Xenetic Biosciences(XBIO)

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Xenetic Biosciences(XBIO) - 2025 Q2 - Quarterly Results
2025-08-13 12:00
[Form 8-K General Information](index=1&type=section&id=Form%208-K%20General%20Information) This section provides essential identification, contact information, and regulatory filing status for Xenetic Biosciences, Inc [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the essential identification and contact information for Xenetic Biosciences, Inc., the entity filing this Form 8-K - Company Name: **Xenetic Biosciences, Inc.**[2](index=2&type=chunk) - Jurisdiction of Incorporation: **Nevada**[2](index=2&type=chunk) - Commission File Number: **001-37937**[2](index=2&type=chunk) - Principal Executive Offices Address: **945 Concord Street, Framingham, Massachusetts 01701**[2](index=2&type=chunk) - Registrant's Telephone Number: **(781) 778-7720**[2](index=2&type=chunk) [Filing Status and Provisions](index=1&type=section&id=Filing%20Status%20and%20Provisions) This part clarifies the specific regulatory provisions under which the Form 8-K is submitted and indicates the registrant's status regarding emerging growth company criteria - The Form 8-K is not intended to simultaneously satisfy filing obligations under **Rule 425, Rule 14a-12, Rule 14d-2(b), or Rule 13e-4(c)**[3](index=3&type=chunk) - The registrant is not an **'emerging growth company'** as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) This section details the announcement of Xenetic Biosciences, Inc.'s financial results for the three months ended June 30, 2025 [Financial Results Announcement](index=2&type=section&id=Financial%20Results%20Announcement) Xenetic Biosciences, Inc. announced its financial results for the three months ended June 30, 2025, through a press release issued on August 13, 2025, which is incorporated by reference as Exhibit 99.1 - Date of Announcement: **August 13, 2025**[6](index=6&type=chunk) - Period Covered: **Three months ended June 30, 2025**[6](index=6&type=chunk) - Method of Announcement: **Press release (Exhibit 99.1** to this Current Report on Form 8-K)[6](index=6&type=chunk)[7](index=7&type=chunk) - The information in this Item 2.02, including Exhibit 99.1, is **'furnished' and not 'filed'** for purposes of Section 18 of the Securities Exchange Act of 1934, unless expressly set forth by specific reference in a filing[7](index=7&type=chunk) [Forward-Looking Statements](index=2&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section provides a cautionary disclaimer for forward-looking statements, outlining their nature, risks, and update policy [Disclaimer and Risk Factors](index=2&type=section&id=Disclaimer%20and%20Risk%20Factors) This section serves as a cautionary note, indicating that the Form 8-K contains forward-looking statements subject to the safe harbor provisions, outlining their nature, associated risks, and the company's policy on updating such statements - Purpose: Intended to be subject to the **safe harbor provisions of the Private Securities Litigation Reform Act of 1995**[8](index=8&type=chunk) - Identification: Statements other than historical facts, identifiable by words such as **"expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates"**[8](index=8&type=chunk) - Actual activities, performance, achievements, or results may differ materially due to factors described in the **"Risk Factors" section of the Company's SEC reports** (Form 10-K, 10-Q, 8-K), general market/economic conditions, public health issues, geopolitical events, competitive product development, regulations, manufacturing issues, patent positions, litigation, and shareholder activism[8](index=8&type=chunk) - The Company does not undertake any obligation to update forward-looking statements, except as required by law[8](index=8&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits.) This section provides a comprehensive list of all documents filed as exhibits to this Form 8-K [List of Exhibits](index=2&type=section&id=List%20of%20Exhibits) This section provides a detailed list of all documents filed as exhibits to this Form 8-K, including the press release announcing financial results and the interactive data file - **Exhibit 99.1**: Press Release dated **August 13, 2025**, pertaining to the financial results of the Company for the **three months ended June 30, 2025**[9](index=9&type=chunk) - **Exhibit 104**: Cover Page Interactive Data File (embedded within the Inline XBRL document)[9](index=9&type=chunk) [Signatures](index=3&type=section&id=SIGNATURES) This section formally concludes the Form 8-K with the signature of an authorized officer [Authorized Signatory](index=3&type=section&id=Authorized%20Signatory) This section formally concludes the Form 8-K with the signature of an authorized officer, confirming the report's submission on behalf of Xenetic Biosciences, Inc - Registrant: **XENETIC BIOSCIENCES, INC.