On April 25, 2018 Varian (NYSE: VAR) reported its second quarter fiscal year 2018 results (Press release, Varian Medical Systems, APR 25, 2018, View Source [SID1234525702]).

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We are proud of the team’s progress in the second quarter toward executing on our long-term value creation strategy," said Dow Wilson, Chief Executive Officer of Varian. "We continued to strengthen our leadership in radiation therapy and extend our global footprint with the Mobius and Evinance acquisitions. In addition, we are expanding our addressable markets into interventional oncology with the acquisition of Sirtex, expected to close by the end of May."

The company ended the quarter with $740 million in cash and cash equivalents and $255 million of debt. Net cash provided by operating activities was $66 million. During the quarter, the company invested $36 million to repurchase 325,000 shares of common stock.

Oncology Systems Segment
In the fiscal second quarter, Oncology revenues totaled $698 million, up 10 percent in dollars and 6 percent in constant currency. Gross orders were $664 million, up 5 percent in dollars and 1 percent in constant currency. Gross orders in the Americas increased 2 percent in dollars and in constant currency. In EMEA, gross orders rose 11 percent in dollars and were flat in constant currency; in APAC, gross orders increased 3 percent in dollars and 1 percent in constant currency. Operating earnings for the segment increased 16 percent.

Particle Therapy Segment
In the fiscal second quarter, Particle Therapy revenues totaled $32 million, up 2 percent. The company did not book any new ProBeam orders in the quarter.

Acquisition-Related Expenses and Impairment Charges in Q2
Varian’s GAAP net earnings include acquisition-related expenses totaling $20 million for the quarter, primarily driven by $16 million related to hedging the Australian dollar purchase price of the Sirtex acquisition, as well as an impairment charge of $11 million related to the expected refinancing of the Maryland Proton Treatment Center in Baltimore. These costs and the associated tax effects reduced Varian earnings in the second quarter of fiscal 2018 by $0.26 per diluted share on a GAAP basis, and were excluded from non-GAAP results.

FY18 Annual Guidance Updated
Considering the financial and operational performance in the first half and the impact of currency, fiscal year 2018 guidance is updated to the following:

Revenue growth range of 6 percent to 9 percent, which now includes the impact from currency for the remainder of the year
Non-GAAP Operating earnings as a percentage of revenues range of 18 percent to 19 percent
Non-GAAP effective tax rate of 20 percent
Weighted average diluted shares of 93 million
Non-GAAP Earnings per diluted share range of $4.43 to $4.53
Cash flow from operations range of $475 million to $550 million
This updated guidance does not reflect the impact of the Sirtex acquisition, which is expected to close at the end of May.

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 second quarter fiscal year 2018 conference call at 2 p.m. PT today. To hear a live webcast or replay of the call, visit the investor relations page on our web site at www.varian.com/investors where it will be archived for a year. 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 confirmation code 13677574. The telephone replay will be available through 5 p.m. PT, Friday, April 27, 2018.

On April 25, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that three abstracts describing CB-839, the Company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 1 to June 7, 2018 in Chicago, Illinois (Press release, Calithera Biosciences, APR 25, 2018, View Source [SID1234535240]).

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Calithera’s collaborators will present the following results:

Phase I clinical trial of the glutaminase inhibitor CB-839 plus capecitabine in patients with advanced solid tumors Abstract #2562 Presenter: Jennifer R. Eads, M.D., Case Comprehensive Cancer Center
Date: June 4, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall
A Developmental Therapeutics–Clinical Pharmacology and Experimental Therapeutics Funding for this study was provided in part by Stand Up To Cancer1. Calithera and clinical collaborators will present two trials-in-progress abstracts, which describe the design of ongoing studies.

CANTATA: A randomized phase 2 study of CB-839 in combination with cabozantinib vs. placebo with cabozantinib in patients with advanced metastatic renal cell carcinoma.
Abstract #TPS4601 Presenter: Nizar M. Tannir, M.D., MD Anderson Cancer Center
Date: June 2, 2018
Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Genitourinary (Non-Prostate) Cancer

Novel PET/CT imaging biomarkers of CB-839 in combination with panitumumab and irinotecan in patients with metastatic and refractory RAS wildtype colorectal cancer: A phase I/II study Abstract #TPS3616 Presenter: Satya Das, M.D., Vanderbilt University Cancer Center Date: June 3, 2018 Poster Display: 8:00 a.m.-11:30 a.m. CT, Hall A Gastrointestinal (Colorectal) Cancer About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

On April 25, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that the abstract highlighting new data from the Company’s adaptive Phase 1 clinical trial for ZW25 has been selected for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from June 1 through 5, 2018 (Press release, Zymeworks, APR 25, 2018, View Source [SID1234525665]).

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The oral presentation, entitled "Single Agent Activity of ZW25, a HER2 Targeted Bispecific Antibody, in Heavily Pretreated HER2 Expressing Cancers," is scheduled for Friday June 1, 2018 at 2:45 pm CT during the session on Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics in room S406.

"We look forward to sharing the updated ZW25 data and are honored that it has been selected by ASCO (Free ASCO Whitepaper) for an oral presentation at their annual meeting," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "With over 35,000 oncology professionals from around the world anticipated to attend, it is an excellent opportunity to share an update of the data and to establish new relationships to realize the full potential of this therapeutic candidate."

Phase 1 Testing of ZW25

Zymeworks’ adaptive Phase 1 study is divided into three parts. Enrollment in the first portion of the study (the dose-escalation phase) has been completed. The Company has previously reported preliminary results from this part of the trial showing encouraging tolerability and anti-tumor activity in heavily pretreated patients with HER2-expressing cancers, including breast and gastric cancers.

In the second part of the study, which is now ongoing, expansion cohorts are being enrolled to further assess ZW25’s tolerability and single agent anti-cancer activity. The five cohorts include patients with HER2 high breast, HER2 high gastric, HER2 intermediate breast, HER2 intermediate gastric, and other HER2-expressing cancers.

The third part of the study, which is also ongoing, is evaluating the safety and anti-tumor activity of ZW25 in combination with selected chemotherapy agents in patients with HER2 low to high-expressing breast cancer or HER2 intermediate to high-expressing gastric cancers.

About ZW25

ZW25 is being evaluated in a Phase 1 clinical trial in the United States and Canada. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function and has led to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2.

On April 25, 2018 Cerus Corporation (Nasdaq:CERS) reported that its first quarter results will be released on Tuesday, May 8, 2018, after the close of the stock market (Press release, Cerus, APR 25, 2018, View Source [SID1234525685]). The company will host a conference call and webcast at 4:15 PM ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2366225. The replay will be available approximately three hours after the call through May 22, 2018.

On April 25, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that the company will host a conference call and webcast on Wednesday, May 2 at 4:30 p.m. Eastern Time to discuss its first quarter 2018 financial results (Press release, Genomic Health, 25 25, 2018, View Source [SID1234525703]). The call and webcast will follow the release of the first quarter financial results after market close.

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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

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Conference Call Details
To access the live conference call on May 2 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 2186716. Please dial in approximately ten minutes prior to the start of the call.

To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary.