Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 09, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | XBIO | |
Entity Registrant Name | Xenetic Biosciences, Inc. | |
Entity Central Index Key | 0001534525 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 6,296,227 | |
Current Reporting Status | Yes | |
Entity Small Business | true | |
Entity Emerging Growth | false | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Incorporation State Country Code | NV | |
Entity File Number | 001-37937 | |
Security 12g Title | Common Stock, $0.001 par value per share |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 7,054,387 | $ 10,367,920 |
Prepaid expenses and other | 937,596 | 722,079 |
Total current assets | 7,991,983 | 11,089,999 |
Property and equipment, net | 0 | 757 |
Indefinite-lived intangible assets | 0 | 9,243,128 |
Other assets | 704,431 | 1,213,042 |
Total assets | 8,696,414 | 21,546,926 |
Current liabilities: | ||
Accounts payable | 251,033 | 931,128 |
Accrued expenses and other current liabilities | 537,440 | 484,029 |
Total current liabilities | 788,473 | 1,415,157 |
Deferred tax liability | 0 | 2,918,518 |
Total liabilities | 788,473 | 4,333,675 |
Commitments (Note 11) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 12,500,000 shares authorized as of September 30, 2020 and December 31, 2019; 6,323,218 and 6,092,432 shares issued as of September 30, 2020 and December 31, 2019, respectively; 6,296,227 and 6,065,441 shares outstanding as of September 30, 2020 and December 31, 2019, respectively | 6,322 | 6,092 |
Additional paid in capital | 188,628,352 | 188,240,451 |
Accumulated deficit | (175,702,061) | (166,008,620) |
Accumulated other comprehensive income | 253,734 | 253,734 |
Treasury stock | (5,281,180) | (5,281,180) |
Total stockholders' equity | 7,907,941 | 17,213,251 |
Total liabilities and stockholders' equity | 8,696,414 | 21,546,926 |
Preferred Class A [Member] | ||
Stockholders' equity: | ||
Preferred stock, 10,000,000 shares authorized | 970 | 970 |
Preferred Class B [Member] | ||
Stockholders' equity: | ||
Preferred stock, 10,000,000 shares authorized | $ 1,804 | $ 1,804 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Common stock, par value | $ 0.001 | $ .001 |
Common stock, shares authorized | 12,500,000 | 12,500,000 |
Common stock, shares issued | 6,323,218 | 6,092,432 |
Common stock, shares outstanding | 6,296,227 | 6,065,441 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
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 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue | ||||
Total revenues | $ 115,934 | $ 0 | $ 285,610 | $ 0 |
Operating costs and expenses: | ||||
Research and development | (573,061) | (3,520,638) | (1,240,612) | (4,471,939) |
General and administrative | (804,149) | (2,142,505) | (2,519,515) | (3,896,657) |
Asset impairment charges | (9,243,128) | (3,283,379) | (9,243,128) | (3,283,379) |
Total operating costs and expenses | (10,620,338) | (8,946,522) | (13,003,255) | (11,651,975) |
Loss from operations | (10,504,404) | (8,946,522) | (12,717,645) | (11,651,975) |
Other income (expense): | ||||
Other income (expense) | 585 | (223) | 643 | 267 |
Interest income, net | 24,931 | 46,617 | 105,043 | 46,930 |
Total other income | 25,516 | 46,394 | 105,686 | 47,197 |
Loss before income taxes | (10,478,888) | (8,900,128) | (12,611,959) | (11,604,778) |
Income tax benefit | 2,918,518 | 0 | 2,918,518 | 0 |
Net loss | (7,560,370) | (8,900,128) | (9,693,441) | (11,604,778) |
Deemed dividend | 0 | (1,404,932) | 0 | (5,284,379) |
Net loss applicable to common stockholders | $ (7,560,370) | $ (10,305,060) | $ (9,693,441) | $ (16,889,157) |
Basic and diluted loss per share | $ (1.20) | $ (2.67) | $ (1.55) | $ (9.07) |
Weighted-average shares of common stock outstanding, basic and diluted | 6,296,227 | 3,862,936 | 6,272,722 | 1,861,867 |
Royalty [Member] | ||||
Revenue | ||||
Total revenues | $ 115,934 | $ 0 | $ 285,610 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Treasury Stock | Total |
Beginning balance, shares at Dec. 31, 2018 | 2,774,394 | 810,856 | |||||
Beginning balance, value at Dec. 31, 2018 | $ 2,774 | $ 811 | $ 168,170,244 | $ (153,233,595) | $ 253,734 | $ (5,281,180) | $ 9,912,788 |
Issuance of common stock and warrants in registered direct offering, net of issuance costs, shares | 86,667 | ||||||
Issuance of common stock and warrants in registered direct offering, net of issuance costs, value | $ 87 | 2,698,963 | 2,699,050 | ||||
Issuance of common stock and warrants in July 2019 public offering, net of issuance costs, shares | 1,746,666 | ||||||
Issuance of common stock and warrants in July 2019 public offering, net of issuance costs, value | $ 1,747 | 13,420,203 | 13,421,950 | ||||
Issuance of common stock in connection with purchase of in-process research and development, shares | 624,995 | ||||||
Issuance of common stock in connection with purchase of in-process research and development, value | $ 625 | 3,030,601 | 3,031,226 | ||||
Exercise of pre-funded warrants, shares | 492,417 | ||||||
