Anavex Life Sciences Reports Fiscal 2020 Third Quarter Financial Results And Provides Business 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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal 2020 third quarter.

“It is an accomplishment having three ongoing clinical studies in Rett syndrome in progress with ANAVEX®2-73 (blarcamesine) and we expect respective clinical trial results to be reported as we progress,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “It is important to point out that all clinical studies with ANAVEX®2-73 (blarcamesine), including the ongoing Alzheimer’s disease Phase 2b/3 trial and Parkinson’s disease dementia Phase 2 study, which read out is upcoming, includes the entire genome and exome sequencing, opens the possibility of using big data-driven unbiased genome-wide patient analysis, hence, maintaining the focus on Precision Medicine for neurological disorders.”

Program Updates:

Yesterday Anavex announced it has received compassionate use Special Access Scheme (SAS) approval for Alzheimer’s disease patients continued treatment with ANAVEX®2-73 (blarcamesine) by the Australian Government Department of Health - Therapeutic Goods Administration (TGA).
In June 2020, Anavex announced it has received Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) as well as a ‘No Objection Letter’ from Health Canada to expand the footprint of the international Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX®2-73-AD-004) of ANAVEX2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into the UK and Canada, respectively.
In June 2020, Anavex announced it exceeded by 50% its enrollment target for the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 study in Rett syndrome. The Company expects to announce topline results from this study in calendar Q4 2020.
In July 2020, Anavex announced that the first pediatric patient was dosed in the Phase 2/3 ANAVEX®2-73-RS-003 EXCELLENCE clinical trial for the treatment of Rett syndrome with ANAVEX®2-73 (blarcamesine).
In July 2020, Anavex announced the enrollment of the first participant in a Phase 1 clinical trial of ANAVEX®3-71 (AF710B), an orally-administered small molecule targeting sigma-1 and M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases, with topline data anticipated in the first half of 2021.

Financial Highlights:

Cash and cash equivalents of $27.6 million at June 30, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
Research and development expenses of $6.7 million for the quarter, compared to $5.8 million in the comparable quarter in 2019.
General and administrative expenses of $1.4 million for the quarter as well as for the comparable quarter in 2019.
Net loss of $6.5 million, or $0.11 per share for the quarter, compared to net loss of $6.5 million, or $0.13 per share in the comparable quarter of 2019.

The financial information for the fiscal quarter ended June 30, 2020 should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov 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 11:00 a.m. ET.

The live webcast of the conference call can be accessed online at https://wsw.com/webcast/cc/avxl14.

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 901-2585 and international callers should dial 1 (404) 835-7099. Please use confirmation number 49865428, 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. (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 clinical 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.
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
As at June 30, 2020 and September 30, 2019
Expressed in US Dollars
	June 30, 2020		September 30,2019
	(Unaudited)
ASSETS
Current
Cash and cash equivalents	$	27,619,145	$	22,185,630
Incentive and taxe receivables	3,547,972		2,642,745
Prepaid expenses and deposits	438,631		500,998
Deferred costs	24,508		-
Total assets	$	31,630,256	$	25,329,373

LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable	$	3,980,204	$	3,523,332
Accrued liabilities	2,968,994		1,516,342
Total liabilities	6,949,198		5,039,674
Common stock	60,083		52,652
Additional paid-in capital	178,332,979		153,633,807
Accumulated deficit	(153,712,004)		(133,396,760)
Total stockholders' equity	24,681,058		20,289,699
Total liabilities and stockholders' equity	$	31,630,256	$	25,329,373

ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2020 and 2019
(Unaudited)
Expressed in US Dollars
	2020			2019
Operating Expenses
General and administrative	$	1,381,477		$	1,388,729
Research and development	6,725,002			5,758,446
Total operating expenses	8,106,479			7,147,175

Operating Loss	(8,106,479		)	(7,147,175		)
Other income
Grant income	-			74,944
Research and development incentive income	1,319,913			552,335
Interest income, net	56,096			34,838
Gain on settlement of accounts payable	-			36,978
Foreign exchange gain (loss), net	248,665			(54,546		)
Total other income	1,624,674			644,549
Net loss before income taxes	(6,481,805		)	(6,502,626		)
Income tax expense, current	(4,817		)	(19,300		)
Net loss	$	(6,486,622	)	$	(6,521,926	)

Net loss per Share
Basic and Diluted	$	(0.11	)	$	(0.13	)

Weighted Average Number of Shares Outstanding
Basic and Diluted	59,105,399			49,622,465

ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
NINE MONTHS ENDED JUNE 30, 2020 AND 2019
(Unaudited)
Expressed in US Dollars
	2020			2019
Operating Expenses
General and administrative	$	4,453,654		$	5,211,287
Research and development	19,126,717			17,549,442
Total operating expenses	23,580,371			22,760,729

Other income
Grant income	149,888			223,999
Research and development incentive income	2,980,456			1,727,007
Interest income, net	172,996			165,103
Gain on settlement of accounts payable	-			36,978
Foreign exchange gain (loss), net		(24,182	)		(4,854	)
Total other income	3,279,158			2,148,233
Net loss before income taxes		(20,301,213	)		(20,612,496	)
Income tax expense, current		(14,031	)		(76,065	)
Net loss	$	(20,315,244	)	$	(20,688,561	)

Net loss per Share
Basic and Diluted	$	(0.35	)	$	(0.43	)

Weighted Average Number of Shares Outstanding
Basic and Diluted	57,401,387			47,691,921