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Xenetic Biosciences, Inc. Reports Full Year 2023 Financial Results

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Xenetic Biosciences (XBIO) reports financial results for 2023, highlighting progress in its DNase-based oncology program towards a Phase 1 clinical study for treating pancreatic carcinoma and other solid tumors. The company ended the year with $9.0 million in cash to fund operations.
Positive
  • Xenetic Biosciences is focusing on advancing innovative immune-oncology technologies targeting hard-to-treat cancers.
  • The company entered into agreements with the University of Virginia to further develop its DNase program.
  • Positive preclinical data is guiding the approach towards a first-in-human trial for the DNase-based oncology platform.
  • Xenetic Biosciences' CEO, Jeffrey Eisenberg, expressed optimism about the potential of the DNase platform to provide therapies for pancreatic carcinoma and other solid tumors.
  • The company reported a net loss of approximately $4.1 million for the fiscal year 2023.
  • Research and development expenses decreased by 26.7% to $3.5 million, primarily due to the absence of in-process R&D expenses related to the DNase platform licensing in 2022.
  • Royalty payments from a sublicense with Takeda Pharmaceuticals increased by 48.8% to approximately $2.5 million in 2023.
  • General and administrative expenses decreased slightly to $3.6 million, with a decrease in employee-related costs offset by higher consulting and legal costs.
  • Xenetic Biosciences ended the year with around $9.0 million in cash.
Negative
  • None.

The financial results reported by Xenetic Biosciences, Inc. for the fiscal year 2023 appear to show a strategic focus on their DNase-based oncology program, which is a significant move considering the high unmet need in the treatment of pancreatic carcinoma and other challenging solid tumors. The net loss of $4.1 million, while substantial, is not uncommon for a biopharmaceutical firm at this stage of development, where investment in R&D is pivotal. The decrease in R&D expenses, primarily due to the absence of a one-time in-process R&D expense from the previous year, indicates a streamlined focus on their current projects. The increase in royalty payments from Takeda Pharmaceuticals suggests a growing revenue stream, which is a positive indicator for investors. The cash position of $9.0 million provides the company with a runway to fund operations, but it is critical to monitor the burn rate and future financing needs.

The progression of Xenetic's DNase-based oncology program towards a Phase 1 clinical study is a noteworthy development in the field of immune-oncology. DNase therapies are designed to target and dismantle the protective barrier around cancer cells, potentially enhancing the efficacy of cancer treatments. The preclinical data that has been characterized as 'encouraging' suggests that the company is on the right track with its research and development. However, it's important to recognize that the transition from preclinical to clinical stages is fraught with risk and many compounds fail to demonstrate efficacy or safety in humans. The strategic partnerships, like the one with UVA, are essential in bolstering the research momentum and can be a signal of credibility to stakeholders. The impact on the stock market will hinge on the outcomes of the Phase 1 trials and subsequent clinical milestones.

From a market perspective, Xenetic Biosciences' focus on hard-to-treat cancers such as pancreatic carcinoma addresses a significant market gap. Pancreatic cancer has one of the lowest survival rates among major cancers and new treatment modalities are in high demand. The DNase platform's multiple treatment modalities could position Xenetic as a potential leader in a niche market. However, the competitive landscape in oncology is intense and investor sentiment often fluctuates with clinical trial results. The company's ability to maintain its financial health while advancing its clinical programs will be important for sustaining investor confidence. Additionally, the biopharmaceutical sector is highly sensitive to regulatory news and any updates from the FDA regarding the DNase program will likely have a direct impact on the company's stock performance.

  • Continued advancement of DNase-based oncology program towards Phase 1 clinical study for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors
  • Ended the year with $9.0 million of cash to fund operations

FRAMINGHAM, MA / ACCESSWIRE / March 22, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, today reported its financial results for the year ended December 31, 2023.

Recent Highlights

  • Entered into a Research Funding Agreement and a Material Transfer Agreement with the University of Virginia ("UVA") to advance the development of the DNase program.
  • Generated growing body of encouraging preclinical data guiding the approach to a first in human trial for systemic DNase-based oncology platform.

