Protalix BioTherapeutics (PLX) Issues 2016 Review, 2017 Outlook

Protalix BioTherapeutics, Inc. (NYSE: PLX) announced a review of the Company’s clinical and financial highlights for 2016, as well as an outlook for anticipated future strategic milestones.

“2016 was a building year for Protalix. We aggressively pushed our clinical pipeline programs forward, which included high level regulatory agency discussions and the initiation of clinical trials for all three of our disclosed leading assets,” said Moshe Manor, Protalix’s President and Chief Executive Officer. “Given our recent financing and the projected revenue stream from sales of alfataliglicerase in Brazil, we are well capitalized to deliver on our anticipated, value building milestones. Over the course of 2017 and into 2018, we expect to announce data from our phase III clinical trial on Fabry disease, final results from our phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis and results from our phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. We expect that 2017 will be an extremely important, inflection year for us, with a number of significant commercial and clinical milestones that should bring considerable value to our stockholders.”

2016 and Recent Clinical Highlights

• Received purchase order from the Brazilian Ministry of Health for purchase of alfataliglicerase to treat Gaucher patients in Brazil. The order consists of a number of shipments during 2017, in increasing volumes, for a total of approximately $24.3 million. The size of the final shipment of the order represents annual revenues of approximately $42.0 million. The Brazilian Ministry of Health’s order was published in the December publication of Brazil’s Official Diary of the Union (Diário Oficial).
• Reported positive interim results from the Company’s phase II clinical trial of alidornase alfa (PRX-110) for the treatment of Cystic Fibrosis, which results include a clinically meaningful increase in percent predicted forced expiratory volume in one second (ppFEV1).
• Initiated patient enrollment in the Company’s phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. The Company is developing OPRX-106 to be the first ever oral protein treatment, as currently there are no other oral protein treatments available.
• Received regulatory approval of alfataliglicerase in Brazil for children four years old and above with a confirmed diagnosis of Type I Gaucher disease.
• Worked closely with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to determine the phase III clinical trial program for pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease:
  • Initiated and enrolled patients in a global phase III trial of pegunigalsidase alfa versus Fabrazyme® to support a BLA filing in the United States, with a 12-month non-inferiority interim analysis to support an MAA filing with the EMA.
  • Determined a 12-month switch-over study from Replagal® will also be conducted to support FDA and EMA filings.
• Presented positive 6- and 12-month interim clinical data on pegunigalsidase alfa at the 12th Annual WORLD Symposium™ in March 2016.
• Exchanged $54.1 million principal amount of the Company’s $69.0 million 4.50% Senior Convertible Notes due 2018 for $40.2 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2021 and approximately 23.8 million shares of common stock. Concurrently, the Company sold, in a private placement, $22.5 million principal amount of 2021 Notes.
• The Company had a strong cash balance of approximately $63.0 million as of December 31, 2016, which is currently projected to fund operations into late 2019.

2017 Outlook and Projected Future Milestones

• Full results for the phase II efficacy and safety study of alidornase alfa expected to be announced during the first quarter of 2017.
• Full results for the phase II efficacy and safety study of OPRX-106 expected to be announced during the second half of 2017.
• Completion of enrollment in the phase III trial of pegunigalsidase alfa for the treatment of Fabry disease expected in 2017; interim data analysis anticipated in 2018 to support EMA and other regulatory filings outside of the United States.
  • If superiority to Fabrazyme is not yet achieved at that time, as shown in the interim data, the trial will continue for an additional year before reporting two-year data to support a U.S. regulatory filing.
• Present, via two key opinion leader (KOL) presentations and a poster, pegunigalsidase alfa clinical data at the 13th Annual WORLD Symposium™ to be held in February 2017.
• Present at the 5th Update on Fabry Nephropathy: Biomarkers, Progression and Treatment Opportunities in April 2017.
• Present, at the 40th European Cystic Fibrosis Conference, full data from the Company’s phase II efficacy and safety study of alidornase alfa, in June 2017, and at the North American Cystic Fibrosis Conference in November 2017.
• Potential partnership for alidornase alfa.
• Potential collaboration for alidornase alfa with the Cystic Fibrosis Foundation.
• Potential partnership for oral anti-TNF.

A copy of the Company’s January 2017 Corporate Update will be posted in the Presentations page of the Investors tab of its corporate website.

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