On October 23, 2019 Varian (NYSE: VAR) reported it has been selected by Penn Medicine to install a Varian ProBeam 360° proton therapy system in a single-room configuration at Lancaster General Health Ann B. Barshinger Cancer Institute in south central Pennsylvania (Press release, Varian Medical Systems, OCT 23, 2019, View Source [SID1234542494]). In addition to the equipment, Varian will also provide its ARIA information management system and Eclipse treatment planning system. Construction of the new center began in September 2019, with the first patient treatments expected in 2021.

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!

In addition to the agreement on the proton therapy system, Penn Medicine and Varian also signed a research collaboration agreement. The goal of the collaboration is to enable global clinics to more easily adopt, use, and innovate modern proton therapy techniques.

With a 30 percent smaller footprint than the previous system, ProBeam 360° offers uncompromised clinical capabilities while reducing vault construction costs by approximately 25 percent. The new system has a 360-degree rotating gantry, the most powerful particle accelerator available today to treat cancer, iterative cone-beam CT imaging, and high-definition pencil-beam scanning technology. The system can also provide clinicians a viable path to potential next-generation treatments such as FLASH therapy.

The 360-degree rotating gantry of ProBeam 360° enables efficient Intensity Modulated Proton Therapy (IMPT), and faster treatment times by minimizing patient repositioning and re-imaging and allowing high-quality cone beam CT (CBCT) imaging from almost any angle. RapidScan technology, available on the ProBeam 360°, simplifies the process of motion management by delivering each field in a single breath-hold. This capability increases the number of patients who can comply with breath-hold treatments like lung SBRT.

"We look forward to continuing our strong partnership with Penn Medicine on the installation of the ProBeam 360° system and increasing access to this advanced technology," said Kolleen Kennedy, chief growth officer and president of Proton Therapy Solutions, Varian.

On October 23, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a business update that will be discussed in more detail on the company’s investor and analyst call to be held today at 10am Eastern Time / 7am Pacific Time (Press release, Rigel, OCT 23, 2019, View Source [SID1234542441]).

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!

"This is an exciting time for Rigel with significant advancements in all segments of our business," said Raul Rodriguez, Rigel’s president and CEO. "We continue to grow sales of TAVALISSE in the U.S. and are making substantial strides in expanding our pipeline. Our clinical development efforts will be led by our newly appointed chief medical officer, Dr. Wolfgang Dummer. We are excited to leverage his experience and depth of knowledge as we continue to pursue our clinical development goals."

Business Update Highlights

TAVALISSE Revenues Increase

Preliminary estimates indicate that TAVALISSE (fostamatinib disodium hexahydrate) net product sales continued to achieve double digit quarter over quarter growth, increasing 15% to $11.7 million from $10.2 million in the second quarter of 2019. This information is preliminary, has not been audited and is subject to change upon completion of Rigel’s closing procedures.

IRAK1/4 Program Shows Proof-of-Mechanism in Humans

Rigel completed a Phase 1 clinical trial of R835, an interleukin-1 receptor-associated kinase 1/4 (IRAK 1/4) inhibitor. In addition to positive tolerability and pharmacokinetic data, R835 showed consistent inhibition of cytokine production in an LPS (lipopolysaccharide) challenge which was designed to gauge the molecule’s impact on inflammatory stimulation.

New RIP1 Inhibitor Program

For the first time today, Rigel announced its new receptor-interacting protein kinase (RIP1) inhibitor program. The lead molecule, R552, has initiated a Phase 1 clinical trial. RIP1 is believed to be a key driver of necroptosis which is implicated in a broad range of key inflammatory cellular processes including cell death and cytokine production.

