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): August 13, 2025 ________________________ Xenetic Biosciences, Inc. (Exact name of registrant as specified in charter) (State or other jurisdiction of incorporation) (Commission File Number) Nevada 001-37937 45-2952962 (IRS Employer Identification No.) ☐ Pre-commencement ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q 781-778-7720 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37937 XENETIC BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Nevada (State or other ...

DNase I Oncology Platform - The company is focused on advancing its proprietary DNase I technology platform to address multiple high-value cancer indications[2, 5] - DNase I targets Neutrophil Extracellular Traps (NETs) to improve immunotherapies and chemotherapies[2, 5] - DNase I digests both double and single-stranded DNA, as well as DNA:RNA hybrids, exposing cancer cells to the immune system and reducing therapy resistance[6] - Systemic administration of DNase I improves the efficacy of PD-1 blockade, resulting in the lowest tumor volume growth compared to either DNase I or anti-PD-1 alone[19] Pipeline and Clinical Development - The company's lead program, XBIO-015, combines systemic DNase I with chemotherapy for pancreatic carcinoma[7] - A Phase 1 study is planned, featuring dose escalation and expansion in subjects with locally advanced or metastatic solid tumors, with pancreatic cancer and other solid tumor indications[2, 40] - The company believes that an ORR greater than 50% or PFS greater than 9 months would be a meaningful improvement to the current standard of care for pancreatic cancer[45] Market Opportunity - The company is initially targeting pancreatic carcinoma, a multi-billion-dollar indication with significant unmet need, with a projected market of $48 billion by 2025[2, 39] - Approximately 62,000 people are diagnosed with pancreatic cancer annually, and approximately 50,000 die from it annually[39] - There were approximately 19 million new solid tumor cases in the U S in 2022, leading to approximately 6 million solid tumor-related deaths[46] Collaboration and Intellectual Property - The company is collaborating with VolitionRX to develop proprietary adoptive cell therapies potentially targeting multiple solid cancer types[2, 58] - VolitionRX is expected to fund the research program, with both parties sharing proceeds from commercialization or licensing of any resulting products[60] - The company has an IP portfolio covering the co-administration of Systemic DNase I with ICIs, radiation, and chemo, as well as DNase I for pancreatic cancer and DNase I-secreting CAR T cells[62, 64]

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): May 14, 2025 ________________________ 945 Concord Street Framingham, Massachusetts 01701 (Address of principal executive offices) (Zip Code) (781) 778-7720 (Registrant's telephone number, including area code) Xenetic Biosciences, Inc. (Exact name of registrant as specif ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 show a reduced net loss and decreased cash, with notes detailing DNase technology and liquidity [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $5.8 million from $6.9 million, driven by a $1.0 million cash reduction, while total equity declined to $5.1 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $5,163,676 | $6,165,568 | | Total current assets | $5,477,296 | $6,587,522 | | **Total assets** | **$5,791,217** | **$6,901,443** | | **Liabilities & Equity** | | | | Total current liabilities | $667,927 | $894,263 | | **Total liabilities** | **$667,927** | **$894,263** | | **Total stockholders' equity** | **$5,123,290** | **$6,007,180** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, royalty revenue increased by 16.1% to $0.6 million, operating expenses decreased by 13.7%, resulting in a reduced net loss of $0.9 million Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Royalty revenue | $593,261 | $510,817 | | Total operating costs and expenses | ($1,535,670) | ($1,779,231) | | Loss from operations | ($942,409) | ($1,268,414) | | **Net loss** | **($903,141)** | **($1,195,113)** | | **Basic and diluted net loss per share** | **($0.59)** | **($0.78)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for Q1 2025 was $1.0 million, leading to a $1.0 million decrease in cash balance, ending at $5.2 million with no investing or financing activities Cash Flow Summary (Unaudited) | Cash Flow Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,001,892) | ($1,159,345) | | Cash at beginning of period | $6,165,568 | $8,983,046 | | **Cash at end of period** | **$5,163,676** | **$7,823,701** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's DNase technology focus, going concern assessment, key collaboration agreements, and the expiration of Series A Warrants - The company is a biopharmaceutical firm focused on advancing its proprietary DNase technology to target neutrophil extracellular traps (NETs) in difficult-to-treat cancers[22](index=22&type=chunk) - Management believes existing resources are adequate to fund operations for at least **twelve months** from