On July 28, 2016 Cytokinetics, Inc. (Nasdaq:CYTK) reported total revenues for the second quarter of 2016 were $5.8 million, compared to $6.5 million, during the same period in 2015 (Press release, Cytokinetics, JUL 28, 2016, View Source;p=RssLanding&cat=news&id=2189723 [SID:1234514112]). The net loss for the second quarter was $11.6 million, or $0.29 per basic and diluted share. This is compared to the net loss for the same period in 2015 of $10.6 million, or $0.27 per basic and diluted share. As of June 30, 2016, cash, cash equivalents and investments totaled $98.0 million.

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"We had a productive quarter advancing key clinical, regulatory and commercial planning initiatives across our portfolio of muscle-biology directed drug candidates," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Our recently expanded collaboration with Astellas aligns our interests with regard to tirasemtiv and ALS and provides a path forward for our two skeletal muscle activators as potential treatments for ALS. Toward that objective, we expect that VITALITY-ALS will soon conclude patient enrollment, a major milestone for our Phase 3 clinical trial of tirasemtiv in patients with ALS. We also continue to prepare for the start of a potential Phase 3 development program for omecamtiv mecarbil in collaboration with Amgen. These are especially promising and hopeful times at Cytokinetics as our programs advance towards late-stage milestones."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil

Announced the start of a double-blind, randomized, placebo-controlled, multi-center Phase 2 clinical trial to evaluate the safety, pharmacokinetics and efficacy of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction.
Presented a poster titled "COSMIC-HF: Improved Contractility and Evolution of Ventricular Remodeling through Time" at Heart Failure 2016, the annual congress of the Heart Failure Association of the European Society of Cardiology. The results indicated that omecamtiv mecarbil improved left ventricular (LV) systolic function, LV end-diastolic volume and NT-proBNP over time, suggesting potentially favorable ventricular remodeling and progressive reduction in myocardial wall stress.
Participated with Amgen in additional regulatory interactions with the FDA, EMA and Health Canada to inform the design and conduct of a potential Phase 3 development program for omecamtiv mecarbil.
Conducted clinical, regulatory, non-clinical and commercial planning activities in collaboration with Amgen to support the potential advancement of omecamtiv mecarbil to a Phase 3 development program.
Expect to make a decision regarding the advancement of omecamtiv mecarbil to Phase 3 in the third quarter of 2016.
Skeletal Muscle Program

tirasemtiv

Recently announced that we have granted Astellas an option right for the development and commercialization of tirasemtiv outside of North America, Europe and other select countries.*
Completing screening of patients in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an ongoing, international Phase 3 clinical trial designed to assess the effects of tirasemtiv versus placebo on slow vital capacity (SVC) and other measures of skeletal muscle strength in patients with ALS.
Expect to complete enrollment of VITALITY-ALS in August 2016. Expect data from VITALITY–ALS in the second half of 2017.
Conducted regulatory interactions with each of FDA and EMA to inform the design and conduct of an open-label extension clinical trial for patients who complete VITALITY-ALS.

Expect to begin an open-label extension trial for patients who complete VITALITY-ALS in the fourth quarter of 2016.
CK-2127107

Recently announced that we have amended our collaboration agreement with Astellas to enable the development of CK-2127107 for the potential treatment of ALS.*

Continued enrollment of the ongoing Phase 2 clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA) in collaboration with Astellas.

Expect to complete enrollment of Cohort 1 in the Phase 2 clinical trial of CK-2127107 in patients with SMA in the second half of 2016. Expect data from this clinical trial in first half of 2017.
Announced the start of a Phase 2 clinical trial of CK-2127017 in patients with COPD. Expect to complete enrollment and to analyze data from this clinical trial in 2017.
Pre-Clinical Research

Continued research activities under our joint research program with Amgen directed to the discovery of next-generation cardiac muscle activators and under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators. In addition, company scientists continued independent research activities directed to our other muscle biology programs.

Recently announced that we have extended our joint research program with Astellas focused on the discovery of next-generation skeletal muscle activators through 2017.*

Anticipate potential advancement of one next-generation compound from a joint research program into pre-clinical development during 2016.
Corporate

Expect to receive $65 million in committed capital from Astellas which includes upfront payments for Astellas’ option right exercisable for tirasemtiv and amended terms of the companies’ collaboration agreement to include ALS for CK-2127107. In addition, Cytokinetics expects to receive approximately $30 million in additional sponsored research and development funding through 2017 from Astellas.*
Received 2016 Essey Commitment to a Cure Award from the ALS Association Golden West Chapter.
Announced appointment of Edward M. Kaye, M.D. to Cytokinetics Board of Directors.

