Anavex Reports Fiscal Second Quarter 2015 Financial Results
NEW YORK, NY — May 15, 2015 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the three and six months ended March 31, 2015.
Financial Highlights:
• Anavex had cash and cash equivalents of approximately $6.3 million as of March 31, 2015, compared with approximately $7.0 million as at December 31, 2014. Cash was used in operations and for the advancement of clinical trial work. The Company has sufficient cash for approximately two years and intends to use the majority to complete the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
• Operating expenses for the second quarter of fiscal year 2015 were approximately $0.8 million, compared to approximately $1.0 million for the quarter ended March 31, 2014. The decrease was primarily attributable to the one-time, non-cash charges during the comparative three-month period ended March 31, 2014. This was offset by an increase in research and development expenses in the current period, primarily related to the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
• The net loss for the second quarter of fiscal year 2015 was approximately $1.7 million or $0.03 per share, compared to net loss of approximately $1.0 million or $0.03 per share for the same period in 2014. The increased loss was primarily attributable to the non-cash charges during the current three-month period ended March 31, 2015.
“Our team has made exceptional progress to date in advancing both our clinical and business strategies,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS continues to progress, with preliminary data expected around the Q3 timeframe. We are excited by the potential of ANAVEX 2-73 as a potential platform drug for multiple neurodegenerative diseases beyond Alzheimer’s and by our other advancing pipeline products in CNS as well as pain and cancer.”
Recent Achievements
On April 23, 2015, Dr. Missling presented at the World Orphan Drug Congress in Washington, D.C. He discussed the role of sigma-1 receptors in additional indications beyond Alzheimer’s disease. The Company stated that, in parallel with the ongoing Alzheimer’s trial of ANAVEX 2-73 and ANAVEX PLUS, it is able to expand the development of ANAVEX 2-73 into rare or orphan CNS diseases.
On April 7, 2015, Anavex said it was encouraged by the findings of a new report in the latest issue of peer-reviewed scientific journal Neuroscience Letters. The study showed for the first time through real-time in vivo imaging how microglial inflammation, which is involved in devastating neurodegenerative diseases, can be resolved by sigma-1 receptor activation. The report underscored the potential therapeutic application of proprietary Anavex compounds in multiple neurological diseases.
On March 23, 2015, Anavex announced promising new preclinical data for both ANAVEX 2-73 and ANAVEX 3-71 (formerly AF710B), which was unveiled in two separate presentations at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD 2015) in Nice, France.
On March 17, 2015, Dr. Missling presented at ‘The Physiopathology of Sigma-1 Receptors’ symposium held at the Nice Sophia Antipolis University in Nice, France. His presentation, entitled ‘Clinical trial design for Sigma-1 Receptor agonists,’ included an overview of the Phase 2a clinical trial design of ANAVEX 2-73 and ANAVEX PLUS, which is ongoing in Alzheimer’s patients.
On March 12, 2015, Anavex announced the appointment of Jacqueline French, MD, FAAN, to the Company's Scientific Advisory Board. An award-winning, internationally recognized expert on epilepsy, new therapeutic interventions and clinical trial methodology, Dr. French is Professor in the Department of Neurology at New York University (NYU), Co-Director of Epilepsy Research and Clinical Trials at NYU’s Comprehensive Epilepsy Center and Director of the Epilepsy Study Consortium.
On March 5, 2015, Anavex announced the appointment of Corinne Lasmezas, DVM, PhD, to the Company’s Scientific Advisory Board. A professor at The Scripps Research Institute for the past 10 years, Dr. Lasmézas is internationally recognized in the field of neurogenerative diseases with a focus now on studying the mechanisms of neurodegeneration.
On February 25, 2015, Anavex announced the findings of a research report in the current issue of peer-reviewed scientific journal Frontiers in Cellular Neuroscience. Among its conclusions, the report revealed that ANAVEX 2-73 prevents mitochondrial dysfunction and blocks resulting oxidative stress and apoptosis (cell death) in a nontransgenic mouse model of Alzheimer’s disease. By preserving mitochondrial functionality and reducing other key AD hallmarks, Anavex said, its drug candidate ANAVEX 2-73 has the potential to prevent, stop, slow or reverse the disease, in addition to treating its symptoms.
The financial information for the three and six months ended March 31, 2015 should be read in conjunction with the Company’s interim consolidated financial statements, which have been filed on U.S. Securities and Exchange Commission’s EDGAR system and will be available on the Anavex website at www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases, pain and various types of cancer. The Company’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently being evaluated in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and has successfully completed a Phase 1 study with a clean data profile. Preclinical studies demonstrate its potential to halt and/or reverse the course of Alzheimer’s disease. The drug combination, ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. Recent positive preclinical data indicates that ANAVEX 2-73 also exhibits anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties, indicating its potential to treat additional CNS disorders, including epilepsy and others. Further information is available at www.anavex.com.
