Anavex Life Sciences Reports Fiscal 2019 First Quarter Financial Results And Provides Clinical Study Updates

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 diseases including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal 2019 first quarter.

“We are very pleased with the pace of enrollment for the novel genomic marker driven later-stage CNS precision medicine clinical studies in Parkinson’s disease dementia and Alzheimer’s disease. We are looking forward to continuous updates on enrollment for these studies as we advance into 2019,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

ANAVEX®2-73 Program Update:

Since enrollment started on October 30, 2018 for the Phase 2 ANAVEX®2-73 Parkinson’s disease dementia (PDD) study1, over one-third of the total patient enrollment target has been achieved to date.
Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study2 is proceeding as planned with over 80 patients screened to date.
Successfully submitted Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study3 to respective United States Institutional Review Boards (IRB) of the first three clinical trial sites.

1 ClinicalTrials.gov Identifier: NCT037744592 ClinicalTrials.gov Identifier: NCT037907093 ClinicalTrials.gov Identifier: NCT03758924

Financial Highlights:

Cash and equivalents of $20.7 million at December 31, 2018, compared to $22.9 million at September 30, 2018.
Cash used to fund operations for first quarter fiscal 2019 was $4.2 million, compared to $3.6 million for the comparative first quarter in fiscal 2018.
Operating expenses for first quarter fiscal 2019 of $7.5 million compared to $4.1 million for the comparative fiscal quarter. Research and development expenses increased as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73, and non-recurring expenses of approximately $1.0 million associated with large-scale manufacturing of ANAVEX®2-73 in quantities reserved for potential future commercial use.
Net loss for the quarter of $7.3 million, or $0.16 per share, compared to a net loss of $4.1 million, or $0.09 per share for the first quarter of fiscal 2018. The fiscal quarter in 2019 contains non-cash expenses of approximately $2.1 million and non-recurring expenses of approximately $1.0 million.

Recent Corporate Highlights:

January 2, 2019 – Anavex announced the appointment of Walter E. Kaufmann, MD as Chief Medical Officer (CMO). Dr. Kaufmann’s clinical focus is on developing novel therapies for genetic disorders associated with intellectual disability. A major focus of Dr. Kaufmann’s research has been Rett syndrome, a field where he has published extensively on neurobiology and clinical aspects.

The financial information for the fiscal quarter ended December 31, 2018 should be read in conjunction with the Company’s consolidated 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/avxl8.

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 48199094, 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 diseases 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, recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®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 Alzheimer’s disease. ANAVEX®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 Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 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 neuroinflammation and mitochondrial dysfunction. 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.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
Unaudited

Expressed in US Dollars	December 31,			September 30,
ASSETS	2018			2018
Current
Cash and cash equivalents	$	20,715,169		$	22,930,638
Sales tax recoverable		30,372			40,171
Prepaid expenses and deposits		1,155,958			1,251,798
Deferred financing charges		151,133			101,133
Deposits		43,047			-
Total current assets		22,095,679			24,323,740
Deposits		-			52,396
Total assets	$	22,095,679		$	24,376,136

LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities	$	4,875,895		$	3,884,626
Total liabilities		4,875,895			3,884,626
Common stock		46,888			45,935
Additional paid-in capital		133,438,276			129,377,542
Accumulated deficit		(116,265,380	)		(108,931,967	)
Total stockholders' equity		17,219,784			20,491,510
Total liabilities and stockholders' equity	$	22,095,679		$	24,376,136


ANAVEX LIFE SCIENCES CORP.
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017
(Unaudited)

		2018			2017
Operating Expenses
General and administrative	$	1,761,307		$	1,397,803
Research and development		5,712,210			2,694,312
Total operating expenses		7,473,517			4,092,115

Operating Loss		(7,473,517	)		(4,092,115	)
Other income
Grant income		74,528			-
Interest income, net		78,800			30,376
Foreign exchange gain (loss)		(4,507	)		11,979
Total other income		148,821			42,355
Net loss before income taxes		(7,324,696	)		(4,049,760	)
Income tax expense - current		(8,717	)		(9,405	)
Net loss	$	(7,333,413	)	$	(4,059,165	)

Net loss per Share
Basic and Diluted	$	(0.16	)	$	(0.09	)

Weighted Average Number of Shares Outstanding
Basic and Diluted		46,327,482			43,882,939