On Thursday, in the course of Afternoon trade, Shares of OncoGenex Pharmaceuticals Inc (NASDAQ:OGXI), dropped -7.86%, and is now trading at $2.58.
OncoGenex Pharmaceuticals declared second quarter 2015 financial results.
Recent Developments and Anticipated Near-term Milestones
Custirsen – Phase 3 Lung and Prostate Cancer Trials
- On July 13, 2015, the company declared that its Phase 3 ENSPIRIT trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is ongoing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC). This decision was based upon completion of the second and final planned interim futility analysis that comprised of a more rigorous evaluation for determining futility in achieving a survival benefit associated with custirsen in NSCLC. Based on current enrollment projections, the company believes final survival results could be accessible in the second half of 2016.
- On June 10, 2015, OncoGenex declared that the U.S. Food and Drug Administration (FDA) have agreed to the company’s projected amendment to the Phase 3 AFFINITY protocol and statistical analysis plan. The projected amendment comprises the addition of a co-primary survival objective designed to prospectively evaluate the survival benefit of custirsen in men who are at raised risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (CRPC). Patients at risk for poor outcomes will be identified as having two or more of five common risk factors. In addition, OncoGenex and the FDA agreed that an interim analysis will occur for the entire study population when the final analysis for the poor prognosis subpopulation occurs. Advice from the European Medicines Agency through its Scientific Review process will be accomplished preceding to finalizing the protocol amendment. Subject to finalizing the pending protocol amendment, timing for the final analysis of the poor prognosis subpopulation is projected to occur by the end of 2015, while the final analysis for the entire study population is projected to occur in the second half of 2016.
- On May 30, 2015, the company declared that results from a retrospective analysis of the Phase 3 SYNERGY trial showed a benefit with custirsen therapy in men with metastatic CRPC who were at risk for poor outcomes. The analysis, exploring the effect of clusterin inhibition in men at risk for poor outcomes, showed that over 40% of men in the trial had at least two of five common risk factors for poor prognosis. In these men, the analysis found a 27% lower risk of death when custirsen was used in combination with first-line docetaxel contrast to docetaxel alone. These results were presented at the 51st Annual Meeting of the American Society of Clinical Oncology in Chicago .
OncoGenex Pharmaceuticals, Inc., a biopharmaceutical company, develops and commercializes therapies that address treatment resistance in cancer patients. The company’s product candidates comprise Custirsen that is in Phase III clinical development for the treatment in men with metastatic castrate-resistant prostate cancer, in addition to in patients with non-small cell lung cancer; and Apatorsen, which is in two Phase I and seven randomized Phase II trials for the treatment of bladder, lung, pancreatic, and prostate cancers.
During an Afternoon trade, Shares of Navient Corp (NASDAQ:NAVI), dipped -1.98%, and is now trading at $14.33.
Navient, declared the issuance of $700 million in private education loan asset-backed securities. The collateral backing the Navient Private Education Loan Trust 2015-B transaction comprises of seasoned, high-credit quality performing loans primarily from the SLM Private Education Loan Trust 2010-B whose notes were paid off in connection with the new issuance. The weighted average interest rate of the AAA-rated notes issued by the Navient Private Education Loan Trust 2015-B priced at one-month LIBOR plus 1.54 percentage points.
Navient Corporation provides financial products and services in the United States. The company operates in four segments: FFELP Loans, Private Education Loans, Business Services, and Other.
Shares of Delphi Automotive PLC (NYSE:DLPH), during its Thursday’s current trading session fell -1.09%, and is now trading at $76.13.
Delphi Automotive PLC declared it has named Bethany J. Mayer to its board of directors effective Oct. 1.
Mayer is the president and chief executive officer of Ixia, a provider of comprehensive network solutions. Ixia specializes in assisting organizations build secure network architectures designed to mitigate security breaches throughout the network’s lifecycle.
“Bethany’s technical expertise and extensive corporate background will assist further Delphi’s mission as we continue to focus on vehicle connectivity and automotive software,” said Rajiv Gupta, Delphi chairman of the board. “We look forward to her insight and guidance on the Delphi board of directors.”
Preceding to joining Ixia in 2014, Mayer held several key executive roles at Hewlett-Packard Co. (HP), most recently serving as HP’s senior vice president and general manager of its Network Functions Virtualization (NFV) business and leading the company’s NFV initiative.
