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Anavex Life Sciences Provides Business Update and Reports Fiscal 2021 Year End Financial Results

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Webcast and Conference Call Today at 4:30 p.m. Eastern Time

NEW YORK, Nov. 24, 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 year ended September 30, 2021.

"Anavex concluded an exceptional fiscal year 2021 while continuing its momentum, highlighted by the efficient execution and full enrollment of three Precision Medicine clinical trials, including the Phase 2b/3 ANAVEX®2-73 clinical trial in Alzheimer’s disease, the Phase 2/3 ANAVEX®2-73 clinical trial in Rett syndrome as well as the Phase 1 of ANAVEX®3-71. As we look to the remainder of 2021 and into 2022, I am very excited about the Company’s potential as we continue to advance and expand our Precision Medicine clinical programs," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "As we look ahead, we will continue to focus on 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:

  • Top-line results from the second placebo-controlled AVATAR Phase 2/3 ANAVEX®2-73-RS-002 study for the treatment of adult patients with Rett syndrome are expected around year end 2021.

  • Top-line results from the placebo-controlled Phase 1 ANAVEX®3-71-001 study evaluating ANAVEX®3-71 in humans are expected around year end 2021.

  • A scientific presentation on ANAVEX®2-73 for the potential treatment of amyotrophic lateral sclerosis (ALS) will be shared at the 4th Annual ALS ONE Research Symposium, November 29th & 30th, 2021.

  • Top-line results from the placebo-controlled EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 study for the treatment of pediatric patients with Rett syndrome are expected 1H 2022.

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

  • Pipeline expansion for ANAVEX®2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need are expected 1H 2022:

    • Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study.

    • Planned initiation of a 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.

Recent Business Highlights:

  • On October 13, 2021, Anavex announced that the Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 2b/3 Alzheimer’s disease study of its investigational compound ANAVEX®2-73 completed its recent pre-planned review of the preliminary Phase 2b/3 study data. As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study. Upon review of the interim safety data, the DSMB recommendation is to continue the studies without modification.

  • On August 26, 2021, Anavex announced that preclinical data of ANAVEX®2-73 in Fragile X Syndrome was published in the peer-reviewed journal, Scientific Reports. The study evaluated ANAVEX®2-73 in Fmr1 knockout (KO) mice, a validated animal model for the disease, which resulted in the reversal of hyperactivity and restoration of associative learning. Furthermore, ANAVEX®2-73 demonstrated dose dependent SIGMAR1 receptor occupancy in a Positron Emission Tomography (PET) study.

Financial Highlights:

  • Cash and cash equivalents of $152.1 million on September 30, 2021, an increase of $122.9 million compared to $29.2 million from September 30, 2020.

  • Net loss of $37.9 million, or $0.54 per share for the year, compared to net loss of $26.3 million, or $0.45 per share in fiscal 2020.

  • Research and development expenses of $33.0 million for the year, compared to $25.2 million in fiscal 2020.

  • General and administrative expenses of $9.0 million for the year, compared to $5.9 million in fiscal 2020.

The financial information for the year ended September 30, 2021, should be read in conjunction with the Company’s 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/avxl20/1492110.

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 50258076, 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.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

For the years ended September 30, 2021 and 2020

Expressed in US Dollars

2021

2020

Operating Expenses

General and administrative

$

9,017,511

$

5,856,609

Research and development

32,983,674

25,231,623

Total operating expenses

(42,001,185

)

(31,088,232

)

Other income (expenses)

Grant income

54,100

149,888

Research and development incentive income

4,547,099

4,375,025

Interest income, net

26,261

179,973

Foreign exchange gain (loss), net

(267,344

)

125,540

Total other income, net

4,360,116

4,830,426

Net loss before provision for income taxes

(37,641,069

)

(26,257,806

)

Income tax expense, current

(267,565

)

(22,664

)

Net loss and comprehensive loss

$

(37,908,634

)

$

(26,280,470

)

Net loss per share

Basic and diluted

$

(0.54

)

$

(0.45

)

Weighted average number of shares outstanding

Basic and diluted

69,802,960

58,194,894




ANAVEX LIFE SCIENCES CORP.

CONSOLIDATED BALANCE SHEETS

As at September 30, 2021 and 2020

Expressed in US Dollars

2021

2020

ASSETS

Current

Cash and cash equivalents

$

152,107,745

$

29,249,018

Incentive and tax receivables

9,136,831

4,849,340

Prepaid expenses and deposits

355,549

443,839

Deferred financing charges

16,365

-

Total Assets

$

161,616,490

$

34,542,197

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities

Accounts payable

$

4,739,781

$

3,989,054

Accrued liabilities

5,614,774

3,316,574

Deferred grant income

443,831

-

Total Liabilities

10,798,386

7,305,628

Capital Stock

75,920

62,047

Additional paid-in capital

348,328,048

186,851,752

Accumulated deficit

(197,585,864

)

(159,677,230

)

Total Stockholders' Equity

150,818,104

27,236,569

Total Liabilities and Stockholders' Equity

$

161,616,490

$

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