Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics First Quarter 2024 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. Mike Moyer of LifeSci Advisors, Investor Relations for Protallix. You may begin your conference.

Thank you, Operator, and welcome to the Protallix Biotherapeutics First Quarter 2024 Financial Results and Business Update Conference Call. With me today are Drew Arubashan, President and CEO of Bratalex, and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the business and clinical updates was issued this morning and is available now on the Bratalex 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 Procalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Dror Bashan. Dror?

Thank you, Mike, and welcome, everyone, to our first quarter of 2024 Financial Results and Business Update Call. I will begin by reviewing our recent accomplishments before handing the call to Eyal, who will provide a more detailed review of our financial results. And we will then open the line for questions. I will turn first to PRX115. As announced this morning, given the encouraging initial top line results from the first seven cohorts of the company's phase one first study, of our recombinant URICAS candidate, PRX115, and following the review and acceptance of the safety data by the Safety and Monitoring Committee, the company has decided to expand the study by adding an eighth cohort. Consistent with the initial seven cohorts, the new cohort will consist of eight new subjects and will analyze a higher dose of PRX115 and the potential of a higher dose will result in increased exposure time. In addition to the expansion of the first in-human study, the company also decided to commence preparations for a Phase II clinical trial of PRX115. PRX115, to remind you, is a recombinant pegylated uricase product candidate produced using our ProCellExpress platform. The study is a double-blind, placebo-controlled, single ascending dose, First in human phase one clinical trial, the company designed to evaluate the safety pharmacokinetics and pharmacodynamics following a single dose of PRX115 in subjects with elevated uric acid levels. Of the 56 randomized subjects enrolled in the study across seven cohorts, 42 subjects were treated with PRX115 and 14 subjects were treated with placebo. Gout is the most common inflammatory arthritis, and it affects approximately 14 million adults in the US, over 7 million in Europe, and over 190 million in China. It is estimated that about 5% of the gout patients are considered to have chronic refractory disease. The preliminary results from the first seven cohorts demonstrate the exposure to PRX115 increased in a dose-dependent manner and the PRX115 rapidly reduced plasma uric acid concentration to below 6 milligram per deciliter over time following a single administration. With regard to the safety, a PRX115 was found to be well tolerated. Twenty-six percent of the subjects treated with PRX115 reported the study-related adverse events, and the majority of these were mild to moderate and transient in nature. One subject in cohort number two experienced an anaphylactic reaction immediately following the start of the infusion, but the reaction was fully resolved. There were no other serious adverse events reported, and no adverse events were reported in the highest dose cohort number six and seven. We look forward to updating you on the full results from the expanded trial following the completion of the new cohort. Our next pipeline candidate, Abel also being expressed through Procellex is PRX119. PRX119 is a pegylated recombinant human DNase-1 candidate in development for the potential treatment of diseases associated with neutrophil extracellular traps or NETs. Excessive formation of accumulation of the NETs can result in different pathological effects and have been observed in various autoimmune, inflammatory, and fibrotic conditions. Animal studies with PRX119 have shown that our product candidate has the potential to be an effective treatment for these conditions. And additional proclinical studies of PRX119 are ongoing. In addition to PRX119 and PRX115, the company is focusing its research and development efforts on early stage development assets to build its product development pipeline. We look forward to providing you with updates on potential development candidates as they become more mature. Finally, as you know, our second approved drug, Alfabrio, continues to gain approvals, regulatory approvals, for the treatment of adult patients with Fabry disease. Most recently, in January of this year, it was approved in Israel, and our commercial partner, Chiesi, global rare disease, is committed to successful commercialization of Alfabrio, with launches underway in the United States, throughout the European Union, the UK, Switzerland, Israel, and additional markets where approvals were granted. We are confident that Chiesi will continue to position El Fabio for success, and we look forward to the continued growth of El Fabio franchise. Before turning the call to Eyal, I want to emphasize our strong cash position provides us with sufficient cash to enable the repayment of our convertible notes due in September of this year. and for our ongoing operations. In addition, we expect sales to Kiesi to gradually continue as they anticipate future approvals and launches in additional countries. With that, it is now my pleasure to turn the call over to Eyal for a review of the financials.