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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2024
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission File Number: 001-37937
XENETIC BIOSCIENCES, INC.
(Exact name of registrant as specified in its
charter)
Nevada
(State or other jurisdiction of
incorporation or organization) |
45-2952962
(IRS Employer
Identification No.) |
945 Concord Street
Framingham, Massachusetts 01701
(Address of principal executive offices and
zip code)
781-778-7720
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.001 par value per share |
XBIO |
The Nasdaq Stock Market |
Purchase Warrants |
XBIOW |
The Nasdaq Stock Market |
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days: Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files): Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer |
☐ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
|
Smaller reporting company |
☒ |
|
|
|
Emerging growth company |
☐ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ☐ No ☒
As of May 3, 2024, the number of outstanding shares
of the registrant’s common stock was 1,540,684.
XENETIC BIOSCIENCES, INC.
FORM 10-Q
QUARTERLY PERIOD ENDED MARCH 31, 2024
PART I – FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| |
| | |
| |
| |
March 31, 2024 | | |
December 31, 2023 | |
| |
| (Unaudited) | | |
| | |
| |
| | | |
| | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 7,823,701 | | |
$ | 8,983,046 | |
Prepaid expenses and other | |
| 552,043 | | |
| 603,828 | |
Total current assets | |
| 8,375,744 | | |
| 9,586,874 | |
| |
| | | |
| | |
Other assets | |
| 1,018,352 | | |
| 1,018,352 | |
Total assets | |
$ | 9,394,096 | | |
$ | 10,605,226 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 210,483 | | |
$ | 240,832 | |
Accrued expenses and other current liabilities | |
| 506,011 | | |
| 568,753 | |
Total current liabilities | |
| 716,494 | | |
| 809,585 | |
| |
| | | |
| | |
Total liabilities | |
| 716,494 | | |
| 809,585 | |
| |
| | | |
| | |
Commitments and contingencies | |
| – | | |
| – | |
Stockholders' equity: | |
| | | |
| | |
Preferred stock, 10,000,000 shares authorized | |
| | | |
| | |
Series B, $0.001 par value: 1,804,394 shares issued and outstanding as of March 31, 2024 and December 31, 2023 | |
| 1,804 | | |
| 1,804 | |
Common stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 1,543,385 shares issued as of March 31, 2024 and December 31, 2023; 1,540,684 shares outstanding as of March 31, 2024 and December 31, 2023 | |
| 1,544 | | |
| 1,544 | |
Additional paid in capital | |
| 208,131,009 | | |
| 208,053,935 | |
Accumulated deficit | |
| (194,429,309 | ) | |
| (193,234,196 | ) |
Accumulated other comprehensive income | |
| 253,734 | | |
| 253,734 | |
Treasury stock | |
| (5,281,180 | ) | |
| (5,281,180 | ) |
Total stockholders' equity | |
| 8,677,602 | | |
| 9,795,641 | |
Total liabilities and stockholders' equity | |
$ | 9,394,096 | | |
$ | 10,605,226 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| |
| | |
| |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Revenue: | |
| | | |
| | |
Royalty revenue | |
$ | 510,817 | | |
$ | 605,844 | |
Total revenue | |
| 510,817 | | |
| 605,844 | |
| |
| | | |
| | |
Operating costs and expenses: | |
| | | |
| | |
Research and development | |
| (944,321 | ) | |
| (595,276 | ) |
General and administrative | |
| (834,910 | ) | |
| (925,743 | ) |
Total operating costs and expenses | |
| (1,779,231 | ) | |
| (1,521,019 | ) |
Loss from operations | |
| (1,268,414 | ) | |
| (915,175 | ) |
| |
| | | |
| | |
Other income: | |
| | | |
| | |
Other income | |
| 52 | | |
| 4,520 | |
Interest income, net | |
| 73,249 | | |
| 54,101 | |
Total other income | |
| 73,301 | | |
| 58,621 | |
| |
| | | |
| | |
Net loss | |
$ | (1,195,113 | ) | |
$ | (856,554 | ) |
| |
| | | |
| | |
Basic and diluted loss per share | |
$ | (0.78 | ) | |
$ | (0.56 | ) |
| |
| | | |
| | |
Weighted-average shares of common stock outstanding, basic and diluted | |
| 1,540,684 | | |
| 1,516,659 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
EQUITY
(Unaudited)
THREE MONTHS ENDED MARCH 31, 2024
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Preferred
Stock | | |
Common
Stock | | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Number
of Shares | | |
Par Value
($0.001) | | |
Number
of Shares | | |
Par Value
($0.001) | | |
Additional Paid
in Capital | | |
Accumulated
Deficit | | |
Other Comprehensive
Income | | |
Treasury Stock | | |
Total Stockholders'
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance as of January 1, 2024 | |
| 1,804,394 | | |
$ | 1,804 | | |
| 1,543,385 | | |
$ | 1,544 | | |
$ | 208,053,935 | | |
$ | (193,234,196 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 9,795,641 | |
Share-based expense | |
| – | | |
| – | | |
| – | | |
| – | | |
| 77,074 | | |
| – | | |
| – | | |
| – | | |
| 77,074 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,195,113 | ) | |
| – | | |
| – | | |
| (1,195,113 | ) |
Balance as of March 31, 2024 | |
| 1,804,394 | | |
$ | 1,804 | | |
| 1,543,385 | | |
$ | 1,544 | | |
$ | 208,131,009 | | |
$ | (194,429,309 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 8,677,602 | |
THREE MONTHS ENDED MARCH 31, 2023
| |
Preferred
Stock | | |
Common
Stock | | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Number
of Shares | | |
Par Value ($0.001) | | |
Number
of Shares | | |
Par Value ($0.001) | | |
Additional Paid
in Capital | | |
Accumulated Deficit | | |
Other Comprehensive Income | | |
Treasury Stock | | |
Total Stockholders' Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance as of January 1, 2023 | |
| 2,774,394 | | |
$ | 2,774 | | |
| 1,519,360 | | |
$ | 1,520 | | |
$ | 207,769,904 | | |
$ | (189,099,618 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 13,647,134 | |
Share-based expense | |
| – | | |
| – | | |
| – | | |
| – | | |
| 68,852 | | |
| – | | |
| – | | |
| – | | |
| 68,852 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (856,554 | ) | |
| – | | |
| – | | |
| (856,554 | ) |
Balance as of March 31, 2023 | |
| 2,774,394 | | |
$ | 2,774 | | |
| 1,519,360 | | |
$ | 1,520 | | |
$ | 207,838,756 | | |
$ | (189,956,172 | ) | |
$ | 253,734 | | |
$ | (5,281,180 | ) | |
$ | 12,859,432 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
| | |
| |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (1,195,113 | ) | |
$ | (856,554 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Share-based expense | |
| 77,074 | | |
| 68,852 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other | |
| 51,785 | | |
| (320,445 | ) |
Other assets | |
| – | | |
| 222,500 | |
Accounts payable, accrued expenses and other liabilities | |
| (93,091 | ) | |
| (216,791 | ) |
Net cash used in operating activities | |
| (1,159,345 | ) | |
| (1,102,438 | ) |
| |
| | | |
| | |
Net change in cash | |
| (1,159,345 | ) | |
| (1,102,438 | ) |
Cash at beginning of period | |
| 8,983,046 | | |
| 13,097,265 | |
| |
| | | |
| | |
Cash at end of period | |
$ | 7,823,701 | | |
$ | 11,994,827 | |
| |
| | | |
| | |
SUPPLEMENTAL CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid for interest | |
$ | – | | |
$ | – | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
XENETIC BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Background
Xenetic Biosciences, Inc. (“Xenetic”
or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company
focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company’s proprietary Deoxyribonuclease
(“DNase”) platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil
extracellular traps (“NETs”), which have been implicated in cancer progression and resistance to cancer treatments. Xenetic
is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally
advanced or metastatic solid tumors. Additionally, Xenetic has partnered with biotechnology and pharmaceutical companies to develop its
proprietary drug delivery platform, PolyXen®, and receives royalty payments under an exclusive license arrangement in the
field of blood coagulation disorders.