**[12](index=12&type=chunk) - Signatory: **James Parslow**[12](index=12&type=chunk) - Title: **Interim Chief Executive Officer & Chief Financial Officer**[12](index=12&type=chunk) - Date: **August 13, 2025**[12](index=12&type=chunk)
Xenetic Biosciences (XBIO) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-12 23:26
Group 1: Earnings Performance - Xenetic Biosciences reported a quarterly loss of $0.45 per share, better than the Zacks Consensus Estimate of a loss of $0.64, and improved from a loss of $0.83 per share a year ago, representing an earnings surprise of +29.69% [1] - The company posted revenues of $0.59 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 7.81%, and down from $0.73 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Group 2: Stock Performance and Outlook - Xenetic Biosciences shares have lost about 30.8% since the beginning of the year, while the S&P 500 has gained 8.4% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.65 on $0.72 million in revenues, and -$2.56 on $2.7 million in revenues for the current fiscal year [7] Group 3: Industry Context - The Medical - Drugs industry, to which Xenetic Biosciences belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]
Xenetic Biosciences(XBIO) - 2025 Q2 - Quarterly Report
2025-08-12 21:00
PART I FINANCIAL INFORMATION This section covers the company's unaudited condensed consolidated financial statements, management's analysis, market risk, and internal controls [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets, operations, equity, and cash flows, with notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :------------------ | | Cash | $4,779,846 | $6,165,568 | | Total current assets | $5,353,700 | $6,587,522 | | Total assets | $5,353,700 | $6,901,443 | | Total current liabilities | $903,430 | $894,263 | | Total stockholders' equity | $4,450,270 | $6,007,180 | - Cash decreased by approximately **$1.39 million** from December 31, 2024, to June 30, 2025[9](index=9&type=chunk) - Total assets decreased by approximately **$1.55 million**, and total stockholders' equity decreased by approximately **$1.56 million** during the six-month period[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Royalty revenue | $589,897 | $726,404 | $1,183,158 | $1,237,221 | | Research and development | $(656,557) | $(933,771) | $(1,535,586) | $(1,878,092) | | General and administrative | $(657,752) | $(1,130,029) | $(1,314,393) | $(1,964,939) | | Loss from operations | $(724,412) | $(1,337,396) | $(1,666,821) | $(2,605,810) | | Net loss | $(688,703) | $(1,273,970) | $(1,591,844) | $(2,469,083) | | Basic and diluted net loss per share | $(0.45) | $(0.83) | $(1.03) | $(1.60) | - Net loss for the three months ended June 30, 2025, decreased by **45.9%** to **$0.69 million** from **$1.27 million** in the prior year[12](index=12&type=chunk) - Net loss for the six months ended June 30, 2025, decreased by **35.5%** to **$1.59 million** from **$2.47 million** in the prior year[12](index=12&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in stockholders' equity, including net loss and share-based expenses, for the period ended June 30, 2025 | Metric | June 30, 2025 | January 1, 2025 | | :----------------------- | :------------ | :-------------- | | Total Stockholders' Equity | $4,450,270 | $6,007,180 | | Accumulated Deficit | $(198,786,315) | $(197,194,471) | | Share-based expense (6 months) | $34,934 | N/A | | Net loss (6 months) | $(1,591,844) | N/A | - Total stockholders' equity decreased from **$6.01 million** at January 1, 2025, to **$4.45 million** at June 30, 2025, primarily due to the net loss incurred[17](index=17&type=chunk) - Accumulated deficit increased by approximately **$1.59 million** during the six months ended June 30, 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the cash flow activities, including operating, investing, and financing, for the six months ended June 30, 2025, and 2024 | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(1,591,844) | $(2,469,083) | | Net