On May 6, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it is conducting preparatory work for a planned pivotal Phase III study of its drug candidate Namodenoson in the treatment of advanced liver cancer in patients as a first line and second line treatment (Press release, Can-Fite BioPharma, MAY 6, 2019, View Source [SID1234535745]). The Company recently announced results from its Phase II study of Namodenoson in the treatment of advanced liver cancer. Namodenoson was found to increase overall survival in hepatocellular carcinoma (HCC) patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint.

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An end of Phase II meeting with the U.S. Food and Drug Administration to review study data and to present the design of the Phase III clinical trial is expected soon. The FDA has granted Namodenoson both Orphan Drug and Fast Track status providing a pathway for accelerated approval based on unmet need in the treatment of advanced liver cancer. Fast Track designation offers advantages including more frequent meetings with the FDA and rolling review, which provides the opportunity to submit parts of its New Drug Application (NDA) for review prior to completing the entire application for commercialization. Orphan Drug designation includes 7-year market exclusivity following marketing approval, FDA assistance during the drug development process, and exemption of application fees.

Key Opinion Leader in liver cancer, Dr. Josep Llovet is slated to be the Principal Investigator of the planned Phase III trial and is currently working closely with Can-Fite on the study’s protocol and design. Dr. Llovet is the Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine, New York University, and Professor of Research-ICREA Liver Unit, IDIBAPS-Hospital Clinic, University of Barcelona.

Dr. Llovet commented, "Today, patients with advanced liver cancer and severe liver dysfunction do not have any accepted standard of care that is effective. Based on Namodenoson’s signal of efficacy in the recently completed Phase II trial, a Phase III study in the population of patients with HCC Child Pugh B7 is warranted and I am pleased to help with the design of the Phase III study and to serve as the Principal Investigator of the trial."

Can-Fite has engaged the services of a clinical research organization (CRO), the Weinberg Group, based in Washington DC to help with the preparation of all materials for the FDA meeting.

"We look forward to our upcoming meeting with the FDA regarding our Phase III study design. We are hopeful that based on efficacy data in the largest subgroup of the patient population from our Phase II study, we can move forward into a pivotal Phase III trial for marketing approval with the guidance of the FDA," stated Can-Fite CEO Pnina Fishman."

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 May 6, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that the first patient has been dosed in XmAb23104-01 (DUET-3), a Phase 1 clinical study to evaluate the safety and tolerability of XmAb23104, a bispecific antibody that simultaneously targets the immune receptors PD-1 and ICOS, for the treatment of patients with advanced solid tumors (Press release, Xencor, MAY 6, 2019, View Source [SID1234535764]).

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"Despite the success of checkpoint inhibitors, the benefit of therapy is not universal. We designed XmAb23104 to improve anti-tumor responses through a novel mechanism of action that activates and induces proliferation of T cells through simultaneous checkpoint inhibition and co-stimulation," said Paul Foster, M.D., senior vice president and chief medical officer at Xencor. "Both PD-1 and ICOS are more highly expressed on T cells in the tumor microenvironment than on those in the periphery, and through preferential targeting of cells that express both of these receptors, we hope to be able to drive a stronger anti-tumor response than anti-PD-1 monotherapy with improved tolerability for patients."

DUET-3 is a Phase 1, multiple-dose, dose-escalation study that will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of intravenous administration of XmAb23104 in patients with selected advanced solid tumors. For more information about DUET-3, please visit View Source (identifier: NCT03752398).

About XmAb23104

XmAb23104 is a bispecific antibody that simultaneously targets PD-1, an immune checkpoint receptor, and ICOS, an immune co-stimulatory receptor, and is designed to promote tumor-selective T-cell activation. Xencor’s XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture. XmAb bispecific Fc domains have been engineered to eliminate Fc gamma receptor (FcγR) binding, with the intent to prevent activation and/or depletion of T cells via engagement by FcγR-expressing cells. XmAb23104 is being evaluated in XmAb23104-01 (DUET-3), a Phase 1 study for the treatment of advanced solid tumors.

On May 6, 2019 Veloxis Pharmaceuticals A/S (OMX: VELO) reported its Interim Report for the first three months of 2019 (Press release, Veloxis Pharmaceuticals, MAY 6, 2019, View Source [SID1234535782]). This Company Release should be read in conjunction with Veloxis’s full Interim Report for the first three months of 2019, which is attached to this release and also available on Veloxis’s website at: View Source

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Product revenue for Q1 2019 was tUSD 14,261, an increase of 96% compared with the same period last year.
US revenue increased 91% to tUSD 12,285
EU revenue increased 133% to tUSD 1,961
Over 91% of US transplant centers have utilized Envarsus since its launch.
Cash balance, tUSD 28,394 on March 31.
Veloxis reported a net income of tUSD 111 for the first quarter of 2019 compared to a net loss of tUSD 4,030 for the same period in 2018.
In connection with the Interim Report, Veloxis’s CEO, Craig Collard said:

"Veloxis is off to a terrific start in 2019 as sales of Envarsus continue to accelerate through the first quarter. We are seeing increased interest from the transplant community driven largely by the approval of the de novo indication in December 2018. We are very excited about what this means for the Envarsus franchise long-term and look forward to a successful year."

Outlook for 2019

Veloxis maintains its 2019 outlook of revenues to be in the range of USD 58 – 68 million and operating income before accounting for stock compensation in the range of USD 4 – 10 million.

Conference Call

A conference call will be held tomorrow, May 7, 2019 at 4:00 p.m. CET (Denmark); 3:00 p.m. GST (London); and 10:00 a.m. EST (New York).

