Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 04, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
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 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 Common Stock, Shares Outstanding | 1,532,600 | |
Common Stock, $0.001 par value per share [Member] | ||
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | XBIO | |
Security Exchange Name | NASDAQ | |
Purchase Warrants [Member] | ||
Title of 12(b) Security | Purchase Warrants | |
Trading Symbol | XBIOW | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 10,725,707 | $ 13,097,265 |
Prepaid expenses and other | 1,319,035 | 556,094 |
Total current assets | 12,044,742 | 13,653,359 |
Other assets | 704,431 | 1,066,931 |
Total assets | 12,749,173 | 14,720,290 |
Current liabilities: | ||
Accounts payable | 221,281 | 287,360 |
Accrued expenses and other current liabilities | 650,034 | 785,796 |
Total current liabilities | 871,315 | 1,073,156 |
Total liabilities | 871,315 | 1,073,156 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 1,535,301 and 1,519,360 shares issued as of June 30, 2023 and December 31, 2022, respectively; 1,532,600 and 1,516,659 shares outstanding as of June 30, 2023 and December 31, 2022, respectively | 1,536 | 1,520 |
Additional paid in capital | 207,908,129 | 207,769,904 |
Accumulated deficit | (191,007,135) | (189,099,618) |
Accumulated other comprehensive income | 253,734 | 253,734 |
Treasury stock | (5,281,180) | (5,281,180) |
Total stockholders' equity | 11,877,858 | 13,647,134 |
Total liabilities and stockholders' equity | 12,749,173 | 14,720,290 |
Series B Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred Stock, Value, Issued | 1,804 | 1,804 |
Series A Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred Stock, Value, Issued | $ 970 | $ 970 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 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 | 1,535,301 | 1,519,360 |
Common stock, shares outstanding | 1,532,600 | 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 | 970,000 | 970,000 |
Preferred stock, shares outstanding | 970,000 | 970,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue: | ||||
Royalty revenue | $ 651,005 | $ 416,710 | $ 1,256,849 | $ 805,703 |
Total revenue | 651,005 | 416,710 | 1,256,849 | 805,703 |
Operating costs and expenses: | ||||
Research and development | (903,243) | (2,077,499) | (1,498,519) | (3,178,898) |
General and administrative | (945,950) | (1,026,290) | (1,871,693) | (1,933,599) |
Total operating costs and expenses | (1,849,193) | (3,103,789) | (3,370,212) | (5,112,497) |
Loss from operations | (1,198,188) | (2,687,079) | (2,113,363) | (4,306,794) |
Other income (expense): | ||||
Other income (expense) | 21,122 | (1,076) | 25,642 | (877) |
Interest income, net | 126,103 | 15,965 | 180,204 | 41,870 |
Total other income | 147,225 | 14,889 | 205,846 | 40,993 |
Net loss | $ (1,050,963) | $ (2,672,190) | $ (1,907,517) | $ (4,265,801) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (Parenthetical) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Statement [Abstract] | ||||
Earnings Per Share, Basic | $ (0.69) | $ (1.90) | $ (1.25) | $ (3.10) |
Earnings Per Share, Diluted | $ (0.69) | $ (1.90) | $ (1.25) | $ (3.10) |
Weighted Average Number of Shares Outstanding, Basic | 1,524,717 | 1,406,657 | 1,520,710 | 1,375,505 |
Weighted Average Number of Shares Outstanding, Diluted | 1,524,717 | 1,406,657 | 1,520,710 | 1,375,505 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - 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 | $ 88 | 804,912 | 805,000 | ||||
Issuance of common stock in connection with purchase of in-process research and development, shares | 87,500 | ||||||
Share-based expense | 255,465 | 255,465 | |||||
Exercise of purchase warrants | |||||||
Exercise of purchase warrants, shares | 199 | ||||||
Net loss | (4,265,801) | (4,265,801) | |||||
Ending balance, value at Jun. 30, 2022 | $ 2,774 | $ 1,435 | 207,025,224 | (186,813,066) | 253,734 | (5,281,180) | 15,188,921 |
Ending balance, shares at Jun. 30, 2022 | 2,774,394 | 1,434,360 | |||||
Beginning balance, value at Mar. 31, 2022 | $ 2,774 | $ 1,347 | 206,084,442 | (184,140,876) | 253,734 | (5,281,180) | 16,920,241 |
Beginning balance, shares at Mar. 31, 2022 | 2,774,394 | 1,346,830 | |||||
Issuance of common stock in connection with purchase of in-process research and development | $ 88 | 804,912 | 805,000 | ||||
Issuance of common stock in connection with purchase of in-process research and development, shares | 87,500 | ||||||
Share-based expense | 135,870 | 135,870 | |||||
Exercise of purchase warrants | |||||||
Exercise of purchase warrants, shares | 30 | ||||||
Net loss | (2,672,190) | (2,672,190) | |||||
Ending balance, value at Jun. 30, 2022 | $ 2,774 | $ 1,435 | 207,025,224 | (186,813,066) | 253,734 | (5,281,180) | 15,188,921 |
Ending balance, shares at Jun. 30, 2022 | 2,774,394 | 1,434,360 | |||||
Beginning balance, value at Dec. 31, 2022 | $ 2,774 | $ 1,520 | $ 207,769,904 | $ (189,099,618) | $ 253,734 | $ (5,281,180) | $ 13,647,134 |
Beginning balance, shares at Dec. 31, 2022 | 2,774,394 | 1,519,360 | |||||
Issuance of common stock to adjust for reverse split rounding | 0 | 16 | (16) | 0 | 0 | 0 | 0 |
Issuance of common stock to adjust for reverse split rounding, shares | 15,941 | ||||||
Share-based expense | $ 138,241 | $ 138,241 | |||||
Net loss | (1,907,517) | (1,907,517) | |||||