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Financial Highlights:
• Anavex had cash and cash equivalents of approximately $6.3 million as of March 31, 2015, compared with approximately $7.0 million as at December 31, 2014. Cash was used in operations and for the advancement of clinical trial work. The Company has sufficient cash for approximately two years and intends to use the majority to complete the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
• Operating expenses for the second quarter of fiscal year 2015 were approximately $0.8 million, compared to approximately $1.0 million for the quarter ended March 31, 2014. The decrease was primarily attributable to the one-time, non-cash charges during the comparative three-month period ended March 31, 2014. This was offset by an increase in research and development expenses in the current period, primarily related to the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
• The net loss for the second quarter of fiscal year 2015 was approximately $1.7 million or $0.03 per share, compared to net loss of approximately $1.0 million or $0.03 per share for the same period in 2014. The increased loss was primarily attributable to the non-cash charges during the current three-month period ended March 31, 2015.
“Our team has made exceptional progress to date in advancing both our clinical and business strategies,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS continues to progress, with preliminary data expected around the Q3 timeframe. We are excited by the potential of ANAVEX 2-73 as a potential platform drug for multiple neurodegenerative diseases beyond Alzheimer’s and by our other advancing pipeline products in CNS as well as pain and cancer.”
Recent Achievements
On April 23, 2015, Dr. Missling presented at the World Orphan Drug Congress in Washington, D.C. He discussed the role of sigma-1 receptors in additional indications beyond Alzheimer’s disease. The Company stated that, in parallel with the ongoing Alzheimer’s trial of ANAVEX 2-73 and ANAVEX PLUS, it is able to expand the development of ANAVEX 2-73 into rare or orphan CNS diseases.
On April 7, 2015, Anavex said it was encouraged by the findings of a new report in the latest issue of peer-reviewed scientific journal Neuroscience Letters. The study showed for the first time through real-time in vivo imaging how microglial inflammation, which is involved in devastating neurodegenerative diseases, can be resolved by sigma-1 receptor activation. The report underscored the potential therapeutic application of proprietary Anavex compounds in multiple neurological diseases.
On March 23, 2015, Anavex announced promising new preclinical data for both ANAVEX 2-73 and ANAVEX 3-71 (formerly AF710B), which was unveiled in two separate presentations at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD 2015) in Nice, France.
On March 17, 2015, Dr. Missling presented at ‘The Physiopathology of Sigma-1 Receptors’ symposium held at the Nice Sophia Antipolis University in Nice, France. His presentation, entitled ‘Clinical trial design for Sigma-1 Receptor agonists,’ included an overview of the Phase 2a clinical trial design of ANAVEX 2-73 and ANAVEX PLUS, which is ongoing in Alzheimer’s patients.
On March 12, 2015, Anavex announced the appointment of Jacqueline French, MD, FAAN, to the Company's Scientific Advisory Board. An award-winning, internationally recognized expert on epilepsy, new therapeutic interventions and clinical trial methodology, Dr. French is Professor in the Department of Neurology at New York University (NYU), Co-Director of Epilepsy Research and Clinical Trials at NYU’s Comprehensive Epilepsy Center and Director of the Epilepsy Study Consortium.
On March 5, 2015, Anavex announced the appointment of Corinne Lasmezas, DVM, PhD, to the Company’s Scientific Advisory Board. A professor at The Scripps Research Institute for the past 10 years, Dr. Lasmézas is internationally recognized in the field of neurogenerative diseases with a focus now on studying the mechanisms of neurodegeneration.
On February 25, 2015, Anavex announced the findings of a research report in the current issue of peer-reviewed scientific journal Frontiers in Cellular Neuroscience. Among its conclusions, the report revealed that ANAVEX 2-73 prevents mitochondrial dysfunction and blocks resulting oxidative stress and apoptosis (cell death) in a nontransgenic mouse model of Alzheimer’s disease. By preserving mitochondrial functionality and reducing other key AD hallmarks, Anavex said, its drug candidate ANAVEX 2-73 has the potential to prevent, stop, slow or reverse the disease, in addition to treating its symptoms.
The financial information for the three and six months ended March 31, 2015 should be read in conjunction with the Company’s interim consolidated financial statements, which have been filed on U.S. Securities and Exchange Commission’s EDGAR system and will be available on the Anavex website at www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases, pain and various types of cancer. The Company’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently being evaluated in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and has successfully completed a Phase 1 study with a clean data profile. Preclinical studies demonstrate its potential to halt and/or reverse the course of Alzheimer’s disease. The drug combination, ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. Recent positive preclinical data indicates that ANAVEX 2-73 also exhibits anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties, indicating its potential to treat additional CNS disorders, including epilepsy and others. Further information is available at www.anavex.com.
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