Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Third Quarter Financial Results

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) reported promising developments in its late-stage clinical trials for ANAVEX®2-73 (blarcamesine). A total of 509 patients have been enrolled in the Phase 2b/3 trial for Alzheimer’s disease, exceeding enrollment targets. The company holds a strong cash position of $157.6 million. However, the net loss for the quarter totaled $10.2 million, or $0.14 per share, which is an increase from $6.5 million in the same quarter last year. Upcoming topline data releases in 2H 2021 for Rett syndrome and 2H 2022 for Alzheimer’s disease are anticipated.

Positive

• 509 patients enrolled in the ANAVEX®2-73 Alzheimer’s Phase 2b/3 trial, exceeding targets.
• Strong cash position of $157.6 million, up from $29.2 million since September 2020.

Negative

• Net loss of $10.2 million, or $0.14 per share for the quarter, increased from $6.5 million in the previous year.
• R&D expenses rose to $9.0 million from $6.7 million year-over-year.

• Total of 509 Patients Enrolled in Confirmatory Late-stage Precision Medicine ANAVEX^®2-73 (blarcamesine) Phase 2b/3 Clinical Trial in Patients with Alzheimer’s Disease
  
  
• Exceeding of Enrollment Target for the Precision Medicine ANAVEX^®2-73 (blarcamesine) Phase 2/3 AVATAR Clinical Trial in Patients with Rett Syndrome
  
  
• Current Cash Position of $157.6 million
  
  
• Webcast and Conference Call Today at 4:30 p.m. EDT
  

NEW YORK, Aug. 12, 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 June 30, 2021.

“We are pleased with the rigorous and efficient execution of the confirmatory late-stage Precision Medicine ANAVEX^®2-73 Phase 2b/3 randomized, double-blind, placebo-controlled clinical trial with a total of 509 patients with Alzheimer’s disease and are excited to be able to provide top-line data by 2H 2022. The steadfast clinical trial execution capabilities of the Anavex team also extend to the Precision Medicine ANAVEX^®2-73 Phase 2/3 AVATAR clinical trial in patients with Rett syndrome, which exceeded the enrollment target, and currently topline results from this study are expected by 2H 2021,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We are excited about the potential of our SIGMAR1 platform, and we continue working to advance new programs to the clinic, all with the aim of meeting the unmet clinical needs of patients with both degenerative and developmental neurological disorders around the world.”

Recent Business Highlights:

• On May 25, 2021, Anavex announced the appointment of Ms. Jiong Ma, PhD to its Board of Directors. Ms. Ma is a Senior Board executive with over 25 years of experience in investing, building, and scaling of companies with a focus on innovative product launches in digital health, technology, and new energy transition.
• On June 8, 2021, Anavex announced that it exceeded its enrollment target for the confirmatory late-stage ANAVEX^®2-73 Phase 2b/3 randomized, double-blind, placebo-controlled trial in Alzheimer’s disease. The Company expects to announce topline results from this study by 2H 2022.
• On June 21, 2021, Anavex reported complete data from its ANAVEX^®2-73 U.S. Rett syndrome Phase 2 study. Predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary clinical efficacy endpoints from the U.S. Phase 2 randomized, double-blind, placebo-controlled trial of ANAVEX^®2-73 in patients with Rett syndrome.
• On June 24, 2021, Anavex announced the closing of $50 million registered direct offering to Deep Track Capital, an investment firm focused exclusively on the life sciences industry.
• On June 28, 2021, Anavex reported complete data from its ANAVEX^®2-73 Parkinson’s disease dementia (PDD) Phase 2 study. Predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial of 132 patients with Parkinson’s disease dementia.
• Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on www.anavex.com.

Financial Highlights:

• Cash and cash equivalents of $157.6 million on June 30, 2021, an increase of over $128 million compared to $29.2 million from September 30, 2020.
• Net loss of $10.2 million, or $0.14 per share for the quarter, compared to net loss of $6.5 million, or $0.11 per share in comparative quarter of fiscal 2020.
• Research and development expenses of $9.0 million for the quarter, compared to $6.7 million for comparable quarter of fiscal 2020.
• General and administrative expenses of $2.4 million for the quarter, compared to $1.4 million for comparable quarter of fiscal 2020.

