On November 20, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at Evercore ISI’s Healthcare Conference in Boston, MA on Tuesday, November 27, 2018 at 8:45 a.m., ET (Press release, Alexion, NOV 20, 2018, View Source [SID1234531565]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

On November 20, 2018 Medtronic plc (NYSE: MDT) reported financial results for its second quarter of fiscal year 2019, which ended October 26, 2018 (Press release, Medtronic, NOV 20, 2018, View Source;p=RssLanding&cat=news&id=2377762 [SID1234531598]).

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The company reported second quarter worldwide revenue of $7.481 billion, an increase of 6.1 percent as reported or 7.5 percent on an organic basis, which adjusts for a $95 million negative impact from foreign currency. As reported, second quarter GAAP net income and diluted earnings per share (EPS) were $1.115 billion and $0.82, respectively. As detailed in the financial schedules included through the link at the end of this release, second quarter non-GAAP net income and non-GAAP diluted EPS were $1.660 billion and $1.22, respectively, both increases of 14 percent. Adjusting for a positive 1 cent impact from foreign currency, second quarter non-GAAP diluted EPS increased 13 percent.

Second quarter U.S. revenue of $4.045 billion represented 54 percent of company revenue and increased 8.3 percent as reported. Non-U.S. developed market revenue of $2.282 billion represented 31 percent of company revenue and increased 1.8 percent as reported and 3.1 percent on a constant currency basis. Emerging market revenue of $1.154 billion represented 15 percent of company revenue and increased 7.3 percent as reported and 13.5 percent on a constant currency basis.

"This was an outstanding quarter for Medtronic. We are executing on multiple fronts, resulting in robust top-line growth, solid margin expansion, and increasing free cash flow," said Omar Ishrak, Medtronic chairman and chief executive officer. "Yet, even more exciting than our results this quarter is the progress we are making on our new product pipeline, which is stronger than at any time in our company’s history."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG worldwide second quarter revenue of $2.858 billion increased 3.1 percent, or 4.4 percent on a constant currency basis. CVG revenue performance was driven by high-single digit growth in CSH and APV, and low-single digit growth in CRHF, all on a constant currency basis.

CRHF second quarter revenue of $1.472 billion increased 0.3 percent, or 1.4 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by high-single digit constant currency growth in Pacing on strong sales of the Micra Transcatheter Pacing System and the Azure wireless pacemaker. Arrhythmia Management results were also driven by high-twenties growth of the TYRX Absorbable Antibacterial Envelope and mid-teens growth in AF Solutions, both on a constant currency basis.
CSH second quarter revenue of $906 million increased 6.1 percent, or 7.8 percent on a constant currency basis, led by mid-teens constant currency growth in transcatheter aortic valves resulting from the global strength of the CoreValve Evolut PRO. Coronary grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth of drug-eluting stents, low-double digit growth of coronary balloons, and high-teens growth of guide catheters, all on a constant currency basis.
APV second quarter revenue of $480 million increased 6.2 percent, or 7.3 percent on a constant currency basis. The strength in the division was broad based, with high-teens growth in endoVenous given strong demand for the VenaSeal(TM) closure system, low-double digit growth of the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) with continued strength in Japan, and mid-single digit growth in abdominal aortic aneurysm (AAA) stent graft systems.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide second quarter revenue of $2.047 billion increased 4.9 percent, or 6.8 percent on a constant currency basis. MITG revenue performance was balanced by high-single digit constant currency growth in both SI and RGR.

SI second quarter revenue of $1.393 billion increased 4.4 percent, or 6.6 percent on a constant currency basis, driven by low-double digit constant currency growth in Advanced Energy resulting from the strength of the LigaSure(TM) vessel sealing instruments with innovative nano-coating and Valleylab(TM) FT10 energy platform. Advanced Stapling grew in the high-single digits on a constant currency basis, driven by strong demand for Tri-Staple(TM) 2.0 endo stapling specialty reloads and the Signia(TM) powered stapler.
RGR second quarter revenue of $654 million increased 5.8 percent, or 7.3 percent on a constant currency basis. Growth was driven by Patient Monitoring, which grew in the high-single digits on a constant currency basis as a result of strength in Nellcor(TM) pulse oximetry. GI Solutions grew in the low-double digits on a constant currency basis, led by a strong performance in GI Diagnostics. Renal Care Solutions grew in the mid-single digits on a constant currency basis, driven by strength in renal access products.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide second quarter revenue of $1.993 billion increased 7.0 percent, or 7.8 percent on a constant currency basis. Group results were driven by high-teens growth in Pain Therapies, low-double digit growth in Specialty Therapies, high-single digit growth in Brain Therapies, and flat results in Spine, all on a constant currency basis.