Ending balance, value at Jun. 30, 2023 | $ 2,774 | $ 1,536 | 207,908,129 | (191,007,135) | 253,734 | (5,281,180) | 11,877,858 |
Ending balance, shares at Jun. 30, 2023 | 2,774,394 | 1,535,301 | |||||
Beginning balance, value at Mar. 31, 2023 | $ 2,774 | $ 1,520 | $ 207,838,756 | $ (189,956,172) | $ 253,734 | $ (5,281,180) | $ 12,859,432 |
Beginning balance, shares at Mar. 31, 2023 | 2,774,394 | 1,519,360 | |||||
Issuance of common stock to adjust for reverse split rounding | 0 | 16 | (16) | 0 | 0 | 0 | 0 |
Issuance of common stock to adjust for reverse split rounding, shares | 15,941 | ||||||
Share-based expense | $ 69,389 | $ 69,389 | |||||
Net loss | (1,050,963) | (1,050,963) | |||||
Ending balance, value at Jun. 30, 2023 | $ 2,774 | $ 1,536 | $ 207,908,129 | $ (191,007,135) | $ 253,734 | $ (5,281,180) | $ 11,877,858 |
Ending balance, shares at Jun. 30, 2023 | 2,774,394 | 1,535,301 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (1,907,517) | $ (4,265,801) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development | 0 | 1,305,000 |
Amortization of right of use asset | 0 | 19,087 |
Share-based expense | 138,241 | 255,465 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other | (762,941) | 11,579 |
Other assets | 362,500 | 0 |
Accounts payable, accrued expenses and other liabilities | (201,841) | (141,920) |
Net cash used in operating activities | (2,371,558) | (2,816,590) |
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 | (2,371,558) | (3,316,590) |
Cash at beginning of period | 13,097,265 | 18,244,030 |
Cash at end of period | 10,725,707 | 14,927,440 |
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 | $ 805,000 |
The Company
The Company | 6 Months Ended |
Jun. 30, 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. XCART ™ ® As used in this Quarterly Report on Form 10-Q (“Quarterly Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,” “we” or “us” refer to Xenetic Biosciences, Inc. and its wholly-owned subsidiaries. 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 may be used throughout this Quarterly 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 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 | 6 Months Ended |
Jun. 30, 2023 | |
Risks and Uncertainties [Abstract] | |
Risks and Uncertainties | 2. Risks and Uncertainties Effects of the COVID-19 Pandemic During March 2020, a global pandemic was declared by the World Health Organization related to the outbreak of a novel strain of coronavirus, or COVID-19. The pandemic significantly affected economic conditions in the U.S., accelerating during the first half of March 2020 and continuing throughout 2021 and 2022 and into 2023, as federal, state and local governments reacted to the public health crisis with mitigation measures, creating significant uncertainties in the U.S. economy. The Company continues to evaluate the effects of the COVID-19 pandemic on its business and while there has been no significant impact to the Company’s operations to date, the Company at this time remains uncertain of the impact this event may have on the Company’s future operations. The extent to which the COVID-19 pandemic affects our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict, and such uncertainty is expected to continue for some time. Impact of the conflict in Ukraine on Operations The short and long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time. The imposition of 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 | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Preparation of Interim Financial Statements The accompanying condensed consolidated interim financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results for the full year. The condensed consolidated financial statements contained herein should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 22, 2023, and amended on April 28, 2023. 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 were proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option to purchase common stock were proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each share of preferred stock were 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 Quarterly Report, on a retroactive basis, to reflect this 1-for-10 Reverse Stock Split Principles of Consolidation The condensed 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 intercompany balances and transactions have been eliminated in consolidation. 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. Cash deposits are insured by the Federal Deposit Insurance Corporations up to $ 250,000 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. For the three and six months ended June 30, 2023 and 2022, basic and diluted net loss per share are the same for each respective period 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. 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 | 6 Months Ended |
