On Friday, Shares of TrovaGene, Inc. (NASDAQ:TROV), surged 20.14% to $8.53, hitting its highest level.
TrovaGene, declared that clinical data presented at the 2015 European Lung Cancer Conference (ELCC) demonstrate that its urine-based Precision Cancer Monitoring℠ (PCM) platform outperformed tissue biopsy for the detection and monitoring of EGFR T790M mutations in metastatic lung cancer patients. The abstract, titled Detection of EGFR T790M Mutation in Urinary Circulating Tumor DNA from Metastatic Non-Small Cell Lung Cancer Patients, was presented recently by Hatim Husain, M.D., University of California, San Diego Moores Cancer Center during the ESMO-IASLC Best Abstracts session in Geneva, Switzerland.
In an interim analysis of 34 patients from an ongoing clinical study, Trovagene’s PCM platform detected the T790M mutation in all patients who were positive for the mutation in tissue biopsy. The Company’s urine-based assay identified additional patients as T790M-positive, counting those who had clinical suspicion of T790M-progressive disease, but were either negative by tissue biopsy or had not yet undergone tissue biopsy for confirmation. Trovagene’s PCM platform detected EGFR T790M resistance mutations months earlier than radiologic detection of progression in patients.
Early pharmacodynamic events occurring within hours or days of anti-EGFR drug treatment were evaluated in the study by implementing daily monitoring of urinary ctDNA. Initial results demonstrated that immediate changes in EGFR mutational load using a urine specimen may identify patients who respond to anti-EGFR therapy much earlier than with follow-up CT-scans. This new clinical utility of urinary ctDNA is being further validated in a larger patient cohort.
Trovagene, Inc., a molecular diagnostic company, focuses on the development and commercialization of proprietary urine-based cell-free molecular diagnostic technology for use in disease detection and monitoring across various medical disciplines.
Shares of TCP International Holdings Ltd. (NYSE:TCPI), gained 16.81% to $4.03, during its last trading session.
TCP International Holdings, declared its 2014 fourth quarter and full year financial results.
Net sales for the fourth quarter of 2014 were $153.1 million, a 25% raise contrast with $122.9 million in the third quarter of 2014 and a 34% raise contrast with $114.5 million in the fourth quarter of 2013. Net income in the fourth quarter was $2.1 million, or $0.07 per diluted share, contrast to $4.5 million, or $0.16 per diluted share, in the third quarter of 2014 and a loss of $1.6 million, or $0.08 per diluted share, in the fourth quarter of 2013. Adjusted earnings per share were $0.13 for the fourth quarter of 2014, contrast to $0.16 in the third quarter of 2014.
Net sales for the full year 2014 were $489.5 million, a 14% raise contrast with $428.9 million in 2013. Net income for 2014 was $12.4 million, or $0.52 per diluted share, contrast to $8.2 million, or $0.40 per diluted share, in 2013.
Fourth Quarter 2014 Summary:
- Net sales were $153.1 million, a raise of $30.2 million, or 25%, from the third quarter of 2014 and a raise of $38.6 million, or 34%, from the fourth quarter of 2013.
- LED sales were $54.9 million, a raise of $1.6 million, or 3%, from the third quarter of 2014 and a raise of $20.1 million, or 58%, from the fourth quarter of 2013, driven by raised sales in the commercial and industrial, or C&I, channel and with Walmart in the retail channel.
- CFL sales were $90.5 million, a raise of $30.9 million, or 52% from the third quarter of 2014 and $17.8 million, or 24%, from the fourth quarter of 2013, primarily due to the replenishment of CFL inventories by The Home Depot.
- Gross margin was 17.7%, down from 21.7% in the third quarter of 2014 and 18.1% in the fourth quarter of 2013, due to a raise in retail CFL sales and a $4.5 million charge for the write-down of Connected by TCP™ inventory.