the financial statement issuance date, but anticipates needing additional long-term capital[25](index=25&type=chunk) - Royalty revenue from Takeda was approximately **$0.6 million** for Q1 2025, based on single-digit royalties on net sales of certain products using the company's PolyXen technology[32](index=32&type=chunk) - The company has ongoing research and manufacturing agreements with Catalent, Scripps Research, and the University of Virginia (UVA) to advance the development of its DNase technology[33](index=33&type=chunk)[34](index=34&type=chunk)[37](index=37&type=chunk) - Series A Warrants to purchase approximately **462,963 shares** of common stock expired in February 2025[40](index=40&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial performance, noting increased revenue, decreased expenses, and a narrowed net loss, while focusing on DNase program advancement and future financing needs [Business Overview](index=15&type=section&id=Business%20Overview) Xenetic focuses on advancing its DNase technology for oncology, particularly for pancreatic carcinoma, while generating revenue from legacy PolyXen technology royalties - The company's core focus is advancing its proprietary DNase technology for immune-oncology applications, aiming to improve outcomes of existing cancer treatments[58](index=58&type=chunk) - The primary development goal is to move the systemic DNase program into the clinic for pancreatic carcinoma and other solid tumors[58](index=58&type=chunk) - To date, none of the company's drug candidates have received regulatory marketing authorization. Revenue is generated from ongoing royalties via a legacy technology license[59](index=59&type=chunk) [Results of Operations](index=15&type=section&id=Results%20of%20Operations) Q1 2025 saw a 16.1% revenue increase and significant reductions in R&D and G&A expenses, leading to a 24.4% decrease in net loss Comparison of Operations for Quarters Ended March 31 | Description | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Royalty revenue | $593,261 | $510,817 | 16.1% | | Research and development | ($879,029) | ($944,321) | (6.9)% | | General and administrative | ($656,641) | ($834,910) | (21.4)% | | **Net loss** | **($903,141)** | **($1,195,113)** | **(24.4)%** | - The decrease in R&D expenses was mainly due to lower personnel and share-based costs related to the departure of the former Chief Scientific Officer in Q2 2024[63](index=63&type=chunk) - The decrease in G&A expenses was primarily due to lower personnel and share-based costs related to the departure of the former Chief Executive Officer in Q2 2024[64](index=64&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $5.2 million in cash and $4.8 million in working capital, believing it has sufficient liquidity for 12 months but will require additional long-term capital - As of March 31, 2025, the company had approximately **$5.2 million** in cash and working capital of **$4.8 million**[67](index=67&type=chunk)[68](index=68&type=chunk) - Management believes existing resources are adequate for at least the next **twelve months**, but acknowledges the need for additional long-term capital, which is subject to uncertainty[69](index=69&type=chunk) [Cash Flows](index=17&type=section&id=Cash%20Flows) For Q1 2025, approximately $1.0 million in cash was used for operating activities, primarily due to net loss, with no investing or financing cash flows - Cash used in operating activities totaled approximately **$1.0 million** for Q1 2025, primarily due to the net loss[70](index=70&type=chunk) - There were no cash flows from investing or financing activities for the three months ended March 31, 2025 and 2024[71](index=71&type=chunk)[72](index=72&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=18&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is exempt from providing quantitative and qualitative disclosures about market risk - As a "smaller reporting company," the company is exempt from providing quantitative and qualitative disclosures about market risk[77](index=77&type=chunk) [Controls and Procedures](index=18&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of the end of the quarter, the company's disclosure controls and procedures are effective at a reasonable assurance level[79](index=79&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[80](index=80&type=chunk) [PART II - OTHER INFORMATION](index=19&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=19&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, nor is it aware of any threatened against it - The company is not currently subject to any material legal proceedings[82](index=82&type=chunk) [Risk Factors](index=19&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the last Annual Report on Form 10-K - No material changes to risk factors have occurred since the last Annual Report on Form 10-K[83](index=83&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=19&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None[84](index=84&type=chunk) [Other Information](index=19&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 trading arrangement during the quarter ended March 31, 2025 - No director or officer adopted or terminated any Rule 10b5-1 trading arrangement during the quarter[87](index=87&type=chunk) [Exhibits](index=20&type=section&id=Item%206.%20Exhibits) The report lists several exhibits filed, including a consulting agreement, Sarbanes-Oxley Act certifications, and financial statements in inline XBRL - Key exhibits filed include a consulting agreement with Chairman Dmitry Genkin (10.1), CEO/CFO certifications (31.1, 31.2, 32.1), and XBRL data (101)[90](index=90&type=chunk)

