Full Press Release Details
Xenetic Biosciences Reports 2017 Third Quarter
Financial Results and Provides Corporate Update
MA - (November 15, 2017) - 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, announced today its unaudited
financial results for the quarter ended September 30, 2017.
Xenetic also provided
a corporate update and anticipated milestones for the Company's lead product candidate, XBIO-101 (sodium cridanimod), a small-molecule
immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor ("PrR")
expression in endometrial tumor tissue, and an update on its proprietary PolyXen platform technology.
are well positioned to build on the momentum of our recent corporate and clinical achievements. We remain focused on the solid
execution of our Phase 2 study of XBIO-101 for the treatment of endometrial cancer, with the goal of announcing interim data before
the end of next year. Further, our recent right to sublicense agreement with Baxalta not only leverages our PolyXen platform technology
and provides a source of non-dilutive capital, but also positions Xenetic for value driving opportunities in the near and long-term,"
stated Jeffrey Eisenberg, Chief Executive Officer of Xenetic Biosciences.
Patient dosing recently
commenced for the Company's Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of
endometrial cancer. The study targets a population of patients who have either failed progestin monotherapy or who have been identified
as having progesterone receptor negative ("PrR-") tumors.
The primary objective
of this open-label, multi-center, single-arm, two-period Phase 2 study is to assess the anti-tumor activity of XBIO-101 in conjunction
with progestin therapy as measured by Overall Disease Control Rate in women with recurrent or persistent endometrial carcinoma
not amenable to surgical treatment or radiotherapy who have either failed progestin monotherapy or who have been identified as
PrR-. Secondary objectives include assessments of efficacy and safety/tolerability parameters.
The study is expected
to enroll up to 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but
suitable to be treated with progestins. All subjects determined to be PrR- at screening, as well as those subjects who experience
disease progression after at least 4 weeks of progestin monotherapy, will receive XBIO-101 in combination with continued progestin
treatment. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria.
to announce interim data from the Phase 2 study before the end of 2018.
The Company recently announced that it has
entered into a Right to Sublicense Agreement (the "Right to Sublicense Agreement") with Baxalta Incorporated, Baxalta
US Inc., and Baxalta GmbH (collectively, with their affiliates, "Baxalta"), wholly-owned subsidiaries of Shire plc
(LSE: SHP, NASDAQ: SHPG). Pursuant to the Right to Sublicense Agreement, Xenetic granted to Baxalta the right to grant a nonexclusive
sublicense to certain patents related to the Company's PolyXen technology that were previously exclusively licensed to Baxalta
pursuant to an agreement between the Company and Baxalta in connection with products relating to the treatment of blood and bleeding
As part of the Right to Sublicense Agreement,
Baxalta paid Xenetic a one-time payment of $7.5 million and is expected to make single digit royalty payments based upon net sales
of the products covered under the related sublicense throughout the term of the agreement.
Additionally, Xenetic expects to continue to
pursue business development activities to explore partnerships utilizing its PolyXen delivery platform.
Summary of Financial Results for Third Quarter
Net loss for the nine
months ended September 30, 2017, was $8.0 million compared to a net loss of approximately $53.8 million for the same period in
2016. The decrease in net loss was primarily due to a decrease of in-process research and development expense, as well as a decrease
in share-based compensation expense related to warrants previously issued in 2016. These decreases were offset by an increase in
general operating costs and costs related to the initiation of our XBIO-101 Phase 2 clinical study.
the quarter with approximately $0.7 million of cash. With the addition of the $7.5 million milestone payment under the Right to
Sublicense Agreement, as of the date of this release, the Company's current cash position is approximately $8.0 million.
Based on management's current projections, the Company has sufficient cash to fund its operations through the second quarter
About Xenetic Biosciences
Xenetic Biosciences,
Inc. is a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic
drugs and novel orphan oncology therapeutics. Xenetic's lead investigational product candidate is oncology therapeutic XBIO-101
(sodium cridanimod) for the treatment of progesterone resistant endometrial cancer. Further, Xenetic's proprietary drug development
platform, PolyXen, enables next-generation biologic drugs by improving their half-life and other pharmacological properties. The
Company has ongoing business development activities to explore partnerships utilizing its PolyXen delivery platform.
For more information, please visit the Company's
website at www.xeneticbio.com and connect on Twitter, LinkedIn, Facebook and Google+.
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 statements regarding the Company's ability to develop and customize the Company's
PolyXen platform technology to improve the clinical utility of protein and peptide drugs; the Company's anticipated corporate
development strategies and pursuit of current and future collaborations to co-develop new product candidates; its ability to add
new programs to its pipeline and expand the development of its current product candidates into new indications; the initiation,
timing, progress, enrollment and reporting of results of its preclinical programs and clinical trials; the Company's potential
for future growth and creation of shareholder value; the Company's expectation of cash flow from the royalties under the
Right to Sublicense Agreement; and the Company's liquidity and ability to fund its future operations;. 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 or results to differ materially from the activities and results anticipated in forward-looking
statements. These risks and uncertainties include those described in the "Risk Factors" section of the Company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and filed with the Securities and Exchange Commission on
March 31, 2017, and subsequent reports that it may file with the Securities and Exchange Commission. In addition, forward-looking
statements may also be adversely affected by general market factors, 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.
