Protalix BioTherapeutics, Inc. (DE)

Continue to stand by. The conference will begin momentarily. We do appreciate your patience and ask that you please remain on the line. Thank you. Thank you. Thank you. Good morning, ladies and gentlemen, and welcome to the Portalix Biotherapeutics First Quarter 2023 Financial Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors Investor Relations for Portalix. You may now begin.

Thank you, Tina. Welcome, everyone, to the Portalix Biotherapeutics First Quarter 2023 Financial Results and Business Update Conference Call. With me today are Dror Vashon, President and CEO of Protalex, and Ayal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning and is now available on the Protalex 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 statements made. Factors that could cause actual results to differ are described in the disclaimer and fatalities filing with the U.S. Security and Exchange Commission. I will now turn the call over to Mr. Dror Bashar. Dror?

Thank you, Chuck, and welcome everyone to our first quarter 2023 financial results and business update call. I will begin by reviewing our recent progress and accomplishments. Following my remarks, Eyal will provide a more detailed review of our financial results. We will then open the line for questions. As we updated earlier this morning, we, together with our development and commercialization partner, Chiasi Global Rare Diseases, are waiting on an EC decision which should be announced in the next couple of days. In addition to the EU, we are also quickly approaching potential approval in the United States. Our assigned PDUFA target action date is next week, May 9, 2023, and we look forward to providing you with an update when we hear from the FDA. We are grateful for the Protalyx team as well as our partnership with Chiesi that had brought us to this stage. We are confident that if approved, Chiesi is well equipped to realize the full potential of PRX-102 They have ramped up commercial activity and are prepared for launch. Fabry disease represents a potential significant opportunity in a multi-billion dollar market that is in need of an alternative treatment option, and we, together with Chiesi, are prepared to deliver. Now, turning to our pipeline. We are continuing to make progress in our earlier stage programs. PRX115 is a novel pegylated uricase in development. for the treatment of severe gout. In March of 2023, the first patient was dosed in our phase one, first in human clinical trial for PRX115 in patients with elevated uric acid levels, and the trial is a double-blind placebo-controlled single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of PRX115 in up to 56 patients. The study is being conducted in New Zealand, and to date, nine patients already have been dosed in this trial. We look forward to continued enrollment and dosing of patients. We also continue to progress on PRX119, a peculated recombinant human DNase 1 protein designed to elongate DNase half-life in circulation for treatment of NETS-related diseases. We have conducted preclinical studies to demonstrate the feasibility of PRX119. We look forward to providing updates on these programs and others as we look to build our growing pipeline. You may recall that last December in 2022, we announced our decision that it was in our company's best interest to voluntarily delist our common stock from Tel Aviv Stock Exchange. On March 22nd of this year, 2023, our common stock was delisted from the Tel Aviv Stock Exchange, and the last trading day on the Tel Aviv Stock Exchange was March 20th, 2023. Finally, our balance sheet provides us with sufficient runway to the third quarter of 2023, supporting the company through potential approvals, in addition to continuing to develop our earlier stage pipeline programs. I will now turn to Eyal. Thank you. I will now, yes, of course, I will now turn to Eyal for review of our financials. Eyal, please.