As used in this Quarterly Report on Form 10-Q
(“Quarterly Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,”
“we” or “us” refer to Xenetic Biosciences, Inc. and its wholly-owned subsidiaries.
The Company, directly or indirectly, through its
wholly-owned subsidiaries, Hesperix S.A. (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and
the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and
SymbioTec, GmbH (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications
along with unregistered trademarks and service marks, including but not limited to XCART™, OncoHist™, PolyXen, ErepoXen™,
and ImuXen™, which may be used throughout this Quarterly Report. All other company and product names may be trademarks of the respective
companies with which they are associated.
Going Concern and Management’s Plan
Management evaluates whether there are conditions
or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the financial statements are issued. The Company has incurred substantial losses since its inception
and expects to continue to incur operating losses in the near-term. These factors raise substantial doubt about its ability to continue
as a going concern. The Company believes that it has access to capital resources through possible public or private equity offerings,
debt financings, corporate collaborations, related party funding, or other means to continue as a going concern. The Company believes
that its existing resources will be adequate to fund the Company’s operations for a period of at least twelve months from the date
of the issuance of these financial statements. However, the Company anticipates it may need additional capital in the long-term to pursue
its business initiatives. The terms, timing and extent of any future financing will depend upon several factors, including the achievement
of progress in its product development programs, its ability to identify and enter into licensing or other strategic arrangements, its
continued listing on the Nasdaq Stock Market (“Nasdaq”), and factors related to financial, economic, geo-political, industry
and market conditions, many of which are beyond its control. The capital markets for the biotech industry can be highly volatile, which
make the terms, timing and extent of any future financing uncertain.
2. |
Risks and Uncertainties |
Impact of Global
Conflicts on Operations
The short and long-term
implications of Russia’s invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition
of current and future sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our
business, financial condition, and results of operations.
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, 2023 filed with the SEC on March 21, 2024, and amended on April 26, 2024.
On May 15, 2023, the Company effected a reduction,
on a 1-for-10 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
10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number
of shares of common stock into which each outstanding warrant, restricted stock unit, or option to purchase common stock was convertible
into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option
to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each
share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless otherwise indicated,
all of the share numbers, share prices, and exercise prices have been adjusted in this Quarterly Report, on a retroactive basis, to reflect
this 1-for-10 Reverse Stock Split.
Principles of Consolidation
The condensed consolidated financial statements
of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries: Lipoxen, Xenetic Bioscience,
Incorporated, and SymbioTec. All intercompany balances and transactions have been eliminated in consolidation.
Certain prior period amounts have been reclassified
in this Quarterly Report to conform to the presentation for the current period and had no impact on the reported results of operations.
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 months ended March 31, 2024 and
2023, 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.
4. |
Significant Strategic Collaborations |
Takeda Pharmaceutical Co. Ltd. (together
with its wholly-owned subsidiaries, “Takeda”)
In October 2017, the Company granted to Takeda
the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen technology that were previously
exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding disorders. Royalty payments
of approximately $0.5 million and $0.6 million were recorded as revenue by the Company during the three months ended March 31, 2024 and
2023, respectively, and are based on single digit royalties on net sales of certain covered products. 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. At the time the revenue was received, there were no remaining
performance obligations and all other revenue recognition criteria were met.
Belgian Volition SARL Limited (“Volition”)
Collaboration
On August 2, 2022, the Company announced a research
and development collaboration with Volition to develop NETs-targeted adoptive cell therapies for the treatment of cancer. The collaboration
is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q® technology Test and the
Company’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid
cancers. Under the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds
from commercialization or licensing of any products arising from the collaboration. To date, Volition has funded $26,000 under this agreement.
Catalent Pharma Solutions LLC (“Catalent”)
On June 30, 2022, the Company entered into a Statement
of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will
provide certain services to the Company to perform cGMP manufacturing of the Company’s recombinant protein, Human DNase I. The parties
agreed to enter into a Master Services Agreement (“MSA”) that will contain terms and conditions to govern the project contemplated
by the SOW and that will supersede the addendum to the SOW containing Catalent's standard terms and conditions. In addition, in the event
of any conflict between the project-specific terms and conditions set forth in the SOW and the MSA, the MSA terms and conditions shall
govern. The Company has paid Catalent approximately $2.5 million through March 31, 2024, of which $28,000 and $0.1 million has been recognized
as an advance payment and is included in prepaid expenses and other current assets as of March 31, 2024 and December 31, 2023, respectively.
In addition, $0.3 million has been recognized within other assets as of both March 31, 2024 and December 31, 2023.
Scripps Research Institute (“Scripps
Research”)
On March 17, 2023, the Company and Scripps Research
entered into a Research Funding and Option Agreement (the “Agreement”), pursuant to which the Company has agreed to provide
Scripps Research an aggregate of up to $0.9 million to fund research relating to advancing the pre-clinical development of the Company’s
DNase oncology platform technology. Under the Agreement, the Company has the option to acquire a worldwide exclusive license to Scripps
Research’s rights in the Technology or Patent Rights (as defined in the Agreement), as well as a non-exclusive, royalty-free, non-transferrable
license to make and use TSRI Technology (as defined in the Agreement) solely for the Company’s internal research purposes during
the performance of the research program contemplated by the Agreement. Unless earlier terminated, the term of the Agreement continues
from the date of the Agreement for fifteen (15) months. The Agreement may be terminated by the Company with 30 days advance written notice
to Scripps Research or by Scripps Research if the Company fails to make timely payments due under the Agreement, subject to 30 days’
written notice to cure such nonpayment. The Agreement may further be terminated by either party in the event of the other party’s
uncured failure to perform any obligations under the Agreement or the bankruptcy of the other party. The Company has paid Scripps Research
approximately $0.9 million under the Agreement through March 31, 2024, of which approximately $0.1 million and $0.4 million has been recognized
as an advance payment and is included in prepaid expenses and other current assets as of March 31, 2024 and December 31, 2023, respectively.
University of Virginia (“UVA”)
On December 21, 2023, the Company entered into
a Research Funding and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic
DNase program. Under the terms of the UVA Agreement, in
addition to advancing our existing intellectual property, we have an option to acquire an exclusive license to any new intellectual property
arising from the DNase research program. Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair of
the Department of Surgery at the UVA School of Medicine, will oversee the research conducted under
the UVA Agreement. The Company has paid UVA approximately $0.1 million under the UVA Agreement through March 31, 2024, of which
approximately $29,000 has been recognized as an advance payment and is included in prepaid expenses and other current assets as of March
31, 2024. There were no amounts incurred as of December 31, 2023.
Other Agreements
The Company has also entered into various research,
development, license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”)
and SynBio LLC (“SynBio”), a wholly owned subsidiary of Pharmsynthez. The Company and its collaborative partners continue
to engage in research and development activities with no resultant commercial products through March 31, 2024. No amounts were recognized
as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three months ended March 31, 2024 and 2023, respectively.
5. |
Fair Value Measurements |
Accounting Standards Codification Topic 820, Fair
Value Measurement, defines fair value as the price that would be received to sell an asset or be paid to transfer a liability in an
orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which
prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest
level of input that is available and significant to the fair value measurement. Level 1 inputs are quoted prices in active markets for
identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes quoted market
prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency.
Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability
at the measurement date. As of March 31, 2024 and December 31, 2023, 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
during the three months ended March 31, 2024 and 2023.
Common Stock
Each share of the Company’s
common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders
are entitled to dividends when and if declared by the Board of Directors. In the event of any voluntary or involuntary liquidation, dissolution
or winding-up of the Company, the holders of common stock are entitled to share ratably in the assets of the Company available for distribution.