To access the live conference call, please dial one of the following numbers:

DK: +45 32 72 75 18

UK: +44 (0) 203 009 5710

US: +1 917 720 0178

Confirmation Code: 7877813

Following the conference call, a recording will be available on the Company’s website: View Source

About Envarsus

Envarsus is a novel formulation of tacrolimus designed using advance technology which allows for increased bioavailability and controlled, smooth delivery, resulting in in once daily dosing, a lower total daily dose requirement, and lower peak concentrations with less fluctuation.

In addition to the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus, Envarsus is now FDA-approved for use in de novo kidney transplant patients as of December 2018. That means more patients, including hard-to-treat patients such as rapid metabolizers, can benefit from once-daily controlled-release Envarsus. Envarsus is marketed as Envarsus XR in the Unites States.

On May 6, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the first quarter ended March 31, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAY 6, 2019, View Source [SID1234535746]).

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"Achieving our ambitious objectives for 2019 is on track," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Strong positive momentum continues from 2018, and we are working toward the Q4 release of topline results from our pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated Vasculitis. We are making steady progress in our other late-stage trials as well."

"Our AURORA trial of avacopan in hidradenitis suppurativa, a disfiguring skin disorder, represents a particularly large opportunity for us. We are aiming for topline data in this potentially registration-supporting trial in 2020. The HS community has made it abundantly clear: patient interest is intense in an orally-administered long-lasting treatment option."

"We continue our march of progress: being now another quarter closer to realizing our goal of delivering a succession of topline data, starting this year, from late-stage clinical trials. Our financial position is robust: we strengthened the balance sheet with an additional $73.3 million in net proceeds from the issuance of our common stock during the quarter, and expanded our shareholder base with top-tier institutions, reflecting the increasing enthusiasm about the prospects of our innovative pipeline."

Recent Highlights

On track for Q4 topline data from the ADVOCATE Phase III trial of avacopan in ANCA-associated Vasculitis, now including all patients from the Japan cohort of patients for a total of 331 patients in the global study.

Accelerated activation of clinical sites and convened an investigators meeting in April for the Company’s Phase IIb AURORA clinical trial of avacopan for the treatment of Hidradenitis Suppurativa (HS). HS is a chronic disabling skin autoimmune disease characterized by recurrent, painful, nodules, boils and abscesses. The AURORA trial aims to enroll 390 patients with moderate to severe HS.

Surpassed 70 percent enrollment in the Company’s LUMINA 1 clinical trial of CCX140 in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease; the LUMINA 2 trial, evaluating CCX140 in nephrotic syndrome primary FSGS, continues to enroll.

Advanced enrollment in the Company’s randomized controlled clinical trial of avacopan in patients with the kidney disease C3 Glomerulopathy (C3G) to approximately 50 percent. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant, with recurring disease common. There is no approved effective treatment.

Strengthened the balance sheet with an additional $73.3 million in net proceeds from the issuance of common stock during the first quarter, with reported cash and investments totaling $234.1 million at March 31, 2019.

First Quarter 2019 Financial Results

Revenue was $8.3 million for the first quarter of 2019, compared to $9.5 million for the same period in 2018. Revenue is recognized based on the proportionate amount of costs incurred as a percentage of total budgeted costs to fulfill the performance obligation. As such, the decrease in revenue from 2018 to 2019 was primarily due to lower actual costs incurred in 2019 related to the our avacopan collaboration and license agreement, partially offset by a higher actual cost incurred in 2019 related to our CCX140 collaboration and license agreement.

Research and development expenses were $15.4 million for the first quarter of 2019, compared to $14.7 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to the initiation and patient enrollment of the avacopan Phase IIb clinical trial in patients with HS and the CCX140 Phase II clinical trials in patients with FSGS. These increases were partially offset by a decrease in the avacopan ADVOCATE Phase III pivotal trial expenses as the study was fully enrolled in the second half of 2018.

General and administrative expenses were $5.5 million for the first quarter of 2019, compared to $4.7 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the first quarter of 2019 was $11.9 million, compared to $9.4 million for the same period in 2018.

Total shares outstanding at March 31, 2019 were approximately 57.7 million shares.

Cash, cash equivalents and investments totaled $234.1 million at March 31, 2019. The Company expects to utilize cash and investments in the range of $75.0 million to $85.0 million in 2019.

Conference Call and Webcast

The Company will host a conference call and webcast today, May 6, 2019 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 4968809. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On May 6, 2019 Innovus Pharmaceuticals, Inc., ("Innovus Pharma") (OTCQB: INNV), reported preliminary first quarter 2019 net revenue is estimated to be $5.4 million or an approximate 12.8% increase from the fourth quarter of 2018 and 18.0% increase from the first quarter of 2018 (Press release, Innovus Pharmaceuticals, MAY 6, 2019, View Source [SID1234535765]). Innovus Pharma’s first quarter 2019 anticipated revenue results are preliminary and based on the most current information available and are subject to completion of the condensed consolidated financial statements for the first quarter of 2019, which are to be filed with the SEC no later than May 15, 2019.

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"We continue to execute on our controlled growth and profitability plan with focusing our growth in profitable sales channels only," stated Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "The market should also expect to see a more robust ANDA OTC pipeline very soon," continued Dr. Damaj.

The Company will host a conference call on Wednesday, May 15, 2019 at 4:15 p.m. ET/1:15 p.m. PT to discuss the financial results and recent business developments. To participate in the call, please dial 1-877-883-0383 for domestic callers or 1-412-902-6506 for international callers or 1-877-885-0477 for Canadian callers. Participant Elite Entry Number: 0678670. A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Replay Access Code: 10131471. The replay will be available shortly after the end of the conference call