Anavex Life Sciences Corp. $AVXL News
Last updated 12/26/2016 - 4.09
Anavex to Present at 4th Annual OktoberINVESTfest Conference
Oct 12, 2015
OTC Disclosure & News Service
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NEW YORK, Oct. 12, 2015 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX:AVXL) today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the 4th annual OktoberINVESTfest investors conference on Tuesday, October 13, 2015 at 2:30 p.m. ET. The Conference will be held at The New York Academy of Sciences in New York City.
In his presentation, Dr. Missling will provide an overview of Anavex’s ongoing Phase 2a clinical trial of ANAVEX™ 2-73 in Alzheimer’s patients. Full PART A and preliminary PART B Phase 2a clinical trial data will be presented at the CTAD conference on November 7, 2015.
OktoberINVESTfest brings together US and German investors, innovators, industry leaders, Bavarian state representatives as well as a number of innovative North American and German companies. The resulting business and investment ties will deepen transatlantic relations and encourage economic and scientific exchange.
* Anavex’s stock is temporarily trading under the ticker AVXLD.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A and preliminary PART B Phase 2a clinical trial data will be presented at CTAD in November 2015. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and antidepressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex™ Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex™ Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex to Present Interim Phase 2a Clinical Trial Data of ANAVEX 2-73 at Late-Breaking Oral Session of CTAD 2015 Conference
Oct 07, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 07, 2015 (GLOBE NEWSWIRE) -- 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 announced the presentation of full PART A data and preliminary PART B data from the ongoing Phase 2a clinical trial of ANAVEX 2-73 at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference in Barcelona, Spain from November 5-7, 2015. The late-breaking oral session will be presented by the trial’s Principal Investigator, Stephen Macfarlane, FRANZCP, Director and Associate Professor, Aged Psychiatry at Caulfield Hospital in Melbourne, Australia.
Presentation Details
Title: New Exploratory Alzheimer's Drug ANAVEX 2-73: Assessment of Safety and
Cognitive Performance in a Phase 2a Study in mild-to-moderate Alzheimer's
Patients
Date/Time: Saturday, November 7, 2015
9:45 a.m. Central European Time (3:45 a.m. Eastern Time)
Location: Gran Hotel Princesa Sofia, Barcelona, Spain
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is a simple randomized, open-label, two-period, cross-over, adaptive trial lasting up to 36 days for each patient. PART B is an open-label extension for an additional 52 weeks.
The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73. Secondary trial objectives include exploratory cognitive efficacy using mini-mental state examination score (MMSE), dose response, bioavailability, Cogstate and electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), as well as the relationship of ANAVEX 2-73 as an add-on therapy to donepezil (Aricept®).
Additional information regarding the ongoing Phase 2a clinical trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About ANAVEX 2-73
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation. Preclinical data indicates that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015. Full PART A data and preliminary PART B data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
CORRECTING and REPLACING -- Anavex Prepares for Uplisting to NASDAQ, Announces Reverse Stock Split
Oct 06, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 06, 2015 (GLOBE NEWSWIRE) -- 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 announced that it is finalizing an application to uplist trading of its common stock to the NASDAQ Capital Market. To meet the conditions of a NASDAQ listing, the Company announces a one-for-four (1-for-4) reverse stock split of its authorized, issued and outstanding common shares. The Company's common stock will begin trading on a post-split basis at the opening of trading on October 7, 2015.
“It is our belief that uplisting to a major exchange will allow a broader base of worldwide institutions, funds and retail investors to participate in our future success,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This reverse stock split will help us meet the conditions to finalize our application for uplisting to NASDAQ.”
Following the reverse stock split, every four shares of issued and outstanding common stock will be converted to one post-reverse split share. All fractional shares will be rounded up to the nearest whole share.
The reverse stock split will reduce the authorized shares of common stock from 400,000,000 prior to the split to 100,000,000 after the reverse stock split.
As of October 7, Anavex common stock will trade under the ticker symbol AVXLD for a period of 20 business days. After that time or earlier once NASDAQ approves the uplisting requirements, the “D” will be removed and our Company's symbol will once again be AVXL. A new CUSIP number will be assigned to the Company's common stock as a result of the reverse split.
Shareholders should direct any questions concerning the reverse split to their bank or broker or the Company's transfer agent, Nevada Agency and Trust at +1 (775) 322-0626.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Prepares for Uplisting to NASDAQ, Announces Reverse Stock Split
Oct 06, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 06, 2015 (GLOBE NEWSWIRE) -- 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 announced that it is finalizing an application to uplist trading of its common stock to the NASDAQ Capital Market. To meet the conditions of a NASDAQ listing, the Company announces a one-for-four (1-for-4) reverse stock split of its authorized, issued and outstanding common shares. The Company's common stock will begin trading on a post-split basis at the opening of trading on October 7, 2015.
“It is our belief that uplisting to a major exchange will allow a broader base of worldwide institutions, funds and retail investors to participate in our future success,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This reverse stock split will help us meet the conditions to finalize our application for uplisting to NASDAQ.”
Following the reverse stock split, every four shares of issued and outstanding common stock will be converted to one post-reverse split share. All fractional shares will be rounded up to the nearest whole share.
The reverse stock split will reduce the issued and outstanding shares of common stock from 400,000,000 prior to the split to 100,000,000 after the reverse stock split.
As of October 7, Anavex common stock will trade under the ticker symbol AVXLD for a period of 20 business days. After that time or earlier once NASDAQ approves the uplisting requirements, the “D” will be removed and our Company's symbol will once again be AVXL. A new CUSIP number will be assigned to the Company's common stock as a result of the reverse split.
