UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 8-K

 

Current Report
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): June 23, 2016

 

Anavex Life Sciences Corp.
(Exact name of registrant as specified in its charter)

 

Nevada 000-51652 98-0608404
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)

  

51 West 52nd Street, 7th Floor, New York, NY USA 10019
(Address of principal executive offices) (Zip Code)

 

Registrant's telephone number, including area code 1-844-689-3939

 

Not Applicable
(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

On June 23, 2016, Anavex Life Sciences Corp., a Nevada corporation (the “ Company ”) delivered a presentation entitled “ ANAVEX 2-73 as a Potential Treatment for Rett Syndrome and Other Pediatric or Infantile Disorders with Seizure Pathology ” (“ Presentation ”) at the 2016 Rett Syndrome Symposium. The Presentation is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.

 

In connection with the Presentation, the Company issued a press release announcing its participation in the Rett Syndrome Symposium (the “ Press Release ”). A complete copy of the Press Release is attached hereto as Exhibit 99.2 .

 

The information in this Item 7.01 of the Current Report, including Exhibit 99.1 and Exhibit 99.2 , is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 of this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(a) Not applicable
(b) Not applicable
(c) Not applicable
(d) Exhibits .

 

EXHIBIT NO.

 

DESCRIPTION

 

LOCATION

 
           
Exhibit 99.1   Presentation: ANAVEX 2-73 as a Potential Treatment for Rett Syndrome and Other Pediatric or Infantile Disorders with Seizure Pathology     Provided herewith  
             
Exhibit 99.2   Press Release dated June 23, 2016 Regarding Presentation at Rett Syndrome Symposium     Provided herewith  

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ANAVEX LIFE SCIENCES CORP.
   
  /s/ Christopher Missling, PhD
  Name: Christopher Missling, PhD
  Title: Chief Executive Officer

 

Date: June 23, 2016

 

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Exhibit 99.1

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

  

 

 

 

Exhibit 99.2

 

Anavex to Present at the 2016 Rett Syndrome Symposium

 

NEW YORK – June 23, 2016 – 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 announced that preclinical data for ANAVEX 2-73, the company’s lead drug candidate, is featured in a presentation at the 2016 Rett Syndrome Symposium.

 

The session, titled “ ANAVEX 2-73 as a Potential Treatment for Rett Syndrome and Other Pediatric or Infantile Disorders with Seizure Pathology,” is being presented by Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, on Thursday, June 23, 2016, at 3:50 p.m. CDT. The presentation is available on the publications page of the Anavex website.

 

The presentation features preclinical ANAVEX 2-73 data in anxiety, epilepsy, infantile spasms, Rett syndrome, Fragile X syndrome, Autism-related disorders and highlights the underlying commonalities within neurodevelopmental indications.

 

The 14th Annual Rett Syndrome Symposium is an international, interdisciplinary meeting focused on new developments in Rett syndrome research. This year’s conference takes place June 22-24, 2016 at the Eaglewood Resort in Itasca, Illinois and includes sessions on fundamental science, translational and clinical research and neuro-habilitation research.

 

About Rett Syndrome

 

Rett syndrome is a rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat, and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, slowed brain and head growth, problems with walking, seizures, and intellectual disability. There is currently no cure for Rett syndrome and treatment of the disorder is symptomatic. Management of the symptoms is done through a multidisciplinary approach utilizing medication for motor difficulties, breathing irregularities, and control of seizures through anticonvulsant drugs. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately 1 in every 10,000-15,000 live female births.

 

About Infantile Spasms

 

A rare yet devastating condition, infantile spasms is a seizure disorder that typically occurs during the first 4-11 months of childhood. Infantile spasms represent a major issue as they are resistant to treatments, they have dire consequences in terms of delayed development, progression into other devastating epilepsy syndromes and those partially effective treatments have serious side effects, including death. Infantile spasms usually stop by age five, but may be replaced by other seizure types. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In many children, no cause can be found.

 

 

 

 

About Fragile X Syndrome and Autism Spectrum Disorders

 

Fragile X syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism, affecting approximately 1 in 4,000 males and 1 in 6,000 females. The disorder is caused by the unstable expansion of a CGG repeat in the FMR1 gene and abnormal methylation, which results in suppression of FMR1 transcription and decreased protein levels in the brain. The average age of Fragile X syndrome diagnosis of boys and girls are, 35 to 37 months and 42 months, respectively. Behavioral abnormalities, including Autism Spectrum Disorder, are common.

 

Autism Spectrum Disorder is a behavioral diagnosis while Fragile X syndrome is a medical/genetic diagnosis. Many studies have evaluated the Fragile X syndrome-Autism Spectrum Disorders link over the past decade. Since many children with Fragile X syndrome are interested in social interactions, they may not meet the diagnostic criteria for Autism Spectrum Disorders, even though they exhibit some features of Autism Spectrum Disorders such as poor eye contact, shyness, social anxiety, hand-flapping and sensory issues. Autism is much more common in boys with Fragile X syndrome than in girls with Fragile X syndrome. According to the CDC, a national parent survey found that 46% of males and 16% of females with Fragile X syndrome have been diagnosed or treated for Autism Spectrum Disorders.

 

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, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. 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 (MJFF) 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.

 

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.

 

 

 

 

For Further Information:

  

Anavex Life Sciences Corp.

Research & Business Development

Toll-free: 1-844-689-3939

Email: info@anavex.com

 

Investors:

Matt Haines

River East Investor Relations, LLC

917-733-9297

mhaines@rivereastir.com

 

Media:

Jules Abraham

JQA Partners, Inc.

917-885-7378

jabraham@jqapartners.com

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