STOCK TITAN

Xenetic to acquire Santersus in all-stock deal

All-stock acquisition will give Santersus holders about 85% of Xenetic and create Santersus Bio, Inc., a Nasdaq-listed NET-targeting therapeutics company.

(Very High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Xenetic Biosciences, Inc. (XBIO) entered into a Share Exchange Agreement to acquire all of the outstanding share capital of Swiss company Santersus AG in an all‑stock transaction, with Santersus becoming a wholly owned subsidiary. At closing, Santersus shareholders are expected to own approximately 85% and existing Xenetic stockholders about 15% of the combined company on a fully diluted, as‑converted basis, subject to net cash and other adjustments. The combined company is expected to be renamed Santersus Bio, Inc. and listed on the Nasdaq Capital Market under the symbol “SNTS”, with an eight‑member board (six designated by Santersus and two by Xenetic) and Santersus CEO James Ladtkow leading management. Closing is targeted for the fourth quarter of 2026 and is conditioned on Xenetic stockholder approval, effectiveness of a resale Form S‑1, Nasdaq listing approval for the new shares, and other customary conditions; Xenetic may owe a $500,000 termination fee and up to $300,000 in expense reimbursement in certain break scenarios.

Positive

  • Transformative all-stock acquisition combines Xenetic and Santersus into a single NET-targeting therapeutics company with four first-in-class clinical programs, including pivotal-stage sepsis and SLE programs that have received FDA Breakthrough Device Designation.
  • Strategic control and leadership alignment: post-closing board will have eight members (six designated by Santersus), and Santersus CEO James Ladtkow will lead the combined company, supporting unified execution around the NET-focused strategy.
  • Clear capital markets plan: the combined company is expected to remain Nasdaq-listed under the new name Santersus Bio, Inc. and ticker “SNTS,” with a resale Form S-1 planned for shares issued in the acquisition and 180-day lock-ups for key holders.

Negative

  • Significant dilution and change of control: Santersus equity holders are expected to own about 85% of the combined company on a fully diluted, as-converted basis, materially reducing existing Xenetic stockholders’ ownership and influence.
  • Execution and closing risk: completion depends on stockholder approval, effectiveness of a resale Form S-1, Nasdaq listing approval and other conditions; failure or delay could trigger a $500,000 termination fee and up to $300,000 in expense reimbursements.
  • Funding and listing risks disclosed: the companies highlight risks that the combined company may need additional capital, could face clinical and regulatory uncertainties, and might have to pursue a reverse stock split to maintain Nasdaq listing compliance.

Filing Explained

The filing separates a planned dilutive issuance from its later resale registration and reports voting commitments covering about 9.0% of Xenetic shares.

The September 14, 2026 agreement records a planned stock issuance rather than a completed issuance; if it closes, the new shares would reduce existing holders’ percentage ownership.

The shares are offered to Santersus sellers under a private-placement exemption, while the planned Form S-1 would register their later resale; registration alone does not sell the shares.

Separate voting agreements cover approximately 9.0% of Xenetic’s outstanding common stock, with those holders agreeing to support the transaction and oppose competing proposals.

The filing identifies a possible reverse stock split if the combined company needs it to meet Nasdaq’s minimum-price requirement, but announces no split.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 3.02 Unregistered Sales of Equity Securities Securities
The company sold equity securities in a private placement or other unregistered transaction.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Pro forma ownership – Santersus holders Approximately 85% of combined company equity Expected post-closing, fully diluted and as-converted, subject to adjustments
Pro forma ownership – existing Xenetic holders Approximately 15% of combined company equity Expected post-closing, fully diluted and as-converted, subject to adjustments
Voting support stake Approximately 9.0% of outstanding common stock Xenetic officers, directors and other stockholders subject to Company Voting Agreements as of September 14, 2026
Termination fee $500,000 Payable by Xenetic to Santersus if the agreement is terminated under specified circumstances
Expense reimbursement cap Up to $300,000 Potential mutual reimbursement of fees and expenses if certain termination conditions occur
Lock-up period 180 days Duration during which certain officers, directors and stockholders agreed not to sell post-closing shares
Board size post-closing 8 directors Two designated by Xenetic and six by Santersus, with chair designated by Santersus
Expected closing timeframe Fourth quarter of 2026 Targeted completion period for the proposed acquisition, subject to conditions
Share Exchange Agreement regulatory
"entered into a Share Exchange Agreement with Santersus AG and the Sellers"
A share exchange agreement is a legal deal where shareholders trade their shares in one company for shares in another, commonly used in mergers, acquisitions or corporate reorganizations. Think of it like swapping ownership cards in a game: the swap can change who controls the business, how many shares each person owns, and the value and liquidity of those holdings, so investors need to understand the exchange ratio, potential dilution and long-term impact on value and voting power.
Breakthrough Device Designation medical
"pivotal-stage programs in sepsis and systemic lupus erythematosus that have received FDA Breakthrough Device Designation"
A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.
neutrophil extracellular traps medical
"focused on targeting neutrophil extracellular traps (NETs), a driver of disease"
Neutrophil extracellular traps (NETs) are web-like strands of DNA and proteins expelled by certain white blood cells to trap and neutralize invading germs, like a spider spinning a sticky web to catch insects. For investors, NETs matter because they are linked to inflammation, blood clots and chronic disease, making them potential targets for new diagnostics and therapies and a factor in safety and efficacy assessments for drug and device development.
normothermic machine perfusion medical
"developed for use during normothermic machine perfusion of donor livers"
CAR-T cells medical
"DNase technology is being evaluated in combination with anti-CD19 CAR-T cells"
CAR-T cells are a type of therapy where a patient’s own immune cells are removed, genetically reprogrammed to recognize specific cancer markers, and returned to the body so they can seek and destroy tumor cells — like turning ordinary soldiers into guided missiles trained for a single target. Investors care because CAR-T therapies can command high prices and create durable revenue streams but also carry regulatory, manufacturing and safety uncertainties that affect development timelines, costs and returns.
Registration Statement on Form S-1 regulatory
"will file with the SEC a Proxy Statement and Registration Statement on Form S-1"
A registration statement on Form S-1 is a detailed filing a company submits to the U.S. securities regulator to register new shares for public sale; it includes a plain-language prospectus, financial statements, business description and risk factors. For investors it matters because it provides the official, comprehensive blueprint of the offering — like an owner’s manual — allowing buyers to assess risks, inspect financial health and compare valuation before deciding to invest.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What transaction did Xenetic Biosciences (XBIO) announce with Santersus AG?

Xenetic entered into a Share Exchange Agreement to acquire all outstanding share capital of Santersus AG in an all-stock transaction, making Santersus a wholly owned subsidiary once closing conditions, including stockholder approvals, are satisfied.

How will ownership of XBIO change after the Santersus acquisition closes?

On a pro forma, fully diluted and as-converted basis, Santersus equity holders are expected to own about 85% of the combined company and existing Xenetic stockholders about 15%, subject to adjustments such as Xenetic’s net cash at closing.

What will the combined Xenetic–Santersus company be called and where will it trade?

After closing, Xenetic Biosciences is expected to be renamed Santersus Bio, Inc., and shares of the combined company are expected to be listed on the Nasdaq Capital Market under the new ticker symbol “SNTS.”

What shareholder approvals are required for the XBIO–Santersus deal?

Xenetic stockholders will be asked to approve: issuance of the acquisition consideration and the resulting change of control, amendments to increase authorized shares and change the corporate name, and any plan changes needed to implement the acquisition.

Are key Xenetic holders supporting the Santersus transaction?

Yes. Certain Xenetic officers, directors and other stockholders holding about 9.0% of Xenetic’s outstanding common stock signed voting and support agreements to vote for the acquisition and against competing proposals.

What lock-up restrictions apply to Xenetic and Santersus stakeholders?

Certain officers, directors and stockholders of both companies entered into 180-day lock-up agreements restricting sales or transfers of their post-closing common stock, subject to limited exceptions.

When is the Xenetic–Santersus acquisition expected to close?

The proposed transaction is expected to close in the fourth quarter of 2026, subject to Xenetic stockholder approval, effectiveness of a resale Form S-1, Nasdaq listing approval for the new shares, and other customary closing conditions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Learn about SEC filing dates
false 0001534525 0001534525 2026-09-14 2026-09-14 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

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): September 14, 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 1.01. Entry into a Material Definitive Agreement.