Shareholders should direct any questions concerning the reverse split to their bank or broker or the Company's transfer agent, Nevada Agency and Trust at +1 (775) 322-0626.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Completes Patient Enrollment for Phase 2a Alzheimer’s Trial Ahead of Schedule
Sep 28, 2015
OTC Disclosure & News Service
-
NEW YORK, Sept. 28, 2015 (GLOBE NEWSWIRE) -- 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 announced that patient enrollment for the Phase 2a clinical trial of ANAVEX 2-73 has been completed ahead of schedule. With the Phase 2a trial now fully enrolled, Anavex expects to release topline data for PART A before the end of the year.
“There has been significant interest in our Phase 2a Alzheimer’s trial and full enrollment is an important step forward. We are delighted to be ahead of schedule and thank the patients and their families for their participation,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to the full ANAVEX 2-73 Phase 2a trial results and our team is excited to continue moving this clinical program forward.”
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation.
About the ANAVEX 2-73 Phase 2a Study
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients has enrolled 32 patients. It started in January 2015 and all the 32 patients, most who are also taking donepezil, have initiated PART A of the two-part trial.
Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 52 weeks, with daily oral dosing so as to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex to Present at 2015 Ladenburg Thalmann Healthcare Conference
Sep 23, 2015
OTC Disclosure & News Service
-
NEW YORK, Sept. 23, 2015 (GLOBE NEWSWIRE) -- 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 announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the Ladenburg Thalmann 2015 Healthcare Conference on Tuesday, September 29, 2015 at 4 p.m. ET in Track 1. The conference will be held at the Sofitel Hotel in New York City.
Management plans to be available for one-on-one meetings with members of the investment community at the conference. Attendees are invited to contact Anavex at ir@anavex.com to request a meeting with management.
A live audio webcast of the presentation will be available under the conference website at http://wsw.com/webcast/ladenburg/avxl. Investors may also view an archived version of the presentation on 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. Anavex’s lead drug candidate, ANAVEX 2-73 is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Appoints International Alzheimer’s Expert to Scientific Advisory Board
Sep 21, 2015
OTC Disclosure & News Service
-
NEW YORK, Sept. 21, 2015 (GLOBE NEWSWIRE) -- 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 announced the appointment of Harald Hampel, MD, MA, PhD, MSc, to the Company’s Scientific Advisory Board. An internationally recognized expert on Alzheimer’s and related neurodegenerative diseases, Dr. Hampel is Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, the leading university in science, technology and medicine in France. The AXA-UPMC Chair is hosted within the highly specialized Institute for Memory and Alzheimer’s Disease (IM2A), a reference center for Alzheimer’s and other neurodegenerative diseases, and affiliated with a leading neuroscience institution, the Brain and Spine Institute (ICM), as well as the Department of Neurology at the Pitié-Salpétrière University Hospital.
“We are excited to welcome Harald as a Scientific Advisor. He has conducted more than 50 clinical trials over the past 20 years and is recognized as a world-leading researcher who has developed international programs focused on Alzheimer’s therapy, diagnosis and the development of biological and imaging biomarkers, including his current work as AXA-UPMC Chair, which aims to improve early detection at the preclinical ‘silent stage’ before the onset of any clinical signs and symptoms,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We believe Harald’s vast knowledge of Alzheimer’s, his experience and interest in drug development, and focus on early detection, diagnosis and intervention complement our therapeutic approach and offer significant value as we advance ANAVEX 2-73 through the clinic.”
After a post-doctoral fellowship focused on structural and functional neuroimaging of the healthy aging and Alzheimer's disease brain at the NIH/NIA Laboratory of Neurosciences in Bethesda, MD, Dr. Hampel became founding director of the Alzheimer Memorial Center and Professor of Psychiatry at the University of Munich. In 2006, he was appointed as a Professor and Chair of Psychiatry at Trinity College, University of Dublin, Ireland. During this time, he was a leading Principal Investigator at the Trinity College Institute of Neuroscience (TCIN). In 2010, Dr. Hampel was appointed as Professor, Chair and Head of Department of Psychiatry and Co-Director of the Brain Imaging Center (BIC) at the University of Frankfurt.
“I am impressed with Anavex and its potential CNS platform drug, ANAVEX 2-73, which has shown promising interim clinical data from its Phase 2a Alzheimer’s trial,” said Dr. Hampel. “Anavex has also assembled an impressive team of business and scientific leaders, which I am delighted to join. I look forward to advising the company as it continues to focus on developing drugs that meet significant unmet needs in Alzheimer’s and other indications.”
Dr. Hampel has published more than 500 peer-reviewed research papers, 80 book chapters and eight books, many in world-leading scientific journals, such as the New England Journal of Medicine, JAMA, The Lancet, The Lancet Neurology, Nature Genetics, Nature Reviews Drug Discovery and Nature Reviews Neurology. He has won numerous awards for his scientific work on healthy and diseased brains as well as biomarker and therapy discovery in Alzheimer’s. Additionally, Dr. Hampel has been a reviewer for leading international scientific journals and funding agencies in the US, Canada and Europe and is Senior Associate Editor of the leading international Alzheimer’s journal Alzheimer's & Dementia, the journal of the Alzheimer's Association.
He obtained his MD and PhD at the University of Munich. Dr. Hampel also holds an MSc from Cologne University and an MA from Trinity College at the University of Dublin.
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 and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently 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 successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Reports Fiscal Third Quarter 2015 Financial Results
Aug 17, 2015
OTC Disclosure & News Service
-
NEW YORK, Aug. 17, 2015 (GLOBE NEWSWIRE) -- 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 nine months ended June 30, 2015.
