I am hopeful but cautious. Sponsorship here has a well documented record of being long on hype and short on delivery.I talked to management a few months back and asked them about a few technical issues and the balance sheet. I got the usual "hoping to partner" dance re: cash position. Sometimes I wish folks would just be forthright. There is no sin in saying we are going to need to do a raise. At least that piece is done with.
NK killer cells are a mystery--very little detail. Auto-immune applications a stretch at best. I remain convinced that these guys may be unto something in Crohns. Progress in that indication alone could move this to $10 plus quickly . I think approval chances would be good since there should be few if any ancillary (negative)effects of the treatment.
I never get too excited about those promising early results in any drug. When you look at the preclin to PHI to PHII to PHII atrophy rate you understand why. I have seen hundreds of companies that possess "the cure" for a given disease based on mouse and early human data that end up falling to the wayside.
Bottom line--Hopeful on Crohn's --not convinced beyond that.
In our view, the scientific rationale for CNDO-201 is sound and based upon multiple successful clinical trials by various leading researchers. The use of helminths (beneficial parasites) for the treatment of autoimmune disease is based on the belief that the immune systems of populations living in the relatively sterile environments found in developed countries with little or no exposure to parasites may develop in abnormal ways. This "hygiene hypothesis" is based on epidemiologic findings of an inverse relationship between autoimmune diseases and helminthic colonization. The basic reasoning underlying the hygiene hypothesis is based on the premise that many parasites have evolved to suppress the host’s immune system to survive. However, in order for these pathogens to reproduce, they had to fine tune their modulation of the human immune system to avoid being killed, but at the same time avoiding significant damage to the host since a sick or dead host generally harms the parasite as well. In parallel, over millions of years the human immune system evolved and developed in the presence of these pathogens. As such, these pathogens may be instrumental in a healthy immune system perhaps as much as bacterial flora is necessary for a healthy digestive track. The incidence of most autoimmune diseases is highest in the developed world and in temperate climates, with positive correlations noted among persons of higher socioeconomic status and high levels of domestic hygiene experienced in childhood. Conversely, for example, the incidence of inflammatory bowel disease (IBD) is rare in less developed countries and in persons with blue-collar jobs involving exposure to dirt and physical exercise. In contrast to the epidemiologic findings of IBD, the prevalence of helminths is highest in warm climates and in populations characterized by crowding, poor sanitation, and impure food supply. Furthermore, the incidence of IBD has increased over the past several decades, while the prevalence of helminths in the United States and Europe has steadily declined during the same time period.
..... The Opportunity: In our opinion, the current drugs that treat MS, Crohn’s disease and ulcerative colitis are far from silver bullets. Specifically, the portion of patients that actually receive a benefit is generally less than 50%. In addition, compliance is always a problem in many of these indications since some patients do not like injecting themselves on a regular basis. Additionally, all pharmaceutical treatments for these autoimmune conditions carry significant risk of side effects, particularly the MS drugs. The commercial markets for these diseases are sizable and we believe that CNDO-201 has multi-billion dollar potential as it would literally be a major game changer for the treatment of autoimmune disease.
Investment Conclusion: Over the next 12-18 months, we believe CNDO shares will reach at least $20 per share. This is based on our expectation of the clinical success of CNDO-201 in Crohn’s disease alone. Additional autoimmune trial success can multiply this target price. We anticipate investors to primarily focus on CNDO-201 since additional data exists for this compound to treat other immune disorders. Results from two controlled Phase II studies should be announced in this time frame. We believe the data will confirm the results observed to date for several reasons. First, we believe that CNDO-201 is one of the best organisms for this indication given its published efficacy and unique safety profile in humans. Second, we have spoken with leading researchers and physicians that have used the helminths in practice with consistent success. Additionally, the Company has access to an approved GMP manufacturing facility - a valuable proprietary asset – the lack of which prevented other companies from commencing similar studies in the past. Thus, CNDO’s management team has strategically placed itself into a leadership position that is also protected from competition. We are quite familiar with much of CNDO’s senior management as the CEO and Chairman both come from Indevus, where they had success developing and gaining FDA approval for several pharmaceuticals. In addition, they were successful in selling Indevus in 2010 to Endo Pharmaceuticals. We are recommending CDNO as a buy under $8 with 12-18 month target of $20.