Anavex Life Sciences Reports Fiscal 2020 Second Quarter Financial Results And Provides Business Updates

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) provided an update on its financial results for Q2 of fiscal 2020. The company reported a net loss of $7.2 million, or $0.12 per share, consistent with the prior year's loss of $7.2 million but an improvement in loss per share. Cash and cash equivalents increased to $26.6 million from $22.2 million. Clinical trials for ANAVEX®2-73 (blarcamesine) are progressing, with enrollment for the Phase 2 trials in Parkinson’s disease dementia and Rett syndrome exceeding 50%. Topline results for the Parkinson’s trial are expected by mid-2020.

Positive

• Cash and cash equivalents rose to $26.6 million, up from $22.2 million year-over-year.
• Consistent R&D expenses of $6.1 million indicate stable investment in developmental efforts.
• Improvement in loss per share from $0.15 to $0.12 year-over-year.

Negative

• Net loss remains high at $7.2 million, potentially raising concerns regarding financial sustainability.

NEW YORK, May 07, 2020 (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 2020 second quarter.

“We are pleased to report that we are approaching the conclusion of the double-blind Phase 2 Parkinson’s disease dementia trial with ANAVEX®2-73 (blarcamesine) and we expect to report top line results by mid-2020,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Both the Alzheimer’s disease Phase 2b/3 trial and clinical Rett syndrome programs are also proceeding as planned. Our focus on Precision Medicine studies for neurological disorders remains persistent.”

Program Updates:

• Enrollment for the two randomized, double-blind, placebo-controlled Phase 2 ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett syndrome trial¹ and the AVATAR Rett syndrome trial² each have surpassed the 50% mark and continue to enroll.
• Despite the outbreak of COVID-19, all clinical trial programs continue to proceed. While Rett syndrome protocols have always by default allowed at-home visits, Anavex implemented contingency plans as recommended by local regulatory authorities for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study³ and the Phase 2 study in Parkinson’s Disease Dementia (PDD) study⁴ to ensure remote or virtual assessments for all active patients and all respective extension studies. Because ANAVEX®2-73 (blarcamesine) is an oral formulation, study participants are able to receive shipments of their study medication in a controlled and compliant fashion, and direct-to-patient delivery is occurring in multiple countries.
• In January 2020, Anavex announced achieving the enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study in Parkinson’s disease dementia (PDD). Topline results from this randomized, double-blind, placebo-controlled study are expected by mid-2020.
• In February 2020, Anavex announced a publication in the peer-reviewed Journal of Neuroimmunology titled “Sigma-1 Receptor Agonists as Potential Protective Therapies in Multiple Sclerosis“ featuring preclinical data of ANAVEX®2-73 (blarcamesine) relevant to multiple sclerosis.
• In April 2020, Anavex announced a publication in the peer-reviewed journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions, entitled, “A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study” highlights 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 treatments.

Financial Highlights:

• Cash and cash equivalents of $26.6 million at March 31, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
• Research and development expenses of $6.1 million for both the current quarter as well as the comparable quarter in 2019. 
• General and administrative expenses of $1.7 million for the quarter as compared to $2.1 million for the comparable quarter in 2019.
• Net loss of $7.2 million, or $0.12 per share for the quarter, compared to net loss of $7.2 million, or $0.15 per share in the comparable quarter of 2019.

The financial information for the fiscal quarter ended March 31, 2020 should be read in conjunction with the Company’s consolidated interim 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 4:30 p.m. ET.

The live webcast of the conference call can be accessed online at http://www.wsw.com/webcast/cc/avxl13.

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 49673201, 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 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.

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ANAVEX LIFE SCIENCES CORP.
CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
As at March 31, 2020 and September 30, 2019
Expressed in US Dollars
	March 31, 2020	September 30, 2019
	(Unaudited)
ASSETS
Current
Cash and cash equivalents	$	26,563,071		$	22,185,630
Incentives and taxes receivable		4,151,947			2,642,745
Prepaid expenses and deposits		305,559			500,998
Total assets	$	31,020,577		$	25,329,373
LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable	$	3,649,734		$	3,523,332
Accrued liabilities		2,579,097			1,516,342
Total liabilities		6,228,831			5,039,674
Common stock		58,666			52,652
Additional paid-in capital		171,958,462			153,633,807
Accumulated deficit		(147,225,382	)		(133,396,760	)
Total stockholders' equity		24,791,746			20,289,699
Total liabilities and stockholders' equity	$	31,020,577		$	25,329,373

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ANAVEX LIFE SCIENCES CORP.
CONDENSED CONSOLIDATED INTERIM STATEMENT OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2020 and 2019
(Unaudited)
Expressed in US Dollars
		2020			2019
Operating Expenses
General and administrative	$	1,720,142		$	2,061,251
Research and development		6,053,047			6,078,786
Total operating expenses		7,773,189			8,140,037
Operating Loss		(7,773,189	)		(8,140,037	)
Other income
Grant income		74,944			74,527
Research and development incentive income		717,328			760,990
Interest income, net		70,180			51,465
Foreign exchange gain (loss)		(325,960	)		54,199
Total other income		536,492			941,181
Net loss before income taxes		(7,236,697	)		(7,198,856	)
Income tax expense - current		-			(48,048	)
Net loss	$	(7,236,697	)	$	(7,246,904	)
Net loss per Share
Basic and Diluted	$	(0.12	)	$	(0.15	)
Weighted Average Number of Shares Outstanding
Basic and Diluted		58,353,954			47,134,686

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ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED STATEMENT OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2020 AND 2019
(Unaudited)
Expressed in US Dollars
		2020			2019
Operating Expenses
General and administrative	$	3,072,176		$	3,822,559
Research and development		12,401,715			11,790,996
Total operating expenses		15,473,891			15,613,555
Other income
Grant income		149,888			149,055
Research and development incentive income		1,660,543			1,174,672
Interest income, net		116,900			130,265
Foreign exchange gain (loss)		(272,848	)		49,693
Total other income		1,654,483			1,503,685
Net loss before income taxes		(13,819,408	)		(14,109,870	)
Income tax expense - current		(9,214	)		(56,765	)
Net loss	$	(13,828,622	)	$	(14,166,635	)
Net loss per Share
Basic and Diluted	$	(0.24	)	$	(0.30	)
Weighted Average Number of Shares Outstanding
Basic and Diluted		56,554,037			46,726,649

For Further Information:

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

Investors & Media:
Email: ir@anavex.com

¹ ClinicalTrials.gov Identifier: NCT03758924
² ClinicalTrials.gov Identifier: NCT03941444
³ ClinicalTrials.gov Identifier: NCT03790709
⁴ ClinicalTrials.gov Identifier: NCT03774459

FAQ

What were Anavex Life Sciences' financial results for Q2 fiscal 2020?

Anavex reported a net loss of $7.2 million, or $0.12 per share, for Q2 fiscal 2020.

What are the expected results from Anavex's Parkinson’s disease trial?

Topline results from the Phase 2 trial of ANAVEX®2-73 (blarcamesine) in Parkinson’s disease dementia are expected by mid-2020.

How much cash did Anavex Life Sciences have at the end of Q2 2020?

Anavex reported cash and cash equivalents of $26.6 million as of March 31, 2020.

What is the status of Anavex's clinical trials?

Clinical trials for ANAVEX®2-73 are progressing well, with enrollment for key trials exceeding 50%.