"We continued to make steady progress over the course of 2023 and are well positioned to continue on that pathway in 2024. With the encouraging preclinical data we continue to see with our DNase-based oncology platform, we are making noteworthy strides toward our first in human trial. We believe that our DNase platform, comprising multiple treatment modalities, has the potential to generate much needed therapies for pancreatic carcinoma and other locally advanced or metastatic solid tumors, and we are excited to unlock the full potential of our assets," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

Summary of Financial Results for Fiscal Year 2023

Net loss for the year ended December 31, 2023 was approximately $4.1 million. Research and development expenses for the year ended December 31, 2023 decreased by $1.3 million, or 26.7%, to $3.5 million from $4.8 million in the prior year period. This decrease was primarily due to in-process research and development expense of $1.8 million in 2022 associated with our licensing of the DNase platform for which there was no similar expense in 2023. Royalty payments of approximately $2.5 million were received from our sublicense with Takeda Pharmaceuticals Co. Ltd in the year ended December 31, 2023, representing an approximate 48.8% increase over the same period in 2022. General and administrative expenses for the year ended December 31, 2023 were $3.6 million, decreasing by approximately $0.1 million, or 2.5%, compared to the prior year. The decrease was primarily due to a decrease in employee related costs, substantially offset by increases in consulting and legal costs during the year ended December 31, 2023 compared to the prior year.

The Company ended the year with approximately $9.0 million of cash.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company's DNase platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors.

For more information, please visit the Company's website at www.xeneticbio.com and connect on X, LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including, but not limited to, statements regarding: all statements regarding expectations for our DNase-base oncology platform, including statements regarding: our continued advancement of DNase-based oncology program towards Phase 1 clinical study for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors, our belief that we are well positioned to continue on a similar pathway in 2024, encouraging preclinical data and making noteworthy strides toward our first in human trial, our belief that our DNase platform, comprising multiple treatment modalities, has the potential to generate much needed therapies for pancreatic carcinoma and other locally advanced or metastatic solid tumors, our excitement to unlock the full potential of our assets, the DNase platform improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression, and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements; (2) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (3) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (4) failure to realize the anticipated potential of the DNase or PolyXen technologies; (5) the ability of the Company to obtain funding and implement its business strategy; and (6) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak, and geopolitical events, such as the Russian invasion of Ukraine and conflict in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

Contact:

JTC Team, LLC
Jenene Thomas
(833) 475-8247
xbio@jtcir.com

SOURCE: Xenetic Biosciences, Inc.



View the original press release on accesswire.com

FAQ

What is Xenetic Biosciences (XBIO) focusing on?

Xenetic Biosciences is focusing on advancing innovative immune-oncology technologies targeting hard-to-treat cancers.

Who did Xenetic Biosciences enter agreements with to develop its DNase program?

Xenetic Biosciences entered into agreements with the University of Virginia to further develop its DNase program.

What guided the approach towards a first-in-human trial for Xenetic Biosciences' DNase-based oncology platform?

Positive preclinical data is guiding the approach towards a first-in-human trial for the DNase-based oncology platform.

What did Xenetic Biosciences' CEO, Jeffrey Eisenberg, express optimism about?

Jeffrey Eisenberg expressed optimism about the potential of the DNase platform to provide therapies for pancreatic carcinoma and other solid tumors.

What was Xenetic Biosciences' net loss for the fiscal year 2023?

Xenetic Biosciences reported a net loss of approximately $4.1 million for the fiscal year 2023.

How much did research and development expenses decrease by in 2023?

Research and development expenses decreased by 26.7% to $3.5 million in 2023, primarily due to the absence of in-process R&D expenses related to the DNase platform licensing in 2022.

By what percentage did royalty payments from a sublicense with Takeda Pharmaceuticals increase in 2023?

Royalty payments from a sublicense with Takeda Pharmaceuticals increased by 48.8% to approximately $2.5 million in 2023.

How much did general and administrative expenses decrease by in 2023?

General and administrative expenses decreased slightly to $3.6 million in 2023, with a decrease in employee-related costs offset by higher consulting and legal costs.

How much cash did Xenetic Biosciences end the year with?

Xenetic Biosciences ended the year with around $9.0 million in cash.

Xenetic Biosciences, Inc.

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About XBIO

xenetic biosciences (nasdaq: xbio) is a clinical-stage biopharmaceutical company focused on discovery, research and development of next-generation biologic drugs and novel oncology therapeutics. xenetic's proprietary drug development platforms include polyxen™, which enables next generation biologic drugs by improving their half-life and other pharmacological properties. xenetic's lead investigational product candidates include fda orphan designated oncology therapeutic sodium cridanimod for the treatment of progesterone receptor negative endometrial cancer, and a polysialylated form of erythropoietin for the treatment of anemia in pre-dialysis patients with chronic kidney disease. xenetic is also working together with shire plc (formerly baxalta, baxter incorporated and baxter healthcare) to develop a novel series of polysialylated blood coagulation factors, including a next generation factor viii. this collaboration relies on xenetic's polyxen technology to conjugate polysialic acid