Exercise of pre-funded warrants, value | $ 492 | 4,517 | 5,009 | ||||
Exercise of purchase warrants, shares | 1,889,602 | ||||||
Exercise of purchase warrants, value | $ 1,890 | (1,890) | |||||
Issuance of common stock to vendor, shares | 7,836 | ||||||
Issuance of common stock to vendor, value | $ 7 | (7) | |||||
Issuance of warrants in connection with reverse stock split, shares | |||||||
Issuance of warrants in connection with reverse stock split, value | 63,536 | 63,536 | |||||
Issuance of common stock to adjust for reverse split rounding, shares | 1,442 | ||||||
Issuance of common stock to adjust for reverse split rounding, value | $ 1 | (1) | |||||
Deemed dividend related to Series B Preferred Stock down round provision | 5,284,379 | 5,284,379 | |||||
Accretion of deemed dividend related to Series B Preferred Stock down round provision | (5,284,379) | (5,284,379) | |||||
Share-based expense | 683,104 | 683,104 | |||||
Common stock awards to vendors | 47,427 | 47,427 | |||||
Net loss | (11,604,778) | (11,604,778) | |||||
Ending balance, shares at Sep. 30, 2019 | 2,774,394 | 5,660,481 | |||||
Ending balance, value at Sep. 30, 2019 | $ 2,774 | $ 5,660 | 188,116,697 | (164,838,373) | 253,734 | (5,281,180) | 18,259,312 |
Beginning balance, shares at Jun. 30, 2019 | 2,774,394 | 949,218 | |||||
Beginning balance, value at Jun. 30, 2019 | $ 2,774 | $ 948 | 171,352,760 | (155,938,245) | 253,734 | (5,281,180) | 10,390,791 |
Issuance of common stock and warrants in July 2019 public offering, net of issuance costs, shares | 1,746,666 | ||||||
Issuance of common stock and warrants in July 2019 public offering, net of issuance costs, value | $ 1,747 | 13,420,203 | 13,421,950 | ||||
Issuance of common stock in connection with purchase of in-process research and development, shares | 624,995 | ||||||
Issuance of common stock in connection with purchase of in-process research and development, value | $ 625 | 3,030,601 | 3,031,226 | ||||
Exercise of pre-funded warrants, shares | 450,000 | ||||||
Exercise of pre-funded warrants, value | $ 450 | 4,050 | 4,500 | ||||
Exercise of purchase warrants, shares | 1,889,602 | ||||||
Exercise of purchase warrants, value | $ 1,890 | (1,890) | |||||
Issuance of warrants in connection with reverse stock split, shares | |||||||
Issuance of warrants in connection with reverse stock split, value | 63,536 | 63,536 | |||||
Deemed dividend related to Series B Preferred Stock down round provision | 1,404,932 | 1,404,932 | |||||
Accretion of deemed dividend related to Series B Preferred Stock down round provision | (1,404,932) | (1,404,932) | |||||
Share-based expense | 232,437 | 232,437 | |||||
Common stock awards to vendors | 15,000 | 15,000 | |||||
Net loss | (8,900,128) | (8,900,128) | |||||
Ending balance, shares at Sep. 30, 2019 | 2,774,394 | 5,660,481 | |||||
Ending balance, value at Sep. 30, 2019 | $ 2,774 | $ 5,660 | 188,116,697 | (164,838,373) | 253,734 | (5,281,180) | 18,259,312 |
Beginning balance, shares at Dec. 31, 2019 | 2,774,394 | 6,092,432 | |||||
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 |
Exercise of purchase warrants, shares | 229,598 | ||||||
Exercise of purchase warrants, value | $ 229 | (229) | |||||
Issuance of common stock to vendor, shares | 1,188 | ||||||
Issuance of common stock to vendor, value | $ 1 | (1) | |||||
Share-based expense | 388,131 | 388,131 | |||||
Net loss | (9,693,441) | (9,693,441) | |||||
Ending balance, shares at Sep. 30, 2020 | 2,774,394 | 6,323,218 | |||||
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 |
Beginning balance, shares at Jun. 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 |
Share-based expense | 110,799 | 110,799 | |||||
Net loss | (7,560,370) | (7,560,370) | |||||
Ending balance, shares at Sep. 30, 2020 | 2,774,394 | 6,323,218 | |||||
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 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (9,693,441) | $ (11,604,778) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development | 0 | 3,031,226 |
Asset impairment charges | 9,243,128 | 3,283,379 |
Deferred income taxes | (2,918,518) | 0 |
Depreciation | 757 | 3,366 |
Amortization of right of use asset | 20,042 | 16,629 |
Gain on sale of property and equipment | 0 | (2,000) |
Gain on settlement with vendor | (143,639) | 0 |
Share-based expense | 388,131 | 683,104 |
Issuance of warrants in connection with reverse stock split | 0 | 63,536 |
Vendor share-based payments | 0 | 47,427 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 273,052 | (297,712) |
Accounts payable, accrued expenses and other liabilities | (483,045) | 54,171 |
Net cash used in operating activities | (3,313,533) | (4,721,652) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Proceeds from sale of property and equipment | 0 | 2,000 |
Net cash provided by investing activities | 0 | 2,000 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net proceeds from issuance of common stock and warrants in July 2019 public offering | 0 | 13,421,950 |
