Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics First Quarter 2025 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mike Moyer of LifeSci Advisors, Investor Relations for Protallix. Thank you. Please go ahead.

Thank you, operator, and welcome to the Protallix Biotherapeutics First Quarter. 2025 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Bratallix, and Ayal Rubin, Senior Vice President and Chief Financial Officer. Press release announcing the financial results for the quarter and corporate updates was issued this morning and is available now on the Bratallix website. Please take a moment to read the disclaimer and 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 Protox's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Michaud. Sure.

Thank you, Mike. And thank you, everyone, for joining for our first quarter of 2025 financial results and business update quote. I will begin with the reviewing of our accomplishments over the quarter in recent weeks. Following my remarks, Eyal will provide a detailed review of our financial results. And then we will open the line for your questions, of course. With another solid quarter, with an increase in revenues from selling goods compared to the same period last year, giving the promising results obtained in 2024 from our first inhuman study, of our GOUT product candidate, PRX115. We are focused on building on the momentum and working towards initiating a phase two clinical trial in patients with GOUT later this year. At the same time, we continue to evaluate additional pipeline candidates for potential further development, including PRX119, as well as other early stage clinical assets. Eyal will discuss the details of our financial achievements in a few minutes, and I would like to start with PRX115. As we announced with our results for 2024, we completed all cohorts in the first in human phase one clinical trial of PRX115. The study involved a single dose of PRX115 in subjects with elevated uric acid levels. Overall, PRX115 exposures increased, and in a single dose of PRX115, rapidly reduced plasma uric acid levels, both in dose-dependent manner both in dose-dependent manner, I'm sorry. Their encouraging results from these studies suggest a long-acting effect and may enable us to potentially widen the dosing interval, which could enhance patients' compliance and treatment flexibility. I encourage you to check the publication section of our website where we have uploaded a poster that was presented at the ACR conference in November of 2024 describing the results. We are excited to progress with the clinical development of PRX115, and our goal continues to be initiation of this phase two study in the second half of this year. I now turn to Olfabrio. Last year, our commercial partner, Chiesi, Global Royal Diseases, continued to increase its focus on Olfabrio and invest substantially in medical and commercial programs. Last December, Chiesi announced I'm sorry. The European Medicine Agency, or EMA, validated a variation submission for PEG-UNIGR-C-DAS-alpha. This submission is to reduce the dosing frequency in the label to be 2 mg per kg every four weeks. The currently approved dose is 1 mg per kg administered every two weeks. The application was supported by the revised population PK model and a new exposure response analysis of the clinical data from the previously completed Bright Phase III clinical study, as well as the related extension study. We look forward to working closely with both Chiesi and the EMA throughout the review process, and we expect to hear from the EMA during the fourth quarter of this year. We continue to appreciate Chiesi's partnership and dedication to Fabry disease patients and patient community. Our next pipeline candidate, also expressed for Procelex, is PRS119. PRX109 is a pegylated recombinant human DNase-1 candidate in development of the production treatments of diseases associated with no-to-fill extracellular traps or NETs. The clinical of PRX119 remain ongoing. As we have been discussing throughout the past year, we have been focusing our early efforts on early stage development assets to build our product development pipeline. This includes leveraging our ProCEDEX platform and pegylation capabilities. evaluating drug delivery systems that may allow protective delivery of different modalities, and focusing on therapeutic areas to renal rare diseases. We will continue these efforts throughout 2025, and we hope to provide with further updates as these programs become more mature. For now, let me say that I'm excited about our R&D efforts, and we are laying the groundwork for future developments. With that, It is now my pleasure to turn the call over to Eyal to review our financials. Eyal, please go ahead.