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InNexus Bio Provides Summary of 2010 Accomplishments and 2011 Outlook
-- Developing Opportunities for Ophthalmology, Dermatology and Oncology Markets --
CHANDLER, ARIZONA, 3 March 2011 – InNexus Biotechnology Inc. (TSX:IXS.V, www.ixsbio.com), a leading drug development company commercializing the next generation of antibodies based on its proprietary DXL™ and Transmab™ technologies, provided a synopsis of its accomplishments and progress during 2010, as well as the company’s outlook for 2011.
InNexus is developing commercial opportunities based on the expanding field of monoclonal antibodies, naturally occurring proteins that fight infection and disease, utilizing its proprietary technologies in three focus areas: Ophthalmology, dermatology and oncology. During 2010, with the continuing challenge for small publicly traded companies to raise capital, we recognized we should refocus our company, team and R&D efforts. With limited cash resources available, we could not continue large-scale programs so we shifted our strategy to emphasize collaboration and identifying programs that represent more near term opportunities.
Operations
Early in 2010 we raised funds through a small private placement from existing investors. This allowed for us to place our plan of refocus into full gear and we moved our laboratories into new state-of-the-art R&D Innovations facilities, negotiating a year-free of lease payments at the new facility. Later during the year, and to further support our operations, we were awarded a cash grant by the U.S. government relating to qualified investments in the Therapeutic Discovery Project Program.
Collaborations
In keeping with our strategy we continued collaborating with multiple large pharmaceutical companies that we had entered into agreements with during the previous years. The majority of work within the agreements takes place at the pharmaceutical companies’ facilities in the U.S. and Europe. InNexus does not direct the work of these large corporations, but does collaborate, as the focus of their efforts is to evaluate our technologies and, in some cases, they have developed additional products through a combination of technologies and efforts. Numerous factors affect the activities and timing of these types of agreements, which is typical of the relationship between large pharmaceutical companies and small innovator companies like InNexus. Our agreements forbid us from sharing who the pharmaceutical companies are or the reporting of the progress of our efforts. We would like these relationships to convert into licensing deals for the Company and, although no one can predict if this will happen, we will continue to seek out strategic collaborators.
During the year, we also entered into collaboration with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH) to research proprietary technologies developed by InNexus to enhance immunotoxins currently under study at the NCI. Like our pharmaceutical company collaborations, this relationship continues.
Research & Development
During 2010 we continued to publish our scientific achievements in the Journal of Anti-Cancer Drugs. The manuscript showcased in detail how InNexus’ lead product, DXL625 induces cancer cell death in a manner not previously seen with the commercially available Rituxan, through multiple comparative studies. We also continued to file for increased patent protection covering a range of diagnostic and research tools based on our proprietary technologies. This is an unending process but essential to our industry and business model.
While we continued our efforts, we were hard at work, identifying our most significant opportunity. It became clear, our Transmab™ technology platform would allow us to pursue multiple opportunities, continue to advance our overall company and build a diversified research and development pipeline based on our proprietary technologies and unique scientific expertise. We initialized a Transmab™ discovery program to identify targets and prospective products based on the technology’s unique ability to penetrate cell membranes and dermal barriers. Led by our Chief Scientific Officer, Dr. Kindt, multiple discoveries were made, the first of which target Psoriasis and the second for Age-related Macular Degeneration (AMD), an epidemic level disease of the eye. During the year, we advanced multiple product candidates for each ailment, both having multiple billion-dollar marketplaces.
Ophthalmology, Dermatology and Oncology
With the success of Transmab™ discovery work during 2010, oncology is still part of our focus but the DXL technology and DXL oncology assets become a lower priority. They represent significant opportunity now and into the future. We believe and have always believed DXL625 is a great product that has performed exceedingly well at the FDA and in all comparative studies versus the market leader Rituxan. We also believe DXL625 is better suited to a company that has the resources to further this validated and very late stage preclinical product into the clinic. Since DXL625 also has a milestone payment of $15M scheduled to be awarded from our partner, Royalty Pharma, following the filing of an Investigational New Drug (IND) Application, we believe that the positive performance of the product to date, along with the milestone payment following a direct path to IND, affirmed by the FDA’s review, represents an attractive asset for buyers. Since there is also a significant cash burn rate with DXL625 as it waits to gain FDA approval, we have already begun to consider various forms of divestiture that could leave InNexus with a minority, non-controlling interest. To date, we have had multiple parties express interest in both DXL625 and the DXL technology platform.
It’s also important to note that a macro-level interest of the global pharmaceutical industry is toward the development of generics for monoclonal antibodies, often called biosimilars. InNexus has been developing multiple programs that could become biosimilars targeting a large number of the market leading antibodies that are currently commercially available.
Fund raising
Over the past year, we have explored and completed many fund raising opportunities including grants, loans, private placements and other equity financing to fund our operations. As previously stated, we were awarded a cash grant of $117,000 recently and that along with infusions from our largest investor and the senior management team, have provided the necessary working capital to continue the business. We have evaluated all of our expenses to reduce our cash burn and have repositioned the Company’s overhead structure by moving our laboratory and offices to a smaller, less costly facility.
However, our ability to advance our various products forward is dependent upon obtaining additional long-term financing. We currently are evaluating several financing opportunities that would provide the necessary capital to our programs but with some dilution to shareholders. These financing opportunities may also require us to request from our current stockholders that a consolidation of our common shares outstanding take place in order to provide us with a stock price that will be more attractive to investors and will allow us to issue shares above the Discounted Market Price set by the TSX. Although a share consolidation is not our preferred option, it may be necessary to move InNexus forward.
Over the past year, while we have evaluated financing options, multiple groups have made informal approaches to the company to purchase all of InNexus, but these offers were rejected as they were not in the best interest of our shareholders. Other groups have recommended the consolidation of shares take place before investing, while others are still evaluating our proposals. Our plan is to make a decision on the various financing alternatives we currently have in front of us while continuing to keep the interests of our shareholders front and center when pursuing any financing arrangement.
Summary
InNexus is developing commercial opportunities based on its proprietary technology platforms in three distinct healthcare markets: ophthalmology, dermatology and oncology. Each of these market segments contain indications that are poorly served or have no approved FDA treatments available, with multiple hundred-million to billion-dollar revenue potential. InNexus’ strategy is to address these market opportunities either through partnerships and collaborations or by rapidly developing and licensing its technology and products to a commercial event.
Commenting on InNexus’ 2010 accomplishments, Jeff Morhet, InNexus’ Chairman and Chief Executive Officer, stated, “During 2010, we have refocused the efforts of InNexus on three distinct healthcare markets. We have multiple candidates in each of the opportunities and believe this strategy has the potential to increase InNexus’ probability of success and decrease risk to shareholder investment.” Morhet continued, “We expect to enter into multiple strategic collaborations in the early part of this year, gaining access to expertise and resources. We will also soon increase our leadership team to better focus on business development, licensing and partnering opportunities.”
About InNexus Biotechnology
InNexus is a leading drug development company commercializing the next generation of monoclonal antibodies based on its DXL™ and Transmab™ technology to improve the potency of existing antibodies and to develop novel antibodies based on the unique and patented methods and technologies of InNexus. InNexus has its own in-house developmental and manufacturing facilities, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. InNexus is listed on the TSX Venture Exchange (TSX.V:IXS).
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.
Contact
Jeff Morhet, Chairman and Chief Executive Officer
Dr. Thomas Kindt, Chief Scientific Officer
InNexus Biotechnology Inc.
1-480-862-7500