 

Share Exchange Agreement

 

On September 14, 2026, Xenetic Biosciences, Inc., a Nevada corporation (“Xenetic” or the “Company”), entered into a Share Exchange Agreement (the “Exchange Agreement”) with Santersus AG, a Swiss corporation (Aktiengesellschaft) (“Santersus”), the sellers listed on Schedule I thereto (each, a “Seller,” and collectively with the holders of Santersus securities who subsequently become parties to the Exchange Agreement, the “Sellers”) and Santersus, in its capacity as representative of the Sellers, pursuant to which, subject to the satisfaction or waiver of the conditions set forth in the Exchange Agreement, Xenetic will acquire the entire issued share capital of Santersus, with Santersus becoming a wholly owned subsidiary of Xenetic (the “Acquisition”). The Acquisition is intended to constitute a tax-free reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended. Unless otherwise defined herein, the capitalized terms used below are defined in the Exchange Agreement.

 

At the closing of the Acquisition (the “Closing”), each issued and outstanding ordinary share of Santersus (the “Santersus Shares”) will be sold to Xenetic in exchange for a number of shares of Xenetic common stock, par value $0.001 per share (“Company Common Stock”), based on the exchange ratio set forth in the Exchange Agreement (the “Exchange Ratio”) rounded to the nearest whole share of Company Common Stock after aggregating all fractional shares of Company Common Stock issuable to each Seller (the “Acquisition Consideration”). No fractional shares of Company Common Stock will be issued. At the Closing, each option to purchase Santersus ordinary shares that is outstanding and unexercised immediately prior to the Closing, whether or not vested, will be converted into and become an option to purchase Company Common Stock, and will be assumed by Xenetic in accordance with the Santersus Option Plan and the applicable option agreement, with the number of shares and exercise price adjusted based on the Exchange Ratio. Xenetic will also assume the Santersus Option Plan solely with respect to such options.

 

Immediately following the Closing, the holders of Santersus Shares are expected to own approximately 85% of the outstanding shares of Company Common Stock, with existing Xenetic stockholders owning the balance, on a fully diluted basis as calculated in the Exchange Agreement and assuming Net Cash of $0 at the Closing. The final ownership percentages of the combined company that each party’s equity holders will own following the Closing is subject to certain adjustments as described in the Exchange Agreement, including the Net Cash calculation. For purposes of the Exchange Agreement, “Santersus Shares” include the issued and outstanding Santersus ordinary shares, the Santersus ordinary shares into which Santersus preferred shares will convert immediately prior to the Closing, and any Santersus ordinary shares issued upon exercise of Santersus options at or prior to the Closing. Santersus has also agreed to cause each person who acquires Santersus ordinary shares after the execution of the Exchange Agreement, including through the conversion of Santersus preferred shares or the exercise of Santersus options, to become a party to the Exchange Agreement by executing a joinder agreement.

 

 

 

 

 2 

 

 

In connection with the Acquisition, Xenetic will prepare and file with the U.S. Securities and Exchange Commission (the “SEC”) a proxy statement (the “Proxy Statement”), and mail the Proxy Statement to Xenetic stockholders, to seek the approval of Xenetic’s stockholders with respect to certain actions related to the Acquisition (such matters related to the Acquisition, the “Company Stockholder Approval Matters”):

 

  · the issuance of the Acquisition Consideration and the change of control of Xenetic resulting from the Acquisition pursuant to applicable Nasdaq rules;
     
  · the amendment of Xenetic’s articles of incorporation to increase the number of authorized shares and to change Xenetic’s name to Santersus Bio, Inc. effective immediately following the Closing; and
     
  · the approval of any amendments to, or the adoption of, any option or warrant plans of Xenetic to give effect to the Acquisition.

 

The Proxy Statement will also seek the approval of Xenetic’s stockholders with respect to certain actions related to Xenetic’s 2026 annual meeting of stockholders, including the election of Xenetic’s director nominees to the Xenetic board of directors (the “Xenetic Board”); ratification of the selection by Xenetic’s Audit Committee of CBIZ CPAs P.C. as the independent registered public accounting firm of Xenetic for its fiscal year ending December 31, 2026; and the approval, by non-binding advisory vote, of a resolution approving the named executive officer compensation.

 

Concurrently with the execution of the Exchange Agreement, certain stockholders of Xenetic, including certain of its officers and directors, entered into voting and support agreements (the “Company Voting Agreements”) in favor of Santersus and the Sellers, pursuant to which such stockholders agreed, among other things, to vote their shares of Company Common Stock (i) in favor of the Company Stockholder Approval Matters, (ii) against any proposal made in opposition to, or in competition with, the Exchange Agreement or the Acquisition and (iii) against any acquisition proposal involving a third party. As of September 14, 2026, such stockholders held, in the aggregate, approximately 9.0% of the outstanding shares of Company Common Stock.

 

The offer of the Company Common Stock to the Sellers was made in reliance on an exemption from the registration provisions of the Securities Act of 1933, as amended (the “Securities Act”), set forth in Section 4(a)(2) thereof and/or Regulation D promulgated thereunder, relating to sales by an issuer not involving a public offering. The Sellers have each represented that it is an “accredited investor” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act. Concurrently with the filing of the Proxy Statement, Xenetic will prepare and file with the SEC a resale registration statement on Form S-1 to register the resale of the shares of Company Common Stock to be issued in the Acquisition (the “Registration Statement”).

 

The Exchange Agreement contains customary representations, warranties and covenants of Xenetic and Santersus, including, among others, covenants that require each of Xenetic and Santersus to (i) conduct its business in the ordinary course during the period between the execution of the Exchange Agreement and the Closing or earlier termination of the Exchange Agreement, subject to certain exceptions, and (ii) not engage in certain kinds of transactions during such period (without the prior written consent of the other). Subject to certain terms and conditions, the Xenetic Board, upon the recommendation of its independent special committee, will recommend the approval of the Company Stockholder Approval Matters. Each of Xenetic and Santersus have agreed not to (i) solicit proposals relating to alternative business combination transactions or (ii) subject to certain exceptions, enter into discussions or negotiations or provide confidential information in connection with any proposals for alternative business combination transactions.

 

Completion of the Acquisition is subject to a number of conditions, including (i) approval by Xenetic’s stockholders of the Company Stockholder Approval Matters; (ii) the effectiveness of the Registration Statement and the absence of any related stop order; (iii) approval of the shares of Company Common Stock to be issued in the Acquisition for listing on Nasdaq, subject to official notice of issuance and consummation of the transactions contemplated by the Exchange Agreement; (iv) the accuracy of the representations and warranties, subject to certain materiality qualification, (v) compliance by the parties with their respective covenants, (vi) no law or order preventing the Acquisition and related transactions, and (vii) certain other customary closing conditions. The Exchange Agreement contains certain termination rights for both Xenetic and Santersus, and further provides that upon termination of the Exchange Agreement under specified circumstances, Xenetic may be required to pay Santersus a termination fee of $500,000. In addition, under certain conditions, Xenetic and Santersus may each be required to reimburse the other party for fees and expenses up to $300,000.

 

 

 

 3 

 

 

Governance

 

Following the Closing, it is expected that the board of directors of the combined company will consist of eight members, two of whom will be designated by Xenetic and six of whom will be designated by Santersus, with the chairman of the board to be designated by Santersus. Following the Closing, the Company will change its name to Santersus Bio, Inc. and it is expected that shares of common stock of the combined company will be listed on the Nasdaq Capital Market under the symbol “SNTS.”

 

Lock-Up Agreements

 

Concurrently with the execution of the Exchange Agreement, certain officers, directors and stockholders of Xenetic and Santersus entered into lock-up agreements (collectively, the “Lock-Up Agreements”), pursuant to which such parties agreed, among other things, to not sell or transfer their shares of post-Closing Company Common Stock for a 180-day period following the Closing, other than certain limited exceptions.

 

The foregoing summary descriptions of the Exchange Agreement, Company Voting Agreements, and Lock-Up Agreements do not purport to be complete and are subject to and qualified in their entirety by reference to the Exchange Agreement, the form of Company Voting Agreements, the form of Company Lock-Up Agreement and the form of Santersus Lock-Up Agreement, copies of which are attached hereto as Exhibits 2.1, 10.1, 10.2 and 10.3 respectively, and the terms of which are incorporated herein by reference.