Appointed Caryn McDowell, Cytokinetics’ General Counsel as Chief Compliance Officer.

Rang the closing bell at NASDAQ accompanied by leaders of the ALS Association in recognition of ALS Awareness month and the company’s commitment to education, awareness, research and development activities focused to amyotrophic lateral sclerosis (ALS).
* The effectiveness of the amended agreement with Astellas is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Financials

Revenues for the second quarter of 2016 were $5.8 million, compared to $6.5 million during the same period in 2015. Revenues for the second quarter of 2016 included $2.9 million of research and development revenues and $1.9 million of license revenues from our collaboration with Astellas, $0.6 million in research and development revenues from our collaboration with Amgen and $0.3 million in research and development revenues from our collaboration with ALSA. Revenues for the same period in 2015 were comprised of $3.0 million of license revenues and $2.9 million of research and development revenues from our collaboration with Astellas, and $0.6 million of research and development revenues from our collaboration with Amgen. The decrease in revenues for the second quarter of 2016, compared with the same period in 2015, was mainly due to timing of license revenue recorded under the Astellas collaboration agreement, due to the extension of the timeframe of development services.

Total research and development (R&D) expenses for the second quarter of 2016 were $9.7 million, compared to $12.6 million for the same period in 2015. The $2.9 million decrease in R&D expenses for the second quarter of 2016, compared with the same period in 2015, was primarily due to a decrease of $2.3 million in outsourced preclinical costs associated with clinical manufacturing activities, and a decrease of $1.7 million in outsourced clinical costs, partially offset by an increase of $1.3 million in personnel related expenses due to increased headcount costs. The decrease in outsourced clinical costs was comprised of an increase of $2.8 million in outsourced clinical costs mainly associated with the ongoing VITALITY-ALS trial, offset by a $4.5 million litigation settlement in June 2016 from a contract research organization for our Phase 2 BENEFIT-ALS clinical trial which was concluded in 2014.

Total general and administrative (G&A) expenses for the second quarter of 2016 were $7.1 million compared to $4.5 million for the same period in 2015. The $2.6 million increase in G&A expenses for the second quarter of 2016, compared to the same period in 2015, was primarily due to an increase of $1.1 million in personnel related expenses due to increased non-cash stock compensation expense and increased headcount, an increase of $0.7 million in outsourced costs related to accounting and finance and commercial development, and an increase of $0.8 million in corporate and patent legal fees.

Revenues for the six months ended June 30, 2016 were $14.2 million, compared to $11.0 million for the same period in 2015. Revenues for the first six months of 2016 included $6.6 million of research and development revenues and $5.9 million of license revenues from our collaboration with Astellas, $1.2 million of research and development revenues from our collaboration with Amgen, and $0.5 million in research and development revenues from our collaboration with ALSA. Revenues for the same period in 2015 included $5.0 million of research and development revenues and $4.7 million of license revenues from our collaboration with Astellas, and $1.3 million of research and development revenues from our collaboration with Amgen.

Total R&D expenses for the six months ended June 30, 2016 were $23.3 million, compared to $21.6 million for the same period in 2015. The $1.7 million increase in R&D expenses in the first six months of 2016, over the same period in 2015, was primarily due to an increase of $2.4 million in outsourced clinical costs and an increase of $2.3 million in personnel related expenses due to increased headcount, partially offset by a decrease of $2.9 million in outsourced preclinical costs associated with clinical manufacturing activities. The increase in outsourced clinical costs was comprised of an increase of $6.9 million in outsourced clinical costs mainly associated with the ongoing VITALITY-ALS trial, offset by a $4.5 million settlement in June 2016 with a contract research organization for our Phase 2 BENEFIT-ALS clinical trial which was concluded in 2014.

