Last week shares of Lpath, Inc. (LPTN) took a twenty percent dive after news circulated of a financing agreement that priced shares well below the price for which they were trading on the open market.

Just a short time before that shares had already taken a hit following news that two ongoing proof-of-concept trials for iSONEP were halted in January. The trials were not halted due to concerns about iSONEP's safety profile, however, rather it was concerns from FDA that the company's fill/finish contractor, Formatech, Inc., was not in compliance with FDA's current Good Manufacturing Practice (cGMP) requirements that led to the trial stop.

In a statement issued by the company via press release at the time of the trial halt, Lpath stated that "it has taken appropriate steps to oversee Formatech's manufacturing in order to ensure product quality, it has suspended dosing as a precaution to ensure the continued safety of all patients in its clinical trials."

A follow-up statement was issued on Monday informing investors that both trials are planned to continue in August, as a new finish/fill contractor has been identified. It was also noted that there have yet to be any safety or patient tolerability concerns for iSONEP, more evidence that the trial halt looks like just a minor bump in the road that could be providing investors the opportunity to jump in on a potentially novel new technology.

Lpath is the noted leader in lipidomics-based antibody therapeutics whose ImmuneY2 drug-discovery engine, which has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The technology is breakthrough enough that Pfizer (PFE) jumped in early and took up a significant stake in the small company, with the option to ante-up even more, if the company so chooses.

August is still a long way off in relation to the highly-volatile investing world, but the trial re-start is certainly a potential catalyst. Another move towards a dollar could materialize as investors regain confidence in the trials.

Disclosure: Long LPTN.

Contact: vfc@vfcsstockhouse.com

Originally published at: http://vfcsstockhouse.com

ShareBuilder Flip 336x280 Banner

Add a Comment