Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 05, 2021 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2021 | |
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 | 40 Speen Street | |
Entity Address, Address Line Two | Suite 102 | |
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 | 13,387,978 | |
Common Stock, $0.001 par value per share | ||
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | XBIO | |
Security Exchange Name | NASDAQ | |
Purchase Warrants | ||
Title of 12(b) Security | Purchase Warrants | |
Trading Symbol | XBIOW | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 19,702,729 | $ 11,527,552 |
Prepaid expenses and other | 878,243 | 841,958 |
Total current assets | 20,580,972 | 12,369,510 |
Other assets | 704,430 | 809,985 |
Total assets | 21,285,402 | 13,179,495 |
Current liabilities: | ||
Accounts payable | 248,485 | 327,396 |
Accrued expenses and other current liabilities | 873,010 | 609,532 |
Total current liabilities | 1,121,495 | 936,928 |
Other long-term liabilities | 27,043 | |
Total liabilities | 1,121,495 | 963,971 |
Commitments (Note 11) | ||
Stockholders' equity: | ||
Preferred Stock, Value, Issued | ||
Common stock, $0.001 par value; 50,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 13,413,013 and 8,772,198 shares issued as of September 30, 2021 and December 31, 2020, respectively; 13,386,022 and 8,745,207 shares outstanding as of September 30, 2021 and December 31, 2020, respectively | 13,411 | 8,771 |
Additional paid in capital | 205,880,753 | 194,133,511 |
Accumulated deficit | (180,705,585) | (176,902,086) |
Accumulated other comprehensive income | 253,734 | 253,734 |
Treasury stock | (5,281,180) | (5,281,180) |
Total stockholders' equity | 20,163,907 | 12,215,524 |
Total liabilities and stockholders' equity | 21,285,402 | 13,179,495 |
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 | Sep. 30, 2021 | Dec. 31, 2020 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 13,413,013 | 8,772,198 |
Common stock, shares outstanding | 13,386,022 | 8,745,207 |
Preferred Class B [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 |
Preferred Class A [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 | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 349,269 | $ 115,934 | $ 828,088 | $ 285,610 |
Operating costs and expenses: | ||||
Research and development | (780,153) | (573,061) | (1,934,432) | (1,240,612) |
General and administrative | (945,115) | (804,149) | (2,766,397) | (2,519,515) |
Asset impairment charges | 0 | (9,243,128) | 0 | (9,243,128) |
Total operating costs and expenses | (1,725,268) | (10,620,338) | (4,700,829) | (13,003,255) |
Loss from operations | (1,375,999) | (10,504,404) | (3,872,741) | (12,717,645) |
Other income (expense): | ||||
Other income (expense) | (2,906) | 585 | (1,784) | 643 |
Interest income, net | 28,029 | 24,931 | 71,026 | 105,043 |
Total other income | 25,123 | 25,516 | 69,242 | 105,686 |
Loss before income taxes | (1,350,876) | (10,478,888) | (3,803,499) | (12,611,959) |
Income tax benefit | 0 | 2,918,518 | 0 | 2,918,518 |
Net loss | $ (1,350,876) | $ (7,560,370) | $ (3,803,499) | $ (9,693,441) |
Basic and diluted net loss per share | $ (0.13) | $ (1.20) | $ (0.41) | $ (1.55) |
Weighted-average shares of common stock outstanding, basic and diluted | 10,162,167 | 6,296,227 | 9,223,560 | 6,272,722 |
Royalty [Member] | ||||
Revenue: | ||||
Total revenue | $ 349,269 | $ 115,934 | $ 828,088 | $ 285,610 |
CONDENSED CONSOLIDATED STATEM_2
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 [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 2,774 | $ 6,092 | $ 188,240,451 | $ (166,008,620) | $ 253,734 | $ (5,281,180) | $ 17,213,251 |
Beginning balance, shares at Dec. 31, 2019 | 2,774,394 | 6,092,432 | |||||
Exercise of purchase warrants | $ 229 | (229) | |||||
Exercise of purchase warrants, shares | 229,598 | ||||||
Issuance of common stock to vendor | $ 1 | (1) | |||||
Issuance of common stock to vendor, shares | 1,188 | ||||||
Share-based expense | 388,131 | 388,131 | |||||
Net loss | (9,693,441) | (9,693,441) | |||||
Ending balance, value at Sep. 30, 2020 | $ 2,774 | $ 6,322 | 188,628,352 | (175,702,061) | 253,734 | (5,281,180) | 7,907,941 |
Ending balance, shares at Sep. 30, 2020 | 2,774,394 | 6,323,218 | |||||