cash used in operating activities | $(1,385,722) | $(1,684,449) | | Cash at end of period | $4,779,846 | $7,298,597 | - Net cash used in operating activities decreased by approximately **$0.3 million** for the six months ended June 30, 2025, compared to the same period in 2024[25](index=25&type=chunk) - Cash at the end of the period decreased to **$4.78 million** as of June 30, 2025, from **$7.30 million** as of June 30, 2024[25](index=25&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements - Xenetic Biosciences, Inc. is a biopharmaceutical company focused on immune-oncology technologies, specifically advancing its proprietary DNase technology for pancreatic carcinoma and solid tumors[28](index=28&type=chunk)[66](index=66&type=chunk) - The Company has incurred substantial losses since inception and expects to continue incurring operating losses. While existing resources are believed to be adequate for the next 12 months, additional long-term capital will be needed[31](index=31&type=chunk)[84](index=84&type=chunk) - Key strategic collaborations include Takeda Pharmaceutical Co. Ltd. (royalty revenue from PolyXen technology), Catalent Pharma Solutions LLC (cGMP manufacturing for Human DNase I), Scripps Research Institute (research funding for DNase technology, with an option for an exclusive license), and University of Virginia (research funding for systemic DNase program)[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk)[47](index=47&type=chunk) - Share-based expense for the six months ended June 30, 2025, was approximately **$35,000**, a decrease from **$0.1 million** in the prior year, primarily due to lower personnel costs[52](index=52&type=chunk)[53](index=53&type=chunk)[78](index=78&type=chunk) - The Company has no provision for income taxes due to incurred losses and maintains a valuation allowance against deferred tax assets, which increased to approximately **$41.6 million** as of June 30, 2025[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and results for the three and six months ended June 30, 2025, covering operations, liquidity, and capital [BUSINESS OVERVIEW](index=16&type=section&id=BUSINESS%20OVERVIEW) This section provides an overview of Xenetic Biosciences' biopharmaceutical focus on immune-oncology and its proprietary DNase technology - Xenetic Biosciences is a biopharmaceutical company focused on immune-oncology, specifically advancing its proprietary DNase technology to improve outcomes for pancreatic carcinoma and solid tumors by targeting NETs[66](index=66&type=chunk) - The company's internal efforts during the six months ended June 30, 2025, were primarily focused on the advancement of its DNase technology[67](index=67&type=chunk) - The company receives ongoing royalties from a license of its legacy PolyXen technology to an industry partner, but none of its drug candidates have yet received regulatory marketing authorization[67](index=67&type=chunk) [RESULTS OF OPERATIONS](index=17&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes the company's financial performance, including revenue, expenses, and net loss, for the recent reporting periods Quarterly Financial Performance (YoY Change) | Metric | June 30, 2025 | June 30, 2024 | Increase (Decrease) | Percentage Change | | :-------------------------- | :------------ | :------------ | :------------------ | :---------------- | | Royalty revenue | $589,897 | $726,404 | $(136,507) | (18.8)% | | Research and development | $(656,557) | $(933,771) | $(277,214) | (29.7)% | | General and administrative | $(657,752) | $(1,130,029) | $(472,277) | (41.8)% | | Loss from operations | $(724,412) | $(1,337,396) | $(612,984) | (45.8)% | | Net loss | $(688,703) | $(1,273,970) | $(585,267) | (45.9)% | Six-Month Financial Performance (YoY Change) | Metric | June 30, 2025 | June 30, 2024 | Increase (Decrease) | Percentage Change | | :-------------------------- | :------------ | :------------ | :------------------ | :---------------- | | Royalty revenue | $1,183,158 | $1,237,221 | $(54,063) | (4.4)% | | Research and development | $(1,535,586) | $(1,878,092) | $(342,506) | (18.2)% | | General and administrative | $(1,314,393) | $(1,964,939) | $(650,546) | (33.1)% | | Loss from operations | $(1,666,821) | $(2,605,810) | $(938,989) | (36.0)% | | Net loss | $(1,591,844) | $(2,469,083) | $(877,239) | (35.5)% | - The decrease in R&D expenses for both periods was primarily due to lower personnel costs and