On May 11, 2023, the Company filed a Certificate
of Change to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effect the Reverse Stock Split. The
Reverse Stock Split was effective at 12:01 a.m., Eastern Time, on May 15, 2023. No fractional shares were issued as a result of the Reverse
Stock Split and any remaining share fractions were rounded up to the nearest whole share, resulting in 15,941 new shares of common stock
being issued to existing holders of the Company’s common stock.
Warrants
The Company
has warrants to purchase approximately 462,963 shares of the Company’s common stock (the “Series A Warrants”) outstanding
as of both March 31, 2024 and December 31, 2023. The Series A Warrants are immediately exercisable at a price of $33.00 per share of common
stock and expire on February 23, 2025. No Series A Warrants were exercised or forfeited during the three months ended March 31, 2024 and
2023.
In addition, the Company has publicly traded warrants
to purchase approximately 2,100 shares of common stock outstanding as of both March 31, 2024 and December 31, 2023. These warrants have
an exercise price of $130.00 per share of common stock and expire on July 17, 2024. The warrants trade on Nasdaq under the symbol “XBIOW.”
The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is
lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis
for one share of common stock. None of these warrants were exercised or forfeited during the three months ended March 31, 2024 and 2023.
The Company also has warrants to purchase approximately
800 shares of the Company’s common stock outstanding as of both March 31, 2024 and
December 31, 2023. These warrants have an exercise price of $29.09 per share of common stock and expire on July 3, 2026. None of these
warrants were exercised or forfeited during the three months ended March 31, 2024 and 2023.
Total share-based expense related to stock options
and restricted stock units (“RSUs”) was approximately $0.1 million during each of the three months ended March 31, 2024 and
2023.
Share-based expense is classified in the condensed
consolidated statements of operations as follows:
Schedule of Share-Based Compensation Expense | |
| | |
| |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Research and development expenses | |
$ | 15,237 | | |
$ | 13,688 | |
General and administrative expenses | |
| 61,837 | | |
| 55,164 | |
| |
$ | 77,074 | | |
$ | 68,852 | |
Employee Stock Options
No stock option awards to purchase shares of common
stock were granted during the three months ended March 31, 2024 and 2023. The Company recognized a total of approximately $0.1 million of share-based expense related to employee stock options during each of the three months ended March 31, 2024 and 2023. No employee stock
options or RSUs were exercised and none expired during the three months ended March 31, 2024 and 2023.
Non-Employee Stock Options
There were no non-employee stock options granted
or exercised during the three months ended March 31, 2024 and 2023. No non-employee stock option grants expired during the three months
ended March 31, 2024. During the three months ended March 31, 2023, non-employee stock option grants to purchase approximately 100 shares
of common stock expired. The Company did not recognize any share-based expense related to non-employee stock options during the three
months ended March 31, 2024 and 2023.
During the three months ended March 31, 2024 and
2023, there was no provision for income taxes as the Company incurred losses during both periods. 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 $40.1 million and $39.7 million as of March 31, 2024 and December 31, 2023, respectively.
As of March 31, 2024 and December 31, 2023,
the Company did not record any unrecognized tax positions.
9. |
Related Party Transactions |
The Company has entered into various research,
development, license and supply agreements with Serum Institute and Pharmsynthez, each a related party whose relationship has not materially
changed from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC
on March 21, 2024, as amended on April 26, 2024.
During the fourth quarter
of 2019, the Company entered into a loan agreement with Pharmsynthez (the “Pharmsynthez Loan”), pursuant to which the Company
advanced Pharmsynthez an aggregate principal amount of up to $500,000 to be used for the development of a specific product under the Company’s
Co-Development Agreement with Pharmsynthez. The Pharmsynthez Loan had an initial term of 15-months and accrued interest at a rate of 10% per annum. The Pharmsynthez Loan was guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt,
and was secured by all of the common and preferred stock of the Company owned by Pharmsynthez and SynBio.
Pharmsynthez paid all
obligations due under the Pharmsynthez Loan in May 2023, and no further amounts are due under the Pharmsynthez Loan. As a result, no amounts
were outstanding as of March 31, 2024 and December 31, 2023. The Company did not recognize any interest income related to the Pharmsynthez
Loan during the three months ended March 31, 2024 and 2023.
The Company performed a review of events subsequent
to the balance sheet date through the date the financial statements were issued and determined that there were no such events requiring
recognition or disclosure in the financial statements.
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements
within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A
of the Securities Act of 1933, as amended. All statements contained in this Quarterly Report other than statements of historical fact,
including statements regarding our future results of operations and financial position, our business strategy and plans, future revenues,
projected costs, prospects and our objectives for future operations, are forward-looking statements. These forward-looking statements
include, but are not limited to, statements concerning: anticipated effects of geopolitical events, including the conflicts in the Ukraine
and the Middle East and associated sanctions imposed by the U.S. and other countries in response; our plans to develop our proposed drug
candidates; our expectations regarding the nature, timing and extent of clinical trials and proposed clinical trials; our expectations
regarding the timing for proposed submissions of regulatory filings; our expectations regarding the nature, timing and extent of collaboration
arrangements; the expected results pursuant to collaboration arrangements, including the receipts of future payments that may arise pursuant
to collaboration arrangements; the outcome of our plans to obtain regulatory approval of our drug candidates; the outcome of our plans
for the commercialization of our drug candidates; our plans to address certain markets, engage third party manufacturers, and evaluate
additional drug candidates for subsequent commercial development along with the likelihood and extent of competition to our drug candidates;
our plans to advance innovative immune-oncology technologies addressing hard to treat oncology indications; expectations regarding our
Deoxyribonuclease (“DNase”) platform, such as regarding the DNase platform being in development for the treatment of solid
tumors and being aimed at improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular
traps (“NETs”); our expectations to focus our efforts and resources on advancing the DNase platform into the clinic as an
adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors; and our expectations regarding our PolyXen®
platform, including concerning our plans to leverage the platform.
In some cases, these statements may be identified
by terminology such as “may,” “will,” “would,” “could,” “should,” “expect,”
“plan,” “anticipate,” “believe,” “estimate,” “seek,” “approximately,”
“intend,” “predict,” “potential,” “projects,” or “continue,” or the negative
of such terms and other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements
contained herein are reasonable, we cannot guarantee future results, the levels of activity, performance or achievements. These statements
involve known and unknown risks and uncertainties that may cause our or our industry's results, levels of activity, performance or achievements
to be materially different from those expressed or implied by forward-looking statements.
The Management’s Discussion and Analysis
of Financial Condition and Results of Operations (the “MD&A”) should be read together with our condensed consolidated
financial statements and related notes included elsewhere in this Quarterly Report. This Quarterly Report, including the MD&A, contains
trend analysis and other forward-looking statements. Any statements in this Quarterly Report that are not statements of historical facts
are forward-looking statements. These forward-looking statements made herein are based on our current expectations, involve a number of
risks and uncertainties and should not be considered as guarantees of future performance.
