On May 21, 2014 Xenetic Biosciences (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported financial results for the quarter ended March 31, 2014 (Press release, Xenetic Biosciences, MAY 21, 2014, View Source [SID1234537819]).
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Scott Maguire, CEO of Xenetic Biosciences said, "Having been appointed CEO of Xenetic 10 years ago, I am pleased to be part of the Company’s evolution from a small U.K.-based research company to a growing U.S. biopharma focused on developing a broad and diverse clinical development pipeline, all centered around our unique, cutting-edge technology platforms. Our years as a research company has positioned us well with over 140 issued patents and 90 patents pending. As a U.S. company, we are now focused on utilizing these patents to create new and improved therapies with the hope of treating and curing a number of insidious diseases. Ultimately, what gives any executive in this industry passion and motivation is playing a role in having a positive impact on human health, and that is our key focus at Xenetic.
"In addition to relocating our corporate headquarters and research operations to Lexington, MA, we have also significantly bolstered our team with the additions of three healthcare industry veterans to our Board, including Mark Leuchtenberger as Non-Executive Chairman. Earlier this year, we also further strengthened our hemophilia partnership with Baxter International, Inc., including a $10 million equity investment from Baxter and a substantial increase in the future economics, now representing up to $100 million in potential milestones, plus royalty payments arising from the PSA-rFactor VIII, BAX 826, program," continued Mr. Maguire.
"Looking ahead to the remainder of 2014, our priority is advancing OncoHist for refractory and relapsed Acute Myeloid Leukemia (AML) into a U.S. FDA clinical trial, as well as focusing on our most advanced clinical candidate, ErepoXen for the treatment of anemia. In parallel, we will be receiving patient data on a number of candidates from our Russian partners, which will provide the Company further U.S. pipeline expansion opportunities."
Recent Business Highlights
Appointed biopharmaceutical industry veteran Mark Leuchtenberger as Non-Executive Chairman of the Board of Directors
Announced positive results from a Phase 1 clinical trial of PSA-Oxyntomodulin for the treatment of Type II Diabetes and obesity, conducted by Russian partner, OJSC Pharmsynthez
Expected 2014 Milestones
Present interim data from Phase 2 Australia/New Zealand trial of ErepoXen for the treatment of chronic anemia in patients with renal disease
Advance ongoing clinical development of OncoHist, with planned U.S. IND filings for AML and an additional cancer indication
Secure U.S. Orphan Drug Designation for additional oncology indication for OncoHist
Present interim data from Phase 2 Russia trial of OncoHist in patients with refractory AML and Non Hodgkin’s Lymphoma
Initiate Phase 2 trial of PulmoXen for the treatment of cystic fibrosis, conducted by Russian partner, OJSC Pharmsynthez
Commence IV trials for ErepoXen for in-center dialysis patients in India based on Xenetic’s positive Phase 2 data for pre-dialysis patients
In addition to these expected milestones, one of the primary goals of management and the Board is to seek a NASDAQ Capital Market uplist at the earliest practical date
First Quarter 2014 Financial Results
Net loss for the first quarter of 2014 was $4.1 million, compared to a net loss of $1.4 for the same period in 2013. The Company did not recognize revenues for both the first quarter of 2014 and the comparable period in 2013.
Research and development expenses were $0.6 million for both the first quarter of 2014 and the comparable period in 2013. Xenetic expects an increase in R&D expense in 2014 as the company further advances development of its clinical programs and brings its Lexington, MA research facility to full operational activity.
General and administrative expenses were $2.4 million for the first quarter of 2014, compared to $0.8 million for the same period in 2013. The increase in G&A expenses was primarily due to increased accounting, legal and other professional consulting fees associated with the Company’s strategic decision to move from a U.K.-based, London AIM quoted, organization, to a U.S.-based, publicly traded company, which resulted in increased expenses during the first quarter of 2014.
As of March 31, 2014, Xenetic’s cash and cash equivalents totaled $10.9 million and there were approximately 146.7 million shares of common stock outstanding.