Xenetic Biosciences, Inc. Reports First Quarter 2019 Financial Results and Provides Corporate Update

On May 13, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, Xenetic Biosciences, MAY 13, 2019, View Source [SID1234536226]).

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"We expect 2019 to be a transformative year for Xenetic. With the anticipated closing of our acquisition of XCART, our differentiated CAR T platform technology, on track for this quarter, I believe Xenetic will be well positioned to drive momentum in the innovation and development of new oncology therapeutics where there remains significant unmet need," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "We plan to focus our R&D efforts initially on leveraging the XCART platform to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas. All of this marks a very important moment in the evolution of Xenetic, and I firmly believe the Company can become a significant player in the oncology space with this potentially transformative technology platform, providing therapeutic solutions for physicians and individuals fighting cancer and their families as well as driving value for our shareholders."

XCART Technology

On March 1, 2019, the Company entered into agreements to acquire a novel CAR T ("Chimeric Antigen Receptor T Cell") platform technology, called "XCART." XCART is a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. The XCART technology, developed by The Scripps Research Institute in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells. The acquisition is subject to conditions typical for a transaction of this kind, including appropriate stockholder approvals, and is expected to close by the end of the second quarter.

The XCART technology platform was designed by its originators to utilize an established screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor ("BCR") on the surface of an individual patient’s malignant tumor cells. The peptide is then inserted into the antigen-binding domain of a CAR, and a subsequent transduction/transfection process is used to engineer the patient’s T cells into a CAR T format which redirects the patient’s T cells to attack the tumor. Essentially, the XCART screening platform is the inverse of a typical CAR T screening protocol wherein libraries of highly specific antibody domains are screened against a given target. In the case of XCART screening, the target is itself an antibody domain, and hence highly specific by its nature. The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.

An expected result for XCART is reduced off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Once the acquisition is consummated, the Company intends to pursue development efforts of the XCART technology as well as other development efforts in the area of CAR T therapy.

Summary of Financial Results for First Quarter 2019

Net loss for the three months ended March 31, 2019, was approximately $1.3 million compared to a net loss of approximately $1.8 million for the same period in 2018. Working capital (deficit) was approximately $1.2 million and $(0.4) million at March 31, 2019 and December 31, 2018, respectively. During the quarter ended March 31, 2019, the Company’s working capital increased by $1.6 million due to the issuance of common stock and warrants in our March 2019 offering resulting in $2.7 million of net proceeds to Xenetic. The Company ended the quarter with approximately $2.0 million of cash.