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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________
FORM 8-K
________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The
Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): March 13,
2026
________________________
Xenetic Biosciences,
Inc.
(Exact name of registrant as specified in charter)
| Nevada |
|
001-37937 |
|
45-2952962 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
| 945
Concord Street |
|
| Framingham, Massachusetts |
01701 |
| (Address of principal executive offices) |
(Zip Code) |
(781) 778-7720
(Registrant’s telephone number, including
area code)
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the
Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):
☐ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
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. ☐
| Item 2.02. |
Results of Operations and Financial Condition. |
On March 13, 2026, Xenetic Biosciences, Inc. (the
“Company”) issued a press release announcing results for the year ended December 31, 2025.
The full text of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K and hereby incorporated in this Item 2.02 by reference. The information in this Item
2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended,
except as shall be expressly set forth by specific reference in such filing.
FORWARD-LOOKING STATEMENTS
This Form 8-K, including the press release, contains
forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. All statements contained in this Form 8-K, including the press release, other than statements of historical facts may constitute
forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,”
“plans,” “projects,” “will,” “may,” “anticipates,” “believes,”
“should,” “intends,” “estimates,” and other words of similar meaning. Any forward-looking statements
contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause
our actual activities, performance, achievements or results to differ materially from the activities and results anticipated in forward-looking
statements. These risks and uncertainties include those described in the “Risk Factors” section as detailed from time to
time in the Company’s reports filed with the Securities and Exchange Commission (“SEC”), including the Company’s
annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC.
In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions,
including potential adverse effects of public health issues and geopolitical events, such as the conflicts in the Ukraine and in the
Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation,
the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation,
and shareholder activism, among other factors. The forward-looking statements contained in this Form 8-K, including the press release,
speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements,
except as required by law.
| Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
|
Description |
| |
|
|
| 99.1 |
|
Press Release dated March 13, 2026 pertaining to the financial results of the Company for
the year ended December 31, 2025. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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 hereunto
duly authorized.
| |
XENETIC BIOSCIENCES, INC. |
| |
|
|
| |
By: |
/s/ James Parslow |
| Date: March 13, 2026 |
Name: |
James Parslow |
| |
Title: |
Interim Chief Executive Officer and Chief Financial Officer |
Exhibit 99.1
Xenetic Biosciences,
Inc. Reports Full Year 2025 Financial Results
Encouraging preclinical and translational data
supporting DNase-based approaches to target NETs in difficult-to-treat cancers
Strategic focus on investigator-initiated exploratory studies and institutional collaborations
Continued progress toward IND-enabling activities for DNase I program
Ended the year with $7.9 million of cash to fund operations
FRAMINGHAM,
MA – (March 13, 2026) – Xenetic Biosciences,
Inc. (NASDAQ: XBIO) (“Xenetic” or the “Company”), a biopharmaceutical
company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, today reported its financial
results for the year ended December 31, 2025.
Recent Highlights
| · | Expanded and presented preclinical and translational evidence supporting
neutrophil extracellular traps (NETs) as drivers of cancer progression and highlighting the therapeutic potential of Deoxyribonuclease
(DNase) -based interventions; |
| · | Progressed investigator-initiated exploratory studies in Israel evaluating DNase I in combination with
standard-of-care and immunotherapy platforms, including: |
| o | Ongoing pancreatic ductal adenocarcinoma (PDAC) study; |
| o | Proposed large B-cell lymphoma (LBCL) study in combination with Chimeric Antigen Receptor (CAR) T cell
therapy; |
| · | Advanced clinical manufacturing activities for DNase I toward Investigational New Drug (IND) application; |
| · | Current focus on mechanism-of-action and translational research studies supported by encouraging CAR-T
proof-of-concept studies with Scripps Research; and |
| · | Pursuing strategic alternatives to maximize shareholder value. |
"During 2025, we continued to advance our
DNase-based technology toward Phase 1 clinical development while making steady progress across scientific, operational and strategic fronts,”
said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. “We strengthened the evidence linking
NETs to cancer progression and the therapeutic promise of DNase-based strategies, advanced multiple investigator-initiated studies and
progressed toward IND-enabling activities. We believe these efforts position the Company well as we move through 2026, while remaining
disciplined in our use of capital and focused on creating long-term shareholder value.”