Financial Results - Xenetic Biosciences, Inc. reported financial results for the year ended December 31, 2024[6] - The press release detailing the financial results was issued on March 19, 2025[6] - The financial results and additional details are included in Exhibit 99.1 of the report[9] Risks and Uncertainties - The company is subject to risks and uncertainties that could affect future performance, including market conditions and regulatory processes[8] - The company does not undertake any obligation to update forward-looking statements except as required by law[8]

Financial Condition and Profitability - The company has never been profitable and may never achieve or sustain profitability, which could materially and adversely affect its financial condition and results of operations [22]. - The company requires substantial additional funding to achieve its goals, and failure to obtain necessary capital may force delays or termination of product development efforts [22]. - The company may not continue to meet the continued listing requirements of the Nasdaq Stock Market, which could result in a delisting of its common shares [22]. - The company has never been profitable and may require substantial additional funding to achieve its goals, which could lead to dilution for existing shareholders [22]. Business Dependence and Competition - The company's business is substantially dependent on the success of its DNase technology, which targets neutrophil extracellular traps (NETs) to address oncology indications [23][26]. - The company operates in an extremely competitive environment, and there are no assurances that competing technologies will not harm its business development [23]. - The company faces competition from major pharmaceutical and biotechnology firms, which may have greater resources and expertise in R&D and marketing [121]. - The company may encounter significant competition from generic products, which are expected to increase in availability over the coming years [123]. - The company faces competition from various platforms for drug delivery, including PEGylation and Fc-fusion, as well as from academic institutions and smaller pharmaceutical companies [129]. Clinical Development and Regulatory Challenges - The company may face substantial delays in clinical trials, which could prevent timely commercialization of its drug candidates [23]. - The company relies on third parties for clinical studies, and unsatisfactory performance by these parties may harm its business [23]. - The FDA regulates drug approvals under the FDCA and PHSA, requiring substantial time and financial resources for compliance [73]. - The IND becomes effective 30 days after submission unless the FDA places the trial on clinical hold due to safety concerns [74]. - Human clinical trials consist of three phases: Phase I focuses on safety and dosage, Phase II evaluates efficacy and safety in a limited population, and Phase III assesses overall risk-benefit in a larger population [81]. - The FDA reviews NDAs and BLAs to ensure safety, efficacy, and compliance with cGMP standards before granting approval [83]. - A Complete Response Letter from the FDA indicates deficiencies in the NDA or BLA, requiring resubmission to address these issues [84]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained, and post-approval changes may require further review [93]. Drug Development and Market Opportunities - The systemic DNase program targets multi-billion-dollar indications including pancreatic ductal adenocarcinoma (PDAC) and colorectal carcinoma (CRC) with significant unmet needs [27]. - The market opportunities for the company's drug candidates may be limited to patients who are ineligible for or have failed prior treatments [23]. - The commercial success of any current or future pharmaceutical products will depend on market acceptance by physicians, patients, and third-party payors [23]. - The company is advancing its DNase technology as an adjunctive therapy to improve responses to existing treatments for solid tumors [36]. - The company has a drug candidate pipeline that includes innovative oncology treatments, with ongoing studies evaluating combinations with standard chemotherapies and immune checkpoint inhibitors [48]. Collaborations and Partnerships - A collaboration with the University of Virginia aims to investigate combinations of DNase I with immunotherapies in colorectal cancer models [39]. - The company has committed up to $0.9 million to Scripps Research for advancing pre-clinical development of DNase technology, with an additional funding of approximately $400,000 planned [40][41]. - Catalent Pharma Solutions LLC is collaborating with the company to provide cGMP manufacturing services for its recombinant protein, Human DNase I [58]. - A collaboration with Volition aims to develop NETs-targeted adoptive cell therapies for cancer treatment, with shared proceeds from commercialization [57]. - Significant collaborations with Scripps Research and UVA to advance drug candidate development and enhance CAR T cell function in solid tumors [55]. Intellectual Property and Regulatory Exclusivity - The company may encounter risks related to intellectual property rights, including potential claims of infringement or challenges to patent ownership [24]. - The company holds exclusive license agreements to develop interventional DNase technology aimed at improving outcomes of existing treatments, including immunotherapies [46]. - The company has 35 U.S. and international patents and pending patent applications covering various aspects of its technologies as of February 28, 2025 [64]. - The Orphan Drug Act provides a seven-year exclusive marketing period for drugs developed for rare diseases affecting fewer than 200,000 persons in the U.S. [86]. - The FDA's Fast Track program expedites the review process for drugs intended to treat serious conditions and address unmet medical needs [89]. Market Trends and Legislative Impact - The Inflation Reduction Act of 2022 allows Medicare to negotiate prices for certain high-expenditure prescription drugs starting in 2026 and 2028 for Parts B and D respectively [110]. - The Act requires manufacturers to pay rebates if drug prices rise faster than inflation, impacting reimbursement strategies [110]. - The U.S. Supreme Court's decision in Loper Bright Enterprises v. Raimondo may lead to increased scrutiny of healthcare regulations, potentially altering enforcement [111]. - State legislatures are increasingly implementing regulations to control pharmaceutical pricing, including price constraints and transparency measures [112]. - The Affordable Care Act has faced numerous challenges, which could affect government reimbursement rates and demand for pharmaceutical products [114].

Financial Results - Xenetic Biosciences, Inc. reported financial results for the three months ended September 30, 2024, with a focus on business updates[3] - The press release detailing the financial results is included as Exhibit 99.1, which is referenced in the report[4] Risks and Uncertainties - The company emphasizes that forward-looking statements are subject to risks and uncertainties, including market factors and regulatory processes[5] Management - The report was signed by James Parslow, Interim Chief Executive Officer & Chief Financial Officer, on November 13, 2024[7]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $614,243, slightly up from $611,174 for the same period in 2023, indicating a growth of approximately 0.3%[10] - Net loss for the three months ended September 30, 2024, was $436,671, compared to a net loss of $1,055,555 for the same period in 2023, reflecting an improvement of about 58.7%[10] - Basic and diluted net loss per share improved from $(0.69) in Q3 2023 to $(0.28) in Q3 2024, a reduction of approximately 59.4%[10] - Net loss for the nine months ended September 30, 2024, was $2,905,754, compared to a net loss of $2,963,072 for the same period in 2023, representing a decrease of approximately 1.9%[17] - The company reported a net loss of approximately $2.9 million for the nine months ended September 30, 2024, with an accumulated deficit of approximately $196.1 million[78] - The company incurred a net loss of approximately $2.1 million for the nine months ended September 30, 2024, compared to a net loss of approximately $3.3 million for the same period in 2023, indicating a reduction in losses[81] Assets and Equity - Total current assets decreased from $9,586,874 as of December 31, 2023, to $7,027,648 as of September 30, 2024, representing a decline of approximately 26.7%[6] - Total assets decreased from $10,605,226 as of December 31, 2023, to $8,046,000 as of September 30, 2024, a reduction of about 24.1%[7] - Total stockholders' equity decreased from $9,795,641 as of December 31, 2023, to $7,036,593 as of September 30, 2024, a decline of about 28.3%[7] - Cash at the end of the period was $6,839,560, down from $9,776,073 as of September 30, 2023, indicating a decrease of approximately 30%[17] - Working capital decreased by approximately $2.8 million to $6.0 million at September 30, 2024, compared to $8.8 million at December 31, 2023[78] Expenses - Research and development expenses for the three months ended September 30, 2024, were $367,985, down from $1,020,618 in the same period of 2023, a decrease of approximately 64.1%[10] - General and administrative expenses increased slightly from $737,241 in Q3 2023 to $745,731 in Q3 2024, an increase of about 1.9%[10] - Research and development expenses decreased by approximately $652,633, or 63.9%, to $367,985 for the quarter ended September 30, 2024, compared to $1,020,618 in the prior year[67] - Research and development expenses for the nine