Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics Third Quarter 2023 Financial and Business Results Conference Call. As a reminder, this conference call is being recorded. I will now turn the conference over to our host, Mr. Chuck Padilla of LifeSci Advisors Investor Relations for Protallix. You may begin your conference.

Thank you, Operator, and welcome to the Portalix Biotherapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Portalix, 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 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 Portalex's filing with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

Thank you, Chuck. and welcome everyone to our third quarter 2023 financial results and business update call. Before we begin, I would like to take a moment to acknowledge the situation here in Israel. We at Protalyx are horrified by the devastating events that have been taking place in recent weeks. It is an extremely challenging time and we are heartbroken for the victims, families, friends and loved ones, many of us being personally impacted. Our hearts and prayers go out to all those affected, and we remain dedicated to the safety and well-being of our team. We are committed to provide our families, friends, and colleagues any and all support they need at this time. At the same time, we want to reassure you that we are continuing to operate as usual. There have been no disruptions to our facility. and we do not currently anticipate any interruption to the supply of our products El Fabrio and El Elizo. We appreciate all those who have been reached out to Protalyx to express their concern and support, and we thank you for joining us today. I will now review our recent progress and accomplishments. Following my remarks, Eyal will provide a more detailed review of our financial results, and then, of course, we will open the line for questions. Let me now turn to our accomplishments this quarter. Since receiving FDA and EMA approval for El Fabrio, our commercial partner Chiesi has focused on commercial launch in both the United States and the European Union. We are also pleased that El Fabrio has been granted additional regulatory approvals outside the EU, like in Great Britain and Switzerland, and we look forward to continued global growth of El Fabrio. Having now secured the approval of two drug products, Elfabio and Elilizer, we are now focusing our attention to develop our pipeline assets with the potential to address high unmet needs for patients with limited therapeutic options. Our most advanced development candidate is PRX115 for the potential treatment of severe gout. We are currently sponsoring a Phase 1 first in human clinical trial of PRX115 to evaluate its safety, pharmacokinetics, pharmacodynamics, and immunogenicity. It is a double-blind placebo-controlled single ascending dose trial of up to 56 participants. 42 participants have been dosed today in this first in human trial. We expect to announce top-line results from this study in mid-2024. We believe PRX115 is potentially a good candidate to target this market. Our next pipeline candidate is PRX119 for the potential treatment of NETS-related diseases. NETS are web-like structures released by activated neutrophils that trap and kill a variety of microorganisms. Excessive formation or ineffective clearance of NETS can result in different pathological effects. and has been observed in various autoimmune, inflammatory, and fibrotic conditions. We look forward to providing with updates on these programs as they progress. There are currently several other preclinical programs, and we will update regarding these programs once applicable. On the corporate side, we welcome Dr. Elliot Fosser as chairman of our board of directors, succeeding Mr. Ze'ev Bornfeld, who retired from his position on our board. As an independent director, Dr. Foster was also appointed to our nominating committee. Elliot's reputation in management and leadership in the life science field speaks for itself, and he has a record of success in the United States, the European Union, and Asia. We are grateful to Ze'ev for his dedication and leadership since the founding of Protonix many, many years ago, and we look forward to working with Elliot and leveraging his expertise as we enter this exciting phase of development for this company. Before turning the call over to Eyal, I want to note that our strong balance sheet provides us with sufficient cash runway to maintain current operations without the need for near-term capital infusion. With that, it is now my pleasure to turn the call over to Eyal to review our financials. Eyal, please.