Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics Full Year 2021 Earnings Call. At this time, all participants are on a listen-only mode, and the conference is being recorded. I will now turn the conference over to our host, Mr. Chuck Padalla of LifeSciAdvisors Investor Relations for Protallix. Thank you. Please go ahead.

Thank you, Donna. Welcome to the Protallix Biotherapeutics Physical Year 2021 Financial Results and Business Update Conference Call. With me today are Jorba Shahan, President and CEO of Pertalix, and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning and is available on the Pertalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and this teleconference include forward-looking statements. These forward-listing statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in the Protolix filing with the U.S. Securities and Exchange Commission. With that, I will now turn the call over to Mr. Dror Bishan.

Dror? Thank you for the introduction, Chuck, and welcome everyone to Protolix Fiscal Year 2021 Financial Results and Business Update Corner. During this call, I will review the progress of our key clinical programs and provide an update of some of our future plans. Following my remarks, Mr. Yael Rubin, our Chief Financial Officer, will review our financial results and we will then open the line for questions. I'm very pleased with the progress we made during 2021. Over the course of last year, we made significant strides in multiple fronts. First, we have finalized the BALANCE Phase III study and we plan to share top-line results of this study by next week. We have reviewed, with applicable regulatory agencies, our pathway for regulatory submissions. And for the EU, we have reviewed our pathway for submission of a marketing authorization agreement, or MAA, for PRX102 with European Medicine Agency, or EMA, which was actually submitted in February of 2022. For the United States, we have reviewed the pathway for resubmission of the Biologic License Application, or PLA, for PRX102, which we expect to be submitted to the FDA later this year. I want to emphasize the close collaboration we continue to have with our commercial partner, Chiesi Global Rare Disease, in all aspects of PRX102 program, and we thank them very much for their efforts and appreciate their partnerships. In parallel, we invested resources in our early stage pipeline to advance a number of programs. Our goal is to continue to invest both human and financial capital into new product candidates and establish a more significant pipeline while maintaining our focus in bringing PRX 102 to the finish line. Finally, we strengthened our financial balance sheet in the second half of this year, of last year actually, and now we have sufficient cash runway until Q3 2023. Let me now review our results and our expected milestone in greater detail. In September of 2021, we, together with Chiesi, completed a Type A meeting with the FDA regarding PRX102-BLA.