Anavex Life Sciences Reports Fiscal 2017 Financial Results And Provides Update On Therapeutic Programs
Monday, December 11, 2017 7:00:26 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, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the fiscal year ended September 30, 2017.
The Company also provided an update on its most advanced programs for ANAVEX(R)2-73 for the treatment of Rett syndrome (RTT), a severe neurological disorder caused by mutations in the X-linked gene MECP2 (methyl-CpG-binding protein 2), Alzheimers disease and Parkinsons disease.
"We are entering fiscal 2018 with our strongest balance sheet to date, which allows the Company to carry out planned clinical studies for ANAVEX(R)2-73. This year has been an extraordinarily productive period for Anavex, with advanced preparation underway for studies in Rett syndrome, Alzheimers disease and Parkinsons disease - all indications with high unmet need," said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "The upcoming year will be focused on deploying key programs through clinical trials, with the anticipation of a number of data readouts in 2018."
ANAVEX(R)2-73 Program Update:
-- The Company filed an IND for ANAVEX(R)2-73 in Rett syndrome, for which the Company received orphan drug designation by the FDA, and is expecting feedback from the FDA to finalize the clinical trial protocol for this study. As start-up activities with clinical trial sites have been underway, the Company anticipates dosing the first patient in due course following FDA approval of the IND.
-- With the integration of genome sequencing information from ANAVEX(R)2-73-treated patients, the Company is now able to enhance the planned Alzheimers Phase 2/3 study. It is expected that incorporating this novel precision medicine approach as well as including comprehensive fluid-based biomarkers and multimodal neuroimaging, will enable a more robust regulatory submission, anticipated within the upcoming quarter. The randomized, double-blind, placebo-controlled study will be aimed at evaluating the safety, tolerability and efficacy of ANAVEX(R)2-73 in Alzheimers disease patients and will be conducted in both Australia and North America. Further details of the study will be shared in upcoming announcements.
-- Due the strength of the preclinical Parkinsons disease data on ANAVEX(R)2-73 from a collaboration with Michael J. Fox Foundation, Anavex plans to file an upcoming clinical trial application (CTA) with European regulatory authorities to conduct a Phase 2 trial for ANAVEX(R)2-73 in Parkinsons disease patients.
-- Cash and equivalents of $27.4 million at September 30, 2017, compared to $9.2 million at September 30, 2016.
-- Cash used to fund operations was $9.0 million for the 2017 fiscal year, compared to $9.2 million for the comparative 2016 fiscal year. This is in line with the Companys cash utilization guidance, after adjusting for tax incentive income of $2.0 million.
-- Operating expenses of $15.7 million for the 2017 fiscal year compared to $15.6 million for the comparative 2016 fiscal year. The results included a 47% increase in research and development expenditures over the comparative year. The increase was associated with expenditures incurred in preparation of our planned clinical studies, and an increase in preclinical activities for ANAVEX(R)3-71 and ANAVEX(R)1066.
-- Net loss for the 2017 fiscal year of $13.5 million, or $0.33 per share, compared to a net loss of $14.7 million, or $0.42 per share for the comparative 2016 fiscal year.
-- November 4, 2017 - Anavex presented pharmacokinetic (PK) and pharmacodynamic (PD) data for ANAVEX(R)2-73 in a late-breaking oral presentation at the 2017 Clinical Trials on Alzheimers Disease (CTAD) Meeting. Data presented included new results from the Phase 2a study and data from the first year of the Phase 2a long-term extension study. Data from patients with the highest ANAVEX(R)2-73 concentrations pointed towards the continued ability of the compound to stop the decline in the exploratory secondary endpoints cognition (MMSE) and function (ADCS-ADL). In addition, ANAVEX(R)2-73 continued to demonstrate favorable safety and tolerability through 109 weeks.
-- October 12, 2017 - Anavex announced PK and PD data for ANAVEX(R)2-73 from its positive Phase 2a study in mild-to-moderate Alzheimers disease patients, which demonstrated a clear concentration-effect relationship between ANAVEX(R)2-73 and study measurements. The Company is identifying the best responders to ANAVEX(R)2-73 by using Ariana Pharmas KEM(R) advanced Artificial Intelligence technology. These data provide support to proceed with the clinical development of ANAVEX2-73 for Alzheimers disease using a precision medicine paradigm, including DNA whole exome sequencing, RNA expression and gut microbiome characterization.
-- October 30, 2017 - Anavex announced additional data for ANAVEX(R)2-73 in a model for experimental parkinsonism at The Michael J. Fox Foundations Parkinsons Disease Therapeutics Conference. These results support the notion that ANAVEX(R)2-73 is a promising clinical candidate for Parkinsons disease.
-- October 27, 2017 - Anavex announced additional preclinical data related to multiple sclerosis (MS) in which ANAVEX(R)2-73 demonstrated the potential to protect and repair myelin-forming cells at the 7th ECTRIMS-ACTRIMS Meeting MSPARIS2017.
The financial information for year ended September 30, 2017, should be read in conjunction with the Companys consolidated 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, December 11, 2017.
The live webcast of the conference call can be accessed online at http://wsw.com/webcast/cc/avxl3 .
To join the conference call live via telephone, dial the toll-free number: 1-(866) 939-3921 or 1-(678) 302-3550 from outside the United States. Please use confirmation number 46142537, followed by the pound sign (#). A replay of the conference call will also be available on 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. ANAVEX(R)2-73 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, 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.
CONSOLIDATED BALANCE SHEETS
ASSETS 2017 2016
Cash and cash equivalents $ 27,440,257 $ 9,186,814
Sales tax recoverable 9,748 79,347
Prepaid expenses and deposits 335,928 180,124
Total current assets 27,785,933 9,446,285
Deposits 52,396 52,396
Total assets $ 27,838,329 $ 9,498,681
LIABILITIES AND STOCKHOLDERS EQUITY
Accounts payable and accrued liabilities $ 3,584,334 $ 3,119,993
Deferred grant income - 70,532
Total liabilities 3,584,334 3,190,525
Common stock 43,332 36,169
Additional paid-in capital 115,689,221 84,290,140
Accumulated deficit (91,478,558 ) (78,018,153 )
Total stockholders equity 24,253,995 6,308,156
Total liabilities and stockholders equity $ 27,838,329 $ 9,498,681
ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2017, 2016, AND 2015
2017 2016 2015
General and administrative $ 5,008,275 $ 8,334,740 $ 4,836,978
Research and development 10,672,086 7,254,303 2,271,736
Total operating expenses 15,680,361 15,589,043 7,108,714
Operating Loss (15,680,361 ) (15,589,043 ) (7,108,714 )
Other income (expenses)
Grant income 140,942 141,195 -
Research and development incentive income 2,022,902 571,093 -
Interest income, net 88,098 11,322 (71,825 )
Gain on settlement of accounts payable 75,204 151,402 -
Gain on settlement of debt - 61,205 -
Financing related charges and adjustments - (5,812 ) (4,998,145 )
Foreign exchange gain (loss) (47,583 ) (48,445 ) 70,554
Total other income 2,279,563 881,960 (4,999,416 )
Net loss before income taxes (13,400,798 ) (14,707,083 ) (12,108,130 )
Income tax expense - current (59,607 ) (29,615 ) -
Net loss $ (13,460,405 ) $ (14,736,698 ) $ (12,108,130 )
Net loss per Share
Basic and Diluted $ (0.33 ) $ (0.42 ) $ (0.65 )
Weighted Average Number of Shares Outstanding
Basic and Diluted 40,841,033 35,153,426 18,584,820
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Investors & Media:
The Trout Group
Tel: (646) 378-2900
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