−Removed: ITEM 1 – FINANCIAL
+Added: ITEM 1 – FINANCIAL STATEMENTS
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
+Added: September 30,
Current assets:
11 unchanged sentences
Series B, $ 0.001 par value:
−Removed: 1,804,394 shares issued and outstanding as of June 30, 2022 and December 31, 2021
+Added: 1,804,394 shares issued and outstanding as of September 30, 2022 and December 31, 2021
Series A, $ 0.001 par value:
−Removed: 970,000 shares issued and outstanding as of June 30, 2022 and December 31, 2021
+Added: 970,000 shares issued and outstanding as of September 30, 2022 and December 31, 2021
Common stock, $ 0.001 par value;
−Removed: 50,000,000 shares authorized as of June 30, 2022 and December 31, 2021;
−Removed: 14,343,587 and 13,466,603 shares issued as of June 30, 2022 and December 31, 2021, respectively;
−Removed: 14,316,596 and 13,439,612 shares outstanding as of June 30, 2022 and December 31, 2021, respectively
+Added: 50,000,000 shares authorized as of September 30, 2022 and December 31, 2021;
+Added: 14,343,587 and 13,466,603 shares issued as of September 30, 2022 and December 31, 2021, respectively;
+Added: 14,316,596 and 13,439,612 shares outstanding as of September 30, 2022 and December 31, 2021, respectively
Additional paid in capital
8 unchanged sentences
Total liabilities and stockholders' equity
−Removed: The accompanying notes are an integral part of
−Removed: these unaudited condensed consolidated financial statements.
+Added: The accompanying notes are an integral part of these
+Added: unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
1 unchanged sentence
THREE MONTHS ENDED
−Removed: SIX MONTHS ENDED
+Added: SEPTEMBER 30,
+Added: NINE MONTHS ENDED
+Added: SEPTEMBER 30,
Royalty revenue
4 unchanged sentences
( 1,934,432 )
−Removed: ( 1,154,279 )
General and administrative
1 unchanged sentence
( 2,766,397 )
−Removed: ( 1,821,282 )
Total operating costs and expenses
7 unchanged sentences
( 3,872,741 )
−Removed: ( 2,496,742 )
Other income (expense):
−Removed: Other income (expense)
+Added: Other expense
Interest income, net
5 unchanged sentences
Basic and diluted net loss per share
−Removed: Weighted-average shares of common stock
−Removed: outstanding, basic and diluted
−Removed: The accompanying notes are an integral part of
−Removed: these unaudited condensed consolidated financial statements.
+Added: Weighted-average shares of common stock outstanding, basic and diluted
+Added: The accompanying notes are an integral part of these
+Added: unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
−Removed: THREE MONTHS ENDED JUNE 30, 2022
+Added: THREE MONTHS ENDED SEPTEMBER 30, 2022
Comprehensive
Stockholders'
−Removed: Balance as of April 1, 2022
+Added: as of July 1, 2022
$ 207,012,317
1 unchanged sentence
$ ( 5,281,180 )
−Removed: Issuance of common stock in connection with purchase of in-process research
−Removed: and development
Share-based expense
−Removed: Exercise of purchase warrants
−Removed: ( 2,672,190 )
−Removed: ( 2,672,190 )
−Removed: Balance as of June 30, 2022
+Added: of September 30, 2022
$ 207,149,681
1 unchanged sentence
$ ( 5,281,180 )
−Removed: SIX MONTHS ENDED JUNE 30, 2022
−Removed: Preferred Stock
−Removed: Number of Shares
−Removed: Par Value ($0.001)
−Removed: Number of Shares
−Removed: Par Value ($0.001)
−Removed: Paid in Capital
−Removed: Accumulated Deficit
−Removed: Comprehensive Income
−Removed: Treasury Stock
−Removed: Stockholders' Equity
+Added: NINE MONTHS ENDED SEPTEMBER 30, 2022
+Added: Comprehensive
+Added: Stockholders'
Balance as of January
2 unchanged sentences
$ ( 5,281,180 )
−Removed: Issuance of common stock in connection with purchase of in-process research and development
+Added: Issuance of common stock in connection
+Added: with purchase of in-process research and development
Share-based expense
2 unchanged sentences
( 5,069,818 )
−Removed: as of June 30, 2022
+Added: of September 30, 2022
$ 207,149,681
1 unchanged sentence
$ ( 5,281,180 )
−Removed: The accompanying notes are an integral part of
−Removed: these unaudited condensed consolidated financial statements.