Beginning balance, value at Jun. 30, 2020 | $ 2,774 | $ 6,322 | 188,517,553 | (168,141,691) | 253,734 | (5,281,180) | 15,357,512 |
Beginning balance, shares at Jun. 30, 2020 | 2,774,394 | 6,323,218 | |||||
Share-based expense | 110,799 | 110,799 | |||||
Net loss | (7,560,370) | (7,560,370) | |||||
Ending balance, value at Sep. 30, 2020 | $ 2,774 | $ 6,322 | 188,628,352 | (175,702,061) | 253,734 | (5,281,180) | 7,907,941 |
Ending balance, shares at Sep. 30, 2020 | 2,774,394 | 6,323,218 | |||||
Beginning balance, value at Dec. 31, 2020 | $ 2,774 | $ 8,771 | 194,133,511 | (176,902,086) | 253,734 | (5,281,180) | 12,215,524 |
Beginning balance, shares at Dec. 31, 2020 | 2,774,394 | 8,772,198 | |||||
Issuance of common stock and warrants, net of issuance costs | $ 950 | 11,449,916 | 11,450,866 | ||||
Issuance of common stock and warrants, net of issuance costs ,shares | 950,000 | ||||||
Exercise of pre-funded warrants | $ 3,679 | 3,679 | |||||
Exercise of pre-funded warrants ,shares | 3,679,630 | ||||||
Exercise of purchase warrants | $ 4 | (4) | |||||
Exercise of purchase warrants, shares | 4,032 | ||||||
Issuance of common stock to vendor | $ 7 | (7) | |||||
Issuance of common stock to vendor, shares | 7,153 | ||||||
Share-based expense | 297,337 | 297,337 | |||||
Net loss | (3,803,499) | (3,803,499) | |||||
Ending balance, value at Sep. 30, 2021 | $ 2,774 | $ 13,411 | 205,880,753 | (180,705,585) | 253,734 | (5,281,180) | 20,163,907 |
Ending balance, shares at Sep. 30, 2021 | 2,774,394 | 13,413,013 | |||||
Beginning balance, value at Jun. 30, 2021 | $ 2,774 | $ 8,772 | 194,319,716 | (179,354,709) | 253,734 | (5,281,180) | 9,949,107 |
Beginning balance, shares at Jun. 30, 2021 | 2,774,394 | 8,773,683 | |||||
Issuance of common stock and warrants, net of issuance costs | $ 950 | 11,449,916 | 11,450,866 | ||||
Issuance of common stock and warrants, net of issuance costs ,shares | 950,000 | ||||||
Exercise of pre-funded warrants | $ 3,679 | 3,679 | |||||
Exercise of pre-funded warrants ,shares | 3,679,630 | ||||||
Exercise of purchase warrants | $ 3 | (3) | |||||
Exercise of purchase warrants, shares | 2,547 | ||||||
Issuance of common stock to vendor | $ 7 | (7) | |||||
Issuance of common stock to vendor, shares | 7,153 | ||||||
Share-based expense | 111,131 | 111,131 | |||||
Net loss | (1,350,876) | (1,350,876) | |||||
Ending balance, value at Sep. 30, 2021 | $ 2,774 | $ 13,411 | $ 205,880,753 | $ (180,705,585) | $ 253,734 | $ (5,281,180) | $ 20,163,907 |
Ending balance, shares at Sep. 30, 2021 | 2,774,394 | 13,413,013 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (3,803,499) | $ (9,693,441) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Asset impairment charges | 0 | 9,243,128 |
Deferred income taxes | 0 | (2,918,518) |
Depreciation | 0 | 757 |
Amortization of right of use asset | 26,199 | 20,042 |
Gain on settlement with vendor | 0 | (143,639) |
Share-based expense | 297,337 | 388,131 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 43,071 | 273,052 |
Accounts payable, accrued expenses and other liabilities | 157,524 | (483,045) |
Net cash used in operating activities | (3,279,368) | (3,313,533) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net proceeds from issuance of common stock and warrants | 11,450,866 | 0 |
Proceeds from exercise of warrants | 3,679 | 0 |
Net cash provided by financing activities | 11,454,545 | 0 |
Net change in cash | 8,175,177 | (3,313,533) |
Cash at beginning of period | 11,527,552 | 10,367,920 |
Cash at end of period | 19,702,729 | 7,054,387 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | 0 | 0 |
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Issuance of common stock to vendor | 7 | 1 |
Issuance of common stock from cashless exercise of purchase warrants | $ 4 | $ 229 |
The Company
The Company | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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 progressing XCART ™ Additionally, Xenetic is leveraging its proprietary drug delivery platform, PolyXen ® 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, and unregistered trademarks and service marks, including but not limited to XCART, OncoHist™, PolyXen, ErepoXen™, and ImuXen™, which are 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. On December 4, 2020, the Company closed on a $6.0 million registered direct offering of the Company’s common stock, par value $0.001, resulting in $ 5.4 11.5 |