Financial Highlights:
Anavex had cash and cash equivalents of approximately $8.0 million as of June 30, 2015, compared with approximately $6.3 million as at March 31, 2015. Approximately $3.0 million was raised as a result of warrants exercised during the quarter. Cash was used in operations and for the advancement of clinical trial work. The Company has sufficient cash for approximately two years.
Operating expenses for the third quarter of fiscal year 2015 were approximately $1.5 million, compared to approximately $1.0 million for the quarter ended June 30, 2014. The increase was primarily attributable to higher research and development expenses in the current period, mainly related to the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
“We are pleased with our progress to date,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Our Phase 2a clinical trial of ANAVEX 2-73 for the treatment of Alzheimer’s disease is progressing on schedule, with PART A expected to be completed by the end of the year. Additionally, we are expanding PART B, the extension period, from 26 to 52 weeks based on positive initial clinical data and at the request of study participants. In parallel, we are conducting preclinical work with other disease indications including Parkinson’s, which is being funded by a grant from the Michael J. Fox Foundation for Parkinson’s Research.”
Recent Achievements
On August 12, 2015, Anavex announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. Upon issuance, the patent will provide intellectual property protection until at least 2030. The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.
On August 10, 2015, Anavex announced that it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX 2-73 for the treatment of Parkinson’s disease. The MJFF grant is expected to fully fund a preclinical study worth $286,456 on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model, which seeks to provide a solid dataset that will justify moving forward to clinical development. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
On July 22, 2015, Anavex announced initial Phase 2a study data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. ANAVEX 2-73 showed positive cognitive effects in 83 percent (10/12) of patients during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately four times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
On June 18, 2015, Anavex announced the appointment of Steffen Thomas, PhD, to its Board of Directors. Dr. Thomas has 15 years of experience in intellectual property, patent law and proprietary technology rights as well as significant expertise in small molecule pharmaceuticals. Dr. Thomas is currently a patent attorney, European patent attorney and European trademark attorney at Epping Hermann Fischer, a major European intellectual property law firm.
On May 21, 2015, Anavex said it is encouraged by recent data published in the Proceedings of the National Academy of Sciences. The research determines that activating the sigma-1 receptor with agonists can potentially reduce the devastating impact of tau dysfunction. Alzheimer’s is the most widely recognized neurodegenerative disease associated with the aggregation of tau protein in the brain, with others including progressive supranuclear palsy (PSP) and frontotemporal dementia. It has been previously reported that ANAVEX 2-73, targeting the sigma-1 receptor in a dose-dependent study, blocked tau and amyloid-beta proteins as well as memory deficits in a mouse model of Alzheimer’s disease.
On May 18, 2015, Anavex announced that full preclinical anti-seizure data for ANAVEX 2-73 was revealed in a presentation on Friday, May 15, 2015 at the Antiepileptic Drug Trials XIII Conference. ANAVEX 2-73 demonstrated convincing data in three well-established and, according to experts, highly predictive preclinical anti-seizure models with a potentially more favorable side effect profile than currently marketed epilepsy drugs. The cognitive-enhancing features of ANAVEX 2-73 might be a differentiating factor since seizures cause neuro-cognitive impairments, which can be worsened by current epilepsy medications. The strong performance of ANAVEX 2-73 was also confirmed in combination with three generations of epilepsy drugs currently on the market.
The financial information for the three and nine months ended June 30, 2015 should be read in conjunction with the Company’s interim consolidated financial statements, which have been filed on the 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 and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently 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 successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED BALANCE SHEETS
ASSETS
June 30, September 30,
2015 2014
Current
Cash $ 7,961,331 $ 7,262,138
Prepaid expenses 16,054 89,117
Total current assets 7,977,385 7,351,255
Equipment 1,501 2,247
Total assets $ 7,978,886 $ 7,353,502
LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities $ 1,259,051 $ 1,249,084
Promissory notes payable 92,516 192,065
Total current liabilities 1,351,567 1,441,149
Non-interest bearing liabilities 57,962 5,719,727
Total liabilities 1,409,529 7,160,876
Common stock 86,217 47,201
Additional paid-in capital 65,030,871 52,078,750
Common stock to be issued 777,415 640,000
Accumulated deficit (59,325,146 ) (52,573,325 )
Total stockholders' equity 6,569,357 192,626
Total liabilities and stockholders' equity $ 7,978,886 $ 7,353,502
ANAVEX LIFE SCIENCES CORP.
INTERIM STATEMENTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2015
2015 2014
OPERATING EXPENSES
Research and development $ 799,462 $ 265,015
General and administrative 713,498 733,818
Total operating expenses 1,512,960 998,833
OPERATING LOSS (1,512,960 ) (998,833 )
OTHER INCOME
Interest and finance expenses, net 1,254 (8,492 )
Financing related charges and adjustments (2,716,640 ) 5,420
Foreign exchange loss (11,898 ) (7,185 )
Total other income (2,727,284 ) (10,257 )
NET LOSS $ (4,240,244 ) $ (1,009,090 )
NET LOSS PER COMMON SHARE
BASIC $ (0.06 ) $ (0.03 )
DILUTED $ (0.06 ) $ (0.03 )
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
BASIC 76,380,219 39,260,098
DILUTED 76,380,219 39,260,098
2015 2014
Net loss and comprehensive loss - GAAP basis $ (4,240,244 ) $ (1,009,090 )
Add back:
Non-cash financing related charges and adjustments 2,716,640 (5,420 )
Net loss and comprehensive loss - Non-GAAP basis $ (1,523,604 ) $ (1,014,510 )
NET LOSS PER COMMON SHARE
BASIC $ (0.02 ) $ (0.03 )
DILUTED $ (0.02 ) $ (0.03 )
ANAVEX LIFE SCIENCES CORP.