Net proceeds from issuance of common stock and warrants in March 2019 registered direct offering | 0 | 2,699,050 |
Proceeds from exercise of warrants | 0 | 5,009 |
Net cash provided by financing activities | 0 | 16,126,009 |
Net change in cash | (3,313,533) | 11,406,357 |
Cash at beginning of period | 10,367,920 | 638,115 |
Cash at end of period | 7,054,387 | 12,044,472 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | 0 | 8 |
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Right of use assets obtained in exchange for lease liability | 0 | 43,330 |
Issuance of common stock to vendor | 1 | 7 |
Issuance of common stock to acquire in-process research and development | 0 | 3,031,226 |
Issuance of common stock to adjust for Reverse Stock Split | 0 | 1 |
Issuance of common stock from cashless exercise of purchase warrants | $ 229 | $ 1,890 |
1. The Company
1. The Company | 9 Months Ended |
Sep. 30, 2020 | |
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 had an accumulated deficit of approximately $175.7 million at September 30, 2020 as compared to an accumulated deficit of approximately $166.0 million at December 31, 2019. Working capital was approximately $7.2 million and $9.7 million at September 30, 2020 and December 31, 2019, respectively. During the nine months ended September 30, 2020, our working capital decreased by $2.5 million primarily due to our net loss for the nine months ended September 30, 2020. The Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital or pursue other strategic alternatives in the near term in order to continue the pursuit of its business plan and 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. During 2019, the Company completed two stock offerings that resulted in $16.1 million of net proceeds to the Company. The Company believes that its existing resources will be adequate to fund the Company’s operations through mid-2021. However, the Company anticipates it may need additional capital in the near 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 clinical development programs, its ability to identify and enter into licensing or other strategic arrangements, and factors related to financial, economic and market conditions, many of which are beyond its control. While these condensed consolidated financial statements have been prepared on a going concern basis, if the Company does not successfully raise additional working capital, there can be no assurance that the Company will be able to continue its operations and these conditions raise substantial doubt about its ability to continue as a going concern. Under such circumstances, the Company would have to further reduce the planned scale of, or possibly suspend, some or all of its pre-clinical development initiatives and clinical trials. In addition, the Company would have to continue to reduce its general and administrative and other operating expenses and delay or cease the purchase of clinical research services if and until the Company is able to obtain additional financing. The accompanying condensed consolidated financial statements do not include any adjustments related to the recoverability or classification of asset carrying amounts or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern. |
2. Impact of COVID-19
2. Impact of COVID-19 | 9 Months Ended |
Sep. 30, 2020 | |
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 and continuing into November, 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. |
3. Summary of Significant Accou
3. Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
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, 2019 filed with the SEC on March 26, 2020 and amended on April 29, 2020. On June 25, 2019, the Company effected a reduction, on a 1 for 12 basis, in its authorized common stock, par value $0.001, along with a corresponding and proportional decrease in the number of shares issued and outstanding (the “Reverse Stock Split”). On the effective date of the Reverse Stock Split, (i) every 12 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 for 12 basis; and (iv) the number of shares of common stock into which each share of preferred stock could be converted 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, on a retroactive basis, to reflect this Reverse Stock Split. Certain prior period amounts have been reclassified to conform to the presentation for the current period. 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, 2020 and 2019, 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 November 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-18, Clarifying the Interaction between Topic 808 and Topic 606 In August 2018, the FASB issued ASU 2018-13, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement |
4. Significant Strategic Collab
4. Significant Strategic Collaborations | 9 Months Ended |
Sep. 30, 2020 | |
Significant Strategic Collaborations | |