Impact of COVID-19
Impact of COVID-19 | 9 Months Ended |
Sep. 30, 2021 | |
Impact Of Covid-19 | |
Impact of COVID-19 | 2. Impact of COVID-19 During March 2020, a global pandemic was declared by the World Health Organization related to the rapidly growing outbreak of a novel strain of coronavirus, or COVID-19. The pandemic has significantly affected economic conditions in the U.S., accelerating during the first half of March 2020 and continuing into 2021, as federal, state and local governments react 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 is 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020 filed with the SEC on March 16, 2021 and amended on April 28, 2021. 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. 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 nine months ended September 30, 2021 and 2020, 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 | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Significant Strategic Collaborations | 4. Significant Strategic Collaborations The Company has entered into various research, development, license and supply agreements with Takeda Pharmaceuticals Co. Ltd. (“Takeda”), Serum Institute of India (“Serum Institute”), 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 September 30, 2021. 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 $ 0.3 0.8 0.1 0.3 No On May 15, 2020, the Company and Scripps Research entered into a Research Funding and Option Agreement (the “Scripps Agreement”), pursuant to which the Company has agreed to provide Scripps Research an aggregate of up to $3.0 million to fund research relating to advancing the pre-clinical development of XCART. The research funding is payable by the Company to Scripps Research on a quarterly basis in accordance with a negotiated budget, which provides for an initial payment of approximately $300,000 on the date of the Scripps Agreement and subsequent quarterly payments of approximately $300,000 over a 27-month period. Under the Scripps Agreement, Scripps Research has granted the Company a license within the Field (as defined in the Scripps Agreement) to any Patent Rights or Technology (as defined in the Scripps Agreement) under the terms of that certain license agreement with Scripps Research, dated February 25, 2019, assigned to the Company on March 1, 2019. Additionally, the Company has the option to acquire a worldwide exclusive license to Scripps Research’s rights in the Technology or Patent Rights not already licensed to the Company, as well as a non-exclusive, royalty-free, non-transferrable license to make and use Scripps Research Technology (as defined in the Scripps Agreement) solely for the Company’s internal research purposes during the performance of the research program contemplated by the Scripps Agreement. The Company has paid $ 1.8 0.2 |
Property and Equipment, net
Property and Equipment, net | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment, net consists of the following: Schedule of Property and Equipment, Net September 30, December 31, Office and computer equipment $ 42,289 $ 42,289 Furniture and fixtures 14,738 14,738 Property and equipment – at cost 57,027 57,027 Less accumulated depreciation (57,027 ) (57,027 ) Property and equipment – net $ – $ – There was no no 800 |
Indefinite-Lived Intangible Ass
Indefinite-Lived Intangible Assets | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Indefinite-Lived Intangible Assets | 6. Indefinite-Lived Intangible Assets The Company’s indefinite-lived intangible asset, OncoHist, is in-process research and development (“IPR&D”) relating to the Company’s business combination with SymbioTec in 2012. IPR&D is tested for impairment whenever events or changes in circumstances indicate that the carrying value may not be recoverable, although it is to be tested at least annually until the project is completed or abandoned. The Company completed an impairment analysis of the IPR&D during 2020 and concluded that the following factors indicated that the IPR&D was impaired: a decision by