Appointment of Wolfgang Dummer, MD, PhD as CMO

The Company is pleased to announce the appointment of Wolfgang Dummer, MD, PhD to the role of Chief Medical Officer. Dr. Dummer has more than 20 years of clinical and drug development experience at world class institutions, as well as an extensive academic history. Most recently, he served as Chief Medical Officer at Aridis Pharmaceuticals, Inc. where he was responsible for overseeing all aspects of drug development in the field of antimicrobial immunotherapy. Prior to that, he served as Vice President of Clinical Development at BioMarin Pharmaceutical Inc., where he led the development of a deep rare disease pipeline, including the company’s leading marketed product, Vimizim (elosulfase alpha). Prior to Biomarin, Dr. Dummer served for 11 years in capacities of increasing importance in Clinical Research and Development at Genentech, Inc. (now part of Roche), overseeing numerous programs, including Rituximab. Dr. Dummer is a board-certified clinical dermatologist and allergist/immunologist. Over the course of his career, he has published more than 50 peer reviewed journal articles and has more than 40 abstracts, presentations, and book contributions.

Business Update Conference Call

As previously announced, Rigel will host a conference call today to provide a business update. Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

About ITP

In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About R8351

R835 is an oral investigational candidate that is a potent and selective inhibitor of IRAK1 and IRAK4 shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. Dysregulation of the TLR and IL-1R pathways may be associated with a variety of inflammatory conditions including psoriasis, rheumatoid arthritis, lupus and gout (among others).

About R5521

R552 is an investigational candidate that is a receptor-interacting protein kinase (RIP1) inhibitor. RIP1 is believed to play a critical role in necroptosis, a type of regulated cell death. In necroptosis, cells rupture leading to the dispersion of cell contents, which signals an immune response and enhances inflammation. It is implicated in a broad range of key inflammatory cellular processes including cell death and cytokine production. In preclinical studies, R552 showed prevention of joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage.

About TAVALISSE
Indication

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (>Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

Common adverse reactions (>5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

On October 23, 2019 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, reported financial results for the quarter ended September 30, 2019 (Press release, Edwards Lifesciences, OCT 23, 2019, View Source [SID1234542458]).

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!

Third Quarter and Recent Highlights

Sales grew 21% to $1.1 billion; underlying1 sales grew 19%
TAVR sales grew 26%; underlying sales grew 27%
R&D spending up 21% versus prior year to 18% of sales
EPS was $1.30; adjusted1 EPS was $1.41
2019 adjusted EPS guidance raised to $5.50 to $5.65 from $5.20 to $5.40
$27 million charge related to TAVR strategy
FDA approved SAPIEN 3 and SAPIEN 3 Ultra systems indication expansion
"We are very pleased to report strong third quarter results, which reflected a large increase in the number of patients that were treated with transcatheter heart valve therapy," said Michael A. Mussallem, chairman and CEO. "Our results were significantly higher than expected this quarter following the strong PARTNER 3 trial evidence that led to the recent FDA indication expansion of our SAPIEN 3 and SAPIEN 3 Ultra systems. Additionally, at a recent clinical meeting it was exciting to observe new evidence that once again demonstrated significant quality of life improvements for patients that received SAPIEN valves."

Third Quarter 2019 Results

Sales for the quarter ended September 30, 2019 were $1.1 billion, up 21 percent over the prior year, or 19 percent on an underlying basis. Diluted earnings per share for the quarter were $1.30, while adjusted earnings per share grew 32 percent, higher than expected, to $1.41.

Transcatheter Aortic Valve Replacement (TAVR)

For the quarter, the company reported TAVR sales of $700 million, an increase of 26 percent over the third quarter last year, or 27 percent on an underlying basis. Global average selling prices remained stable, and the company estimates its global competitive position was consistent with the second quarter and prior year.

"The recent indication expansion approval of our SAPIEN 3 and SAPIEN 3 Ultra systems represents a significant milestone and allows all patients diagnosed with severe aortic stenosis to be considered for TAVR based on their individual needs," said Mussallem.

He added, "While still early in the 2020 forecasting process and difficult to predict, we are modeling a return to low double-digit global TAVR procedure growth next year, consistent with our estimate of a $7 billion opportunity in 2024."