 

The Exchange Agreement, Company Voting Agreements and Lock-Up Agreements (collectively, the “Transaction Agreements”) have been included as exhibits to this Current Report on Form 8-K to provide investors and security holders with information regarding their respective terms. They are not intended to provide any other financial information about the respective parties thereto or their respective subsidiaries or affiliates. The representations, warranties and covenants contained in the Transaction Agreements were made only for purposes of those agreements and as of specific dates; were solely for the benefit of the parties thereto; may be subject to limitations agreed upon by such parties, including being qualified by confidential disclosures made for the purposes of allocating contractual risk between the parties thereto instead of establishing these matters as facts; and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the parties to the Transaction Agreements or any of their respective subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations, warranties and covenants may change after the date of the Transaction Agreements, which subsequent information may or may not be fully reflected in public disclosures by the parties thereto.

 

Item 3.02. Unregistered Sales of Equity Securities.

 

The disclosure contained in Item 1.01 above is hereby incorporated into this Item 3.02 by reference.

 

 

 

 4 

 

 

Item 7.01. Regulation FD Disclosure.

 

Attached as Exhibit 99.1 is a copy of the joint press release issued by Xenetic and Santersus on September 16, 2026 announcing the execution of the Exchange Agreement. Xenetic and Santersus will host a joint conference call and webcast on September 16, 2026 at 8:30 a.m. Eastern Time to discuss the proposed Acquisition. A copy of the slide presentation to be used during the joint conference call is attached hereto as Exhibit 99.2.

 

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is being furnished, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.

 

Additional Information and Where to Find It

 

This communication relates to the proposed acquisition transaction involving Xenetic and Santersus and may be deemed to be solicitation material in respect of the Acquisition. In connection with the Acquisition, Xenetic will file with the SEC a Proxy Statement and Registration Statement on Form S-1. Each party may also file other documents regarding the Acquisition with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY THE PROXY STATEMENT, REGISTRATION STATEMENT ON FORM S-1, AND OTHER RELEVANT DOCUMENTS FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE ACQUISITION, RELATED MATTERS AND THE PARTIES TO THE ACQUISITION. Investors and security holders may obtain a free copy of the Proxy Statement, the Registration Statement on Form S-1, and other relevant documents (if and when they become available) that are or will be filed with the SEC for free at the SEC’s website at www.sec.gov. Copies of the documents (when they become available) filed with the SEC by Xenetic Biosciences will be available free of charge on Xenetic’s website at http://xeneticbio.com.

 

Participants in the Solicitation

 

Xenetic, and its directors and executive officers, and Santersus, and its directors and officers, may be deemed to be participants in the solicitation of proxies from the stockholders of Xenetic in connection with the Acquisition under the rules of the SEC. Information about the interests of these directors and executive officers and other persons who may be deemed to be participants in the solicitation of stockholders of Xenetic in connection with the Acquisition and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the Proxy Statement related to the Acquisition, which will be filed with the SEC. Additional information about Xenetic, the directors and executive officers of Xenetic and their ownership of Xenetic common stock can also be found in its Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and amended on April 24, 2026, and its definitive proxy statement, as filed with the SEC on October 31, 2025, and other documents subsequently filed by Xenetic with the SEC. Free copies of these documents may be obtained as described above. To the extent holdings of Xenetic securities by its directors or executive officers have changed since the amounts set forth in such documents, such changes have been or are expected to be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the Proxy Statement relating to the Acquisition when it is filed with the SEC.

 

 

 

 5 

 

 

No Offer or Solicitation

 

This Current Report on Form 8-K is for informational purposes only. This communication shall not constitute an offer to subscribe for, buy or sell or the solicitation of an offer to subscribe for, buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of, or offer to sell or buy, securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This communication is for informational purposes only. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act, and otherwise in accordance with applicable law.

 

Forward-Looking Statements

 

This Current Report on Form 8-K, including the press release, contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding the structure, timing and completion of the Acquisition; the combined company’s listing on Nasdaq after closing of the Acquisition; expectations regarding the ownership structure of the combined company; the anticipated timing of closing; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of NucleoCapture and Xenetic’s DNase technology; anticipated clinical drug development activities and related timelines, including the expected timing for data and other clinical results; the competitive landscape of the combined company; the expected board composition of the combined company; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and were based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Xenetic, Santersus or the combined company’s control. Actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) the risk that the conditions to the closing of the Acquisition are not satisfied, including the failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing of the consummation of the Acquisition and the ability of each of Xenetic and Santersus to consummate the Acquisition; (iii) risks related to each parties’ ability to manage its operating expenses and its expenses associated with the Acquisition pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Acquisition; (v) the risk that as a result of adjustments to the exchange ratio, Xenetic stockholders and Santersus stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Xenetic common stock relative to the value suggested by the exchange ratio; (vii) unexpected costs, charges or expenses resulting from the Acquisition; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Acquisition; (ix) the uncertainties associated with Xenetic platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its clinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (xiii) risks associated with the possible failure to realize certain anticipated benefits of the Acquisition, including with respect to future financial and operating results, (xiv) risks related to the inability of the combined company to maintain compliance with Nasdaq listing requirements following Closing, and the potential need for the combined company to effect a reverse stock split of the Company Common Stock in order to satisfy Nasdaq listing requirements; (xv) risks related to the combined company raising additional working capital and financing its business; and (xvi) the other factors discussed under the heading “Risk Factors” in Xenetic’s most recent Annual Report on Form 10-K and other filings with the SEC, among others. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in filings that Xenetic makes and will make with the SEC in connection with the Acquisition, including Xenetic’s Proxy Statement described above under “Additional Information and Where to Find It.” You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Xenetic, Santersus and the combined company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

 

 

 

 6 

 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
2.1   Share Exchange Agreement, dated as of September 14, 2026, by and among Xenetic Biosciences, Inc., Santersus AG, the Sellers listed on Schedule I thereto and Santersus AG, as Representative of the Sellers.*
10.1   Form of Company Voting Agreement.
10.2   Form of Company Lock-Up Agreement.
10.3   Form of Santersus Lock-Up Agreement.
99.1   Joint Press Release, dated September 16, 2026.
99.2   Presentation.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

* Exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. Xenetic hereby undertakes to furnish supplementally copies of any of the omitted exhibits or schedules upon request by the SEC.

 

 

 

 

 

 

 7 

 

 

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: September 16, 2026 Name: James Parslow
  Title: Interim Chief Executive Officer and Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 8 

Exhibit 99.1

 

 

Xenetic Biosciences and Santersus AG Announce Definitive Share Exchange Agreement to Create Global Leader in NET-Targeting Therapeutics

 

Transaction expected to create a Nasdaq-listed, multi-indication clinical-stage company focused on targeting neutrophil extracellular traps (NETs), a driver of disease across critical care, autoimmune disease, transplantation and oncology

 
Union of two companies brings together Santersus’ NucleoCapture® technology, designed to physically remove NETs from circulation, with Xenetic’s DNase technology, designed to enzymatically degrade NETs in tissue

 

Joint pipeline includes four first-in-class programs, including pivotal-stage programs in sepsis and systemic lupus erythematosus (SLE), both of which have received FDA Breakthrough Device Designation

 

Companies to host Business Update Conference Call and Webcast Today, Wednesday, September 16th at 8:30 AM ET

 

FRAMINGHAM, MA – (September 16, 2026)Xenetic Biosciences, Inc. (Nasdaq: XBIO) (“Xenetic”), a biopharmaceutical company advancing its Deoxyribonuclease (“DNase”) technology, and Santersus AG (“Santersus”), a privately held therapeutic medical device company advancing its NucleoCapture® selective blood purification platform, today announced that they have entered into a definitive share exchange agreement pursuant to which Xenetic will, subject to stockholder approval, acquire all of the outstanding share capital of Santersus in exchange for newly issued shares of Xenetic in an all-stock transaction (the “Proposed Transaction”). The combined company is expected to continue to trade on the Nasdaq Capital Market as Santersus Bio, Inc. under new ticker symbol “SNTS.”

 

The Proposed Transaction is expected to create a Nasdaq-listed, multi-indication clinical-stage company focused on a single high-impact therapeutic target: neutrophil extracellular traps, or NETs. Increasing evidence implicates NETs in the pathology of diseases spanning critical care, autoimmune disease, transplantation and oncology. By combining two complementary approaches to targeting NETs, NucleoCapture®, which is designed to physically remove NETs from circulation, and Xenetic’s DNase technology, which is designed to enzymatically degrade NETs in tissue — the combined company is expected to have a differentiated therapeutic platform capable of targeting NET-driven disease through two distinct modalities.

