Full Press Release Details
Biosciences, Inc. Reports Third Quarter 2020 Financial Results and Provides Corporate Update
Continued advancement of XCART platform towards an IND filing and Phase 1 Study
Leveraging partnerships with leading global academic institutions, including Scripps Research
MA - (November 13, 2020) - 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, today reported its financial results for
the three and nine months ended September 30, 2020 and provided a corporate update.
"We continue to make progress as
we work to advance XCART through preclinical development and into a Phase 1 study as quickly as possible. This includes finalizing
the protocol of our upcoming exploratory study in Belarus which will be used to evaluate the XCART process in a clinical setting,"
commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "As we proceed through our preclinical development phase,
we, along with our scientific advisors, continue to refine our analysis to identify which NHL patient populations would most benefit
from XCART therapy, including those who can no longer be treated effectively with CD19 targeting therapeutics due to loss of the
Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy for
the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to
address an initial global market opportunity of over $5 billion annually.[1] Xenetic believes XCART has the potential
to transform 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.
Market Reports World GLOBAL NON-HODGKIN LYMPHOMA THERAPEUTICS MARKET - SEGMENTED BY TYPE OF TREATMENT - GROWTH, TRENDS AND FORECASTS
(2018 - 2023); BioPharm Insight Surveillance, Epidemiology, and End Results (SEER) 9 registries, National Cancer Institute, 2017
Summary of Financial Results for Third
nine months ended September 30, 2020 was approximately $9.7 million compared to a net loss of approximately $11.6 million for the
same period in 2019. The results for the nine months ended September 30, 2020 included $6.3 million of non-cash expenses representing
the impairment of indefinite-lived intangibles of $9.2 million less a $2.9 million income tax benefit. The results for the nine
months ended September 30, 2019 included $6.3 million of non-cash expenses composed of in-process research and development expenses
of $3.0 million and Goodwill impairment of $3.3 million, as well as $1.1 million of transactions costs related to our acquisition
of XCART. Excluding the non-cash charges of $6.3 million for both the nine months ended September 30, 2020 and 2019, respectively,
and the $1.1 million of transaction costs in 2019, adjusted net loss was $3.4 million and $4.2 million for the nine months ended
September 30, 2020 and 2019, respectively. As of September 30, 2020, working capital was $7.2 million compared to $9.7 million
as of December 31, 2019. The decrease in working capital was primarily due to the Company's net loss for the nine months
ended September 30, 2020. The Company ended the quarter with approximately $7.1 million of cash.
is a Non-GAAP financial measure, which is utilized by management in comparing our operating performance on a consistent basis.
We present this non-GAAP financial measure because we believe such measure provides important supplemental information to management
and investors regarding financial and business trends relating to the Company's financial condition and results of operations.
Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information calculated
in accordance with GAAP.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical
company focused on progressing XCART , a personalized CAR T platform technology engineered to target patient- and tumor-specific
neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of
an individual patient's malignant tumor cells for the treatment of B-cell lymphomas. XCART has the potential to fuel
a robust pipeline of therapeutic assets targeting high-value oncology indications.
Additionally, Xenetic is leveraging PolyXen , its proprietary drug delivery platform, by partnering with biotechnology and
pharmaceutical companies. PolyXen has demonstrated its ability to improve the half-life and other pharmacological properties
of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field
of coagulation disorders and receives royalty payments under this agreement.
For more information, please visit the Company's website at www.xeneticbio.com
and connect on Twitter, LinkedIn, and Facebook.
This press release contains forward-looking
statements for purposes of 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: our progress advancing XCART through preclinical
development towards an IND filing and a Phase 1 study, including finalizing the exploratory study in Belarus; expectations regarding
the collaboration with Pharmsynthez optimizing the overall XCART workflow and ultimately dosing NHL patients; our plans to initially
apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual
patient's malignant tumor cells for the treatment of B-cell lymphomas; our expectations that XCART has the potential to fuel
a robust pipeline of therapeutic assets targeting high-value oncology indications; our belief that our significantly differentiated,
proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an
area of significant unmet need, has the potential to address an initial global market opportunity of over $5 billion annually;
our belief that XCART has the potential to transform CAR T therapy; our plans to leverage PolyXen by partnering with biotechnology
and pharmaceutical companies; and our expectation regarding receipt of royalty payments under the exclusive license agreement with
Takeda Pharmaceuticals Co. Ltd. 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 the acquisition of XCART; (2) uncertainty of the expected
financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential
of the XCART technology; (4) the ability of the Company to implement its business strategy; (5) failure of Scripps Research and/or
Pharmsynthez or the other academic institutions in Belarus and Russia (as applicable) to perform their obligations under the respective
agreements; (6) failure of the Company and Pharmsynthez to reach agreements with the contract sites on terms favorable to the Company,
or at all; and (7) 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, periodic 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 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.