Transcatheter Mitral and Tricuspid Therapies (TMTT)

The company made important progress in the third quarter in advancing its portfolio of technologies to bring important solutions to underserved mitral and tricuspid patients with few options today. Enrollment is ongoing in the CLASP IID and CLASP IIF Pivotal Trials. In September the company received FDA approval for the CLASP IITR Pivotal Trial to study the PASCAL system in patients with symptomatic severe tricuspid regurgitation. The company remains on track to initiate a U.S. pivotal trial of the SAPIEN M3 system before the end of the year. Third quarter sales in TMTT were $10 million, lifted principally by commercial sales of the PASCAL transcatheter mitral system in Europe. For full year 2019, Edwards now expects TMTT revenue to be below $40 million as the company continues a disciplined introduction and premium pricing strategy, which is moderating site activation.

Surgical Structural Heart and Critical Care

Surgical Structural Heart sales for the quarter were $204 million, up 11 percent compared to the third quarter last year, or up three percent on an underlying basis. Growth was lifted by the sales of premium products, particularly through adoption of the INSPIRIS RESILIA aortic valve, which drove an increasing share of surgical aortic valve procedures.

Critical Care sales were $180 million for the quarter, representing an increase of ten percent versus the third quarter last year, or up seven percent on an underlying basis. All product categories and geographies contributed to this performance, including our HemoSphere advanced monitoring platform.

Additional Financial Results

For the quarter, the company’s adjusted gross profit margin was 75.9 percent, compared to 75.5 percent in the same period last year. This improvement was driven primarily by the favorable impacts from foreign exchange and product mix, partially offset by spending in support of the new European device regulations and manufacturing variances.

Selling, general and administrative expenses increased 14 percent to $306 million for the quarter, driven by transcatheter structural heart field personnel related expenses, including expanding the TMTT field organization in Europe.

Research and development for the third quarter increased 21 percent to $196 million, or 18 percent of sales. This increase was primarily the result of significant investments in the company’s transcatheter structural heart programs, including generating clinical evidence.

During the quarter, the company recorded an additional $27 million charge, primarily inventory, related to last quarter’s strategic decisions regarding its transcatheter aortic valve portfolio.

Adjusted free cash flow for the third quarter was $319 million, defined as cash flow from operating activities of $437 million, less capital spending of $76 million, and excluding a $42 million tax benefit related to the company’s previously announced litigation settlement.

Cash, cash equivalents and short-term investments totaled $1.4 billion at September 30, 2019. Total debt was $594 million.

Outlook

For 2019, the company now expects total sales around the top of its previous $4.0 billion to $4.3 billion range. Additionally, the company raised its full year 2019 adjusted earnings per share guidance to $5.50 to $5.65 from $5.20 to $5.40.

"We are very pleased with our strong year-to-date performance. As patients and clinicians increasingly choose TAVR, we remain optimistic about the long-term growth opportunity. We are committed to aggressively investing in our future, consistent with our focused innovation strategy. We remain confident that the innovative therapies resulting from our investments will benefit a broader group of patients suffering from structural heart disease and continue to drive strong organic growth," said Mussallem.

On October 23, 2019 Varian Reported the Results for Fourth Quarter and Full Fiscal Year 2019 (Press release, Varian Medical Systems, OCT 23, 2019, View Source [SID1234542442]).

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!