Some factors that could
cause actual results to differ materially include without limitation:
|
· |
uncertainty of the expected financial performance of the Company; |
|
· |
failure to realize the anticipated potential of the DNase or PolyXen technologies; |
|
· |
our ability to implement our business strategy; |
|
· |
our failure to maintain compliance with the continued listing requirements of the Nasdaq Stock Market (“Nasdaq”); |
|
· |
our need to raise additional working capital in the future for the purpose of further developing our pipeline and to continue as a going concern; |
|
· |
our ability to finance our business; |
|
· |
our ability to successfully execute, manage and integrate key acquisitions and mergers; |
|
· |
product development and commercialization risks, including our ability to successfully develop the DNase technology; |
|
· |
the impact of adverse safety outcomes and clinical trial results for our therapies; |
|
· |
our ability to secure and maintain a manufacturer for our technologies; |
|
· |
the impact of new therapies and new uses of existing therapies on the competitive environment; |
|
· |
our ability to successfully commercialize our current and future drug candidates; |
|
· |
our ability to achieve milestone and other payments associated with our current and future co-development collaborations and strategic arrangements; |
|
· |
our reliance on consultants, advisors, vendors and business partners to conduct work on our behalf; |
|
· |
the impact of new technologies on our drug candidates and our competition; |
|
· |
changes in laws or regulations of governmental agencies; |
|
· |
interruptions or cancellation of existing contracts; |
|
· |
impact of competitive products and pricing; |
|
· |
product demand and market acceptance and risks; |
|
· |
the presence of competitors with greater financial resources; |
|
· |
continued availability of supplies or materials used in manufacturing at the current prices; |
|
· |
the ability of management to execute plans and motivate personnel in the execution of those plans; |
|
· |
our ability to attract and retain key personnel; |
|
· |
costs, diversion and other adverse effects of the actions of activist shareholders; |
|
· |
adverse publicity related to our products or the Company itself; |
|
· |
adverse claims relating to our intellectual property; |
|
· |
the adoption of new, or changes in, accounting principles; |
|
· |
the costs inherent with complying with statutes and regulations applicable to public reporting companies, such as the Sarbanes-Oxley Act of 2002; |
|
· |
other new lines of business that we may enter in the future; |
|
· |
general economic and business conditions, as well as inflationary trends and financial market instability or disruptions to the banking system due to bank failures; |
|
· |
the impact of natural disasters or public health emergencies, such as the COVID-19 global pandemic, and geopolitical events, such as the Russian invasion of Ukraine and conflict in the Middle East, and related sanctions and other economic disruptions or concerns, on our financial condition and results of operations; and |
|
· |
other factors set forth in the Risk Factors section of our Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission (“SEC”). |
These factors are not necessarily all of the important
factors that could cause actual results to differ materially from those expressed in the forward-looking statements in this Quarterly
Report. Other unknown or unpredictable factors also could have material adverse effects on our future results, including, but not limited
to, those discussed in the section titled “Risk Factors.” The forward-looking statements in this Quarterly Report are made
only as of the date of this Quarterly Report, and we do not undertake any obligation to publicly update any forward-looking statements
to reflect subsequent events or circumstances. We intend that all forward-looking statements be subject to the safe-harbor provisions
of the Private Securities Litigation Reform Act of 1995.
BUSINESS OVERVIEW
We are a biopharmaceutical company focused on
advancing innovative immune-oncology technologies addressing hard to treat cancers. Our DNase platform is designed to improve outcomes
of existing treatments, including immunotherapies, by targeting NETs, which have been implicated in cancer progression and resistance
to cancer treatments. We are currently focused on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic
carcinoma and locally advanced or metastatic solid tumors. Additionally, we have partnered with biotechnology and pharmaceutical companies
to develop our proprietary drug delivery platform, PolyXen, and receive royalty payments under an exclusive license arrangement in the
field of blood coagulation disorders.
We incorporate our patented and proprietary technologies
into drug candidates currently under development with biotechnology and pharmaceutical industry collaborators to create what we believe
will be the next-generation biologic drugs with improved pharmacological properties over existing therapeutics. Our drug candidates have
resulted from our research activities or that of our collaborators and are in the development stage. As a result, we have committed a
significant amount of our resources to our research and development activities and anticipate continuing to do so for the near future.
To date, none of our drug candidates have received regulatory marketing authorization or approval in the U.S. by the Food and Drug Administration
nor in any other countries or territories by any applicable agencies. We are receiving ongoing royalties pursuant to a license of our
PolyXen technology to an industry partner. Although we hold a broad patent portfolio, the focus of our internal efforts during the three
months ended March 31, 2024, was on the advancement of our DNase technology.
Impact of the Global Conflicts on Our Operations
The short and long-term implications of Russia’s
invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition of current and future sanctions
and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition,
and results of operations.
RESULTS OF OPERATIONS
Comparison of Quarter Ended March 31, 2024
and 2023
The comparison of our historical results of operations
for the fiscal quarter ended March 31, 2024 to the fiscal quarter ended March 31, 2023 is as follows:
Description | |
Quarter Ended March 31, 2024 | | |
Quarter Ended March 31, 2023 | | |
Increase (Decrease) | | |
Percentage Change | |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Royalty revenue | |
$ | 510,817 | | |
$ | 605,844 | | |
$ | (95,027 | ) | |
| (15.7 | ) |
Operating costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| (944,321 | ) | |
| (595,276 | ) | |
| 349,045 | | |
| 58.6 | |
General and administrative | |
| (834,910 | ) | |
| (925,743 | ) | |
| (90,833 | ) | |
| (9.8 | ) |
Total operating costs and expenses | |
| (1,779,231 | ) | |
| (1,521,019 | ) | |
| 258,212 | | |
| 17.0 | |
Loss from operations | |
| (1,268,414 | ) | |
| (915,175 | ) | |
| 353,239 | | |
| 38.6 | |
Other income: | |
| | | |
| | | |
| | | |
| | |
Other income | |
| 52 | | |
| 4,520 | | |
| (4,468 | ) | |
| (98.8 | ) |
Interest income, net | |
| 73,249 | | |
| 54,101 | | |
| 19,148 | | |
| 35.4 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,195,113 | ) | |
$ | (856,554 | ) | |
$ | 338,559 | | |
| 39.5 | |
Revenue
Revenue for the three months ended March 31, 2024
decreased by $0.1 million, or 15.7%, to $0.5 million from approximately $0.6 million for the three months ended March 31, 2023. This decrease
represents a decrease in royalty revenue resulting from the timing of rebates related to our sublicense agreement with Takeda Pharmaceuticals
Co. Ltd. as compared to the same period in 2023.
Research and Development Expenses
Research & development (“R&D”)
expenses for the three months ended March 31, 2024 increased by approximately $0.3 million, or 58.6%, to approximately $0.9 million from
approximately $0.6 million in the comparable quarter in 2023. The table below sets forth the R&D costs incurred by the Company by
category of expense for the quarters ended March 31, 2024 and 2023:
| |
Quarter Ended | |
Category of Expense | |
March 31, 2024 | | |
March 31, 2023 | |
Outside services and contract research organizations | |
$ | 745,672 | | |
$ | 423,868 | |
Personnel costs | |
| 145,805 | | |
| 124,793 | |
Share-based expense | |
| 15,237 | | |
| 13,688 | |
Other | |
| 37,607 | | |
| 32,927 | |
Total research and development expense | |
$ | 944,321 | | |
$ | 595,276 | |
The increase in outside
services and contract research organizations expense was primarily due to increased spending in connection with our pre-clinical development
efforts related to our DNase platform.
General and Administrative Expenses
General and administrative expenses for the three
months ended March 31, 2024 decreased by approximately $0.1 million, or 9.8%, to approximately $0.8 million from approximately $0.9 million
in the comparable quarter in 2023. The decrease was primarily due to a decrease in accounting and legal fees during the three months ended
March 31, 2024 compared to the same period in 2023.
Other Income
Other income was approximately $52 for the three
months ended March 31, 2024 compared to approximately $4,500 of other income for the comparable quarter in 2023. This decrease in other
income was primarily related to unfavorable changes in foreign currency exchange rates during the three months ended March 31, 2024 as
compared to the same period in 2023.
Interest Income
Interest income increased to approximately $73,000
during the three months ended March 31, 2024 as compared to approximately $54,000 for the same period in the prior year. This increase
is primarily due to higher interest rates on invested funds during the three months ended March 31, 2024 compared to the same period in
2023.
Liquidity and Capital Resources
We incurred a net loss
of approximately $1.2 million for the three months ended March 31, 2024. We had an accumulated deficit of approximately $194.4 million
at March 31, 2024, as compared to an accumulated deficit of approximately $193.2 million at December 31, 2023. Working capital was approximately
$7.7 million at March 31, 2024 and $8.8 million at December 31, 2023. During the three months ended March 31, 2024, our working capital
decreased by $1.1 million primarily due to our net loss for the three months ended March 31, 2024.