management to delay indefinitely any further development of the IPR&D and to not support the underlying intellectual property; the failure to sell or license the IPR&D to a third party; and the reduction in market capitalization. The Company recorded an asset impairment charge of $ 9.2 Schedule of Indefinite- Lived Intangible Asset Balance as of January 1, 2020 $ 9,243,128 Impairment (9,243,128 ) Balance as of September 30, 2020 $ – |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. Fair Value Measurements Accounting Standards Codification Topic 820, Fair Value Measurement, no |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | 8. Stockholders’ Equity Private Placement On July 26, 2021, the Company entered into a securities purchase agreement in connection with a private placement with the purchaser named on the signature page thereto (“Purchaser”), pursuant to which the Company issued and sold to Purchaser, in a private placement priced at-the-market under Nasdaq rules, (i) 950,000 shares of the Company’s common stock, par value $0.001 per share (the “Shares”), (ii) warrants to purchase an aggregate of 4,629,630 shares of the Company’s common stock, with an exercise price of $3.30 per share (the “Series A Warrants”) which expire three and one half years from the earlier of (a) the six month anniversary of the initial exercise date and (b) the date that the registration statement registering all of the warrant shares underlying the Series A Warrants is declared effective, and (iii) pre-funded warrants to purchase up to 3,679,630 shares of the Company’s common stock, with an exercise price of $0.001 per share (the “Series B Warrants”) with no expiration (the “Private Placement”), at a purchase price of $2.70 per one Share and one Series A Warrant and $2.699 per one Series B Warrant and one Series A Warrant. The Private Placement closed on July 28, 2021 resulting in gross proceeds from the Private Placement of approximately $12.5 million, before deducting placement agent fees and offering expenses, and excluding the exercise of any such warrants. Net proceeds from the Private Placement were $ 11.5 On July 26, 2021, in connection with the Private Placement, the Company entered into a registration rights agreement with Purchaser, pursuant to which the Company filed a registration statement on Form S-3 to register for resale the Shares, as well as the shares of the Company’s common stock issuable upon exercise of the Series A Warrants and the Series B Warrants, which was declared effective on August 23, 2021. Warrants In connection with certain of the Company’s collaboration agreements and consulting arrangements, the Company has issued warrants to purchase shares of common stock as payment for services. As of September 30, 2021 and December 31, 2020, collaboration warrants to purchase 0 30,307 No 30,307 none The Series B Warrants are immediately exercisable at a price of $0.001 per share of Common Stock. The holders of the Series B Warrants will not have the right to exercise any portion of the Series B Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% 9.3 During the three and nine months ended September 30, 2021, Warrants to purchase 3,679,630 3,679 The Series A Warrants are immediately exercisable at a price of $3.30 per share of Common Stock. The holders of the Series A Warrants will not have the right to exercise any portion of the Series A Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% The Company evaluated the terms of the warrants issued and determined that they should be classified as equity instruments. The grant date fair value of these warrants was estimated to be $1.98 per share, for a total of approximately $9.2 million. The fair value of these warrants was estimated using a Black-Scholes model utilizing the following key valuation assumptions: the Company’s stock price, a risk free rate of 0.49%, an expected life of 3.6 years and an expected volatility of 138.76%. No Series A Warrants were exercised during the three and nine months ended September 30, 2021. In addition, the Company has outstanding warrants to purchase an aggregate of 333,424 378,453 36.14 2,547 4,032 0.2 No 12,000 41,000 0.1 |
Share-Based Expense
