On May 09, 2016 Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), reported financial results for the fiscal quarter ended March 31, 2016 and provided a corporate update (Press release, Protalix, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166296 [SID:1234512126]).

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"Over the past few months, Protalix has made great strides towards moving PRX-102 into phase III development," said Moshe Manor, Protalix’s President and Chief Executive Officer. "We filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), and have since been in close contact with the agency to implement its feedback. We anticipate completing the SPA with the FDA around mid-year 2016, and announcing the commencement of our phase III clinical development program for PRX-102 shortly thereafter. Additionally, we met with the European Medicines Agency (EMA), and we expect to reach and announce a clear path forward for PRX-102 in the European Union as well by mid-year."

"We are also very excited about the advancement of our PRX-110 and PRX-106 product candidates into advanced clinical trials in patients. Given results from earlier trials, both drug candidates have the potential to bring significant benefit to currently underserved patient populations worldwide."

Financial Results for the Period Ended March 31, 2016
Net loss for the quarter was $8.6 million, or $0.09 per share, for the three months ended March 31, 2016, an increase of $2.6 million, or 43%, from $6.0 million, or $0.06 per share, for the same period in 2015.

Total operating expenses increased to $8.0 million for the three months ended March 31, 2016 compared to $6.8 million for three months ended March 31, 2015, primarily due to the advancement of our entire pipeline into more advanced clinical stages.

Cash and cash equivalents as of March 31, 2016 were $66.7 million, which we expect to be sufficient to finance our activities into 2018 through significant milestones.

First Quarter Clinical and Corporate Highlights
Positive six and twelve month interim clinical data for PRX-102 for the treatment of Fabry Disease were presented at the 12th Annual WORLDSymposiumTM 2016 held in San Diego, CA. PRX-102 demonstrated effectiveness across all disease parameters including cardiac and kidney functions and showed very low levels of antibody formation.

SPA submitted to the FDA in connection with PRX-102 for the treatment of Fabry disease.

Successfully completed phase I clinical trial of PRX-110 in 18 healthy volunteers with clean safety profile.

Received approval from the Israeli Ministry of Health of the protocol for our phase II clinical trial of PRX-110 in Cystic Fibrosis patients. We anticipate initiation of the study before mid-year.

Proposed protocol for a phase II clinical trial of PRX-106 in Ulcerative Colitis patients in Israel filed with the Israeli Ministry of Health; the protocol is expected to be filed with a number of European ethics committees shortly, as well. We expect to announce initiation of the study during the third quarter.