Nice move up today on news, copied below for the r
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Posted On: 08/07/2019 10:54:27 AM
Nice move up today on news, copied below for the record.
NEW YORK, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal 2019 third quarter.
“We remain focused on our core strategic goal of bringing novel biomarker driven CNS precision medicine therapies to patients with devastating rare diseases, as well as the largest unmet medical need of aging population, Alzheimer’s and Parkinson disease, as quickly as possible. We are very pleased with the execution of advancing our pipeline and look forward to providing updates on four clinical programs by year end,” said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 (blarcamesine) Program Update:
Enrollments for the U.S. Phase 2 Rett syndrome study1 and the AVATAR Rett syndrome study2 of ANAVEX®2-73 (blarcamesine) are advancing with high priority.
The independent Data Safety Monitoring Board (DSMB) for the U.S. Phase 2 Rett syndrome study of ANAVEX®2-73 (blarcamesine) completed its recent pre-planned review of the preliminary Phase 2 efficacy and safety data. Upon review of the most recent data, the DSMB made the recommendation to continue the study without modification.
The enrollment of the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD) study3 is proceeding well and is getting closer to reach completion. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is in preparation including microbiome assessment.
Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study4 is proceeding as scheduled. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is planned.
A recent peer-reviewed scientific publication titled, Neuronal Sigma-1 receptors: signaling functions and protective roles in neurodegenerative diseases, details the mechanism of action of Sigma-1 receptors (S1R) and references ANAVEX®2-73 among the relevant S1R ligands. The paper summarizes: “In conclusion, S1R is incredibly versatile in its ability to foster neuronal homeostasis in the context of several neurodegenerative disorders.”5
Financial Highlights:
Cash and cash equivalents of $21.2 million at June 30, 2019, compared to $22.9 million at September 30, 2018.
Existing cash and cash equivalents, along with existing financial commitments from third parties, are sufficient to meet cash utilization for in excess of two years.
Operating expenses for third quarter fiscal 2019 of $7.1 million compared to $4.6 million for the comparative fiscal quarter. Research and development expenses have increased in the current fiscal year as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73 (blarcamesine).
Net loss for the quarter of $7.1 million, or $0.14 per share, compared to a net loss of $2.8 million, or $0.06 per share for the third quarter of fiscal 2018.
The financial information for the fiscal quarter ended June 30, 2019 should be read in conjunction with the Company’s consolidated interim financial statements, which will appear on EDGAR and will be available on the Anavex website at www.anavex.com.
Conference Call / Webcast Information
The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl10.
To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 48906457, followed by the pound sign (#).
A replay of the conference call will also be available on www.anavex.com approximately one hour after the call.
NEW YORK, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal 2019 third quarter.
“We remain focused on our core strategic goal of bringing novel biomarker driven CNS precision medicine therapies to patients with devastating rare diseases, as well as the largest unmet medical need of aging population, Alzheimer’s and Parkinson disease, as quickly as possible. We are very pleased with the execution of advancing our pipeline and look forward to providing updates on four clinical programs by year end,” said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 (blarcamesine) Program Update:
Enrollments for the U.S. Phase 2 Rett syndrome study1 and the AVATAR Rett syndrome study2 of ANAVEX®2-73 (blarcamesine) are advancing with high priority.
The independent Data Safety Monitoring Board (DSMB) for the U.S. Phase 2 Rett syndrome study of ANAVEX®2-73 (blarcamesine) completed its recent pre-planned review of the preliminary Phase 2 efficacy and safety data. Upon review of the most recent data, the DSMB made the recommendation to continue the study without modification.
The enrollment of the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD) study3 is proceeding well and is getting closer to reach completion. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is in preparation including microbiome assessment.
Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study4 is proceeding as scheduled. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is planned.
A recent peer-reviewed scientific publication titled, Neuronal Sigma-1 receptors: signaling functions and protective roles in neurodegenerative diseases, details the mechanism of action of Sigma-1 receptors (S1R) and references ANAVEX®2-73 among the relevant S1R ligands. The paper summarizes: “In conclusion, S1R is incredibly versatile in its ability to foster neuronal homeostasis in the context of several neurodegenerative disorders.”5
Financial Highlights:
Cash and cash equivalents of $21.2 million at June 30, 2019, compared to $22.9 million at September 30, 2018.
Existing cash and cash equivalents, along with existing financial commitments from third parties, are sufficient to meet cash utilization for in excess of two years.
Operating expenses for third quarter fiscal 2019 of $7.1 million compared to $4.6 million for the comparative fiscal quarter. Research and development expenses have increased in the current fiscal year as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73 (blarcamesine).
Net loss for the quarter of $7.1 million, or $0.14 per share, compared to a net loss of $2.8 million, or $0.06 per share for the third quarter of fiscal 2018.
The financial information for the fiscal quarter ended June 30, 2019 should be read in conjunction with the Company’s consolidated interim financial statements, which will appear on EDGAR and will be available on the Anavex website at www.anavex.com.
Conference Call / Webcast Information
The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl10.
To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 48906457, followed by the pound sign (#).
A replay of the conference call will also be available on www.anavex.com approximately one hour after the call.
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