AVXL Anavex Life Sciences Corporation

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 year ended September 30, 2019.

“Anavex continues to make steady progress towards reaching several important milestones and is poised for an exciting 2020,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Bringing novel biomarker-driven CNS precision medicine therapies to patients with devastating rare diseases, as well as the largest unmet medical need of the aging population, Alzheimer’s and Parkinson disease has been the key vision for the development of ANAVEX®2-73 (blarcamesine) with multiple data read outs.”

ANAVEX®2-73 (blarcamesine) Program Update:

• The U.S. Food and Drug Administration (FDA) granted the Rare Pediatric Disease (RPD) designation for ANAVEX®2-73 (blarcamesine) for the treatment of Rett syndrome. The RPD designation provides the opportunity for the award of a pediatric review voucher at the time of marketing approval.
• To offer all participants access to ANAVEX®2-73 (blarcamesine) after completion of the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett syndrome study1 and the AVATAR Rett syndrome study2, 12-week and 48-week open-label extension studies, respectively were initiated. Currently 90% and 100% of eligible participants have continued into the corresponding extension studies.
• The international EXCELLENCE Rett syndrome study of ANAVEX®2-73 (blarcamesine) in pediatric patients was approved by the Australian Human Research Ethics Committee and is scheduled to initiate early 2020.
• Anavex Life Sciences presented data at the 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019 Conference reporting baseline-matched Real-World external control data of Alzheimer’s Disease Neuroimaging Initiative (ADNI) with ANAVEX®2-73 (blarcamesine) Phase 2a clinical data, demonstrating a significantly lower cognitive decline of the sufficiently dosed ANAVEX®2-73 (blarcamesine) Phase 2a study cohort compared to the ADNI control cohort at the interim 2-Year (104-Week) timepoint. Separately, abundance of Lachnospiraceae and Enterobacteriaceae families were identified as potential biomarkers of response from the 2-Year study interim clinical data analysis of ANAVEX®2-73 (blarcamesine).
• Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study3 is nearly 50% recruited. To offer all participants of the study access to ANAVEX®2-73 (blarcamesine) a voluntary 96-week open-label extension (ATTENTION-AD OLE study) was initiated and currently 95% of eligible participants have opted into the extension study.
• Enrollment for the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD) study4 is expected to be completed by the end of December 2019 with top-line data expected mid-2020. To offer all participants of the study access to ANAVEX®2-73 (blarcamesine), a voluntary 48-week open-label extension, including microbiome assessment, was initiated and currently 100% of eligible participants have opted into the extension study.

Financial Highlights:

• Cash and cash equivalents of $22.2 million at September 30, 2019, compared to $22.9 million at September 30, 2018.
• Operating expenses for fiscal 2019 of $29.1 million compared to $19.3 million for fiscal 2018. Research and development expenses increased as we continue to advance our clinical studies for ANAVEX®2-73 (blarcamesine).
• Net loss of $26.3 million, or $0.54 per share, compared to a net loss of $17.3 million, or $0.39 per share for fiscal 2018.

The financial information for the fiscal year ended September 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

Anavex will host a conference call and webcast today at 4:30 p.m. ET.

The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl11.

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 49249215, 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.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.

Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.

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
As at September 30, 2019 and 2018
Expressed in US Dollars
		2019			2018
ASSETS
Current
Cash and cash equivalents	$	22,185,630		$	22,930,638
Incentives and taxes receivable		2,642,745			1,870,357
Prepaid expenses and deposits		500,998			1,251,798
Total current assets		25,329,373			26,052,793
Deferred costs		-			101,133
Deposits		-			52,396
Total assets	$	25,329,373		$	26,206,322
LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable	$	3,523,332		$	2,955,293
Accrued liabilities		1,516,342			929,333
Total liabilities		5,039,674			3,884,626
Common stock		52,652			45,935
Additional paid-in capital		153,633,807			129,377,542
Accumulated deficit		(133,396,760	)		(107,101,781	)
Total stockholders' equity		20,289,699			22,321,696
Total liabilities and stockholders' equity	$	25,329,373		$	26,206,322

ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED STATEMENT OF OPERATIONS
Years ended September 30, 2019 and 2018
Expressed in US Dollars
		2019			2018
Operating Expenses
General and administrative	$	6,846,599		$	5,989,170
Research and development		22,260,349			13,344,421
Total operating expenses		29,106,948			19,333,591
Other income
Grant income		298,943			149,055
Research and development incentive income		2,465,691			1,830,186
Interest income, net		207,280			255,092
Gain on settlement of accounts payable		115,758			-
Financing related charges		(151,133	)		(30,943	)
Foreign exchange gain (loss)		(42,389	)		(49,789	)
Total other income		2,894,150			2,153,601
Net loss before income taxes		(26,212,798	)		(17,179,990	)
Income tax expense - current		(82,181	)		(72,746	)
Net loss	$	(26,294,979	)	$	(17,252,736	)
Net loss per Share
Basic and Diluted	$	(0.54	)	$	(0.39	)
Weighted Average Number of Shares Outstanding
Basic and Diluted		48,906,470			44,655,725

For Further Information:

Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email:  info@anavex.com

Investors & Media:Email:  ir@anavex.com

1 ClinicalTrials.gov Identifier: NCT037589242 ClinicalTrials.gov Identifier: NCT039414443 ClinicalTrials.gov Identifier: NCT037907094 ClinicalTrials.gov Identifier: NCT03774459