Coronado Implodes over Crohn's Failure, Future Now Uncertain

Health and Healthcare

Published: October 14, 2013 12:00 pm

Investing in biotech and emerging pharmaceutical stocks comes with a huge risk and reward profile for investors. Some wins are exponential, yet some losses are losses of the entire investment. Coronado Biosciences Inc. (NASDAQ: CNDO) is seeing its shares implode on Monday on very disappointing news in its Crohn’s disease drug trial.

Shares are down much more than half. When you look at other indications and other programs inside the company, it seems like it might not be the end of the road, but a stock price implosion of this magnitude means that Wall Street is worried about the company’s future.

Coronado’s top-line results from its TRUST-I phase 2 clinical trial evaluating TSO (Trichuris suis ova, or CNDO-201) failed to meet the primary endpoint in 250 patients with moderate-to-severe Crohn’s disease. Where this gets bad is that the secondary endpoint was not met either. The company said:

The TRUST-I study did not meet its primary endpoint of improving response, defined as a 100-point decrease in the Crohn’s Disease Activity Index (CDAI), nor the key secondary endpoint of remission, defined as achieving CDAI 150 points. In the overall patient population, response rate of patients on TSO did not separate from that of placebo. … TSO showed a non-significant improved response in patients with CDAI > 290. The lack of overall response was driven by higher-than-expected placebo response rate in patients with CDAI.

The only encouragement is that Coronado said that it was heartened to see TSO’s effect in patients with CDAI greater than 290. Unfortunately, having failed the primary and secondary endpoints is no real hope for those who risked capital around this issue.

Now Coronado has to put all of its efforts into its CNDO-109 study. This is the other pipeline candidate, a biologic that activates natural killer cells for the treatment of acute myeloid leukemia and solid tumors. Other study indications for the TSO drug are for ulcerative colitis, multiple sclerosis, autism spectrum disorders and psoriasis.

Shortly before Noon on Monday, Coronado’s shares were down a whopping 67% at $1.89, and they had traded as low as $1.73 earlier in the morning. The 52-week high is $12.70, and the new market cap is only about $60 million. The company’s cash balance was almost $68 million, and its net tangible assets were $48.5 million as of June 30, 2013.

If you want to know just how bad this implosion is, the trading volume in late-morning was 17.3 million shares and the average daily volume is only 544,000 shares.

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