are outstanding during the period, except where such non-participating securities would be anti-dilutive. The Company’s JSOP awards, prior to exercise, are considered treasury shares by the Company and thus do not impact the Company’s net loss per share calculation. For the years ended December 31, 2023 and 2022, basic and diluted net loss per share are the same for each year due to the Company’s net loss position. Potentially dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would be anti-dilutive. As of December 31, 2023 and 2022, approximately 5,000 |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, who is the Company’s Chief Executive Officer, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business in one operating segment. |
Leases | Leases The Company leases administrative facilities under operating leases. Lease agreements may include rent holidays, rent escalation clauses and tenant improvement allowances. The Company recognizes a lease liability and a right-of-use asset for all leases, with the exception of short-term leases, at the commencement date. See Note 13, Commitments and Contingencies |
Acquisitions | Acquisitions The Company has a history of engaging in acquisition transactions that require the Company to evaluate whether the transaction meets the criteria of a business combination. If the transaction does not meet the business combination requirements, the transaction is accounted for as an asset acquisition or recapitalization and no goodwill is recognized. If the acquisition meets the definition of a business combination, the Company allocates the purchase price, including any contingent consideration, to the assets acquired and the liabilities assumed at their estimated fair values as of the date of the acquisition with any excess of the purchase price paid over the estimated fair value of net assets acquired recorded as goodwill. The fair value of the assets acquired and liabilities assumed is typically determined by using either estimates of replacement costs or discounted cash flow valuation methods. When determining the fair value of tangible assets acquired, the Company estimates the cost to replace the asset with a new asset, taking into consideration such factors as age, condition and the economic useful life of the asset. When determining the fair value of intangible assets acquired, the Company uses judgment to estimate the applicable discount rate, growth rates and the timing and amount of future cash flows. The fair value of assets acquired and liabilities assumed is typically determined using the assistance of an independent third-party specialist. Business combination related costs are expensed in the period in which the costs are incurred. Asset acquisition related costs are generally capitalized as a component of cost of the assets acquired. |
Recent Accounting Standards | Recent Accounting Standards In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of estimated useful life of assets | Schedule of estimated useful life of assets Asset Classification Estimated Useful Life Office and computer equipment 3 years Leasehold improvements 5 years or the remaining term of the lease, if shorter Furniture and fixtures 5 years |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Schedule of accrued expenses December 31, December 31, Accrued payroll and benefits $ 216,547 $ 353,539 Accrued professional fees 233,950 288,808 Accrued research costs 70,000 103,500 Other 48,256 39,949 Total accrued expenses $ 568,753 $ 785,796 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of components of loss before income taxes | Schedule of components of loss before income taxes Year ended December 31, 2023 2022 Domestic (U.S.) $ (6,424,969 ) $ (7,905,676 ) Foreign (U.K.) 2,440,857 1,488,938 Foreign (Germany) (136,977 ) (124,279 ) Foreign (Switzerland) (13,489 ) (11,336 ) Loss before income taxes $ (4,134,578 ) $ (6,552,353 ) |
