ArQule to Report Second Quarter 2018 Financial Results on August 1, 2018

On July 18, 2018 ArQule, Inc. (Nasdaq: ARQL) reported it will report financial results for the second quarter of 2018 before the market opens on Wednesday, August 1, 2018 (Press release, ArQule, JUL 18, 2018, View Source [SID1234527763]). The Company will hold a conference call and webcast on the same day at 9:00 a.m. ET to discuss these results and provide a general business update.

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The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

Abbott Reports Second-Quarter 2018 Results

On July 18, 2018 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2018 (Press release, Abbott, JUL 18, 2018, View Source [SID1234527761]).

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Second-quarter worldwide sales of $7.8 billion increased 17.0 percent on a reported basis and 8.0 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.40 in the second quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.73, above Abbott’s previous guidance range.
Abbott is raising its full-year 2018 EPS guidance range, which continues to reflect strong double-digit growth. Abbott projects full-year diluted EPS from continuing operations on a GAAP basis of $1.34 to $1.40. Projected full-year adjusted diluted EPS from continuing operations is now $2.85 to $2.91.
In May, Abbott received approval from the U.S. FDA for XIENCE Sierra, the newest generation of its gold-standard coronary stent system, which offers design and technology advances to provide an easier implant and greater ability to treat complex blockages. During the second quarter, XIENCE Sierra also received national reimbursement in Japan to treat people with coronary artery disease.
In May, Abbott announced U.S. FDA clearance of Advisor HD Grid Mapping Catheter, Sensor Enabled, which creates highly detailed maps of the heart and expands Abbott’s leading electrophysiology product portfolio.
In July, Abbott received U.S. FDA approval for a next-generation version of its leading MitraClip heart valve repair device. This new version includes design advancements that simplify the minimally invasive procedure and enable more patients to be treated with MitraClip.
"All four of our businesses exceeded expectations and contributed to strong growth overall," said Miles D. White, chairman and chief executive officer, Abbott. "We forecast continued strong performance and are raising our full-year outlook despite recent currency shifts."

* See note on organic growth below.

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;
Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017; and
Excludes the impact of foreign exchange.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2018 worldwide sales of $7.8 billion increased 17.0 percent on a reported basis. On an organic basis, worldwide sales increased 8.0 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 7.3 percent on a reported basis in the second quarter, including a favorable 0.9 percent effect of foreign exchange, and increased 6.4 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.4 percent on a reported basis in the second quarter, including a favorable 1.1 percent effect of foreign exchange, and increased 5.3 percent on an organic basis. International sales increased 10.2 percent on a reported basis, including a favorable 2.1 percent effect of foreign exchange, and increased 8.1 percent on an organic basis. Strong performance in the quarter was led by growth in several countries across Asia, including Greater China, and Latin America.

Worldwide Adult Nutrition sales increased 8.5 percent on a reported basis in the second quarter, including a favorable 0.7 percent effect of foreign exchange, and increased 7.8 percent on an organic basis. International sales increased 15.2 percent on a reported basis, including a favorable 1.3 percent effect of foreign exchange, and increased 13.9 percent on an organic basis. Sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/m = Percent change is not meaningful.

Worldwide Diagnostics sales increased 47.2 percent on a reported basis in the second quarter. On an organic basis, sales increased 6.6 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 10.6 percent on a reported basis in the second quarter, including a favorable 2.9 percent effect of foreign exchange, and increased 7.7 percent on an organic basis. Growth in the quarter was driven by continued share gains globally.

Molecular Diagnostics sales increased 7.9 percent on a reported basis in the second quarter, including a favorable 1.9 percent effect of foreign exchange, and increased 6.0 percent on an organic basis. Worldwide sales were led by strong growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market, which was partially offset by a planned scale down in other testing areas, primarily in the U.S.

Point of Care Diagnostics sales decreased 0.8 percent on a reported basis in the second quarter, including a favorable 0.5 percent effect of foreign exchange, and decreased 1.3 percent on an organic basis.

Rapid Diagnostics worldwide sales of $484 million were led by infectious disease and cardiometabolic testing.

Established Pharmaceuticals sales increased 10.5 percent on a reported basis in the second quarter, including an unfavorable 1.8 percent effect of foreign exchange, and increased 12.3 percent on an organic basis.

