VBL Therapeutics to Report First Quarter 2019 Financial Results on May 15

On May 6, 2019 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Wednesday, May 15 at 8:30am Eastern Time to report first quarter ended March 31, 2019 financial results and to provide a corporate update (Press release, VBL Therapeutics, MAY 6, 2019, View Source [SID1234535763]).

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!

Wednesday, May 15th @ 8:30am Eastern Time
From the US: 877-407-9208
International: 201-493-6784
Conference ID: 13690495
Webcast: View Source

Luminex Corporation Reports First Quarter 2019 Financial Results

On May 6, 2019 Luminex Corporation (NASDAQ:LMNX) reported financial results for the first quarter 2019 (Press release, Luminex, MAY 6, 2019, View Source [SID1234535781]). Financial and operating highlights for the quarter include:

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!

First quarter consolidated revenue of $82.4 million compared to the first quarter 2018 revenue of $82.7 million.
In the first quarter, flow cytometry contributed revenue of approximately $11.4 million, offsetting the revenue loss of LabCorp Women’s Health.
Royalty revenue of $14.2 million grew 16% over the first quarter 2018. This reflects $149 million of royalty-bearing end user sales on Luminex technology, an increase of approximately 10% over the comparable period in 2018.
Sample-to-Answer revenue grew 16% over the 1st quarter of 2018 and we placed approximately 50 sample-to-answer molecular systems under contract during the first quarter of 2019. Active sample-to-answer customers approximated 625 in the quarter.
Gross margins of 56% in the first quarter, directly affected by the departure of LabCorp revenue coupled with the Flow Cytometry acquisition and integration.
First quarter GAAP net income was approximately $3.0 million, or $0.07 per diluted share, primarily driven by a discrete tax benefit of $6.6 million in the current quarter related to a tax benefit emanating from the Company’s Canadian subsidiary. On a non-GAAP basis, the Company had a net loss of $3.0 million, or losses of $0.07 per diluted share (see Non-GAAP reconciliation).
"I am pleased with our first quarter results and the continued progress we are making across the company," said Nachum "Homi" Shamir, President & CEO. "I am very excited about our future. We have two more quarters to go until we emerge as a much more diversified company with increasing momentum that is past the loss of LabCorp," continued Shamir. "During this time, we will continue to build a strong foundation through both our sample to answer portfolio and life sciences businesses. By the end of this year, we believe Luminex will be growing at a double digit rate, have improved gross margins, and will return to consistent profitability and cash flow."

FINANCIAL OUTLOOK AND GUIDANCE

The Company intends to provide annual revenue guidance, to be updated, as appropriate, at each quarterly reporting period. Luminex anticipates its second quarter 2019 revenue to be between $80 million and $83 million and reaffirms its full year 2019 revenue guidance of between $337 million and $343 million.

CONFERENCE CALL

Management will host a conference call at 3:30 p.m. CDT / 4:30 p.m. EDT, Monday, May 6, 2019 to discuss the operating highlights and financial results for the first quarter 2019. The conference call will be webcast live and may be accessed at Luminex Corporation’s website at View Source Simply log on to the web at the address above, go to the Company section and access the Investor Relations link. Please go to the website at least 15 minutes prior to the call to register, download and install any necessary audio/video software. If you are unable to participate during the live webcast, the call will be archived for six months on the website using the ‘replay’ link.

At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at www.luminexcorp.com.