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, 2020. 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 $116,000 and $286,000 were recorded as revenue by the Company during the three and nine months ended September 30, 2020, respectively. The Company’s policy is to recognize royalty payments as revenue when they are reliably measurable, which is upon receipt of reports from Takeda. The Company receives these reports in the quarter subsequent to the actual sublicensee sales. There were no remaining performance obligations and all other revenue recognition criteria were met. There were no amounts recognized under this sublicense agreement during the three and nine months ended September 30, 2019. No amounts were recognized as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and nine months ended September 30, 2020 and 2019, respectively. On May 15, 2020, the Company and The Scripps Research Institute (“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. |
5. Property and Equipment, net
5. Property and Equipment, net | 9 Months Ended |
Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment, net consists of the following: 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 ) (56,270 ) Property and equipment – net $ – $ 757 There was no depreciation expense for the three months ended September 30, 2020. Depreciation expense was approximately $1,000 for the three months ended September 30, 2019 and approximately $800 and $3,000 for the nine months ended September 30, 2020 and 2019, respectively. |
6. Goodwill and Indefinite-Live
6. Goodwill and Indefinite-Lived Intangible Assets | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Indefinite-Lived Intangible Assets | 6. Goodwill and Indefinite-Lived Intangible Assets Goodwill Goodwill is comprised of the purchase price of business combinations in excess of the fair value assigned at acquisition to the net tangible and identifiable intangible assets acquired and is not amortized. The Company assessed goodwill for impairment at least annually, or when events or changes in the business environment indicated that the carrying value may not be fully recoverable. The Company performed its annual impairment review during the fourth quarter at the reporting unit level. Goodwill may be considered impaired if the carrying value of the reporting unit, including goodwill, exceeds the reporting unit’s fair value. The Company is comprised of one reporting unit. The Company experienced a significant decline in its stock price during the three months ended September 30, 2019 resulting in a drop in its market capitalization indicating potential impairment. As a result, the Company performed an interim impairment test during the three months ended September 30, 2019 to determine the fair value of the reporting unit using its market capitalization, concluding that the fair value of the reporting unit is less than the carrying amount in excess of Goodwill, therefore fully impairing Goodwill. For the three and nine months ended September 30, 2019, the Company recorded an asset impairment charge of $3.3 million in our condensed consolidated statement of operations related to Goodwill. A reconciliation of the change in the carrying value of Goodwill is as follows: Balance as of January 1, 2019 $ 3,283,379 Impairment (3,283,379 ) Balance as of September 30, 2019 $ – 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 as of September 30, 2020 and concluded that the following factors indicate 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. For the three and nine months ended September 30, 2020, the Company recorded an asset impairment charge of $9.2 million in our condensed consolidated statement of operations, which represents the excess of the IPR&D asset’s carrying value over its estimated fair value. No indefinite-lived intangible asset impairment was recorded during the year ended December 31, 2019. A reconciliation of the change in the carrying value of Indefinite-Lived Intangible Assets is as follows: Balance as of January 1, 2019 $ 9,243,128 No changes – Balance as of December 31, 2019 9,243,128 Impairment (9,243,128 ) Balance as of September 30, 2020 $ – |
7. Fair Value Measurements
7. Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. Fair Value Measurements Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement, |
8. Stockholders' Equity
8. Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity 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, 2020 and December 31, 2019, collaboration warrants to purchase 30,307 and 32,412 shares of common stock were outstanding, respectively. During the nine months ended September 30, 2020, collaboration warrants to purchase 2,105 shares expired. No collaboration warrants expired during the three months ended September 30, 2020. The outstanding warrants as of September 30, 2020 have an average weighted exercise price of $124.74 and expiration dates ranging from April 2021 through May 2021. No collaboration warrants were granted or exercised in connection with collaboration or consulting services during the three and nine months ended September 30, 2020 and 2019, respectively. In addition, the Company has