Schedule of reconciliation of income tax provision | Schedule of reconciliation of income tax provision Year ended December 31, 2023 2022 Federal $ (868,261 ) $ (1,375,995 ) State (373,684 ) (476,802 ) Change in valuation allowance 1,116,036 7,233,525 Permanent differences, net 271,546 197,151 Foreign rate differential 81,227 (39,041 ) Share-based expense, net 7,213 19,087 Enhanced research and development tax credits (238,631 ) (109,792 ) Rate change – (5,120,196 ) Other items 4,554 (327,937 ) Net benefit for income taxes $ – $ – |
Schedule of deferred tax assets and liabilities | Schedule of deferred tax assets and liabilities Year ended December 31, 2023 2022 Deferred tax assets: U.K. net operating loss carryforwards $ 14,664,858 $ 14,812,743 U.K. capital loss carryforwards 1,545,934 1,545,934 U.S. federal net operating loss carryforwards 6,573,614 6,085,858 Switzerland net operating loss carryforwards 23,868 22,722 IPR&D 8,066,098 8,546,593 Share-based expense 2,235,214 2,169,480 Enhanced research and development tax credits 2,038,421 1,820,269 Germany net operating loss carryforwards 693,007 627,780 Capitalized research and experimental expenditure 1,473,049 735,702 U.S. state net operating loss carryforwards 2,142,380 1,913,128 Other 250,669 288,887 Lease liability – – Total deferred tax assets before valuation allowance 39,707,112 38,569,096 Valuation allowance for deferred tax assets (39,707,112 ) (38,569,096 ) Net deferred tax assets – – Deferred tax liabilities: Right of use asset – leases – – Total deferred tax liabilities – – Net deferred liability $ – $ – |
Share-Based Expense (Tables)
Share-Based Expense (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Share-Based Compensation Expense | Schedule of Share-Based Compensation Expense Year Ended December 31, 2023 2022 Research and development expenses $ 56,112 $ 86,305 General and administrative expenses 226,973 425,175 $ 283,085 $ 511,480 |
Schedule of assumptions used | Schedule of assumptions used Year Ended December 31, 2023 2022 Weighted-average expected dividend yield (%) – – Weighted-average expected volatility (%) 121.50 126.51 Weighted-average risk-free interest rate (%) 4.21 2.90 Weighted-average expected life of option (years) 5.76 5.72 Weighted-average exercise price ($) 4.00 8.27 |
Schedule of option activity | Schedule of option activity Number of Weighted- Weighted- Aggregate Outstanding as of January 1, 2022 108,888 $ 62.66 8.22 $ 23,750 Granted 35,000 8.27 Expired – – Outstanding as of December 31, 2022 143,888 $ 49.43 7.78 $ – Granted 57,500 4.00 Expired – – Outstanding as of December 31, 2023 201,388 $ 36.46 7.69 $ – Vested or expected to vest as of December 31, 2023 201,388 $ 36.46 7.69 $ – Exercisable as of December 31, 2022 100,555 $ 65.70 7.14 $ – Exercisable as of December 31, 2023 133,888 $ 52.10 6.69 $ – |
Schedule of non-vested options | Schedule of non-vested options Number of Weighted- Balance as of January 1, 2023 43,334 $ 10.39 Granted 57,500 3.49 Forfeited – – Vested (33,333 ) 9.86 Balance as of December 31, 2023 67,501 $ 4.77 |
Non Employee Stock Options [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of option activity | Schedule of option activity Number of Weighted- Weighted- Aggregate Outstanding as of January 1, 2022 2,009 $ 120.83 2.83 $ 3,255 Granted – – Expired – – Outstanding as of December 31, 2022 2,009 120.83 1.83 – Granted – – Expired (84 ) 231.60 Outstanding as of December 31, 2023 1,925 $ 115.99 0.91 $ – Vested or expected to vest as of December 31, 2023 1,925 $ 115.99 0.91 $ – Exercisable as of December 31, 2022 2,009 $ 120.83 1.83 $ – Exercisable as of December 31, 2023 1,925 $ 115.99 0.91 $ – |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Cash flow information regarding leases | Cash flow information regarding leases Year Ended December 31, Year Ended December 31, 2023 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ – $ 27,043 |
The Company (Details Narrative)
The Company (Details Narrative) - $ / shares | May 15, 2023 | Dec. 31, 2023 | May 30, 2023 | Dec. 31, 2022 |
Common stock, par value | $ 0.001 | $ 0.001 | ||
Common Stock [Member] | ||||
Reverse stock split | 1-for-10 | |||
Common stock, par value | $ 0.001 | |||
