On January 13, 2020 ViewRay, Inc. (NASDAQ: VRAY) reported preliminary results for the fourth quarter and full fiscal year ended December 31, 2019 (Press release, ViewRay, JAN 13, 2020, View Source [SID1234553128]). The preliminary results have not been audited and are subject to change .

Selected Fourth Quarter and Full Year 2019 Preliminary Results:

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Total revenue of approximately $17 million in the fourth quarter of 2019, primarily from three revenue units including one system upgrade, compared to total revenue of $21 million, primarily from four revenue units including one system upgrade, in the fourth quarter of 2018.
Received four new orders for MRIdian systems totaling approximately $21 million in the fourth quarter of 2019, compared to eight new orders totaling approximately $49 million in the fourth quarter of 2018.
Full year 2019 revenue of approximately $88 million, primarily from 15 revenue units, including two system upgrades, compared to 2018 revenue of approximately $81 million, primarily from 15 revenue units, including two system upgrades.
Total backlog was approximately $227 million as of December 31, 2019.
Cash and cash equivalents were approximately $227 million as of December 31, 2019. Cash burn in the fourth quarter of 2019, excluding the impact of the December 2019 financing, was approximately $3 million.
Chief Commercial Officer Jim Alecxih will be leaving the company effective January 17, 2020. At this time the company does not intend to backfill the Chief Commercial Officer role.
"In 2019 we built significant organizational expertise, made progress on our innovation and clinical pipelines, and fortified our balance sheet," said Scott Drake, President and CEO. "We are now better positioned than ever to improve the treatment paradigm for cancer patients. Today we also announced that Jim Alecxih, our Chief Commercial Officer, will be leaving the company to pursue other opportunities. We thank Jim for his service."

Financial guidance for 2020 will be provided on the company’s fourth quarter earnings conference call later this year.

On January 13, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported preliminary unaudited revenue results for the fourth quarter and full year 2019 (Press release, NuVasive, JAN 13, 2020, View Source [SID1234553127]).

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Fourth Quarter 2019 Highlights

Revenue of approximately $310 million, increased approximately 8% on both a reported and constant currency basis;
U.S. Spinal Hardware revenue increased approximately 8%;
U.S. Surgical Support revenue increased approximately 3%; and
International revenue increased approximately 14% on a reported and constant currency basis.
Full Year 2019 Highlights

Revenue of approximately $1.17 billion, increased approximately 6% on a reported basis and approximately 7% on a constant currency basis;
U.S. Spinal Hardware revenue increased approximately 7%;
U.S. Surgical Support revenue increased approximately 1%; and
International revenue increased approximately 10% on a reported basis and 12% on a constant currency basis.
NuVasive will report its full financial results for 2019 and provide its financial outlook for 2020 during its earnings announcement planned for late February.

"NuVasive delivered consistent above-market growth in 2019, with growth in the fourth quarter across all business lines," said J. Christopher Barry, chief executive officer of NuVasive. "We made meaningful progress throughout the organization last year, including the launch of differentiated new products and advancing enabling technologies to support our continued leadership in minimally invasive spine surgery."

38th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 15, 2020
NuVasive will participate in the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 15 at the Westin St. Francis in San Francisco. Mr. Barry will represent the Company in a presentation scheduled for 10:00 a.m. PT/1:00 p.m. ET.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the live webcast.

On January 13, 2020 DNAtrix, a leader in the development of oncolytic viruses for cancer therapy, reported that Jeffrey Knapp has been appointed as Chief Executive Officer and to the Board of Directors (Press release, DNAtrix, JAN 13, 2020, View Source [SID1234553126]). Stephen Dilly has been appointed as Chairman of the Board of Directors.

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"We are pleased to welcome Jeff as Chief Executive Officer of DNAtrix," said Stephen Dilly, MBBS, Ph.D., Chairman of the DNAtrix Board of Directors. "We look forward to benefiting from his deep industry experience as a senior leader in the pharmaceutical industry, who has helped to develop multiple products in the clinic and bring them to market. As we prepare for Phase 3 development and the potential commercialization of our lead program, DNX-2401, Jeff’s knowledge will be invaluable to us as we work to achieve our mission of delivering novel oncolytic virus therapies to patients with some of the most aggressive forms of cancer."

"I am thrilled to be working with DNAtrix at this pivotal time in the company’s growth," said Mr. Knapp. "The data from the Phase 2 trial (CAPTIVE) of DNX-2401 is compelling and it demonstrates the potential of DNX-2401 to transform the standard of care for patients with recurrent glioblastoma. I look forward to working with this impressive team to advance DNAtrix’s pipeline of oncolytic virus candidates through clinical development and to prepare for potential commercialization."

Mr. Knapp joins DNAtrix with over 30 years of experience in the pharmaceutical industry, including 20 in executive management. He has developed and executed strategies supporting clinical development, regulatory approval, and commercial launch of multiple products across a diverse array of therapeutic areas. Mr. Knapp most recently served as Chief Operating Officer at Aimmune Therapeutics where he was responsible for preparing the company’s first asset, AR101, for approval and commercial launch in the United States and Europe as a treatment for children and adolescents with peanut allergies. Previously, Mr. Knapp held several executive and senior management positions in biopharmaceutical companies at similar stages of growth. Mr. Knapp holds a B.A. in Biology with a Minor in Business Administration from Wittenberg University.

Dr. Dilly added, "On behalf of the DNAtrix Board of Directors, I would also like to extend our gratitude to Dr. Frank Tufaro for his leadership over the last several years, particularly for guiding the company through several clinical trials that have brought us to this important point. We are grateful for Dr. Tufaro’s hard work to grow the company and for his commitment to patients."