Our principal source
of liquidity consists of cash. At March 31, 2024, we had approximately $7.8 million in cash and $0.7 million in current liabilities. At
December 31, 2023, we had approximately $9.0 million in cash and $0.8 million in current liabilities. We have historically relied upon
sales of our equity securities to fund our operations.
We evaluate whether there
are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within
one year after the date that the financial statements are issued. We have incurred substantial losses since our inception, and we expect
to continue to incur operating losses in the near-term. These factors raise substantial doubt about our ability to continue as a going
concern. We believe that we have 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. We believe that our existing resources will be adequate
to fund our operations for a period of at least twelve months from the date of the issuance of these financial statements. However, we
anticipate we may need additional capital in the long-term to pursue our business initiatives. The terms, timing and extent of any future
financing will depend upon several factors, including the achievement of progress in our clinical development programs, our ability to
identify and enter into licensing or other strategic arrangements, our continued listing on Nasdaq, and factors related to financial,
economic, geo-political, industry and market conditions, many of which are beyond our control. The capital markets for the biotech industry
can be highly volatile, which make the terms, timing and extent of any future financing uncertain.
Cash Flows from Operating Activities
Cash flows used in operating activities for the
three months ended March 31, 2024 totaled approximately $1.2 million, which was primarily due to our net loss for the period, partially
offset by non-cash charges associated with share-based expense. Cash flows used in operating activities for the three months ended March
31, 2023 totaled approximately $1.1 million, which was primarily due to our net loss for the period, partially offset by non-cash charges
associated with share-based expense and principal repayments on the Pharmsynthez Loan. In addition, prepaid expenses increased and current
liabilities decreased during the three months ended March 31, 2023.
Cash Flows from Investing Activities
There were no cash flows from investing activities
for the three months ended March 31, 2024 and 2023.
Cash Flow from Financing Activities
There were no cash flows from financing activities
for the three months ended March 31, 2024 and 2023.
Contractual Obligations and Commitments
As of March 31, 2024, there were no material changes
in our contractual obligations and commitments from those disclosed in our Annual Report on Form 10-K for the year ended December 31,
2023, filed with the SEC on March 21, 2024, as amended on April 26, 2024.
Off Balance Sheet Arrangements
We do not have any off-balance sheet financing
arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, change in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.
Recent Accounting Standards
See Note 3 in our Annual Report on Form 10-K for
the year ended December 31, 2023, filed with the SEC on March 21, 2024, as amended on April 26, 2024, for a discussion of recent accounting
standards.
Critical Accounting Estimates
Our condensed consolidated financial statements
are prepared in accordance with U.S. generally accepted accounting principles. The preparation of our condensed consolidated financial
statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue,
costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable
under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. The result of these evaluations forms the basis
for making judgments about the carrying values of assets and liabilities and the reported amount of expenses that are not readily apparent
from other sources. Because future events and their effects cannot be determined with certainty, actual results and outcomes may differ
materially from our estimates, judgments and assumptions. There have been no material changes in our critical accounting estimates from
those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024,
as amended on April 26, 2024.
ITEM 3 – QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
We are not required to provide the information
required by this Item because we are a “smaller reporting company” (as defined in Rule 12b-2 of the Exchange Act).
ITEM 4 – CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our
Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), evaluated the effectiveness
of our disclosure controls and procedures as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act, as of the end of the period
covered by this Quarterly Report.
Based on this evaluation, our management, including
our Chief Executive Officer and Chief Financial Officer, concluded that as of the end of the period covered by this Quarterly Report,
our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance
that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized,
and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated
to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding
required disclosure.
Changes in Internal Control over Financial
Reporting
There were no changes in our internal control
over financial reporting that occurred during the period covered by this Quarterly Report that would have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1 – LEGAL PROCEEDINGS
We are not currently subject to any material legal
proceedings, nor, to our knowledge, is any material legal proceeding threatened against us. From time to time, we may be a party to litigation
and subject to claims incident to the ordinary course of business. Although the results of litigation and claims cannot be predicted with
certainty, we currently believe that the final outcome of these ordinary course matters will not have a material adverse effect on our
business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of
management resources and other factors.
ITEM 1A – RISK FACTORS
There have been no material changes to the risk
factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 21, 2024,
as amended on April 26, 2024.
ITEM 2 – UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
None.
ITEM 3 – DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4 – MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5 – OTHER INFORMATION
During the quarter ended March 31, 2024, no director
or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in
Item 408(a) of Regulation S-K.
ITEM 6 – EXHIBITS
The following exhibits are incorporated herein
by reference or filed as part of this report.
EXHIBIT NUMBER |
DESCRIPTION |
31.1* |
Certification of Jeffrey F. Eisenberg, Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2* |
Certification of James Parslow, Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1** |
Certifications of Jeffrey F. Eisenberg, Principal Executive Officer, and James Parslow, Principal Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101* |
The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, formatted in inline XBRL, include: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows and (v) the Notes to the Condensed Consolidated Financial Statements. |
104* |
Cover Page Interactive Data File (formatted in XBRL and included in Exhibit 101). |
* |
Filed herewith. |
** |
Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended, except as otherwise stated in such filing. |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
Xenetic Biosciences, Inc. |
|
|
|
|
|
|
|
|
May 9, 2024 |
|
By: |
/s/ JEFFREY F. EISENBERG |
|
|
|
Jeffrey F. Eisenberg |
|
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ JAMES PARSLOW |
|
|
|
James Parslow
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer) |
EXHIBIT 31.1
I, Jeffrey F. Eisenberg, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Xenetic Biosciences, Inc.; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 9, 2024
By: /s/ Jeffrey F. Eisenberg
Jeffrey F. Eisenberg
Chief Executive Officer
(Principal Executive Officer)
EXHIBIT 31.2
I, James Parslow, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Xenetic Biosciences, Inc.; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: May 9, 2024
By: /s/ James Parslow
James Parslow
Chief Financial Officer
(Principal Financial and Principal Accounting Officer)
EXHIBIT 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule
13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title
18 of the United States Code (18 U.S.C. §1350), Jeffrey F. Eisenberg, Chief Executive Officer of Xenetic Biosciences, Inc. (the “Company”),
and James Parslow, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
The Company’s Quarterly Report on Form 10-Q
for the period ended March 31, 2024, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully
complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
The information contained in the Periodic Report
fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 9, 2024
In Witness Whereof,
the undersigned have set their hands hereto as of the 9th day of May 2024.
/s/ Jeffrey F. Eisenberg |
/s/ James Parslow |
Jeffrey F. Eisenberg |
James Parslow |
Chief Executive Officer |
Chief Financial Officer |
“This certification accompanies the Form 10-Q to which it relates,
is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Xenetic
Biosciences, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before
or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.”
