We have developed compounds with potential application to two broad categories and several specific indications. The two categories are diseases of the central nervous system, and cancer. Specific indications include:
• Alzheimer’s disease – In 2014, an estimated 5.2 million Americans were suffering from Alzheimer’s disease. The Alzheimer’s Association® reports that by 2025, 7.1 million Americans will be afflicted by the disease, a 40 percent increase from currently affected patients. Medications on the market today treat only the symptoms of AD and do not have the ability to stop its onset or its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer’s disease as well as for better symptomatic treatments.
• Depression - Depression is a major cause of morbidity worldwide according to the World Health Organization (WHO). Pharmaceutical treatment for depression is dominated by blockbuster brands, with the leading nine brands accounting for approximately 75% of total sales. However, the dominance of the leading brands is waning, largely due to the effects of patent expiration and generic competition. Our market research leads us to believe that the worldwide market for pharmaceutical treatment of depression exceeds $11 billion annually.
26
• Epilepsy - Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or synchronous neuronal activity in the brain. According to the Centers for Disease Control and Prevention, epilepsy affects 2.2 million Americans. Today, epilepsy is often controlled, but not cured, with medication that is categorized as older traditional anti-epileptic drugs and second generation anti epileptic drugs. Because epilepsy afflicts sufferers in different ways, there is a need for drugs used in combination with both traditional anti-epileptic drugs and second generations anti-epileptic drugs. Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the epilepsy market will increase from $2.9 billion in 2011 to nearly $3.7 billion in 2016.
• Neuropathic Pain – We define neuralgia, or neuropathic pain, as pain that is not related to activation of pain receptor cells in any part of the body. Neuralgia is more difficult to treat than some other types of pain because it does not respond well to normal pain medications. Special medications have become more specific to neuralgia and typically fall under the category of membrane stabilizing drugs or antidepressants. Our market research leads us to believe the worldwide market for pharmaceutical treatment of neuropathic pain exceeds $5 billion annually.
• Malignant Melanoma - Predominantly a skin cancer, malignant melanoma can also occur in melanocytes found in the bowel and the eye. Malignant melanoma accounts for 75% of all deaths associated with skin cancer. The treatment includes surgical removal of the tumor, adjuvant treatment, chemo and immunotherapy, or radiation therapy. According to IMS Health the worldwide Malignant Melanoma market is expected to grow from about $900 million in 2012 to $4.4 billion by 2022.
• Prostate Cancer – Specific to men, prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. The cancer cells may metastasize from the prostate to other parts of the body, particularly the bones and lymph nodes. Drug therapeutics for Prostate Cancer are expected to increase from $8.1 billion in 2012 to nearly $18.6 billion in 2017 according to BCC Research.
• Pancreatic Cancer - Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States approximately 45,000 new cases of pancreatic cancer will be diagnosed this year and approximately 38,000 patients will die as a result of their cancer. Our market research leads us to believe that the market for the pharmaceutical treatment of pancreatic cancer will exceed $1.2 billion by 2015.
Recent Corporate Developments
Since the commencement of our fourth quarter ended September 30, 2014, we have experienced the following significant corporate developments:
• On October 22, 2014, we entered into a Securities Purchase Agreement (the “Subscription Agreement”) with Lincoln Park Capital Fund, LLC, a long time investor of our company, for an equity investment of $500,000 at a price of $0.25 per unit. Pursuant to the terms of the Subscription Agreement, we agreed to sell, and Lincoln Park agreed to purchase, 2,000,000 shares of common stock. In addition, we agreed to issue to Lincoln Park an aggregate of 4,000,000 stock purchase warrants, of which 2,000,000 are exercisable at $0.30 per share and 2,000,000 are exercisable at $0.42 per share, each for a period of five years, subject to adjustment for stock splits, combinations, and reclassification events.
• Effective as of December 12, 2014, our Company’s common stock began being quoted on the OTC Market Group’s OTCQX tier under the Company’s existing stock ticker “AVXL”. The OTCQX is the highest tier of the OTC Market Group’s trading marketplace.
• On January 12, 2015, we announced dosing of the first patient in the Phase 2a clinical trial of our proprietary compound, ANAVEX 2-73 and ANAVEX PLUS, which are being developed as an oral therapy and oral drug combination for the potential treatment of Alzheimer's disease. The approved Phase 2a clinical trial is the first study of ANAVEX 2-73 in Alzheimer’s patients.