Bid price, per share | $ 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Office And Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years or the remaining term of the lease, if shorter |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Asset Impairment Charges | $ 0 | $ 0 |
Prepaid expenses and other | $ 400,000 | |
Antidilutive shares | 5,000 | 5,000 |
Research And Development Expenses [Member] | ||
Prepaid expenses and other | $ 500,000 | $ 300,000 |
Accrued expenses | $ 100,000 | $ 100,000 |
Significant Strategic Collabo_2
Significant Strategic Collaborations (Details Narrative) - USD ($) | 12 Months Ended | ||
Mar. 17, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Revenue | $ 2,539,986 | $ 1,706,925 | |
Research and development expenses | 3,494,765 | 4,770,834 | |
Prepaid expenses and other current assets | 603,828 | $ 556,094 | |
Initial payment for research | $ 78,000 | ||
Prepaid expenses and other | $ 400,000 | ||
Pharmsynthez [Member] | Series B Preferred Stock [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Warrants outstanding | 1,500,000 | ||
Pharmsynthez [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Percent ownership in Xenetic | 3.40% | 2.90% | |
Takeda [Member] | Royalty Revenue [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Revenue | $ 2,500,000 | $ 1,700,000 | |
Catalent Pharma Solutions [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | 2,500,000 | ||
Prepaid expenses and other current assets | 100,000 | $ 300,000 | |
Other assets | 300,000 | ||
Scripps Research [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | 938,000 | ||
Monthly payment | $ 78,000 | ||
Scripps Research [Member] | Scripps Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Research and development expenses | $ 800,000 |
Licensing Arrangements (Details
Licensing Arrangements (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |
Apr. 26, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Offsetting Assets [Line Items] | |||
Research and development costs | $ 3,494,765 | $ 4,770,834 | |
CLS [Member] | |||
Offsetting Assets [Line Items] | |||
Ownership percentage | 9.60% | ||
Sublicense And License Agreements [Member] | |||
Offsetting Assets [Line Items] | |||
Common shares issued | 87,500 | ||
Total consideration | $ 1,300,000 | ||
Cash payment | 500,000 | ||
Number of shares purchase of asset, value | $ 800,000 | ||
Research and development costs | 1,300,000 | ||
Volition [Member] | |||
Offsetting Assets [Line Items] | |||
Research and development costs | $ 100,000 | ||
Patent Assignment [Member] | |||
Offsetting Assets [Line Items] | |||
Research and development costs | 500,000 | ||
D Nase Technology [Member] | CLS [Member] | |||
Offsetting Assets [Line Items] | |||
Consulting, transaction and development costs | $ 400,000 | ||
Sublicense Agreement Shares [Member] | CLS [Member] | |||
Offsetting Assets [Line Items] | |||
Common shares issued | 37,500 | ||
Sublicense And License Agreements [Member] | CLS [Member] | |||
Offsetting Assets [Line Items] | |||
Common shares issued | 50,000 | ||
One-time fee | $ 500,000 |
Other Assets (Details Narrative
Other Assets (Details Narrative) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Serum Institute [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Prepaid clinical supply | $ 700,000 | $ 700,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued payroll and benefits | $ 216,547 | $ 353,539 |
Accrued professional fees | 233,950 | 288,808 |
Accrued research costs | 70,000 | 103,500 |
Other | 48,256 | 39,949 |
Total accrued expenses | $ 568,753 | $ 785,796 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial instruments fair value | $ 0 | $ 0 |
Income Taxes (Details - Income
Income Taxes (Details - Income by geographic regions) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net income (loss) | $ (4,134,578) | $ (6,552,353) |
UNITED STATES | ||
Net income (loss) | (6,424,969) | (7,905,676) |
UNITED KINGDOM | ||
Net income (loss) | 2,440,857 | 1,488,938 |
GERMANY | ||
Net income (loss) | (136,977) | (124,279) |
SWITZERLAND | ||
Net income (loss) | $ (13,489) | $ (11,336) |
Income Taxes (Details - Tax rec