INTERIM STATEMENTS OF OPERATIONS
NINE MONTHS ENDED JUNE 30, 2015
2015 2014
OPERATING EXPENSES
Research and development $ 1,525,233 $ 388,347
General and administrative 1,616,744 1,941,261
Total operating expenses 3,141,977 2,329,608
OPERATING LOSS (3,141,977 ) (2,329,608 )
OTHER INCOME
Interest and finance expenses, net (73,527 ) (16,858 )
Financing related charges and adjustments (3,591,346 ) 687,409
Foreign exchange loss 55,029 (10,256 )
Total other income (3,609,844 ) 660,295
NET LOSS $ (6,751,821 ) $ (1,669,313 )
NET LOSS PER COMMON SHARE
BASIC $ (0.11 ) $ (0.04 )
DILUTED $ (0.11 ) $ (0.04 )
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
BASIC 61,752,000 38,218,237
DILUTED 61,752,000 38,218,237
2015 2014
Net loss and comprehensive loss - GAAP basis $ (6,751,821 ) $ (1,669,313 )
Add back:
Non-cash financing related charges and adjustments 3,591,346 (687,409 )
Net loss and comprehensive loss - Non-GAAP basis $ (3,160,475 ) $ (2,356,722 )
NET LOSS PER COMMON SHARE
BASIC $ (0.05 ) $ (0.06 )
DILUTED $ (0.05 ) $ (0.06 )
Contacts:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Awarded Grant From The Michael J. Fox Foundation for Parkinson’s Research
Aug 10, 2015
OTC Disclosure & News Service
-
NEW YORK, Aug. 10, 2015 (GLOBE NEWSWIRE) -- 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 announced that it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX 2-73 for the treatment of Parkinson’s disease.
The MJFF grant is expected to fully fund a preclinical study on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model, which seeks to provide a solid dataset that will justify moving forward to clinical development in Parkinson’s. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
As a potential platform drug and the Company’s lead therapeutic, ANAVEX 2-73 targets misfolded proteins central to many neurodegenerative diseases, including Parkinson’s and Alzheimer’s. It is believed to enhance the body's own cellular defense mechanisms through both sigma-1 and muscarinic receptors to return diseased cells to a pre-diseased or “homeostatic” state.
“The development of disease-modifying therapies for Parkinson’s disease is the top priority of The Michael J. Fox Foundation and ANAVEX 2-73 presents a promising approach,” said Marco Baptista, PhD, Senior Associate Director of MJFF Research Programs. “Companies that receive funding from MJFF have scientifically compelling plans that hold obvious potential to impact our understanding of Parkinson’s and ultimately the development of improved treatments for people with the disease. To that end, we look forward to the results of the ANAVEX 2-73 study.”
“If successful, this study will accelerate the translation of preclinical findings into the very first clinical trial of ANAVEX 2-73 as a potential disease-modifying therapy for Parkinson’s disease,” said Angela Cenci, MD, PhD, and Professor at Lund University, where the study will be conducted. “We are in the fortunate position that ANAVEX 2-73 has already been tested for safety and tolerability in humans, and was found to be a good clinical drug candidate.”
“Anavex is honored to have The Michael J. Fox Foundation for Parkinson’s Research support the development of our technology and we are pleased to be collaborating with such a prestigious organization,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We hope this research will lead to improved therapies that can maximize the benefits and minimize side effects for Parkinson's patients. After reporting positive initial data last month in our ongoing ANAVEX 2-73 Phase 2a clinical trial in Alzheimer’s patients, we expect the trial to be fully enrolled and to have PART A completed by the end of the year. Our work with MJFF underscores our unwavering commitment to delivering new medications for neurological disorders characterized by deposits of misfolded proteins, including both Parkinson's and Alzheimer's diseases.”
The preclinical study of ANAVEX 2-73 in Parkinson’s disease will be conducted at Lund University in Sweden under supervision of Professor Angela Cenci, MD, PhD.
About Parkinson's Disease
Parkinson’s disease is a chronic and progressive neurological disorder that is characterized by well-known motor symptoms including tremors, stiffness of limbs, slowness of movements, and difficulties with posture and balance, as well as by non-motor symptoms. It is the second most common neurological disorder and approximately one million people in the United States, and from four to six million people worldwide, live with this disease. Parkinson’s disease is more common in people over 60 years of age and its prevalence is expected to increase significantly as the average age of the population increases. Current Parkinson’s treatments are only effective in managing symptoms of the disease, mainly through the use of levodopa and dopamine agonists. As the disease progresses and dopaminergic neurons continue to be lost, these drugs eventually become less effective at treating the symptoms.
About ANAVEX 2-73
ANAVEX 2-73 is an orally available small molecule that targets sigma-1 and muscarinic receptors, which have shown in preclinical studies to reduce stress levels in the brain. It is currently undergoing a Phase 2a clinical trial for Alzheimer’s disease. A Phase 1 trial was successfully completed and showed no safety issues or toxicity signals. In the Phase 1 trial, a total of 22 healthy male volunteers received single, ascending oral doses of ANAVEX 2-73 to determine the maximum tolerated dose and investigate what, if any, side effects may result. ANAVEX 2-73 was well tolerated even at the highest-tested dose of 55 mg. Participants did not exhibit any serious side effects, nor was there any study discontinuation due to adverse events. In addition, ANAVEX 2-73 demonstrated a pharmacokinetics (PK) profile to potentially support once-daily oral dosing.
