Updated Risk Filing with SEC looks a little more scary. They approach Going Concern topics in several areas. Potential for shortening trials as a method of saving money or time... but at risk of not achieving successful results.
While this can hardly be considered news for those following the company, I wonder if there is likely to be some effect from putting the obvious in print. Why have they not been able to attract more money in their offerings? Their early trial results have looked good to very good so far.
I worry about this one the way I should have worried about BTRN. But at least they haven't bought a money losing company, yet.
A few snippets from:
yahoo.brand.edgar-online.com
As of September 30, 2006, we had unrestricted cash of approximately $15.8 million. We currently anticipate spending during the first quarter of 2007 approximately $6 million to fund our preclinical and clinical programs and related general and administrative activities. Our current cash balance, after giving effect to our recently completed offering resulting in gross proceeds to us of approximately $4.8 million, is expected to be sufficient to allow us to maintain our current and planned operations into the third quarter of 2007. We are unable to estimate at this time the additional funds required to finance our operations as we have not determined the therapeutic indications that we will continue to clinically develop into later stages, the extent of the clinical program required to successfully develop a selected therapeutic indication, and if any of these programs will eventually be financed through a collaboration with a better funded partner.
...
Whether or not we can raise sufficient additional capital from a follow-on private placement of our securities or other financing, we may be forced to reduce the size of one or both of our ongoing Phase 3 studies to save costs or speed the completion of the trial. Such a study size reduction would decrease the number of study subjects that would be exposed to talabostat and would increase the risk of failing to complete a successful Phase 3 trial because of the increased efficacy we would have to show given the reduced number of study subjects.
...[The NFLD risk]
We have relatively few employees and do not have sufficient internal resources or experience to conduct human clinical trials without the assistance of third parties. We must therefore contract with third parties to perform the clinical trials required to submit talabostat to the FDA for marketing approval.
Although we continue to increase our internal clinical development capability, including our ability to supervise, manage and, as necessary, replace outside vendors, we still outsource a substantial amount of the clinical trial development process. Thus,
we may lose control over the cost of and time required to conduct these studies. In addition, these third parties might not conduct our clinical trials in accordance with regulatory requirements. The failure of any contractor to carry out its contractual duties could delay or increase the cost of the successful development and commercialization of talabostat.
...
[other risks include NASDAQ compliance for price support and Lead Audit Director vacancy].
graham
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