 

“Therapeutic targeting of neutrophil extracellular traps is rapidly evolving as an important medical concept, and we believe bringing NucleoCapture and DNase together creates a uniquely positioned company focused on translating that biology into therapies across multiple areas of significant unmet medical need,” said James Ladtkow, Chief Executive Officer of Santersus AG. “NucleoCapture® and Xenetic’s DNase technology address the pathological signaling and biological effects mediated by NETs through complementary approaches, one removing NETs from circulation and the other degrading NETs in tissue. The combination is expected to bring four first-in-class clinical programs into a single company built around one therapeutic target, including pivotal-stage programs in sepsis and systemic lupus erythematosus that have each received FDA Breakthrough Device Designation”

 

Mr. Ladtkow continued, “We believe this combination provides an opportunity to establish a leadership position in an emerging therapeutic field while building a company with multiple potential value-creating clinical catalysts. I look forward to leading the combined organization and advancing therapies that have the potential to save lives and improve outcomes for patients across diseases where substantial unmet needs remain.”

 

“As a result of our strategic review process, the combination with Santersus will advance Xenetic closer to the clinic while continuing to advance our core technologies and maximizing stockholder value. Xenetic’s DNase technology was built on the insight that NETs have been implicated in the context of cancer pathogenesis and resistance to cancer therapies and can form mechanical barriers that impede T-cell penetration and occlude T-cell contact with tumor cells that can contribute to resistance to CAR-T therapy,” said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic Biosciences. “Santersus’ NucleoCapture® technology targets the same underlying biology across critical care, autoimmune disease and transplantation. Combining these technologies creates the opportunity to target NET biology on two fronts and expands the potential reach of the platform well beyond either company’s current programs independently.”

 

 

 

 1 

 

 

 

 

Combined Clinical Pipeline

 

The combined company is expected to have a core pipeline comprising four first-in-class programs spanning critical care, autoimmune disease, transplantation and oncology:

 

NucleoCapture® for Sepsis

 

NucleoCapture® is being evaluated in a pivotal clinical study in patients with sepsis in combination with standard of care and has received U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designation for this indication. NucleoCapture® is designed to address the dysregulated host response and resulting organ failure associated with sepsis rather than targeting the underlying infection alone.

 

NucleoCapture® for Systemic Lupus Erythematosus

 

NucleoCapture® is advancing toward a pivotal clinical study in patients with systemic lupus erythematosus (“SLE”) in combination with standard of care and has received a second FDA Breakthrough Device Designation. The program is being developed as a first-in-class, non-immunosuppressive approach to treating SLE through the removal of circulating NETs, with the potential to address both disease activity and associated type II symptoms.

 

NucleoCapture® for Liver Transplantation

 

NucleoCapture® is being developed for use during normothermic machine perfusion of donor livers with the goal of improving liver graft quality and transplantation outcomes and potentially expanding the pool of organs available for transplant. The program is ready to enter pivotal studies based on completed studies involving donated human livers.

 

DNase in Combination with Anti-CD19 CAR-T Cells for B-Cell Lymphoma

 

Xenetic’s DNase technology is being evaluated in a Phase 1b investigator-initiated study in Israel in combination with anti-CD19 CAR-T cells in patients with high-risk large B-cell lymphoma. Xenetic’s DNase technology is designed to degrade NETs in the tumor microenvironment, where they can shield tumor cells from immune attack, potentially addressing a mechanism of resistance to CAR-T therapy.

 

Complementary NET-Targeting Platforms

 

NucleoCapture® is a first-in-class selective apheresis platform designed to bind and remove NETs from the bloodstream or organ perfusion circuits. In addition to its three lead programs, the technology may have potential applications across additional autoimmune indications, neurodegeneration and acute and chronic organ injuries.

 

Xenetic’s DNase technology is a recombinant form of the human DNase I enzyme designed to degrade NETs and eliminate them from the tumor microenvironment. The technology is being evaluated in combination with anti-CD19 CAR-T cells in patients with large B-cell lymphoma and potential applications may include other hematologic and solid tumors as an adjunct to CAR-T therapies, bispecific T-cell engagers and immune checkpoint inhibitors.

 

Together, the two platforms are expected to provide the combined company with complementary approaches to the same underlying therapeutic target, removing NETs from circulation and organ perfusion systems with NucleoCapture® while degrading NETs within tissue with Xenetic’s DNase technology.

 

 

 

 2 

 

 

 

 

Business Update Conference Call and Webcast

 

Xenetic and Santersus will host a business update conference call and webcast on Wednesday, September 16, 2026 at 8:30 AM ET to discuss the Proposed Transaction and provide an overview of the combined company, its complementary NET-targeting platforms, clinical pipeline and strategic priorities.

 

Conference Call and Webcast Details

 

Date: Wednesday, September 16th

Time: 8:30 AM ET

Webcast: Access here.

Dial-in: 877-524-8416 (Domestic) / +1 412-902-1028 (International)

 

A live webcast of the conference call will be available here. A replay of the webcast will be available following the live event and will be archived for a limited time.

 

About the Proposed Transaction

 

Pursuant to the share exchange agreement, Xenetic will acquire all of the outstanding share capital of Santersus in exchange for the issuance of newly issued shares of Xenetic common stock upon closing, subject to the satisfaction or waiver of customary closing conditions, including the receipt of the required approval of the Xenetic stockholders. On a pro forma basis, current Xenetic equity holders and Santersus equity holders will own approximately 15.0% and 85.0%, respectively, of the combined company calculated on a fully diluted basis and as-converted basis, subject to adjustment based on, among other things, Xenetic’s net cash (as defined in the share exchange agreement) balance at the closing of the transaction.

 

The key equity holders, directors and officers of Xenetic, as well as certain parties identified by Santersus, have signed lock-up agreements restricting transfers of the combined company’s stock for 180 days post-closing, subject to limited exceptions.

 

Following completion of the Proposed Transaction, Santersus will become a wholly owned subsidiary of Xenetic. The combined company is expected to be led by James Ladtkow, Chief Executive Officer of Santersus, together with the current Santersus management team. Xenetic Biosciences, Inc. is expected to be renamed Santersus Bio, Inc., with corporate headquarters in Framingham, Massachusetts. The combined company’s Board of Directors is expected to be composed of eight members, including two nominees from Xenetic and six nominees from Santersus.

 

The Proposed Transaction has been unanimously approved by the Board of Directors of Santersus. Xenetic’s Board of Directors – acting on the unanimous recommendation of its independent Special Committee – has also approved the Proposed Transaction and recommends that Xenetic stockholders vote in favor of the Proposed Transaction. The Proposed Transaction is expected to close in the fourth quarter of 2026, subject to approval by Xenetic stockholders, the shares of Xenetic common stock issuable in the Proposed Transaction having been approved for listing on Nasdaq, the effectiveness of a resale registration statement on Form S-1 to be filed with the U.S. Securities and Exchange Commission (“SEC”), and the satisfaction or waiver of other customary closing conditions.

 

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as U.S. legal advisor to Santersus and Lex Futura AG is serving as Swiss legal counsel to Santersus. Holland & Knight LLP is serving as legal advisor to Xenetic, and Canaccord Genuity is serving as financial advisor to Xenetic.

 

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Xenetic with the SEC and will be available at http://www.sec.gov.

 

 

 

 3 

 

 

 

 

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.

 

About Santersus AG

 

Santersus AG is a therapeutic medical device company developing NucleoCapture® - its selective extracorporeal blood purification platform designed to selectively remove neutrophil extracellular traps (NETs) to treat acute and chronic conditions across critical care, autoimmunity and transplantation. For more information, please visit www.santersus.com.