Total G&A expenses for the six months ended June 30, 2016 were $13.9 million, compared to $8.9 million for the same period in 2015. The $5.0 million increase in G&A spending in the first six months of 2016 compared to the same period in 2015, was primarily due to an increase of $2.1 million in personnel related expenses due to increased non-cash stock compensation expense and increased headcount, an increase of $1.3 million in outsourced costs related to accounting and finance and commercial development, and an increase of $1.4 million in corporate and patent legal fees.

The net loss for the six months ended June 30, 2016, was $24.1 million, or $0.61 per basic and diluted share, compared to a net loss of $19.4 million, or $0.50 per basic and diluted share, for the same period in 2015.

Financial Guidance

We will not update our financial guidance until our Q3 Earnings due to the recent expansion of our collaboration with Astellas; at that time we expect to provide updated 2016 financial guidance on both a cash and GAAP basis.

On July 28, 2016 Novocure (NASDAQ:NVCR), a commercial stage oncology company pioneering a novel therapy for solid tumors, reported financial results for the quarter ended June 30, 2016, highlighting year-over-year growth in prescriptions, active patients and reported revenues (Press release, NovoCure, JUL 28, 2016, View Source [SID:1234514114]). Second quarter 2016 highlights include:

Three months ended June 30,
2016 2015 % change
Non-financial
Prescriptions received in period(1) 657 428 54 %
Active patients at period end(2) 891 425 110 %

Financial, in millions (unaudited)
Revenues(3) $ 17.9 $ 6.5 174 %
Net loss $ (40.6 ) $ (29.4 )

Cash and cash equivalents at the end of period $ 80.9 $ 106.5
Short-term investments at the end of period $ 120.0 $ 57.0

(1) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Tumor Treating Fields (TTFields) therapy for a patient not previously on TTFields therapy. Orders to renew or extend treatment are not included in this total. In the future, we may have regulatory approvals and commercial programs for multiple clinical indications, at which time we will recognize a commercial order as a prescription for the same patient for each clinical indication treated. For example, in the future, a patient may have a prescription for the treatment of lung cancer and a prescription for the treatment of brain metastases from the lung cancer. (2) An "active patient" is a patient who is on TTFields therapy under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days. (3) For the reported periods, all revenues were recognized when cash was collected and all other revenue recognition criteria had been met. "Year-over-year prescription, active patient and revenue growth continues and I am proud of the progress we have made since the FDA approval of Optune for newly diagnosed GBM in October 2015. We finished the quarter with 547 prescriptions in the United States and 110 in our ex-U.S. markets," said Asaf Danziger, Chief Executive Officer. "While barriers to full adoption remain, I am optimistic we will overcome the challenges inherent in bringing a completely new therapy into widespread clinical use." "Earlier this week, the National Comprehensive Cancer Network, or NCCN, updated its clinical practice guidelines to add Optune plus temozolomide as a Category 2A treatment option for newly diagnosed GBM. Optune is transforming the standard of care for glioblastoma," continued Mr. Danziger. "Also this month, we received FDA approval for the smaller, lighter second generation Optune System which aims to make Optune therapy even easier for patients. And, later this year, we will publish additional clinical trial data further demonstrating the benefits of Optune therapy for GBM patients." "Optune is the first therapy to demonstrate an improvement in overall survival for newly diagnosed GBM patients in more than a decade and we are committed to bringing this therapy to patients who have such a vital need for improved treatment options," concluded Mr. Danziger. "Scientific evidence suggests TTFields therapy is broadly applicable to solid tumors; and our R&D team continues to make progress toward developing TTFields for additional tumor types," said William Doyle, Executive Chairman. "In the past three months, we enrolled the last patients in our PANOVA and INNOVATE phase 2 pilot trials in advanced pancreatic cancer and recurrent ovarian cancer, respectively, and received FDA approval of our IDE application to initiate our METIS phase 3 pivotal trial in brain metastases." "Recent findings strengthen our belief that treatment with TTFields is compatible with both current standards of care and emerging novel therapies for a variety of solid tumors and we are excited to share data from multiple indications at our R&D day in December," continued Mr. Doyle. "We believe that TTFields, with the potential of superior outcomes and no systemic toxicity, will play a valuable role in the solid tumor treatment paradigm." 2016 Second Quarter Operating Statistics and Financial Update Prescriptions in the quarter ended June 30, 2016, increased by 229 prescriptions, or 54 percent, compared to the same period in 2015. The increase in prescriptions was driven primarily by commercial activities in the United States after the October 2015 U.S. Food and Drug Administration (FDA) approval of Optune for the treatment of newly diagnosed glioblastoma (GBM), increased commercial activities in Germany, and enhanced awareness of Optune following the December 2015 publication of EF-14 phase 3 pivotal trial results in the Journal of the American Medical Association.
In the United States, 547 prescriptions were received in the quarter ended June 30, 2016, an increase of 157 prescriptions, or 40 percent, compared to the same period in 2015.