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v3.24.1.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 7,823,701
|
$ 8,983,046
|
Prepaid expenses and other |
552,043
|
603,828
|
Total current assets |
8,375,744
|
9,586,874
|
Other assets |
1,018,352
|
1,018,352
|
Total assets |
9,394,096
|
10,605,226
|
Current liabilities: |
|
|
Accounts payable |
210,483
|
240,832
|
Accrued expenses and other current liabilities |
506,011
|
568,753
|
Total current liabilities |
716,494
|
809,585
|
Total liabilities |
716,494
|
809,585
|
Commitments and contingencies |
0
|
0
|
Stockholders' equity: |
|
|
Common stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 1,543,385 shares issued as of March 31, 2024 and December 31, 2023; 1,540,684 shares outstanding as of March 31, 2024 and December 31, 2023 |
1,544
|
1,544
|
Additional paid in capital |
208,131,009
|
208,053,935
|
Accumulated deficit |
(194,429,309)
|
(193,234,196)
|
Accumulated other comprehensive income |
253,734
|
253,734
|
Treasury stock |
(5,281,180)
|
(5,281,180)
|
Total stockholders' equity |
8,677,602
|
9,795,641
|
Total liabilities and stockholders' equity |
9,394,096
|
10,605,226
|
Series B Preferred Stock [Member] |
|
|
Stockholders' equity: |
|
|
Preferred stock, value |
$ 1,804
|
$ 1,804
|
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v3.24.1.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
10,000,000
|
10,000,000
|
Common stock, shares, issued |
1,543,385
|
1,543,385
|
Common stock, shares, outstanding |
1,540,684
|
1,540,684
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares issued |
1,804,394
|
1,804,394
|
Preferred stock, shares outstanding |
1,804,394
|
1,804,394
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.1.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Revenue: |
|
|
Royalty revenue |
$ 510,817
|
$ 605,844
|
Total revenue |
510,817
|
605,844
|
Operating costs and expenses: |
|
|
Research and development |
(944,321)
|
(595,276)
|
General and administrative |
(834,910)
|
(925,743)
|
Total operating costs and expenses |
(1,779,231)
|
(1,521,019)
|
Loss from operations |
(1,268,414)
|
(915,175)
|
Other income: |
|
|
Other income |
52
|
4,520
|
Interest income, net |
73,249
|
54,101
|
Total other income |
73,301
|
58,621
|
Net loss |
$ (1,195,113)
|
$ (856,554)
|
X |
- DefinitionThe aggregate total of expenses of managing and administering the affairs of an entity, including affiliates of the reporting entity, which are not directly or indirectly associated with the manufacture, sale or creation of a product or product line.
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v3.24.1.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (Parenthetical) - $ / shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Income Statement [Abstract] |
|
|
Earnings Per Share, Basic |
$ (0.78)
|
$ (0.56)
|
Earnings Per Share, Diluted |
$ (0.78)
|
$ (0.56)
|
Weighted Average Number of Shares Outstanding, Basic |
1,540,684
|
1,516,659
|
Weighted Average Number of Shares Outstanding, Diluted |
1,540,684
|
1,516,659
|
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- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.1.u1
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
|
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Treasury Stock, Common [Member] |
Total |
Beginning balance, value at Dec. 31, 2022 |
$ 2,774
|
$ 1,520
|
$ 207,769,904
|
$ (189,099,618)
|
$ 253,734
|
$ (5,281,180)
|
$ 13,647,134
|
Ending balance, shares at Dec. 31, 2022 |
2,774,394
|
1,519,360
|
|
|
|
|
|
Share-based expense |
|
|
68,852
|
|
|
|
68,852
|
Net loss |
|
|
|
(856,554)
|
|
|
(856,554)
|
Ending balance, value at Mar. 31, 2023 |
$ 2,774
|
1,520
|
207,838,756
|
(189,956,172)
|
253,734
|
(5,281,180)
|
12,859,432
|
Ending balance, shares at Mar. 31, 2023 |
2,774,394
|
|
|
|
|
|
|
Beginning balance, value at Dec. 31, 2023 |
$ 1,804
|
$ 1,544
|
208,053,935
|
(193,234,196)
|
253,734
|
(5,281,180)
|
9,795,641
|
Ending balance, shares at Dec. 31, 2023 |
1,804,394
|
1,543,385
|
|
|
|
|
|
Share-based expense |
|
|
77,074
|
|
|
|
77,074
|
Net loss |
|
|
|
(1,195,113)
|
|
|
(1,195,113)
|
Ending balance, value at Mar. 31, 2024 |
$ 1,804
|
$ 1,544
|
$ 208,131,009
|
$ (194,429,309)
|
$ 253,734
|
$ (5,281,180)
|
$ 8,677,602
|
Ending balance, shares at Mar. 31, 2024 |
1,804,394
|
1,543,385
|
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.1.u1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (1,195,113)
|
$ (856,554)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Share-based expense |
77,074
|
68,852
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other |
51,785
|
(320,445)
|
Other assets |
0
|
222,500
|
Accounts payable, accrued expenses and other liabilities |
(93,091)
|
(216,791)
|
Net cash used in operating activities |
(1,159,345)
|
(1,102,438)
|
Net change in cash |
(1,159,345)
|
(1,102,438)
|
Cash at beginning of period |
8,983,046
|
13,097,265
|
Cash at end of period |
7,823,701
|
11,994,827
|
SUPPLEMENTAL CASH FLOW INFORMATION: |
|
|
Cash paid for interest |
$ 0
|
$ 0
|
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v3.24.1.u1
The Company
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
The Company |
Background
Xenetic Biosciences, Inc. (“Xenetic”
or the “Company”), incorporated in the state of Nevada and based in Framingham, Massachusetts, is a biopharmaceutical company
focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company’s proprietary Deoxyribonuclease
(“DNase”) platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil
extracellular traps (“NETs”), which have been implicated in cancer progression and resistance to cancer treatments. Xenetic
is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally
advanced or metastatic solid tumors. Additionally, Xenetic has partnered with biotechnology and pharmaceutical companies to develop its
proprietary drug delivery platform, PolyXen®, and receives royalty payments under an exclusive license arrangement in the
field of blood coagulation disorders.
As used in this Quarterly Report on Form 10-Q
(“Quarterly Report”), unless otherwise indicated, all references herein to “Xenetic,” the “Company,”
“we” or “us” refer to Xenetic Biosciences, Inc. and its wholly-owned subsidiaries.
The Company, directly or indirectly, through its
wholly-owned subsidiaries, Hesperix S.A. (“Hesperix”) and Xenetic Biosciences (U.K.) Limited (“Xenetic UK”), and
the wholly-owned subsidiaries of Xenetic UK, Lipoxen Technologies Limited (“Lipoxen”), Xenetic Bioscience, Incorporated and
SymbioTec, GmbH (“SymbioTec”), own various United States (“U.S.”) federal trademark registrations and applications
along with unregistered trademarks and service marks, including but not limited to XCART™, OncoHist™, PolyXen, ErepoXen™,
and ImuXen™, which may be used throughout this Quarterly Report. All other company and product names may be trademarks of the respective
companies with which they are associated.
Going Concern and Management’s Plan
Management evaluates whether there are conditions
or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the financial statements are issued. The Company has incurred substantial losses since its inception
and expects to continue to incur operating losses in the near-term. These factors raise substantial doubt about its ability to continue
as a going concern. The Company believes that it has access to capital resources through possible public or private equity offerings,
debt financings, corporate collaborations, related party funding, or other means to continue as a going concern. The Company believes
that its existing resources will be adequate to fund the Company’s operations for a period of at least twelve months from the date
of the issuance of these financial statements. However, the Company anticipates it may need additional capital in the long-term to pursue
its business initiatives. The terms, timing and extent of any future financing will depend upon several factors, including the achievement
of progress in its product development programs, its ability to identify and enter into licensing or other strategic arrangements, its
continued listing on the Nasdaq Stock Market (“Nasdaq”), and factors related to financial, economic, geo-political, industry
and market conditions, many of which are beyond its control. The capital markets for the biotech industry can be highly volatile, which
make the terms, timing and extent of any future financing uncertain.
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- DefinitionThe entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
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v3.24.1.u1
Risks and Uncertainties
|
3 Months Ended |
Mar. 31, 2024 |
Risks and Uncertainties [Abstract] |
|
Risks and Uncertainties |
2. |
Risks and Uncertainties |
Impact of Global
Conflicts on Operations
The short and long-term
implications of Russia’s invasion of Ukraine and conflict in the Middle East are difficult to predict at this time. The imposition
of current and future sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our
business, financial condition, and results of operations.
