Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Portalix Biotherapeutics Fiscal Year 2024 Financial and Business Results Conference Call. As a reminder, this conference call is being recorded. I'll now turn the conference over to your host, Mr. Mike Moyer of LifeSci Advisors Investor Relations for Portalix. You may begin your conference.

Thank you, Operator, and welcome to the Portalix Biotherapeutics Fiscal Year 2024 Financial Results and Business Update Conference Call. With me today are Dhruva Shahan, President and CEO of Pertalex, and IL Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates was issued this morning and is available now on the Pertalex 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 portalics as filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Michon. Gerard?

Thank you, Mike, and thank you, everyone, for joining the Fiscal Year of 2024 Financial Results and Business Update Board. I will begin by reviewing our accomplishments over the past year and recent progress. Following my remarks, Eyal will provide a detailed review of our financial results. We will then open the line for questions, of course. 2024 was a very good year for Protonix, as we brought record revenues from our partners, fully repaid our outstanding debt, and continued to focus R&D efforts on PRX115, PRX119, and other early-stage candidates. I would like to start with PRX115, which is our recombinant pegylated uric health candidate in development for the treatment of uncontrolled gout. We produced PRX115 through our ProCelix platform. As we have announced last quarter, we completed all cohorts in the first in-human phase 1 clinical trial of PRX115. This study was a double-blind, placebo-controlled, single ascending dose study designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics following a single dose of PRX115 in subjects with elevated uric acid levels. The results from this study were presented in the late-breaking poster at ACR Convergent Conference in November of 2024. A copy of the poster is available in the publication section of the Protalix website. We are pleased with the results from this first inhuman study and believe they support moving forward into patients. To that end, we have been preparing for a Phase II clinical trial of PRX115 and have been in dialogue with regulatory authorities in the U.S. regarding such a proposed trial. Our goal is to initiate the Phase II study during the second half of this year. Turning now to El Fabrio. Throughout 2024, our commercial partner, Chiesi Global Rare Diseases, continued to increase its focus on Elfabrio and invest heavily in its medical and commercial program. In December of 2024, we and Chiesi announced that the European Medicine Agency, or EMA, validated the variation submission for PEG-unigal CIDAS-alpha to label an additional, less frequent dose in regimen of 2 mg per kick, administered every in adult patients with Fabry disease in the European Union. The currently approved dose is 1 mg per kg administered every two weeks. This application was supported by a revised population PK model and a new exposure response analysis from the clinical data from the previously completed BRITE Phase 3 program, as well as its extension study. We look forward to working closely with both Chiesi and DMA throughout their review process. And I would like to emphasize that Chiesi deserves our sincere gratitude for their partnership with Protalyx and their dedications to patients with Fabry disease. Our next pipeline candidate, also being expressed for Porcelix, is PRX119. PRX119 is a pegylated recombinant human DNA1 product candidate in development for the potential treatment of diseases associated with neutrophil extracellular traps, or NETs. Preclinical studies are ongoing. As we have been discussing throughout the past year, we have been focusing our R&D efforts on early-stage development assets to expand our product development pipeline. This includes leveraging our Procelex platform and pegylation capabilities, evaluating drug delivery systems that may allow protective delivery of different modalities, and focusing our therapeutic areas to renal rare diseases. We intend to continue this effort throughout 2025 and hope to provide you with further updates as these programs become more mature. For now, let me say that I am excited about our R&D efforts and we are laying the groundwork for future developments that may be truly transformative. Finally, in September of 2024, we repaid in full All of the outstanding principal and interest are under our 7.5% senior secured convertible promissory notes. The repayment was financed entirely with available cash. In addition, since December 31st of 2024, we have issued 908,000 shares of our common stock in connection with the exercise of warrants we issued in 2020, generating proceeds of approximately $2.1 million. The warrants expired on March 11th of 2025. Accordingly, no warrants remain outstanding. This is significant for Protonix, making our balance sheet stronger and enable us to continue executing our strategy. With that, it is now my pleasure to turn the call over to Eyal for review of our financials. Eyal, please.