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In Germany and other EMEA markets, 110 prescriptions were received in the quarter ended June 30, 2016, an increase of 72 prescriptions, or 189 percent, compared to the same period in 2015.

There were 891 active patients on Optune therapy at June 30, 2016, an increase of 466 active patients, or 110 percent, compared to June 30, 2015. The increase in active patients was driven both by prescription growth and by an increase in the percentage of newly diagnosed GBM patients who started Optune in prior periods. The portion of Optune prescriptions for newly diagnosed GBM was more than 50 percent in the second quarter of 2016.

In the United States, there were 736 active patients on Optune therapy at June 30, 2016, an increase of 345 active patients, or 88 percent, compared to June 30, 2015.

In Germany and other EMEA markets, there were 155 active patients on Optune therapy at June 30, 2016, an increase of 121 active patients, or 356 percent, compared to June 30, 2015.

We continued to expand coverage of Optune for the treatment of newly diagnosed and/or recurrent GBM in the second quarter of 2016 to include more than 10 million additional lives through new policies with Blue Cross Blue Shield of Michigan, Emblem Health, Blue Cross Blue Shield of Minnesota, and Group Health Cooperative Washington and Idaho. This brought the total number of covered lives to approximately 116 million in the United States as of June 30, 2016. For the three months ended June 30, 2016, revenues increased to $17.9 million compared to $6.5 million for the same period in 2015, representing 174 percent growth.

This growth was primarily driven by increased Optune adoption. For the three months ended June 30, 2016, cost of revenues, excluding impairment of field equipment, increased to $9.8 million compared to $4.8 million for the same period in 2015, representing 106 percent growth. This was primarily driven by an increase in active Optune patients, resulting in increased transducer array shipment costs and increased field equipment depreciation expenses, as well as increased personnel costs to establish infrastructure necessary to support an increasing volume of shipments to patients. We received FDA approval to market our second generation Optune System in the United States on July 13, 2016 and are in the process of converting all patients from the first generation to the second generation Optune System. We are no longer manufacturing the first generation Optune System. For the three months ended June 30, 2016, we recorded a non-cash impairment loss of $6.4 million for the write-off of first generation Optune System field equipment. We plan to convert all patients in the United States from the first generation to the second generation Optune System over the next three months and do not expect an additional material impairment charge in the future. Research, development and clinical trials expenses for the three months ended June 30, 2016, were $11.3 million compared to $12.8 million for the same period in 2015, representing a decrease of 11 percent. This decrease was primarily due to the conclusion of our EF-14 phase 3 pivotal trial in newly diagnosed GBM and reduced expenses related to clinical education and investigator-sponsored trials, partially offset by an increase in personnel costs. Sales and marketing expenses for the three months ended June 30, 2016, were $14.6 million compared to $8.9 million for the same period in 2015, representing growth of 65 percent. This growth was primarily due to increased personnel costs as well as increased marketing expenses to expand commercial operations in the United States and Germany and to establish commercial operations in Switzerland and Japan. General and administrative expenses for the three months ended June 30, 2016, were $13.0 million compared to $7.4 million for the same period in 2015, representing growth of 77 percent. This growth was primarily due to increased personnel costs as well as increased expenses related to professional services and activities associated with being a public company. Personnel costs for the three months ended June 30, 2016, included $5.6 million in non-cash share-based compensation expenses, comprised of $0.2 million in cost of revenues; $0.8 million in research, development and clinical trials; $1.3 million in sales and marketing; and $3.3 million in general and administrative expenses. Total non-cash share-based compensation expenses for second quarter 2015 were $2.6 million. Net losses for the three months ended June 30, 2016, were $40.6 million compared to net losses of $29.4 million for the same period in 2015. As of June 30, 2016, we had $80.9 million in cash and cash equivalents and $120.0 million in short-term investments, for a total balance of $200.9 million in cash, cash equivalents and short-term investments. On June 30, 2016 we provided a drawdown notice for the remaining $75.0 million available under our existing term loan agreement with an investment fund managed by Pharmakon Advisors LP and we received funds from the draw in July 2016. Other recent corporate achievements
NCCN guidelines update: In July 2016, Optune was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Central Nervous Systems Cancers for newly diagnosed GBM. Optune plus temozolomide is now a Category 2A recommendation following standard brain radiation therapy with concurrent temozolomide, and is now a standard treatment option for newly diagnosed patients with GBM.

