×

Anavex Provides Business Update Including Clinical Trial Plans for ANAVEX PLUS in Alzheimer's Disease

Anavex Life Sciences Corp.

NEW YORK, May 15, 2014 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (OTCQB:AVXL), a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, today provided a business update including clinical trial plans for its lead drug candidates in Alzheimer's disease (AD).

Business Update

Anavex plans to initiate clinical trials with ANAVEX PLUS for the treatment of Alzheimer's disease. ANAVEX PLUS is the Company's proprietary compound ANAVEX 2-73 administered in combination with donepezil, the generic version of Aricept®. Donepezil's combination with a Sigma 1 receptor agonist (ANAVEX 2-73) is believed to enhance efficacy. The trials will consist of a prospective, multicenter, two-part study involving up to 300 mild-to-moderate AD patients.

The first part is a scheduled Phase 1b/2a trial of approximately 40 patients who will receive either ANAVEX 2-73 or standard of care (donepezil) with ANAVEX 2-73. The study will explore dose and schedule as well as the efficacy of the combination. Patients in this study will have the option to rollover into a single open-label study in order to further accumulate safety, tolerability and efficacy data.

The second part of the study is designed as a double-blind Phase 2 trial and will randomize AD patients to standard of care (donepezil) or standard of care (donepezil) with ANAVEX 2-73 with a primary outcome measure at 26 weeks efficacy based on standard cognitive measures. All patients from this second study will also have the option to rollover into the single open-label study in order to further accumulate safety, tolerability and efficacy data.

The trial is on track to commence in 2014 and data from the first part is expected to be reported in mid 2015.

"We are very excited to be preparing for the start of this two-part trial and will be completing our toxicology studies and readying manufacturing in advance of patient screening," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We expect rapid enrollment as there is a large, ready pool of patients with Alzheimer's disease currently taking donepezil."

Dr. Missling added, "With respect to other compounds in our pipeline, we note that recent published studies on a Sigma-1 receptor agonist have shown a role in providing functional neurorestoration in animal models of Parkinson's disease. Not only is this similar to the mechanism of action of our Alzheimer's disease drug candidate, but it shows additional potential for our pipeline drug candidates ANAVEX 2-73, ANAVEX 3-71 (AF710B) and ANAVEX 1-41 to be disease-modifying treatments for Parkinson's disease."

Financial Results

Anavex also reported financial results for the three and six months ended March 31, 2014.

  • Anavex had cash and cash equivalents of $9.2 million as of March 31, 2014, compared with $0.3 million as at September 30, 2013. During the second quarter of fiscal 2014 the Company issued $10.0 million in non-interest-bearing convertible debentures.
  • Operating expenses for the second quarter of fiscal year 2014 were $1.0 million, compared to $0.1 million for the quarter ended March 31, 2013. The increase was primarily attributable to higher research and development expenses as the Company prepares to enter clinical studies with ANAVEX PLUS for the treatment of Alzheimer's disease, as well as expenses related to raising capital.
  • The net loss for the second quarter of fiscal year 2014 was $1.0 million or $0.03 per share, compared to a net loss of $0.1 million or $0.00 for the same period in 2013.
  • Operating expenses for the six months ended March 31, 2014 were $1.3 million, compared to $0.5 million for the comparable period in fiscal year 2013.
  • The net loss for the first half of fiscal year 2014 was $0.7 million or $0.04 per share, compared to a net loss of $0.6 million or $0.02 per share for the first half of fiscal year 2013.
  • Anavex used $0.8 million in cash to fund operations during the first half of fiscal year 2014.

Dr. Missling added, "We have made exceptional progress in advancing our clinical and business strategies. The capital we raised during the quarter will enable us to enter the clinic with ANAVEX PLUS for the treatment of Alzheimer's disease and to conduct additional preclinical work with our other pipeline products."

The financial information for the three and six months ended March 31, 2014 should be read in conjunction with the Company's interim consolidated financial statements, which have been filed on EDGAR and will be available on the Anavex website at www.anavex.com.