 

Cautionary Note Regarding Forward-Looking Statements

 

This communication contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding the structure, timing and completion of the Proposed Transaction; the combined company’s listing on Nasdaq after closing of the Proposed Transaction; expectations regarding the ownership structure of the combined company; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of NucleoCapture and Xenetic’s DNase technology; anticipated clinical drug development activities and related timelines, including the expected timing for data and other clinical results; the competitive landscape of the combined company; the expected board composition of the combined company; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and were based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Xenetic, Santersus or the combined company’s control. Actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) the risk that the conditions to the closing of the Proposed Transaction are not satisfied, including the failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing of the consummation of the Proposed Transaction and the ability of each of Xenetic and Santersus to consummate the Proposed Transaction; (iii) risks related to each parties’ ability to manage its operating expenses and its expenses associated with the Proposed Transaction pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Proposed Transaction; (v) the risk that as a result of adjustments to the exchange ratio, Xenetic stockholders and Santersus stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Xenetic common stock relative to the value suggested by the exchange ratio; (vii) unexpected costs, charges or expenses resulting from the Proposed Transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Proposed Transaction; (ix) the uncertainties associated with Xenetic platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its clinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (xiii) risks associated with the possible failure to realize certain anticipated benefits of the Proposed Transaction, including with respect to future financial and operating results, (xiv) risks related to the inability of the combined company to maintain compliance with Nasdaq listing requirements following closing of the Proposed Transaction, and the potential need for the combined company to effect a reverse stock split in order to satisfy Nasdaq listing requirements; (xv) risks related to the combined company raising additional working capital and financing its business; and (xvi) the other factors discussed under the heading “Risk Factors” in Xenetic’s most recent Annual Report on Form 10-K and other filings with the SEC, among others. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in filings that Xenetic makes and will make with the SEC in connection with the Proposed Transaction, including Xenetic’s Proxy Statement described below under “Additional Information and Where to Find It.” You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Xenetic, Santersus and the combined company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

 

 

 

 4 

 

 

 

No Offer or Solicitation

 

This communication is not intended to and shall not constitute an offer to subscribe for, buy or sell or the solicitation of an offer to subscribe for, buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of, or offer to sell or buy, securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This communication is for informational purposes only. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

 

Additional Information and Where to Find It

 

This communication relates to the proposed acquisition transaction involving Xenetic and Santersus and may be deemed to be solicitation material in respect of the Proposed Transaction. In connection with the Proposed Transaction, Xenetic will file with the SEC a Proxy Statement and Registration Statement on Form S-1. Each party may also file other documents regarding the Proposed Transaction with the SEC. Investors and security holders are urged to read carefully the proxy statement, registration statement on Form S-1, and other relevant documents filed or will be filed with the SEC, as well as any amendments or supplements thereto and any documents incorporated by reference therein, in their entirety if and when they become available because they contain or will contain important information about the proposed transaction, related matters and the parties to the proposed transaction.

 


Investors and security holders may obtain a free copy of the Proxy Statement, the Registration Statement on Form S-1, and other relevant documents (if and when they become available) that are or will be filed with the SEC for free at the SEC’s website at
http://www.sec.gov. Copies of the documents (when they become available) filed with the SEC by Xenetic Biosciences will be available free of charge on Xenetic’s website at www.xeneticbio.com.

 

Participants in the Solicitation

 

Xenetic, and its directors and executive officers, and Santersus, and its directors and officers, may be deemed to be participants in the solicitation of proxies from the stockholders of Xenetic in connection with the Proposed Transaction under the rules of the SEC. Information about the interests of these directors and executive officers and other persons who may be deemed to be participants in the solicitation of stockholders of Xenetic in connection with the Proposed Transaction and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the Proxy Statement related to the Proposed Transaction, which will be filed with the SEC. Additional information about Xenetic, the directors and executive officers of Xenetic and their ownership of Xenetic common stock can also be found in its Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and amended on April 24, 2026, and its definitive proxy statement, as filed with the SEC on October 31, 2025, and other documents subsequently filed by Xenetic with the SEC. Free copies of these documents may be obtained as described above. To the extent holdings of Xenetic securities by its directors or executive officers have changed since the amounts set forth in such documents, such changes have been or are expected to be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the Proxy Statement relating to the Proposed Transaction when it is filed with the SEC.

 

Contact:

JTC Team, LLC

Jenene Thomas

(908) 824-0775

xbio@jtcir.com

 

 

 

 

 5 

 

Exhibit 99.2

 

Advancing NET - Targeted Therapies for Immune - Driven Diseases and Cancer INVESTOR PRESENTATION SEPTEMBER 2026

 
 

2 This communication contains “forward - looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 , including but not limited to, express or implied statements regarding the structure, timing and completion of the proposed transaction ; the combined company’s listing on Nasdaq after closing of the proposed transaction ; expectations regarding the ownership structure of the combined company ; the anticipated timing of closing ; each company’s and the combined company’s expected cash position at the closing of the proposed transaction and cash runway of the combined company ; the future operations of the combined company ; the nature, strategy and focus of the combined company ; the development and commercial potential and potential benefits of NucleoCapture and DNase ; anticipated clinical drug development activities and related timelines, including the expected timing for data and other clinical results ; the competitive landscape of the combined company ; and other statements that are not historical fact . All statements other than statements of historical fact contained in this communication are forward - looking statements . These forward - looking statements are made as of the date they were first issued, and were based on the then - current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management . Forward - looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Xenetic Biosciences , Santersus or the combined company’s control . Actual results could differ materially from those stated or implied in forward - looking statements due to a number of factors, including but not limited to (i) the risk that the conditions to the closing of the proposed transaction are not satisfied, including the failure to timely obtain shareholder approval for the transaction, if at all ; (ii) uncertainties as to the timing of the consummation of the proposed transaction and the ability of each of Xenetic Biosciences and Santersus to consummate the proposed transaction ; (iii) risks related to each parties’ ability to manage its operating expenses and its expenses associated with the proposed transaction pending closing ; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi - governmental entity necessary to consummate the proposed transaction ; (v) the risk that as a result of adjustments to the exchange ratio, Xenetic Biosciences shareholders and Santersus stockholders could own more or less of the combined company than is currently anticipated ; (vi) risks related to the market price of Xenetic Biosciences common stock relative to the value suggested by the exchange ratio ; (vii) unexpected costs, charges or expenses resulting from the transaction ; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transaction ; (ix) the uncertainties associated with Xenetic Biosciences platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials ; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its clinical programs ; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom ; (xii) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market ; (xiii) risks associated with the possible failure to realize certain anticipated benefits of the proposed transaction, including with respect to future financial and operating results ; (xiv) risks related to the inability of the combined company to maintain compliance with Nasdaq listing requirements following the closing of the proposed transaction, and the potential need for the combined company to effect a reverse stock split in order to satisfy Nasdaq listing requirements ; (xv) risks related to the combined company raising additional working capital and financing its business ; and (xvi) the other factors discussed under the heading “Risk Factors” in Xenetic Biosciences’ most recent Annual Report on Form 10 - K and other filings with the U . S . Securities and Exchange Commission (the “SEC”), among others . Actual results and the timing of events could differ materially from those anticipated in such forward - looking statements as a result of these risks and uncertainties . These and other risks and uncertainties are more fully described in filings that Xenetic Biosciences makes and will make with the SEC in connection with the proposed transaction, including the Proxy Statement described below under “Additional Information and Where to Find It . ” You should not place undue reliance on these forward - looking statements, which are made only as of the date hereof or as of the dates indicated in the forward - looking statements . Xenetic Biosciences , Santersus and the combined company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward - looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based . Xenetic Biosciences and Santersus obtained the industry, market and competitive position data used throughout this presentation from its own internal estimates and research, as well as from industry and general publications, and research, surveys and studies conducted by third parties . Internal estimates are derived from publicly available information released by industry analysts and third - party sources, Xenetic Biosciences and Santersus internal research and its industry experience, and are based on assumptions made by Xenetic Biosciences and Santersus based on such data and its knowledge of the industry and market, which it believes to be reasonable . In addition, while Xenetic Biosciences and Santersus believes the industry, market and competitive position data included in this presentation is reliable and based on reasonable assumptions, Xenetic Biosciences and Santersus has not independently verified any third - party information, and all such data involve risks and uncertainties and are subject to change based on various factors . This presentation contains trademarks, services marks, trade names and copyrights of Xenetic Biosciences and Santersus and other companies, which are the property of their respective owners . The use or display of third parties’ trademarks, service marks, trade name or products in this presentation is not intended to, and does not imply, a relationship with Xenetic Biosciences and Santersus , or an endorsement of sponsorship by Xenetic Biosciences and Santersus . Solely for convenience, the trademarks, service marks and trade names referred to in this presentation may appear with the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that the company will not assert, to the fullest extent under applicable law, their rights or the right of the applicable licensor to these trademarks, service marks and trade name . Additional Information and Where to Find It This communication relates to the proposed acquisition transaction involving Xenetic Biosciences and Santersus and may be deemed to be solicitation material in respect of the proposed transaction. In connection with the proposed transac ti on, Xenetic Biosciences will file with the SEC a proxy statement (“Proxy Statement”) and Registration Statement on Form S - 1 (“Registration Statement”). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY THE PROXY STATEMENT, REGISTRATION STATEMENT, AND OTHER RELEVANT DOCUMENTS FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUME NTS INCORPORATED BY REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION, RELATED MATTERS AND THE PARTIES TO TH E PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Proxy Statement, the Registration Statement, and other relevant doc uments (if and when they become available) that are or will be filed with the SEC for free at the SEC’s website at www.sec.go v. Copies of the documents (when they become available) filed with the SEC by Xenetic Biosciences will be available free of charge on Xene tic Biosciences’ website at http://xeneticbio.com. Participants in the Solicitation Xenetic Biosciences and its directors and executive officers and Santersus and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from the stockholde rs of Xenetic Biosciences in connection with the proposed transaction under the rules of the SEC. Information about the interests of the directors and executive officers of Xenetic Biosciences an d o ther persons who may be deemed to be participants in the solicitation of stockholders of Xenetic Biosciences in connection wi th the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the Proxy Statement related to the proposed transaction, which will be filed with the SEC. Additional information about Xenetic B io sciences, the directors and executive officers of Xenetic Biosciences and their ownership of Xenetic Biosciences common stock can also be f oun d in its Annual Report on Form 10 - K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and its defin itive proxy statement, as filed with the SEC on October 31, 2025, and other documents subsequently filed by Xenetic Biosciences wit h t he SEC. Free copies of these documents may be obtained as described above. To the extent holdings of Xenetic Biosciences secu rit ies by its directors or executive officers have changed since the amounts set forth in such documents, such changes have been or are ex pected to be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 f iled with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by sec urity holdings or otherwise, will be included in the Proxy Statement relating to the Proposed Transaction when it is filed wi th the SEC. No Offer or Solicitation This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitat ion of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except b y means of a prospectus meeting the requirements of Section 10 of the U S. Securities Act of 1933, as amended, and otherwise in accordance wi th applicable law. Disclaimer