About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $450 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
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 and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently 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 successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models. 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Last updated 12/26/2016 - 4.09
Anavex to Present at 4th Annual OktoberINVESTfest Conference
Oct 12, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 12, 2015 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX:AVXL) today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the 4th annual OktoberINVESTfest investors conference on Tuesday, October 13, 2015 at 2:30 p.m. ET. The Conference will be held at The New York Academy of Sciences in New York City.
In his presentation, Dr. Missling will provide an overview of Anavex’s ongoing Phase 2a clinical trial of ANAVEX™ 2-73 in Alzheimer’s patients. Full PART A and preliminary PART B Phase 2a clinical trial data will be presented at the CTAD conference on November 7, 2015.
OktoberINVESTfest brings together US and German investors, innovators, industry leaders, Bavarian state representatives as well as a number of innovative North American and German companies. The resulting business and investment ties will deepen transatlantic relations and encourage economic and scientific exchange.
* Anavex’s stock is temporarily trading under the ticker AVXLD.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A and preliminary PART B Phase 2a clinical trial data will be presented at CTAD in November 2015. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and antidepressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex™ Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex™ Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex to Present Interim Phase 2a Clinical Trial Data of ANAVEX 2-73 at Late-Breaking Oral Session of CTAD 2015 Conference
Oct 07, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 07, 2015 (GLOBE NEWSWIRE) -- 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 announced the presentation of full PART A data and preliminary PART B data from the ongoing Phase 2a clinical trial of ANAVEX 2-73 at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference in Barcelona, Spain from November 5-7, 2015. The late-breaking oral session will be presented by the trial’s Principal Investigator, Stephen Macfarlane, FRANZCP, Director and Associate Professor, Aged Psychiatry at Caulfield Hospital in Melbourne, Australia.
Presentation Details
Title: New Exploratory Alzheimer's Drug ANAVEX 2-73: Assessment of Safety and
Cognitive Performance in a Phase 2a Study in mild-to-moderate Alzheimer's
Patients
Date/Time: Saturday, November 7, 2015
9:45 a.m. Central European Time (3:45 a.m. Eastern Time)
Location: Gran Hotel Princesa Sofia, Barcelona, Spain
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is a simple randomized, open-label, two-period, cross-over, adaptive trial lasting up to 36 days for each patient. PART B is an open-label extension for an additional 52 weeks.
The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73. Secondary trial objectives include exploratory cognitive efficacy using mini-mental state examination score (MMSE), dose response, bioavailability, Cogstate and electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), as well as the relationship of ANAVEX 2-73 as an add-on therapy to donepezil (Aricept®).
Additional information regarding the ongoing Phase 2a clinical trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About ANAVEX 2-73
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation. Preclinical data indicates that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015. Full PART A data and preliminary PART B data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
CORRECTING and REPLACING -- Anavex Prepares for Uplisting to NASDAQ, Announces Reverse Stock Split
Oct 06, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 06, 2015 (GLOBE NEWSWIRE) -- 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 announced that it is finalizing an application to uplist trading of its common stock to the NASDAQ Capital Market. To meet the conditions of a NASDAQ listing, the Company announces a one-for-four (1-for-4) reverse stock split of its authorized, issued and outstanding common shares. The Company's common stock will begin trading on a post-split basis at the opening of trading on October 7, 2015.
“It is our belief that uplisting to a major exchange will allow a broader base of worldwide institutions, funds and retail investors to participate in our future success,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This reverse stock split will help us meet the conditions to finalize our application for uplisting to NASDAQ.”
Following the reverse stock split, every four shares of issued and outstanding common stock will be converted to one post-reverse split share. All fractional shares will be rounded up to the nearest whole share.
The reverse stock split will reduce the authorized shares of common stock from 400,000,000 prior to the split to 100,000,000 after the reverse stock split.
As of October 7, Anavex common stock will trade under the ticker symbol AVXLD for a period of 20 business days. After that time or earlier once NASDAQ approves the uplisting requirements, the “D” will be removed and our Company's symbol will once again be AVXL. A new CUSIP number will be assigned to the Company's common stock as a result of the reverse split.
Shareholders should direct any questions concerning the reverse split to their bank or broker or the Company's transfer agent, Nevada Agency and Trust at +1 (775) 322-0626.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Prepares for Uplisting to NASDAQ, Announces Reverse Stock Split
Oct 06, 2015
OTC Disclosure & News Service
-
NEW YORK, Oct. 06, 2015 (GLOBE NEWSWIRE) -- 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 announced that it is finalizing an application to uplist trading of its common stock to the NASDAQ Capital Market. To meet the conditions of a NASDAQ listing, the Company announces a one-for-four (1-for-4) reverse stock split of its authorized, issued and outstanding common shares. The Company's common stock will begin trading on a post-split basis at the opening of trading on October 7, 2015.
“It is our belief that uplisting to a major exchange will allow a broader base of worldwide institutions, funds and retail investors to participate in our future success,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This reverse stock split will help us meet the conditions to finalize our application for uplisting to NASDAQ.”
Following the reverse stock split, every four shares of issued and outstanding common stock will be converted to one post-reverse split share. All fractional shares will be rounded up to the nearest whole share.
The reverse stock split will reduce the issued and outstanding shares of common stock from 400,000,000 prior to the split to 100,000,000 after the reverse stock split.
As of October 7, Anavex common stock will trade under the ticker symbol AVXLD for a period of 20 business days. After that time or earlier once NASDAQ approves the uplisting requirements, the “D” will be removed and our Company's symbol will once again be AVXL. A new CUSIP number will be assigned to the Company's common stock as a result of the reverse split.