FDA approval for the second generation Optune system: In July 2016, the U.S. FDA approved our premarket approval (PMA) supplement application for the second generation Optune System. The second generation Optune system is less than half the weight and size of the first generation Optune System and aims to make treatment with Optune even easier for GBM patients.
METIS phase 3 pivotal trial IDE approval: In May 2016, we received FDA approval of our investigational device exemption (IDE) application to initiate our METIS trial. The multi-center, open-label randomized study will test the effectiveness of TTFields following stereotactic radiosurgery (SRS) compared with watchful waiting alone in 270 patients with brain metastases stemming from non-small cell lung cancer.

PANOVA phase 2 pilot data first cohort subgroup analysis: Data from the first cohort of PANOVA, a phase 2 pilot trial in advanced pancreatic cancer, demonstrate that progression free survival and overall survival of patients treated with TTFields combined with gemcitabine were more than double those of gemcitabine-treated historical controls. Subgroup analysis of the first cohort of the PANOVA trial were presented at ASCO (Free ASCO Whitepaper) in June 2016 demonstrating an overall survival benefit of TTFields plus gemcitabine in advanced pancreatic patients. Median overall survival exceeded 15 months in patients with locally advanced pancreatic cancer treated with TTFields therapy combined with gemcitabine.

PANOVA phase 2 pilot trial last patient in: Following the approval of nab-paclitaxel, a taxane-based chemotherapy, for the treatment of advanced pancreatic cancer, we expanded the PANOVA study to include 20 additional patients treated with TTFields in combination with nab-paclitaxel and gemcitabine. We finished enrollment of the second patient cohort in May 2016 and, with six months follow-up, phase 2 pilot data for all 40 patients enrolled in the PANOVA trial is expected to be available for presentation in late 2016.

INNOVATE phase 2 pilot trial last patient in: In October 2014, the INNOVATE trial opened to study TTFields in combination with weekly paclitaxel for patients with recurrent ovarian cancer. We finished enrollment in May 2016 and, with six months follow-up, phase 2 pilot data for all 30 patients is expected to be available for presentation in late 2016.

Preclinical data show additive efficacy of TTFields and PD-1 inhibitors: Results presented at the American Association of Immunologists’ Annual Meeting 2016 demonstrate that TTFields enhance immunogenic cell death in non-small cell lung cancer cells in vivo. Preclinical mouse data suggest combining TTFields with anti-PD-1 may achieve tumor control by further enhancing antitumor immunity.

Research and development day scheduled for December 12, 2016 We will hold a research and development day for analysts and investors on Monday, December 12, 2016, from 1:00 to 4:00 p.m. Eastern Time in New York City. The event will provide analyses from completed clinical trials, including the full 695 patient dataset from the EF-14 trial in newly diagnosed GBM, data from the PANOVA phase 2 pilot trial in advanced pancreatic cancer, and data from the INNOVATE phase 2 pilot trial in recurrent ovarian cancer. In addition, we will provide an update of recent preclinical findings related to TTFields and a review of our ongoing clinical pipeline.

On July 28, 2016 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported the results from a study evaluating the performance of its gene expression profile (GEP) test DecisionDx-Melanoma in a cohort of 356 Stage I and II melanoma patients (Press release, Castle Biosciences, JUL 28, 2016, View Source [SID:1234514115]). The data confirm findings from two previously published multicenter clinical validation studies and further support the test’s a bility to identify patients’ risk of melanoma recurrence in the five years following diagnosis. Results from the study, led by Dr. Laura Ferris, M.D., Ph.D., Associate Professor of Dermatology at the University of Pittsburgh, are being presented in a poster at the 2016 American Academy of Dermatology (AAD) Summer Meeting, and will be reviewed in a poster presentation on Saturday, July 30th at 10:20a.m. EDT.

