On May 8, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2018 second quarter ended March 31, 2018 (Press release, Arrowhead Research Corporation, MAY 8, 2018, View Source [SID1234526230]). The company is hosting a conference call at 4:30 p.m. EDT to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 2895628.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 2895628.

Selected Fiscal 2018 Second Quarter and Recent Events

Strengthened the balance sheet with an equity financing yielding gross proceeds of $60.4 million

Received orphan drug designation from the United States Food and Drug Administration (FDA) for ARO-AAT, Arrowhead’s second-generation investigational medicine for the treatment of a rare genetic liver disease associated with alpha-1 antitrypsin deficiency

Initiated dosing in AROAAT1001 (NCT03362242), a Phase 1 single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and effect of ARO-AAT on serum alpha-1 antitrypsin levels in healthy adult volunteers

Initiated dosing in AROHBV1001 (NCT03365947), a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, and to evaluate the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV

Presented clinical data on ARC-520, the company’s prior generation investigational medicine for the treatment of chronic hepatitis B infection, at The International Liver Congress 2018 (ILC), the annual meeting of the European Association for the Study of the Liver (EASL), including the following key results:

Multiple doses of ARC-520 resulted in s-antigen reductions in all patients by as much as 5.3 Log10

Where measurable, multi-log reductions were also seen in e-antigen, core-related antigen, DNA and HBV RNA

One e-antigen negative patient, while remaining on entecavir, serocleared for all measurable viral markers including s-antigen, core-related antigen, HBV RNA, and HBV DNA. We believe this will represent a functional cure

2 out of 3 e-antigen positive and 2 out of 5 e-antigen negative patients, or half of the patients in the study, achieved productive and sustained host responses. These were characterized by mild ALT elevations coinciding with continued reductions in various viral markers which persisted after ARC-520 therapy was removed

Two patients that experienced sustained host responses but had not yet serocleared, appear poised to potentially seroclear if the trends in the decrease of viral markers continues

Presented preclinical data on both ARO-AAT and ARO-HBV at EASL

Made continued progress on the emerging pipeline of RNAi therapeutics developed using the Targeted RNAi Molecule (TRiMTM) platform including:

The cardiometabolic pipeline, which includes ARO-APOC3, targeting apolipoprotein C-III (ApoC3), and ARO-ANG3, targeting angiopoietin-like protein 3 (ANGPTL3)

The pulmonary pipeline, which includes ARO-ENaC, formerly called ARO-Lung1, which is an inhaled RNAi therapeutic targeting the epithelial sodium channel alpha subunit (aENaC) for the treatment of cystic fibrosis

ARO-HIF2 for the treatment of clear cell renal cell carcinoma

On May 8, 2018 TESARO, Inc., an oncology-focused biopharmaceutical company, reported results from a TESARO-sponsored Europe-wide literature review examining the views of both patients and physicians on the communication and treatment needs in the care of women with ovarian cancer (Press release, TESARO, MAY 8, 2018, View Source [SID1234526246]). The comprehensive review confirms that the psychosocial effects of ovarian cancer play a significant part in a woman’s quality of life. The review, ‘Our Way Forward – Ovarian Cancer in Europe’ draws data from approximately 65 publications and patient surveys, spanning the last 15 years.

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The ‘Our Way Forward – Ovarian Cancer in Europe’ literature review is part of TESARO’s commitment to ovarian cancer as exemplified by the Our Way Forward program, an initiative that was launched in the U.S. last year. The review is the first step towards supporting the development of patient-focused information tools and bringing the debate in ovarian cancer higher up the medical and political agenda. The review was conducted with guidance and input from European and global patient advocacy organizations, with support by TESARO, under its Our Way Forwardprogram. Our Way Forward was created by TESARO, Inc. with input from the National Ovarian Cancer Coalition (NOCC) and the Ovarian Cancer Research Fund Alliance (OCRFA). The program was launched in June of 2017 and is a call-to-action for ovarian cancer patients, their loved ones and healthcare providers to rethink how they talk about advanced ovarian cancer and ways to partner together to navigate the physical and emotional challenges that the disease brings.

Orlando Oliveira, Senior Vice President and General Manager, TESARO International, explains "TESARO is committed to offering resources to educate, empower and support those affected by ovarian cancer. There is clearly a need for better information and enhanced dialogue around the care of women with ovarian cancer in Europe, as well as new treatments that don’t impair quality of life. Through Our Way Forward and strong collaboration with the patient advocacy community, we aim to help support women with ovarian cancer to speak out and bring their needs to the attention of those that can make a difference, so both their psychological and physical needs can be met, every step of the way."

