On November 15, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, reported its financial results for the three months ended September 30, 2016 (Press release, Xenetic Biosciences, NOV 15, 2016, View Source [SID1234537809]).

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Xenetic also provided an update to its corporate progress, clinical and regulatory status and anticipated milestones for the Company’s lead product candidates, including ErepoXen, a polysialylated form of erythropoietin for the treatment of anemia in pre-dialysis patients with chronic kidney disease, and FDA orphan designated oncology therapeutics Virexxa and Oncohist for the treatment of progesterone receptor negative endometrial cancer and refractory Acute Myeloid Leukemia.

Recent Corporate Highlights

Announced uplisting and trading of its common stock on The Nasdaq Capital Market;
Closed $10 million public offering; OPKO Health, Inc. (Nasdaq: OPK) along with other healthcare institutional investors participated in the offering;
Commenced collaboration with Excivion Ltd. to develop a vaccine against Zika and dengue viruses utilizing Xenetic’s proprietary IMUXEN Technology; and
Bolstered Board of Directors with appointment of Jeffrey F. Eisenberg; industry veteran with expertise in R&D, operations, manufacturing/quality, business development, strategic partnering, product development, commercialization, and talent management.
"The achievements we’ve made in 2016, including our recent uplist to Nasdaq and announcements of key partnerships and appointments, have enabled us to make substantial corporate progress and created a solid foundation on which we expect to build significant momentum in 2017," stated Scott Maguire, CEO. "Our programs continue to move forward and position Xenetic for success in developing biologic drugs and novel oncology therapeutics, that we believe have the potential to provide safe and well tolerated therapy options for patients with a variety of indications."

Program Updates

Xenetic is working together with Shire plc (formerly Baxalta, Baxter Incorporated and Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors utilizing Xenetic’s PolyXen technology, including a next generation Factor VIII. Shire is currently evaluating their product candidate BAX826, an investigational, extended half-life recombinant Factor VIII treatment for hemophilia A, for the treatment of hemophilia in a Phase 2a clinical study. Shire expects to report topline data from this Phase 2a study in Q1 2017.

ErepoXen: polysialylated form of recombinant human erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production and prevent anemia.

Recent ErepoXen Program Highlights

Reported positive topline data from the third cohort of its Phase 2 dose-escalation study with its lead drug candidate ErepoXen for the treatment of anemia in pre-dialysis chronic kidney disease patients
ErepoXen is under investigation to reduce the required frequency of dosage and side effects and to be less immunogenic than existing treatments. Clinical results of ErepoXen suggest that the drug candidate can be administered once a month. ErepoXen is currently in Phase 2/3 clinical development in collaboration with the Serum Institute of India and SynBio of Russia.

Expected Near-Term Milestones

Complete patient recruitment in Phase 2 dose-escalation study of ErepoXen for the treatment of Anemia; and
Report topline data from fourth and fifth cohorts of Phase 2 dose-escalation study for the treatment of anemia in pre-dialysis chronic kidney disease patients in 2017.
Virexxa: (sodium cridanimod), a small-molecule immunomodulator and interferon inducer, currently being studied in an ongoing Phase 2 multi-national study for the treatment of progesterone receptor negative endometrial cancer. Virexxa is also in pre-clinical development for the treatment of triple negative breast cancer.

Recent Virexxa Program Highlights

Announced the U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug application (IND) to initiate Phase 2 clinical trial of Virexxa in endometrial cancer.
Xenetic is preparing to commence a 78-patient, Phase 2 clinical study of Virexxa in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy. In addition, Virexxa is currently being evaluated in an ongoing Phase 2 multi-national study enrolling 58 subjects with documented evidence of progesterone receptor negative (PrR-negative) endometrial cancer as determined by tumor biopsy. The latter study is being conducted in conjunction with Pharmsynthez PJSC (St. Petersburg Russia) and its subsidiary AS Kevelt (Tallinn, Estonia). For more information on this Phase 2 study, please visit www.clinicaltrials.gov and reference Identifier NCT02064725.

Expected Near-Term Milestones

Initiate Phase 2 clinical study of Virexxa in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy in Q2 2017; and
Submit IND for biomarker study of Virexxa for the treatment of triple negative breast cancer in Q1 2017.
Oncohist: a novel recombinant human histone H1.3 molecule for the treatment of refractory Acute Myeloid Leukemia (AML) with potential to treat numerous other cancer indications.

Oncohist is currently being evaluated in a Phase 1/2 trial for the treatment of Acute Myeloid Leukemia (AML) in refractory patients. This Phase 1/2 trial is designed to evaluate Oncohist as a combination therapy, together with Cytarabine and is being developed with the Company’s Russian partner, Pharmsynthez.