Jenene Thomas Communications, LLC.
Source: Xenetic Biosciences,
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2017 | December 31, 2016 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 694,752 | $ | 4,048,131 | ||||
| Restricted cash | 66,510 | 66,510 | ||||||
| Accounts receivable | 42,500 | 3,000,000 | ||||||
| Prepaid expenses and other | 1,245,252 | 1,224,009 | ||||||
| Total current assets | 2,049,014 | 8,338,650 | ||||||
| Property and equipment, net | 32,293 | 42,366 | ||||||
| Goodwill | 3,283,379 | 3,283,379 | ||||||
| Indefinite-lived intangible assets | 9,243,128 | 9,243,128 | ||||||
| Other assets | 31,831 | 66,342 | ||||||
| Total assets | $ | 14,639,645 | $ | 20,973,865 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,026,728 | $ | 1,006,903 | ||||
| Accrued expenses | 1,113,446 | 838,888 | ||||||
| Deferred revenue and other current liabilities | 21,071 | 20,205 | ||||||
| Total current liabilities | 2,161,245 | 1,865,996 | ||||||
| Deferred tax liability | 2,918,518 | 2,918,518 | ||||||
| Other liabilities | 4,980 | 19,876 | ||||||
| Total liabilities | 5,084,743 | 4,804,390 | ||||||
| Commitments and contingent liabilities | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, 10,000,000 shares authorized | ||||||||
| Series B, $0.001 par value: 2,120,742 and 2,305,742 issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 2,120 | 2,305 | ||||||
| Series A, $0.001 par value: 970,000 shares issued and outstanding as of September 30, 2017 and December 31, 2016 | 970 | 970 | ||||||
| Common stock, $0.001 par value; 45,454,546 shares authorized as of September 30, 2017 and December 31, 2016; 9,041,426 and 8,731,029 shares issued as of September 30, 2017 and December 31, 2016, respectively; 8,717,541 and 8,407,144 shares outstanding as of September 30, 2017 and December 31, 2016, respectively | 9,040 | 8,730 | ||||||
| Additional paid in capital | 164,948,674 | 163,522,921 | ||||||
| Accumulated deficit | (150,378,456 | ) | (142,338,005 | ) | ||||
| Accumulated other comprehensive income | 253,734 | 253,734 | ||||||
| Treasury stock | (5,281,180 | ) | (5,281,180 | ) | ||||
| Total stockholders' equity | 9,554,902 | 16,169,475 | ||||||
| Total liabilities and stockholders' equity | $ | 14,639,645 | $ | 20,973,865 |
XENETIC BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| THREE MONTHS ENDED SEPTEMBER 30, | NINE MONTHS ENDED SEPTEMBER 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | ||||||||||||||||
| Collaboration services | $ | 85,000 | $ | - | $ | 85,000 | $ | - | ||||||||
| Total revenues | 85,000 | - | 85,000 | - | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of research and development revenue | (97,028 | ) | - | (156,119 | ) | - | ||||||||||
| Research and development | (884,797 | ) | (891,828 | ) | (2,979,778 | ) | (3,526,322 | ) | ||||||||
| In-process research and development expense | - | - | - | (39,500,000 | ) | |||||||||||
| General and administrative | (1,343,671 | ) | (1,359,801 | ) | (4,948,675 | ) | (4,339,844 | ) | ||||||||
| Loss from operations | (2,240,496 | ) | (2,251,629 | (7,999,572 | ) | (47,366,166 | ) | |||||||||
| Other non-operating income (expense): | ||||||||||||||||
| Change in fair value of derivative liability | - | 241,298 | - | 2,146,587 | ||||||||||||
| Loss on issuance of hybrid debt instruments | - | (106,566 | ) | - | (1,690,784 | ) | ||||||||||
| Loss on conversion of debt | - | - | - | (6,187,337 | ) | |||||||||||
| Other income (expense) | (14,979 | ) | (13,440 | ) | (49,611 | ) | (26,991 | ) | ||||||||
| Interest income | - | 4 | 10,201 | 31 | ||||||||||||
| Interest expense | (425 | ) | (341,648 | ) | (1,469 | ) | (690,118 | ) | ||||||||
| Total other non-operating expense | (15,404 | ) | (220,352 | ) | (40,879 | ) | (6,448,612 | ) | ||||||||
| Net loss | $ | (2,255,900 | ) | $ | (2,471,981 | ) | $ | (8,040,451 | ) | $ | (53,814,778 | ) | ||||
| Basic and diluted loss per share | $ | (0.26 | ) | $ | (0.28 | ) | $ | (0.93 | ) | $ | (7.54 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 8,717,541 | 8,987,145 | 8,648,314 | 7,134,352 |