According to the findings from the literature review, ovarian cancer is frequently diagnosed late,3 leading to urgency in treatment and little time for healthcare professionals (HCPs) to consider the psychological aspects of care.4 The psychological impact of cancer can have a significant impact on treatment outcomes as 80% of women experienced poor mental health2 and patients with depression and anxiety are at a significantly greater risk of mortality, hospitalization and poorer treatment outcomes.5

Despite this, women feel they receive information about the tangible and practical aspects of treatment, but much less so for the psychosocial aspects of the disease and how to cope.4 Women are also less likely to bring the topic up with their HCPs as most women feel uncomfortable raising psychological and emotional concerns during their appointment as they are concerned about taking up too much time.1 As a result, women with ovarian cancer feel isolated, with little support, and feel the need for more information.4

Elisabeth Baugh, Chair, World Ovarian Cancer Coalition, explains that "As the leading global ovarian cancer patient advocacy organization, the World Ovarian Cancer Coalition is pleased to support the release today of this important research undertaken as part of TESARO’s Our Way Forward program. The focus of this work on improving both physical and psychological outcomes for women with ovarian cancer, in Europe and around the world is welcomed, especially as it complements our own World Ovarian Cancer Coalition’s Every Woman Study findings. As we celebrate World Ovarian Cancer Day 2018, the Coalition is pleased to work with all partners on this important day to highlight the struggles that ovarian cancer patients face."

The review also revealed that the ovarian cancer patient journey is fragmented and unpredictable, leading to considerable fear for disease recurrence. Ovarian cancer recurs in approximately 85% of women with advanced ovarian cancer6 and this is at the very top of mind for ovarian cancer survivors. The review also revealed women with recurrent ovarian cancer are not receiving the same level of support as those who are newly diagnosed, with one study showing that for 53% of patients, no one had discussed symptoms of recurrence, and 63% of nurses claim they don’t have the time do so.2

Recurrence of ovarian cancer also takes a psychological toll with 60% of women with recurrence reporting they can do less than they wanted to do because of their emotional status (versus 16% of women without recurrence) and 66% of women with recurrence reporting having trouble concentrating (versus 26% of women without recurrence).7

An important psychological aspect of treatment in relation to allaying fears of recurrence is a discussion around treatment options. Patients need to make a critical trade-off between efficacy and quality of life. This, however, is often under-addressed by their healthcare team. The review revealed that 86% of patients said they would be willing to try a drug that could improve the quality of their life even if it may not prolong it.8

This is the first phase of the ‘Our Way Forward – Ovarian Cancer in Europe’ review, with a second-phase review of the literature planned with healthcare providers to provide a 360-degree picture of the current treatment journey. The full review will offer fresh insights that will support advocacy groups in amplifying the voice of women with ovarian cancer by helping in the development of resources and tools for these women.

On May 8, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that management will present at the Deutsche Bank’s 43rd Annual Health Care Conference in Boston, MA, on Tuesday, May 8th, at 2:10 pm EDT (Press release, Athenex, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347628 [SID1234526264]).

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The presentation will be webcasted, and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until August 6, 2018.

On May 8, 2018 Endo International plc (NASDAQ: ENDP) reported first-quarter 2018 financial results, including (Press release, Endocrine Pharmaceuticals, AUG 8, 2018, View Source [SID1234526280]):

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Revenues of $701 million, a 32 percent decrease compared to first-quarter 2017 revenues of $1,038 million.
Reported net loss from continuing operations of $498 million compared to first-quarter 2017 reported net loss from continuing operations of $165 million.
Reported diluted loss per share from continuing operations of $2.23 compared to first-quarter 2017 reported diluted loss per share from continuing operations of $0.74.
Adjusted income from continuing operations of $151 million compared to first-quarter 2017 adjusted income from continuing operations of $275 million.
Adjusted diluted EPS from continuing operations of $0.67 compared to first-quarter 2017 adjusted diluted EPS from continuing operations of $1.23.
Adjusted EBITDA of $334 million compared to first-quarter 2017 adjusted EBITDA of $478 million.
"Endo delivered strong first-quarter operating results in our core focus areas as revenue growth accelerated for both our XIAFLEX franchise and Sterile Injectable business. We are currently on target to meet the full-year financial guidance we provided earlier this year," said Paul Campanelli, President and CEO of Endo. "Importantly, we continue to execute our multi-year turnaround plan and build our portfolio for the future by advancing our CCH cellulite treatment development program with the initiation of and recruitment for two pivotal Phase 3 trials. In addition, as we recently announced, we expect to significantly enhance our Sterile Injectables pipeline through the acquisition of Somerset Therapeutics."

On May 8, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will release its financial and operating results for the first quarter of 2018, ended March 31, 2018, on Tuesday, May 15, 2018, after the close of the U.S. financial markets (Press release, Oncocyte, MAY 8, 2018, View Source [SID1234526200]). The Company will host a conference call on Tuesday, May 15, 2018, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 800-263-0877; for international participants, the number is +1-323-794-2094. For all callers, please refer to Conference ID 6365614. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 6365614. Additionally, the archived webcast will be available at View Source