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"The majority of cutaneous melanoma patients who die from their disease each year are initially diagnosed as ‘low risk’ Stage I or II, highlighting the limitations of current staging methods," said University of Pittsburgh’s Dr. Ferris, lead study author. "Improved methods for identifying cases of early stage, high risk melanoma, such as DecisionDx-Melanoma, could have a marked impact on patient care. For instance, the ability to more accurately identify risk in this population could lead to more appropriate surveillance plans that detect metastatic disease sooner, when the tumor burden is lower and the chance of responding to treatment is greatest."

Multicenter Performance Study
In a study titled "Performance of a Prognostic 31-Gene Expression Profile test to Identify High Risk Stage I and II Melanoma Patients" (Abstract # 4067), 356 Stage I and II cutaneous melanoma tumors from 12 centers in the U.S. were analyzed in a CAP/CLIA-accredited laboratory using the DecisionDx-Melanoma test and classified as either low risk Class 1 or high risk Class 2. Study endpoints included recurrence-free survival (RFS), defined as time to either a regional or distant metastatic event, distant metastasis-free survival (DMFS), defined as time to any metastatic event beyond the regional node, and metastasis-free survival (MSS), defined as time from diagnosis to death documented as specifically resulting from melanoma. Topline results are below:

GEP test identified 71% of early stage melanoma tumors that recurred, 70% of those that metastasized distantly, and 80% of those that died from melanoma;
Using Cox multivariate analysis, GEP test was shown to be a significant predictor of both recurrence (p<0.002) and distant metastasis (p<0.04);
Low risk Class 1 patients in the cohort had negative predictive values for RFS, DMFS, and MSS of 90%, 93% and 99%, respectively;
Class 2 Stage I and II patients experienced rapid time to recurrence and distant metastasis (1.6 years median for both)
"This study, along with previously published data, demonstrates that the DecisionDx-Melanoma test can be used to identify high risk patients that may have been staged as low risk by the current staging system," commented Derek Maetzold, President and CEO of Castle Biosciences. "These results, and the high negative predictive value rates for melanoma-specific survival observed in earlier DecisionDx-Melanoma studies, provide physicians an added level of confidence when developing patients’ disease management plans using results from our GEP test."

About Melanoma
Cutaneous melanoma is diagnosed in approximately 76,000 people in the U.S. each year, according to the American Cancer Society. Seventy-five percent are diagnosed as Stage I or II, meaning there is no evidence of the melanoma spreading beyond the primary tumor. It is not the most prevalent form of skin cancer, but it is the most aggressive. Unlike other more common skin malignancies such as basal cell and squamous cell carcinomas, melanoma often spreads to other parts of the body, either via the lymphatic or blood system, resulting in cancers of distant organs including the brain or lungs. So, while it represents just 4% of skin cancers, melanoma accounts for about 80% of skin cancer-related deaths.

On July 27, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, and The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, reported that research results for a lung cancer diagnostic test being developed by The Wistar Institute and OncoCyte under a license from Wistar have been accepted for an Original Investigation Slide Presentation at the prestigious American College of Chest Physician’s CHEST 2016 annual meeting, which will be held in Los Angeles this October (Press release, BioTime, JUL 27, 2016, View Source;p=RssLanding&cat=news&id=2188711 [SID:1234514058]).

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The Presentation "A Blood Based Non-Small Cell Lung Cancer Diagnostic" will be presented by Louise Showe, Ph.D., professor of Molecular and Cellular Oncogenesis Program at The Wistar Institute and lead scientist on the study. Dr. Showe will report on results of a study that was conducted at Wistar and analyzed 610 human blood samples. Preliminary study results were announced in April of this year. The study replicated a previous study that was carried out at Wistar, the results of which were presented by Wistar at the American Thoracic Society conference in May of 2015.

OncoCyte must now independently validate the current results in its own follow-up study. In this study the Company will examine samples that it is collecting and will analyze them using its own laboratory facility and equipment. OncoCyte anticipates the validation study will begin in August 2016 and will be completed during the fourth quarter of 2016.

If the validation study is successful, OncoCyte intends to implement its commercialization plans with respect to the lung cancer diagnostic test, including hiring a dedicated sales force, building out its commercial infrastructure, and moving towards completion of and obtaining CLIA certification for its own diagnostic laboratory. The Company plans to launch its lung cancer diagnostic test in the first half of 2017.