 
 

3 Pioneering Breakthrough NET - Targeted Therapies to Transform the Treatment Paradigm of Immune - Driven Diseases and Cancer Positive clinical outcomes with no adverse events across 80+ compassionate use cases in patients with sepsis, autoimmune disease and cancer treated with NucleoCapture® and DNase Extensive IP portfolio through 2038 and potential to extend 20 years with each indication World - leading medical device company invested in Series A NET - Targeting Platforms • Two FDA Breakthrough Device Designations • Lead program targeting potential EU market launch in Q2 2028 • Extracorporeal device pathway offers faster and more capital - efficient route to approval NucleoCapture ® Blood purification device designed to selectively remove circulating NETs DNase Systemic DNase enzyme platform designed to degrade NETs in tissues and blood 1. Grand View Research, “Sepsis Therapeutics Market Size, Share & Trends Analysis Report, 2025 – 2030,” accessed September 1, 2026 ; 2. Mordor Intelligence, Systemic Lupus Erythematosus: Market Share Analysis, Industry Trends & Statistics, Growth Forecasts, 2026 – 2031, May 2026; 3. Grand View Research, Lymphoma Treatment Market Size, Share & Trends Analysis Report, 2025 – 2030 , updated July 2026; 4. Persistence Market Research, Liver Transplantation Market Size, Share, and Growth Forecast, 2026 – 2033 , June 2026. 4 Clinical Stage Programs Targeting Multibillion - Dollar Markets: Investigator - initiated study in Israel in combination with CAR T cells for large B - cell lymphoma initiated by Tel - Aviv Sourasky team, with initial efficacy data expected in Q2 2027 Large B - Cell Lymphoma Liver Transplantation Systemic Lupus Erythematosus Sepsis ~$8.7 Billion 4 ~$1.6 Billion 3 ~$3.4 Billion 2 ~$5.6 Billion 1

 
 

4 DNase Blood Purification Device for Circulating NETs Removes NETs directly from circulation via extracorporeal blood purification Targeting high levels of circulating NETs in the blood Pharmacological / Enzymatic for Tissue Based NETs Degrades NETs within solid tissue via enzymatic digestion of the NET DNA backbone Targets NETs embedded in tissue and the tumor microenvironment NucleoCapture ® Definitive Share Exchange Agreement to Create Global Leader in NET - Targeting Therapeutics • Target pathogenic NETs as the common upstream driver of disease • Complementary, not redundant: together addressing NET burden across both circulating and tissue - resident compartments A Shared Mechanistic Basis Two Complementary Technologies. One Target. Neutrophil Extracellular Traps (NETs) Advancing a Pipeline of Multiple Billion - Dollar Opportunities

 
 

5 Excessive and Persistent NETs Are Convergent Upstream Driver of Inflammation, Tissue Injury, Immune Dysregulation and Treatment Resistance Neutrophil extracellular traps (NETs) are web - like structures composed of DNA, histones and antimicrobial proteins released by activated neutrophils to trap and neutralize pathogens. Unchecked NET accumulation in blood and tissues triggers a destructiv e c ascade that damages tissue, dysregulates immunity, and accelerates disease progression • Breach endothelial barriers and destroy surrounding tissue • Perpetuate chronic inflammation and drive immune dysregulation • Expose autoantigens and fuel autoimmune attack • Drive immunothrombosis, microvascular obstruction and organ failure • Shield tumor cells from T cell and NK - cell attack • Inactivate cytotoxic T cells and CAR T cells • Capture circulating tumor cells and support metastatic seeding • Reprogram the tumor microenvironment and reactivate dormant tumor cells • Drive resistance to chemotherapy, checkpoint inhibitors and radiotherapy A Validated Driver Across Multiple Serious Disease Areas Critical Illness Autoimmune Disease Transplantation Cancer Cardiovascular Disease Neurodegeneration Kidney Disease Lung Disease Oncology Immune and Inflammatory Disease

 
 

6 NucleoCapture® Sepsis in Combination with SoC Systemic Lupus Erythematosus (SLE) in Combination with SoC Liver Graft Perfusion in Combination with OrganOx Metra Device Large B - Cell Lymphoma in Combination with anti - CD - 19 CAR T cells DNase THERAPEUTIC BLOOD PURIFICATION DEVICE PIPELINE SYSTEMIC BIOLOGIC THERAPEUTIC PIPELINE PROGRAM INDICATIONS INITIAL CLINICAL STAGE PIVOTAL CLINICAL TRIAL Advancing Two NET - Targeted Platforms Across Immune - Driven Diseases and Cancer PROGRAM INDICATIONS PRECLINICAL PHASE 1 PHASE 2/3 KEY HIGHLIGHTS • Recruitment in progress • Interim analysis and CE Mark submission: Q4 2027 • EU market launch: Q2 2028 • Start of pivotal study: Q4 2026 • Interim analysis: Q4 2027 • sPMA submission: Q3 2027 • US market launch: Q3 2028 KEY HIGHLIGHTS • Investigator - initiated study in advanced LBCL with CD19 CAR T 1 • Recruitment in progress • Proof - of - concept data: Q2 2027 APPROVAL IND ENABLING 1. Investigator - initiated study being conducted at the Tel Aviv Sourasky University Medical Center in Israel Note: Actual milestones and timeline may vary, as they are based on current expectations, estimates and projections regarding fu ture events. There can be no assurance that the milestones will be achieved within the timeframes indicated, or at all.