The financial information for the fiscal quarter ended June 30, 2021, 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.

Webcast / Conference Call Information:

The live webcast of the conference call can be accessed online at https://wsw.com/webcast/cc/avxl19/1500606.

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 50210582, 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), successfully completed a Phase 2a clinical trial for Alzheimer’s disease and recently 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, Instagram 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 June 30, 2021 and 2020
(Unaudited)
Expressed in US Dollars
		2021			2020
Operating Expenses
General and administrative	$	2,434,127		$	1,381,477
Research and development		8,964,528			6,725,002
Total operating expenses		(11,398,655	)		(8,106,479	)
Other income (expenses)
Grant income		43,280			-
Research and development incentive income		1,363,661			1,319,913
Interest income, net		11,453			56,096
Foreign exchange gain (loss), net		(160,880	)		248,665
Total other income, net		1,257,514			1,624,674
Net loss before provision for income taxes		(10,141,141	)		(6,481,805	)
Income tax expense, current		(39,000	)		(4,817	)
Net loss and comprehensive loss	$	(10,180,141	)	$	(6,486,622	)
Net loss per share
Basic and diluted	$	(0.14	)	$	(0.11	)
Weighted average number of shares outstanding
Basic and diluted		70,589,561			59,105,399

ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the nine months ended June 30, 2021 and 2020
(Unaudited)
Expressed in US Dollars
		2021			2020
Operating Expenses
General and administrative	$	6,138,528		$	4,453,654
Research and development		23,610,888			19,126,717
Total operating expenses		(29,749,416	)		(23,580,371	)
Other income (expenses)
Grant income		54,100			149,888
Research and development incentive income		3,593,856			2,980,456
Interest income, net		19,110			172,996
Foreign exchange gain (loss), net		17,191			(24,182	)
Total other income, net		3,684,257			3,279,158
Net loss before provision for income taxes		(26,065,159	)		(20,301,213	)
Income tax expense, current		(125,269	)		(14,031	)
Net loss and comprehensive loss	$	(26,190,428	)	$	(20,315,244	)
Net loss per share
Basic and diluted	$	(0.39	)	$	(0.35	)
Weighted average number of shares outstanding
Basic and diluted		67,810,774			57,401,387

ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
As at June 30, 2021 and September 30, 2020
Expressed in US Dollars
	June 30, 2021			September 30, 2020
ASSETS	(Unaudited)
Current
Cash and cash equivalents	$	157,560,045		$	29,249,018
Incentive and tax receivables		8,601,258			4,849,340
Prepaid expenses and deposits		258,198			443,839
Total Assets	$	166,419,501		$	34,542,197
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable	$	4,176,707		$	3,989,054
Accrued liabilities		4,653,234			3,316,574
Deferred grant income		443,831			-
Total Liabilities		9,273,772			7,305,628
Capital Stock		75,151			62,047
Additional paid-in capital		342,938,236			186,851,752
Accumulated deficit		(185,867,658	)		(159,677,230	)
Total Stockholders' Equity		157,145,729			27,236,569
Total Liabilities and Stockholders' Equity	$	166,419,501		$	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

FAQ

What is Anavex Life Sciences' stock symbol?

Anavex Life Sciences trades under the stock symbol AVXL on Nasdaq.

When will Anavex announce topline results for Alzheimer’s disease?

Topline results for the Alzheimer’s disease trial are expected in the second half of 2022.

What were Anavex's financial highlights for Q2 2021?

Anavex reported a net loss of $10.2 million, with cash and cash equivalents of $157.6 million as of June 30, 2021.

How many patients were enrolled in the ANAVEX®2-73 Alzheimer’s trial?

A total of 509 patients were enrolled in the Phase 2b/3 clinical trial for Alzheimer’s disease.