outstanding warrants to purchase an aggregate of 378,453 and 658,557 shares of common stock in connection with debt and equity financing arrangements as of September 30, 2020 and December 31, 2019, respectively. These warrants have an average weighted exercise price of $38.41 as of September 30, 2020 and expiration dates ranging from March 2021 through September 2026. There were prefunded warrants to purchase approximately 0.5 million and 0.6 million shares of Common Stock issued during the three and nine months ended September 30, 2019, respectively, of which approximately 0.5 million were exercised during the three and nine months ended September 30, 2019 with the remaining 0.1 million of prefunded warrants having been exercised during the fourth quarter of 2019. As of December 31, 2019, there were no pre-funded warrants outstanding. During the three and nine months ended September 30, 2019 debt and equity warrants to purchase approximately 2.5 million and 2.6 million shares of common stock were granted and 1.9 million debt and equity warrants were exercised during the three and nine months ended September 30, 2019. During the nine months ended September 30, 2020, debt and equity financing warrants to purchase approximately 0.2 million shares of common stock were exercised on a cashless one-for-one basis. In addition, approximately 0.1 million of debt and equity warrants expired during the nine months ended September 30, 2020. No debt and equity warrants expired during the nine months ended September 30, 2019. |
9. Share-Based Expense
9. Share-Based Expense | 9 Months Ended |
Sep. 30, 2020 | |
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 were approximately $0.1 million and $0.2 million during the three months ended September 30, 2020 and 2019, respectively, and approximately $0.4 million and $0.7 million for the nine months ended September 30, 2020 and 2019, respectively. Share-based compensation expense is classified in the condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expenses $ 13,078 $ 38,843 $ 39,372 $ 81,921 General and administrative expenses 97,721 208,594 348,759 648,610 $ 110,799 $ 247,437 $ 388,131 $ 730,531 Employee Stock Options There were no employee stock options or RSUs granted or exercised during the nine months ended September 30, 2020. During the three and nine months ended September 30, 2019, the Company granted 50,000 stock option awards. The weighted average grant date fair value per option share was $1.18. Key assumptions used in the Black-Scholes option pricing model for options granted during the three and nine months ending September 30, 2019 were the Company’s stock price, a risk free rate of 1.60%, an expected life of 5.5 years and an expected volatility of 119.11%. Non-Employee Stock Options The Company did not grant any non-employee stock options during the nine months ended September 30, 2020 and 2019. There were no non-employee stock options exercised during the nine months ended September 30, 2020 and 2019. The Company recognized approximately $4,000 and $11,000 of expense during the three and nine months ended September 30, 2020, respectively. The Company did not recognize any expense related to non-employee stock options during the three and nine months ended September 30, 2019, respectively. Common Stock Awards During the three and nine months ended September 30, 2019, the Company granted 7,153 and 9,026 common stock awards, respectively, based on the value of the professional services provided and the average stock price during the respective periods. As all services were rendered during the three and nine months ended September 30, 2019, approximately $15,000 and $47,000 of expense related to common stock awards was recognized, respectively. There were no common stock awards granted during the three and nine months ended September 30, 2020. During the nine months ended September 30, 2020, the Company issued 1,188 shares related to these awards. As of September 30, 2020, there were 7,406 common stock awards authorized but not issued. |
10. Income Taxes
10. Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company records a valuation allowance against its deferred tax assets as the Company believes it is more likely than not the deferred tax assets will not be realized. The valuation allowance against deferred tax assets was approximately $26.5 million and $25.9 million as of September 30, 2020 and December 31, 2019, respectively. As of December 31, 2019, the net deferred tax liability of $2.9 million on the condensed consolidated balance sheets is related to book and tax basis differences for intangible assets with indefinite lives. In accordance with ASC 740-10-30-18, the deferred tax liability related to the intangible assets cannot be used to offset deferred tax assets when determining the amount of the valuation allowance for deferred tax assets which are not more-likely-than-not to be realized. This results in a net deferred tax liability, even though the Company has a full valuation allowance on its other net deferred tax assets. During the three and nine months ended September 30, 2020, the related intangible assets were impaired and the net deferred tax liability was eliminated. As a result, the Company recorded an income tax benefit of $2.9 million during the three and nine months ended September 30, 2020. There was no provision for income taxes for the three and nine months ended September 30, 2019 as the Company incurred losses during both periods. As of September 30, 2020 and December 31, 2019, the Company did not record any unrecognized tax positions. |