Shareholders should direct any questions concerning the reverse split to their bank or broker or the Company's transfer agent, Nevada Agency and Trust at +1 (775) 322-0626.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Completes Patient Enrollment for Phase 2a Alzheimer’s Trial Ahead of Schedule
Sep 28, 2015
OTC Disclosure & News Service
-
NEW YORK, Sept. 28, 2015 (GLOBE NEWSWIRE) -- 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 announced that patient enrollment for the Phase 2a clinical trial of ANAVEX 2-73 has been completed ahead of schedule. With the Phase 2a trial now fully enrolled, Anavex expects to release topline data for PART A before the end of the year.
“There has been significant interest in our Phase 2a Alzheimer’s trial and full enrollment is an important step forward. We are delighted to be ahead of schedule and thank the patients and their families for their participation,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to the full ANAVEX 2-73 Phase 2a trial results and our team is excited to continue moving this clinical program forward.”
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation.
About the ANAVEX 2-73 Phase 2a Study
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients has enrolled 32 patients. It started in January 2015 and all the 32 patients, most who are also taking donepezil, have initiated PART A of the two-part trial.
Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 52 weeks, with daily oral dosing so as to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
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 Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For further information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex to Present at 2015 Ladenburg Thalmann Healthcare Conference
Sep 23, 2015
OTC Disclosure & News Service
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NEW YORK, Sept. 23, 2015 (GLOBE NEWSWIRE) -- 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 announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the Ladenburg Thalmann 2015 Healthcare Conference on Tuesday, September 29, 2015 at 4 p.m. ET in Track 1. The conference will be held at the Sofitel Hotel in New York City.
Management plans to be available for one-on-one meetings with members of the investment community at the conference. Attendees are invited to contact Anavex at ir@anavex.com to request a meeting with management.
A live audio webcast of the presentation will be available under the conference website at http://wsw.com/webcast/ladenburg/avxl. Investors may also view an archived version of the presentation on 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. Anavex’s lead drug candidate, ANAVEX 2-73 is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Appoints International Alzheimer’s Expert to Scientific Advisory Board
Sep 21, 2015
OTC Disclosure & News Service
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NEW YORK, Sept. 21, 2015 (GLOBE NEWSWIRE) -- 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 announced the appointment of Harald Hampel, MD, MA, PhD, MSc, to the Company’s Scientific Advisory Board. An internationally recognized expert on Alzheimer’s and related neurodegenerative diseases, Dr. Hampel is Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, the leading university in science, technology and medicine in France. The AXA-UPMC Chair is hosted within the highly specialized Institute for Memory and Alzheimer’s Disease (IM2A), a reference center for Alzheimer’s and other neurodegenerative diseases, and affiliated with a leading neuroscience institution, the Brain and Spine Institute (ICM), as well as the Department of Neurology at the Pitié-Salpétrière University Hospital.
“We are excited to welcome Harald as a Scientific Advisor. He has conducted more than 50 clinical trials over the past 20 years and is recognized as a world-leading researcher who has developed international programs focused on Alzheimer’s therapy, diagnosis and the development of biological and imaging biomarkers, including his current work as AXA-UPMC Chair, which aims to improve early detection at the preclinical ‘silent stage’ before the onset of any clinical signs and symptoms,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We believe Harald’s vast knowledge of Alzheimer’s, his experience and interest in drug development, and focus on early detection, diagnosis and intervention complement our therapeutic approach and offer significant value as we advance ANAVEX 2-73 through the clinic.”
After a post-doctoral fellowship focused on structural and functional neuroimaging of the healthy aging and Alzheimer's disease brain at the NIH/NIA Laboratory of Neurosciences in Bethesda, MD, Dr. Hampel became founding director of the Alzheimer Memorial Center and Professor of Psychiatry at the University of Munich. In 2006, he was appointed as a Professor and Chair of Psychiatry at Trinity College, University of Dublin, Ireland. During this time, he was a leading Principal Investigator at the Trinity College Institute of Neuroscience (TCIN). In 2010, Dr. Hampel was appointed as Professor, Chair and Head of Department of Psychiatry and Co-Director of the Brain Imaging Center (BIC) at the University of Frankfurt.
“I am impressed with Anavex and its potential CNS platform drug, ANAVEX 2-73, which has shown promising interim clinical data from its Phase 2a Alzheimer’s trial,” said Dr. Hampel. “Anavex has also assembled an impressive team of business and scientific leaders, which I am delighted to join. I look forward to advising the company as it continues to focus on developing drugs that meet significant unmet needs in Alzheimer’s and other indications.”
Dr. Hampel has published more than 500 peer-reviewed research papers, 80 book chapters and eight books, many in world-leading scientific journals, such as the New England Journal of Medicine, JAMA, The Lancet, The Lancet Neurology, Nature Genetics, Nature Reviews Drug Discovery and Nature Reviews Neurology. He has won numerous awards for his scientific work on healthy and diseased brains as well as biomarker and therapy discovery in Alzheimer’s. Additionally, Dr. Hampel has been a reviewer for leading international scientific journals and funding agencies in the US, Canada and Europe and is Senior Associate Editor of the leading international Alzheimer’s journal Alzheimer's & Dementia, the journal of the Alzheimer's Association.
He obtained his MD and PhD at the University of Munich. Dr. Hampel also holds an MSc from Cologne University and an MA from Trinity College at the University of Dublin.
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 and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently 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 successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Reports Fiscal Third Quarter 2015 Financial Results
Aug 17, 2015
OTC Disclosure & News Service
-
NEW YORK, Aug. 17, 2015 (GLOBE NEWSWIRE) -- 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 nine months ended June 30, 2015.
Financial Highlights:
Anavex had cash and cash equivalents of approximately $8.0 million as of June 30, 2015, compared with approximately $6.3 million as at March 31, 2015. Approximately $3.0 million was raised as a result of warrants exercised during the quarter. Cash was used in operations and for the advancement of clinical trial work. The Company has sufficient cash for approximately two years.