Jun. 30, 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 $ 0.7 million 1.3 million 0.4 million 0.8 million CLS Therapeutics Ltd. (“CLS”) On April 26, 2022, the Company entered into an Exclusive Sublicense Agreement (the “Sublicense 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 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. Concurrent with the Sublicense Agreement, 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. Volition Collaboration On August 2, 2022, the Company announced a research and development collaboration with Belgian Volition SARL Limited (“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 ® 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 is 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. Unless earlier amended or terminated, the manufacturing services contemplated by the SOW are currently targeted to be completed by the first half of 2024. The SOW is terminable by the Company at any time with 30 days’ prior written notice to Catalent. The SOW also contains customary provisions related to, among other things, confidentiality, warranties, intellectual property and indemnification. The Company has paid Catalent approximately $ 1.8 million 0.9 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 $ 0.3 million 37,000 Other Agreements The Company has also entered into various research, development, license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”) and SynBio LLC (“SynBio”), a wholly owned subsidiary of Pharmsynthez. The Company and its collaborative partners continue to engage in research and development activities with no resultant commercial products through June 30, 2023. No |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements Accounting Standards Codification Topic 820, Fair Value Measurement, no |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | 6. Stockholders’ Equity Common Stock 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 Warrants 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 30 199 None The Company also has outstanding warrants to purchase approximately 800 29.09 July 3, 2026 None |
Share-Based Expense
Share-Based Expense | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Expense | 7. Share-Based Expense Total share-based expense related to stock options, restricted stock units and common stock awards was approximately $ 0.1 million 0.1 million 0.3 million Share-based compensation expense is classified in the condensed consolidated statements of operations as follows: Schedule of share-based compensation expense Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development expenses $ 13,778 $ 23,128 $ 27,466 $ 42,306 General and administrative expenses 55,611 112,742 110,775 213,159 $ 69,389 $ 135,870 $ 138,241 $ 255,465 Employee Stock Options No 20,000 0.1 million 0.1 million 0.3 million No none Non-Employee Stock Options There were no 100 No no |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes During the three and six months ended June 30, 2023 and 2022, there was no 39 38.6 million As of June 30, 2023 and December 31, 2022, the Company did no |
Commitments
Commitments | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Supplemental cash flow information and non-cash activity related to the Company’s operating leases are as follows: Cash flow information regarding leases Six Months Ended June 30, Six Months Ended June 30, 2023 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ – $ 19,087 Supplemental balance sheet information related to the Company’s operating leases is as follows: Supplemental information related to operating leases Balance Sheet Classification June 30, 2023 June 30, 2022 Right-of-use assets - ST Prepaid expenses and other $ – $ 9,611 Current lease liabilities Accrued expenses and other current liabilities $ – $ 9,611 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 11. 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 has not materially changed from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 22, 2023, as amended on April 28, 2023. 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 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. 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 except as described in footnote 4. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Preparation of Interim Financial Statements | Preparation of Interim Financial Statements The accompanying condensed consolidated interim financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results for the full year. The condensed consolidated financial statements contained herein should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 22, 2023, and amended on April 28, 2023. 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 were proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option to purchase common stock were proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each share of preferred stock were 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 Quarterly Report, on a retroactive basis, to reflect this 1-for-10 Reverse Stock Split |
Principles of Consolidation | Principles of Consolidation The condensed 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 intercompany balances and transactions have been eliminated in consolidation. |
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. Cash deposits are insured by the Federal Deposit Insurance Corporations up to $ 250,000 |
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. For the three and six months ended June 30, 2023 and 2022, basic and diluted net loss per share are the same for each respective period 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. |
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 |
Share-Based Expense (Tables)
Share-Based Expense (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of share-based compensation expense | Schedule of share-based compensation expense Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development expenses $ 13,778 $ 23,128 $ 27,466 $ 42,306 General and administrative expenses 55,611 112,742 110,775 213,159 $ 69,389 $ 135,870 $ 138,241 $ 255,465 |
Commitments (Tables)