 
 

7 NucleoCapture ®: FDA - Designated Breakthrough Treatment for Sepsis Proprietary therapeutic blood purification device that physically bind to and remove NETs from blood circulation without affecting neutrophils defensive functions Ongoing pivotal multicenter study, up to 350 patients with sepsis and respiratory failure in EU and US Independent studies in over 3,000 sepsis ICU patients show elevated NET level are associated with increased risk of mortality, septic shock, organ failure and ARDS Designed for rapid deployment in acute and critical - care settings Integrates with standard plasma - separation equipment with no additional hospital capital expenditure Breakthrough Designation from US FDA for Sepsis

 
 

8 Demonstrated 100% 7 - Day Survival with Rapid, Repeated Reductions in Circulating NET Levels in Sepsis Patients Reduction in Key Biomarkers Before After Before After Before After Before After Circulating NET Level, ng/mL n=10 Treatment Treatment Treatment Reduction in Circulating Net Levels Circulating NET levels declined after each treatment session and remained below the initial pretreatment level across the treatment course. x 32 NucleoCapture ® treatment sessions in 10 extremely sick sepsis patients x Demonstrated to be safe and well tolerated with no adverse events x Consistently reduced inflammation, organ damage and vasopressor dependence

 
 

9 Ongoing Pivotal Multicenter Study for Treatment of Sepsis and Respiratory Failure Study Design Number of Subjects: up to 350 Randomized: 1:1 Treatment: SoC or SoC + NucleoCapture ® Primary Effectiveness Endpoint: Composite outcome evaluated using win ratio methodology: • All - cause mortality through Day 28 / Organ Support - Free Days (OSFD) through Day 28 First time ever FDA agrees on primary composite endpoint of 28 - day mortality and OSFD Anticipated Development Path to Potential Commercialization in US and EU Q4 2027 Q4 2027 EU Regulatory Submission Distribution Agreement Executed Q4 2027 First Interim Analysis (100 Patients) Q2 2028 CE Certificate and EU Market Launch Q2 2029 Enrollment Completed Q2 2029 PMA Submission Q4 2029 PMA Approval and US Market Launch Mortality benefit is the sepsis graveyard Probability of success for the composite endpoint is much higher Concurrent Medicare Coverage via RAPID

 
 

10 After the Course of Procedures Before Improvement in Key Indicator Lupus Disease Activity 1 8.0 [4; 12] 17.5 [10; 25] SLEDAI, Me [25th; 75th percentiles] Lupus QoL 76.6 [51.6; 92.2] 57.8 [42.2; 67.2] Physical Health ( ↑ = Improvement) 87.5 [66.7; 91.7] 58.3 [41.7; 70.8] Pain ( ↑ = Improvement) 75.0 [52.1; 85.4] 60.4 [25; 77.1] Emotional health ( ↑ = Improvement) 65.6 [25.0; 78.1] 53.1 [15.6; 71.9] Fatigue Improvement ( ↑ = Improvement) HADS 4 [3; 13] 9 [6; 15] HADS — anxiety 6 [1; 8] 7 [3.5; 10] HADS — depression FACIT - Fatigue 37.5 [20.5; 46.5] 24.5 [14.5; 37] Total FACIT - Fatigue score x No add on immunosuppression x Quick onset of action x Potential to control Type II symptoms NucleoCapture ®: FDA - Designated Breakthrough Treatment for SLE In a retrospective analysis of compassionate use cases (n= 10 ), three treatments were associated with immediate powerful reduction of of disease activity, clinical manifestations and broad quality - of - life improvements 54 % Reduction in Disease Activity 1 Median SLEDAI - 2K decreased from 17.5 to 8.0 after three treatments p=0.009 Resolution of Key Clinical Manifestations Vasculitis resolved in 5 of 5 patients Polyarthritis resolved in 3 of 5 patients Fever resolved without additional NSAIDs or steroids Significant Attenuation of Autoimmune and Inflammatory Response Significant reductions in anti - dsDNA, anti - ssDNA and HMGB1 Significant Decrease in Anxiety Trends towards improvement of physical health, pain, emotional health and fatigue Standard of Care Treatment Typically Takes 6 Months to Achieve Comparable Reductions of Disease Activity 1 1. Aringer M, et al. Lupus Sci Med. 2025;12(1):e001336. doi:10.1136/lupus - 2024 - 001336

 
 

11 NucleoCapture ®: Restoring Viability in Donor Organs During Ex Vivo Machine Perfusion Liver Revitalization Before After 6 hour Perfusion ~84% Reduction in Circulating NETs 13.54 ± 8.53 to 2.21 ± 0.69 µg/mL From hour 1 to hour 12 of NMP ~67% Reduction in Lactate 13.54 ± 8.53 to 2.21 ± 0.69 µg/mL From hour 1 to hour 12 of NMP , a strategic investor in , acquired for $1.5 billion in 2025 Targeting a 15 - month FDA regulatory pathway through a supplement to the existing OrganOx metra ® PMA Improved viability - associated parameters in 8 discarded human liver grafts meeting ex vivo transplantation criteria Significantly improved graft function and metabolic recovery and reduced inflammation on modelling of transplantation *DCD = Donation After Circulatory Death

 
 

12 DNase for LBCL: Overcoming Tumor Immune Evasion EGFR CAR T EGFR CAR T plus DNase Metastatic melanoma node; Green and yellow = NETosis area DNase driven survival benefit in mouse model of human lymphoma ( NSG/Raji) Removal of barrier to CAR T cells Deoxyribonuclease I (DNase) is a human endonuclease enzyme responsible for degrading NETs in tissues and blood via enzymatic cleavage of NETs DNA backbone • Investigator - initiated study in 12 patients with LBCL in combination with CAR T ongoing • Designed to be universal CAR T adjunct platform for hematologic and solid tumors acting by reversing tumor induced immunosuppression • Encouraging preclinical data and clinical compassionate use data suggesting clinical efficacy of combination of DNase with CAR T cells • Potential to reduce tumor induced immunosuppression

 
 

13 Leadership and Development Team James Ladtkow BSME, MBA Chief Executive Officer Andrew Aswani, MD PhD MRCP FRCA EDIC FFICM Chief Medical Officer and SAB Chairman Elisabeth Barabash, BS, MS Chief Clinical Operations Alexey Stepanov, II, MS, PhD Head of Immunooncology Paul Rowden, BS, MS Head of Quality Marianna Lupi, BS,MS PRRC Dmitry Genkin, MD Chief Scientific Officer Aleksander Zaporoztsev Chief Financial Officer 35+ years in medical device development. Led clinical development and approval of the Spectra Optia therapeutic apheresis system Consultant in Intensive Care Medicine and Anaesthesia . PhD research on circulating cfDNA in shock states 13+ years in clinical operations. Prior industry experience at Pfizer and AstraZeneca Dr. Stepanov develops advanced immuno - oncology therapies, specializing in CAR T cell engineering and solid tumors 27+ years as regulatory partner for medical devices and IVD manufacturers in 30+ countries. 600+ first time approval across FDA 510(k), CE, UKCA, ISO 13485, MDSAP and CMDR International regulatory and clinical affairs executive with extensive Class II and III medical device expertise Founder of the Santersus. inventor of 20+ patents in NETosis and cell - free DNA therapeutics Over 20 years of financial experience, 10 of those years of financial and management expertise in the biopharmaceutical industry

 
 

14 Upcoming Value Driving Milestones NucleoCapture ® SLE Program NucleoCapture ® Liver Transplantation Program DNase Large B - Cell Lymphoma Program Q4 2027 Q4 2027 Q4 2027 Q2 2028 First Interim Analysis (100 patients) Exclusive Distribution Agreement EU Regulatory Submission CE Certification and EU Market Launch Q2 2029 Q2 2029 Q4 2029 PMA Submission Enrollment Completed PMA Approval and US Market Launch NucleoCapture ® Sepsis Q1 2027 Q4 2027 Q4 2027 Q4 2028 Q4 2028 Q2 2029 Q4 2029 First Patient In Interim Analysis Exclusive Distribution Agreement Enrollment Completed EU Regulatory Submission CE Certification and EU Market Launch Initiate US Pivotal Study with Potential Partner Q1 2027 Q3 2027 Q3 2028 Exclusive License and Supply Agreement sPMA Submission sPMA Approval and US Market Launch Q2 2027 Q2 2027 Q2 2028 Q3 2028 Enrollment Completed (12 patients) Primary Efficacy Readouts Secondary Efficacy Readouts Initiate US Phase 2 Study with Potential Partner Note: Actual milestones and timeline may vary, as they are based on current expectations, estimates and projections regarding fu ture events. There can be no assurance that the milestones will be achieved within the timeframes indicated, or at all.

 
 

15 Positioned to Lead the Emerging Field of NET - Targeted Therapeutics Building an integrated therapeutic portfolio around NETs, an increasingly recognized driver of disease progression across immune - driven diseases and cancer Four prioritized programs spanning sepsis, SLE, liver transplantation and large B - cell lymphoma Lead NucleoCapture ® programs targeting regulatory submissions beginning in 2027 and a potential first EU market launch in 2028 Diversified Pipeline Clear Path Toward Potential Commercialization Two complementary platforms designed to address the issues of excessive or persistent NETs Growing clinical and regulatory momentum Targeting multi - billion - dollar indications with significant unmet needs Multiple key value - driving milestones expected over the next 12 - 24 months

 
 

16 Transaction Highlights Proposed Transaction is Expected to Close in the Fourth Quarter of 2026 1 Santersus will become a wholly owned subsidiary of Xenetic and will continue as the operating business of the combined company . Combined company is expected to trade on Nasdaq under the ticker symbol “SNTS . ” Combined Company 1. Subject to approval by the stockholders of Xenetic At closing, each outstanding Santersus share will be exchanged for shares of Xenetic common stock . Outstanding unexercised Santersus options will be assumed by Xenetic and converted into options to purchase Xenetic common stock . Definitive Share Exchange Agreement Pre - transaction Santersus shareholders are expected to own approximately 85 % of the combined company and pre - merger Xenetic stockholders are expected to own approximately 15 % of the combined company, subject to adjustment . Ownership

 
 

Advancing NET - Targeted Therapies for Immune - Driven Diseases and Cancer Thank you!

