On August 13, 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 second quarter of 2021 and provided a corporate update (Press release, Xenetic Biosciences, AUG 13, 2021, View Source [SID1234586555]).

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"Over the course of the second quarter, we continued to execute our innovative and differentiated XCART program, and the technical progress we’ve accomplished brings us closer to the critical milestone of conducting IND-enabling studies in the United States. In light of that progress, we are taking important steps to validate the key workflow and manufacturing components that we believe will maximize the XCART opportunity," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Additionally, with our recently completed $12.5 million private placement and the royalty growth we have seen through our PolyXen license agreement, I believe we are in a strong position moving forward to maintain optionality and execute on advancing our development program."

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:

Collaboration with Pharmsynthez and multiple academic institutions in Eastern Europe which provides access to methods and materials, including clinical samples, for optimizing the overall XCART workflow.
Ongoing research and development collaboration with Scripps Research covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
Ongoing exploratory patient biopsy study in Eastern Europe. The work being performed under this collaboration has achieved its initial objective of supporting further XCART platform development, including that of downstream XCART processes.
"Through the experience gained in Eastern Europe, the ongoing work at Scripps, and the enthusiasm of our expanding network of subject matter experts and contract development partners, we’ve made considerable progress in advancing toward conducting IND-enabling studies for XCART," added Curtis Lockshin, Ph.D., Chief Scientific Officer of Xenetic. "We look forward to building on that momentum as we continue to advance XCART beyond its academic foundation toward a commercially viable platform, including a clinical manufacturing process for generating patient-specific CAR T products."

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 June 30, 2021 from the sublicense of the Company’s partner, 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 Second Quarter 2021

Net loss for the quarter ended June 30, 2021 was approximately $1.1 million. Research and development expenses for the three months ended June 30, 2021 increased by approximately $0.2 million, or 70.4%, to $0.5 million from $0.3 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 June 30, 2021 was $0.9 million, increasing $0.1 million, or 13.1%, compared to the same period in the prior year. The increase was primarily due to reduced general and administrative expenses by $0.1 million during the three months ended June 30, 2020 due to a gain on settlement of certain vendor amounts to close out our XBIO-101 trial during such period. At June 30, 2021, the Company reported working capital was approximately $9.2 million. The Company ended the quarter with approximately $9.3 million of cash. Subsequent to quarter end, the Company completed a $12.5 million private placement of common stock and warrants to purchase common stock resulting in approximately $11.4 million of net proceeds to the Company.