Income Taxes (Details - Tax reconciliation) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal | $ (868,261) | $ (1,375,995) |
State | (373,684) | (476,802) |
Change in valuation allowance | 1,116,036 | 7,233,525 |
Permanent differences, net | 271,546 | 197,151 |
Foreign rate differential | 81,227 | (39,041) |
Share-based expense, net | 7,213 | 19,087 |
Enhanced research and development tax credits | (238,631) | (109,792) |
Rate change | 0 | (5,120,196) |
Other items | 4,554 | (327,937) |
Net benefit for income taxes | $ 0 | $ 0 |
Income Taxes (Details - Deferre
Income Taxes (Details - Deferred Tax Assets) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Foreign net operating loss carryforwards | $ 6,573,614 | $ 6,085,858 |
IPR&D | 8,066,098 | 8,546,593 |
Share-based expense | 2,235,214 | 2,169,480 |
Enhanced research and development tax credits | 2,038,421 | 1,820,269 |
Capitalized research and experimental expenditure | 1,473,049 | 735,702 |
U.S. state net operating loss carryforwards | 2,142,380 | 1,913,128 |
Depreciation | 250,669 | 288,887 |
Lease liability | 0 | 0 |
Total deferred tax assets before valuation allowance | 39,707,112 | 38,569,096 |
Valuation allowance for deferred tax assets | (39,707,112) | (38,569,096) |
Net deferred tax assets | 0 | 0 |
Right of use asset - leases | 0 | 0 |
Total deferred tax liabilities | 0 | 0 |
Net deferred tax assets and liabilities | 0 | 0 |
UNITED KINGDOM | ||
Foreign net operating loss carryforwards | 14,664,858 | 14,812,743 |
Foreign capital loss carryforwards | 1,545,934 | 1,545,934 |
SWITZERLAND | ||
Foreign net operating loss carryforwards | 23,868 | 22,722 |
GERMANY | ||
Foreign net operating loss carryforwards | $ 693,007 | $ 627,780 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Uncertain tax positions | $ 0 | $ 0 |
Unrecognized tax benefits | 0 | 0 |
Interest and penalties | 0 | 0 |
UNITED KINGDOM | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 61,300,000 | 61,900,000 |
UNITED STATES | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 31,300,000 | 29,000,000 |
Operating loss carryforwards expiration date | begin to expire in 2031 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 33,900,000 | 30,300,000 |
GERMANY | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 2,200,000 | 2,000,000 |
SWITZERLAND | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 300,000 | $ 300,000 |
Operating loss carryforwards expiration date | 2026 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 21, 2022 | Nov. 19, 2021 | Jul. 31, 2021 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Common stock, shares authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||
Prepaid expenses and other current | $ 603,828 | $ 556,094 | |||
Publicly Traded Warrants [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Exercise price | $ 130 | ||||
Maturity date | Jul. 17, 2024 | ||||
Purchase of outstanding warrants | 2,100 | 2,100 | |||
Warrants exercised shares | 0 | 200 | |||
Other Warrants [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Exercise price | $ 29.09 | ||||
Maturity date | Jul. 03, 2026 | ||||
Purchase of outstanding warrants | 800 | 800 | |||
Warrants exercised shares | 0 | 0 | |||
Warrants forfeited shares | 0 | 0 | |||
Series A Preferred Stock [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Preferred stock share authorized | 1,000,000 | ||||
Preferred stock stated value per share | $ 4.80 | ||||
Dividend rate | 5% | ||||
Preferred stock issued | 1,000,000 | ||||
Preferred stock outstanding | 0 | 1,000,000 | |||
Converted shares | 8,084 | ||||
Series B Preferred Stock [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Preferred stock share authorized | 2,500,000 | ||||
Preferred stock stated value per share | $ 4 | ||||
Preferred stock issued | 1,800,000 | 1,800,000 | |||
Preferred stock outstanding | 1,800,000 | 1,800,000 | |||
Stock converted, shares converted | 0 | 0 | |||
Convertible common stock in each year | 60,000 | ||||
Series A Warrants [Member] | Private Placement [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Warrants issued | 462,963 | ||||