Share-Based Expense | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Expense | 9. Share-Based Expense Total share-based expense related to stock options, restricted stock units (“RSUs”) and common stock awards was approximately $ 0.1 0.3 0.4 Share-based compensation expense is classified in the condensed consolidated statements of operations as follows: Schedule of Share-Based Compensation Expense Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development expenses $ 19,236 $ 13,078 $ 48,972 $ 39,372 General and administrative expenses 91,895 97,721 248,365 348,759 $ 111,131 $ 110,799 $ 297,337 $ 388,131 Employee Stock Options During the nine months ended September 30, 2021, the Company granted 200,000 2.34 the Company’s stock price, a risk free rate of 1.08 5.88 134.47 0.1 0.3 0.4 Non-Employee Stock Options The Company did not grant any non-employee stock options during the three and nine months ended September 30, 2021 and 2020. The Company did not recognize any expense related to non-employee stock options during the three and nine months ended September 30, 2021. The Company recognized approximately $ 4,000 11,000 Common Stock Awards The Company did not grant any common stock awards during the three and nine months ended September 30, 2021 and September 30, 2020, respectively. During the three and nine months ended September 30, 2021, the Company issued 7,153 1,188 253 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes During the three and nine months ended September 30, 2021, there was no 30.5 29.6 As of September 30, 2021 and December 31, 2020, the Company did no |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 11. Commitments Supplemental cash flow information and non-cash activity related to our operating leases are as follows: Cash flow information regarding leases Nine Months Ended September 30, 2021 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 26,199 Supplemental balance sheet information related to our operating leases are as follows: Supplemental information related to operating leases Balance Sheet Classification September 30, 2021 Right-of-use assets - ST Prepaid expenses and other $ 36,326 Right-of-use assets - LT Other assets $ – Current lease liabilities Accrued expenses and other current liabilities $ 36,326 Non-current lease liabilities Other long-term liabilities $ – |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 12. Related Party Transactions The Company has entered into various research, development, license and supply agreements with Serum Institute and Pharmsynthez (as well as SynBio), 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, 2020, filed with the SEC on March 16, 2021, as amended on April 28, 2021, except as otherwise set forth below. 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 12,000 35,000 13,000 38,000 Effective January 23, 2021, the Company entered into a First Amendment to Loan Agreement and Other Loan Documents with Pharmsynthez, Kevelt and SynBio (the “Pharmsynthez Loan Extension”) to modify the repayment terms and maturity of the Pharmsynthez Loan to January 2022. The terms of the Pharmsynthez Loan Extension called for two (2) equal monthly principal payments of $ 25,000 Subsequent to the third quarter of 2021, the Company entered into a Second Amendment to Loan Agreement and Other Loan Documents, effective August 31, 2021, with Pharmsynthez, Kevelt and SynBio (the “Second Pharmsynthez Loan Extension”) to modify the repayment terms and maturity of the Pharmsynthez Loan to July 2022. The terms of the Second Pharmsynthez Loan Extension call for an upfront fee of $ 12,500 25,000 0.4 0.5 0.1 During the third quarter of 2019, the Company entered into a Sponsored Research Agreement with Pharmsynthez (the “SRA”) related to experiments identified by the Company to support its efforts for initial tech transfer of the XCART methods to a future academic collaborator. Under the agreement, the Company made a $ 350,000 0.1 0.2 No 40,000 25,000 Under the MSA, Pharmsynthez agreed to provide services pursuant to work orders agreed upon by the parties from time to time, which services include, but are not limited to, acting as the Company’s primary contract research organization to assist in managing collaborations with multiple academic institutions in Russia