About ANAVEX PLUS

ANAVEX PLUS is a "cocktail" of ANAVEX 2-73 and donepezil (Aricept®). ANAVEX 2-73 is an orally available small molecule with multiple modes of action that holds potential to be disease modifying in Alzheimer's disease. In several Alzheimer's disease models including Tg2576, AVANEX 2-73 has shown a reversal of memory loss and neuroprotection. Studies with ANAVEX 2-73 have shown a clear synergistic memory effect of up to 80% in combination with donepezil, and up to 7 points cognition improvement in ADAS-Cog at 12 weeks and 5.5 points at 26 weeks in a human calibrated realistic cortical network computer model. Anavex has filed a patent application for the combination of ANAVEX 2-73 and donepezil.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (www.anavex.com) is a clinical-stage biopharmaceutical company engaged in the development of novel drug candidates to treat Alzheimer's disease, other CNS diseases and various types of cancer. ANAVEX 2-73, an orally available drug candidate developed to treat Alzheimer's disease through potential disease modification, has undergone an initial Phase 1 human clinical trial and was well tolerated in doses up to 55mg. Results from preclinical studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties. A highly encouraging synergistic effect has also been observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer's disease models versus when the drugs were used individually. Anavex is a publicly traded corporation quoted as AVXL.

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 BALANCE SHEETS
(Unaudited)
ASSETS
March 31, September 30,
2014 2013
Current
Cash $ 9,193,558 $ 345,074
Prepaid expenses 28,478 48,375
Total current assets 9,222,036 393,449
Deferred financing charges 1,068,541 --
Equipment 1,943 --
Total assets $ 10,292,520 $ 393,449
LIABILITIES AND STOCKHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities $ 1,689,605 $ 1,741,797
Promissory notes payable 193,720 210,863
Total current liabilities 1,883,325 1,952,660
Derivative financial instruments - warrants -- 904,000
Convertible debentures, net of debt discounts 1,011 --
Total liabilities 1,884,336 2,856,660
Common stock 38,261 37,238
Additional paid-in capital 49,595,118 38,644,523
Common stock to be issued 640,000 60,000
Accumulated deficit (41,865,195) (41,204,972)
Total stockholders' equity (capital deficit) 8,408,184 (2,463,211)
Total liabilities and stockholders' equity $ 10,292,520 $ 393,449
ANAVEX LIFE SCIENCES CORP.
STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2014 AND 2013
(unaudited)
2014 2013
OPERATING EXPENSES
Research and development $ 118,152 $ 560
General and administrative 903,015 126,551
Total operating expenses 1,021,167 127,111
OPERATING LOSS (1,021,167) (127,111)
OTHER INCOME
Interest and finance expenses, net (5,079) (16,558)
Accretion of debt discounts (1,011) --
Foreign exchange gain 8,397 37,569
Total other income 2,307 21,011
NET LOSS $ (1,018,860) $ (106,100)
NET LOSS PER COMMON SHARE
BASIC $ (0.03) $ (0.00)
DILUTED $ (0.03) $ (0.00)
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
BASIC 37,881,209 30,240,687
DILUTED 37,881,209 30,240,687
ANAVEX LIFE SCIENCES CORP.
STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2014 AND 2013
(unaudited)
2014 2013
OPERATING EXPENSES
Research and development $ 123,332 $ 127,563
General and administrative 1,207,443 415,415
Total operating expenses 1,330,775 542,978
OPERATING LOSS (1,330,775) (542,978)
OTHER INCOME
Interest and finance expenses, net (8,366) (26,783)
Accretion of debt discounts (1,011) --
Change in fair value of derivative financial instruments 683,000 --
Foreign exchange gain (loss) (3,071) 10,144
Total other income 670,552 (16,639)
NET LOSS $ (660,223) $ (559,617)
NET LOSS PER COMMON SHARE
BASIC $ (0.02) $ (0.02)
DILUTED $ (0.04) $ (0.02)
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
BASIC 37,680,823 30,240,687
DILUTED 37,680,823 30,240,687

CONTACT: Anavex Life Sciences Corp. Research & Business Development Email: info@anavex.com Shareholder & Media Relations Toll-free: 1-866-505-2895 Outside North America: +1 (416) 489-0092 Email: ir@anavex.com www.anavex.com

Source:Anavex Life Sciences Corp.