On May 9, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months ended March 31, 2018 and provided a corporate update (Press release, Protalix, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348043 [SID1234526319]).
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"We continue to execute against our upcoming milestones, including the completion of enrollment in our phase III clinical trials of PRX-102 and exploring potential partnering opportunities for our clinical assets," said Moshe Manor, Protalix’s President and Chief Executive Officer. "We reported positive results for OPRX-106 in the first quarter of this year, which not only demonstrate the drug’s potential in the treatment of ulcerative colitis, but also highlight the potential of our ProCellEx platform technology to deliver biologics orally."
2018 First Quarter and Recent Clinical Highlights
Continued enrollment in the three Phase III trials, the BALANCE, BRIDGE and BRIGHT studies, for pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease at nearly 50 clinical trial sites worldwide.
Testing of blood samples from certain patients screened for the BALANCE study were analyzed for anti-drug antibody (ADA) presence and neutralizing activity, and the cross-reactivity and inhibition of such antibodies to PRX-102. A description of the data from the analysis has been accepted as a poster presentation scheduled on May 25, 2018 at the 55th ERA-EDTA Congress (European Renal Association – European Dialysis and Transplant Association) being held in Copenhagen, Denmark, May 24-27, 2018.
Reported positive top-line clinical results for the Company’s OPRX-106 phase IIa clinical trial in ulcerative colitis patients.
Oral presentation detailing the results from the Company’s phase IIa clinical trial of OPRX-106 for the treatment of ulcerative colitis accepted for the Digestive Disease Week (DDW) 2018 Annual Meeting in Washington, D.C., June 2-5, 2018.
The presentation at the DDW will include new clinical data and detailed per patient results further supporting the consistent effect in patients.
Financial Results for Three Months ended March 31, 2018
The Company reported a net loss of $9.4 million, or $0.06 per share, basic and diluted for the three-month period ended March 31, 2018 compared to a net loss of $8.4 million, or $0.07 per share, basic and diluted, excluding a one-time, non-cash charge of $52.3 million in connection with the remeasurement of a derivative, for the three-month period ended March 31, 2017.
The Company recorded total revenues of $4.6 million for the three-month period ended March 31, 2018, compared to $2.9 million for the same period of 2017. The increase is attributed mainly to increased sales of alfataliglicerase in Brazil.
Research and development expenses were $7.3 million for the three-month period ended March 31, 2018, compared to $6.0 million for the same period of 2017. The increase is mainly due to the advanced stages of the Company’s clinical trials of its drug candidates.
Selling, general and administrative expenses were $2.5 million for the three-month period ended March 31, 2018 and March 31, 2017.
As of March 31, 2018, the Company had $41.3 million of cash and cash equivalents.
Conference Call and Webcast Information
The Company will host a conference call on Wednesday, May 9, 2018, at 8:30 am ET to review the clinical, corporate and financial highlights.
To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8190507.
The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.