On November 12, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Xenetic Biosciences, NOV 12, 2021, View Source [SID1234595451]).
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"Our team continues to advance the XCART program and validate key workflow and manufacturing components which move us closer to conducting IND-enabling studies. Building on the proven success of CAR T therapy, we believe that Xenetic’s approach is innovative and is well-positioned to have a meaningful impact by addressing the significant unmet needs in certain hematological malignancies. As we continue to advance this important program and witness the potential of the XCART platform, our confidence holds strong in its ability to target cancers with a patient- and tumor-specific approach," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.
XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. Lead program for Non-Hodgkin lymphoma, an area of significant unmet need, with the potential to address an initial global market opportunity of over $7 billion annually.1
Program Highlights:
Advancing preclinical efforts through ongoing research and development collaborations including with Scripps Research and other institutions covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
The exploratory biopsy study in Eastern Europe achieved its initial objective of supporting further XCART platform development, including that of downstream XCART processes, and has provided materials and methods needed to proceed with IND-enabling studies.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.
Program Highlights:
Royalty payments of approximately $0.3 million were received in the quarter ended September 30, 2021, from the Company’s sublicense with Takeda. Takeda’s sublicensee has now launched the relevant product in multiple global markets.
Company’s partner, Pharmsynthez, has filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for Third Quarter 2021
Net loss for the quarter ended September 30, 2021, was approximately $1.4 million. Research and development expenses for the three months ended September 30, 2021, increased by approximately $0.2 million, or 36.1%, to $0.8 million from $0.6 million in the comparable quarter in 2020. The increase was due to the Company’s increased spending on the XCART platform technology. General and administrative expenses for the three months ended September 30, 2021, was $0.9 million, increasing $0.1 million, or 17.5%, compared to the same period in the prior year. The increase was primarily due to increases in employee related, legal and consulting costs during the three months ended September 30, 2021, compared to the same period in 2020. In July 2021, the Company completed a $12.5 million private placement of common stock and warrants to purchase common stock resulting in approximately $11.5 million of net proceeds to the Company. At September 30, 2021, the Company reported working capital was approximately $19.5 million. The Company ended the quarter with approximately $19.7 million of cash.