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- DefinitionThe entire disclosure for any concentrations existing at the date of the financial statements that make an entity vulnerable to a reasonably possible, near-term, severe impact. This disclosure informs financial statement users about the general nature of the risk associated with the concentration, and may indicate the percentage of concentration risk as of the balance sheet date.
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v3.24.1.u1
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
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, 2023 filed with the SEC on March 21, 2024, and amended on April 26, 2024.
On May 15, 2023, the Company effected a reduction,
on a 1-for-10 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
10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number
of shares of common stock into which each outstanding warrant, restricted stock unit, or option to purchase common stock was convertible
into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option
to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each
share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless otherwise indicated,
all of the share numbers, share prices, and exercise prices have been adjusted in this Quarterly Report, on a retroactive basis, to reflect
this 1-for-10 Reverse Stock Split.
Principles of Consolidation
The condensed consolidated financial statements
of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries: Lipoxen, Xenetic Bioscience,
Incorporated, and SymbioTec. All intercompany balances and transactions have been eliminated in consolidation.
Certain prior period amounts have been reclassified
in this Quarterly Report to conform to the presentation for the current period and had no impact on the reported results of operations.
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 months ended March 31, 2024 and
2023, 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.
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v3.24.1.u1
Significant Strategic Collaborations
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Significant Strategic Collaborations |
4. |
Significant Strategic Collaborations |
Takeda Pharmaceutical Co. Ltd. (together
with its wholly-owned subsidiaries, “Takeda”)
In October 2017, the Company granted to Takeda
the right to grant a non-exclusive sublicense to certain patents related to the Company’s PolyXen technology that were previously
exclusively licensed to Takeda in connection with products related to the treatment of blood and bleeding disorders. Royalty payments
of approximately $0.5 million and $0.6 million were recorded as revenue by the Company during the three months ended March 31, 2024 and
2023, respectively, and are based on single digit royalties on net sales of certain covered products. 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. At the time the revenue was received, there were no remaining
performance obligations and all other revenue recognition criteria were met.
Belgian Volition SARL Limited (“Volition”)
Collaboration
On August 2, 2022, the Company announced a research
and development collaboration with Volition to develop NETs-targeted adoptive cell therapies for the treatment of cancer. The collaboration
is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q® technology Test and the
Company’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid
cancers. Under the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds
from commercialization or licensing of any products arising from the collaboration. To date, Volition has funded $26,000 under this agreement.
Catalent Pharma Solutions LLC (“Catalent”)
On June 30, 2022, the Company entered into a Statement
of Work (the “SOW”) with Catalent to outline the general scope of work, timeline, and pricing pursuant to which Catalent will
provide certain services to the Company to perform cGMP manufacturing of the Company’s recombinant protein, Human DNase I. The parties
agreed to enter into a Master Services Agreement (“MSA”) that will contain terms and conditions to govern the project contemplated
by the SOW and that will supersede the addendum to the SOW containing Catalent's standard terms and conditions. In addition, in the event
of any conflict between the project-specific terms and conditions set forth in the SOW and the MSA, the MSA terms and conditions shall
govern. The Company has paid Catalent approximately $2.5 million through March 31, 2024, of which $28,000 and $0.1 million has been recognized
as an advance payment and is included in prepaid expenses and other current assets as of March 31, 2024 and December 31, 2023, respectively.
In addition, $0.3 million has been recognized within other assets as of both March 31, 2024 and December 31, 2023.
Scripps Research Institute (“Scripps
Research”)
On March 17, 2023, the Company and Scripps Research
entered into a Research Funding and Option Agreement (the “Agreement”), pursuant to which the Company has agreed to provide
Scripps Research an aggregate of up to $0.9 million to fund research relating to advancing the pre-clinical development of the Company’s
DNase oncology platform technology. Under the Agreement, the Company has the option to acquire a worldwide exclusive license to Scripps
Research’s rights in the Technology or Patent Rights (as defined in the Agreement), as well as a non-exclusive, royalty-free, non-transferrable
license to make and use TSRI Technology (as defined in the Agreement) solely for the Company’s internal research purposes during
the performance of the research program contemplated by the Agreement. Unless earlier terminated, the term of the Agreement continues
from the date of the Agreement for fifteen (15) months. The Agreement may be terminated by the Company with 30 days advance written notice
to Scripps Research or by Scripps Research if the Company fails to make timely payments due under the Agreement, subject to 30 days’
written notice to cure such nonpayment. The Agreement may further be terminated by either party in the event of the other party’s
uncured failure to perform any obligations under the Agreement or the bankruptcy of the other party. The Company has paid Scripps Research
approximately $0.9 million under the Agreement through March 31, 2024, of which approximately $0.1 million and $0.4 million has been recognized
as an advance payment and is included in prepaid expenses and other current assets as of March 31, 2024 and December 31, 2023, respectively.
University of Virginia (“UVA”)
On December 21, 2023, the Company entered into
a Research Funding and Material Transfer Agreement with UVA (the “UVA Agreement”) to advance the development of our systemic
DNase program. Under the terms of the UVA Agreement, in
addition to advancing our existing intellectual property, we have an option to acquire an exclusive license to any new intellectual property
arising from the DNase research program. Allan Tsung, MD, a member of the Company’s Scientific Advisory Board and Chair of
the Department of Surgery at the UVA School of Medicine, will oversee the research conducted under
the UVA Agreement. The Company has paid UVA approximately $0.1 million under the UVA Agreement through March 31, 2024, of which
approximately $29,000 has been recognized as an advance payment and is included in prepaid expenses and other current assets as of March
31, 2024. There were no amounts incurred as of December 31, 2023.
Other Agreements
The Company has also entered into various research,
development, license and supply agreements with Serum Institute of India (“Serum Institute”), PJSC Pharmsynthez (“Pharmsynthez”)
and SynBio LLC (“SynBio”), a wholly owned subsidiary of Pharmsynthez. The Company and its collaborative partners continue
to engage in research and development activities with no resultant commercial products through March 31, 2024. No amounts were recognized
as revenue related to the Serum Institute, Pharmsynthez or SynBio agreements during the three months ended March 31, 2024 and 2023, respectively.
|
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- DefinitionThe entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants.
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v3.24.1.u1
Fair Value Measurements
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
5. |
Fair Value Measurements |
Accounting Standards Codification Topic 820, Fair
Value Measurement, defines fair value as the price that would be received to sell an asset or be paid to transfer a liability in an
orderly transaction between market participants at the measurement date. The Company applies the following fair value hierarchy, which
prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest
level of input that is available and significant to the fair value measurement. Level 1 inputs are quoted prices in active markets for
identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 utilizes quoted market
prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency.
Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability
at the measurement date. As of March 31, 2024 and December 31, 2023, 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
during the three months ended March 31, 2024 and 2023.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.1.u1
Stockholders’ Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Common Stock
Each share of the Company’s
common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders
are entitled to dividends when and if declared by the Board of Directors. In the event of any voluntary or involuntary liquidation, dissolution
or winding-up of the Company, the holders of common stock are entitled to share ratably in the assets of the Company available for distribution.
On May 11, 2023, the Company filed a Certificate
of Change to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effect the Reverse Stock Split. The
Reverse Stock Split was effective at 12:01 a.m., Eastern Time, on May 15, 2023. No fractional shares were issued as a result of the Reverse
Stock Split and any remaining share fractions were rounded up to the nearest whole share, resulting in 15,941 new shares of common stock
being issued to existing holders of the Company’s common stock.
Warrants
The Company
has warrants to purchase approximately 462,963 shares of the Company’s common stock (the “Series A Warrants”) outstanding
as of both March 31, 2024 and December 31, 2023. The Series A Warrants are immediately exercisable at a price of $33.00 per share of common
stock and expire on February 23, 2025. No Series A Warrants were exercised or forfeited during the three months ended March 31, 2024 and
2023.