months ended September 30, 2024, decreased by approximately $273,060, or 10.8%, to $2,246,077 from $2,519,137 in the comparable period in 2023[74] - General and administrative expenses increased by approximately $101,736, or 3.9%, to $2,710,670 for the nine months ended September 30, 2024, compared to $2,608,934 in the same period of 2023[75] Cash Flow and Operating Activities - Net cash used in operating activities for the nine months ended September 30, 2024, was $2,143,486, a reduction of 35.5% from $3,321,192 in the prior year[17] - Cash flows used in operating activities decreased by approximately $1.2 million from the previous year, reflecting improved operational efficiency[81] - There were no cash flows from investing or financing activities for the nine months ended September 30, 2024 and 2023, indicating a lack of new investments or financing arrangements during this period[82] Future Outlook and Financing - The company has incurred substantial losses since inception and expects to continue incurring operating losses in the near term, indicating ongoing financial challenges[22] - The company anticipates needing additional capital in the long term to pursue its business initiatives, highlighting the need for future financing[22] - The company anticipates needing additional capital in the long-term to pursue business initiatives, with access to potential public or private equity offerings and debt financings[80] Research and Collaborations - The company has entered into a research collaboration with Volition, which has funded $26,000 to date for developing NETs-targeted adoptive cell therapies[31] - The company has committed up to $0.9 million to Scripps Research for advancing the pre-clinical development of its DNase oncology platform technology[33] - The company has entered into a Research Funding Agreement with UVA, paying approximately $0.2 million to advance the development of its systemic DNase program[35] - The Company entered into a Second Amendment to Research Funding and Option Agreement with Scripps, providing up to approximately $400,000 for ongoing research[53] Stock and Warrants - Weighted-average shares of common stock outstanding increased from 1,532,600 in Q3 2023 to 1,541,722 in Q3 2024, an increase of approximately 0.6%[10] - The Company granted 20,000 stock options during the nine months ended September 30, 2024, with no options granted in the same period of 2023[45] - The Company has approximately 462,963 Series A Warrants outstanding, exercisable at a price of $33.00 per share, expiring on February 23, 2025[41] - No public warrants were outstanding as of September 30, 2024, following the expiration of warrants that allowed for cashless exercise[43] Tax and Legal Matters - As of September 30, 2024, the valuation allowance against deferred tax assets was approximately $40.6 million, up from $39.7 million as of December 31, 2023[47] - The Company did not record any unrecognized tax positions as of September 30, 2024[48] - The company is not currently subject to any material legal proceedings, which may positively impact its financial stability[91] Internal Controls and Risk Factors - Management evaluated the effectiveness of disclosure controls and procedures, concluding they are effective for timely reporting[88] - There were no changes in internal control over financial reporting that would materially affect the company's financial reporting[89] - There have been no material changes to the risk factors previously disclosed in the Annual Report for the year ended December 31, 2023[92] - As of September 30, 2024, there were no material changes in contractual obligations and commitments from those disclosed in the Annual Report for the year ended December 31, 2023[82] - The company does not have any off-balance sheet financing arrangements that could materially affect its financial condition[83]

Financial Performance - Xenetic Biosciences, Inc. reported financial results for the three months ended June 30, 2024[3]. - The company issued a press release on August 14, 2024, detailing its financial performance and business updates[3]. - The company has not provided specific numerical financial results in the extracted documents[2]. Forward-Looking Statements - Forward-looking statements indicate expectations for future performance, subject to various risks and uncertainties[4]. - The press release and forward-looking statements are intended to provide insights into the company's future strategies and expectations[4]. Risks and Uncertainties - The company is subject to market factors and economic conditions that may impact its operations and product development[4]. - Risks include public health issues, geopolitical events, and regulatory challenges that could affect performance[4]. Compliance and Reporting - The report was signed by James Parslow, Interim Chief Executive Officer & Chief Financial Officer[6]. - The company is registered with the SEC and complies with reporting requirements[1]. - The press release is incorporated by reference in the Form 8-K filing, but the information is not deemed "filed" under the Securities Exchange Act[3].