Key Emerging Markets comprise several countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 8.4 percent on a reported basis in the second quarter, including an unfavorable 3.6 percent effect of foreign exchange, and increased 12.0 percent on an organic basis. Sales growth was led by double-digit growth across several geographies, including India and China.

Worldwide Medical Devices sales increased 11.3 percent on a reported basis in the second quarter. On an organic basis, sales increased 8.2 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Cardiovascular and Neuromodulation sales growth in the quarter was led by double-digit growth in Electrophysiology and Structural Heart.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation as well as share gains from the recent U.S. launch of Abbott’s Confirm Rx Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias. In May, Abbott announced U.S. FDA clearance of Advisor HD Grid Mapping Catheter, Sensor Enabled, which creates highly detailed maps of the heart and expands Abbott’s leading electrophysiology product portfolio.

In Vascular, during the second quarter, Abbott received approval from the U.S. FDA for XIENCE Sierra, the newest generation of its gold-standard coronary stent system, which offers design and technology advances to provide an easier implant and greater ability to treat complex blockages. During the quarter, XIENCE Sierra also received national reimbursement in Japan to treat people with coronary artery disease.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZER PFO Occluder and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation. In July, Abbott announced U.S. FDA approval for a next-generation version of MitraClip, with an enhanced design that provides even greater precision and accuracy.

In Diabetes Care, where sales increased 39.8 percent on a reported basis and 33.6 percent on an organic basis, growth was led by continued rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring (CGM) system, which removes the need for routine fingersticks1 for people with diabetes.

ABBOTT’S FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott projects 2018 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.34 to $1.40.

Abbott forecasts net specified items for the full year 2018 of approximately $1.51 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses.

Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $2.85 to $2.91 for the full year 2018.

Abbott is issuing third-quarter 2018 guidance for diluted earnings per share from continuing operations under GAAP of $0.32 to $0.34. Abbott forecasts specified items for the third quarter 2018 of $0.41 primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.73 to $0.75 for the third quarter.

ABBOTT DECLARES 378TH CONSECUTIVE QUARTERLY DIVIDEND

On June 8, 2018, the board of directors of Abbott declared the company’s quarterly dividend of $0.28 per share. Abbott’s cash dividend is payable Aug. 15, 2018, to shareholders of record at the close of business on July 13, 2018.

Abbott has increased its dividend payout for 46 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

Clovis Oncology to Announce Second Quarter 2018 Financial Results and Host Webcast Conference Call on August 1

On July 18, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its second quarter 2018 financial results on Wednesday, August 1, 2018, after the close of the U.S. financial markets (Press release, Clovis Oncology, JUL 18, 2018, View Source [SID1234527759]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss second quarter 2018 results on August 1 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s website at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 9289064.

Atossa Genetics Announces Intraductal Microcatheter ImmunoOncology Pre-Clinical Program

On July 18, 2018 Atossa Genetics Inc. (ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it is advancing its intraductal microcatheter immunotherapy program with pre-clinical studies being conducted by Translational Drug Development, LLC ("TD2") (Press release, Atossa Genetics, JUL 18, 2018, View Source [SID1234527758]). The purpose of the initial study is to develop and validate preclinical methods of using Atossa’s proprietary intraductal microcatheter technology to administer immunotherapy to the site of tumor initiation.

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"While there has been recent success treating blood cancers with chimeric antigen receptor therapy (or, CAR-T), there has not been much success using CAR-T to treat solid tumors like breast cancer," commented Steve Quay, Ph.D., MD, President and CEO of Atossa. "We are, however, encouraged by a recent case study reported June 4, 2018 in Nature Medicine (N. Zacharakis, et al.), in which a patient with metastatic breast cancer who was not responding to chemotherapy had complete tumor regression 22 months after being treated with an intravenous infusion of eighty billion T-cells and interleukin. We believe our proprietary intraductal microcatheter technology may provide a unique and more efficacious and cost-effective treatment method by delivering a significantly smaller number of T-cells directly to the site of the cancer prior to metastasis, rather than through the blood stream, where they are diluted into the entire body. These studies are the first of several steps to develop our intraductal microcatheter technology to treat breast cancer with cell-based immunotherapy, such as CAR-T. These pre-clinical studies will form the basis for the design of human studies, with the ultimate goal of treating breast cancer by administering an immunotherapy with our proprietary microcatheter technology," added Dr. Quay.

