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 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 second quarter.

“We are very pleased with the progress we made related to enrollment for the novel genomic marker driven CNS precision medicine clinical studies in Parkinson’s disease dementia and Alzheimer’s disease and initiating a second Rett syndrome study,” said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

ANAVEX®2-73 Program Update:

• 70% of the total patient enrollment target has been achieved to date for the Phase 2 ANAVEX®2-73 Parkinson’s disease dementia (PDD) study1.
• Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study2 is proceeding as planned with over 20% patients enrolled to date.
• 40% of the total patient enrollment target has been achieved to date for the Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study3.
• Anavex received approval by the Australian Human Research Ethics Committee to initiate an approximately 30 patient Phase 2 double-blind, randomized, placebo-controlled, study of ANAVEX®2-73 for the treatment of Rett syndrome, called AVATAR study4. The AVATAR study is scheduled to initiate this quarter.

Financial Highlights:

• Cash and equivalents of $19.5 million at March 31, 2019, compared to $22.9 million at September 30, 2018.
• Cash used to fund operations for second quarter fiscal 2019 was $4.3 million, compared to $2.8 million for the comparative second quarter in fiscal 2018.
• Operating expenses for second quarter fiscal 2019 of $8.1 million compared to $4.7 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.
• Net loss for the quarter of $8.0 million, or $0.17 per share, compared to a net loss of $4.8 million, or $0.11 per share for the second quarter of fiscal 2018. The fiscal quarter in 2019 contains non-cash expenses of approximately $1.9 million.

The financial information for the fiscal quarter ended March 31, 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/avxl9.

To join the conference call live via telephone, interested parties within the U.S. should dial, toll-free, 1-866-866-1333 and international callers should dial 1-404-260-1421. Please use confirmation number 48595200, 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	March 31			September 30,
	ASSETS		2019			2018
	Current
	Cash and cash equivalents	$	19,457,845		$	22,930,638
	Sales tax recoverable		76,160			40,171
	Prepaid expenses and deposits		849,642			1,251,798
	Deferred financing charges		151,133			101,133
	Deposits		15,000			-
	Total current assets		20,549,780			24,323,740
	Deposits		-			52,396
	Total assets	$	20,549,780		$	24,376,136
	LIABILITIES AND STOCKHOLDERS' EQUITY
	Current
	Accounts payable and accrued liabilities	$	6,370,604		$	3,884,626
	Total liabilities		6,370,604			3,884,626
	Common stock		48,175			45,935
	Additional paid-in capital		138,696,975			129,377,542
	Subscriptions receivable		(292,700	)		-
	Accumulated deficit		(124,273,274	)		(108,931,967	)
	Total stockholders' equity		14,179,176			20,491,510
	Total liabilities and stockholders' equity	$	20,549,780		$	24,376,136

 

	ANAVEX LIFE SCIENCES CORP.
	CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
	THREE MONTHS ENDED MARCH 31, 2019 AND 2018
	(Unaudited)
	Expressed in US Dollars
			2019			2018
	Operating Expenses
	General and administrative	$	2,061,251		$	1,489,450
	Research and development		6,078,786			3,245,023
	Total operating expenses		8,140,037			4,734,473
	Operating Loss		(8,140,037	)		(4,734,473	)
	Other income
	Grant income		74,527			-
	Interest income, net		51,465			28,647
	Foreign exchange gain (loss)		54,199			(18,337	)
	Total other income		180,191			10,310
	Net loss before income taxes		(7,959,846	)		(4,724,163	)
	Income tax expense - current		(48,048	)		(27,861	)
	Net loss	$	(8,007,894	)	$	(4,752,024	)
	Net loss per Share
	Basic and Diluted	$	(0.17	)	$	(0.11	)
	Weighted Average Number of Shares Outstanding
	Basic and Diluted		47,134,686			44,545,523

 

	ANAVEX LIFE SCIENCES CORP.
	CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
	SIX MONTHS ENDED MARCH 31, 2019 AND 2018
	(Unaudited)
	Expressed in US Dollars
			2019			2018
	Operating Expenses
	General and administrative	$	3,822,559		$	2,887,253
	Research and development		11,790,996			5,939,335
	Total operating expenses		15,613,555			8,826,588
	Operating Loss		(15,613,555	)		(8,826,588	)
	Other income
	Grant income		149,055			-
	Interest income, net		130,265			59,023
	Foreign exchange gain (loss)		49,693			(6,358	)
	Total other income		329,013			52,665
	Net loss before income taxes		(15,284,542	)		(8,773,923	)
	Income tax expense - current		(56,765	)		(37,266	)
	Net loss	$	(15,341,307	)	$	(8,811,189	)
	Net loss per Share
	Basic and Diluted	$	(0.33	)	$	(0.20	)
	Weighted Average Number of Shares Outstanding
	Basic and Diluted		46,726,649			44,210,591

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: NCT03774459

2 ClinicalTrials.gov Identifier: NCT03790709

3 ClinicalTrials.gov Identifier: NCT03758924

4 ANAVEX®2-73 assessment of safety and efficacy in Rett syndrome patients