+Added: The accompanying notes are an integral part of these
+Added: unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
−Removed: THREE MONTHS ENDED JUNE 30, 2021
−Removed: Value ($0.001)
−Removed: Value ($0.001)
−Removed: Comprehensive
−Removed: Stockholders'
−Removed: Balance as of April 1, 2021
+Added: THREE MONTHS ENDED SEPTEMBER 30, 2021
+Added: Paid in Capital
+Added: Comprehensive Income
+Added: Stockholders' Equity
+Added: Balance as of July 1,
$ 194,319,716
+Added: $ ( 179,354,709 )
+Added: $ ( 5,281,180 )
+Added: Issuance of common stock and warrants,
+Added: net of issuance costs
+Added: Exercise of pre-funded warrants
+Added: Exercise of purchase warrants
+Added: Issuance of common stock to vendor
Share-based expense
−Removed: Balance as of June 30, 2021
( 1,350,876 )
−Removed: SIX MONTHS ENDED JUNE 30, 2021
−Removed: Value ($0.001)
−Removed: Value ($0.001)
−Removed: Comprehensive
−Removed: Stockholders'
+Added: ( 1,350,876 )
+Added: of September 30, 2021
+Added: $ 205,880,753
+Added: $ ( 180,705,585 )
+Added: $ ( 5,281,180 )
+Added: NINE MONTHS ENDED SEPTEMBER 30, 2021
+Added: Paid in Capital
+Added: Comprehensive Income
+Added: Stockholders' Equity
Balance as of January
$ 194,133,511
−Removed: Share-based expense
+Added: $ ( 176,902,086 )
+Added: $ ( 5,281,180 )
+Added: Issuance of common stock and warrants,
+Added: net of issuance costs
+Added: Exercise of pre-funded warrants
Exercise of purchase warrants
−Removed: Balance as of June 30, 2021
+Added: Issuance of common stock to vendor
+Added: Share-based expense
( 3,803,499 )
−Removed: The accompanying notes are an integral part of
−Removed: these unaudited condensed consolidated financial statements.
+Added: ( 3,803,499 )
+Added: of September 30, 2021
+Added: $ 205,880,753
+Added: $ ( 180,705,585 )
+Added: $ ( 5,281,180 )
+Added: The accompanying notes are an integral part of these
+Added: unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
CASH FLOWS FROM OPERATING ACTIVITIES:
6 unchanged sentences
Changes in operating assets and liabilities:
−Removed: Prepaid expenses and other assets
+Added: Prepaid expenses and other
+Added: Other long-term assets
Accounts payable, accrued expenses and other liabilities
5 unchanged sentences
Net cash used in investing activities
+Added: CASH FLOWS FROM FINANCING ACTIVITIES:
+Added: Net proceeds from issuance of common stock and warrants
+Added: Proceeds from exercise of warrants
+Added: Net cash provided by financing activities
Net change in cash
( 4,395,858 )
−Removed: ( 2,245,998 )
Cash at beginning of period
4 unchanged sentences
Issuance of common stock to acquire in-process research and development
+Added: Issuance of common stock to vendor
Issuance of common stock from cashless exercise of purchase warrants
−Removed: The accompanying notes are an integral part of
−Removed: these unaudited condensed consolidated financial statements.
+Added: The accompanying notes are an integral part of these
+Added: unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
1 unchanged sentence
Xenetic Biosciences, Inc.
−Removed: or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company
+Added: (“Xenetic” or
+Added: the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company
focused on advancing innovative immune-oncology technologies addressing hard to treat cancers.
1 unchanged sentence
platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps
−Removed: The Company is also developing its personalized Chimeric Antigen Receptor (“CAR”) T platform technology,
−Removed: XCART ™ , to develop cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s
−Removed: malignant tumor cells, for the treatment of B-cell lymphomas.
−Removed: On April 26, 2022, the Company entered into exclusive license and sublicense
−Removed: agreements with CLS Therapeutics Ltd.
−Removed: (“CLS”) to develop its interventional DNase based oncology platform as more fully described
−Removed: Additionally, Xenetic has partnered with biotechnology and pharmaceutical companies to develop its proprietary drug delivery
−Removed: platform, PolyXen ® , and receives royalty payments under an exclusive license arrangement in the field of blood coagulation
−Removed: As used in this Quarterly Report on Form 10-Q
−Removed: (“Quarterly Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,”
−Removed: “we” or “us” refer to Xenetic Biosciences, Inc.
+Added: Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for
+Added: pancreatic carcinoma and locally advanced or metastatic solid tumors.
+Added: The Company is also developing its personalized Chimeric Antigen
+Added: Receptor (“CAR”) T platform technology, XCART ™ , to develop cell-based therapeutics targeting the unique B-cell
+Added: receptor on the surface of an individual patient’s malignant tumor cells, for the treatment of B-cell lymphomas.
+Added: Additionally, Xenetic
+Added: has partnered with biotechnology and pharmaceutical companies to develop its proprietary drug delivery platform, PolyXen ® ,
+Added: and receives royalty payments under an exclusive license arrangement in the field of blood coagulation disorders.
+Added: As used in this Quarterly Report on Form 10-Q (“Quarterly
+Added: Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,” “we”
+Added: or “us” refer to Xenetic Biosciences, Inc.
and its wholly owned subsidiaries.
−Removed: The Company, directly or indirectly, through its
−Removed: wholly-owned subsidiaries, Hesperix S.A.