11. Commitments
11. Commitments | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | 11. Commitments The Company determines whether an arrangement is a lease at inception. On October 1, 2020, the Company entered into a two-year lease for its corporate headquarters in Framingham, Massachusetts. This lease calls for total future minimum rent payments of approximately $78,000 and has a termination date of September 30, 2022. The Company does not have options to extend, termination options or material residual value guarantees. As the lease agreement was not executed until October 1, 2020, the Company will record a right-of-use (“ROU”) asset and corresponding lease liability of approximately $71,000 in the fourth quarter of 2020. As the lease does not provide an implicit rate, we used our incremental borrowing rate (10.2%) based on the information available at the lease’s commencement date in determining the present value of lease payments. Supplemental cash flow information and non-cash activity related to our operating leases are as follows: Nine Months Ended September 30, 2020 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 20,042 As the Company’s existing operating lease expired on September 30, 2020, there was no ROU or lease liability reflected on the September 30, 2020 balance sheet. |
12. Related Party Transactions
12. Related Party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
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, a wholly owned subsidiary of 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, 2019 filed with the SEC on March 26, 2020, as amended on April 29, 2020. On July 19, 2019, the Company acquired the XCART technology platform from Hesperix and Opko Pharmaceuticals LLC (“OPKO”). Dr. Dmitry Genkin, one of our directors and Chairman of Pharmsynthez, was a director and significant shareholder of Hesperix. In addition, the Company agreed to repay an approximate $225,000 loan that Dr. Genkin entered into with Hesperix. Mr. Adam Logal, one of our directors, is Senior Vice President, Chief Financial Officer, Chief Accounting Officer and Treasurer of OPKO Health, Inc., the parent company of OPKO. 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 payment to Pharmsynthez during the third quarter of 2019, which is refundable on pro rata basis if the project is terminated prematurely as a result of Pharmsynthez failing to perform the work. The Company expensed approximately $0.2 million related to this agreement during the nine months ended September 30, 2020. The Company did not record any expense during the three months ended September 30, 2020 as the Company and Pharmsynthez entered into a Master Services Agreement (“MSA”) on June 12, 2020 that terminated and superseded the SRA. As of September 30, 2020 and December 31, 2019, approximately $0.1 million and $0.2 million, respectively, was recorded as an advanced payment and included in Prepaid expenses and other on the condensed consolidated balance sheets. In October 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 to be used for the development of a specific product under the August 2011 Stock Subscription and Collaborative Development of Pharmaceutical Products Agreement between the Company and SynBio. The Pharmsynthez Loan has a term of 15-months and accrues interest at a rate of 10% per annum. The Pharmsynthez Loan is guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt, and is secured by all of the equity interests of the Company owned by Pharmsynthez and SynBio. The Company recognized approximately $13,000 and $38,000 of interest income related to this loan during the three and nine months ended September 30, 2020, respectively. As of September 30, 2020, the Pharmsynthez Loan was included in Prepaid expenses and other on the condensed consolidated balance sheets. As of December 31, 2019, the Pharmsynthez Loan was included in Other assets on the condensed consolidated balance sheets. On June 12, 2020, the Company and Pharmsynthez entered into the MSA to advance the development of the Company’s XCART technology for B-cell malignancies. 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 MSA terminated and superseded the SRA between the Company and Pharmsynthez. 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 are currently 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 provides for additional pass-through costs to be invoiced by Pharmsynthez upon execution of contracts with third party sites, which will be further credited against the SRA. The total cost under the Work Order is currently estimated to be approximately $1.8 million. Additionally, the Work Order provides 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. For the three and nine months ended September 30, 2020, the Company expensed $34,000 under the Work Order. |
