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

On May 8, 2018 SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended March 31, 2018, and provided an update on recent operational and clinical developments (Press release, Scynexis, MAY 8, 2018, View Source [SID1234526231]).

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"The first quarter of 2018 was one of significant clinical progress in what has the potential to be a transformative year for SCYNEXIS with multiple anticipated milestones," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We remain on track to report top-line data from the Phase 2b, dose-finding study evaluating oral SCY-078 for the treatment of vulvovaginal candidiasis (VVC) by July 2018, with Phase 3 initiation planned for the fourth quarter. We also anticipate continued progress toward expanding the therapeutic utility of SCY-078 with the planned initiation of clinical trials in invasive candidiasis and invasive aspergillosis in the second half of the year, as well as the advancement of our programs targeting refractory invasive fungal infections. We are well-positioned to realize the promise of SCY-078 as a potent and versatile antifungal agent."

Clinical and Regulatory Update for Lead Program – SCY-078 as a Treatment for VVC

In May 2018, SCYNEXIS announced it has completed enrollment in the Phase 2b, dose-finding study of oral SCY-078 for the treatment of VVC (the DOVE study). SCYNEXIS is on-track to announce top-line data by July 2018. Following successful dose-identification from this trial, SCYNEXIS plans to initiate a Phase 3 registration program of oral SCY-078 in VVC in the fourth quarter of 2018, with potential NDA filing for VVC expected in 2020.
In May 2018, SCYNEXIS announced the receipt of Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of VVC and prevention of recurrent VVC. The QIDP designation allows SCYNEXIS to have priority review and an additional five years of market exclusivity in the U.S. for SCY-078. The FDA’s Fast Track Drug Development Program is a process designed to facilitate the development and expeditious review of drugs to treat serious conditions and fill unmet medical needs.
Continued Advancement of IV SCY-078 Program with Liposomal Formulation

Pre-clinical work on the liposomal IV formulation of SCY-078 continues, and SCYNEXIS remains on track to initiate a Phase 1 trial evaluating the safety and tolerability of this formulation in healthy volunteers in the third quarter of 2018.
If successful, following completion of the Phase 1 study and pending FDA review, SCYNEXIS plans to initiate a Phase 2b, IV-oral step-down study of SCY-078 in invasive candidiasis patients with the liposomal IV and oral formulations of SCY-078 in the fourth quarter of 2018.
Pre-clinical Data Support Continued Development of SCY-078 for Invasive Fungal Infections

In April 2018, at the 28thEuropean Congress of Clinical Microbiology and Infectious Disease (ECCMID), SCYNEXIS presented pre-clinical data demonstrating SCY-078’s potent antifungal activity against Aspergillus spp., including azole-resistant isolates, as well as synergistic activity with approved antifungals against Aspergillus strains. Additionally, SCYNEXIS presented in vivo data in a mouse model of Pneumocystis pneumonia that demonstrated the activity of SCY-078 as determined by improved survival and reduction of fungal burden, supporting future development for prophylaxis indications.
In March 2018, at Superbugs and Superdrugs 2018, SCYNEXIS presented pre-clinical data demonstrating the inhibitory effect of SCY-078 against Candida auris biofilms, as well as SCY-078’s ability to affect the ultrastructure of C. auris cells and interrupt cell division.
In February 2018, at the 8th Advances Against Aspergillosis, SCYNEXIS presented new pre-clinical data demonstrating synergistic in vivo activity and improved outcomes of SCY-078 in combination with isavuconazole for the treatment of invasive pulmonary aspergillosis. The Company plans to initiate a Phase 2 study in the third quarter of 2018 to test the clinical efficacy of oral SCY-078 in combination with standard of care for the treatment of invasive aspergillosis.
All posters and presentations are available on the Scientific Publications page of the SCYNEXIS website.
Corporate Update

In April 2018, SCYNEXIS received confirmation of the renewal of its Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA). With this designation, SCYNEXIS is eligible to receive financial incentives, regulatory fee reductions and waivers, and European Union funding. SCYNEXIS remains committed to the European market and has designed its registration programs such that concurrent FDA and EMA approvals would be possible. European sites are actively enrolling in the FURI study, a global, open-label study, designed to evaluate oral SCY-078 for the treatment of fungal infections that are refractory to or intolerant of standard therapies.
On March 8, 2018, SCYNEXIS raised $30.0 million in gross proceeds by issuing 17,751,500 shares of the Company’s common stock and two series of warrants to purchase up to an aggregate of 21,301,800 shares of the Company’s common stock. The offering resulted in approximately $27.9 million of net proceeds after deducting the underwriting discount and estimated offering expenses.
First Quarter 2018 Financial Results

Cash and cash equivalents and short-term investments totaled $63.7 million as of March 31, 2018, with net working capital of $53.5 million.

Research and development expenses increased to $5.3 million in the first quarter of 2018, compared to $4.0 million in the first quarter of 2017. The increase of $1.3 million, or 33%, was primarily driven by an increase of $0.7 million in pre-clinical development expense, a $0.7 million increase in clinical development expense, a $0.4 million increase in chemistry, manufacturing, and controls (CMC), and a net increase of $0.2 million in other research and development costs; offset by a decrease in consulting expense of $0.7 million.

Selling, general and administrative expenses of $2.0 million in the first quarter of 2018 were consistent compared to the selling, general and administrative expenses of $2.1 million in the first quarter of 2017.

Total other income increased to $3.2 million in the first quarter of 2018 due to a $3.6 million non-cash gain recorded on the fair value adjustment of the warrant liabilities.

Net loss for the first quarter of 2018 was $4.0 million, or $0.12 basic net loss per share. This compares to a net loss for the first quarter of 2017 of $4.9 million, or $0.19 basic net loss per share.