−Removed: (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and
−Removed: the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and
−Removed: SymbioTec, GmbH (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications,
−Removed: and unregistered trademarks and service marks, including but not limited to XCART, OncoHist™, PolyXen, ErepoXen™, and ImuXen™,
−Removed: which are used throughout this Quarterly Report.
−Removed: All other company and product names may be trademarks of the respective companies with
−Removed: which they are associated.
+Added: The Company, directly or indirectly, through its wholly-owned
+Added: subsidiaries, Hesperix S.A.
+Added: (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and the wholly-owned
+Added: subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and SymbioTec, GmbH
+Added: (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications, and unregistered
+Added: trademarks and service marks, including but not limited to XCART, OncoHist™, PolyXen, ErepoXen™, and ImuXen™, which
+Added: are used throughout this Quarterly Report.
+Added: All other company and product names may be trademarks of the respective companies with which
+Added: they are associated.
Going Concern and Management’s Plan
9 unchanged sentences
The Company believes that
−Removed: its existing resources will be adequate to fund the Company’s operations into the third quarter of 2023.
+Added: its existing resources will be adequate to fund the Company’s operations into the first quarter of 2024.
However, the Company anticipates
13 unchanged sentences
of the Notice to regain compliance with the Bid Price Requirement.
−Removed: Accordingly, the Company has until November 30, 2022 (the "Compliance
−Removed: Date"), to regain compliance with the Bid Price Requirement and may be eligible for an additional 180 calendar day compliance period
−Removed: if certain other criteria are met.
−Removed: Impact of COVID-19
−Removed: During March 2020, a
−Removed: global pandemic was declared by the World Health Organization related to the outbreak of a novel strain of coronavirus, or COVID-19.
−Removed: pandemic has significantly affected economic conditions in the U.S., accelerating during the first half of March 2020 and continuing throughout
+Added: Accordingly, the Company has until November 30, 2022 to regain compliance
+Added: with the Bid Price Requirement and may be eligible for an additional 180 calendar day compliance period if certain other criteria are
+Added: and Uncertainties
+Added: Effects of the COVID-19
+Added: During March 2020, a global
+Added: pandemic was declared by the World Health Organization related to the outbreak of a novel strain of coronavirus, or COVID-19.
+Added: has significantly affected economic conditions in the U.S., accelerating during the first half of March 2020 and continuing throughout
2021 and into 2022, as federal, state and local governments reacted to the public health crisis with mitigation measures, creating significant
6 unchanged sentences
to continue for some time.
+Added: Impact of the
+Added: conflict in Ukraine on Operations
+Added: The short and long-term
+Added: implications of Russia’s invasion of Ukraine are difficult to predict at this time.
+Added: The imposition of sanctions and counter sanctions
+Added: may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations.
Summary of Significant Accounting Policies
Preparation of Interim Financial Statements
−Removed: The accompanying condensed consolidated interim
−Removed: financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”)
+Added: The accompanying condensed consolidated interim financial
+Added: 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
10 unchanged sentences
Principles of Consolidation
−Removed: The condensed consolidated financial statements
−Removed: of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries:
+Added: The condensed consolidated financial statements of
+Added: the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries:
Lipoxen, Xenetic Bioscience,
2 unchanged sentences
Basic and Diluted Net Loss per Share
−Removed: The Company computes basic net loss per share
−Removed: by dividing net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding
−Removed: during the period.
−Removed: The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options
−Removed: that are outstanding during the period, except where such non-participating securities would be anti-dilutive.
−Removed: For the three and six months ended June 30, 2022
+Added: The Company computes basic net loss per share by dividing
+Added: net loss applicable to common stockholders by the weighted-average number of shares of the Company’s common stock outstanding during
+Added: The Company computes diluted net loss per share after giving consideration to the dilutive effect of stock options that are
+Added: outstanding during the period, except where such non-participating securities would be anti-dilutive.
+Added: For the three and nine months ended September 30,
2022 and 2021, basic and diluted net loss per share are the same for each respective period due to the Company’s net loss position.
−Removed: dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their inclusion would
−Removed: be anti-dilutive.
+Added: Potentially dilutive, non-participating securities have not been included in the calculations of diluted net loss per share, as their
+Added: inclusion would be anti-dilutive.
Recent Accounting Standards
−Removed: In June 2016, the Financial Accounting Standards
−Removed: Board issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326):
−Removed: of Credit Losses on Financial Instruments .
−Removed: The guidance modifies the measurement and recognition of credit losses for most financial
−Removed: assets and certain other instruments.
−Removed: The amendment updates the guidance for measuring and recording credit losses on financial assets
−Removed: measured at amortized cost by replacing the “incurred loss” model with an “expected loss” model.
−Removed: This may result
−Removed: in earlier recognition of allowance for losses.
−Removed: ASU 2016-13 is effective for smaller reporting public entities for fiscal years beginning
−Removed: after December 15, 2022 but early adoption is permitted.
−Removed: The Company is currently evaluating the impact of adoption, but it does not anticipate
−Removed: that adoption will have a material effect on the Company’s consolidated financial statements.