and Belarus. The Company is required to pay reasonable fees, expenses and pass-through costs incurred by Pharmsynthez in providing the services in accordance with a budget and payment terms set forth in each work order. Additionally, in the event that a work order provides for milestone payments, the Company is required to make such payments to Pharmsynthez, or third party service providers designated by Pharmsynthez, in accordance with the terms set forth in the work order, which milestone payments may be made, at the sole discretion of the Company, in cash or shares of the Company’s common stock. The Company and Pharmsynthez executed a work order on June 12, 2020 (the “Work Order”) under the MSA pursuant to which Pharmsynthez agreed to conduct a Stage 1 study of the Company’s XCART technology under the research program as set forth in the Work Order. The activities to be performed under the Work Order were expected to take approximately 20 months unless earlier terminated in accordance with the MSA. Under the terms of the Work Order, the Company paid Pharmsynthez $51,000 as an initial payment for trial startup costs, which amount was credited against the amounts paid under the SRA. The Work Order provided for additional pass-through costs to be invoiced by Pharmsynthez upon execution of contracts with third party sites, which were to be further credited against the SRA. Through September 30, 2021, all costs incurred under the MSA were credited against the amounts paid under the SRA. Additionally, the Work Order provided for milestone payments of up to an aggregate of $1,050,000, or, in the Company’s sole discretion, up to an aggregate of 1,000,000 shares of the Company’s common stock, to be paid or issued, as applicable, by the Company upon achievement of milestones associated with completion of early stages of the research program as set forth in the Work Order. As of September 30, 2021, approximately $0.1 million of milestone payments had been paid. On October 12, 2021, the Company entered into an Amendment Number One to the Master Services Agreement (the “MSA Amendment”) with Pharmsynthez to, among other things, terminate all work orders under the MSA. As a result, no further services were to be performed under the Work Order and any additional services will be covered by new work orders. In exchange, the Company entered into a new work order (the “Second Work Order”) simultaneously with the MSA Amendment. Under the terms of the Second Work Order, Pharmsynthez shall provide certain enumerated services to support the Company’s development of its XCART technology upon the written request of the Company, which work may be requested by the Company from time to time. Pursuant to the MSA Amendment and Second Work Order, upon entry into the Second Work Order, the Company made a one-time $40,000 payment to Pharmsynthez, of which $21,000 was a one-time payment in full for all money and other compensation owed by the Company under the Work Order, and the remaining $19,000 will be creditable against any out of pocket costs and expenses incurred by Pharmsynthez on behalf of the Company pursuant to any new work orders initiated after the effective date of the MSA Amendment, including the Second Work Order. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. 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 other than described in Note 12, there were no other such events requiring recognition or disclosure in the financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020 filed with the SEC on March 16, 2021 and amended on April 28, 2021. |
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. |
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 nine months ended September 30, 2021 and 2020, 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 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Schedule of Property and Equipment, Net September 30, December 31, Office and computer equipment $ 42,289 $ 42,289 Furniture and fixtures 14,738 14,738 Property and equipment – at cost 57,027 57,027 Less accumulated depreciation (57,027 ) (57,027 ) Property and equipment – net $ – $ – |
Indefinite-Lived Intangible A_2