"The acceptance of the data for presentation at CHEST is another step in validating our approach to diagnosing lung cancer and bringing it closer to commercialization by OncoCyte," said Dr. Showe.

"CHEST’s acceptance of this presentation on the effectiveness of our non-invasive diagnostic for the early detection of lung cancer is a significant development for OncoCyte and Wistar," commented William Annett, Chief Executive Officer of OncoCyte. "Each year there are 160,000 deaths related to lung cancer, in part because there is no effective test to reliably diagnose lung cancer at an early enough stage. We believe that OncoCyte’s non-invasive lung cancer diagnostic could represent an important step forward for patients, doctors and payers by improving outcomes and lowering costs. We look forward to continuing the next steps in the product development process and to providing additional updates in the coming months."

On July 27, 2016 The Medicines Company (NASDAQ:MDCO) reported its business and financial results for the second quarter ended June 30, 2016 (Press release, Medicines Company, JUL 27, 2016, View Source;p=RssLanding&cat=news&id=2188751 [SID:1234514063]).

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During the second quarter of 2016, the Company delivered strong execution against its strategic objectives by driving further advancement of its four potential blockbuster development programs and taking actions that generated non-dilutive capital and strategic and operational flexibility to enable it to continue to unlock the value of these programs.

Key highlights included:

PRODUCT DEVELOPMENT

CARBAVANCE (meropenem-vaborbactam): Announced that Carbavance met both FDA and EMA pre-specified primary endpoints in the Phase 3 TANGO 1 clinical trial in patients with complicated urinary tract infections. Carbavance also demonstrated statistical superiority over piperacillin-tazobactam, with overall success in 98.4% of patients treated with Carbavance, using the FDA primary endpoint. Carbavance was well-tolerated in the trial. This follows the granting of Fast Track status for Carbavance by the Food and Drug Administration (FDA) in April 2016 and the designation of Carbavance as a Qualified Infectious Disease Product, as authorized under the GAIN Act, in 2013. Enrollment is continuing in the Phase 3 TANGO 2 clinical trial, comparing Carbavance’s safety, tolerability, and efficacy with best available therapy in patients with serious infections due to confirmed or suspected CRE. The Company expects to submit a New Drug Application to the FDA in early 2017.

PCSK9si (PCSK9 synthesis inhibitor): Announced completion of patient enrollment ahead of schedule in the Phase 2 ORION-1 clinical trial of PCSK9si, an investigational first-in-class RNA interference proprotein convertase subtilisin/kexin type 9 synthesis inhibitor. Interim three-month and six-month efficacy and safety data from patients in ORION-1 are expected to be available, analyzed and presented before the end of 2016.

MDCO-216: Completed enrollment of more than 100 of 120 total planned patients in the MILANO-PILOT study evaluating MDCO-216’s effects on atherosclerotic plaque burden. Pursuant to the Interim Statistical Analysis Plan governing monitoring by the Independent Data Monitoring Committee (IDMC), an interim safety and efficacy analysis is currently being performed for the first 40 patients who have completed the end of treatment. The interim analysis will be reviewed by the IDMC in August. The Company is blinded and firewalled from all clinical data during the IDMC’s evaluation. If there are no safety concerns that require further evaluation and if pre-defined efficacy criteria are met, the IDMC will provide efficacy data from the first 40 patients to the Company. In any event, the Company expects to provide an update on the MILANO-PILOT trial in August.

ABP-700: Completed Phase 1 clinical pharmacology, dosing and safety studies in more than 300 subjects, including ABP-700’s use with pre- and co-medications routinely given as part of procedural sedation and induction of general anesthesia. In June, the Company dosed the first patient in a Phase 2 clinical trial for procedural sedation. The trial is expected to enroll 75 patients undergoing elective colonoscopies at three sites in The Netherlands. In consultation with the FDA, the Company will perform an additional animal study to support the submission of an Investigational New Drug Application in the United States. We expect to report results from the Phase 2 trial before the end of 2016.