"Moving forward, we remain committed to aggressively advancing the development of our pipeline. We believe that our expected near term corporate and clinical advancements will continue to unlock and build shareholder value, in both the short-term and long-term," concluded Mr. Maguire.

Summary of Financial Results for Third Quarter 2016

For the three months ended September 30, 2016, the Company reported a net loss of $2,471,981, or a net loss per diluted share of $0.28, compared to a net loss of $5,323,699, or a net loss per diluted share of $1.26 for the three months ended September 30, 2015.

For the nine months ended September 30, 2016, the Company reported a net loss of $53,814,778, or a net loss per diluted share of $7.54, compared to a net loss of $8,880,086, or a net loss per diluted share of $2.10 for the nine months ended September 30, 2015.

The Company ended the quarter with approximately $0.2 million of cash and cash equivalents.

On November 7, 2016, the Company closed on a $10 million public offering and commenced trading of its common stock on The Nasdaq Capital Market.

On November 15, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) announced today it will present first-in-human data from its Phase 1 clinical trials of anti-RSPO3 (OMP-131R10) and anti-DLL4/VEGF bispecific antibody (OMP-305B83) at the upcoming 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium being held November 28 — December 2, 2016 in Munich, Germany. Abstracts for the presentations have been posted to www.ecco-org.eu/ENA.

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Data will be presented on Tuesday, November 29, 2016:

Poster #P039; Abstract #68: Initial results from a Phase 1a/b study of OMP-131R10, a first-in-class anti-RSPO3 antibody, in advanced solid tumors and previously treated metastatic colorectal cancer (CRC)
Session: Molecular targeted agents I
Presenting author: Johanna Bendell, M.D., Sarah Cannon Research Institute

Poster #P057; Abstract #87: A first-in-man Phase 1a study of the bispecific anti-DLL4/anti-VEGF antibody OMP-305B83 in patients with previously treated solid tumors
Session: Molecular targeted agents I
Presenting author: Kathleen Moore, M.D., University of Oklahoma Stephenson Cancer Center

The posters will be available on OncoMed’s website following the presentation at www.oncomed.com.

About Anti-RSPO3
OncoMed is currently enrolling patients in an ongoing Phase 1a/b clinical trial of anti-RSPO3 that was started in July 2015. The Phase 1a/b trial initially enrolled patients with advanced refractory solid tumors and includes an expansion arm for biomarker-selected patients to receive single-agent therapy. The Phase 1b portion, which began enrollment in January 2016, is testing anti-RSPO3 with FOLFIRI in patients with second-line metastatic colorectal cancer. Anti-RSPO3 is believed to be the first drug candidate in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

About Anti-DLL4/VEGF
OncoMed initiated a single-agent study of its anti-DLL4/VEGF bispecific in January 2015 in patients with advanced refractory solid tumors. Dose escalation is completed in the Phase 1a trial and enrollment in an expansion cohort is ongoing. The anti-DLL4/VEGF bispecific antibody is designed to combine the anti-cancer stem cell, dysangiogenic and immunotherapy mechanisms of anti-DLL4 with the anti-angiogenic activity of an anti-VEGF agent. The bispecific antibody was discovered using OncoMed’s proprietary MAbTrap antibody display technology, which enables the rapid identification of monoclonal antibodies that bind targets with high affinity and specificity. The antibody is the first program based on OncoMed’s BiMAb bispecific platform technology to enter clinical testing.

On November 15, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported the publication of data demonstrating enhanced persistence of genetically modified T cells targeting leukemia through utilization of its non-viral Sleeping Beauty (SB) system to co-express membrane-bound IL-15 (mbIL15) and a CD19-specific chimeric antigen receptor (CAR) (Press release, Ziopharm, NOV 15, 2016, View Source [SID1234516794]). The article, titled "Tethered IL-15 augments antitumor activity and promotes a stem-cell memory subset in tumor-specific T cells," was published in the Proceedings of the National Academy of Sciences (PNAS) and is available online here.

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Using the SB system, researchers generated genetically modified T cells that preserved stem-cell memory (TSCM) by co-expressing the CAR with a fusion variant of IL-15. These engineered T cells were effective in treating established CD19+ leukemia in mice by facilitating the long-term persistence of TSCM cells sustained by signaling through mbIL15. These findings provide for a translational pipeline of immunotherapies with improved potential by combining mbIL15 and T cells with diverse specificities.

"The ability to generate CAR-T cells with preserved stem-cell memory is a novel strategy for promoting long-lived persistence and effectiveness of immunotherapies for the treatment of patients with cancers. Producing this rare, but highly desirable, T-cell subset has historically been a challenge," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and an author of the publication.

