Anavex Life Sciences Reports Fiscal 2021 First Quarter Financial Results And Business Outlook

NEW YORK, Feb. 11, 2021 (GLOBE NEWSWIRE) -- 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 quarter ended December 31, 2020.

“We are thrilled to begin the new year with this business outlook, which adds to the breadth of strong clinical data we’ve reported across our precision medicine pipeline using orally once daily ANAVEX®2-73 (blarcamesine) for Rett syndrome, Parkinson’s disease dementia and Alzheimer’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to providing on a timely basis in 2021 multiple clinical data read-outs from these clinical programs. The converging biomarker-driven clinical data is giving us added confidence in our efforts to meet our goal of potentially bringing new therapeutic interventions to patients.”

Anavex Life Sciences’ product portfolio includes small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.

ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.¹

Anavex Life Sciences’ 2021 Business and Clinical Outlook:

Underlying cause of Alzheimer's disease and therapeutic intervention:

• Researchers at the University of California San Diego have identified the underlying cause of Alzheimer's disease in neurons. They discovered that changes in the structure of chromatin are responsible.² Sigma-1 Receptor (SIGMAR1), the direct target which gets activated with ANAVEX®2-73 demonstrated to restore chromatin structures.³

• ANAVEX®2-73 linked to the prevention and treatment of age-associated diseases through induction of the autophagy “cellular recycling” process and enhanced protein clearance in cells.⁴

• ANAVEX®2-73 is currently in a Phase 2b/3 Alzheimer's disease clinical trial utilizing differentiated patient selection criteria and study is presently over 86% recruited.⁵

ANAVEX®2-73 program for Rett syndrome and other pipeline updates:

• Potential accelerated approval strategy planning underway as Phase 2 U.S. Rett syndrome trial clinical data showed positive clinical activity and safety data with progress within ongoing Phase 2/3 AVATAR adult Rett syndrome and Phase 2/3 EXCELLENCE pediatric Rett syndrome studies.

• U.S. Food and Drug Administration (FDA) approved extension of ANAVEX®2-73 U.S. Rett syndrome Phase 2 open-label extension study from 12 weeks to 36 weeks.

• Anavex received compassionate use Special Access Scheme (SAS) approval in Australia for Rett syndrome patients to continue treatment with ANAVEX®2-73 after completing the Phase 2/3 AVATAR adult Rett syndrome clinical extension study.

• Anavex has sufficient ANAVEX®2-73 available to support all ongoing and planned clinical trials and first-year commercial launch needs for the Rett syndrome program.

• ANAVEX®2-73 drug substance and oral solution exhibit excellent chemical stability based upon 3 years of stability data in both cases.

• New clinical pipeline compound ANAVEX®3-71 Phase 1 study is on track: Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 1 study of its new investigational compound ANAVEX®3-71, also a small molecule activating SIGMAR1, has completed its recent pre-planned review of the preliminary Phase 1 safety data. The DSMB recommendation is to continue the study without modification.⁶

• Anavex is pioneering the approach of big data in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease, Parkinson’s disease and Rett syndrome treatments.

• Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on www.anavex.com.

Recent Business Highlights:

• In January 2021, Anavex announced that it has been awarded a research grant of $995,862.51 from the Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson’s disease.

Financial Highlights:

• On February 11, 2021, cash and cash equivalents of approximately $75 million, sufficient cash runway for up to three (3) years.

• Cash and cash equivalents of $47.4 million as of December 31, 2020, compared to $29.2 million at September 30, 2020.

• Net loss of $7.9 million, or $0.12 per share for the quarter, compared to net loss of $6.6 million, or $0.12 per share in comparative quarter of fiscal 2020.

• Research and development expenses of $7.9 million for the quarter, compared to $6.3 million for comparable quarter of fiscal 2020.

The financial information for the fiscal quarter ended December 31, 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:

The live webcast of the conference call can be accessed online at https://wsw.com/webcast/cc/avxl17/1498482.

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 451-7964 and international callers should dial 1 (847) 944-7134. Please use confirmation number 50097999, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

¹ Advances in Experimental Medicine and Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease and as Therapeutic Targets.
² https://medicalxpress.com/news/2020-11-neurons-identity-hallmark-alzheimer-disease.html; Caldwell et al., Dedifferentiation and neuronal repression define familial Alzheimer's disease. Sci Adv. 2020 Nov 13;6(46).
³ Couly et al., Knocking Out Sigma-1 Receptors Reveals Diverse Health Problems. Cell Mol Neurobiol (2020); Lee et al., Sigma-1 receptor chaperones rescue nucleocytoplasmic transport deficit seen in cellular and Drosophila ALS/FTD models. Nat Commun. 2020 Nov 4;11(1):5580.
⁴ Christ et al., Sigma-1 Receptor Activation Induces Autophagy and Increases Proteostasis Capacity In Vitro and In Vivo. Cells. 2019; 8(3):211.
⁵ ClinicalTrials.gov Identifier: NCT03790709
⁶ ClinicalTrials.gov Identifier: NCT04442945

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 successfully a Phase 2a clinical trials for Alzheimer’s disease and a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 study in adult patients with Rett syndrome. 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 muscarinic receptors, is a promising clinical stage 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 STATEMENTS OF OPERATIONS
For the three months ended December 31, 2020 and 2019
(Unaudited)
Expressed in US Dollars
		2020			2019
Operating Expenses
General and administrative	$	1,470,656		$	1,352,035
Research and development		7,925,519			6,348,668
Total operating expenses		(9,396,175	)		(7,700,703	)
Other income (expenses)
Grant income		-			74,944
Research and development incentive income		1,269,316			943,215
Interest (expense) income, net		(1,559	)		46,720
Foreign exchange gain, net		332,634			53,113
Total other income, net		1,600,391			1,117,992
Net loss before provision for income taxes		(7,795,784	)		(6,582,711	)
Income tax expense, current		(59,281	)		(9,214	)
Net loss and comprehensive loss	$	(7,855,065	)	$	(6,591,925	)
Net loss per share
Basic and diluted	$	(0.12	)	$	(0.12	)
Weighted average number of shares outstanding
Basic and diluted		64,295,143			54,773,685

ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
As at December 31, 2020 and September 30, 2020
Expressed in US Dollars
	December 31, 2020			September 30, 2020
ASSETS	(Unaudited)
Current
Cash and cash equivalents	$	47,357,599		$	29,249,018
Incentive and tax receivables		6,577,807			4,849,340
Prepaid expenses and deposits		398,840			443,839
Total Assets	$	54,334,246		$	34,542,197
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable	$	4,216,948		$	3,989,054
Accrued liabilities		3,816,521			3,316,574
Total Liabilities		8,033,469			7,305,628
Capital Stock		66,964			62,047
Additional paid-in capital		213,766,108			186,851,752
Accumulated deficit		(167,532,295	)		(159,677,230	)
Total Stockholders' Equity		46,300,777			27,236,569
Total Liabilities and Stockholders' Equity	$	54,334,246		$	34,542,197

For Further Information:

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

Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com