Fourth Quarter 2019 Summary

Oncology Systems gross orders grew 7% in dollars and 7% in constant currency; North America gross orders grew 10%; 17 Ethos orders received in Europe and Australia
Total company revenues grew 10% in dollars, or 11% in constant currency, to $879 million
GAAP operating earnings declined 3% representing 14.7% of revenues; Non-GAAP operating earnings grew 13% representing 18.1% of revenues
GAAP net earnings per diluted share of $0.97; Non-GAAP net earnings per diluted share of $1.21
Tariff exclusions had a $21 million benefit to revenues, a $4 million benefit to cost of revenues and a $2 million expense triggered by receiving the exclusion, with a net benefit to Non-GAAP operating earnings of $23 million
Fiscal Year 2019 Summary

Oncology Systems gross orders grew 9% in dollars, or 11% in constant currency
Total company revenues grew 10% in dollars, or 12% in constant currency, to $3.2 billion
Organic revenues, which excludes the year over year impact of FX and growth from the acquisitions of CTSI, Endocare, Alicon and the Boston Scientific bead portfolio, grew 11%
GAAP operating earnings declined 7% representing 12.6% of revenues; Non-GAAP operating earnings grew 6% representing 16.8% of revenues
GAAP net earnings per diluted share of $3.38; Non-GAAP net earnings per diluted share of $4.63
New President of Interventional Oncology and New Chief Financial Officer

Effective December 1, 2019, Gary E. Bischoping, Jr., currently senior vice president, Finance & chief finance officer, will take on a new role as president, Interventional Oncology Solutions; J. Michael Bruff, currently senior vice president, Finance and Investor Relations, will succeed Bischoping as senior vice president, Finance & chief finance officer
Varian (NYSE: VAR) reported its fourth quarter and full fiscal year 2019 results and new appointments to key leadership roles.

"This is the second consecutive fiscal year we have reported double-digit revenue growth and 9 percent Oncology orders growth; our core business is strong and being powered by our continuous innovation cycle, and our acquisitions are delivering on growth expectations," said Dow Wilson, Chief Executive Officer of Varian. "While we have more work to do in sharpening our execution, our order and revenue growth has us looking forward to the next fiscal year. We have strong momentum exiting our fourth quarter and our long-term growth and value creation strategy is delivering for patients, clinicians and our shareholders."

Non-GAAP net earnings and Non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets and inventory step-up, acquisition-related expenses and in-process research and development, impairment charges, significant litigation charges or benefits and legal costs, gains and losses on equity investments, and significant non-recurring tax expense or benefit.

The company ended the quarter with $531 million in cash and cash equivalents and $412 million in debt. Net cash provided by operating activities was $118 million, up 9%. Cash Flows from operations were $372 million for the fiscal year, down 18% due to higher working capital to support product transition and growth. During the quarter, the company invested $32 million to repurchase 279,000 shares of common stock.

Oncology Systems Segment

Continued leadership in innovation and market execution drove strong worldwide growth in 2019. Oncology revenues totaled $820 million for the fourth quarter, up 8%, and $3.1 billion for the full year, up 11%. Operating earnings for the segment increased 3% for the quarter and were flat for the full year.

Gross orders for the fourth quarter were $1.1 billion, up 7%, and $3.4 billion for the full year, up 9%. Gross orders in the Americas were up 11% for the fourth quarter. In EMEA, gross orders in the quarter rose 10%, driven in part by orders for 13 TrueBeam systems as a part of the Tata Trusts framework agreement. In APAC, gross orders decreased 9% with a challenging quarter in Japan that was partially offset by growth in China and South East Asia and Korea.

Proton Solutions Segment

Proton Solutions revenues totaled $42 million for the fourth quarter, down 9%, and $144 million for the full year, down 3%. We took one new order at Ohio State University in the fourth quarter for a total of four proton orders in the full year.

Other Segment

Revenues for our Other segment were $17 million in the fourth quarter. The Other segment is comprised of our interventional oncology business, including cryoablation, embolic microspheres, and microwave ablation, as well as our cardiac radioablation assets.