+Added: In June 2016, the Financial Accounting Standards Board
+Added: issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326):
+Added: Measurement of Credit
+Added: Losses on Financial Instruments .
+Added: The guidance modifies the measurement and recognition of credit losses for most financial assets
+Added: and certain other instruments.
+Added: The amendment updates the guidance for measuring and recording credit losses on financial assets measured
+Added: at amortized cost by replacing the “incurred loss” model with an “expected loss” model.
+Added: This may result in earlier
+Added: recognition of allowance for losses.
+Added: ASU 2016-13 is effective for smaller reporting public entities for fiscal years beginning after December
+Added: 15, 2022 but early adoption is permitted.
+Added: The Company is currently evaluating the impact of adoption, but it does not anticipate that
+Added: adoption will have a material effect on the Company’s consolidated financial statements.
Significant Strategic Collaborations
−Removed: The Company has entered into various research,
−Removed: development, license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”)
+Added: The Company has entered into various research, development,
+Added: license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”)
and SynBio LLC (“SynBio”), a wholly owned subsidiary of Pharmsynthez.
The Company’s collaborative partners continue
−Removed: to engage in research and development activities with no resultant commercial products through June 30, 2022.
+Added: to engage in research and development activities with no resultant commercial products through September 30, 2022.
No amounts were recognized
−Removed: as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and six months ended June 30, 2022 and 2021,
−Removed: respectively.
−Removed: In October 2017, the Company granted to Takeda
−Removed: Pharmaceuticals Co.
−Removed: (“Takeda”) the right to grant a non-exclusive sublicense to certain patents related to the Company’s
−Removed: PolyXen technology that were previously exclusively licensed to Takeda in connection with products related to the treatment of blood and
−Removed: bleeding disorders.
−Removed: Royalty payments of approximately $ 0.4 million and $ 0.8 million were recorded as revenue by the Company during the
−Removed: three and six months ended June 30, 2022, respectively, and approximately $ 0.3 million and $ 0.5 million were recorded as revenue by the
−Removed: Company during the three and six months ended June 30, 2021, respectively.
+Added: as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three and nine months ended September 30, 2022
+Added: and 2021, respectively.
+Added: In October 2017, the Company granted to Takeda Pharmaceuticals
+Added: (“Takeda”) the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen
+Added: technology that were previously exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding
+Added: Royalty payments of approximately $ 0.4 million and $ 1.2 million were recorded as revenue by the Company during the three and
+Added: nine months ended September 30, 2022, respectively, and approximately $ 0.3 million and $ 0.8 million were recorded as revenue by the Company
+Added: during the three and nine months ended September 30, 2021, respectively.
These payments are based on single digit royalties on net sales
21 unchanged sentences
As a result, Scripps Research agreed to continue to perform work under
−Removed: the agreement until funding previously advanced is expended.
+Added: the agreement until funding previously advanced was expended.
The Company paid $ 2.4 million to Scripps Research under this agreement through
−Removed: June 30, 2022.
−Removed: As of December 31, 2021, approximately $ 0.2 million has been recognized as an advance payment under this agreement and
−Removed: is included in prepaid expenses and other current assets.
−Removed: There were no amounts recognized as an advance payment under this agreement
−Removed: or accrued as of June 30, 2022.
+Added: September 30, 2022.
+Added: There were no amounts recognized as an advance payment under this agreement or accrued as of September 30, 2022.
+Added: of December 31, 2021, approximately $ 0.2 million has been recognized as an advance payment under this agreement and is included in prepaid
+Added: expenses and other current assets.
On June 30, 2022, the Company entered into a Statement
13 unchanged sentences
SOW also contains customary provisions related to, among other things, confidentiality, warranties, intellectual property and indemnification.
−Removed: No payments were made or costs incurred during the three and six months ended June 30, 2022.
+Added: During the three and nine months ended September 30, 2022, the Company paid Catalent $ 0.3 million , which has been recorded as a long-term
+Added: prepayment as of September 30, 2022.
+Added: Licensing Arrangements
Exclusive Sublicense Agreement
−Removed: On April 26, 2022, the Company entered into an
−Removed: Exclusive Sublicense Agreement (the “Sublicense Agreement”) with CLS pursuant to which the Company received an exclusive license,
−Removed: under certain patent rights and know-how owned or controlled by CLS, to develop and commercialize pharmaceutical products and methods
−Removed: incorporating DNase enzyme for use in treatment of cancer (the “Sublicensed Products”).
−Removed: Under the terms of the Sublicense
−Removed: Agreement, the Company will have sole responsibility for, and shall use commercially reasonable efforts to, among other things, research,
−Removed: develop and obtain marketing approval for the Sublicensed Products in the U.S.
−Removed: and certain European markets, and to commercialize such
−Removed: Sublicensed Products in the relevant market once marketing approval is obtained.
+Added: On April 26, 2022, the Company entered into an Exclusive
+Added: Sublicense Agreement (the “Sublicense Agreement”) with CLS Therapeutics Ltd.