Commitments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Cash flow information regarding leases | Cash flow information regarding leases Six Months Ended June 30, Six Months Ended June 30, 2023 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ – $ 19,087 |
Supplemental information related to operating leases | Supplemental information related to operating leases Balance Sheet Classification June 30, 2023 June 30, 2022 Right-of-use assets - ST Prepaid expenses and other $ – $ 9,611 Current lease liabilities Accrued expenses and other current liabilities $ – $ 9,611 |
The Company (Details Narrative)
The Company (Details Narrative) - $ / shares | May 15, 2023 | Jun. 30, 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_3
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | May 15, 2023 | Jun. 30, 2023 |
Accounting Policies [Abstract] | ||
Reverse stock split | 1-for-10 Reverse Stock Split | |
Cash deposits | $ 250,000 |
Significant Strategic Collabo_2
Significant Strategic Collaborations (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Mar. 17, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue | $ 651,005 | $ 416,710 | $ 1,256,849 | $ 805,703 | ||
Research and development expenses | 903,243 | 2,077,499 | 1,498,519 | 3,178,898 | ||
Prepaid Expense and Other Assets, Current | 1,319,035 | 1,319,035 | $ 556,094 | |||
Prepaid expenses and other | 37,000 | 37,000 | ||||
Revenues | 651,005 | 416,710 | 1,256,849 | 805,703 | ||
Collaborative Agreements [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenues | 0 | 0 | 0 | 0 | ||
Takeda [Member] | Royalty Revenue [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Revenue | 700,000 | $ 400,000 | 1,300,000 | $ 800,000 | ||
Catalent Pharma Solutions [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expenses | 1,800,000 | |||||
Prepaid Expense and Other Assets, Current | $ 900,000 | 900,000 | $ 300,000 | |||
Scripps Research [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expenses | $ 938,000 | |||||
Initial payment for research | 78,000 | |||||
Monthly payment | $ 78,000 | |||||
Scripps Research [Member] | Scripps Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Research and development expenses | $ 300,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - USD ($) | Jun. 30, 2023 | Jun. 30, 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 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - $ / shares | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jul. 31, 2021 | |
Publicly Traded Warrants [Member] | ||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||
Exercise Price | $ 130 | $ 130 | ||||
Maturity date | Jul. 17, 2024 | Jul. 17, 2024 | ||||
Purchase of outstanding warrants | 2,100 | 2,100 | 2,100 | |||
Warrants exercised shares | 0 | 30 | 0 | 199 | ||
Other Warrants [Member] | ||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||
Exercise Price | $ 29.09 | $ 29.09 | ||||
Maturity date | Jul. 03, 2026 | Jul. 03, 2026 | ||||
Purchase of outstanding warrants | 800 | 800 | 800 | |||
Warrants exercised shares | 0 | 0 | 0 | 0 | ||
Warrants forfeited shares | 0 | 0 | 0 | 0 | ||
Private Placement [Member] | Series A Warrants [Member] | ||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||
Warrants issued | 462,963 | |||||
Exercise Price | $ 33 | |||||
Maturity date | Feb. 23, 2025 | |||||
Warrants exercised | 0 | 0 | 0 | 0 | ||
Warrants forfeited | 0 | 0 | 0 | 0 | ||
Common Stock [Member] | ||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||
Issuance of common stock to adjust for reverse split rounding, shares | 15,941 | 15,941 |
Share-Based Expense (Details)
Share-Based Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | $ 69,389 | $ 135,870 | $ 138,241 | $ 255,465 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | 13,778 | 23,128 | 27,466 | 42,306 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | $ 55,611 | $ 112,742 | $ 110,775 | $ 213,159 |
Share-Based Expense (Details Na
Share-Based Expense (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock options expense recognized | $ 100,000 | $ 100,000 | $ 100,000 | $ 300,000 |
Employee Stock Options [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock option granted | 0 | 0 | 20,000 | |
Stock options exercised | 0 | 0 | 0 | 0 |
Stock options expired | 0 | 0 | 0 | 0 |
Non Employee Stock Options [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock options expense recognized | $ 0 | $ 0 | $ 0 | $ 0 |
Stock option granted | 0 | 0 | 0 | 0 |
Stock options exercised | 0 | 0 | 0 | 0 |
Stock options expired | 0 | |||
Non employee stock option grants to purchase shares of common stock expired | 100 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 0 | $ 0 | $ 0 | $ 0 | |
Deferred tax valuation allowance | 39,000,000 | 39,000,000 | $ 38,600,000 | ||
Unrecognized tax positions | $ 0 | $ 0 | $ 0 |
Commitments (Details)
Commitments (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating cash flow information: | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 0 | $ 19,087 |
Commitments (Details1)
Commitments (Details1) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Right-of-use assets - ST | $ 0 | $ 9,611 |
Current lease liabilities | $ 0 | $ 9,611 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Dec. 31, 2019 | Jun. 30, 2023 | Jun. 30, 2022 | 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 | $ 40,000 | $ 9,000 | ||
Pharmsynthez [Member] | Sponsored Research Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Prepaid expenses and other current asset | $ 400,000 |