10.09.2007 18:43:00
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InNexus Biotechnology Releases CEO Letter to Shareholders
InNexus Biotechnology Inc. (OTCBB: IXSBF) (TSX VENTURE: IXS), a drug
development company commercializing the next generation of monoclonal
antibodies based on its Dynamic Cross Linking (DXL™)
technology, today announced that Chairman and Chief Executive Officer,
Jeff Morhet, has released a letter to shareholders.
Dear Shareholders and Friends,
We are building a new company driven by innovation. As I write this
letter to you, we are putting the finishing touches on our annual filing
for fiscal year 2007 (FY07). A lot has happened within InNexus since I
have been involved, particularly this last year. When I was first
introduced to InNexus prior to my initial appointment as COO in January
2006, I found a company with great technology, but no products, focused
almost entirely on trying to license its technology to other companies –
with very limited success. It became apparent that InNexus needed a new
strategy. I have always been convinced that success in Biotechnology
comes from creating new and valuable products – if you want to lead, you have to create. I became
convinced then – as I am now –
that for InNexus to succeed, it had to develop products.
I also became convinced that our Dynamic Cross Linking (DXL™)
technology gave us a strategic competitive advantage that few
other Biotech companies have:
The ability to take existing, FDA approved products and modify them with
DXL™ to make them more effective and extend
their patent life, but without changing the fundamental characteristics
of how the product seeks its target such as cancer. This gave us the
chance to cut years of time and millions of dollars off the typical
product development cycle, allowing us to establish value for our
products or ‘monetize’
our R&D efforts much more quickly than our competitors.
We had an opportunity. But to take advantage of it, we needed to change
the fundamental nature of our company. We needed to shift from being a
technology licensing company to a product development company. This
required many sweeping changes in facilities, operations, staff,
collaborative partners, finance and many other areas –
virtually, the entire company. These are enormous changes, but very
positive ones. I am pleased to report that, to a large extent, this is
what InNexus has achieved during FY07 –
perhaps one of the most exciting times in the history of our company. I
have set out some of the key events of FY07 below along with our outlook
for fiscal year 2008 (FY08).
Key Events in FY07 Completed Financings
We began FY07 by completing a CDN$5,435,325 private placement in August
2006. Later in the year, we received an additional USD$1,000,000 private
placement as part of the Royalty Pharma transaction referred to below
plus USD$2,000,000 from the sale of a partial royalty interest. This
gave us the resources needed to implement the number of strategic
changes made throughout the year.
Strengthened Senior Management and Scientific Team
Leadership is the key to success in any organization. At InNexus, our
leadership team is made up of the directors, officers and key advisors
that oversee our decisions and activities. FY07 saw a number of significant
and sophisticated changes in our Board of Directors and the senior
management team.
In early September 2006, I was honored to be appointed as CEO, which was
followed by a number of other additions and changes to our team.
Board of Directors
At our Annual Shareholder Meeting in December 2006, we added two new
highly qualified members to our Board of Directors and in February 2007
a third dynamic member was added:
Larry Luke (who also serves as the Chairman of the Audit
Committee) is a retired lawyer and founding partner of a prominent law
firm. He brings a deep understanding of corporate governance and
business experience to the Company.
Dr. Leroy Chiao (who also serves as Chairman of the
Compensation Committee) is an engineering professor at LSU who spent
fifteen plus years of his career as a NASA Astronaut, including four
missions into space and was most recently the Commander of the
International Space Station. He has considerable international and
senior executive experience.
Glenn Williamson is an international investment banker, with
extensive experience in corporate finance, corporate governance and
public company operations, finance and stewardship. He is also
Chairman of the Canadian Arizona Business Council.
These three have significantly contributed to the depth and intensity of
our Board’s decision-making process and
corporate governance practices.
Senior Science Team and Scientific Advisory Board
In early 2007 a number of highly qualified, commercially experienced
scientists joined our team forming a world-class Scientific Advisory
Board and Senior Science team. They are all excellent additions to our
team and I would like to highlight three of them:
In May 2007, Dr. Thomas Kindt became our new Chief
Scientific Officer. Dr. Kindt is an accomplished scientist with
extensive knowledge of antibodies, immunology and the biotechnology
industry in general. He was most recently Director of Intramural
Research and Chief of Laboratory of Immunogenetics at the National
Institute of Health, NIAID. He has authored and co-authored 225
scientific publications, two books and multiple patents and his
extreme knowledge and forethought helps him manage and direct our
scientific assets toward and for the creation of products.