+Added: (“CLS”) pursuant to which the Company
+Added: received an exclusive license, under certain patent rights and know-how owned or controlled by CLS, to develop and commercialize pharmaceutical
+Added: products and methods incorporating DNase enzyme for use in treatment of cancer (the “Sublicensed Products”).
+Added: Under the terms
+Added: of the Sublicense Agreement, the Company will have sole responsibility for, and shall use commercially reasonable efforts to, among other
+Added: things, research, develop and obtain marketing approval for the Sublicensed Products in the U.S.
+Added: and certain European markets, and to
+Added: commercialize such Sublicensed Products in the relevant market once marketing approval is obtained.
In consideration for the license and other rights
12 unchanged sentences
Exclusive License Agreement
−Removed: On April 26, 2022, the Company entered into an
−Removed: Exclusive License Agreement (the “License Agreement”) with CLS, pursuant to which the Company received an exclusive license
−Removed: under certain patent rights and know-how owned or controlled by CLS to develop and commercialize pharmaceutical products and methods incorporating
−Removed: DNase in conjunction with CAR T therapies (the “Licensed Products”).
−Removed: Under the terms of the License Agreement, the Company
−Removed: will have sole responsibility for, and shall use commercially reasonable efforts to, among other things, research, develop and obtain
−Removed: marketing approval for the Licensed Products in the U.S.
−Removed: and certain European markets, and to commercialize such Licensed Products in
−Removed: the relevant market once marketing approval is obtained.
+Added: On April 26, 2022, the Company entered into an Exclusive
+Added: License Agreement (the “License Agreement”) with CLS, pursuant to which the Company received an exclusive license under certain
+Added: patent rights and know-how owned or controlled by CLS to develop and commercialize pharmaceutical products and methods incorporating DNase
+Added: in conjunction with CAR T therapies (the “Licensed Products”).
+Added: Under the terms of the License Agreement, the Company will
+Added: have sole responsibility for, and shall use commercially reasonable efforts to, among other things, research, develop and obtain marketing
+Added: approval for the Licensed Products in the U.S.
+Added: and certain European markets, and to commercialize such Licensed Products in the relevant
+Added: market once marketing approval is obtained.
In consideration for the license and other rights
6 unchanged sentences
consideration received by the Company from any sublicensees.
−Removed: The total consideration for the Sublicense
−Removed: and License Agreements was approximately $ 1.3
−Removed: million, which consists of a $ 0.5
−Removed: million cash payment and the fair value of the 875,000
−Removed: common shares issued of $ 0.8
−Removed: million utilizing the closing market price of the Company’s stock price at the closing date.
+Added: The total consideration for the Sublicense and License
+Added: Agreements was approximately $ 1.3 million , which consists of a $ 0.5 million cash payment and the fair value of the 875,000 common shares
+Added: issued of $ 0.8 million utilizing the closing market price of the Company’s stock price at the closing date.
As there was no future
−Removed: alternative use for the sublicense and license, the Company recorded an expense of $ 1.3
−Removed: million to research and development expense for the three months ended June 30, 2022.
−Removed: In addition, the Company incurred approximately
−Removed: million and $ 0.2
−Removed: million related to consulting and transaction costs in connection with the Sublicense and License Agreements in the three and six
−Removed: months ended June 30, 2022, respectively.
+Added: alternative use for the sublicense and license, the Company recorded an expense of $ 1.3 million to research and development expense for
+Added: the nine months ended September 30, 2022.
+Added: In addition, the Company incurred approximately $ 0.2 million and $ 0.4 million related to consulting,
+Added: transaction and development costs in connection with the Sublicense and License Agreements in the three and nine months ended September
+Added: 30, 2022, respectively.
+Added: Patent Assignment and Volition Collaboration
+Added: On October 4, 2022, the Company completed a patent
+Added: assignment related to its collaboration with Belgian Volition SARL Limited (“Volition”) and CLS.
+Added: In connection with the patent
+Added: assignment, the Company entered into a Subscription Agreement with CLS Therapeutics, LLC, a Delaware limited liability company (“CLS
+Added: LLC ”) on October 12, 2022, pursuant to which the Company agreed to issue to CLS LLC, and CLS LLC agreed to subscribe for, 850,000
+Added: shares of the Company’s common stock (the “Shares”) as consideration for the assignment by CLS and its affiliates to
+Added: the Company of certain patent rights owned by CLS and its affiliates.
+Added: The Shares were issued on October 12, 2022.
+Added: 2022, the Company announced a research and development collaboration with Volition to develop NETs-targeted adoptive cell therapies
+Added: for the treatment of cancer.
+Added: The collaboration is an early exploratory program to evaluate the potential combination of Volition’s
+Added: Nu.Q® technology Test and the Company’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially
+Added: targeting multiple types of solid cancers.
+Added: Under the terms of the collaboration agreement, Volition will fund a research program and the
+Added: two parties will share proceeds from commercialization or licensing of any products arising from the collaboration.