The studies are being conducted for Atossa by Translational Drug Development, LLC, which is an oncology development organization that provides innovative services and is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases.

FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC)

On July 18, 2018 FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC) .Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Hoffmann-La Roche, JUL 18, 2018, View Source [SID1234527752]). The designation is based on data from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin.

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"Hepatocellular carcinoma is an aggressive cancer with limited treatment options and a major cause of cancer deaths worldwide," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Preliminary data from the combination of Tecentriq and Avastin in this disease are promising and we look forward to working with health authorities to make this potential treatment regimen available to people with hepatocellular carcinoma as soon as possible."

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. This is the 22nd Breakthrough Therapy Designation for Roche’s portfolio of medicines and the 3rd for Tecentriq.

Roche presented data from a Phase Ib study in HCC at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, in June 2018. These data showed that after a median follow-up of 10.3 months, responses (independent review facility (IRF) per RECIST v1.1) were seen in 15 (65 percent) of 23 efficacy-evaluable patients. Responses were seen in all subgroups, including on the basis of the cause of their disease (etiology: Hepatitis B, Hepatitis C, and non-viral), region (Asia excl. Japan or Japan/US), baseline alpha-fetoprotein levels (high/low) or spread of tumour beyond the liver (yes/no). Assessment by investigators (INV) assessed per RECIST v1.1 demonstrated a response rate of 61 percent (14 out of 23 patients). Median progression free survival (PFS), duration of response (DOR), time to progression (TTP) and overall survival (OS) have not yet been reached after a median follow-up of 10.3 months; results will be presented at a future medical congress when updated data from an expanded cohort are available. In the safety-evaluable population (n=43), 28 percent of patients (n=12) experienced Grade 3-4 treatment-related adverse events and no treatment-related Grade 5 adverse events were observed. No new safety signals were identified beyond the established safety profiles for the individual medicines. Roche provided additional data per FDA request and the Breakthrough Therapy Designation has been granted based on the totality of these data.

Earlier this year, Roche initiated IMbrave150 (NCT03434379), an open-label, multicentre, randomised Phase III study investigating the combination of Tecentriq and Avastin versus sorafenib in people with previously-untreated (first-line) locally advanced, unresectable or metastatic HCC. This study is currently enrolling. Further information about the trial can be found on clinicaltrials.gov.

About the Phase Ib study (NCT02715531)
This Phase Ib, open-label, multicentre study is evaluating the safety and clinical activity of a number of cancer immunotherapy combinations in different solid tumours, including Tecentriq and Avastin in patients with advanced, unresectable or metastatic first-line HCC (Arm A). Participants in Arm A receive Tecentriq (1200 mg) and Avastin (15 mg/kg) intravenously (IV) every three weeks until loss of clinical benefit or unacceptable toxicity. The primary objectives of Arm A are to assess the clinical activity, based on objective response rate (ORR) assessment by independent review facility (IRF) per RECIST v1.1 and to assess the safety and tolerability of the combination. Secondary efficacy endpoints include objective response rate (ORR) by investigator assessment (INV), as well as progression-free survival (PFS), duration of response (DOR), time to progression (TTP) all by INV and IRF per RECIST v1.1; and overall survival (OS).

About Hepatocellular Carcinoma (HCC)
Liver cancer is the second most common cause of cancer death globally1 and HCC is the most common primary malignancy of the liver. Globally, HCC is the fifth most common cancer in men and the seventh most common cancer among women, with over half a million new cases diagnosed annually1. HCC develops predominantly in those people with cirrhosis due to chronic hepatitis B or C2.

About IMbrave150 (NCT03434379)
IMbrave150 is a Phase III, multicentre, randomised, open-label study enrolling approximately 480 people with untreated advanced, unresectable or metastatic HCC 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq will be administered IV, 1200mg on day 1 of each 21-day cycle and Avastin will be administered IV, 15mg/kg on day 1 of each 21-day cycle. Sorafenib will be administered by mouth, 400mg twice per day, on days 1-21 of each 21-day cycle. Participants will receive the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints are OS and investigator-assessed ORR. Secondary endpoints include investigator-assessed PFS, TTP, DOR and IRF-assessed ORR, PFS, TTP and DOR.

About the Tecentriq (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support the use of Tecentriq and Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Avastin (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasize).