×

Anavex Reports Fiscal Second Quarter 2017 Financial Results

NEW YORK, May 10, 2017 (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 diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the fiscal quarter ended March 31, 2017.

Financial Highlights:

  • Cash and equivalents of $23.4 million at March 31, 2017, compared to $9.2 million at September 30, 2016.
  • During the first six months of fiscal year 2017, Anavex used $3.9 million in cash to fund operations, after receipt of $2.1 million in research and development incentive income.
  • Operating expenses of approximately $3.6 million compared to approximately $2.2 million for the comparative quarter. This increase was a result of increased spending on research and development and clinical preparatory activities.
  • Net loss for the quarter of approximately $1.5 million, or $0.04 per share, compared to a net loss of approximately $2.0 million, or $0.06 per share for the comparative quarter.

“We are continuing 2017 with a stronger balance sheet than the previous quarter and a strengthened corporate team,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We are on track to initiate placebo-controlled efficacy and safety trials this year in Alzheimer’s and Parkinson’s disease as well as Rett syndrome, for which ANAVEX 2-73 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).”

Corporate Highlights

  • May 1, 2017 – Anavex announced the appointment of Emmanuel O. Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24 years of regulatory experience within the U.S. Food and Drug Administration (FDA), having held leadership positions at the FDA’s Center for Drug Evaluation and Research (CDER).
  • April 3, 2017 – Anavex announced the presentation of new mechanism of action data related to ANAVEX compounds targeting the sigma-1 receptor at the 13th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2017).
    - Preclinical data was presented indicating that in addition to reducing oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 demonstrate protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.
    - Additional data was presented for ANAVEX 3-71 indicating that during pathological conditions, ANAVEX 3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases such as Alzheimer’s and Parkinson’s, synaptogenesis is believed to be impaired.
  • February 13, 2017 – Anavex announced the appointment of Peter Donhauser, D.O. to its Board of Directors. Mr. Donhauser has more than 20 years of expertise in clinical research followed by practicing osteopathic medicine with an integrated medical approach in private practice since 2000.

The financial information for the three and six months ended March 31, 2017 should be read in conjunction with the Company’s condensed consolidated interim financial statements, which will appear on EDGAR and will be available on the Anavex website at 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 diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. 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. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com and 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.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31,September 30,
ASSETS 2017 2016
Current
Cash$23,351,567 $9,186,814
Sales Tax Recoverable 60,636 79,347
Prepaid expenses and deposits 141,989 180,124
Total current assets 23,554,192 9,446,285
Deposits 52,396 52,396
Total assets$23,606,588 $9,498,681
LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities$2,033,692 $3,119,993
Deferred grant income 86,205 70,532
Total liabilities 2,119,897 3,190,525
Common stock 41,377 36,169
Additional paid-in capital 104,159,213 84,290,140
Accumulated deficit (82,713,899) (78,018,153)
Total stockholders' equity 21,486,691 6,308,156
Total liabilities and stockholders' equity$23,606,588 $9,498,681


ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2017 AND 2016
(Unaudited)
2017 2016
Operating Expenses
General and administrative$1,116,014 $1,089,641
Research and development 2,492,933 1,090,527
Total operating expenses 3,608,947 2,180,168
Operating Loss (3,608,947) (2,180,168)
Other income (expenses)
Grant income 16,684 26,879
Research and development incentive income 2,022,902 -
Interest income, net 18,147 2,064
Financing related charges and adjustments - 151,330
Foreign exchange gain (loss) 11,722 (30,906)
Total other income (expenses) 2,069,455 149,367
Net loss before income taxes (1,539,492) (2,030,801)
Income tax expense - current (9,595) -
Net loss$ (1,549,087)$ (2,030,801)
Net loss per Share
Basic$(0.04)$(0.06)
Diluted$(0.04)$(0.06)
Weighted Average Number of Shares Outstanding
Basic 41,159,707 35,214,793
Diluted 41,159,707 35,214,793


ANAVEX LIFE SCIENCES CORP.
CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2017 AND 2016
(Unaudited)
2017 2016
Operating Expenses
General and administrative$2,242,198 $3,982,746
Research and development 4,535,423 2,729,856
Total operating expenses 6,777,621 6,712,602
Operating Loss (6,777,621) (6,712,602)
Other income (expenses)
Grant income 51,970 65,934
Research and development incentive income 2,022,902 571,093
Interest income, net 21,802 4,206
Financing related charges and adjustments - 150,235
Foreign exchange gain (loss) 25,804 (46,561)
Total other income 2,122,478 744,907
Net loss before income taxes (4,655,143) (5,967,695)
Income tax expense - current (40,603) (17,615)
Net loss$ (4,695,746)$ (5,985,310)
Net loss per Share
Basic$(0.12)$(0.17)
Diluted$(0.12)$(0.17)
Weighted Average Number of Shares Outstanding
Basic 39,761,612 34,589,957
Diluted 39,761,612 34,589,957


For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.com Investors: Matthew Haines River East Investor Relations, LLC 917-733-9297 mhaines@rivereastir.com Media: Dennis Dobson, Jr. Dobson Media Group 203-258-0159 dennisdobsonjr@dobsonmediagroup.com Social Media: Bill Douglass Gotham Communications 646-504-0890 bill@gothamcomm.com

Source:Anavex Life Sciences Corp.