Fair Value Measurements
11 unchanged sentences
at the measurement date.
−Removed: As of June 30, 2022 and December 31, 2021, the carrying amounts of the Company’s financial instruments
+Added: As of September 30, 2022 and December 31, 2021, the carrying amounts of the Company’s financial instruments
approximates fair value due to their short maturities.
There were no financial instruments classified as Level 3 in the fair value hierarchy
−Removed: during the three and six months ended June 30, 2022 and 2021.
+Added: during the three and nine months ended September 30, 2022 and 2021.
Stockholders’ Equity
4 unchanged sentences
common stock and expire on February 23, 2025 .
−Removed: No Series A Warrants were exercised or forfeited during the three and six months ended June
−Removed: In addition to the Series A Warrants, warrants
−Removed: to purchase approximately 29,000 and 31,000 shares of the Company’s common stock were outstanding as of June 30, 2022 and December
+Added: No Series A Warrants were exercised or forfeited during the three and nine months ended
+Added: September 30, 2022.
+Added: In addition to the Series A Warrants, warrants to
+Added: purchase approximately 29,000 and 31,000 shares of the Company’s common stock were outstanding as of September 30, 2022 and December
31, 2021, respectively, as described below.
Publicly traded warrants to purchase approximately
−Removed: 21,000 and 23,000 shares of common stock were outstanding as of June 30, 2022 and December 31, 2021, respectively.
−Removed: These warrants have
−Removed: an exercise price of $ 13.00 per share and expire on July 17, 2024 .
+Added: 21,000 and 23,000 shares of common stock were outstanding as of September 30, 2022 and December 31, 2021, respectively.
+Added: These warrants
+Added: have an exercise price of $ 13.00 per share and expire on July 17, 2024 .
The warrants trade on NASDAQ under the symbol “XBIOW.”
2 unchanged sentences
for one share of common stock.
−Removed: Warrants to purchase approximately 1,984 shares and 1,485 shares of common stock were exercised on a cashless,
−Removed: one-for-one basis during the six months ended June 30, 2022 and 2021, respectively.
−Removed: Warrants to purchase approximately 300 shares of common
−Removed: stock were exercised on a cashless, one-for-one basis during the three months ended June 30, 2022.
−Removed: No warrants were exercised during the
−Removed: three months ended June 30, 2021.
−Removed: None of these warrants were forfeited during the three and six months ended June 30, 2022 and 2021.
−Removed: Warrants to purchase approximately 8,000 shares
−Removed: of the Company’s common stock were outstanding as of June 30, 2022 and December 31, 2021.
+Added: No warrants to purchase shares of common stock were exercised during the three months ended September 30,
+Added: Warrants to purchase approximately 2,547 shares of common stock were exercised on a cashless, one-for-one basis during the three
+Added: months ended September 30, 2021.
+Added: Warrants to purchase approximately 1,984 shares and 4,032 shares of common stock were exercised on a
+Added: cashless, one-for-one basis during the nine months ended September 30, 2022 and 2021, respectively.
+Added: None of these warrants were forfeited
+Added: during the three and nine months ended September 30, 2022 and 2021.
+Added: Warrants to purchase approximately 8,000 shares of
+Added: the Company’s common stock were outstanding as of September 30, 2022 and December 31, 2021.
These warrants have an exercise price
of $ 2.91 per share and expire on July 3, 2026 .
−Removed: None of these warrants were exercised or forfeited during the three and six months ended
−Removed: June 30, 2022 and 2021.
+Added: None of these warrants were exercised or forfeited during the three and nine months ended
+Added: September 30, 2022 and 2021.
Share-Based Expense
−Removed: Total share-based expense related to stock options, restricted stock units and common stock awards was approximately $ 0.1 million for each of the three months ended June 30, 2022 and 2021
−Removed: and approximately $ 0.3 million and $ 0.2 million for the six months ended June 30, 2022 and 2021, respectively.
+Added: Total share-based expense related to stock options,
+Added: restricted stock units and common stock awards was approximately $ 0.1 million for each of the three months ended September 30, 2022 and
+Added: 2021 and approximately $ 0.4 million and $ 0.3 million for the nine months ended September 30, 2022 and 2021, respectively.
Share-based compensation expense is classified in the condensed consolidated
1 unchanged sentence
Schedule of Share-Based Compensation Expense
−Removed: Three Months Ended June 30,
−Removed: Six Months Ended June 30,
+Added: Three Months Ended September 30,
+Added: Nine Months Ended September 30,
Research and development expenses
1 unchanged sentence
Employee Stock Options
−Removed: During the six months ended June 30, 2022, the
+Added: During the nine months ended September 30, 2022, the
Company granted 200,000 stock option awards to purchase shares of common stock.
1 unchanged sentence
share was $ 0.99 .
−Removed: Key assumptions used in the Black-Scholes option pricing model for options granted during the six months ending June
+Added: Key assumptions used in the Black-Scholes option pricing model for options granted during the nine months ending September
30, 2022 were the Company’s stock price, a risk free rate of 2.38 %, an expected life of 5.88
years and an expected volatility rate of 126.32 %.