Exercise price | $ 33 | ||||
Maturity date | Feb. 23, 2025 | ||||
Warrants exercised | 0 | 0 | |||
Purchase Warrants | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Price per share | $ 0.001 | ||||
Number of shares issued | 0 | 0 | |||
Prepaid expenses and other current | $ 200,000 | ||||
Common Stock [Member] | |||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||
Issuance of common stock to adjust for reverse split rounding, shares | 15,941 | 172,500 |
Share-Based Expense (Details -
Share-Based Expense (Details - Share based expense) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | $ 283,085 | $ 511,480 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | 56,112 | 86,305 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation | $ 226,973 | $ 425,175 |
Share-Based Expense (Details _2
Share-Based Expense (Details - Assumptions Employee) - Share-Based Payment Arrangement, Option [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Weighted-average expected dividend yield | 0% | 0% |
Weighted-average expected volatility | 121.50% | 126.51% |
Weighted-average risk-free interest rate | 4.21% | 2.90% |
Weighted-average expected life of option | 5 years 9 months 3 days | 5 years 8 months 19 days |
Weighted-average exercise price | $ 4 | $ 8.27 |
Share-Based Expense (Details _3
Share-Based Expense (Details - Employee option activity) - Share-Based Payment Arrangement, Option [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Options outstanding, beginning balance | 143,888 | 108,888 | |
Weighted-average exercise price outstanding, beginning balance | $ 49.43 | $ 62.66 | |
Weighted-average remaining life outstanding ending | 7 years 8 months 8 days | 7 years 9 months 10 days | 8 years 2 months 19 days |
Aggregate intrinsic value, outstanding beginning balance | $ 0 | $ 23,750 | |
Options granted | 57,500 | 35,000 | |
Weighted-average exercise price, granted | $ 4 | $ 8.27 | |
Options expired | 0 | 0 | |
Weighted-average exercise price, expired | $ 0 | $ 0 | |
Options outstanding, ending balance | 201,388 | 143,888 | 108,888 |
Weighted-average exercise price, ending balance | $ 36.46 | $ 49.43 | $ 62.66 |
Aggregate intrinsic value, outstanding ending balance | $ 0 | $ 0 | $ 23,750 |
Options vested or expected to vest | 201,388 | ||
Weighted-average exercise price, vested or expected to vest | $ 36.46 | ||
Weighted-average remaining life, vested or expected to vest | 7 years 8 months 8 days | ||
Aggregate intrinsic value, vested or expected to vest | $ 0 | ||
Options exercisable | 133,888 | 100,555 | |
Weighted-average exercise price, exercisable | $ 52.10 | $ 65.70 | |
Weighted-average remaining life, exercisable | 6 years 8 months 8 days | 7 years 1 month 20 days | |
Aggregate intrinsic value, exercisable | $ 0 | $ 0 |
Share-Based Expense (Details _4
Share-Based Expense (Details - Non-Vested employee Option activity) - Non Vested Employee Stock Option [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Non-vested options outstanding, beginning balance | shares | 43,334 |
Non-vested weighted-average grant date fair value per share, beginning balance | $ / shares | $ 10.39 |
Options granted | shares | 57,500 |
Weighted-average grant date fair value per share, options granted | $ / shares | $ 3.49 |
Options forfeited | shares | 0 |
Weighted-average grant date fair value per share, options forfeited | $ / shares | $ 0 |
Options vested | shares | (33,333) |
Weighted-average grant date fair value per share, options vested | $ / shares | $ 9.86 |
Non-vested options outstanding, ending balance | shares | 67,501 |
Non-vested weighted-average grant date fair value per share, ending balance | $ / shares | $ 4.77 |
Share-Based Expense (Details _5
Share-Based Expense (Details - Non-employee option activity) - Non Employee Stock Options [Member] - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Options outstanding, beginning balance | 2,009 | 2,009 | |
Weighted-average exercise price outstanding, beginning balance | $ 120.83 | $ 120.83 | |