Tariff Exclusion

The company received two tariff exclusions in the fourth quarter. The exclusions had a $21 million benefit to revenues, a $4 million benefit to cost of revenues and triggered a $2 million expense due to receiving the exclusion in China. The net benefit to operating earnings was $23 million, or $0.19 on a Non-GAAP earnings per share basis. The net benefit was mostly offset by an increase in tax rate driven by updates to the estimated impact of the Global Intangible Low Tax Income (GILTI) and Base Erosion and Anti-Abuse Tax (BEAT) provisions of the Tax Cuts and Jobs Act, and expenses related to annual discretionary contributions to US-based foundations that independently fund research and training. Additionally, operational spend in our core businesses came in above expectations although this higher spend was partially offset by early momentum in our recent acquisitions.

Incrementally, the company did not record approximately $11 million of potential tariff refund in the fourth quarter due to timing of recognition. We expect to recognize this benefit in fiscal year 2020.

Guidance for Full Fiscal Year 2020

Our guidance continues to consider the projected market growth and momentum of our products and solutions in the market.

Our fiscal year 2020 guidance considers the recently announced tariff exclusions from both China and the United States Trade Representative. Expecting to continue our strong operational performance, the company plans to invest in our growth initiatives including: driving core business growth in China, fueling growth of our recent acquisitions by building out global sales and distribution capacity, and touching more patients by ramping research and development investments in technology-enabled services, FLASH technology, our Noona patient reported outcome offering, and cloud-based software. Continuing to invest in meaningful innovation, go-to-market capabilities, and scalable infrastructure is aligned with our commitment to drive long-term growth for shareholders.

Organic growth excludes the year over year impact of FX and growth from the acquisitions of CTSI, Endocare, Alicon and the Boston Scientific bead portfolio.

(2)

These values are presented on a non-GAAP basis. We have not provided a reconciliation of non-GAAP guidance measures to the corresponding GAAP measures on a forward-looking basis due to potential significant variability and limited visibility of the excluded items.

The guidance assumes a Non-GAAP effective tax rate of 22.5% to 23.5% and a weighted average diluted share count of 92 million. The guidance also assumes currency rates as of the beginning of fiscal year 2020, includes acquisitions announced to date, and includes the expected impact of all currently enacted tariffs.

Varian Appoints New President of Interventional Oncology; New Chief Financial Officer

Effective Dec. 1, 2019, Gary E. Bischoping, Jr., currently senior vice president, Finance & chief finance officer, will take on a new role as president, Interventional Oncology Solutions. J. Michael Bruff, currently senior vice president, Finance and Investor Relations, will succeed Bischoping as senior vice president, Finance & chief finance officer. Both executives will report directly to Dow Wilson, Varian CEO.

Earlier this year, we combined the recently acquired businesses of Endocare, Alicon and the microsphere and bland embolic bead assets from Boston Scientific to create our Interventional Oncology Solutions business under the Chief Growth Office, reporting to Kolleen Kennedy, president, Proton Solutions and chief growth officer. Based on the success of the integration and the robust early performance by our Interventional Oncology Solutions business, it is the right time to move this new business from the incubation stage under the Chief Growth Office, and it will now report directly to Bischoping in his new role as president of Interventional Oncology Solutions. Kennedy will continue in her role as president, Proton Solutions and chief growth officer, in which capacity she will focus on incubating emerging technologies, including FLASH therapy and cardiac radioablation, as well as leading our acquisition integration office.

"These moves will optimally position Varian for continued growth and are the result of our strong succession planning process," said Wilson. "During his tenure as CFO, Gary reset resource and capital allocation to invest in organic and inorganic opportunities focused on driving long-term growth and value creation. In addition, he led a successful initiative to build and strengthen the broader CFO organization’s capabilities. Gary will leverage his keen business expertise to further build Varian’s Interventional Oncology Solutions’ go-to-market organization, product portfolio and business management system to take advantage of the exciting opportunities we see in the interventional oncology space."