−Removed: During the six months ended June 30, 2021, the Company granted 200,000 stock
−Removed: option awards to purchase shares of common stock.
−Removed: The Company recognized a total of $ 0.1 million of compensation expense related to employee
−Removed: stock options during each of the three months ended June 30, 2022 and 2021 and $ 0.3 million and $ 0.2 million during the six months ended
−Removed: June 30, 2022 and 2021, respectively.
+Added: During the nine months ended September 30, 2021, the Company granted 200,000
+Added: stock option awards to purchase shares of common stock.
+Added: The Company recognized a total of $ 0.1 million of compensation expense related
+Added: to employee stock options during each of the three months ended September 30, 2022 and 2021 and $ 0.4 million and $ 0.3 million during the
+Added: nine months ended September 30, 2022 and 2021, respectively.
Non-Employee Stock Options
−Removed: The Company did no t grant any non-employee stock
−Removed: options during the six months ended June 30, 2022 and 2021.
+Added: The Company did no t grant any non-employee stock options
+Added: during the nine months ended September 30, 2022 and 2021.
The Company did not recognize any expense related to non-employee stock options
−Removed: during the three and six months ended June 30, 2022 and 2021, respectively.
−Removed: During the three and six months ended June 30,
+Added: during the three and nine months ended September 30, 2022 and 2021, respectively.
+Added: During the three and nine months ended September 30,
2022 and 2021, there was no provision for income taxes as the Company incurred losses during both periods.
5 unchanged sentences
The valuation allowance against deferred tax assets
−Removed: was approximately $ 32.6 million and $ 31.4 million as of June 30, 2022 and December 31, 2021, respectively.
−Removed: As of June 30, 2022 and December 31, 2021,
+Added: was approximately $ 32.8 million and $ 31.4 million as of September 30, 2022 and December 31, 2021, respectively.
+Added: As of September 30, 2022 and December 31, 2021,
the Company did no t record any unrecognized tax positions.
−Removed: Supplemental cash flow information and non-cash
−Removed: activity related to the Company’s operating leases are as follows:
+Added: Supplemental cash flow information and non-cash activity
+Added: related to the Company’s operating leases are as follows:
Cash flow information regarding leases
+Added: September 30,
+Added: September 30,
Operating cash flow information:
Cash paid for amounts included in the measurement of lease liabilities
−Removed: Supplemental balance sheet information related
−Removed: to the Company’s operating leases is as follows:
+Added: Supplemental balance sheet information related to
+Added: the Company’s operating leases is as follows:
Supplemental information related to operating leases
Balance Sheet Classification
−Removed: June 30, 2022
−Removed: June 30, 2021
+Added: September 30,
+Added: September 30, 2021
Right-of-use assets - ST
6 unchanged sentences
Related Party Transactions
−Removed: The Company has entered into various research,
−Removed: development, license and supply agreements with Serum Institute and Pharmsynthez each a related party whose relationship has not materially
−Removed: changed from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC
−Removed: on March 22, 2022, as amended on April 28, 2022.
+Added: The Company has entered into various research, development,
+Added: license and supply agreements with Serum Institute and Pharmsynthez each a related party whose relationship has not materially changed
+Added: from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March
+Added: 22, 2022, as amended on April 28, 2022.
During the fourth quarter
of 2019, the Company entered into a loan agreement with Pharmsynthez (the “Pharmsynthez Loan”), pursuant to which the Company
−Removed: advanced Pharmsynthez an aggregate principal amount of up to $ 500,000
−Removed: to be used for the development of a specific product under the Company’s Co-Development Agreement with Pharmsynthez.
−Removed: Pharmsynthez Loan had a term of 15-months and accrued interest at a rate of 10 %
−Removed: The Pharmsynthez Loan is guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt,
+Added: advanced Pharmsynthez an aggregate principal amount of up to $ 500,000 to be used for the development of a specific product under the Company’s
+Added: Co-Development Agreement with Pharmsynthez.
+Added: The Pharmsynthez Loan had a term of 15-months and accrued interest at a rate of 10 % per annum.
+Added: The Pharmsynthez Loan is guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt (“Kevelt”),
and is secured by all of the common and preferred stock of the Company owned by Pharmsynthez and SynBio.
The Company recognized approximately
−Removed: of interest income related to this loan during the three months ended June 30, 2021 and approximately $ 9,000
−Removed: of interest income related to this loan during the six months ended June 30, 2022 and 2021, respectively.
−Removed: The Company did no t
−Removed: recognize any interest income during the three months ended June 30, 2022 as Pharmsynthez informed the Company that it could not make
−Removed: interest payments during the second quarter as a result of Russian sanctions imposed in response to sanctions from the U.S.
−Removed: countries, as discussed below.