Statements made in this release that express Luminex’s or management’s intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding expected revenue and cost savings and projected 2019 performance, including revenue guidance. The words "believe," "expect," "intend," "estimate," "anticipate," "will," "could," "should" and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company’s actual results or performance could differ materially from those anticipated or projected in such forward-looking statements. Factors that could cause Luminex’s actual results or performance to differ materially include risks and uncertainties relating to, among others, concentration of Luminex’s revenue in a limited number of direct customers and strategic partners, some of which may be experiencing decreased demand for their products utilizing or incorporating Luminex’s technology, budget or finance constraints in the current economic environment, or periodic variability in their purchasing patterns or practices as a result of internal resource planning challenges; market demand and acceptance of Luminex’s products and technology, including ARIES, MultiCode, xMAP, VERIGENE, Guava, Muse, Amnis and NxTAG products; Luminex’s ability to scale manufacturing operations and manage operating expenses, gross margins and inventory levels; Luminex’s ability to obtain and enforce intellectual property protections on Luminex’s products and technologies; the impact on Luminex’s growth and future results of operations with respect to the loss of the LabCorp women’s health business; Luminex’s ability to successfully launch new products in a timely manner; dependence on strategic partners for development, commercialization and distribution of products; risks and uncertainties associated with implementing Luminex’s acquisition strategy, Luminex’s challenge to identify acquisition targets, including Luminex’s ability to obtain financing on acceptable terms; Luminex’s ability to integrate acquired companies or selected assets, including the Flow-Cytometry assets recently acquired from Millipore Sigma, into Luminex’s consolidated business operations, and the ability to fully realize the benefits of Luminex’s acquisitions; the timing of and process for regulatory approvals; competition and competitive technologies utilized by Luminex’s competitors; fluctuations in quarterly results due to a lengthy and unpredictable sales cycle; fluctuations in bulk purchases of consumables; fluctuations in product mix, and the seasonal nature of some of Luminex’s assay products; Luminex’s ability to comply with applicable laws, regulations, policies and procedures; the impact of the ongoing uncertainty in global finance markets and changes in governmental and governmental agency funding, including effects on the capital spending policies of Luminex’s partners and end users and their ability to finance purchases of Luminex’s products; changes in principal members of Luminex’s management staff; potential shortages, or increases in costs, of components or other disruptions to Luminex’s manufacturing operations; Luminex’s increasing dependency on information technology to improve the effectiveness of Luminex’s operations and to monitor financial accuracy and efficiency; the implementation, including any modification, of Luminex’s strategic operating plans; the uncertainty regarding the outcome or expense of any litigation brought against or initiated by Luminex; risks relating to Luminex’s foreign operations, including fluctuations in exchange rates, tariffs, customs and other barriers to importing/exporting materials and products in a cost effective and timely manner; difficulties in accounts receivable collections; Luminex’s ability to monitor and comply with foreign and international laws and treaties; and Luminex’s ability to comply with changes in international taxation policies; budget or finance constraints in the current economic environment, or periodic variability in their purchasing patterns or practices as a result of material resource planning challenges; reliance on third party distributors for distribution of specific Luminex-developed and manufactured assay products, as well as the risks discussed under the heading "Risk Factors" in Luminex’s Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward-looking statements, including the financial guidance and 2019 outlook, contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

PharmaCyte Biotech Advances Manufacturing Process for Clinical Trial in Pancreatic Cancer

On May 6, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that advances have been completed in the manufacturing process for the clinical trial product that will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, MAY 6, 2019, View Source [SID1234535887]).

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!

Since PharmaCyte’s last press release describing the manufacturing process for its clinical trial product and the testing of that product, the data from the manufacturing process has been reviewed, analyzed and discussed in great detail among PharmaCyte’s management team, including the leader of its clinical development program in pancreatic cancer and designated Principal Investigator (PI) for the LAPC trial, Prof. Manuel Hidalgo of the Harvard Medical School, Austrianova’s management team (the manufacturer of the clinical trial product), cGMP Validation (PharmaCyte’s cGMP expert consulting firm), Eurofins Lancaster Laboratories (who produced the cells for PharmaCyte’s Master Cell Bank) and several consulting cellular biologists.

The data obtained to date from the encapsulation parameters of the manufacturing process itself indicate that the encapsulation portion of the process is fault free and reproducible, which is a fundamental requirement of the FDA.

On the advice of PharmaCyte’s cGMP expert, the company plans to conduct two additional and staggered manufacturing runs in order to maximize the chances for a successful IND submission given the novelty and complexity of the entire process. In the time since the last manufacturing run, which we reported on in January of this year, those involved with the manufacturing process have been concentrating on changes that can be made to improve the process. We believe that these changes will improve the cGMP manufacturing process to the point that the entire process can be shown to be consistently reproducible and robust as required by the FDA, and to ensure that the end-products of these manufacturing runs will convert the cancer prodrug ifosfamide into its cancer-killing form as well as they should.

This intensive effort has involved several independent tests by Austrianova and Eurofins. The results of these tests strongly indicate that, after the suggested changes are implemented, positive results should be obtained. When the changes are made to the cGMP manufacturing process, they should significantly improve the growth of the cells obtained from the Master Cell Bank both before and after encapsulation takes place. PharmaCyte and Austrianova and its team of consultants are in the final stages of optimizing this aspect of the manufacturing process.

Meanwhile, PharmaCyte’s clinical development program in pancreatic cancer is progressing. As explained by Prof. Hidalgo, "PharmaCyte has a strong clinical trial program for pancreatic cancer. The trial design has been thoroughly vetted by a team of the best pancreatic cancer specialists in the country. I continue to lead PharmaCyte’s program in pancreatic cancer, and I am eager to get underway as its PI for the LAPC trial. Members of PharmaCyte’s team are working on various aspects of implementing the program. I remain excited about the potential that PharmaCyte’s technology can offer patients who are suffering from LAPC and am looking forward to what a successful trial may mean for the way some types of solid cancerous tumors are treated in the future."

Can-Fite Announces Preparation for End-of-Phase II Meeting with FDA to Initiate the Phase III Liver Cancer Study for Namodenoson

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.

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!

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.

Xencor Doses First Patient in Phase 1 Study of XmAb®23104 for the Treatment of Patients with Advanced Solid Tumors

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]).

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!

"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.