Anavex Life Sciences Provides Clinical Programs Update and Reports Fiscal First Quarter 2018 Financial Results
Wednesday, February 07, 2018 7:00:09 AM ET
Conference Call and Webcast Today at 4:30 p.m. ET
Anavex Life Sciences Corp. ("Anavex" or the "Company") (AVXL ), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimers disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for the three months ended December 31, 2017.
The Company also provided an update on its most advanced clinical programs for ANAVEX(R)2-73 for the treatment of Alzheimers disease, Rett syndrome, and Parkinsons disease.
ANAVEX(R)2-73 Programs Update:
The Company has completed both RNA and whole exome DNA genome sequencing from ANAVEX(R)2-73-treated patients utilizing Illumina HiSeq 2500 Next Generation Sequencing (NGS) technology. The analysis of this data has characterized several genomic alterations in well-characterized targets that have the potential to be used as biomarkers, which the Company plans to use to identify optimal patients in forthcoming clinical trials. This novel, precision-medicine approach will enable enriched clinical trial populations, more robust regulatory submissions and better characterized clinical trial designs. Full details of the genomic sequencing analysis have been submitted for presentation at an upcoming scientific meeting.
In consideration of the new genomic results, the investigational new drug application (IND) filing for ANAVEX(R)2-73 for the treatment of Rett syndrome will be updated and submitted during the current quarter to include this data. The FDA previously granted ANAVEX(R)2-73 orphan drug designation for the treatment of Rett syndrome. Start-up activities with clinical trial sites are underway to be prepared to dose the first patient following FDA approval of the updated IND.
Additionally, with the availability of this new genome sequencing information, the Company plans to submit an IND to the FDA within the first half of this year for the planned Alzheimers Phase 2/3 study. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and efficacy of ANAVEX(R)2-73 in Alzheimers disease patients and will be conducted in both Australia and North America. The Company is planning to use a similar process and trial design for the Parkinsons disease Phase 2 study, for which the clinical site validation has been completed.
"We believe Anavex is pioneering the inclusion of advanced genomic biomarkers into late-stage CNS precision medicine trials, including our Rett syndrome, Alzheimers disease and Parkinsons disease trials. It was a strategic decision to start the new clinical trials after genetic data were collected and analyzed. We are expecting to leverage these important findings to more precisely target patients based on specific genomic profiles that may be highly responsive to ANAVEX(R)2-73," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "This should allow us to improve upon existing trial designs and expedite other aspects of our clinical development program."
-- Cash and equivalents of $28.0 million at December 31, 2017, compared to $27.4 million at September 30, 2017.
-- Cash utilized in operations was $3.6 million for the first quarter of fiscal 2018, compared to $3.2 million for the comparative quarter in fiscal 2017.
-- Operating expenses of $4.1 million for the first quarter of fiscal 2018 compared to $3.2 million for the comparative quarter in fiscal 2017. The increase in operating expenses is primarily attributable to an increase in research and development activities due to a ramp up of expenses incurred in preparation for upcoming clinical trials.
-- Net loss for the first quarter of fiscal 2018 of $4.1 million, or $0.09 per share, compared to a net loss of $3.1 million, or $0.08 per share for the comparative quarter in fiscal 2017.
Recent Corporate Highlights:
-- January 16, 2018 - Anavex reported that the peer-reviewed scientific journal The Journal of Clinical Hypertension published a post-hoc analysis of blood pressure data collected during the Phase 2a study in mild-to-moderate Alzheimers disease patients demonstrating that ANAVEX(R)2-73 seems to normalize systolic blood pressure (SBP) in a patient population with risk for hypertension.
The financial information for three months ended December 31, 2017, should be read in conjunction with the Companys condensed 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
Anavex will host a conference call at 4:30 p.m. ET today, February 7, 2018.
The live webcast of the conference call can be accessed online at http://wsw.com/webcast/cc/avxl4 . To listen to the live call by phone, 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 46430090. A replay of the call will be available approximately one hour after the end of the call at www.anavex.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (AVXL ) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimers disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavexs lead drug candidate, ANAVEX(R)2-73, recently completed a successful a Phase 2a clinical trial for Alzheimers disease. ANAVEX(R)2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimers disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinsons Research has awarded Anavex a research grant to develop ANAVEX(R)2-73 for the treatment of Parkinsons disease. The grant fully funds a preclinical study, which could justify moving ANAVEX(R)2-73 into a Parkinsons disease clinical trial. ANAVEX(R)3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimers hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.
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 Companys 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.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
December 31, September 30,
ASSETS 2017 2017
Cash and cash equivalents $ 28,048,644 $ 27,440,257
Sales tax recoverable 7,377 9,748
Prepaid expenses and deposits 235,390 335,928
Total current assets 28,291,411 27,785,933
Deposits 52,396 52,396
Total assets $ 28,343,807 $ 27,838,329
LIABILITIES AND STOCKHOLDERS EQUITY
Accounts payable and accrued liabilities $ 2,798,472 $ 3,584,334
Total liabilities 2,798,472 3,584,334
Common stock 44,423 43,332
Additional paid-in capital 121,038,635 115,689,221
Accumulated deficit (95,537,723 ) (91,478,558 )
Total stockholders equity 25,545,335 24,253,995
Total liabilities and stockholders equity $ 28,343,807 $ 27,838,329
ANAVEX LIFE SCIENCES CORP.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2017 AND 2016
General and administrative $ 1,397,803 $ 1,126,184
Research and development 2,694,312 2,042,490
Total operating expenses 4,092,115 3,168,674
Operating Loss (4,092,115 ) (3,168,674 )
Grant income - 35,286
Interest income, net 30,376 3,655
Foreign exchange gain 11,979 14,082
Total other income 42,355 53,023
Net loss before income taxes (4,049,760 ) (3,115,651 )
Income tax expense - current (9,405 ) (31,008 )
Net loss $ (4,059,165 ) $ (3,146,659 )
Net loss per Share
Basic and Diluted $ (0.09 ) $ (0.08 )
Weighted Average Number of Shares Outstanding
Basic and Diluted 43,882,939 38,393,910
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Investors & Media:
The Trout Group
Tel: (646) 378-2900
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