VBL Therapeutics Announces Third Quarter 2018 Financial Results

On November 20, 2018 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, VBL Therapeutics, NOV 20, 2018, View Source [SID1234531467]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue the development of our novel anticancer drug VB-111, as we enroll and treat patients in the ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer while exploring the opportunity to develop it in other indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We are excited about the potential of our MOSPD2-targeting platform and are advancing two parallel programs exploring MOSPD2 as a therapeutic target in both oncology and inflammatory disease."

"VBL is well capitalized with more than $53 million in cash and equivalents at September 30, 2018. We believe this will be sufficient to support our Phase 3 clinical trial for VB-111 for ovarian cancer, and advance our pipeline, including the VB-600 platform targeting MOSPD2, for at least the next three years," concluded Dr. Harats.

Third Quarter and Recent Corporate Highlights:

Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer.
° OVAL is evaluating VB-111 in combination with chemotherapy, without any change from the regimen which demonstrated overall survival (OS) benefit in the Phase 2 study for ovarian cancer.
° An efficacy interim readout is expected to occur in the fourth quarter of 2019.
° Data on the immune mechanism of VB-111 in platinum resistant ovarian cancer will be presented in March 2019 at the 50th Annual Meeting conference of the Society of Gynecologic Oncology (SGO) in Hawaii.
Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with recurrent glioblastoma at the 2018 Society for Neuro-Oncology (SNO) annual meeting.
VBL is developing two independent platforms of proprietary monoclonal antibodies targeting MOSPD2; one for inflammatory indications using classical antibodies, and a second, separate platform for oncology indications, based on bi-specific antibodies.
Presented new data on the Company’s MOSPD2 oncology program:
° In July 2018, a paper published in the International Journal of Cancer featured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells.
° Previously, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting, the Company presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to MOSPD2.
Presented new data on the Company’s MOSPD2 inflammatory disease program:
° At the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), VBL presented data demonstrating that MOSPD2 is essential for the disease development and progression in the experimental autoimmune encephalomyelitis (EAE) model for multiple sclerosis. VBL’s proprietary monoclonal antibodies were successfully used both to prevent development, as well as to treat EAE once symptoms had appeared.
Published positive new data on Lecinoxoid drug candidates for the treatment of renal fibrosis in Basic and Clinical Pharmacology and Toxicology.
° The paper published in Basic and Clinical Pharmacology and Toxicology describes the role of the Company’s lecinoxoid drug candidates, VB-201 and VB-703, in slowing the decline of kidney function in renal fibrosis.
° Recently granted US patent provides patent protection for lecinoxoids treatment of liver and renal fibrosis until at least November 2035 and supports potential partnering opportunities.
Continued to strengthen the Company’s intellectual property portfolio – European Patent Office issued Patent No. 2908865, extending exclusive protection for VB-111 until October 2033, before any further potential extension. Similar VB-111 composition-of-matter patents have also been granted in the US, Japan, China and additional countries.
Strengthened the Board of Directors with the appointment of Dr. Shmuel ("Muli") Ben Zvi, a well-known pharmaceutical executive in Israel and former senior manager at Teva Pharmaceuticals Industries Ltd.
Third quarter Ended September 30, 2018 Financial Results:

Revenues: Revenues related to the Company’s collaboration in Japan amounted to $0.1 million in the third quarter ended September 30, 2018.
Cash Position: Cash, cash equivalents and short-term bank deposits at September 30, 2018, were $53.7 million and working capital was $50.1 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years and is expected to be sufficient to support the Company’s Phase 3 clinical trial for VB-111 for ovarian cancer, and to advance its pipeline, including the VB-600 platform targeting MOSPD2 during this period.
R&D Expenses: Research and development expenses for the quarter ended September 30, 2018, were approximately $4.1 million, compared to approximately $4.8 million in the comparable period in 2017.
G&A Expenses: General and administrative expenses for the quarter ended September 30, 2018 were $1.4 million, compared to $1.7 million for the comparable period in 2017.
Comprehensive Loss: The Company reported a comprehensive loss for third quarter ended September 30, 2018 of $5.4 million, or ($0.15) per share, compared to a net loss of $6.5 million, or ($0.24) per share in third quarter ended September 30, 2017.
For further details on VBL’s financials, including the results for the nine month period ended September 30 2018, refer to Form 6-K filed with the S.E.C.

