Protalix BioTherapeutics, Inc. (DE)

Greetings and welcome to the Brutalix Biotherapeutics third quarter 2022 financial and business results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce to your host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protallix. Sir, you may begin your conference.

Thank you, Operator, and welcome to the Protallix BioTube Therapeutics 3rd Quarter 2022 Financial Results and Business Update Conference Call. With me today are Dwarah Prashan, President and CEO of Protallix, 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 Portalix 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-looking 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 portalics filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Jorah Bishan.

Jorah? Thank you, Chuck, and welcome everyone to our third quarter 2022 financial results and business update call. I will begin with a review of our progress and accomplishments over the quarter, along with our plans for the coming months. Following my remarks, Eyal will provide a more detailed review of our financial results and will then open the line for questions. I'll begin with a significant milestone recently achieved. We are pleased to report that last week we, together with our development and commercialization partner, Chiasi Global Rare Diseases, resubmitted the Biologic License Application, or BLA, to the U.S. FDA for PRX102. for the proposed treatment of adults with Fabry disease. The data package contained in the BLA resubmission includes, in addition to the Phase I-II studies, the final two years' analysis of our Phase III balanced clinical trial and the final Phase III open-label BRITE study report. In addition, we have provided data from our long-term open-label extension studies. Achieving these milestones is a testament to the dedication of Frotalix and Chiesi teams to delivering this potential new treatment to patients with Fabry disease, and we are grateful for their hard work and commitment to our program. We and Chiesi anticipate that the FDA will complete its review of the resubmission BLA within six months of receipt. With respect to the PRX-MMA submitted to the European Medicine Agency, the EMA, earlier this year, The EMA is currently reviewing our application. Our dialogue with the EMA is ongoing. As we approach year-end, Protalix is entering into an exciting time as we are moving closer to a potential approval of PRX-102 for the treatment of adult patients with Fabry disease. We believe that PRX-102 has significant potential for patients and families affected by Fabry disease. and we remain committed to continue collaboration with the FDA and EMEA to work towards our goal of successfully bringing this much-needed treatment to the patients in need. Turning to our earlier stage pipeline, we are continuing to develop additional programs expressed through our proprietary protein expression system prosthetics. PRX115 is a novel pegylated uricase in development for treatment of severe gout. We are on track to initiate a first in human phase one clinical study of PRX115 in the first quarter of 2023. In the support for this first in human study, we are finalizing our toxicology package. In addition, we continue to make progress on PRX119, a peculated recombinant human DNase 1 protein designator designed to elongate DNase half-life in circulation for treatment of NET-related diseases. We have conducted preclinical studies to demonstrate feasibility of PRX119, and we look forward to providing updates on these two and other programs as we progress. Finally, our balance sheet provides us with sufficient cash runway to the fourth quarter of 2023, enough to support the company through the potential approval, in addition to continuing to develop our early-stage pipeline programs. I will now turn to Eyal to review our financials. Ayad, go ahead.