Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Portalix Biotherapeutics Third Quarter 2021 Financial Results and Business Update Conference Call. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Chuck Padala of Lifesize Advisors Investor Relations for Portalix. Thank you. You may begin your presentation.

Thank you, Laura. Welcome to the Portalix Biotherapeutics Third Quarter 2021 Financial Results and Business Update Conference Call. With me today are Dror Bishan, President and CEO of Portalix, and Eyal Rubin, Chief Financial Officer. A press release announcing the results and the update was issued this morning and is available on Portalix's website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and 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 Portalix's filing with the U.S. Securities and Exchange Commission. I will now turn the call over to Portalix CEO, Mr. Jorba Shah. Jor?

Thank you, Chuck, and welcome, everyone, to the company's third quarter 2021 financial results and business update call. During the call today, I will review the progress of our key clinical programs and provide an update on our strategic roadmap for the remainder of 2021 and beyond. Following my remarks, our Chief Financial Officer, Mr. Jan Rubin, will review the company's financial results before we open the line for questions. In September of this year, Propalix and our partner, Kiesi, participated in a Type A meeting with the FDA during which the FDA in principle agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support the traditional approval for PRX102 for the treatment of Fabry disease. The planned data package for the BLA resubmission, given the change regulatory landscape in the United States, will include the final two-year analysis of the balance study, and we were pleased with this outcome, and we intend to continue to work collaboratively with the FDA and resolve the issues noted in the CRA with the goal of commercializing a new alternative drug to treat fabrications. We anticipate the resubmission of the biological license application, BLA, for the PRS-102 to the FDA in the second half of next year. In October of 2021, Brotalix and Chiesi announced that a meeting has been held with the Rapporteur and Co-Rapporteur of the European Medicine Agency regarding PRX-102. At the meeting, Chiesi and Protalic discussed the scope of the anticipated marketing authorization application submission for the European Union. And the Rapporteur and the Co-Rapporteur were generally supportive of a planned MAA submission for PRX-102. This is an important step in the necessary resubmission activities leading up to an MAA submission. Based on the interim analysis of the 12-month data generated from the balance study that the company announced in June of 2021, and in combination with the previously reported positive data from the BRIDE and BRIDGE study, the company and Chiesi expect to submit an MAA to the EMA for PRX102 during the first quarter of 2022. We are confident in the overall clinical profile of PRX102 that we have assembled through our extensive development program. In October, We, together with SCIA-Z, announced the final dosing of the last patients in the balanced study for the proposed treatment of Fabry disease. The balanced study is a 24-month randomized double-blind active control study of PRS-102 in Fabry patients with impaired renal function. We anticipate the release of the unblinded top-line data during the second quarter of 2022 after all remaining patients have completed the 24-month treatment period. We plan to initiate a toxicity study for PRX115, which is a plant cell-expressed recombinant pegylated uricase chemically modified enzyme to treat refractory gout in the first quarter of 2022. And in addition, we are working on the plans for development of PRX119, which is a plant cell-expressed pegylated recombinant human DNA for net-related diseases. PRX115 has been shown in several preclinical studies to have higher specifics. specific activity, and longer half-life. And accordingly, the company intends to explore the possibility of developing PRX115 for treatment every two months, which would lessen the frequency of necessary hospitalization as part of the treatment, thereby reducing the physical and financial burden experienced by patients and the patient community. And with respect to PRX119, several experiments in my CLP model demonstrate the feasibility of PRX119 as a treatment for sepsis. The data showed promising results in determining a dose-dependent response in mice survival. In addition, we've begun working with a third party to develop new methodologies for protein modification. We continue to evaluate potential strategic marketing partnerships and collaboration programs with biotechnology and pharmaceutical companies for PRX110, a plant cell recombinant DNAs, for which we are considering a potential treatment for various respiratory indications, as well as our other early-stage product candidates. We will update you on our early-stage pipeline as events unfold. I would like to close this section of my comments with acknowledging the importance the resiliency and greed of our team members and partners during such a challenging time, and emphasize how much your efforts are making a difference towards our mission of bringing important new medicines to market for patients with high unmet medical needs. I will now turn to Eyal to review our financials. Eyal, please go ahead. Thank you, Jor.