Mike Bruff joined Varian two years ago with extensive finance, accounting and operational experience. Since then, he has built a robust investor relations strategy and enhanced the company’s financial planning and business partnership functions. Prior to joining Varian, Bruff held a series of senior international and domestic roles, including business segment CFO, and roles in financial planning, accounting and internal audit at Dell Technologies. He also held leadership positions in corporate reporting at MCI Telecommunications and served as vice president, Services Accounting and Finance at CA, Inc. Bruff began his career in accounting and auditing at Deloitte and Touche in Washington, D.C.

"Mike understands the Varian processes and strategy, and he has the right background and experience to help navigate Varian through the next growth stages," said Wilson. "As Varian continues to evolve and grow, our deep bench of leadership capabilities across the organization will help propel our business to success in the near- and long-term."

Unless otherwise stated in this release, all growth rates are year-over-year, any references to orders are gross orders, and all periods referred to are fiscal periods. Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call

Varian Medical Systems is scheduled to conduct its fourth quarter fiscal year 2019 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13694509. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, October 25, 2019.

On October 23, 2019 Envisagenics, Inc., a New York-based biotechnology company leveraging artificial intelligence (AI) and RNA-splicing analytics for discovery and development of disease specific therapeutics, reported that it was awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, Envisagenics, OCT 23, 2019, View Source [SID1234542459]). This grant will provide $300,000 over 1 year to expand Envisagenics’ proprietary drug discovery platform, SpliceCore, for the discovery of novel targets for immuno-oncology (IO) therapeutic development.

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!

This is Envisagenics’ third SBIR grant and the first from the NCI. Envisagenics was previously awarded Phase I and Phase II grants from the National Institute of General Medical Sciences (NIGMS, NIH) to develop the SpliceCore software platform. SpliceCore generates actionable insights using AI to drive development of splicing-based therapeutics. Using the SpliceCore platform, Envisagenics developed its first therapeutic asset pipeline for triple negative breast cancer (TNBC). Its lead compound targets a novel isoform that is present in 65% of TNBC patients and is currently undergoing pre-clinical studies at Envisagenics’ laboratory located at Johnson & Johnson Innovation, JLABS at New York City (JLABS @ NYC).

"What makes SpliceCore truly unique is its exon-centric view of the transcriptome. While mainstream transcriptomics is all about genes, we focus on exons because they are the minimal and most powerful informative unit for RNA-therapeutics development. This grant proposal aims to extend the value of SpliceCore for the identification of tumor-associated ectodomains (TAEs), which are small protein domains encoded by three exons or less," said Martin Akerman, co-founder and CTO of Envisagenics. TAEs are peptides present on cell membranes that can elicit an immune response. They may serve as novel targets for IO therapeutics or diagnostic biomarkers. IO therapies represent a major advancement in the treatment of cancers. However, existing IO treatments remain ineffective for a significant number of patients. Current methods to detect TAEs utilize antibody- and/or proteomic-based techniques, which are costly and time-consuming approaches that rely on previous domain knowledge and are limited in their ability to identify novel TAEs. Envisagenics’ RNA-based approach utilizes high-throughput sequencing data from patient samples and takes advantage of the high sensitivity of RNA-seq data to uncover novel TAE isoforms. Isoform viability and immunogenicity is then predicted using a set of machine learning algorithms.

Envisagenics will be collaborating in this research with Dr. Omar Abdel-Wahab, an expert in the field of splicing and hematologic malignancies. Dr. Abdel-Wahab is currently an Associate Member in Human Oncology and Pathogenesis Program (HOPP) and an Associate Attending Physician on the Leukemia Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSKCC). "I am excited to collaborate on this grant," said Dr. Abdel-Wahab. "This software represents an opportunity for cancer and immunology research, allowing for the discovery and profiling of transmembrane proteins using RNA-seq data instead of lower throughput proteomics methods."

"This is a very exciting moment for Envisagenics. While we focus on developing our TNBC assets, this grant will allow us to further explore and develop innovative applications of our platform for therapeutic development, with the ultimate goal of helping patients in need," said Maria Luisa Pineda, co-founder and CEO.