27 January 2012
Second Quarter 2012 shareholder update
Dear Shareholder,
With 2011 behind us, we thought it would be appropriate to
send a brief note to recount what has been a pivotal year for
Agenix and provide some insights into what we are looking
forward to in 2012.
As a result of your support and the efforts of our team in
China and Australia, Agenix made a number of significant
achievements on several fronts in 2011. As we look forward to
2012,
we anticipate another year of progress towards building
long-term shareholder value through the delivery of key
milestones.
While we have set ourselves a range of major objectives for
2012, our key priorities are:
1. The sale or licensing of our ThromboView® diagnostic for
blood clots
2. Completion of pre-clinical studies for our hepatitis B
drug AGX-1009 focused on
China's rapidly growing hepatitis B market
3. Filing of our application for approval to begin human
trials of AGX-1009 in China
4. Expansion of our current product pipeline.
We are on the verge of hitting a number of key development
milestones and are focused on doing everything we can to take
advantage of the significant opportunities in front of
us.
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Agenix today released its cash flow statement for the quarter
ended 31 December 2011. As you will notice from our cash flow
statements, our spending in the fourth quarter was steady
compared to prior quarters but will reduce significantly from
January 2012. This is largely
due to our focus on cost controls, winding back on surplus
personnel and the wash-through of historical legacy
liabilities in December 2011. Options and shares have become
a large part of remuneration in a demonstration of confidence
by key-people including the Chief of our Scientific Advisory
Board Professor Timothy Morris and our Chief Scientific
Officer - ThromboView®, Dr Mike Gerometta and also by me as
Chairman & CEO.
Cash at the end of the quarter was $670,000. This is less
than we had planned for after a funding opportunity expected
last year did not eventually materialise. As we head into
2012, we are focused on ensuring Agenix has sufficient
capital to meet its development
milestones. The Board has a number of strategies and
initiatives in place to address our capital needs in a timely
manner which will be detailed at the appropriate juncture.
In China, we remain on track to meet our pre-clinical
development milestones for our new hepatitis B drug and to
file our formal clinical trial approval application in the
middle of 2012 with China's State Food and Drug
Administration (SFDA). Our goal is to begin Phase I trials in
China in late 2012 or early 2013.
It is worth remembering that AGX-1009 is based on an active
and approved compound currently marketed and used extensively
in the US and Europe and that our patented compound is
undergoing pre-clinical testing conducted by very experienced
hands at the Institute of Pharmacology and Toxicology of the
Academy of Military Medical Sciences in Beijing, China.
Our strategic partner from whom we purchased this patented
technology, the internationally renowned Institute of
Medicinal Biotechnology (IMB) of the Chinese Academy of
Medical Sciences in Beijing, is also very experienced at
navigating the State Food and Drug Administration (SFDA)
regulatory processes in China. It is also worth remembering
that Agenix already has a track record for successfully
obtaining SFDA clearance for a Hepatitis B small molecule
therapeutic with the YouHeDing project, which the company
subsequently
divested.
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Over time, there will be multiple market opportunities for
AGX-1009 - it has potential to be used in combination with
Interferon therapies or in combination with other small
molecule drugs and in other markets such as HIV. These facts
significantly reduce our risks and provide a solid
foundation.
Our good relationship with IMB, cemented in a co-operation
agreement signed in October
2011, also provides Agenix with potential access to a large
pipeline of new medical therapies and the opportunity to
expand our product pipeline in 2012 and beyond.
The other valuable world class asset we are actively seeking
to exploit is a patented monoclonal antibody diagnostic,
ThromboView®.
We are in active discussions with a number of international
businesses that have expressed an interest in buying or
licensing this promising technology. These discussions are
progressing in a positive and timely manner and we look
forward to providing you with a detailed update in the coming
months.
ThromboView® promises to give medical professionals an
accurate method of detecting deadly live blood clots and
pulmonary embolisms without exposing patients to the high
radiation and toxic chemicals used in current
technologies.
We are encouraged by the growing body of independent clinical
evidence that shows ThromboView® is safe and effective. A
recent report in the highly influential American Journal of
Respiratory and Critical Care described ThromboView® as 'not
just a new diagnostic method; it is a new imaging
concept.'
The ability of ThromboView® to stratify and manage
anti-coagulation patients fulfils a significant unmet medical
need.
We believe Agenix is ideally positioned to partner
ThromboView® for global commercialisation as a patient
management tool and also to take advantage of current and
future opportunities in the rapidly evolving Chinese
healthcare market together with our partner, the Institute of
Medicinal Biotechnology (IMB) of the Chinese Academy of
Medical
Sciences.
Page 3 of 4
Our focus on China will help us create significant value over
the long term.
In 2011 the Chinese government unveiled a number of
incentives to nurture its domestic pharmaceutical and
biotechnology industries and there are significant new
opportunities unfolding for the development of drugs relevant
for the Chinese market like our hepatitis B compound
AGX-1009.
China's biotechnology industry is one of seven strategic
sectors the government committed to support in its Five-Year
Plan for 2011 to 2015. China's goal is to become a
global drug development hub and there is strong support for
the rapid development of new cost-effective treatments for
disease like hepatitis B which are a major health issue.
Agenix's hepatitis B drug AGX-1009 is one of the drug
candidates supported by the Chinese
Government's State Special Funds for Important
Newly-Developed Drugs.
China is considered to be the most important future market in
terms of sales, clinical trial opportunities, and potential
investment for many global biotechnology and life science
firms.
International healthcare market researcher IMS Health Inc has
said China is now the world's third-largest
pharmaceutical market and has been estimated that China's
domestic drug market be the world's largest drug market by
2020, overtaking Japan, Europe and the US.
This growth is fueled by growing wealth, urbanization and the
ageing of China's population combined with a global demand
for cheap, effective medicines.
We firmly believe Agenix's experience and established
presence in China gives us a leading edge and ensures our
long-term growth potential for 2012 and beyond.
All of us at Agenix appreciate your ongoing support and look
forward to providing you with updates over the coming months
as we work to build shareholder wealth.
Yours sincerely,
Nicholas Weston
Chairman & Chief Executive Officer www.agenix.com
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