Indefinite-Lived Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Indefinite- Lived Intangible Asset | Schedule of Indefinite- Lived Intangible Asset Balance as of January 1, 2020 $ 9,243,128 Impairment (9,243,128 ) Balance as of September 30, 2020 $ – |
Share-Based Expense (Tables)
Share-Based Expense (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Share-Based Compensation Expense | Schedule of Share-Based Compensation Expense Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development expenses $ 19,236 $ 13,078 $ 48,972 $ 39,372 General and administrative expenses 91,895 97,721 248,365 348,759 $ 111,131 $ 110,799 $ 297,337 $ 388,131 |
Commitments (Tables)
Commitments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Cash flow information regarding leases | Cash flow information regarding leases Nine Months Ended September 30, 2021 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 26,199 |
Supplemental information related to operating leases | Supplemental information related to operating leases Balance Sheet Classification September 30, 2021 Right-of-use assets - ST Prepaid expenses and other $ 36,326 Right-of-use assets - LT Other assets $ – Current lease liabilities Accrued expenses and other current liabilities $ 36,326 Non-current lease liabilities Other long-term liabilities $ – |
The Company (Details Narrative)
The Company (Details Narrative) - USD ($) | 9 Months Ended | 11 Months Ended |
Sep. 30, 2021 | Dec. 04, 2020 | |
Offsetting Assets [Line Items] | ||
Proceed from private placement | $ 11,500,000 | |
Direct Offering [Member] | ||
Offsetting Assets [Line Items] | ||
Proceeds from stock offering | $ 5,400,000 | |
Private Placement [Member] | ||
Offsetting Assets [Line Items] | ||
Proceed from private placement | $ 11,500,000 |
Significant Strategic Collabo_2
Significant Strategic Collaborations (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenue | $ 349,269 | $ 115,934 | $ 828,088 | $ 285,610 | |
Research and development expenses | 780,153 | 573,061 | 1,934,432 | 1,240,612 | |
Prepaid expenses and other current asset | 878,243 | 878,243 | $ 841,958 | ||
Takeda [Member] | Royalty Revenue [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenue | 300,000 | 100,000 | 800,000 | $ 300,000 | |
Serum Institute [Member] | Royalty Revenue [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenue | 0 | 0 | |||
Syn Bio [Member] | Royalty Revenue [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenue | 0 | 0 | |||
Pharmsynthez [Member] | Royalty Revenue [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenue | 0 | $ 0 | |||
Scripps Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Research and development expenses | 1,800,000 | ||||
Prepaid expenses and other current asset | $ 200,000 | $ 200,000 | $ 200,000 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment - at cost | $ 57,027 | $ 57,027 |
Less accumulated depreciation | (57,027) | (57,027) |
Property and equipment, net | 0 | 0 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - at cost | 42,289 | 42,289 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - at cost | $ 14,738 | $ 14,738 |
Property and Equipment, net (_2
Property and Equipment, net (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 0 | $ 0 | $ 0 | $ 800 |
Indefinite-Lived Intangible A_3
Indefinite-Lived Intangible Assets (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill, beginning balance | $ 0 | $ 9,243,128 |
Goodwill impairment | (9,243,128) | |
Goodwill, ending balance | $ 0 |
Indefinite-Lived Intangible A_4
Indefinite-Lived Intangible Assets (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Indefinite-lived Intangible Assets [Line Items] | ||||
Asset Impairment Charges | $ 0 | $ 9,243,128 | $ 0 | $ 9,243,128 |
OncoHist [Member] | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Asset Impairment Charges | $ 9,200,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - USD ($) | Sep. 30, 2021 | Sep. 30, 2020 |
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) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from private placement | $ 11,500,000 | ||||
Proceeds from warrants exercised | $ 3,679 | $ 0 | |||
Colllaboration Warrants [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants outstanding | 0 | 0 | 30,307 | ||
Warrants granted | 0 | 0 | 0 | 0 | |