13. Subsequent Events
13. Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
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 11, there were no such events requiring recognition or disclosure in the financial statements. |
3. Summary of Significant Acc_2
3. Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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, 2019 filed with the SEC on March 26, 2020 and amended on April 29, 2020. On June 25, 2019, the Company effected a reduction, on a 1 for 12 basis, in its authorized common stock, par value $0.001, along with a corresponding and proportional decrease in the number of shares issued and outstanding (the “Reverse Stock Split”). On the effective date of the Reverse Stock Split, (i) every 12 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 for 12 basis; and (iv) the number of shares of common stock into which each share of preferred stock could be converted 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, on a retroactive basis, to reflect this Reverse Stock Split. Certain prior period amounts have been reclassified to conform to the presentation for the current period. |
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, 2020 and 2019, 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 November 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-18, Clarifying the Interaction between Topic 808 and Topic 606 In August 2018, the FASB issued ASU 2018-13, Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement |
5. Property and Equipment, net
5. Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following: 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 ) (56,270 ) Property and equipment – net $ – $ 757 |
6. Goodwill and Indefinite-Li_2
6. Goodwill and Indefinite-Lived Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Reconciliation of change in carrying value of Goodwill | A reconciliation of the change in the carrying value of Goodwill is as follows: Balance as of January 1, 2019 $ 3,283,379 Impairment (3,283,379 ) Balance as of September 30, 2019 $ – |
Reconciliation of change in carrying value of Indefinite-Lived Intangible Assets | A reconciliation of the change in the carrying value of Indefinite-Lived Intangible Assets is as follows: Balance as of January 1, 2019 $ 9,243,128 No changes – Balance as of December 31, 2019 9,243,128 Impairment (9,243,128 ) Balance as of September 30, 2020 $ – |
9. Share-Based Expense (Tables)
9. Share-Based Expense (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Share-Based Compensation Expense | Share-based compensation expense is classified in the condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expenses $ 13,078 $ 38,843 $ 39,372 $ 81,921 General and administrative expenses 97,721 208,594 348,759 648,610 $ 110,799 $ 247,437 $ 388,131 $ 730,531 |
11. Commitments (Tables)
11. Commitments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Cash flow information regarding leases | Supplemental cash flow information and non-cash activity related to our operating leases are as follows: Nine Months Ended September 30, 2020 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 20,042 |
1. The Company (Details Narrati
1. The Company (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accumulated deficit | $ (175,702,061) | $ (166,008,620) |
Working capital | 7,200,000 | 9,700,000 |
Working capital decreased | $ (2,500,000) | |
Direct Offering [Member] | ||
Proceeds from stock offering | $ 16,100,000 |
3. Summary of Significant Acc_3
3. Summary of Significant Accounting Policies (Details Narrative) | 6 Months Ended |
Jun. 25, 2019 | |
Accounting Policies [Abstract] | |
Reverse stock split | 1-for-12 reverse stock split |
Reverse stock split ratio | 0.08333 |
4. Significant Strategic Coll_2
4. Significant Strategic Collaborations (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | May 15, 2020 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Revenue | $ 115,934 | $ 0 | $ 285,610 | $ 0 | |
Takeda [Member] | Royalty [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Revenue | $ 116,000 | $ 286,000 | |||
Scripps Research [Member] | Scripps Agreement [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Research commitment | $ 3,000,000 |
5. Property and Equipment, ne_2
5. Property and Equipment, net (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment - at cost | $ 57,027 | $ 57,027 |
Less accumulated depreciation | (57,027) | (56,270) |
Property and equipment, net | 0 | 757 |
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 |
5. Property and Equipment, ne_3
5. Property and Equipment, net (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 0 | $ 1,000 | $ 757 | $ 3,366 |