Weighted-average remaining life outstanding ending | 10 months 28 days | 1 year 9 months 29 days | 2 years 9 months 29 days |
Aggregate intrinsic value, outstanding beginning balance | $ 0 | $ 3,255 | |
Options granted | 0 | 0 | |
Weighted-average exercise price, granted | $ 0 | $ 0 | |
Options expired | (84) | 0 | |
Weighted-average exercise price, forfeited/expired | $ 231.60 | $ 0 | |
Options outstanding, ending balance | 1,925 | 2,009 | 2,009 |
Weighted-average exercise price, ending balance | $ 115.99 | $ 120.83 | $ 120.83 |
Aggregate intrinsic value, outstanding ending balance | $ 0 | $ 0 | $ 3,255 |
Options vested or expected to vest | 1,925 | ||
Weighted-average exercise price, vested or expected to vest | $ 115.99 | ||
Weighted-average remaining life, vested or expected to vest | 10 months 28 days | ||
Aggregate intrinsic value, vested or expected to vest | $ 0 | ||
Options exercisable | 1,925 | 2,009 | |
Weighted-average exercise price, exercisable | $ 115.99 | $ 120.83 | |
Weighted-average remaining life, exercisable | 10 months 28 days | 1 year 9 months 29 days | |
Aggregate intrinsic value, exercisable | $ 0 | $ 0 |
Share-Based Expense (Details Na
Share-Based Expense (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based compensation expense | $ 300,000 | $ 500,000 |
Share-Based Payment Arrangement, Option [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options granted | 57,500 | 35,000 |
Weighted average grant date fair value | $ 3.49 | $ 7.29 |
Options exercised | 0 | 0 |
Options vested | 33,333 | 37,503 |
Fair value of options vested | $ 300,000 | $ 600,000 |
Unrecognized compensation expense | $ 300,000 | |
Unrecognized compensation expense recognition period | 2 years 1 month 6 days | |
Restricted Stock Units (RSUs) [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Common stock awards granted | 417 | 417 |
Other than options, grant date fair value per share | $ 253.70 | |
Other than options, shares expired | 0 | 0 |
Non Employee Stock Options [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based compensation expense | $ 0 | $ 0 |
Options granted | 0 | 0 |
Options exercised | 0 | 0 |
Common Stock Awards [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Common stock awards granted | 0 | 0 |
JSOP [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based compensation expense | $ 0 | $ 0 |
Other than options, shares outstanding | 2,701 | 2,701 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Plan 401 K [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Contribution to defined contribution plan | $ 41,000 | $ 38,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details - Cash flow Information) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating cash flow information: | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 0 | $ 27,043 |
Commitments and Contingencies_3
Commitments and Contingencies (Details Narrative) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Corporate Headquarters [Member] | |
Lessee, Operating Lease, Description | On October 1, 2020, the Company entered into a two-year lease for its corporate headquarters in Framingham, Massachusetts. |
Future minimum rental payments | $ 78,000 |
Lease termination date | Sep. 30, 2022 |
Office Space [Member] | |
Future minimum rental payments | $ 15,000 |
Lease term | 12 months |
Office Space Miami Fl [Member] | |
Lessee, Operating Lease, Description | Effective November 1, 2023, the Company renewed its Miami office lease for twelve-months to November 2024. |
Future minimum rental payments | $ 15,000 |
Lease term | 12 months |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | |
Co Development Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Interest and fee income, other loans | $ 65,000 | ||
Pharmsynthez [Member] | Co Development Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Payments to acquire notes receivable | $ 500,000 | ||
Accrued interest rate | 10% | ||
Interest and fee income, other loans | $ 40,000 | $ 9,000 | |
Pharmsynthez [Member] | Sponsored Research Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Prepaid expenses and other current asset | $ 400,000 |