share-based expense, partially offset by increased consulting and exploratory study costs[72](index=72&type=chunk)[78](index=78&type=chunk) - General and administrative expenses decreased significantly due to severance and benefits expensed in connection with the separation agreement with the former Chief Executive Officer in Q2 2024[73](index=73&type=chunk)[79](index=79&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, working capital, and ability to meet short-term and long-term financial obligations - The company reported a net loss of approximately **$1.6 million** for the six months ended June 30, 2025, and an accumulated deficit of approximately **$198.8 million**[82](index=82&type=chunk) | Metric | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Cash | $4.8 million | $6.2 million | | Working Capital | $4.5 million | $5.7 million | | Current Liabilities | $0.9 million | $0.9 million | - Working capital decreased by approximately **$1.2 million** during the six months ended June 30, 2025, primarily due to the net loss[82](index=82&type=chunk) - Management believes existing resources are adequate for the next 12 months but anticipates needing additional capital long-term, relying on potential equity offerings, debt financings, or collaborations[84](index=84&type=chunk) - Net cash used in operating activities was approximately **$1.4 million** for the six months ended June 30, 2025, a decrease from **$1.7 million** in the prior year[85](index=85&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Xenetic Biosciences, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing market risk disclosures as it qualifies as a "smaller reporting company" under Rule 12b-2 of the Exchange Act[92](index=92&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures are effective, with no material changes in internal control - Management concluded that disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[94](index=94&type=chunk) - No material changes in internal control over financial reporting occurred during the period covered by this Quarterly Report[95](index=95&type=chunk) PART II OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=22&type=section&id=Item%201%20Legal%20Proceedings) Xenetic Biosciences, Inc. is not currently subject to any material legal proceedings, nor are any material legal proceedings threatened against the company - The company is not currently involved in any material legal proceedings, and none are known to be threatened[98](index=98&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to the risk factors have occurred since the filing of the Annual Report on Form 10-K for the year ended December 31, 2024[99](index=99&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[100](index=100&type=chunk) [Item 3. Defaults Upon Senior Securities](index=22&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report during the period - No defaults upon senior securities occurred during the reporting period[101](index=101&type=chunk) [Item 4. Mine Safety Disclosures](index=22&type=section&id=Item%204%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to Xenetic Biosciences, Inc - Mine safety disclosures are not applicable to the company's operations[102](index=102&type=chunk) [Item 5. Other Information](index=22&type=section&id=Item%205%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - No changes in Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers were reported during the quarter[103](index=103&type=chunk) [Item 6. Exhibits](index=22&type=section&id=Item%206%20Exhibits) This section lists the exhibits incorporated by reference or filed as part of this report, including amendments to agreements and certifications - Exhibits include the Third Amendment to Research Funding and Option Agreement with Scripps Research Institute, certifications from the Interim Principal Executive Officer and Principal Financial Officer, and XBRL financial statements[105](index=105&type=chunk)
Xenetic Biosciences (XBIO) Earnings Call Presentation
2025-07-07 08:37
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]
Xenetic Biosciences(XBIO) - 2025 Q1 - Quarterly Results
2025-05-14 12:27
