Xenetic Biosciences, Inc. (NASDAQ: XBIO), is a clinical-stage biopharmaceutical company, focused on the discovery, research, and development of next-generation biologic drugs and novel orphan oncology therapeutics. The company’s lead investigational product candidate is oncology therapeutic XBIO-101 (sodium cridanimod) for the treatment of progesterone resistant endometrial cancer.
On Monday, August 13, 2018, XBIO shares surged to an intra-day high of $4.60, a 44% jump from the previous Friday’s close. Share volume exceeded the daily average by a factor of ten.
The Company has entered into various research, development, license and supply agreements with Shire plc (“Shire”), Serum Institute of India (“Serum Institute”), its controlling stockholder PJSC Pharmsynthez (“Pharmsynthez”) and SynBio LLC (“SynBio”), which is now a wholly owned subsidiary of Pharmsynthez.
In 2018, an estimated 63,000 cases of endometrial cancer will be diagnosed in the U.S., and an estimated 11,000 disease-associated deaths will occur. While the incidence and mortality of endometrial cancer (EC) have been steadily increasing in the United States, the number of FDA-approved treatment options for late-stage EC remains extremely limited. In particular, there is a significant unmet need for therapies to treat advanced, recurrent, or metastatic EC.
XBIO-101 The primary objective of the current open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor 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-negative. Interim Phase 2 data is expected in 2018.
The Company’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.
XBIO-101 Phase II clinical trial
The primary objective of the open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor 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-negative.
Secondary objectives of the study are to assess progression-free survival, time to response, time to progression, duration of overall survival and Overall Disease Control Rate for subjects receiving XBIO-101 and progestin therapy; and to evaluate the safety and tolerability of XBIO-101 in conjunction with progestin therapy, as measured by adverse events, laboratory safety parameters, and cardiac safety assessments.
The study is expected to enroll a total of 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but suitable to be treated with progestin. All subjects determined to be PrR-negative at screening, as well as those subjects who experience disease progression after at least four 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.
Xenetic Biosciences, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery, research, and development of next-generation biologic drugs and novel orphan oncology therapeutics. The company’s lead investigational product candidate is oncology therapeutic XBIO-101 (sodium cridanimod) for the treatment of progesterone resistant endometrial cancer. Its proprietary drug development platform, PolyXen, enables next-generation biologic drugs by improving their half-life and other pharmacological properties. The company has a research, development, license, and supply agreements with Shire plc, Serum Institute of India, PJSC Pharmsynthez, and SynBio LLC. Xenetic Biosciences, Inc. is headquartered in Lexington, Massachusetts.
Financial review Q2 2018
XBIO is a development stage biopharma company and has not generated revenues.
The Company incurred a net loss of approximately $3.8 million for the six months ended June 30, 2018. The Company had an accumulated deficit of approximately $149.8 million as of June 30, 2018 as compared to an accumulated deficit of approximately $145.9 million at December 31, 2017. Working capital was approximately $2.4 million as of June 30, 2018, and approximately $3.9 million as of December 31, 2017. The Company expects to continue incurring losses for the foreseeable future and will need to raise additional capital or pursue other strategic alternatives in the very near term in order to continue pursuit of its business plan and continue as a going concern.
Stock influences and risk factors
Any report of developments in the XBIO-101 Phase II trial could impact the company shares.
XBIO may require additional funding to achieve goals. Failure to obtain this capital when needed on acceptable terms, or at all, may force them to delay, limit or terminate product development efforts.
We may find it difficult to enroll patients in our clinical studies, which could delay or prevent clinical studies of our pharmaceutical products.
The business is substantially dependent on the success of clinical trials for XBIO-101 and the ability to achieve regulatory approval for the marketing of this product.
On Monday, August 13, 2018, XBIO was trading at $4.13 (+28.85%) on volume of 6.0 million shares. The current RSI (14) is 61.09
At $4.31, XBIO shares are trading above their 50 DMA and 200 DMA of $3.28 and $2.36 respectively.
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