Protalix BioTherapeutics Provides Update And Reports 2016 Third Quarter Results

Patient Enrollment Ongoing for Phase III Fabry Clinical Trial with approximately 10 Patients Currently in Evaluation and Screening Stages

Enrollment for the Phase II Cystic Fibrosis Clinical Trial in Final Stages with Results Expected around Year-End

Phase II Ulcerative Colitis Study Expected to Commence Before Year-End

CARMIEL, Israel, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) today announced financial results for the fiscal quarter ended September 30, 2016 and provided a business update.

"We are very excited by the progress made with our product candidates," said Moshe Manor, Protalix's President and Chief Executive Officer.  "We are currently enrolling patients in seven sites globally for our phase III clinical trial of PRX-102 for the treatment of Fabry disease, and we are finalizing enrollment in our phase II clinical trial of AIR DNase TM (PRX-110) for the treatment of Cystic Fibrosis (CF)."

Financial Results for the Quarter Ended September 30, 2016
  • Net loss for the quarter was $7.3 million, or $0.07 per share, for the three months ended September 30, 2016, an increase of $3.5 million from $3.8 million, or $0.04 per share, for the same period in 2015.  The increase is primarily the result of the initiation during 2016 of both our phase III clinical trial of Fabry disease and our phase II clinical trial of CF. 
  • Total operating expenses were $7.1 million for the three months ended September 30, 2016 compared to $6.1 million for three months ended September 30, 2015.
  • Cash and cash equivalents as of September 30, 2016 were $51.3 million, which provides the Company with capital into 2018.

Recent Company Highlights and Business Update
  • First patient was enrolled in the Company's phase III clinical trial of PRX-102 for the treatment of Fabry disease, with approximately 10 patients in the evaluation or screening process across seven sites.
  • Enrollment in the Company's phase II clinical trial of AIR DNase for the treatment of CF is in its final stages, with top-line results expected around year-end.
  • Sites are being initiated for the Company's phase II clinical trial of Oral Anti-TNF, or OPRX-106, for the treatment of Ulcerative Colitis, with patient enrollment expected to commence before year-end.
  • Advanced, direct negotiations with the Brazilian Ministry of Health are in process for the supply of a significant amount of vials of alfataliglicerase for Gaucher disease in 2017.  If these negotiations are concluded successfully, the Company would expect to recognize markedly higher revenues than those that the Company has reported to date. 
  • Discussions are ongoing with potential collaboration partners for AIR DNase and Oral Anti-TNF. 

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx(R).  Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner.  Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries.  Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix's development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others.

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