"We have demonstrated the ability to incorporate membrane-bound IL-15 via the non-viral Sleeping Beauty platform, thereby enhancing T-cell survival and raising our expectations for corresponding therapeutic benefit. The fundamental role that IL-15 plays in T-cell activation and propagation makes it an attractive candidate to incorporate into engineered immunotherapies, and we are advancing CAR-modified T cells co-expressing mbIL15 to testing in humans," added Dr. Cooper.

The SB transposon-transposase is a unique non-viral system for introducing genes into cells and is exclusively licensed by Intrexon Corporation (NYSE:XON) through The University of Texas MD Anderson Cancer Center and accessed as part of ZIOPHARM’s collaboration with Intrexon.

On November 14, 2016 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported financial results for the three months ended September 30, 2016 and provided an overview of recent corporate highlights (Filing, Q3, RestorGenex, 2016, NOV 14, 2016, View Source [SID1234516713]). The third quarter results will be filed on the Quarterly Report on Form 10-Q with the SEC.

David Kalergis, Chairman and Chief Executive Officer, stated, "I am very excited about the progress that we have made in advancing the clinical development of our lead candidate, trans sodium crocetinate (TSC). The completion of the reverse stock split and subsequent uplisting to the Nasdaq Capital Market is an important step for the Company and I am extremely pleased that we have reached this stage of growth. The successful completion of our three month animal toxicology studies is also an important milestone in support of Diffusion’s readiness to conduct a Phase 3 pivotal trial of TSC in newly diagnosed GBM patients. Our newly assembled Scientific Advisory Board will serve as a valuable resource as we prepare to begin this Phase 3 trial, and will also guide our research as we seek to develop TSC for therapeutic use in other hypoxia-related diseases."

Corporate Highlights

In August 2016, Diffusion announced a 1-for-10 reverse stock split in preparation for its proposed uplisting to Nasdaq Capital Market.

In September 2016, Diffusion announced the successful completion of animal toxicity studies in preparation for a Phase 3 pivotal trial of TSC in newly diagnosed GBM patients.

In September 2016, the Company also established a Scientific Advisory Board of distinguished experts to serve as a resource for the development of TSC in its many areas on therapeutic use for indications involving hypoxic conditions.

In November 2016, the Company subsequently announced that its shares of common stock were approved for listing on the Nasdaq Capital Market, effective November 9, 2016.

Three Months Ended September 30, 2016 Financial Results

Research and development expenses were $1.9 million for the three months ended September 30, 2016, compared to $0.9 million for the three months ended September 30, 2015. This increase was primarily a result of the $1.0 million non-cash impairment charge upon the abandonment of the future development efforts of the RES-440 IPR&D asset acquired from RestorGenex.

General and administrative expenses were $3.9 million for the three months ended September 30, 2016, compared to $0.4 million for the three months ended September 30, 2015. The increase was primarily attributable to a $2.5 million non-cash litigation settlement with an investor in September 2016 and an increase in incremental costs in connection with operating as a public company.

Net loss was $5.4 million, or $0.53 per share, for the three months ended September 30, 2016, compared to a net loss of $1.4 million, or $0.64 per share, for the three months ended September 30, 2015. The increase in the net loss was due primarily to higher expenses associated with the increased research and development expenses and general and administrative expenses.

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On November 14, 2016 Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies including dermatology, oncology, anti-inflammatory, and antibiotic applications, reported a general business update and announced select financial results for the first quarter of fiscal year 2017 ended September 30, 2016 (Filing, Q3, CellCeutix, 2016, NOV 14, 2016, View Source [SID1234516621]).

Recent Highlights

Management Team Additions

· Arthur P. Bertolino, MD, PhD, MBA – President and Chief Medical Officer

· Jane Harness – Vice President of Clinical Sciences and Portfolio Management

· Dr. LaVonne Lang – Vice President of Regulatory Affairs

Dr. Bertolino, Ms. Harness and Dr. Lang are distinguished in their respective fields and cumulatively bring about 70 years of drug development experience to Cellceutix earned during highly relevant positions at major pharmaceutical companies including Parke-Davis, Pfizer and Novartis. "In their brief time at Cellceutix, Dr. Bertolino, Ms. Harness and Dr. Lang have proven to be extremely valuable in efficiently moving our pipeline forward," said Leo Ehrlich, CEO of Cellceutix.