 
 

Appendix

 
 

19 NucleoCapture ® is designed to selectively remove circulating NETs, potentially reducing the autoantigen and inflammatory burden without suppressing immune cells. NucleoCapture ®: Breakthrough Treatment for SLE Excessive NET formation and impaired clearance expose autoantigens, amplify type I interferon signaling and contribute to tissue injury. Rapid, clinically meaningful improvement in disease activity, including a 54% reduction in median SLEDAI - 2K after three treatments. Broad quality - of - life improvements including physical health, pain, fatigue and emotional well - being, with a significant reduction in anxiety. Demonstrated clinical responses without escalation of immunosuppression , including no increase in other immunosuppressive therapies or steroids. Compelling compassionate - use responses across severe autoimmune diseases , including disease control, dialysis independence and improved cardiac function. Self - Reinforcing NET Cycle and Disease Amplification Ⓡ

 
 

20 SLE: Significant Reduction in SLE Disease Activity in Retrospective Analysis After 3 NucleoCapture® Treatments Before Indicator 8.0 [4; 12] 17.5 [10; 25] SLEDAI, Me [ 25th; 75th percentiles] 5.2 [3.8 – 5.5] 3.95 [2.4; 5.1] Leukocytes, × 10 9 /µL, Me [25th; 75th percentiles] 16 [12; 18] 25 [18; 40] ESR, mm/h, Me [25th; 75th percentiles] 10.225 [7.3; 15.95] 12.9 [9; 17.5] IgG, g/L, Me [25th; 75th percentiles] 342.2 [54.1; 684] 592.5 [42; 784] Anti - dsDNA, IU/mL, Me [25th; 75th percentiles] 249.4 [123; 422.8] 392 [297.1; 584.1] Anti - ssDNA, IU/mL, Me [25th; 75th percentiles] 0.465 [0.195; 3.47] 5.59 [0.89; 10.5] HMGB1, ng/mL, Me [25th; 75th percentiles] Standard of Care Treatment Typically Takes 6 Months to Achieve Comparable Reductions of Disease Activity 1 54% Reduction in Disease Activity • Median SLEDAI - 2K decreased from 17.5 to 8.0 after three treatments p=0.009 Resolution of Key Clinical Manifestations • Vasculitis resolved in 5 of 5 patients Polyarthritis resolved in 3 of 5 patients • Fever resolved without additional NSAIDs or steroids Significant Autoimmune and Inflammatory Response • Significant reductions in anti - dsDNA, anti - ssDNA and HMGB1 Leukocyte Levels Trended Toward Normalization • Median leukocyte count increased from 3.95 to 5.2 × 10⁹/ Lp =0.078 1. Aringer M, et al. Lupus Sci Med. 2025;12(1):e001336. doi:10.1136/lupus - 2024 - 001336

 
 

21 SLE: Quality - of - Life Improvements in Patients with SLE Flares After The Course of Procedures Before Improvement in Key Indicator Lupus QoL 76.6 [51.6; 92.2] 57.8 [42.2; 67.2] Physical Health ( ↑ = Improvement) 87.5 [66.7; 91.7] 58.3 [41.7; 70.8] Pain ( ↑ = Improvement) 54.2 [16.7; 83.3] 58.3 [25; 79.2] Planning ( ↓ = Improvement) 56.3 [25; 75] 65.5 [25; 93.8] Intimate Relationships ( ↓ = Improvement) 62.5 [37.5; 79.2] 54.2 [20.8; 75] Burden to Others ( ↑ = Improvement) 75.0 [52.1; 85.4] 60.4 [25; 77.1] Emotional Health ( ↑ = Improvement) 62.5 [54.2; 85] 75.8 [56.7; 91.3] Body Image ( ↓ = Improvement) 65.6 [25.0; 78.1] 53.1 [15.6; 71.9] Fatigue Improvement ( ↑ = Improvement) HADS 4 [3; 13] 9 [6; 15] HADS — Anxiety 6 [1; 8] 7 [3.5; 10] HADS — Depression FACIT - Fatigue 37.5 [20.5; 46.5] 24.5 [14.5; 37] Total FACIT - Fatigue Score In a retrospective analysis, patients (n=10) reported broad quality - of - life improvements, with a statistically significant reduction in anxiety. Positive clinical outcomes in 20+ compassionate use cases in patients with neurolupus, ANCA vasculitis, antiphospholipid syndrome, juvenile polyarteritis nodosa.

 
 

22 Upcoming Pivotal Multicenter Study in EU and Hong Kong for Treatment of SLE Study Design Number of Subjects: up to 110 with active SLE, SLEDAI - 2K score ≥ 8 Randomized: 1:1 Treatment: SoC or SoC + NucleoCapture ® Primary Effectiveness Endpoint: Proportion of participants achieving a SLE Responder Index 4 (SRI - 4) response at D30 Secondary Effectiveness Endpoint: • Control of Type II symptoms • Reduction of corticosteroid usage Anticipated Development Path to Potential Commercialization in US and EU Q4 2028 Q4 2029 Q1 2027 First Patient In Q4 2027 Q4 2027 Q4 2028 Q3 2029 Interim Analysis Distribution Agreement Executed Enrollment Completed EU Regulatory Submission CE Certification and EU Market Launch Initiate US Pivotal Study with Potential Partner Anticipated Development Path to Potential Commercialization in US and EU

 
 

23 Demonstrated Sustained cfDNA Reduction and Metabolic Recovery in Discarded Human Livers Eight discarded extended - criteria donor human livers underwent 12 hours of OrganOx metra ® NMP with NucleoCapture , followed by six hours of whole - blood reperfusion modeling ~84% Reduction in Circulating NETs 13.54 ± 8.53 to 2.21 ± 0.69 µg/mL From hour 1 to hour 12 of NMP ~67% Reduction in Lactate 5.30 ± 3.56 to 1.75 ± 0.86 mmol/L Significant lactate clearance during NMP, p=0.011 Significant reduction in circulating neutrophils during the first 60 minutes of whole - blood reperfusion During NMP*, NucleoCapture® is designed to remove NETs, helping prevent microcirculatory collapse and inflammation in the graft . Path to Potential FDA Approved Integration with OrganOx Metra Q3 2027 Q3 2028 sPMA Submission sPMA Approval and US Market Launch Q1 2027 Exclusive License and Supply Agreement

 
 

24 DNase Improves In Vivo Efficacy of CAR T Cells Mice treated by CAR19 T cells in combination with DNase demonstrate improved survival and primary tumor clearance in leukemia and lymphoma models with improved CAR19 T cells expansion and persistence DNase survival benefit in mouse model of human lymphoma ( NSG/Raji) Enhanced CAR19 T cells Expansion and Persistence In vivo tracking of CAR19 T cells in mouse model of human lymphoma ( NSG/Raji)

 
 

25 Investigator - Initiated Study in Large B - Cell Lymphoma Anticipated Development Path Q2 2027 Q2 2028 Q3 2028 Primary Efficacy Readouts Secondary Efficacy Readouts Initiate US Phase 2 Study with Potential Partner Q2 2027 Completion of Enrollment Study Design CRR (complete response rate) at 1 month post CAR T infusion • ORR at 1 and 3 months after CART • PFS at 12 months post CAR T cells • Duration of response (DOR) • Overall survival (OS) at 12 months post CAR T cells • Frequency and severity of CAR T related adverse events (CRS ICANS, TLS) Primary Effectiveness Endpoint Secondary Effectiveness Endpoint Number of Subjects Treatment 12 subjects with stable/progressive LBCL prior to lymphodepletion CAR T cells ( tisagenlecleucel , axicabtagene ciloleucel or lisocabtagene maraleucel ) in combination with DNase

 

 

Filing Exhibits & Attachments

9 documents

Keep reading