6. Goodwill and Indefinite-Li_3
6. Goodwill and Indefinite-Lived Intangible Assets (Details - Goodwill) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill at beginning | $ 3,283,379 |
Impairment | 3,283,379 |
Goodwill at end | $ 0 |
6. Goodwill and Indefinite-Li_4
6. Goodwill and Indefinite-Lived Intangible Assets (Details - Indefinite-Lived Intangible Assets) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Carrying value of indefinite-lived intangible asset at beginning | $ 9,243,128 | $ 9,243,128 |
Impairment of indefinite-lived intangible asset | (9,243,128) | 0 |
Carrying value of indefinite-lived intangible asset at end | $ 0 | $ 9,243,128 |
6. Goodwill and Indefinite-Li_5
6. Goodwill and Indefinite-Lived Intangible Assets (Details - Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Impairment of goodwill | $ (3,283,379) | ||
Impairment of indefinite-lived intangible asset | $ (9,243,128) | $ 0 |
8. Stockholders' Equity (Detail
8. Stockholders' Equity (Details Narrative) - $ / shares | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Colllaboration Warrants [Member] | |||||
Warrants outstanding | 30,307 | 32,412 | 30,307 | ||
Warrants expired | 0 | 2,105 | |||
Warrants weighted average exercise price | $ 124.74 | $ 124.74 | $ 124.74 | ||
Warrant expiration dates | April 2021 through May 2021 | ||||
Warrants granted | 0 | 0 | 0 | 0 | |
Warrants exercised | 0 | 0 | 0 | 0 | |
Warrants [Member] | Debt and Equity Financing Arrangements [Member] | |||||
Warrants outstanding | 378,453 | 658,557 | 378,453 | ||
Warrants weighted average exercise price | $ 38.41 | $ 38.41 | |||
Warrant expiration dates | March 2021 through September 2026 | ||||
Prefunded Warrants [Member] | |||||
Warrants outstanding | 0 | ||||
Warrants granted | 500,000 | 600,000 | |||
Warrants exercised | 100,000 | 500,000 | 500,000 | ||
Debt and equity warrants [Member] | |||||
Warrants granted | 2,500,000 | 2,600,000 | |||
Warrants exercised | 1,900,000 | 200,000 | 1,900,000 | ||
Warrants expired | 100,000 | 0 |
9. Share-Based Expense (Details
9. Share-Based Expense (Details - Share based expense) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based compensation | $ 110,799 | $ 247,437 | $ 388,131 | $ 730,531 |
Research and Development Expense [Member] | ||||
Share-based compensation | 13,078 | 38,843 | 39,372 | 81,921 |
General and Administrative Expense [Member] | ||||
Share-based compensation | $ 97,721 | $ 208,594 | $ 348,759 | $ 648,610 |
9. Share-Based Compensation (De
9. Share-Based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based compensation expense | $ 110,799 | $ 247,437 | $ 388,131 | $ 730,531 |
Employee Stock Options [Member] | ||||
Share-based compensation expense | $ 100,000 | $ 200,000 | $ 400,000 | $ 700,000 |
Options granted | 0 | 50,000 | 0 | 50,000 |
Options exercised | 0 | 0 | 0 | 0 |
Weighted average grant date fair value | $ 1.18 | $ 1.18 | ||
Non Employee Stock Options [Member] | ||||
Share-based compensation expense | $ 4,000 | $ 0 | $ 11,000 | $ 0 |
Options granted | 0 | 0 | ||
Options exercised | 0 | 0 | ||
Common Stock Awards [Member] | ||||
Share-based compensation expense | $ 15,000 | $ 47,000 | ||
Other than options granted | 0 | 7,153 | 0 | 9,026 |
Common stock awards authorized, not issued | 7,406 | 7,406 | ||
Common stock issued upon exercise of common stock awards | 1,188 |
10. Income Taxes (Details Narra
10. Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 2,918,518 | $ 0 | $ 2,918,518 | $ 0 | |
Deferred tax valuation allowance | 26,500,000 | 26,500,000 | $ 25,900,000 | ||
Deferred tax liability | 2,900,000 | ||||
Unrecognized tax positions | $ 0 | $ 0 | $ 0 |
11. Commitments (Details - Cash
11. Commitments (Details - Cash flow Information) | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Operating cash flow information: | |
Cash paid for amounts included in the measurement of lease liabilities | $ 20,042 |
11. Commitments (Details Narrat
11. Commitments (Details Narrative) - USD ($) | Oct. 02, 2020 | Sep. 30, 2020 |
Commitments and Contingencies Disclosure [Abstract] | ||
Future minimum rent payments | $ 78,000 | |
Right-of-use asset | $ 71,000 | |
Lease liability | $ 71,000 | |
Borrowing rate | 10.20% |
12. Related Party Transactions
12. Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Research and development expense | $ 573,061 | $ 3,520,638 | $ 1,240,612 | $ 4,471,939 | |
Advanced payment | 937,596 | 937,596 | $ 722,079 | ||
Related party cost | 34,000 | 34,000 | |||
Hesperix [Member] | |||||
Repayment of loan | 225,000 | ||||
Pharmsynthez [Member] | Sponsored Research Agreement [Member] | |||||
Research and development expense | 100,000 | ||||
Payment for research agreement | 350,000 | ||||
Advanced payment | 100,000 | 100,000 | 200,000 | ||
Pharmsynthez [Member] | Co-Development Agreement [Member] | |||||
Payment for note receivable | $ 500,000 | ||||
Note receivable outstanding | $ 500,000 | $ 500,000 | |||
Note receivable interest rate | 10.00% | 10.00% | |||
Interest income | $ 13,000 | $ 38,000 |