Spine second quarter revenue of $656 million decreased 0.5 percent or increased 0.2 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, including robotics, navigation, imaging, and powered surgical instruments that are recognized in the Brain Therapies division, global Spine revenue grew in the low-single digits on a constant currency basis and U.S. Core Spine increased in the mid-single digits on a constant currency basis. Posterior Cervical grew in the low-double digits on a constant currency basis, driven by the recent launch of the Infinity(TM) OCT System.
Brain Therapies second quarter revenue of $618 million increased 7.5 percent, or 8.7 percent on a constant currency basis. Neurovascular grew in the mid-teens on a constant currency basis, with high-twenties constant currency growth of stents for acute ischemic stroke, including the Solitaire(TM) Platinum. Neurovascular also had strength in neuro access products, coils and intrasaccular therapies, and flow diversion products. Neurosurgery grew in the high-single digits, led by strong capital equipment sales of the StealthStation S8 surgical navigation system, Mazor X(TM) robotic guidance system, and Visualase MRI-guided laser ablation system.
Specialty Therapies second quarter revenue of $405 million increased 11.0 percent, or 11.5 percent on a constant currency basis. Results were led by mid-teens constant currency growth in Pelvic Health on strong sales of the InterStim(TM) II system.
Pain Therapies second quarter revenue of $314 million increased 18.9 percent, or 19.7 percent on a constant currency basis. The division had strong, mid-thirties constant currency growth in Pain Stimulation on the continued strength of the Intellis(TM) platform for spinal cord stimulation, as well as low-double digit constant currency growth in Targeted Drug Delivery.
Diabetes Group
The Diabetes Group includes the Advanced Insulin Management (AIM) and Emerging Technologies divisions. Diabetes Group worldwide second quarter revenue of $583 million increased 26.2 percent, or 27.5 percent on a constant currency basis. The group is experiencing strong, sustained global demand for its sensor-augmented insulin pump systems.

AIM second quarter revenue grew in the mid-twenties on a constant currency basis, driven by the sustained U.S. market demand for the MiniMed 670G hybrid closed loop insulin pump system with the Guardian sensor 3. AIM launched the MiniMed 670G in several European countries in the quarter, and initial user feedback has been very positive. The global adoption of its sensor-augmented insulin pump systems has resulted in strong sensor attachment rates, with integrated CGM sales growing in the mid-sixties on a constant currency basis.
Emerging Technologies second quarter revenue more than doubled on a constant currency basis, driven by the ongoing launch of the Guardian Connect CGM system with Sugar.IQ(TM) personal diabetes assistant.
Guidance
The company today updated its fiscal year 2019 guidance.

For fiscal year 2019, the company is increasing its organic revenue growth guidance from a range of 4.5 to 5.0 percent to a range of 5.0 to 5.5 percent. If recent exchange rates hold for the remainder of the fiscal year, the company’s fiscal year 2019 revenue would be negatively affected by approximately $420 million to $520 million.

Medtronic’s operational outperformance in the first half of fiscal year 2019 is allowing the company to absorb incremental expenses, including an increased impact of foreign exchange since the beginning of the fiscal year and expected impacts of China tariffs and the pending Mazor acquisition in the second half of the fiscal year, such that the company is maintaining its fiscal year 2019 diluted non-GAAP EPS guidance in the range of $5.10 to $5.15. If recent exchange rates hold for the remainder of the fiscal year, foreign exchange would have a neutral impact on the company’s fiscal year 2019 EPS, implying a constant currency EPS growth forecast of 9 to 10 percent.

"Our end markets are strong, and we are leading in most of the fastest growing markets in medical technology," said Ishrak. "Over the remainder of this fiscal year and into fiscal 2020, we expect to develop and bring to market a number of innovative new technologies, which will improve the lives of millions of people around the world, help healthcare systems become more efficient, and generate significant value for our shareholders."

Webcast Information
Medtronic will host a webcast today, November 20, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the second quarter financial schedules and non-GAAP reconciliations, click here. To view the second quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

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]).

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"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

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]).

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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.

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.

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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