Dr. Dilly brings over two decades of executive and senior management experience in the biopharmaceutical industry to the DNAtrix Board of Directors. He also serves as Board Chairman of Cognoa, a pediatric behavioral health company, is a Board member of Sangamo Therapeutics and Adjuvance Technologies, and is on the Industry Advisory Board of Longitude Ventures. Previously, Dr. Dilly served as Chief Executive Officer and Board Member of Aimmune Therapeutics, where he currently serves as Special Advisor on Clinical and Regulatory affairs. Earlier in his career, Dr. Dilly served in executive and senior management roles associated with the development and launch of marketed drugs for many therapeutic areas. Dr. Dilly holds an M.B.B.S., the equivalent of an M.D. in the U.S., from the University of London in the U.K. and a Ph.D. in Cardiac Physiology from University of London.

On January 13, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported an update on its Nu Q Clinical Assays which use a magnetic particle-based assay format (Press release, VolitionRX, JAN 13, 2020, View Source [SID1234553125]). Volition has completely re-engineered its Nu.Q assays leading to a step-change improvement in analytical performance. Volition expects this enhanced analytical performance to translate into improved clinical performance in the studies to be carried out and reported in the coming months.

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Relative to Volition’s ELISA plate Nu.Q assay format, the magnetic particle-based assay format demonstrates:

A 10-20-fold improvement in analytical sensitivity of the assays.
Typical within-day reproducibility of quantitative test results below 3% (previously <10%).
Decrease in test result turnaround time from 6 hours to approximately 1 hour and 20 minutes, allowing much higher throughput.
The ability to be developed and processed on fully-automated Random-Access platforms (allowing the use of a wide range of commercial automated platforms).
Commenting on the assay transfer program Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition said, "I am incredibly proud of the effort the whole team has made in the assay development program over the last two years and in particular, I would like to thank Mhammed Bougoussa, our recently appointed Assay Validation Expert for his significant contribution to the project. We now plan to finalize blood plasma sample pre-analytics with these assays and are excited to utilize these automated magnetic chemiluminescent assays in our clinical studies and aim to start reporting data during this quarter, and throughout 2020."

Volition has continued to create assets by:

Developing recombinant nucleosomes as calibrants which provide for assay specificity and reliable quantitation. Volition developed synthetic nucleosomes with its partners but has now brought this expertise in-house with the recent acquisition of Octamer, Gmbh announced January 10.
Internalizing key processes such as chemiluminescent antibody labeling and coating of magnetic beads. This secures our supply chain and provides flexibility to speed up our assay development work.
Moving from a microtiter plate format to a magnetic particle-based assay format. This improves assay kinetics and hence assay sensitivity and reduces assay time and increases assay throughput.
Moving from a traditional colorimetric endpoint format to a chemiluminescent endpoint. This further reduces background, leading to further improvements in assay sensitivity as well as greatly extending the usable range of the assays. Moreover, the combination of a chemiluminescent endpoint with a magnetic particle-based assay format greatly improved the specificity of Nu.Q assays.
Moving all these improvements onto an FDA-approved automated immunoassay analyzer which is currently in clinical use across USA and Europe. This further decreases assay processing time and greatly increases the reproducibility and reliability of assay results so that the same correct result is produced for any patient sample regardless of where or when the test is done or who operates the instrument.
Moving from blood serum to blood plasma as the test sample which reduces assay interference.

On January 13, 2020 John Theurer Cancer Center at Hackensack University Medical Center in New Jersey were part of the CANDOR global phase III clinical trial for patients with refractory (persistent) multiple myeloma (Press release, John Theurer Cancer Center, JAN 13, 2020, View Source [SID1234553124]). The study was selected as the prestigious plenary presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the world’s leading conference for hematologic cancers and blood disorders, held in Orlando in December.

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The CANDOR study showed that the addition of the anti-CD38 monoclonal antibody daratumumab to treatment with carfilzomib and dexamethasone was more effective than conventional carfilzomib and dexamethasone. Patients receiving the three-drug regimen experienced a 37% reduction in the risk of disease progression or death, establishing a new standard of care. Patients in the CANDOR trial had been heavily pretreated and most had failed to respond to lenalidomide, an immunomodulating drug that forms the backbone of most multiple myeloma treatment regimens.

"In this population, we have had limited choices. This study shows that we can safely combine what are arguably the most active drugs for the treatment of myeloma," explained David Siegel, M.D., Ph.D., founding director of John Theurer Cancer Center’s Multiple Myeloma Institute, who led John Theurer Cancer Center’s involvement in the study. "Treatment with daratumumab, carfilzomib, and dexamethasone represents a new effective regimen for patients with recurrent or persistent multiple myeloma, especially those whose disease came back or continues to grow after lenalidomide therapy."

The phase III CANDOR study included 466 patients with multiple myeloma that persisted despite one to three prior regimens of therapy. Patients were randomly assigned 2:1 to receive either daratumumab, carfilzomib, and dexamethasone or carfilzomib and dexamethasone. After a median follow-up of 17 months, the median progression-free survival was not yet reached in the three-drug combination group, versus 16 months in patients receiving the standard therapy. Patients receiving three drugs had a better overall response rate (84.3% versus 74.7%) and a better rate of complete response or better (28.5% versus 10.4%), and the achievement of undetectable disease was nearly ten times higher (12.5% versus 1.3%). It was too early to detect any differences in overall survival.