Dr. Levitt: Genaera in the current market climate is trying to be competitive with other biotechnology and pharmaceutical companies in developing breakthrough medicines. Thus, we have focused our efforts and investment on a few later stage clinical programs. We have reduced our expenses and thus our burn rate to very low levels. The goal was to achieve a very efficient utilization of our remaining cash on these later clinical programs. Our natural product discovery and development programs cover anti-angiogenesis for 'wet' age related macular degeneration or 'AMD' and cancer; and genomics-based development programs targeting unmet respiratory needs. We recently announced exciting data for squalamine, our potent direct acting anti-angiogenic molecule which blocks growth factors including VEGF (vascular endothelial growth factor). These data indicate that squalamine is restoring vision in patients with wet AMD of both classic and occult subtypes. A good number of patients describe a very substantial and significant improvement in vision. Clinical investigators also observed shrinkage in the AMD lesions in the back of the eye, and this improvement seems to be maintained for a number of months. Squalamine also has a number of marketing advantages as a noninvasive therapy. Our primary competitors require chronic needle injections into the eye as often as once a month. We believe our noninvasive therapy has the potential to work as well as the competition and by avoiding regular intraoccular needle injections will have better patient and physician acceptance. So we are hopeful that squalamine represents a breakthrough medicine for AMD. That's very exciting for us. We also have two respiratory genomics-based programs where the underlying target is proprietary. That target is associated with a genetic or genomic basis for disease. These are all large markets as well. Our IL9 (interleukin- 9) program is partnered with MedImmune which covers all of these expenses. MEDI is developing a humanized antibody treatment for asthma targeting interleukin-9. This is a well-validated proprietary genomics target, with substantial data pointing to this target as a key regulator of asthma, and pivotal controlling factor of many other mediators implicated in this disorder including many cytokines (e.g. IL4, IL5, and IL13), chemokines and IgE production. It also regulates epithelial mucus production and is a critical growth factor for lung mast cells that produce leukotrienes, histamine and other mediators of asthma. We have no further investment to make in this program. MedImmune has announced that they will start in the clinic later this year, which triggers a milestone for us, one out of the 55 million in potential milestone payments to us from MedImmune. As the program advances, should things go well, we'll have a very substantial royalty income from this product. This single cytokine intervention for asthma is based on our understanding of the root cause of the disease. Most of our current therapies are nonspecific, target either histamine or leukotrienes, but not both, and really only provide symptomatic improvement. Thus, your readers should understand IL9 is both necessary and sufficient to produce asthma and has the potential to be a breakthrough medicine to treat the underlying root cause of asthma. The other genomics-based program and investment we have made over the last year is on our mucoregulator program that focuses on mucus overproduction in a large variety of chronic respiratory patients. The program also includes a genomics-based proprietary target and small molecule oral therapeutic in Phase II trials. Our small molecule mucoregulator, called LOMUCIN_, targets cystic fibrosis (CF), but may potentially represent an important new therapeutic for approximately 65 million patients in the US annually who suffer with mucus overproduction in their airways and in their digestive system. We have financial and intellectual support from the CF Foundation for this program. CF is our clinical focus with our small- molecule oral mucoregulator therapy LOMUCIN_. We're currently running a double-blind placebo controlled Phase II clinical trial in Ireland with the CF Foundation and well-known CF investigators. We have a strong partnership with the CF Foundation and we appreciate their assistance on this program. CF represents approximately a 250 million worldwide market and can be detailed with fewer than one-dozen sale representatives. We should have data from this trial in the second half of 2003. So there has been real progress in these genomics-based programs over the last year that makes Genaera very competitive in these major markets.
Tickers included in this excerpt: GENR
For more information call (212) 952 7433. The Wall Street Transcript does not endorse any of the comments made by interviewees, and does not make stock recommendations.