[Form 8-K Filing Information](index=1&type=section&id=Form%208-K%20Filing%20Information) This section details the registrant's identification, incorporation, SEC filing particulars, and registered securities information [Registrant and Filing Details](index=1&type=section&id=Registrant%20and%20Filing%20Details) This section identifies Xenetic Biosciences, Inc. as the registrant, detailing its incorporation, SEC file number, and the Form 8-K filing date - **Registrant**: Xenetic Biosciences, Inc.[2](index=2&type=chunk) - **Date of Report**: May 14, 2025[2](index=2&type=chunk) - **State of Incorporation**: Nevada[2](index=2&type=chunk) - **Commission File Number**: 001-37937[2](index=2&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) This section details the company's registered securities, including Common Stock on Nasdaq, and confirms its non-emerging growth status Registered Securities | 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 | - Registrant is **not an emerging growth company**[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) This section details the announcement of Xenetic Biosciences, Inc.'s Q1 2025 financial results via a press release, furnished as Exhibit 99.1 [Q1 2025 Financial Results Announcement](index=2&type=section&id=Q1%202025%20Financial%20Results%20Announcement) Xenetic Biosciences, Inc. announced Q1 2025 financial results via a May 14, 2025 press release, furnished as Exhibit 99.1, not deemed "filed" for Section 18 purposes - Company issued a press release on **May 14, 2025**, announcing results for the three months ended **March 31, 2025**[6](index=6&type=chunk) - The press release is furnished as **Exhibit 99.1** to this Form 8-K and incorporated by reference[7](index=7&type=chunk) - Information in Item 2.02, including Exhibit 99.1, is **not deemed 'filed'** for Section 18 of the Securities Exchange Act of 1934 purposes[7](index=7&type=chunk) [Forward-Looking Statements](index=2&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section provides a disclaimer for forward-looking statements, highlighting inherent risks and the company's limited obligation to update them [Disclaimer on Future Projections](index=2&type=section&id=Disclaimer%20on%20Future%20Projections) This disclaimer states that Form 8-K contains forward-looking statements subject to safe harbor provisions, based on current expectations, and involve risks - This Form 8-K contains forward-looking statements subject to the **safe harbor provisions of the Private Securities Litigation Reform Act of 1995**[8](index=8&type=chunk) - Forward-looking statements are based on current expectations and involve **risks and uncertainties**, as detailed in the Company's SEC reports[8](index=8&type=chunk) - The Company does not undertake to update forward-looking statements, except as **required by law**[8](index=8&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits.) This section provides a comprehensive list of exhibits accompanying the Form 8-K, including the Q1 2025 financial results press release [Exhibits List](index=2&type=section&id=Exhibits%20List) This section lists the Form 8-K exhibits, including the Q1 2025 financial results press release (Exhibit 99.1) and the Cover Page Interactive Data File (Exhibit 104) Form 8-K Exhibits | Exhibit No. | Description | | --- | --- | | 99.1 | Press Release dated May 14, 2025 pertaining to the financial results of the Company for the three months ended March 31, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURES) This section confirms the authorized signing of the Form 8-K by the Interim Chief Executive Officer & Chief Financial Officer [Authorized Signatory](index=3&type=section&id=Authorized%20Signatory) The report was duly signed by James Parslow, Interim CEO & CFO, on May 14, 2025, as per Securities Exchange Act of 1934 requirements - Report signed by **James Parslow**, Interim Chief Executive Officer & Chief Financial Officer[12](index=12&type=chunk) - **Date of signature**: May 14, 2025[12](index=12&type=chunk) - Signing pursuant to the requirements of the **Securities Exchange Act of 1934**[11](index=11&type=chunk)
Xenetic Biosciences(XBIO) - 2025 Q1 - Quarterly Report
2025-05-13 21:00
[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)
Xenetic Biosciences(XBIO) - 2024 Q4 - Annual Results
2025-03-19 12:05
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]
Xenetic Biosciences(XBIO) - 2024 Q4 - Annual Report
2025-03-18 20:30
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].
Xenetic Biosciences(XBIO) - 2024 Q3 - Quarterly Results
2024-11-13 13:30
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]
Xenetic Biosciences(XBIO) - 2024 Q3 - Quarterly Report
2024-11-12 21:30
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]