Operating expenses for the third quarter of fiscal year 2015 were approximately $1.5 million, compared to approximately $1.0 million for the quarter ended June 30, 2014. The increase was primarily attributable to higher research and development expenses in the current period, mainly related to the ongoing Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS.
“We are pleased with our progress to date,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Our Phase 2a clinical trial of ANAVEX 2-73 for the treatment of Alzheimer’s disease is progressing on schedule, with PART A expected to be completed by the end of the year. Additionally, we are expanding PART B, the extension period, from 26 to 52 weeks based on positive initial clinical data and at the request of study participants. In parallel, we are conducting preclinical work with other disease indications including Parkinson’s, which is being funded by a grant from the Michael J. Fox Foundation for Parkinson’s Research.”
Recent Achievements
On August 12, 2015, Anavex announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. Upon issuance, the patent will provide intellectual property protection until at least 2030. The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.
On August 10, 2015, Anavex announced that it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX 2-73 for the treatment of Parkinson’s disease. The MJFF grant is expected to fully fund a preclinical study worth $286,456 on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model, which seeks to provide a solid dataset that will justify moving forward to clinical development. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
On July 22, 2015, Anavex announced initial Phase 2a study data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. ANAVEX 2-73 showed positive cognitive effects in 83 percent (10/12) of patients during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately four times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
On June 18, 2015, Anavex announced the appointment of Steffen Thomas, PhD, to its Board of Directors. Dr. Thomas has 15 years of experience in intellectual property, patent law and proprietary technology rights as well as significant expertise in small molecule pharmaceuticals. Dr. Thomas is currently a patent attorney, European patent attorney and European trademark attorney at Epping Hermann Fischer, a major European intellectual property law firm.
On May 21, 2015, Anavex said it is encouraged by recent data published in the Proceedings of the National Academy of Sciences. The research determines that activating the sigma-1 receptor with agonists can potentially reduce the devastating impact of tau dysfunction. Alzheimer’s is the most widely recognized neurodegenerative disease associated with the aggregation of tau protein in the brain, with others including progressive supranuclear palsy (PSP) and frontotemporal dementia. It has been previously reported that ANAVEX 2-73, targeting the sigma-1 receptor in a dose-dependent study, blocked tau and amyloid-beta proteins as well as memory deficits in a mouse model of Alzheimer’s disease.
On May 18, 2015, Anavex announced that full preclinical anti-seizure data for ANAVEX 2-73 was revealed in a presentation on Friday, May 15, 2015 at the Antiepileptic Drug Trials XIII Conference. ANAVEX 2-73 demonstrated convincing data in three well-established and, according to experts, highly predictive preclinical anti-seizure models with a potentially more favorable side effect profile than currently marketed epilepsy drugs. The cognitive-enhancing features of ANAVEX 2-73 might be a differentiating factor since seizures cause neuro-cognitive impairments, which can be worsened by current epilepsy medications. The strong performance of ANAVEX 2-73 was also confirmed in combination with three generations of epilepsy drugs currently on the market.
The financial information for the three and nine months ended June 30, 2015 should be read in conjunction with the Company’s interim consolidated financial statements, which have been filed on the 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 and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently 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 successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED BALANCE SHEETS
ASSETS
June 30, September 30,
2015 2014
Current
Cash $ 7,961,331 $ 7,262,138
Prepaid expenses 16,054 89,117
Total current assets 7,977,385 7,351,255
Equipment 1,501 2,247
Total assets $ 7,978,886 $ 7,353,502
LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities $ 1,259,051 $ 1,249,084
Promissory notes payable 92,516 192,065
Total current liabilities 1,351,567 1,441,149
Non-interest bearing liabilities 57,962 5,719,727
Total liabilities 1,409,529 7,160,876
Common stock 86,217 47,201
Additional paid-in capital 65,030,871 52,078,750
Common stock to be issued 777,415 640,000
Accumulated deficit (59,325,146 ) (52,573,325 )
Total stockholders' equity 6,569,357 192,626
Total liabilities and stockholders' equity $ 7,978,886 $ 7,353,502
ANAVEX LIFE SCIENCES CORP.
INTERIM STATEMENTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2015
2015 2014
OPERATING EXPENSES
Research and development $ 799,462 $ 265,015
General and administrative 713,498 733,818
Total operating expenses 1,512,960 998,833
OPERATING LOSS (1,512,960 ) (998,833 )
OTHER INCOME
Interest and finance expenses, net 1,254 (8,492 )
Financing related charges and adjustments (2,716,640 ) 5,420
Foreign exchange loss (11,898 ) (7,185 )
Total other income (2,727,284 ) (10,257 )
NET LOSS $ (4,240,244 ) $ (1,009,090 )
NET LOSS PER COMMON SHARE
BASIC $ (0.06 ) $ (0.03 )
DILUTED $ (0.06 ) $ (0.03 )
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
BASIC 76,380,219 39,260,098
DILUTED 76,380,219 39,260,098
2015 2014
Net loss and comprehensive loss - GAAP basis $ (4,240,244 ) $ (1,009,090 )
Add back:
Non-cash financing related charges and adjustments 2,716,640 (5,420 )
Net loss and comprehensive loss - Non-GAAP basis $ (1,523,604 ) $ (1,014,510 )
NET LOSS PER COMMON SHARE
BASIC $ (0.02 ) $ (0.03 )
DILUTED $ (0.02 ) $ (0.03 )
ANAVEX LIFE SCIENCES CORP.
