Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Full Year 2022 Earnings Call. As a reminder, this conference is being recorded. I will now turn the conference over to your host, Monique Coffey of LifeSci Advisor Investor Relations for Protallix. Thank you. You may begin.

Thank you, Operator, and welcome to the Protallix Biotherapeutics Fiscal Year 2022 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Proctelix, 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 now on the Proctelix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings released in 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 Protolix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

Thank you, Monique, and welcome everyone to our fiscal year 2022 financial results and business update call. I will begin by reviewing our progress and accomplishments over the past year, along with our plans for the coming month. Following my remarks, Eyal will provide a more detailed review of our financial results, and we will then open the line for questions. So 2022 was a strong year for Protonix, and over the last year we made significant progress on multiple fronts. I would like to begin by highlighting our most recent achievement, together with our development and commercialization partner, Chiasi Global Rare Diseases. We are pleased, or very pleased, that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, adapted a positive opinion and recommended marketing authorization of PRX-102 for the treatment of adults with Fabry disease. This is a significant step towards the potential approval of PRX-102 in Europe and brings us closer to delivering this treatment option to Fabry patients around the world. The final decision is now referred to the European Commission, which is expected to provide a decision marketing authorization in early May of this year. Not only we are approaching potential approval in Europe, but we also look forward to potential approval in the United States. As previously announced, the U.S. FDA accepted our resubmitted biologic license application for review in December. It was resubmitted already in November 9th. We received this acknowledgement letter on December 9th, and are assigned the PDUFA target action date of May 9th, 2023, is quickly approaching. Including in these regulatory submissions to the EMA and FDA were the comprehensive results from our Phase III preclinical program, as well as long-term data from our ongoing open-label extension studies. Final results from our Phase III BRITE and BALANCE trials were completed and announced earlier this year, and both studies met their respective efficacy and safety objectives. This robust set of data represents hundreds of years of patient exposure to PRX102 and we believe provides a compelling case to the regulators to consider this important potential treatment option for adults affected by Fabry disease. We look forward to providing you with updates as we approach potential approval in the EU and the US. If approved, PRX102 will be a second approved drug from our proprietary protein expression system called Procelex, providing even further validation of this unique and innovative platform. As we enter into what will be an exciting year for Protalyx, we would like to reiterate our appreciation for Chiesi's partnership and dedication to this program, and we thank both Protalyx and Chiesi's teams for all their efforts to deliver this potential new treatment to patients with Fabry disease. Turning to our early stage pipeline, we are continuing to develop promising candidates expressed through our prosthetics protein expression system. PRX115 is a novel pegylated uric acid in development for the treatment of severe gout. Final results from the first stage of one month's multiple dosing toxicity study of PRX115 in two species to support the phase one study show no indication of safety concerns. Our current development plan goal is to initiate a Phase I clinical trial in the next couple of weeks. In addition, we continue to make progress on PRX119, a pegylated recombinant human DNase I protein designed to elongate DNase half-life in circulation for the treatment of NETS-related diseases. We have conducted preclinical studies to demonstrate the feasibility of PRX119. and we look forward to providing updates on this program as we progress throughout this year. Finally, our balance sheets provide us with sufficient cash runway to the first quarter of 2024, supporting the company through potential approval, in addition to continuing developing our early-stage pipeline programs, as I mentioned. Now, before I turn to Eyal for review of our financials, I would like to say that with regard to the PROSAP filed earlier this morning, I ask to clarify that the PROSAP was filed with connection to the ATM program, and the company has to emphasize this is not an announcement of a fundraising. Now I'll turn to Eyal. Eyal, please.