Portfolio Development

· Brilacidin (Inflammatory Bowel Disease)

· Initial comments received on the first patient in the Company’s Phase 2a trial of Brilacidin for ulcerative proctitis (UP) / ulcerative proctosigmoiditis (UPS), (Inflammatory Bowel Disease; IBD), showed a significant decrease in symptoms within one week of the lowest scheduled dose of Brilacidin therapy

· New data received during the current quarter shows clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. The final two patients in the first cohort are currently receiving Brilacidin therapy

· In four patients evaluated to date, concentrations of Brilacidin in plasma were undetectable, meaning that risk of systemic exposure during localized treatment appears to be minimized

· Completion of the first cohort and start of second cohort is anticipated in December 2016

· Visiongain forecasts IBD medicines market to rise to $9.3 billion in 2019

1

· Brilacidin-OM (Oral Mucositis)

· Phase 2 trial evaluating the oral rinse Brilacidin-OM for treating and preventing chemoradiation-induced oral mucositis (OM) in head and neck cancer patients remains ongoing

· Interim analysis anticipated 1H 2017

· Data from UP/UPS trial provide evidentiary support to the anti-inflammatory activity of Brilacidin in localized therapy; Cellceutix is optimistic the lack of systemic exposure will translate to the OM trial

· Brilacidin (Anti-Infective)

· Phase 2b trial was successfully completed previously showing Brilacidin non-inferior with similar safety profile to blockbuster daptomycin in treating Acute Skin and Skin Structure Infections (ABSSSI)

· Now working with U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) agreement – will be positioned to move into Phase 3 research upon finalizing SPA and securing funding as to not impede other pipeline developments

· Kevetrin (Solid Tumors)

· Phase 1 successfully completed previously in patients with advanced solid tumors

· Now preparing for Phase 2a study to better define the mechanism of action of Kevetrin, specifically the modulation of p53 within the tumor

· Phase 2a trial planned to be initiated

· Laboratory work being conducted to develop an oral formulation of Kevetrin with the goal of capitalizing on Kevetrin’s short half-life of only approximately two hours
· Oral dosing is the preferred method for patients; the value of a new oral drug can be significant

· An oral delivery formulation greatly increases ease of treatment and viability of multiple daily or weekly doses of Kevetrin

· Cellceutix is attempting to develop and commercialize not only the world’s first p53-modulating drug, but the first oral formulation of a p53-modulating drug

· Prurisol (Chronic Plaque Psoriasis)

· Phase 1 (healthy subjects) and Phase 2a (mild to moderate psoriasis patients) already successfully completed

· Phase 2b underway in patients with moderate to severe psoriasis

· Value of new oral treatment for psoriasis demonstrated by high valuations in recent M&A activity

· Interim analysis from the Phase 2b trial expected 1H 2017

"It was a great quarter for Cellceutix as we achieved some of the most important developments yet in the history of our Company. Specifically, we demonstrated limited systemic risk in localized Brilacidin therapy, with drug concentrations in plasma below the lower limit of quantification (<100 ng/mL); advancements have been made for an oral formulation of Kevetrin; and we are progressing in our clinical trials," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "These discoveries and advancements are proving the potential of our drug candidates and attracting attention from larger peers, as measured by the fact that we have engaged in more high level meetings recently than at any other time since inception. We have yet to fail in any clinical trial with any of our drug candidates and remain on target with our long-term goal to grow shareholder value by developing our drugs for hard-to-treat indications to provide relief for millions of people suffering worldwide. I believe that is more than ample reason to be excited about all that we have accomplished, our future and the litany of catalysts expected in 2017."

Financial Results for the First Quarter of Fiscal 2017

The current primary potential source of cash available to the Company, are equity investments through its equity purchase agreement with Aspire Capital. The Company has financed its operations to date through the sale of its common stock. The Company had raised approximately $8.2 million for the fiscal year ended June 30, 2016 and $1.9 million for the three months ended September 30, 2016, through its equity purchase agreement with Aspire Capital.

At September 30, 2016, the Company had approximately $5.6 million in cash compared to approximately $6.3 million in cash at June 30, 2016. Stockholders’ equity was approximately $2.1 million compared to approximately $3.0 million at June 30, 2016.

For the three months ended September 30, 2016, the Company’s net loss was approximately $3.0 million, or a loss of $0.02 per share compared to a net loss of $2.6 million, or a loss of $0.02 per share, for the three months ended September 30, 2015.

Stock-based compensation expense was $0.3 million for the three months ended September 30, 2016 compared to $0.1 million for the three months ended September 30, 2015. For the three months ended September 30, 2016, the Company’s cash flows used in operating activities were $2.6 million versus $2.1 million for the three months ended September 30, 2015. This is primarily due to an increase in our operating expenses, which includes research and development expenses, in 2016.

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