Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Second Quarter 2022 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. Chuck Padala of LifeSci Advisors, Investor Relations for Protallix. Thank you. You may begin your conference.

Thank you, Operator, and welcome to the Protallix Biotherapeutics Second Quarter 2022 Financial Results and Business Update Conference Call. With me today are Dror Bishan, President and CEO of Portalix, and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning, and it's available now on the Portalix website. Please take a moment to read the disclaimers 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 these statements made. Factors that could cause actual results to differ are described in the disclaimer and in the portalics filing with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

Thank you, Chuck, and welcome everyone to our second quarter 2022 financial results and business update call. I will begin with a review of our progress and accomplishments over the second quarter, along with our plans for the coming months. Following my remarks, Eyal will provide a more detailed review of our financial results. We will then open the line for questions. Let me begin with a review of our Phase III balanced clinical trial for PRX102 for the treatment of Fabry disease in adults. In April, we announced positive top-line results from the trial, showing that PRX102 successfully met its primary endpoint on kidney function and presented a favorable tolerability and immunogenicity profile. I'm happy to report that the clinical study report, which is called also as the CSR, for the balanced trial has been completed. The final analysis of the balanced study confirms the positive top-line results and favorable tolerability profile. These encouraging results highlight our confidence that PRX-102 has the potential to become an important treatment option for patients with Fabry disease. We are excited to move closer to potential approval of PRX-102 and then the commercial launch. The BLA resubmission will include the positive results from our three completed Phase III clinical trials, the BALANCE, the BRIDGE, and the BRIGHT, as well as our Phase I-II safety study. With respect to PRX102-MAA submitted to the EMA, we are working closely with Chiesi Global Rare Disease to advance the review process. The MMA was submitted earlier this year, in February of 2022. This is an exciting time for Portalix. As we move closer to a potential approval for PRX102 for the treatment of Fabry disease, we believe that the totality of our clinical data which is based on hundreds of years of aggregate patient exposure, demonstrates that PRX-102 can be an important new treatment option for patients with Fabry disease. Chiesi, our global partner, has been working on the commercialization plan to provide a solid foundation to successfully bring PRX-102 to the market upon its anticipated approval. With regard to our broader pipeline, we continue to invest in new product candidates to support our goal of becoming a significant biotherapeutic company. To that end, we have established a pipeline of early-stage programs in development, from discovery stage to phase one, which will start early next year. And all of these programs involve molecules that we express for prosthetics, our proprietary protein expression system, which enables us to express and develop potential products which will address real unmet needs on the market. In parallel, we continue to work to improve our technological capabilities, both on the Procelec system and in the chemical modifications area. We are moving forward with PRX115 and novel pegylated uricase for treating severe gout patients, and the first inhuman phase one study is planned to commence in the first quarter of 2023. As support for this first inhuman study, we are finalizing our toxicology package, of course. With respect to PRX119, we have conducted several experiments, practical studies to demonstrate the feasibility of PRX119, and we look forward to providing updates on these and additional programs as they progress. Our 2022 annual meeting of stockholders was held on June 30, 2022. At the meeting, our stockholders approved all of the items on the agenda. In addition, our board of directors appointed Shmuel Bentsvi, for Muli to be a member of the board of directors. As David Granot's stature on the board ended as of the meeting. On behalf of Portalix, I would like to thank David for his dedicated service to our company and wish him the best in his future endeavors. Muli has extensive financial and economical knowledge as well as considerable management, business, and auditing experience. Muli is now the chairman of our audit committee and a member of the compensation committee. We are very happy to welcome Muli to Portalix. Finally, our balance sheet provides us with sufficient cash runway to the third quarter of 2023, enough to support our plans for resubmission and potential approval, in addition to continuing to develop our early-stage pipeline programs. I will now turn to Eyal for review of our financials. Eyal, please go ahead.