27
• On January 13, 2015, our Company’s president and Chief Executive Officer, Christopher Missling, PhD presented at the 8th annual OneMedForum conference in San Francisco. OneMedForum is recognized as a leading annual event showcasing promising, innovative growth companies in healthcare and life sciences and we provided an overview of our Company and its progress of the Phase 2a clinical trial evaluating ANAVEX 2-73 and ANAVEX PLUS.
• On February 9, 2015, we confirmed positive preclinical data for our lead drug candidate ANAVEX 2-73 for the potential treatment of epilepsy, validating it also as a prospective platform drug for the treatment of other neurodegenerative diseases beyond Alzheimer’s. The data demonstrates significant improvement in the reduction of seizures relative to three generations of epilepsy drugs currently on the market, as well as significant synergy with each of these drugs.
• On March 5, 2015 we announced the appointment of Corinne Lasmezas, DVM, PhD, to the Company’s scientific advisory board. A professor at The Scripps Research Institute for the past 10 years, Dr. Lasmezas is an internationally recognized expert in the field of neurogenerative disease.
• On March 11, 2015 our Company’s president and Chief Executive Officer, Christopher Missling, PhD presented at the 27th annual ROTH conference Dana Point, California. The presentation included an overview of our advancing clinical development programs, including the current Phase 2a clinical trial evaluating ANAVEX 2-73 and ANAVEX PLUS in Alzheimer’s patients.
• On March 12, 2015, we announced the appointment of Jacqueline French, MD, FAAN, to the Company's Scientific Advisory Board. Dr. French is an award-winning, internationally recognized expert on epilepsy, new therapeutic interventions and clinical trial methodology.
• On March 23, 2015, we unveiled new promising preclinical data for both ANAVEX 2-73 and ANAVEX 3- 71 (formerly AF710B) in two separate presentations at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders in Nice, France.
• On March 26, 2015, pursuant to a special meeting of stockholders, our stockholders approved an amendment to the Company’s Articles of Incorporation to increase the Company’s authorized common stock from 150,000,000 to 400,000,000 shares, which amendment became effective upon the filing of a Certificate of Amendment with the Secretary of State of Nevada on March 27, 2015.
• Alzheimer’s disease – In 2014, an estimated 5.2 million Americans were suffering from Alzheimer’s disease. The Alzheimer’s Association® reports that by 2025, 7.1 million Americans will be afflicted by the disease, a 40 percent increase from currently affected patients. Medications on the market today treat only the symptoms of AD and do not have the ability to stop its onset or its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer’s disease as well as for better symptomatic treatments.
• Depression - Depression is a major cause of morbidity worldwide according to the World Health Organization (WHO). Pharmaceutical treatment for depression is dominated by blockbuster brands, with the leading nine brands accounting for approximately 75% of total sales. However, the dominance of the leading brands is waning, largely due to the effects of patent expiration and generic competition. Our market research leads us to believe that the worldwide market for pharmaceutical treatment of depression exceeds $11 billion annually.
26
• Epilepsy - Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or synchronous neuronal activity in the brain. According to the Centers for Disease Control and Prevention, epilepsy affects 2.2 million Americans. Today, epilepsy is often controlled, but not cured, with medication that is categorized as older traditional anti-epileptic drugs and second generation anti epileptic drugs. Because epilepsy afflicts sufferers in different ways, there is a need for drugs used in combination with both traditional anti-epileptic drugs and second generations anti-epileptic drugs. Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the epilepsy market will increase from $2.9 billion in 2011 to nearly $3.7 billion in 2016.
• Neuropathic Pain – We define neuralgia, or neuropathic pain, as pain that is not related to activation of pain receptor cells in any part of the body. Neuralgia is more difficult to treat than some other types of pain because it does not respond well to normal pain medications. Special medications have become more specific to neuralgia and typically fall under the category of membrane stabilizing drugs or antidepressants. Our market research leads us to believe the worldwide market for pharmaceutical treatment of neuropathic pain exceeds $5 billion annually.
• Malignant Melanoma - Predominantly a skin cancer, malignant melanoma can also occur in melanocytes found in the bowel and the eye. Malignant melanoma accounts for 75% of all deaths associated with skin cancer. The treatment includes surgical removal of the tumor, adjuvant treatment, chemo and immunotherapy, or radiation therapy. According to IMS Health the worldwide Malignant Melanoma market is expected to grow from about $900 million in 2012 to $4.4 billion by 2022.