STRATEGIC ACTIONS

Generated non-dilutive capital by completing the sale of the Company’s non-core cardiovascular products (Cleviprex (clevidipine) injection emulsion, Kengreal (cangrelor), and rights to Argatroban for injection) to Chiesi for an initial payment of $264 million in cash plus the potential to receive up to $480 million in sales-based milestone payments.
Continued to implement the previously announced restructuring plan designed to reduce operating expenses and R&D by $65 million to $80 million annually.
Completed the offering and sale of $402.5 million aggregate principal amount of 2.75% convertible notes due 2023 and repurchased $220 million (approximately 80%) of the Company’s 2017 convertible notes.
Continued to build senior management depth with the addition of Tony Kingsley, President and Chief Operating Officer, to help oversee the day-to-day operations and lead the Company’s commercial activities.
"We continue our focus on saving lives, alleviating suffering, and improving the economic efficiency of healthcare, but our purpose has magnified with the scale of the problems we are addressing with our programs and the numbers of patients we can potentially touch," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "Through our execution over the last three quarters we have put ourselves in a position to focus on these big problems with our four core clinical development projects. We expect the pace of our progress to continue through the rest of 2016 with important clinical milestones for PCSK9si, MDCO-216, Carbavance and ABP-700."

Second-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $54.7 million in the second quarter of 2016 compared to $74.5 million in the second quarter of 2015. Included in total net revenue for the second quarter of 2016 was $24.4 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $15.8 million in the second quarter of 2016 compared to $65.6 million in the second quarter of 2015, with net product sales in the United States decreasing to $12.8 million in the second quarter of 2016 from $60.5 million in the second quarter of 2015, driven by the loss of Angiomax exclusivity in July 2015. Other products, including Ionsys, Minocin for Injection, and Orbactiv, along with the recently-divested non-core cardiovascular products, recorded sales of $14.5 million in the second quarter of 2016 compared to $8.9 million in the second quarter of 2015.

The sale of the Company’s non-core cardiovascular products resulted in a gain of $288.3 million, which was recorded in the second quarter of 2016.

Net income from continuing operations in the second quarter of 2016 was $181.8 million, or $2.51 per share, compared to net loss from continuing operations of $67.4 million, or $1.02 per share, in the second quarter of 2015. Adjusted net loss(1) from continuing operations in the second quarter of 2016 was $43.0 million, or $0.62(1) per share, compared to $45.2 million, or $0.69(1) per share, in the second quarter of 2015.

Second-Quarter 2016 Financial Summary from Discontinued Operations

In the first quarter of 2016, the Company completed the sale of its hemostasis products. Net income from discontinued operations in the second quarter of 2016 was $0.6 million, or $0.01 per share, compared to $20.9 million, or $0.31 per share, in the second quarter of 2015.

First-Half 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $105.0 million in the first half of 2016 compared to $184.6 million in the first half of 2015. Included in total net revenue in the first half of 2016 was $43.3 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox(bivalirudin) net product sales were $32.7 million in the first half of 2016 compared to $166.3 million in the first half of 2015, with net product sales in the United States decreasing to $26.0 million in the first half of 2016 from $155.6 million in the first half of 2015, driven by the loss of Angiomax exclusivity in July 2015. Other products, including Ionsys, Minocin for Injection, and Orbactiv, along with the recently-divested non-core cardiovascular products, recorded sales of $29.0 million in the first half of 2016 compared to $18.3 million in the first half of 2015.

The sale of the Company’s non-core cardiovascular products resulted in a gain of $288.3 million, which was recorded in the second quarter of 2016.

Net income from continuing operations in the first half of 2016 was $91.5 million, or $1.27 per share, compared to net loss from continuing operations of $63.1 million, or $0.96 per share, in the first half of 2015. Adjusted net loss(1) from continuing operations in the first half of 2016 was $114.1 million, or $1.64(1) per share, compared to $44.8 million, or $0.68(1) per share in the first half of 2015.

First-Half 2016 Financial Summary from Discontinued Operations

Net loss from discontinued operations in the first half of 2016 was $1.5 million, or $0.02 per share, compared to net income from discontinued operations of $21.5 million, or $0.33 per share, in the first half of 2015.

(1)
Adjusted net loss and adjusted loss per share from continuing operations are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss per Share sections of this release for explanations of the amounts excluded and included to arrive at adjusted net loss and adjusted loss per share amounts.
At June 30, 2016, the Company had $644 million in cash and investments compared to $373 million at the end of 2015.