Warrants expired | 30,307 | 0 | 30,307 | 0 | |
Series B Warrants [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Intrinsic value of warrants | $ 9,300,000 | ||||
Warrants exercised | 3,679,630 | ||||
Proceeds from warrants exercised | $ 3,679 | ||||
Debt And Equity Financing Warrants [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants outstanding | 333,424 | 333,424 | 378,453 | ||
Warrants expired | 12,000 | 100,000 | 41,000 | 100,000 | |
Warrants exercised | 2,547 | 0 | 4,032 | 200,000 | |
Warrants weighted average exercise price | $ 36.14 | $ 36.14 | $ 36.14 |
Share-Based Expense (Details -
Share-Based Expense (Details - Share based expense) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | $ 111,131 | $ 110,799 | $ 297,337 | $ 388,131 |
Research and Development Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | 19,236 | 13,078 | 48,972 | 39,372 |
General and Administrative Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation | $ 91,895 | $ 97,721 | $ 248,365 | $ 348,759 |
Share-Based Expense (Details Na
Share-Based Expense (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 111,131 | $ 110,799 | $ 297,337 | $ 388,131 |
All Awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 100,000 | 100,000 | 300,000 | 400,000 |
Employee Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 100,000 | 100,000 | $ 300,000 | 400,000 |
Options granted | 200,000 | |||
Weighted average grant date fair value | $ 2.34 | |||
Risk free rate | 1.08% | |||
Expected term | 5 years 10 months 17 days | |||
Volatility rate | 134.47% | |||
Non Employee Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 4,000 | $ 11,000 | ||
Common Stock Awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Other than options granted | 7,153 | 1,188 | 7,153 | 1,188 |
Common stock awards authorized, not issued | 253 | 253 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 0 | $ (2,918,518) | $ 0 | $ (2,918,518) | |
Deferred tax valuation allowance | 30,500,000 | 30,500,000 | $ 29,600,000 | ||
Unrecognized tax positions | $ 0 | $ 0 | $ 0 |
Commitments (Details - Cash flo
Commitments (Details - Cash flow Information) | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Operating cash flow information: | |
Cash paid for amounts included in the measurement of lease liabilities | $ 26,199 |
Commitments (Details - lease in
Commitments (Details - lease information) | Sep. 30, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Right-of-use assets - ST | $ 36,326 |
Right-of-use assets - LT | 0 |
Current lease liabilities | 36,326 |
Non-current lease liabilities | $ 0 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 13 Months Ended | ||||
Oct. 31, 2021 | Feb. 28, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2019 | Jan. 23, 2021 | Dec. 31, 2020 | |
Related Party Transaction [Line Items] | |||||||||
Prepaid expenses and other current asset | $ 878,243 | $ 878,243 | $ 841,958 | ||||||
Research and development expense | 780,153 | $ 573,061 | 1,934,432 | $ 1,240,612 | |||||
Research expense accrued | $ 873,010 | 873,010 | 609,532 | ||||||
Pharmsynthez [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Monthly principal payments | $ 25,000 | $ 25,000 | |||||||
Loan extension fees | $ 12,500 | ||||||||
Pharmsynthez [Member] | Subsequent Event [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Monthly principal payments | $ 25,000 | ||||||||
Pharmsynthez [Member] | Co Development Agreement [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Payment for note receivable | $ 500,000 | ||||||||
Note receivable interest rate | 10.00% | 10.00% | |||||||
Interest income | $ 12,000 | 13,000 | $ 35,000 | 38,000 | |||||
Pharmsynthez [Member] | Sponsored Research Agreement [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Prepaid expenses and other current asset | 100,000 | ||||||||
Payment for research agreement | $ 350,000 | ||||||||
Research and development expense | 0 | $ 0 | 100,000 | $ 200,000 | |||||
Advanced payment | 25,000 | ||||||||
Pharmsynthez [Member] | Sponsored Research Agreement [Member] | Prepaid Expenses And Other [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Prepaid expenses and other current asset | 400,000 | 400,000 | $ 500,000 | ||||||
Research expense accrued | $ 40,000 | $ 40,000 |