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 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, 2021.

“The first quarter marked significant progress across our portfolio, highlighted by the positive top-line results of the randomized, placebo-controlled AVATAR Phase 3 study (ANAVEX®2-73-RS-002) for the treatment of adult patients with Rett syndrome and the positive top-line results from the placebo-controlled Phase 1 study of ANAVEX®3-71, which is in development for the treatment of neurodegenerative diseases including Frontotemporal Dementia (FTD). The clinical trial data-driven evidence of efficacy and safety of our broad SIGMAR1 platform portfolio allows us to plan to expand further within the rare disease space including implementing expanded access for adult patients with Rett syndrome, an underserved population,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “At the same time, we are advancing both ANAVEX®2-73 and ANAVEX®3-71 in the planned studies with the goal to driving meaningful growth across our broad SIGMAR1 platform portfolio to deliver transformational treatments for patients with both degenerative and developmental neurological disorders around the world.”

Key Company Updates:

• Anavex reported positive top-line results from the second randomized, placebo-controlled AVATAR Phase 3 study (ANAVEX®2-73-RS-002) for the treatment of adult patients with Rett syndrome. The study met its primary and secondary efficacy and safety endpoints, with consistent and clinically meaningful improvements in all efficacy measures.

• Anavex reported positive top-line results from the placebo-controlled Phase 1 clinical trial (ANAVEX®3-71-001) in development for the treatment of neurodegenerative diseases including Frontotemporal Dementia (FTD), for which ANAVEX®3-71 has been granted Orphan Drug Designation (ODD) by the FDA. The study reached primary and secondary safety endpoints.

• Top-line results from the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of pediatric patients with Rett syndrome are expected 2H 2022. The extended enrollment duration is triggered by Country and local Government requirements for full COVID-19 vaccination among children prior to joining the pediatric EXCELLENCE trial.

• Top-line results from the placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of Alzheimer’s disease is expected 2H 2022.

• Pipeline expansion of the ANAVEX platform pipeline using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 2022:
  • Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study.
  • Planned initiation of a potentially pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.
  • Planned initiation of a Phase 2/3 clinical trial for the treatment of a new rare-disease indication.
  • Planned initiation of ANAVEX®3-71 Phase 2 clinical trials for FTD, schizophrenias and Alzheimer’s disease indications.

Financial Highlights:

• Cash and cash equivalents of $151.1 million on December 31, 2021, compared to $152.1 million on September 30, 2021.

• Net loss of $10.9 million, or $0.14 per share for the quarter, inclusive of non-cash compensation charges of $3.9 million, compared to net loss of $7.9 million, or $0.12 per share, inclusive of non-cash compensation charges of $0.9 million for the comparable quarter of fiscal 2021.

• Research and development expenses of $8.7 million, inclusive of non-cash compensation charges of $2.2 million for the quarter, compared to $7.9 million, inclusive of non-cash compensation charges of $0.5 million for the comparable quarter of fiscal 2021.

• General and administrative expenses of $3.1 million, inclusive of non-cash compensation charges of $1.7 million for the quarter, compared to $1.5 million, inclusive of non-cash compensation charges of $0.4 million for the comparable quarter of fiscal 2021.

The financial information for the fiscal quarter ended December 31, 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 will be available on Anavex’s website at www.anavex.com.

The conference call can be also accessed by dialing +1 929 205 6099 for participants in the U.S. using the reference passcode 911357. A replay of the conference call will also be available on Anavex’s website for up to 30 days.

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 and Comprehensive Loss
For the three months ended December 31, 2021 and 2020
(Unaudited)
Expressed in US Dollars
		2021			2020
Operating Expenses
General and administrative	$	3,066,951		$	1,470,656
Research and development		8,656,439			7,925,519
Total operating expenses		(11,723,390	)		(9,396,175	)
Other income (expenses)
Research and development incentive income		810,730			1,269,316
Interest income (expense), net		4,910			(1,559	)
Foreign exchange gain, net		55,363			332,634
Total other income, net		871,003			1,600,391
Net loss before provision for income taxes		(10,852,387	)		(7,795,784	)
Income tax expense, current		(29,980	)		(59,281	)
Net loss and comprehensive loss	$	(10,882,367	)	$	(7,855,065	)
Net loss per share
Basic and diluted	$	(0.14	)	$	(0.12	)
Weighted average number of shares outstanding
Basic and diluted		75,997,738			64,295,143

Anavex Life Sciences Corp.
Interim Condensed Consolidated Balance Sheets
Expressed in US Dollars
	December 31,			September 30,
		2021			2021
Assets	(Unaudited)
Current
Cash and cash equivalents	$	151,146,355		$	152,107,745
Incentive and tax receivables		5,372,153			9,136,831
Prepaid expenses and other current assets		377,860			371,914
Total Assets	$	156,896,368		$	161,616,490
Liabilities and stockholders’ equity
Current Liabilities
Accounts payable	$	4,634,791		$	4,739,781
Accrued liabilities		5,450,040			5,614,774
Deferred grant income		443,831			443,831
Total Liabilities		10,528,662			10,798,386
Capital Stock		76,156			75,920
Additional paid-in capital		354,759,781			348,328,048
Accumulated deficit		(208,468,231	)		(197,585,864	)
Total Stockholders’ Equity		146,367,706			150,818,104
Total Liabilities and Stockholders’ Equity	$	156,896,368		$	161,616,490

For Further Information:

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

Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: andrew@barwicki.com