Actinogen Medical Limited (ASX:ACW)

Dr Bill Ketelbey
CEO & MD
Market Cap (AUD): 53.66M
Sector: Health Care
Last Trade (AUD): 0.048 +0 (+0%)
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1. About

 

Actinogen Medical is an ASX-listed biotechnology company developing innovative treatments for Alzheimer’s disease and the cognitive decline associated with neurodegenerative diseases and metabolic diseases, like Type 2 diabetes.

Our management team, clinical and scientific advisory boards include world-renowned Alzheimer’s disease and dementia researchers, and industry specialists in drug design and clinical trial management.

Actinogen Medical’s drug candidate XanamemTM has been specifically designed to block the production of cortisol in the brain. Drugs that reduce cortisol in the brain offer a promising new approach to slowing, or even preventing, the cognitive decline associated with Alzheimer’s disease. Additionally, the underlying mechanism of action through the inhibition of cortisol, offers Xanamem a broad platform of significant additional disease applications for which it can be developed, including diabetes cognitive impairment, PTSD and post-myocardial infarction.

Actinogen Medical is currently conducting XanADu, a Phase II double-blind, 12-week, randomised, placebo-controlled study to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s disease. XanADu, will enrol 174 patients at 20 research sites across Australia, the UK and the USA.

Recruitment and treatment of patients started in 2017, with results expected in early 2019.

For more information visit www.actinogen.com.au

For more information on the XanADu trial visit www.clinicaltrials.gov with identifier: NCT02727699

2. Business model

 

The company is registered as Actinogen Limited, and trades as Actinogen Medical as a single entity. The company is in the clinical research phase of developing its lead research compound as a promising new treatment for Alzheimer’s disease:[1]

 

Business

Revenue ($)

% of Revenue

% of Loss  (before Tax)

Profit drivers

Actinogen Medical

$155,768

100%

100%

The Company has not commercialised its operation. It is in clinical research, phase II

3. Strategy

 

Key strategies include:

 

• Completing the clinical development of Xanamem, the company's very promising research compound for Alzheimer’s disease. XanADu, the definitive proof-of-concept Phase II study of Xanamem in mild Alzheimer’s disease, is currently enrolling patients. It is being conducted at 20 research sites in the USA, the UK and Australia, with regulatory approval under and IND received from the FDA in the US, and with similar regulatory approvals from the authorities in the UK and Australia.

 

• The last patient is expected to be enrolled in Q4 2018, with top-line results available in Q1 2019.

 

• The nature of Xanamems mechanism of action, through inhibiting the production of cortisol, opens up a broad platform of potential additional indications over and above Alzheimer’s. Additional potential uses for the product under evaluation include, diabetes cognitive impairement, PTSD, Parkinson’s associated dementia, cognitive decline associated with schizophrenia and depression and post-myocardial infarction. While Alzheimer’s disease remains the primary focus for the development of Xanamem, these other indications are being evaluated for concurrent development.

4. Markets

 

Indications

Pharma Industry annual revenue (global)

Growth rate – Alzheimer’s population

Alzheimer’s disease

US$14bn+

Doubling every 20 years

 

Industry (Australia)

Industry Revenue (2015)

Growth Rate (annual 10-15)

Biotechnology

$7 billion

3.5%

 

[2]

5. Competition

 

Many major Big Pharma companies are currently undertaking Alzheimer’s research, as are numerous smaller biotechs. Importantly, none of this ongoing research is directly competitive to Xanamem. None is as advanced as Actinogen in actively researching cortisol inhibition as a potential therapy for Alzheimer’s disease. Additionally, Alzheimer’s treatment will likely be combination therapy for the foreseeable future, targeting the disease from a number of directions. Consequently, Actinogen does not consider any of the current Alzheimer’s research to be in direct competition to Xanamem.

6. History

 

2007
Actinogen’s lead treatment candidate Xanamem™ was discovered by professors Brian Walker and Scott Webster at the University of Edinburgh. Seven major patent families registered protecting the IP.

 

Nov. 2014   
Actinogen acquires the global licence for Xanamem from the University of Edinburgh University.

 

Dec. 2014   
Dr Bill Ketelbey employed as CEO and Managing Director.

 

2015/2016   
Actinogen successfully completes all the clinical stages of the pre-clinical and Phase I studies necessary for the definitive Phase II trial in mild Alzheimer’s disease.

 

2016/2017

Actinogen completes the design for XanADu, their Phase II proof-of-concept study of Xanamem in mild Alzheimers disease, and applies for regulatory approval from the authorities in the USA, UK and Australia. All approvals are received in late 2016 and early 2017.

 

2017

ICON, the CRO selected to conduct the study, initiates XanADu, with the first patient recruited in May 2017. As at end September, 34 patients had been enrolled into XanADu. 

[3]  [4]   

7. Team

 

Board of Directors [5]

 

 

Dr Geoff Brooke – Chairman

Dr. Bill Ketelbey – CEO & Managing Director

Dr. Jason Loveridge – Non-Executive Director

Vincent Ruffles – Vice President of Drug Development

Peter Webse – Company Secretary


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8. Financials

 

Financial Year 2014/2015 (ended 30 June): [6]

 

Business

Revenue ($)

% Change

 

Loss (before Tax) ($)

% Change

Actinogen Medical

$155,768

-24%

($3,190,338)

12%

9. Risk

Major risks include: [7]

 

Market Risk

 

Foreign Exchange Risk

Foreign exchange risk arises from future commercial transactions and recognised assets and liabilities denominated in a currency that is not the entity’s functional currency and net investments in foreign operations. During the financial year, the Company acquired Corticrine Limited, a company located in the United Kingdom. The subsidiary’s cash and cash equivalents are denominated in Great British Pounds.

 

Price Risk

Equity price risk represents the risk that the value of a financial instrument will fluctuate as a result of changes in market prices, whether those changes are caused by factors specific to the individual instrument or its issuer or factors affecting all instruments in the market.

 

Interest Rate Risk

The Company’s main interest rate risk exposure relates primarily to the Company’s cash at bank and funds held on deposit that are both held with variable interest rates.

 

Credit Risk

Credit risk is the risk of financial loss to the Company if a counterparty to a financial instrument fails to meet its contractual obligations. The Company’s main credit risk exposure relates to the financial assets of the Company, which comprise cash and cash equivalents and trade and other receivables. The Company’s exposure to credit risk arises from potential default of the counterparty, with the maximum exposure equal to the carrying amount of these instruments.

 

Liquidity Risk

Liquidity risk is the risk that the Company will not be able to meet its financial liabilities as and when they fall due.