Prior to the conference, Yale Jen of Maxim stated in a research update:
- 3Q10: In preparation for results from the Deferiprone Phase II trial in CIN and the commencement of a Neutrolin pivotal trial; Increasing financial estimates; Reiterate Buy rating and $5 Price Target,
- 3Q10 financial results. CRMD reported a 3Q10 net loss of $1.4MM or ($0.12) per share, compared to our estimate of a $2.1MM loss or ($0.18) per share and the Street consensus of $2.1MM loss or ($0.19) per share. The company ended 3Q10 with cash and cash equivalents of approximately $9.5MM, which we believe is sufficient for its operations into 1Q12.
- Patient enrollment underway for Deferiprone (CRMD001) Phase II study in CIN prevention. Our discussion with management indicated that patient enrollment is underway for Deferiprone in the contrast-induced nephropathy (CIN) prevention Phase II study, with interim results from a biomarker analysis expected in 1Q11. In our opinion, a positive outcome from the study would serve as a critical clinical proof-of-concept that could increase the value of CRMD-001 significantly.
- Neutrolin (CRMD001) development update. The company has entered the final stage of manufacturing scale-up with Neutrolin for the prevention of catheter-related bloodstream infection (CRBI). Management expects to submit an investigational device exemption (IDE) application to the FDA and a CE market application to EMEA for Neutrolin before year-end 2010. Several earlier clinical studies have exhibited antimicrobial activities vs. the current standard of care, and the addition of heparin boosted the anticoagulation activities of Neutrolin, both which bode well for the success of the upcoming Neutrolin Phase III study for CRBI prevention, in our opinion. We anticipate a pivotal Phase III trial in the U.S. to start in 1H11. Further, if it gets a positive response, Neutrolin could potentially receive CE mark approval in Europe in mid-2011 or 2H11. The company could potentially start a Phase III study in the U.S. in 1H11.Reiterate Buy rating and 12-month target price of $5. With the company’s: 1) lead product Neutrolin expected to start Phase III study in 1H11; 2) Deferiprone undergoing a Phase II study, with interim data expected in 1Q11; and 3) low visibility to investment community, CRMD shares remain undervalued, in our opinion.