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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Commission File Number: 001-37937 XENETIC BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Nevada (State or other jurisdiction of incorporation or organization) 45-2952962 (IRS Employer Identification No.) 945 Concord Street Framingham, Massachusetts 017 ...

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].

Financial Performance - Xenetic Biosciences reported a quarterly loss of $0.83 per share, which aligns with the Zacks Consensus Estimate, compared to a loss of $0.69 per share a year ago [1] - The company posted revenues of $0.73 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 34.44%, and up from $0.65 million year-over-year [2] - Over the last four quarters, Xenetic has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2][3] Stock Performance and Outlook - Xenetic Biosciences shares have declined approximately 5.2% since the beginning of the year, while the S&P 500 has gained 12.1% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.15 on $0.57 million in revenues for the upcoming quarter and -$0.96 on $2.2 million in revenues for the current fiscal year [4][7] Industry Context - The Medical - Drugs industry, to which Xenetic belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor sentiment and stock performance [5][6]

Financial Performance - Total revenue for the three months ended June 30, 2024, was $726,404, an increase of 11.6% compared to $651,005 for the same period in 2023[7]. - Net loss for the three months ended June 30, 2024, was $1,273,970, compared to a net loss of $1,050,963 for the same period in 2023, representing a 21.2% increase in losses[7]. - The total operating costs and expenses for the three months ended June 30, 2024, were $2,063,800, an increase from $1,849,193 for the same period in 2023, reflecting an increase of 11.6%[7]. - For the six months ended June 30, 2024, royalty revenue decreased by 1.6% to $1,237,221 compared to $1,256,849 for the same period in 2023[64]. - Net loss for the six months ended June 30, 2024 was $2,469,083, a 29.4% increase from a net loss of $1,907,517 in the prior year[64]. Research and Development - Research and development expenses for the six months ended June 30, 2024, were $1,878,092, up from $1,498,519 for the same period in 2023, indicating a 25.4% increase[7]. - Research and development expenses for the quarter ended June 30, 2024 were $933,771, a 3.4% increase from $903,243 in the prior year[56]. - The company has paid approximately $0.9 million to Scripps Research to fund research related to its DNase oncology platform technology, with an option to acquire exclusive licensing rights[27]. - The company has entered into a research funding agreement with the University of Virginia, paying approximately $0.2 million to advance its systemic DNase program[29]. - The company is focused on advancing its systemic DNase program as an adjunctive therapy for pancreatic carcinoma and metastatic solid tumors[53]. Assets and Liabilities - Total current assets decreased to $8,014,978 as of June 30, 2024, down from $9,586,874 as of December 31, 2023, reflecting a decline of 16.4%[6]. - Total liabilities increased to $1,587,602 as of June 30, 2024, compared to $809,585 as of December 31, 2023, marking a significant rise of 96%[6]. - Stockholders' equity decreased to $7,445,728 as of June 30, 2024, down from $9,795,641 as of December 31, 2023, representing a decline of 24%[6]. - Working capital decreased by approximately $2.3 million to approximately $6.4 million at June 30, 2024, down from approximately $8.8 million at December 31, 2023[71]. - The company had approximately $7.3 million in cash and approximately $1.6 million in current liabilities at June 30, 2024, down from approximately $9.0 million in cash and approximately $0.8 million in current liabilities at December 31, 2023[71]. Cash Flow and Financing - Cash flows used in operating activities totaled approximately $1.7 million for the six months ended June 30, 2024, compared to approximately $2.4 million for the same period in 2023[74]. - The company anticipates needing additional capital in the long term to pursue its business initiatives, highlighting potential future financing needs[16]. - The company expects to continue incurring operating losses in the near term but believes existing resources will fund operations for at least twelve months from the issuance of the financial statements[72]. - There were no cash flows from investing or financing activities for the six months ended June 30, 2024 and 2023[75][76]. - The company anticipates needing additional capital in the long term to pursue business initiatives, with potential access to capital resources through various means[72]. Collaborations and Agreements - The company has a collaboration with Volition to develop NETs-targeted adoptive cell therapies, with Volition funding $26,000 to date[25]. - The Company has entered into various research, development, license, and supply agreements with Serum Institute, Pharmsynthez, and SynBio, with no revenue recognized from these agreements during the three and six months ended June 30, 2024 and 2023[30]. Stock and Equity - The Company granted 20,000 stock options during the three months ended June 30, 2024, with no stock option awards granted during the same period in 2023[40]. - Total share-based expense related to stock options and RSUs was approximately $42,000 for the three months ended June 30, 2024, compared to $0.1 million for the same period in 2023[38]. - The Company had approximately 462,963 Series A Warrants outstanding as of June 30, 2024, with an exercise price of $33.00 per share[35]. Tax and Valuation - The valuation allowance against deferred tax assets was approximately $40.4 million as of June 30, 2024, reflecting the Company's belief that it is more likely than not that these assets will not be realized[42]. - The Company did not record any unrecognized tax positions as of June 30, 2024[42]. - The Company has no financial instruments classified as Level 3 in the fair value hierarchy during the three and six months ended June 30, 2024 and 2023[32]. General Observations - The company has incurred substantial losses since inception and expects to continue incurring operating losses in the near term, indicating ongoing financial challenges[16]. - There have been no material changes to risk factors previously disclosed in the Annual Report for the year ended December 31, 2023[88].

Financial Results - Xenetic Biosciences, Inc. reported financial results for the three months ended March 31, 2024[6]. - The company issued a press release on May 10, 2024, detailing its business update and financial performance[6]. - The press release is included as Exhibit 99.1, which contains comprehensive financial results for the quarter[9]. Company Classification - The company is classified as an emerging growth company under the Securities Act[5]. Forward-Looking Statements - Forward-looking statements indicate potential risks and uncertainties affecting future performance, including market conditions and regulatory processes[8]. Data Availability - Specific financial metrics and user data were not provided in the extracted content, but the press release is referenced for detailed results[7].