• Prostate Cancer – Specific to men, prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. The cancer cells may metastasize from the prostate to other parts of the body, particularly the bones and lymph nodes. Drug therapeutics for Prostate Cancer are expected to increase from $8.1 billion in 2012 to nearly $18.6 billion in 2017 according to BCC Research.
• Pancreatic Cancer - Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States approximately 45,000 new cases of pancreatic cancer will be diagnosed this year and approximately 38,000 patients will die as a result of their cancer. Our market research leads us to believe that the market for the pharmaceutical treatment of pancreatic cancer will exceed $1.2 billion by 2015.
Recent Corporate Developments
Since the commencement of our fourth quarter ended September 30, 2014, we have experienced the following significant corporate developments:
• On October 22, 2014, we entered into a Securities Purchase Agreement (the “Subscription Agreement”) with Lincoln Park Capital Fund, LLC, a long time investor of our company, for an equity investment of $500,000 at a price of $0.25 per unit. Pursuant to the terms of the Subscription Agreement, we agreed to sell, and Lincoln Park agreed to purchase, 2,000,000 shares of common stock. In addition, we agreed to issue to Lincoln Park an aggregate of 4,000,000 stock purchase warrants, of which 2,000,000 are exercisable at $0.30 per share and 2,000,000 are exercisable at $0.42 per share, each for a period of five years, subject to adjustment for stock splits, combinations, and reclassification events.
• Effective as of December 12, 2014, our Company’s common stock began being quoted on the OTC Market Group’s OTCQX tier under the Company’s existing stock ticker “AVXL”. The OTCQX is the highest tier of the OTC Market Group’s trading marketplace.
• On January 12, 2015, we announced dosing of the first patient in the Phase 2a clinical trial of our proprietary compound, ANAVEX 2-73 and ANAVEX PLUS, which are being developed as an oral therapy and oral drug combination for the potential treatment of Alzheimer's disease. The approved Phase 2a clinical trial is the first study of ANAVEX 2-73 in Alzheimer’s patients.
27
• On January 13, 2015, our Company’s president and Chief Executive Officer, Christopher Missling, PhD presented at the 8th annual OneMedForum conference in San Francisco. OneMedForum is recognized as a leading annual event showcasing promising, innovative growth companies in healthcare and life sciences and we provided an overview of our Company and its progress of the Phase 2a clinical trial evaluating ANAVEX 2-73 and ANAVEX PLUS.
• On February 9, 2015, we confirmed positive preclinical data for our lead drug candidate ANAVEX 2-73 for the potential treatment of epilepsy, validating it also as a prospective platform drug for the treatment of other neurodegenerative diseases beyond Alzheimer’s. The data demonstrates significant improvement in the reduction of seizures relative to three generations of epilepsy drugs currently on the market, as well as significant synergy with each of these drugs.
• On March 5, 2015 we announced the appointment of Corinne Lasmezas, DVM, PhD, to the Company’s scientific advisory board. A professor at The Scripps Research Institute for the past 10 years, Dr. Lasmezas is an internationally recognized expert in the field of neurogenerative disease.
• On March 11, 2015 our Company’s president and Chief Executive Officer, Christopher Missling, PhD presented at the 27th annual ROTH conference Dana Point, California. The presentation included an overview of our advancing clinical development programs, including the current Phase 2a clinical trial evaluating ANAVEX 2-73 and ANAVEX PLUS in Alzheimer’s patients.
• On March 12, 2015, we announced the appointment of Jacqueline French, MD, FAAN, to the Company's Scientific Advisory Board. Dr. French is an award-winning, internationally recognized expert on epilepsy, new therapeutic interventions and clinical trial methodology.
• On March 23, 2015, we unveiled new promising preclinical data for both ANAVEX 2-73 and ANAVEX 3- 71 (formerly AF710B) in two separate presentations at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders in Nice, France.
• On March 26, 2015, pursuant to a special meeting of stockholders, our stockholders approved an amendment to the Company’s Articles of Incorporation to increase the Company’s authorized common stock from 150,000,000 to 400,000,000 shares, which amendment became effective upon the filing of a Certificate of Amendment with the Secretary of State of Nevada on March 27, 2015.