Xenetic continues to advance its DNase-based technology toward Phase 1 clinical development for the treatment of pancreatic carcinoma
and other locally advanced or metastatic solid tumors. During 2025, the Company completed preclinical studies evaluating DNase I in combination
with chemotherapy, immunotherapies and CAR-T approaches across both solid and hematologic cancer models. Data generated from these studies
are informing ongoing translational work and manufacturing activities as the Company progresses toward U.S. IND submission.
Summary of Financial Results for Fiscal Year
2025
Net loss for the year ended December 31, 2025 was approximately $2.7 million, reflecting investment in the Company’s most promising
scientific programs. Royalty revenue from the Company’s sublicense with Takeda Pharmaceuticals Co. Ltd increased approximately 19%
to $3.0 million in the year ended December 31, 2025 from $2.5 million for the year ended December 31, 2024 primarily due to royalty payments
received from certain countries. Research and development expenses for the year ended December 31, 2025 decreased by approximately $0.2
million, or 7%, to $3.1 million from $3.3 million in the prior year period. Research and development costs for the year ended December
31, 2024 included a $0.7 million impairment charge that did not reoccur in 2025. This decrease was substantially offset by increased spending
in connection with the Company's DNase process development efforts. General and administrative expenses for the year ended December 31,
2025 were $2.7 million, decreasing by approximately $0.7 million, or 20%, compared to the prior year. This decrease was primarily due
to certain severance and benefits expensed during the year ended December 31, 2024 in connection with a separation agreement entered into
during the second quarter of 2024 with our former Chief Executive Officer.
The Company ended the year with approximately
$7.9 million of cash, representing an increase of approximately $1.7 million compared to the prior year-end, primarily due to net proceeds
of approximately $4.0 million from an underwritten public offering completed in October 2025.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical
company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers. The Company's proprietary
DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular
traps (NETs), which are involved in cancer progression. 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.
For more information, please visit the Company's website at www.xeneticbio.com and connect on X, LinkedIn, and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements
that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained
in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal
securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will,"
"may," "anticipates," "believes," "should," "intends," "estimates," "remain,"
"focus", "confidence in", "potential", "continues", "warrants", and other words of similar
meaning, including, but not limited to, all statements regarding our belief that our efforts position the Company well as we move through
2026, while remaining disciplined in our use of capital and focused on creating long-term shareholder value, expectations regarding data
generated informing ongoing translational work and manufacturing activities as the Company progresses toward U.S. IND submission, our
focus on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, the DNase platform improving outcomes
of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression,
and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced
or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations and are subject to a number
of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially
from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance,
achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs,
charges or expenses resulting from our manufacturing and collaboration agreements; (2) unexpected costs, charges or expenses resulting
from the licensing of the DNase platform; (3) uncertainty of the expected financial performance of the Company following the licensing
of the DNase platform; (4) failure to realize the anticipated potential of the DNase or PolyXen technologies; (5) the ability of the Company
to obtain funding and implement its business strategy; (6) risks and uncertainties as to the outcome and timing of the strategic review
process being conducted by the Board and a special independent committee thereof, including the possibility that the Board may decide
not to undertake a strategic alternative following the evaluation process, the Company's inability to consummate any proposed strategic
alternative resulting from the review due to, among other things, market, regulatory and other factors, the potential for disruption to
our business resulting from the review process, and potential adverse effects on the Company's stock price from the announcement, suspension
or consummation of the evaluation process and the results thereof, as well as risks and uncertainties related to the potential impacts
of consummation of a strategic transaction on the Company's current business operations, anticipated business strategy and product development
plans; and (7) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report
on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing
list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors,
general economic and business conditions, including potential adverse effects of public health issues, and geopolitical events, such as
the conflicts in Ukraine and in the Middle East, on economic activity, competitive product development, product availability, federal
and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may
arise, patent positions, litigation, and shareholder activism, among other factors. The forward-looking statements contained in this press
release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking
statements, except as required by law.
Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
xbio@jtcir.com