- Selling, general and administrative expenses were $21.1 million, an raise of $1.7 million from the third quarter of 2014 and $3.8 million from the fourth quarter of 2013, primarily due to share-based compensation expenses associated with restricted share units granted in connection with our IPO and an raise in marketing costs.
- Net income was $2.1 million, a decrease from $4.5 million in the third quarter of 2014, and a raise from a loss of $1.6 million in the fourth quarter of 2013. Diluted net income per share was $0.07, a decrease from diluted net income per share of $0.16 in the third quarter of 2014.
- Adjusted EPS was $0.13, contrast to $0.16 in the third quarter of 2014.
At December 31, 2014, cash and cash equivalents were $31.4 million, down from $60.4 million at September 30, 2014, as a result of debt repayments of $34.0 million during the fourth quarter. Combined short-term loans and long-term debt was $80.2 million at December 31, 2014, down from $113.9 million at September 30, 2014.
TCP International Holdings Ltd., together with its auxiliaries, designs, develops, manufactures, and markets lighting products and accessories to the commercial, industrial, and retail markets worldwide. It offers various light emitting diode lamps, compact fluorescent lamps, halogen lamps, linear fluorescent lighting, and lighting fixtures; and various compact, and linear fluorescent component parts and accessories, in addition to Internet-based lighting solutions.
At the end of Friday’s trade, Shares of Celanese Corporation (NYSE:CE), gained 15.55% to $67.18, hitting its highest level.
Celanese Corporation, stated first quarter 2015 adjusted earnings per share of $1.72 as compared to $1.28 in the preceding quarter.
First quarter 2015 financial highlights:
- Aligned along two value drivers: Materials Solutions, which comprises the Advanced Engineered Materials and Consumer Specialties segments, and the Acetyl Chain, which comprises the Acetyl Intermediates and Industrial Specialties segments
- Achieved record adjusted earnings of $1.72 per share, up 34 percent from the preceding quarter and 29 percent from the preceding year quarter
- Expanded adjusted EBIT margin to 24.1 percent, a quarterly record and an raise of more than 600 basis points from the preceding quarter and preceding year, driven by strong commercial performance in both Materials Solutions and the Acetyl Chain
- Implemented incremental productivity programs that are predictable to deliver $50 million in annualized cost reductions. Aggregate 2015 productivity savings predictable to be in excess of $100 million
- Generated record first quarter adjusted free cash flow of $181 million driven by strong earnings
- Achieved GAAP earnings of $1.53 per share contrast to a loss of $0.54 per share in the preceding quarter and earnings of $1.25 per share in the preceding year quarter.
Celanese Corporation, a technology and specialty materials company, manufactures and sells value-added chemicals, thermoplastic polymers, and other chemical-based products worldwide. The company’s Advanced Engineered Materials segment develops, produces, and supplies specialty polymers for use in automotive, medical, electronics, and other consumer and industrial applications.
Finally, Oncolytics Biotech Inc. (NASDAQ:ONCY), ended its last trade with 10.27% gain, and closed at $0.76.
Oncolytics Biotech, declared that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for its lead product candidate, REOLYSIN®, for the treatment of malignant glioma. The Company applied for an ODD for pediatric high grade gliomas (HGG), however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages. In three previous brain cancer studies counting gliomas, REOLYSIN® has been shown to infect a variety of brain tumors when delivered intravenously.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, counting a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees.
According to the Central Brain Tumor Registry of the United States (CBTRUS), in 2015, an estimated 68,470 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed of which 23,180 estimated new cases will be primary malignant tumors and 4,620 estimated new cases will be diagnosed in pediatric and adolescent patients. The CBTRUS estimates that the broad category glioma represents about 80% of malignant tumors and in patients between zero and 19 years of age, the overall total incidence of HGG (counting anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma, and malignant glioma) is about 0.8 per 100,000.
Oncolytics Biotech Inc., a development stage biopharmaceutical company, focuses on the discovery and development of pharmaceutical products for the treatment of cancers. The company develops REOLYSIN, a cancer therapeutic that is in various clinical trials for human use.
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