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 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that new preclinical data for the company’s LOXO-292 and LOXO-195 programs will be presented at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place November 29 – December 2, 2016 in Munich, Germany (Press release, Loxo Oncology, NOV 15, 2016, View Source [SID1234516601]).

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The details of the poster presentations are as follows:

LOXO-292

Date: December 1, 2016
Title: The development of a potent, KDR/VEGFR2-sparing RET kinase inhibitor for treating patients with RET-dependent cancers
Session: Molecular targeted agents II
Abstract Code: 441
Poster Number: 120
Location: Exhibition Hall

LOXO-195

Date: December 1, 2016
Title: The development of LOXO-195, a second generation TRK kinase inhibitor that overcomes acquired resistance to 1st generation inhibitors observed in patients with TRK-fusion cancers
Session: Molecular targeted agents II
Abstract Code: 442
Poster Number: 121
Location: Exhibition Hall

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 14, 2016 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three and nine months ended September 30, 2016

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CASI PHARMACEUTICALS REPORTS THIRD QUARTER 2016 FINANCIAL RESULTS.

As of September 30, 2016, CASI had cash and cash equivalents of approximately $24.1 million.

CASI reported a net loss for the third quarter of 2016 of ($1.7 million), or ($0.03) per share. This compares with a net loss of ($1.6 million), or ($0.05) per share, for the same period last year. For the first nine months of 2016, the reported net loss was ($6.8 million), or ($0.15) per share as compared to ($5.5 million), or ($0.17) per share for the first nine months of 2015.

Commenting on these results, Sara B. Capitelli, CASI’s Vice President, Finance, said, "Our third quarter 2016 financial results were in line with expectations. Research and development expenses increased during the 2016 period compared with the previous year primarily due to costs associated with our ENMD-2076 fibrolamellar carcinoma trial which began in late 2015. As we continue to execute our regulatory, clinical and business development plan, we expect operating expenses to increase for the remainder of 2016."

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, "I am pleased with our third quarter financial results. In October, we completed the last closing ($7.8 million) of our previously announced financing, and also completed an additional $3.0 million financing. Participants in the financing included our existing shareholders represented on our Board of Directors. In addition to a positive financial outlook, we look forward to further advancing our proprietary clinical candidate ENMD-2076, as well as MARQIBO, ZEVALIN and EVOMELA in China, and securing additional in-license assets to expand our pipeline. Proceeds from the recent financings will help accelerate these activities."

On November 14, 2016 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported financial results and business highlights for the third quarter ended September 30, 2016 (Press release, Cyclacel, NOV 14, 2016, View Source [SID1234516611]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2016 was $3.0 million, or $0.86 per basic and diluted share, compared to net loss applicable to common shareholders of $2.8 million, or $0.95 per basic and diluted share for the third quarter ended September 30, 2015. As of September 30, 2016, cash and cash equivalents totaled $18.0 million.

"SEAMLESS, a Phase 3 study of oral sapacitabine capsules, represents one of the largest clinical trials conducted in elderly patients with AML who are unfit for or refused intensive chemotherapy. Following completion of follow-up at the beginning of the quarter, we have been conducting data validation operations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pleased to report that this process is nearing completion following which the database will be locked and transferred to our statistical analysis vendor. We anticipate reporting top line results late in the fourth quarter of 2016 or in early 2017."

"The collection and processing of SEAMLESS Phase 3 data represent many years of effort in our search to offer a new treatment regimen for this older patient population. We will soon analyze the data and determine whether the results warrant regulatory submissions," said Dr. Judy Chiao, VP, Clinical Development and Regulatory Affairs. "We are grateful to the patients, their families, the investigators and their teams for their valuable contributions to this study."

"During the quarter data presented at a pediatric cancer meeting demonstrated that CYC065, our second generation Cyclin Dependent Kinase (CDK) inhibitor, prolonged survival in MYCN-addicted neuroblastoma models. The data further validate the mechanism of CYC065 and provide a rationale for clinical investigation in neuroblastoma with MYCN amplification, a major oncogenic driver of this childhood cancer. MYC family proteins are important therapeutic targets in other oncology indications, including certain solid tumors, leukemias and lymphomas. Early clinical and preclinical data from our DNA damage response program suggest that our transcriptional CDK inhibitors may have a synergistic effect with other anticancer agents, including sapacitabine. We look forward to reporting new data from our ongoing clinical studies of sapacitabine and seliciclib in BRCA positive patients and of CYC065 in patients with solid tumors," continued Mr. Rombotis.

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit for or refused intensive chemotherapy; cleaned and validated dataset being finalized and database lock imminent.
DNA damage response program

The Phase 1 combination of sapacitabine and seliciclib is continuing enrollment in an extension study in an enriched population of BRCA positive patients with advanced breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. The sixth dose escalation level has been reached.

Preclinical data presented at the Childhood Cancer Meeting 2016 demonstrated effectiveness of CYC065 against neuroblastoma models with an overexpression and amplification of MYCN, a driver of neuroblastoma.
KEY UPCOMING MILESTONES

SEAMLESS study

Report top-line data and determination of submissibility to regulatory authorities, anticipated late fourth quarter 2016 or early 2017.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Initiate Phase 1 part 3, to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS)

Plan Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
THIRD QUARTER 2016 FINANCIAL RESULTS

Cash and cash equivalents totaled $18.0 million as of September 30, 2016 compared to $20.4 million at December 31, 2015. Approximately $5.2 million was raised from the sale of common stock through the Company’s at-the-market facility with FBR Capital Markets. A further $1.5 million was received in October 2016 through this facility, resulting in a proforma cash balance as of September 30, 2016 of $19.5 million. Based on current plans, the Company estimates that it has capital resources to fund operations through the second quarter of 2018.

Revenue for the three months ended September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily related to grant revenue related to CYC065, for which the grant ended in December 2015.

Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015.

General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.