Conference Call:
Tuesday, November 20th @ 8:30am Eastern Time
US Domestic: 888-204-4368
International: 323-994-2082
Conference ID: 4933637
Webcast: View Source

Prior to Phase II Liver Cancer Data Release Can-Fite Brings on Board an Oncologist Expert

On November 20, 2018 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that Professor Josep Llovet, an experienced leader with deep background in liver cancer research and development, has been commissioned by the Company to assist in the analysis of the Phase II data that is anticipated during the first quarter of 2019 (Press release, Can-Fite BioPharma, NOV 20, 2018, View Source [SID1234531488]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Professor Llovet is Founder and Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine, New York University (USA), and Professor of Research-ICREA in the BCLC Group, Liver Unit, IDIBAPS-Hospital Clínic, University of Barcelona. Professor Llovet has been President, Secretary and Founder of the International Liver Cancer Association (ILCA) and Chairman of the European Clinical Practice Guidelines of management of liver cancer (EASL-EORTC). A renowned key opinion leader, Dr. Llovet has published more than 240 articles in peer-reviewed journals, more than 50 chapters of books, and has delivered more than 500 lectures. He has devoted the past 20 years of his career studying the pathogenesis and treatment of liver cancer.

"We are proud and honored to have the expertise of Prof. Llovet, who is one of the most distinguished Key Opinion Leaders in the field of liver diseases, on our team. We look forward to the insights he will contribute in the analysis of data of our Phase II advanced liver cancer study when the results are unblinded sometime during the first quarter of 2019. We believe his depth of experience both as researcher and as medical practitioner in treatment of liver cancer will be beneficial to Can-Fite. His insight and commitment to this field will be quite helpful as we create a new approach for liver cancer therapy," stated Can-Fite CEO Dr. Pnina Fishman.

Due to patient survival, top line efficacy results are expected during the first quarter of 2019 for Can-Fite’s Phase II clinical trial of drug candidate Namodenoson (CF102) for the treatment of advanced hepatocellular carcinoma (HCC) in patients with a Child Pugh B score whose disease has progressed on sorafenib therapy. Enrollment of 78 patients was completed in August 2017 and the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo). Namodenoson has received Fast Track Status in the U.S. and Orphan Drug Designation in Europe and the U.S.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Curis to Present at the 60th Annual Meeting of the American Society of Hematology

On November 20, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported three upcoming poster presentations at the 60th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Curis, NOV 20, 2018, View Source [SID1234531504]). Curis’s poster presentations will be available for viewing on Monday, December 3 (Session III) from 10 a.m. to 8 p.m. PT with presentations from 6 p.m. to 8 p.m. PT in Hall GH at the San Diego Convention Center.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Curis will present three posters at the ASH (Free ASH Whitepaper) conference providing key information supporting development of fimepinostat in patients with DLBCL, including patients with MYC-alterations, and CA-4948, Curis’s IRAK4 inhibitor, for patients with lymphomas. A pooled analysis of R/R DLBCL patients treated with fimepinostat demonstrates adequate safety and anti-tumor activity supporting the biologic rationale for continued development of fimepinostat in this patient population. Additionally, Curis will present preclinical data and biological rationale that support CA-4948 development in patients with tumors sensitive to the IRAK4 signaling pathway as well as data supporting the potential for IRAK4-based combination regimens to overcome drug tolerance in patients with Non-Hodgkin Lymphoma.

Details of these presentations are as follows:

Curis Presentations at American Society of Hematology (ASH) (Free ASH Whitepaper) 60th Annual Meeting

Viewing Date/Time:

Monday, Dec. 3, 10:00 AM – 8:00 PM PT

Presentation Date/Time:

Monday, Dec. 3, 6:00 PM – 8:00 PM PT

Location:

Hall GH, San Diego Convention Center

Abstract Number:

4168

Presentation Title:

Preclinical Activity of IRAK4 Kinase Inhibitor CA-4948 Alone or in Combination with Targeted Therapies and Preliminary Phase 1 Clinical Results in Non-Hodgkin Lymphoma

Abstract Number:

4184

Presentation Title:

A Pooled Analysis of Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients Treated with the Dual PI3K and HDAC Inhibitor Fimepinostat (CUDC-907), Including Patients with MYC-Altered Disease

Abstract Number:

2649

Presentation Title:

Drug Combinations Co-Targeting Myeloid Cell Leukemia-1 (Mcl-1) Protein Can Overcome Microenvironmentally-Induced Multi-Drug Tolerance in Non-Hodgkin Lymphomas

Bristol-Myers Squibb to Take Part in Evercore ISI HealthCONx Conference

On November 20, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Evercore ISI HealthCONx Conference on Tuesday, November 27, 2018, in Boston (Press release, Bristol-Myers Squibb, NOV 20, 2018, https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-take-part-evercore-isi-healthconx-confere [SID1234531566]). Johanna Mercier, head of U.S. and Large Markets, Worldwide Commercial, will answer questions about the company at 11:45 a.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

Deciphera Pharmaceuticals, Inc. to Present at the 30th Annual Piper Jaffray Healthcare Conference

On November 20, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that Michael D. Taylor, Ph.D., President and Chief Executive Officer, will present at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 2:30 PM ET at the Lotte New York Palace Hotel (Press release, Deciphera Pharmaceuticals, NOV 20, 2018, View Source [SID1234531505]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.