On May 6, 2019 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, 2019 and provided a corporate update (Press release, Protalix, MAY 6, 2019, View Source;p=RssLanding&cat=news&id=2397172 [SID1234535759]).
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"In the first three months of 2019, we have continued to execute on enrollment in our PRX-102 studies and have worked to prepare ourselves for a potential accelerated approval path," said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer. "In addition, we are encouraged by the initial pharmacokinetic (PK) data from our BRIGHT study, which were presented at the 15th Annual WORLDSymposiumTM 2019 in February 2019, that demonstrate the potential for PRX-102 to be infused once-monthly, compared to the current treatment regimen of every two weeks."
First Quarter 2019 and Recent Clinical and Corporate Highlights
The Company’s BRIGHT phase III clinical trial of pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease is currently one patient away from completion of enrollment.
The Company’s BALANCE phase III clinical trial of pegunigalsidase alfa for the treatment of Fabry disease is currently eleven patients away from completion of enrollment.
The Company presented results from the BRIGHT Study at the 15th Annual WORLD Symposium showing that infusion of pegunigalsidase alfa every 4 weeks results in the presence of continuous active enzyme throughout the entire infusion interval.
The Company is scheduled to present three posters during the 6th Update on Fabry Disease international conference being held in Prague, Czech Republic, on May 26-28, 2019.
To date, more than 40 patients are being treated in the Company’s various extension studies after opting to continue treatment with pegunigalsidase alfa after they completed an initial study.
The Company plans to meet with the U.S. Food and Drug Administration (FDA) for a follow up meeting during the second quarter of 2019 in connection with the potential accelerated approval filing path for pegunigalsidase alfa.
First Quarter 2019 Financial Results
The Company recorded total revenues of $10.4 million during the three months ended March 31, 2019, compared to $6.7 million for the same period of 2018. The increase is primary attributable to the recognition of $6.9 million of license revenues in the three months ended on March 31, 2019 compared to the recognition of $2.2 million in the same period of 2018.
Research and development expenses for the three months ended March 31, 2019, were $11.7 million, compared to $7.3 million for the same period in 2018. Selling, general and administrative expenses for the three months ended March 31, 2019 were $2.2 million, compared to $2.5 million incurred during the same period in 2018.
Net loss for the three months ended March 31, 2019 was $7.3 million compared to $7.2 million for the three months ended March 31, 2018.
On March 31, 2019, the Company had $30.4 million of cash and cash equivalents, compared to $37.8 million at March 31, 2018, which is currently projected to fund operations into mid-2020. As of March 31, 2019, the Company had outstanding $57.9 million of its 7.50% convertible promissory notes due November 2021.
Conference Call and Webcast Information
The Company will host a conference call on Monday, May 6, 2019, 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 6169584.
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.