INTERIM STATEMENTS OF OPERATIONS
NINE MONTHS ENDED JUNE 30, 2015
2015 2014
OPERATING EXPENSES
Research and development $ 1,525,233 $ 388,347
General and administrative 1,616,744 1,941,261
Total operating expenses 3,141,977 2,329,608
OPERATING LOSS (3,141,977 ) (2,329,608 )
OTHER INCOME
Interest and finance expenses, net (73,527 ) (16,858 )
Financing related charges and adjustments (3,591,346 ) 687,409
Foreign exchange loss 55,029 (10,256 )
Total other income (3,609,844 ) 660,295
NET LOSS $ (6,751,821 ) $ (1,669,313 )
NET LOSS PER COMMON SHARE
BASIC $ (0.11 ) $ (0.04 )
DILUTED $ (0.11 ) $ (0.04 )
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
BASIC 61,752,000 38,218,237
DILUTED 61,752,000 38,218,237
2015 2014
Net loss and comprehensive loss - GAAP basis $ (6,751,821 ) $ (1,669,313 )
Add back:
Non-cash financing related charges and adjustments 3,591,346 (687,409 )
Net loss and comprehensive loss - Non-GAAP basis $ (3,160,475 ) $ (2,356,722 )
NET LOSS PER COMMON SHARE
BASIC $ (0.05 ) $ (0.06 )
DILUTED $ (0.05 ) $ (0.06 )
Contacts:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Copyright © 2015 GlobeNewswire. All Rights Reserved
The above news release has been provided by the above company via the OTC Disclosure and News Service. Issuers of news releases and not OTC Markets Group Inc. are solely responsible for the accuracy of such news releases.
Anavex Awarded Grant From The Michael J. Fox Foundation for Parkinson’s Research
Aug 10, 2015
OTC Disclosure & News Service
-
NEW YORK, Aug. 10, 2015 (GLOBE NEWSWIRE) -- 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 announced that it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX 2-73 for the treatment of Parkinson’s disease.
The MJFF grant is expected to fully fund a preclinical study on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model, which seeks to provide a solid dataset that will justify moving forward to clinical development in Parkinson’s. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
As a potential platform drug and the Company’s lead therapeutic, ANAVEX 2-73 targets misfolded proteins central to many neurodegenerative diseases, including Parkinson’s and Alzheimer’s. It is believed to enhance the body's own cellular defense mechanisms through both sigma-1 and muscarinic receptors to return diseased cells to a pre-diseased or “homeostatic” state.
“The development of disease-modifying therapies for Parkinson’s disease is the top priority of The Michael J. Fox Foundation and ANAVEX 2-73 presents a promising approach,” said Marco Baptista, PhD, Senior Associate Director of MJFF Research Programs. “Companies that receive funding from MJFF have scientifically compelling plans that hold obvious potential to impact our understanding of Parkinson’s and ultimately the development of improved treatments for people with the disease. To that end, we look forward to the results of the ANAVEX 2-73 study.”
“If successful, this study will accelerate the translation of preclinical findings into the very first clinical trial of ANAVEX 2-73 as a potential disease-modifying therapy for Parkinson’s disease,” said Angela Cenci, MD, PhD, and Professor at Lund University, where the study will be conducted. “We are in the fortunate position that ANAVEX 2-73 has already been tested for safety and tolerability in humans, and was found to be a good clinical drug candidate.”
“Anavex is honored to have The Michael J. Fox Foundation for Parkinson’s Research support the development of our technology and we are pleased to be collaborating with such a prestigious organization,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We hope this research will lead to improved therapies that can maximize the benefits and minimize side effects for Parkinson's patients. After reporting positive initial data last month in our ongoing ANAVEX 2-73 Phase 2a clinical trial in Alzheimer’s patients, we expect the trial to be fully enrolled and to have PART A completed by the end of the year. Our work with MJFF underscores our unwavering commitment to delivering new medications for neurological disorders characterized by deposits of misfolded proteins, including both Parkinson's and Alzheimer's diseases.”
The preclinical study of ANAVEX 2-73 in Parkinson’s disease will be conducted at Lund University in Sweden under supervision of Professor Angela Cenci, MD, PhD.
About Parkinson's Disease
Parkinson’s disease is a chronic and progressive neurological disorder that is characterized by well-known motor symptoms including tremors, stiffness of limbs, slowness of movements, and difficulties with posture and balance, as well as by non-motor symptoms. It is the second most common neurological disorder and approximately one million people in the United States, and from four to six million people worldwide, live with this disease. Parkinson’s disease is more common in people over 60 years of age and its prevalence is expected to increase significantly as the average age of the population increases. Current Parkinson’s treatments are only effective in managing symptoms of the disease, mainly through the use of levodopa and dopamine agonists. As the disease progresses and dopaminergic neurons continue to be lost, these drugs eventually become less effective at treating the symptoms.
About ANAVEX 2-73
ANAVEX 2-73 is an orally available small molecule that targets sigma-1 and muscarinic receptors, which have shown in preclinical studies to reduce stress levels in the brain. It is currently undergoing a Phase 2a clinical trial for Alzheimer’s disease. A Phase 1 trial was successfully completed and showed no safety issues or toxicity signals. In the Phase 1 trial, a total of 22 healthy male volunteers received single, ascending oral doses of ANAVEX 2-73 to determine the maximum tolerated dose and investigate what, if any, side effects may result. ANAVEX 2-73 was well tolerated even at the highest-tested dose of 55 mg. Participants did not exhibit any serious side effects, nor was there any study discontinuation due to adverse events. In addition, ANAVEX 2-73 demonstrated a pharmacokinetics (PK) profile to potentially support once-daily oral dosing.
About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $450 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
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 and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently 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 successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models. 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. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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