Nimotuzumab-cisplatin-radiation versus cisplatin-radiation in HPV negative oropharyngeal cancer

On February 6, 2020 Oncotarget Volume reported in this study, locally advanced head and neck cancer patients undergoing definitive chemoradiation were randomly allocated to weekly cisplatin – radiation {CRT arm} or nimotuzumab -weekly cisplatin -radiation {NCRT arm} (Press release, Oncotarget, FEB 6, 2020, View Source [SID1234553940]).

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An interaction test was performed between the study arms and HPV status prior to doing any HPV specific analysis for each of the studied outcomes.

We had 187 HPV negative oropharyngeal cancers, 91 in the CRT arm and 96 in NCRT arm.

The addition of nimotuzumab to weekly cisplatin-radiation improves outcomes inclusive of OS in HPV negative oropharyngeal cancers.

Dr. Kumar Prabhash from the Department of Medical Oncology at the Tata Memorial Hospital, HBNI in Mumbai India said in their Oncotarget research article, "Locally advanced oropharyngeal cancers possess a unique challenge."

Patients with HPV positive disease have a favorable prognosis as opposed to HPV negative disease.

They had hypothesized that an improvement in outcomes in our study was seen due to the differential patient population in our study when compared to the RTOG 0552 study.

Another phase 3 study, exploring the role of cetuximab along with carboplatin -5 FU with radiation, reported improvement in outcomes with the addition of cetuximab.

Taking this into consideration, the authors decided to perform a subgroup analysis of the HPV negative oropharyngeal cancer cohort, to study the absolute improvement in 2-year outcomes with the addition of nimotuzumab.

The Prabhash Research Team concluded in their Oncotarget article that an interaction test was performed prior to doing the subgroup analysis, to determine whether nimotuzumab had a differential impact or not.

Veracyte to Release Fourth Quarter and Full-Year 2019 Financial Results on February 25, 2020

On January 6, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the fourth quarter and full-year 2019 after the close of market on Tuesday, February 25, 2020 (Press release, Veracyte, FEB 6, 2020, View Source [SID1234553956]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following conclusion of the live broadcast and will be accessible on the company’s website at View Source

Cardinal Health Reports Second Quarter Results for Fiscal Year 2020

On February 6, 2020 Cardinal Health (NYSE: CAH) reported financial results for the second quarter of fiscal 2020 ended December 31, 2019 (Press release, Cardinal Health, FEB 6, 2020, View Source [SID1234553972]). Second quarter revenue was $39.7 billion, an increase of 5% from the second quarter of last year.

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Second quarter GAAP operating earnings decreased 34% to $334 million, which included a $96 million charge in connection to the recently announced voluntary surgical gown-related recalls. Non-GAAP operating earnings increased 1% to $646 million. GAAP diluted earnings per share (EPS) decreased 19% to $0.75, while non-GAAP diluted EPS increased 18% to $1.52. Non-GAAP diluted EPS benefited from a lower effective tax rate and a lower share count.

"With the first half of the year behind us, we are raising our fiscal year 2020 guidance," said Mike Kaufmann, CEO of Cardinal Health. "This increase was driven by improved performance across our Pharmaceutical segment, particularly within our generics program. As we look forward, we remain focused on executing our strategic growth initiatives."

Second quarter revenue for the Pharmaceutical segment increased 6% to $35.7 billion, due to sales growth from Pharmaceutical Distribution and Specialty Solutions customers.

Pharmaceutical segment profit increased 4% to $462 million in the second quarter, reflecting positive performance in the company’s generics program and Specialty Solutions business. This was partially offset by the adverse impact of Pharmaceutical Distribution customer contract renewals.

Medical segment

1Medical segment profit does not include the $96 million charge incurred for inventory write-offs and certain remediation and supply disruption costs associated with the recently announced voluntary surgical gown-related recalls.

Second quarter revenue for the Medical segment was flat at $4.0 billion. Growth in Cardinal Health at Home was offset by a decline in products and distribution.

Medical segment profit increased 4% to $195 million in the second quarter. This increase reflects benefits from cost savings initiatives, partially offset by a decline in products and distribution.

Tax rate

During the second quarters of fiscal 2020 and 2019, GAAP effective tax rates were 21.0% and 31.0%, respectively. Non-GAAP effective tax rates were 24.8% and 28.5%, respectively. The GAAP effective tax rate benefitted from jurisdictional mix and discrete items recognized in the second quarter of 2020, largely driven by changes as a result of tax reform. The Non-GAAP effective tax rate benefitted from jurisdictional mix.

Fiscal year 2020 outlook

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company raises its fiscal year 2020 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to the range of $5.20 to $5.40 from the range of $4.85 to $5.10.

Recent highlights

For the 12th consecutive year in a row, Cardinal Health was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100% on the HRC’s 2020 Corporate Equality Index (CEI).
Cardinal Health was recognized by the Women’s Forum of New York for having at least 40% of board seats held by women.
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until February 5, 2021.

Upcoming webcasted investor events

Barclays Global Healthcare Conference on March 10 at 8:30 a.m. Eastern in Miami Beach, Fla.

Zetagen Therapeutics, Inc. Secures $5.34 Million in Series A Funding to Accelerate Clinical Work

On February 6, 2020 Zetagen Therapeutics, Inc., a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported the close of $5.34M Series A funding round (Press release, Zetagen Therapeutics, FEB 6, 2020, View Source [SID1234643690]). The financing will accelerate the growth of the Company’s ongoing clinical programs for ZetaMet (Zeta-BC-003), a synthetic, small-molecule, inductive biologic being developed to target and resolve metastatic lesions while inhibiting future tumor growth.

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"We are extremely pleased to have reached such an important milestone in Zetagen’s advancement as a biopharmaceutical company, " said Joe C. Loy, CEO of Zetagen Therapeutics, Inc. "This funding is paramount to accelerating our clinical programs around ZetaMet (Zeta-BC-003) by adding the necessary scientific infrastructure that will allow us to prepare for future human clinical trials."

ZetaMet (Zeta-BC-003) is a novel molecular pathway paired with a proprietary, drug-eluting implant technology. The novel therapy is designed to resolve tumor growth, inhibit pain, and regenerate bone. Zetagen exclusively licensed the platform technology from the State University of New York in 2016.

Agenus Announces Investor Day on February 20, 2020

On February 6, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported it will hold an Investor Day Thursday, February 20, 2020 (Press release, Agenus, FEB 6, 2020, View Source [SID1234553925]).

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The Investor Day will present:

Clinical data from pre-planned interim analyses of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4);
Clinical data from a dose-escalation study of AGEN1181, a novel multi-functional T cell engager.
Date:

Thursday, February 20, 2020

Time:

9:00 – 11:00AM

Location:

New York, NY (by invitation only)

Event details: agenusbio.com

Presenters will include global experts in immune-oncology, Dr. Chuck Drake, Co-Director, Cancer Immunotherapy Program, Columbia University Herbert Irving Comprehensive Cancer Center, and Dr. Bradley Monk, M.D., FACS, FACOG, Co‐Director of GOG Partners, Arizona Oncology (US Oncology Network) and Professor, Gynecologic Oncology at University of Arizona, and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona.

The event will be webcast live an may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website at www.agenusbio.com or by using the link below. A replay of the webcast, as well as a copy of the slide presentations that will be presented at the event, will be available on the Agenus website following the event.

Please note that in-person attendance is by invitation only and advanced registration is required. If you are interested in attending or for more information, please contact Regina Grebla, Agenus Investor Relations, at [email protected].