Scancell Holdings (SCLP.PLUS) - still on track for initiation of clinical trials in Q2
SCLP.PLUS
Comment by Objective Capital , Feb 05, 2010
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Within the past week, Scancell released its six-month operational update and issued a statement confirming the submission of its appropriate clinical trial applications for SCIB1. In late December, the Company followed up its face-to-face meeting with the Gene Therapy Advisory Committee (GTAC) with its formal application and, last week, submitted its application to the Devices Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in parallel with its partner, Ichor Medical Systems. As a reminder, Ichor’s TriGrid™ electroporation delivery device will be used to administer SCIB1 to participating patients.

The Company also recently released its operational results for the six months ended October 31, 2009. The overall net loss for the six month period totalled £594k, fuelled in large part by £421k in research and development expenses. The cash balance at the end of the period was £1.1m.

Scancell has also been working recently to secure an agreement with the U.S. Public Health Service (NIH) for a worldwide non-exclusive licence to the melanoma antigens TRP2 and gp100. The SCIB1 vaccine utilises these antigens in the ImmunoBody® platform. This agreement, likely to be consummated within the next month or two, will enable the Company to commercialise SCIB1 worldwide.

Objective's view:

In terms of the regulatory submissions, the expectation from here is that, barring a long list of questions from the regulatory authorities, the process will likely take close to another month to complete and we remain confident that Scancell will ultimately receive the approval necessary to kick off the clinical trials for SCIB1 in the second quarter.

With the operational results, while the research and development expenses were higher than the forecasts, the costs were primarily non-recurring in nature and related to the manufacturing ramp up necessary for the upcoming clinical trials. In talking with management, we were assured that these costs were not unexpected and completely on-budget.

Although the financial results posted by Scancell are important, we continue to view the initiation of the clinical trials for SCIB1 and the successful completion of the necessary capital raise as the critical milestones on the immediate horizon. In regards to the latter, the Company is confident it will attain between £1.5 million and £2 million by the end of the first quarter. This funding will be necessary to allow Scancell to initiate its clinical trials for SCIB1.