In addition, the Company has publicly traded warrants
to purchase approximately 2,100 shares of common stock outstanding as of both March 31, 2024 and December 31, 2023. These warrants have
an exercise price of $130.00 per share of common stock and expire on July 17, 2024. The warrants trade on Nasdaq under the symbol “XBIOW.”
The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is
lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis
for one share of common stock. None of these warrants were exercised or forfeited during the three months ended March 31, 2024 and 2023.
The Company also has warrants to purchase approximately
800 shares of the Company’s common stock outstanding as of both March 31, 2024 and
December 31, 2023. These warrants have an exercise price of $29.09 per share of common stock and expire on July 3, 2026. None of these
warrants were exercised or forfeited during the three months ended March 31, 2024 and 2023.
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v3.24.1.u1
Share-Based Expense
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Expense |
Total share-based expense related to stock options
and restricted stock units (“RSUs”) was approximately $0.1 million during each of the three months ended March 31, 2024 and
2023.
Share-based expense is classified in the condensed
consolidated statements of operations as follows:
Schedule of Share-Based Compensation Expense | |
| | |
| |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Research and development expenses | |
$ | 15,237 | | |
$ | 13,688 | |
General and administrative expenses | |
| 61,837 | | |
| 55,164 | |
| |
$ | 77,074 | | |
$ | 68,852 | |
Employee Stock Options
No stock option awards to purchase shares of common
stock were granted during the three months ended March 31, 2024 and 2023. The Company recognized a total of approximately $0.1 million of share-based expense related to employee stock options during each of the three months ended March 31, 2024 and 2023. No employee stock
options or RSUs were exercised and none expired during the three months ended March 31, 2024 and 2023.
Non-Employee Stock Options
There were no non-employee stock options granted
or exercised during the three months ended March 31, 2024 and 2023. No non-employee stock option grants expired during the three months
ended March 31, 2024. During the three months ended March 31, 2023, non-employee stock option grants to purchase approximately 100 shares
of common stock expired. The Company did not recognize any share-based expense related to non-employee stock options during the three
months ended March 31, 2024 and 2023.
|
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.1.u1
Income Taxes
|
3 Months Ended |
Mar. 31, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
During the three months ended March 31, 2024 and
2023, there was no provision for income taxes as the Company incurred losses during both periods. 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 $40.1 million and $39.7 million as of March 31, 2024 and December 31, 2023, respectively.
As of March 31, 2024 and December 31, 2023,
the Company did not record any unrecognized tax positions.
|
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v3.24.1.u1
Related Party Transactions
|
3 Months Ended |
Mar. 31, 2024 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
9. |
Related Party Transactions |
The Company has entered into various research,
development, license and supply agreements with Serum Institute and Pharmsynthez, each a related party whose relationship has not materially
changed from that disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC
on March 21, 2024, as amended on April 26, 2024.
During the fourth quarter
of 2019, the Company entered into a loan agreement with Pharmsynthez (the “Pharmsynthez Loan”), pursuant to which the Company
advanced Pharmsynthez an aggregate principal amount of up to $500,000 to be used for the development of a specific product under the Company’s
Co-Development Agreement with Pharmsynthez. The Pharmsynthez Loan had an initial term of 15-months and accrued interest at a rate of 10% per annum. The Pharmsynthez Loan was guaranteed by all of the operating subsidiaries of Pharmsynthez, including SynBio and AS Kevelt,
and was secured by all of the common and preferred stock of the Company owned by Pharmsynthez and SynBio.
Pharmsynthez paid all
obligations due under the Pharmsynthez Loan in May 2023, and no further amounts are due under the Pharmsynthez Loan. As a result, no amounts
were outstanding as of March 31, 2024 and December 31, 2023. The Company did not recognize any interest income related to the Pharmsynthez
Loan during the three months ended March 31, 2024 and 2023.
|
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v3.24.1.u1
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
The Company performed a review of events subsequent
to the balance sheet date through the date the financial statements were issued and determined that there were no such events requiring
recognition or disclosure in the financial statements.
|
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v3.24.1.u1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
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, 2023 filed with the SEC on March 21, 2024, and amended on April 26, 2024.
On May 15, 2023, the Company effected a reduction,
on a 1-for-10 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
10 shares of common stock were reduced to one share of common stock, with any fractional amounts rounded up to one share; (ii) the number
of shares of common stock into which each outstanding warrant, restricted stock unit, or option to purchase common stock was convertible
into was proportionately reduced on the same basis as the common stock; (iii) the exercise price of each outstanding warrant or option
to purchase common stock was proportionately increased on a 1-to-10 basis; and (iv) the number of shares of common stock into which each
share of preferred stock was convertible into was proportionately reduced on the same basis as the common stock. Unless otherwise indicated,
all of the share numbers, share prices, and exercise prices have been adjusted in this Quarterly Report, on a retroactive basis, to reflect
this 1-for-10 Reverse Stock Split.
|
Principles of Consolidation |
Principles of Consolidation
The condensed consolidated financial statements
of the Company include the accounts of Hesperix, Xenetic UK and Xenetic UK’s wholly owned subsidiaries: Lipoxen, Xenetic Bioscience,
Incorporated, and SymbioTec. All intercompany balances and transactions have been eliminated in consolidation.
Certain prior period amounts have been reclassified
in this Quarterly Report to conform to the presentation for the current period and had no impact on the reported results of operations.
|
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 months ended March 31, 2024 and
2023, 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.
|
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v3.24.1.u1
Significant Strategic Collaborations (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
|
Mar. 17, 2023 |
Aug. 02, 2022 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Royalty payments |
|
|
$ 510,817
|
$ 605,844
|
|
Research and development expenses |
|
|
944,321
|
595,276
|
|
Prepaid expenses and other current assets |
|
|
552,043
|
|
$ 603,828
|
Revenues |
|
|
510,817
|
605,844
|
|
Volition [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Proceeds from collaborator |
|
$ 26,000
|
|
|
|
Collaborative Agreements [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Revenues |
|
|
0
|
0
|
|
Takeda [Member] | Royalty Revenue [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Royalty payments |
|
|
500
|
$ 600
|
|
Catalent Pharma Solutions [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Research and development expenses |
|
|
2,500,000
|
|
|
Prepaid expenses and other current assets |
|
|
28,000
|
|
100,000
|
Other assets |
|
|
300,000
|
|
300,000
|
Scripps Research [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Research and development expenses |
$ 900,000
|
|
900,000
|
|
|
Prepaid expenses and other current assets |
|
|
100,000
|
|
400,000
|
University Of Virginia [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Research and development expenses |
|
|
100,000
|
|
|
Prepaid expenses and other current assets |
|
|
$ 29,000
|
|
$ 0
|
X |
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Stockholders’ Equity (Details Narrative) - $ / shares
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Maturity date |
Jul. 03, 2026
|
|
|
Publicly Traded Warrants [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Exercise price |
$ 130.00
|
|
|
Maturity date |
Jul. 17, 2024
|
|
|
Warrant Outstanding |
2,100
|
|
2,100
|
Warrants exercised shares |
0
|
0
|
|
Warrants forfeited shares |
0
|
0
|
|
Other Warrants [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Exercise price |
$ 29.09
|
|
$ 29.09
|
Warrant Outstanding |
800
|
|
800
|
Warrants exercised shares |
0
|
0
|
|
Warrants forfeited shares |
0
|
0
|
|
Series A Warrants [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Warrants issued |
462,963
|
|
462,963
|
Exercise price |
$ 33.00
|
|
|
Maturity date |
Feb. 23, 2025
|
|
|
Series A Warrants [Member] | Private Placement [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Warrants exercised |
0
|
0
|
|
Common Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Issuance of common stock to adjust for reverse split rounding, shares |
15,941
|
|
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|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
Share-based compensation |
$ 77,074
|
$ 68,852
|
Research and Development Expense [Member] |
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
Share-based compensation |
15,237
|
13,688
|
General and Administrative Expense [Member] |
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
Share-based compensation |
$ 61,837
|
$ 55,164
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