Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the ProTalix Biotherapeutics Second 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 LifeSite Advisors. You may begin your conference.

Thank you, Operator, and welcome to the ProTalix Biotherapeutics Second Quarter 2024 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Pertalex, and Eyal 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 portalics filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan Dror.

Thank you, Mike, and thank you, everyone, for joining our second quarter 2024 Financial Results and Business Update Group. I will begin by by reviewing our recent accomplishments before handing the call to Eyal, who will provide a review of our financial results. We will then, of course, open the line for questions. I will turn first to PRX115, which is our recombinant pegylated Eureka's candidate produced through our Procelex platform in development for the treatment of uncontrolled gout. We recently announced encouraging results, initial top-line results, from the first seven cohorts of the first in human phase one clinical study of PRX115. As a reminder, this study is 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 preliminary results from the first seven cohorts demonstrated that PRX115 exposure increased in dose-dependent manner, and PRX115 rapidly reduced plasma uric acid concentrations to below the guideline level of 6 mg per dl. PRX115 was also generally well-tolerated. Based on the initial top-line results of these initial seven cohorts, and the review and acceptance of the safety data by the safety monitoring committee for those escalating, we expanded the phase one study by adding an eight cohort so we can analyze a higher dose of PRX115 and its potential to result in an increased exposure time. Dosing in this eight cohort is now complete and the 85 days follow up period is in progress. We expect Top line results from the full study to be available in the fourth quarter of this year. In addition to the expansion of the phase one study, we have also initiated already preparations for a phase two trial of PRX115 in patients with uncontrolled gout. We plan to meet and communicate with the regulatory authorities in the US, Europe, and Europe to discuss our phase two plans and the overall clinical program. with the goal of initiating the phase two study in the middle of next year. Our commercial partner, Chiesi Global Rare Disease, remains committed to a successful commercialization of Alfabrio and has a wealth of experience on their team. Chiesi has invested heavily in the rare disease space and we are confident that they will continue to penetrate the market and build a Fabry franchise for the longer term. Our next pipeline candidate Also expressed for POSELEX is PRX119. PRX119 is a pegylated recombinant uricase human DNA candidate in development for the potential treatment of diseases associated with neutrophil extracellular traps or NETs. Excessive formation or accumulation of NETs can result in different pathological effects which have been observed in various autoimmune, inflammatory, and fibrotic conditions. Beyond PRX115 and PRX119, we are focusing our R&D efforts on early-stage development assets to build our product development pipeline. We have fine-tuned our pathway going forward to focus on leveraging our Procellix platform and prioritizing renal rare disease indications. With regard to the therapeutic areas, our strategy moving forward is to prioritize renal rare disease as the core of portalic development pipeline. This is a logical focus for our company given our existing experience and the network and resources we build through the diligent and dedicated efforts owned throughout the Fabry Development Program. For example, PRX119 is being evaluated for NET-related renal autoimmune-associated diseases. In addition, we have identified potential key high unmet need indication on which we plan to focus our initial efforts. such as ADPKD, Alport syndrome, FSGS, and others. Work is currently ongoing to identify assets for these and other indications. In order to expand our platform, we are evaluating novel plant-based drug delivery systems that may allow protective delivery of different modalities into specific tissues. These exploratory studies are ongoing, and we look forward to updating you on the progress of these efforts as they progress. In addition to our Procellex platform, we intend to explore other modalities, such as small molecules and oligonucleotides to take advantage of highly innovative opportunities. Before turning the call to Eyal, I want to note that our strong cash position will enable the repayment of our convertible notes due next month in September, actually in September 1st, and to maintain our ongoing operation, including the Phase 2 study in GAUT. In addition, we expect sales to Chiesi to gradually continue as Chiesi anticipates future approvals and launches in additional markets. With that, it is now my pleasure to turn the call over to Eyal for review of our financials. Eyal, please.