Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the ProTalex first quarter 2022 financial and business results conference call. If anyone should need operator assistance during the conference, please press star one on your telephone keypad. As a reminder, this conference call is being recorded. I will now turn the conference over to your host, Alexandra Schumann of LifeSci Advisors, Investor Relations for ProTalex. You may begin your conference.

Thank you, Operator, and welcome to the Protallix Biotherapeutics First Quarter 2022 Financial Results and Business Update Conference Call. With me today are Jorah Bashan, President and CEO of Protallix, and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning and is available now on the Protallix 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 Portalex's filings with the United States Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

Thank you, Alexandra. and welcome everyone to our first quarter 2022 financial results and business update course. I will begin with a review of our progress and accomplishments over the first quarter, along with our plans for the coming month. Following my remarks, Eyal will provide a more detailed review of our financial results. We will then open the line for questions, of course. Let me begin with a summary of the positive top-line results announced in April from our phase three balanced clinical trial of PRX102 for the treatment of Fabry disease in adults. We were very pleased to report that the trial successfully met its primary endpoint and that the data showed a favorable tolerability immunogenicity profile for PRX102. We plan to provide a final analysis of the balanced study in the third quarter of this year after we have completed all analysis and discussions of the collected data. At our KOL event, which also took place in April, Dr. David Warnock from the University of Alabama at Birmingham described the balance study, the top-line results of the balance study, and our next steps. He also provided an overview of the $2 billion market, Fabry market, described the need for additional therapies and the potential of PRX102 to meet a significant unmet need of the Fabry community patients. The company, together with its development and collaboration partner, Chiasi Global Rare Disease, or Chiasi, currently plan to resubmit a biological license application, or a BLA, to the FDA in the second half of this year, and continues to be on track to achieve that goal. It is intended that the BLA package will include the positive results from the company's three phase three clinical trials, the BALANCE Bridge and the BRIDE studies, And of course, the COMPANY Phase 1-2 study, which was conducted before. As announced last October, after the COMPANY and Chiesi participated in a Type A end-of-review meeting with the FDA, the COMPANY and Chiesi gained clarity on the pathway for approval. The COMPANY believed that it has a compelling and consistent data set from both treatment-naive and enzyme replacement therapy, experienced patients for inclusion, in the BLA resubmission. In Europe, we submitted the Marketing Authorization Agreement, or MAA, for the PRX-102 with European Medicine Agency, or EMA, on February 7, 2022, which was subsequently validated by the EMA. We believe Portalix is starting a transitional period. The robust data from the three Phase III studies demonstrating the potential of PRX-102 to be a good treatment for patients with Fabry disease. We have full in-house manufacturing capabilities, a commercialization plan with our global partner, Kiesi, and a clear pathway toward the anticipated approval of PRX-102. Additionally, we have a pipeline of existing early-stage programs that we will be highlighting as the progress in development. Our strategy is to continue investing in new product candidates to support our goal of becoming a global commercial world-class biopharmaceutical company. Finally, our balance sheet provides us with sufficient cash runway until Q3 of 2023, enough to support our plans for resubmission and potential approval, in addition to the continuing to develop our early-stage pipelines. We continue advancing our early-stage pipeline and will share the progress made once available. I will now turn to Eyal to review our financial results. Eyal, please go ahead.