Delphi Automotive PLC, together with its auxiliaries, manufacturers vehicle components; and provides electrical and electronic, powertrain, safety, and thermal technology solutions to the automotive and commercial vehicle markets worldwide. The company operates through four segments: Electrical/Electronic Architecture, Powertrain Systems, Electronics and Safety, and Thermal Systems.
Finally, Siliconware Precision Industries (ADR) (NASDAQ:SPIL), gained 3.75% Thursday.
Siliconware Precision Industries Co., declared that its merged sales revenues for the second quarter of 2015 were NT$ 21,240 million, which represented a 2.1% growth in revenues contrast to the first quarter of 2015 and a 3.1% decline in revenues contrast to the second quarter of 2014. SPIL stated a net income of NT$ 3,677 million for the second quarter of 2015, contrast with a net income of NT$ 2,615 million and a net income of NT$ 3,375 million for the first quarter of 2015 and the second quarter of 2014, respectively.
Operating results review:
- For the second quarter of 2015, net revenues from IC packaging were NT$ 18,726 million and represented 88% of total net revenues. Net revenues from testing operations were NT$ 2,514 million and represented 12% of total net revenues.
- Cost of goods sold was NT$ 15,459 million, representing an enhance of 0.7% contrast to the first quarter of 2015 and a decrease of 4.9% contrast to the second quarter of 2014.
- Raw materials costs were NT$ 6,704 million for the second quarter of 2015 and represented 31.6% of total net revenues, whereas raw materials costs were NT$ 6,768 million and represented 32.5% of total net revenues for the first quarter of 2015.
- The accrued expenses of bonuses to employees accounted for under cost of goods sold totaled NT$ 258 million
- Gross profit was NT$ 5,781 million for the second quarter of 2015, representing a gross margin of 27.2%, which raised from a gross margin of 26.2% for the first quarter of 2015 and was up from 25.8% for the second quarter of 2014.
- Total operating expenses for the second quarter of 2015 were NT$ 2,185 million, which comprised of selling expenses of NT$ 260 million, administrative expenses of NT$ 941 million and R&D expenses of NT$ 984 million. Total operating expenses represented 10.3% of total net revenues for the second quarter of 2015.
- The accrued expenses of bonuses to employees, directors accounted for under operating expenses totaled NT$ 143 million.
- Operating income was NT$ 3,596 million for the second quarter of 2015, representing an operating margin of 16.9%, which raised from 16.7% for the first quarter of 2015 and reduced from 18.0% for the second quarter of 2014.
- Non-operating items:
- Our non-operating income was NT$ 961 million, counting net income of NT$ 559 million on fair value change of financial liabilities at fair value through profit or loss, and cash dividends of NT$ 295 million and NT$ 38 million from ChipMos Taiwan and Unimicron Technology Corporation respectively.
- Net income before tax was NT$ 4,332 million for the second quarter of 2015, which raised from a net income before tax of NT$ 3,014 million for the first quarter of 2015 and raised from a net income before tax of NT$ 4,061 million for the second quarter of 2014.
- Income tax expense was NT$ 655 million for the second quarter of 2015, contrast with income tax expense of NT$ 399 million for the first quarter of 2015 and income tax expense of NT$ 686 million for the second quarter of 2014.
- Net income was NT$ 3,677 million for the second quarter of 2015, which raised from a net income of NT$ 2,615 million for the first quarter of 2015 and raised from a net income of NT$ 3,375 million for the second quarter of 2014.
- Total number of shares outstanding was 3,116 million shares as of June 30, 2015. Basic earnings per share for this quarter was NT$ 1.18, and diluted earnings per ordinary share was NT$ 0.93. Basic earnings per ADS for this quarter was US$ 0.19, and diluted earnings per ADS was US$ 0.15.
- Basic earnings per share for this quarter was NT$ 1.18, and diluted earnings per ordinary share was NT$ 0.93. Basic earnings per ADS for this quarter was US$ 0.19, and diluted earnings per ADS was US$ 0.15.
Siliconware Precision Industries Co., Ltd. provides semiconductor packaging and testing services to semiconductor suppliers worldwide. Its packaging and testing solutions comprise advanced packages, substrate packages, and lead-frame packages, in addition to testing for logic and mixed signal devices to measure and ensure the performance, functionality, and reliability of packaged semiconductor devices.
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