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.

On May 20, 2014 AADi, LLC, a clinical stage biopharmaceutical company focused on treating diseases uniquely suited for nanotechnology approaches reported the inlicensing of ABI-009 from Celgene Corporation (NASDAQ: CELG) (Press release, AADi, MAY 20, 2014, View Source [SID:1234514916]). ABI-009 is the nanoparticle albumin-bound (nab) version of the mTOR inhibitor sirolimus or rapamycin and leverages the same technology of the nab platform that is behind the success of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound).

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As part of the licensing agreement, AADi plans to develop ABI-009 initially in oncology and cardiovascular indications. A phase 1 trial for ABI-009 has been completed in patients with advanced non-hematologic malignancies in which the drug was well tolerated with evidence of activity in heavily pretreated patients. Celgene has the option to reacquire ABI-009 at various stages in development.

AADi also announced the enrollment of its first three patients in its new multi-center phase 1/2 clinical trial of ABI-009 for the treatment of non-muscle invasive bladder cancer. This trial is funded in-part through a Fast-Track STTR grant awarded to AADi from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). Columbia University, with its expertise in bladder cancer, is a consortium partner for AADi as part of the awarded grant and will be the primary clinical trial site. Vanderbilt University will also be involved in the clinical trial.

"The NIH trial funding is a testament to the strong scientific and biological rationale for the use of ABI-009 in bladder cancer where the mTOR activation plays a key role in progression of the disease," said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of AADi.

"Columbia University is excited to be part of this NCI-funded clinical study," said Dr. James McKiernan, Principal Investigator, Interim Chairman of the department of Urology at Columbia University Medical Center and New York Presbyterian Hospital and Professor of Urologic Oncology. "It is important that we continue to search for new treatments for bladder cancer patients who are all too often faced with surgical removal of their bladder as their only option."

As part of its focus in cardiovascular disease, AADi plans to initiate clinical studies with ABI-009 in the treatment of peripheral artery disease and pulmonary arterial hypertension. The studies in peripheral artery disease will focus on local delivery of ABI-009 to the arteries of the legs to reduce or prevent restenosis, the re-narrowing of blood vessels that commonly occurs following standard treatments to reopen arteries with plaque buildup. AADi also plans to target the treatment of pulmonary arterial hypertension, a rare, progressive and debilitating disease that is highly dependent on mTOR activation, and which occurs due to abnormal constriction of the arteries in the lungs resulting in shortness of breath and increasing stress on the heart or heart failure.

AADi is currently raising capital in an initial round and plans to seek additional financing to fund its research programs through the end of phase 2 clinical studies.

On May 20, 2014 ImmuNext reportd it has achieved the second milestone in its collaboration with and Janssen Biotech to develop anti-VISTA antagonists for the treatment of cancer (Press release ImmuNext, MAY 20, 2014, http://immunext.com/news.php [SID:1234500869]). ImmuNext has received the second milestone payment as scheduled.

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(SPONSOR BRIEFING DOCUMENT – FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING AstraZeneca, MAY 20, 2014, View Source [SID:1234500603])

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