Coronado Biosciences' New York Investor Presentation

Last week we attended a presentation by Coronado Biosciences which is on our radar screen as a new rising star in the world of small cap biotech. Coronado is anticipating an OTCBB listing in the coming weeks, with plans to apply for an uplisting to NASDAQ shortly thereafter. We note that the company has already raised capital and reports $29M in cash as of the last reported quarter (July 2011).

Coronado management made the point that their current capital will carry them across several quarters, which we believe should translate into a higher valuation for the company.

CNDO-201

• Filed IND - completed
• Report results from Phase I safety study - expected 2012 first quarter
• Initiate Phase 2b Crohn's trial - by second quarter of 2012
• Report additional Phase I MS data - 2012 second quarter potentially

CNDO-109

• Report final Phase I data in AML - Q4 of 2011
• Complete IND-enabling CMC - Q4 of 2011
• File IND - Q1 of 2012
• Initiate US Phase 1/2 Study - Q1 or Q2 of 2012

We would like to take a moment and highlight the Coronado pipeline. The first product is unique in that it is Trichuris suis ova (TSO) or a Porcine (pig) whipworm ova. While initially it does not sound appetizing, the reality is that human beings throughout time have adapted to being carriers of certain parasites.

This is the the “Hygiene Hypothesis”. In the modern world, human beings have clean drinking water and shoes, and are not typoically exposed to these parasites. Coronado believes, based on mountains of scientific literature and trial work done by others, that TSO actually exerts a dramatic therapeutic benefit. This relationship is symbiotic in that both the parasite and the host benefit.

One of the slides from the presentation shows the amount of autoimmune disorders in the western “clean” world (left side) and the whipworm infected populous (right side). The charts show an uncanny correlation !

• TSO represents a novel approach to treating autoimmune diseases – the “Hygiene Hypothesis”.
• Natural immunomodulator - regulates T-Cells (Th1 and Th2) and inflammatory cytokines.
• Proof of principle established in inflammatory bowel disease and MS.
• Natural properties suggest strong potential for a safe profile – not associated with risks of immunosuppressant drugs.
• Oral bi-weekly administration, colonization is self limited in human host and worms do not multiply (so it is safe) and there is no direct transmission.
• Initial indications have well established clinical trial pathways.
• North, South America, and Japanese rights for all indications from OvaMed.

A clinical trial has already shown great results in Crohn’s Disease (which is still a large unmet medical need today).

So what the plan going forward ? Coronado has filed an IND (permission to start clinical trials) on September 16 with U.S. FDA. A phase I trial will investigate safety, efficacy and dosing in n=36 Crohn’s patients and results are expected in the first quarter of 2012. A phase II FDA study will follow.