In August of this year Jur Strobos J.D., M.D. became our
new Chief Medical Officer. Dr. Strobos, both a Medical Doctor and
Lawyer, is an acknowledged FDA expert and has a successful and diverse
background in drug law, medical product development, and health care.
Dr. Strobos served as Director of Policy Research in the office of the
Commissioner of the Food and Drug Administration (FDA) and his
successful track record as an FDA expert and specialist with drug
development, clinical trial design and pharmaceutical manufacturing
makes him a superb choice to lead our preclinical and clinical
development activities.
Also this year, Don Capra M.D. became the Chairman of
our Scientific Advisory Board and not only stewards the full advisory
board but also reviews, oversees and provides direction to the
executive leadership team. Dr. Capra is an outstanding scientist with
a distinguished career and an acknowledged expert in field of
monoclonal antibodies. He is the President Emeritus of the Oklahoma
Medical Research Foundation (OMRF) and is also well known for his
studies of antibody genes and how they are mutated in autoimmune
disorders and was an early leader in the field of monoclonal
antibodies.
Other members of the Scientific Advisory Board include Dr. John Minna,
Dr. Carlos Arteaga, Dr. Ellen Vitetta and Dr. Martin Weigert. To find
more information on our world-class Scientific Advisory Board, I
encourage you to visit InNexus’ website at http://www.ixsbio.com/about_advisory_board.html.
Established New Research Facilities
Becoming a leader in drug creation requires great research facilities.
Prior to this year, our R&D efforts were focused largely on basic
technology enhancement and supporting pre-licensing collaborative
activities. We relied upon outside contract facilities for all R&D work.
During 2007, we completed building our own state-of-the-art facilities
on the Mayo Clinic campus. These facilities are now fully operational
and focused on creating new DXL™ based
products.
Built New Research Team
Great facilities are useless without a great team. Within the last 12
months, we have transformed our research team from a handful of contract
individuals to a world-class team of in-house scientific and FDA
experts. We now have a growing team of 22 scientists and staff in our
Mayo-based facility, backed up and directed by an interactive and
engaged world-class Scientific Advisory Board.
Secured Strong Industry Partner
In June 2007, we announced a historic agreement with Royalty Pharma –
the industry leader in acquiring revenue-producing biopharmaceutical
products with a market value of over $3.2 billion - their first ever
such agreement with a junior company. This agreement was the product of
many months of meetings, discussions and reviews, including extensive
third party review of our DXL™ technology by
Royalty’s experts. When finally concluded,
this historic agreement brought a number of important benefits to our
Company:
1. infusion of USD$3,000,000, including an equity investment of
USD$1,000,000 in our equity shares
2. third party validation of our DXL™
technology by the premier technology-valuer in the Industry
3. our first significant operating revenue
4. an ongoing collaborative relationship with an acknowledged industry
leader
Launched New Product Development
We are determined to show market leadership by bringing compelling new
products to market. During FY07 we launched our first-ever product,
DXL625 (CD20), for the treatment of non-Hodgkin’s
lymphoma (NHL) - a market now served by Rituxan™
developed by Genentech, Inc. and Biogen Idec that generates multiple
billions of USDs in sales yearly.
We are currently preparing the launch of a second cancer targeting
product, anticipated to be announced before the end of calendar year
2007 or early in calendar year 2008.
Improved Financial Results and Instituted Financial Controls
Prior to 2007, our Company efforts were primarily focused on obtaining
licensing or collaborative arrangements and funding. Prior company
strategy failed to produce any significant revenue and included a number
of activities (domestic and international business development trips,
meetings, conferences) that resulted in significant expenses, but few
tangible benefits for the Company. In response, we created stringent
internal financial control procedures to ensure the Company’s
money would be well spent, focusing on our new product creation
strategy. During FY07, we made a significant investment of $2,100,000 in
research and development activities ("R&D”)
squarely focused on the creation of products from our laboratories. This
increased our quarterly operating costs which, by the fourth quarter,
are averaging $1,450,000 per quarter. This change also resulted in our
first significant revenue as a result of our monumental agreement with
Royalty Pharma.
In July 2007 we reduced our operating expenses by almost $85,000 per
month by closing the relationship we had with a laboratory based in
Kentucky and refocusing those activities in our new Mayo Clinic based
facilities.
I encourage you to review our soon-to-be released financial statements
and accompanying Management Discussion and Analysis for a more detailed
discussion of our financial results in FY07.
A sharp new strategic focus
Following my appointment as Chairman and CEO, I began working with Dr.