−Removed: Effective January 23, 2021, the Company entered
−Removed: into a First Amendment to Loan Agreement and Other Loan Documents with Pharmsynthez, Kevelt and SynBio (the “Pharmsynthez Loan Extension”)
+Added: $ 12,000 of interest income related to this loan during the three months ended September 30, 2021 and approximately $ 9,000 and $ 35,000
+Added: of interest income related to this loan during the nine months ended September 30, 2022 and 2021, respectively.
+Added: The Company did no t recognize
+Added: any interest income during the three months ended September 30, 2022 as Pharmsynthez informed the Company that it could not make interest
+Added: payments commencing in the second quarter as a result of Russian sanctions imposed in response to sanctions from the U.S.
+Added: and other countries,
+Added: as discussed below.
+Added: Effective January 23, 2021, the Company entered into
+Added: 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.
5 unchanged sentences
from August 2021 through January 2022.
−Removed: Effective August 31, 2021, the Company entered
−Removed: into a Second Amendment to Loan Agreement and Other Loan Documents with Pharmsynthez, Kevelt and SynBio (the “Second Pharmsynthez
−Removed: Loan Extension”) to modify the repayment terms and maturity of the Pharmsynthez Loan to July 2022.
+Added: Effective August 31, 2021, the Company entered into
+Added: a Second Amendment to Loan Agreement and Other Loan Documents with Pharmsynthez, Kevelt and SynBio (the “Second Pharmsynthez Loan
+Added: Extension”) to modify the repayment terms and maturity of the Pharmsynthez Loan to July 2022.
The terms of the Second Pharmsynthez
7 unchanged sentences
In February 2022, the Company received a request from Pharmsynthez to further extend the principal repayments and the maturity of the
−Removed: While the Company is working with Pharmsynthez to extend the maturity date of the loan, the terms of such extension are under negotiation
−Removed: and have not yet been finalized.
−Removed: As a result of this request and the ongoing economic uncertainty due to the conflict between Russia and
−Removed: Ukraine and associated sanctions imposed by the U.S.
−Removed: and other countries in response, the Company has classified the loan receivable as
−Removed: long-term as of June 30, 2022 and December 31, 2021.
−Removed: The Company assessed the collectability of the loan and determined that the U.S.-based
−Removed: collateral held by the Company, consisting of all of the common and preferred stock of the Company owned by Pharmsynthez and SynBio, was
−Removed: adequate to support the repayment of the outstanding principal balance.
−Removed: As of June 30, 2022 and December 31, 2021, approximately $ 0.4
+Added: Subsequent to quarter end, the Company
+Added: entered into a Third Amendment to Loan Agreement and Other Loan Documents with Pharmsynthez, Kevelt and SynBio dated October 31,
+Added: 2022 (the “Third Pharmsynthez Loan Extension”) primarily to modify the repayment terms and maturity of the Pharmsynthez
+Added: Loan to May 31, 2023.
+Added: The terms of the Third Pharmsynthez Loan Extension require certain payments of principal, interest and fees at
+Added: the signing of the Third Pharmsynthez Loan Extension.
+Added: In addition, the Third Pharmsynthez Loan Extension requires the repayment of
+Added: the remaining principal amount, plus interest, in seven (7) monthly installments from November 30, 2022 through May 31, 2023 as well
+Added: as certain other terms and conditions.
+Added: All other terms of the Pharmsynthez Loan, as amended, remained in effect.
+Added: As the payments
+Added: required under the Third Pharmsynthez Loan Extension have not been received to date and as a result of the ongoing economic
+Added: uncertainty due to the conflict between Russia and Ukraine and associated sanctions imposed by the U.S.
+Added: and other countries in
+Added: response, the Company has classified the loan receivable as long-term as of September 30, 2022 and December 31, 2021.
+Added: assessed the collectability of the loan and determined that the U.S.-based collateral held by the Company, consisting of all of the
+Added: common and preferred stock of the Company owned by Pharmsynthez and SynBio, was adequate to support the repayment of the outstanding
+Added: principal balance.
+Added: As of September 30, 2022 and December 31, 2021, approximately $ 0.4
million was included in other assets on the condensed consolidated balance sheet.
9 unchanged sentences
The Company performed a review of events subsequent
−Removed: to the balance sheet date through the date the financial statements were issued and determined that there were no such events requiring
−Removed: recognition or disclosure in the financial statements except as described below.
−Removed: 2, 2022, the Company announced a research and development collaboration with Belgian Volition SARL Limited to develop NETs-targeted
−Removed: adoptive cell therapies for the treatment of cancer.
−Removed: The collaboration is an early exploratory program to evaluate the potential combination
−Removed: of Volition’s Nu.Q® NETs Test and the Company’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies
−Removed: potentially targeting multiple types of solid cancers.
−Removed: Under the terms of the collaboration agreement, Volition will fund a research program
−Removed: and the two parties will share proceeds from commercialization or licensing of any products arising from the collaboration.
+Added: to the balance sheet date through the date the financial statements were issued and determined that other than described in Notes 5 and
+Added: 11, there were no such events requiring recognition or disclosure in the financial statements.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.