Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics Third Quarter 2024 Financial Business Results Conference Call. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mike Moya, Lifestyle Advisors for Protallix. Please, thank you. You may begin.

Thank you, Operator, and welcome to the Protallix Biotherapeutics Third Quarter 2024 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Pertalex, and Ayal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and business and clinical 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 release and the 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 in Portalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bishan. Gerard?

Thank you, Mike, and thank you, everyone, for joining our third 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 review of our financial results. We will then open the line for questions, of course. I will start with PRX115, which is our common unpegulated uricase candidate produced through our prosthetics platform in development for treatment of uncontrolled gout. As we have announced this morning in our press release, all eight cohorts of the first in human phase one clinical trial of PRX115 are now complete and data analysis ongoing. 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. Preliminary results from the eight cohorts are consistent with the initial promising results from the seven cohorts. Overall, 64 subjects were randomized across the eight cohorts. 48 of these subjects were treated with a single administration of PRX115, and 16 subjects were treated with a placebo. All of the subjects completed the study. Exposure to PRX115 increased in a dose-dependent manner. PRX115 levels were observed for up to 12 weeks in cohorts 6, 7, and 8, the cohorts with the highest doses. In all tested doses, a single dose of PRX115 rapidly reduced plasma uric acid levels. The effect and duration of response were found to be dose-dependent. Following a single dose, mean plasma uric acid levels remained below 6 mg per deciliter for up to 12 weeks at the highest dose levels. PRX115 was also generally well tolerated. Only 25% of subjects receiving PRX115 have reported study drug-related adverse events. The majority of these were mild to moderate and transient in nature. We are encouraged by these preliminary results. The findings from the study suggest PRX115 has the potential to be a promising treatment option for patients with gout. We believe the results demonstrate that PRX115 may offer an effective uric acid lowering treatment with an added benefit of a potential wide dosing interval, which may enhance patient compliance and treatment flexibility. Further studies are needed to confirm the long-term safety and efficacy of PRX115 in the gout patient population. Preliminary results from this study are being presented at the late-breaking poster of the American College of Rheumatology annual meeting, ACR Convergence, which begins today in Washington, D.C. We are continuing our preparations for a Phase II trial of PRX115 in patients with uncontrolled gout. We plan to continue our dialogue with regulatory authorities in the U.S. and Europe regarding our Phase II plans with the goal of initiating the Phase II study in the second half of 2025. And now for El Fabrio. In past course, we have discussed the strong commitment of our commercial partner, Chiesi Global Rare Diseases, to the successful commercialization of El Fabrio and the wealth of experience the team brings to such efforts. Chiesi continues to increase its focus on El Fabrio and invest heavily in its medical and commercial program. As part of its program, Chiesi is sponsoring a number of studies El Fabio, including in a trial in Japan, a pediatric and adult trial, and the maternal and postnatal outcomes study, and other global and international multicenter studies. We look forward to continuing to collaborate with Chiesi in its goal to bring El Fabio to as many patients as possible. Our next pipeline candidate, also being expressed through POSELEX, is PRX119. PRX119 is a regulator that complements human DNA as one candidate in development for potential treatment of diseases associated with neutrophil extracellular traps, or NETs. 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 prosthetics platform and prioritize renal disease indications. In addition, we have begun to evaluate plant-based drug delivery systems that may allow protective delivery of different modalities. These efforts are in preliminary stages, and we look forward to updating you on the progress as these efforts, as they progress, of course. With regard to the therapeutic areas, our strategy moving forward is to prioritize rare renal diseases as the core of proteomics development pipeline. This is a logical focus to us. Given the existing experience, network, and resources we build through the diligent and dedicated efforts earned throughout the Fabry Development Program, we have identified potential key high unmet need indications on which we plan to focus our initial efforts, such as ADPKD, Alport Syndrome, and FSGS and others. Work is currently ongoing to identify assets for the treatment indications. We intend to use the prosthetics platform and the pigulation capabilities as well as other modalities such as small molecules and oligos to take advantage of highly innovative opportunities. We are also exploring novel platform technologies. Finally, in September, we repaid in full all of our outstanding principal and interest under the 7.5% senior secured convertible promissory notes. The repayment was financed entirely with the available cash. This is significant for Portalix as we are now a debt-free company. Our financial discipline and strong balance sheet enable us to support our ongoing operations. And with that, it is now my pleasure to turn the call over to Eyal and review our financials. Eyal, please.