Don Capra, Dr. Thomas Kindt, Dr. Jur Strobos and Dr. Heinz Kohler and
members of our Scientific Advisory Board to find ways to best exploit
our technology. Although DXL™ is
fundamentally diverse technology with important synergies for the
development products, partners and other uses such as diagnostics, we
believe our best opportunities come from rapid product development
using our DXL™ technology. We also
believe that, by focusing on existing FDA approved antibody products
that can be suitably enhanced with DXL™, we
can significantly reduce the time and cost to develop new products.
During initial development and clinical trials, we can offer for sale or
collaborative development our projects to large biotechnology and
pharmaceutical companies, thereby significantly accelerating our ability
to monetize our efforts. In FY08, we are focusing on sustaining that
philosophy and launching additional products.
Our strategy for growth has the following elements:
Invest all of our financial, human and lab resources in DXL625 (CD20)
for near-term growth
Nurture our opportunity with Royalty Pharma
Launch additional DXL™ based products
Capture opportunities with collaborations, licensing and/or joint
activities
R&D investments are not our only strategy for driving growth. InNexus
continues to work with collaborators and new corporate acquaintances to
conduct proof-of-concept and joint scientific exploration activities for
the potential development of innovative products and technologies.
However, as a Company we have undergone a fundamental shift in our
strategy – that already has begun to pay off.
Acknowledgments and Awards
Our efforts this year have not gone unnoticed. Many key InNexus
stakeholders have applauded our first product offering and improved
operations, as well as our new approach to doing business. Excellence
in Biosciences and numerous awards and publications accorded InNexus
significant recognition. We also became one of the 2007 TSX Venture’s
Top 50 companies from a list of over 2,000 companies with InNexus ranked
2nd in the TSX Venture top 10 biotechnology and
life sciences companies. While we appreciate the strong support and
encouragement received to date, we are determined to build on our
success as we look forward to the future.
Outlook for 2008
Within the last 12 months, we have transformed nearly every aspect of
our company and how we do business. The decision to focus on product
development gave us great clarity to our mission. We built a team of
industry and regulatory expert leaders, an interactive and engaged
Scientific Advisory Board, a team of commercially experienced scientists
and added to our Board of Directors a group of highly qualified
independent individuals. We built state-of-the-art R&D laboratories on
the Mayo Clinic campus and staffed them with a team of qualified
professionals focused on the development of DXL™
products. We secured an excellent long-term partner in Royalty Pharma
and also obtained significant funding through equity placements and
payments under the Royalty Pharma transaction. And, perhaps most
significantly, we launched our first-ever product - DXL625 (CD20) for
non-Hodgkin’s lymphoma (NHL).
As a result, we begin FY08 as a fundamentally changed company –
one that has now largely made the shift from a more passive technology
licensing company to a dynamic - and fully operational - drug
development company. In this coming year, as we continue to progress our
company, we believe we are well positioned to take advantage of market
trends as antibody-based products are widely expected to be the primary
source of growth in the Biotechnology industry over the next decade.
Within this space, cancer therapeutics are expected to be the fastest
growing type of product and we also believe our DXL™
technology gives us a significant strategic advantage in developing new
antibody-based cancer therapeutics, such as our DXL625 (CD20), as well
as other DXL™ based products.
Although not everyone applauds change, particularly those with a vested
interest in the status quo, I believe the changes we made this year are
significant and position us very well for the future.
Thank you for your support and encouragement over this past year. We
will continue to communicate how we seek to innovate and create products
that enhance value for our shareholders.
Best wishes to you all, Jeff Morhet
About InNexus
InNexus is a drug development company commercializing the next
generation of monoclonal antibodies based on its DXL™
technology, which improves the potency of existing antibody products
while opening new markets and disease applications. DXL™
antibodies utilize unique, novel and patented methods and technologies
of InNexus.
InNexus is headquartered in British Columbia with principal management
based in Scottsdale, Arizona on the campus of Mayo Clinic and has its
own in-house developmental facilities. These development resources
provide validation of protein and peptide discoveries, enabling InNexus
(and its strategic partners) to advance novel drug therapeutics and
diagnostics. To learn more about InNexus, please visit www.ixsbio.com.
This news release contains certain "forward-looking
statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including, without
limitation, statements regarding future drug development activities or
anticipated products, anticipated future revenues, benefits or
advantages, and the future plans and objectives of the Company, that
involve inherent risks and uncertainties and are subject to factors,
many of which are beyond the Company's control, that may cause actual
results or performance to differ materially from those currently
anticipated in such statements.
The TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this news release.
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