Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics First Quarter 2021 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. Chuck, you may now begin the presentation.

Thank you, Rob. Welcome, everyone, to the Protallix Biotherapeutics First Quarter 2021 Financial Results and Business Update Conference Call. With me today are Mr. Dror Bershon, President and CEO of Portalix, and Mr. Eyal Rubin, Chief Financial Officer. The press release announcing the results and the update was issued this morning and is now available on the Portalix website. Please take a moment to read the disclaimer about the 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 and in the Bortalex filings 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 the company's first quarter 2021 financial results and business updates. During the call today, I will review the progress of our key clinical programs and update on the roadmap of our upcoming strategic milestones. Following my remarks, our chief financial officer, Rial Rubin, will review the company's financial results before we open the lines for questions. We were obviously disappointed with the recent receipt of the complete response letter from the FDA last month, but we are encouraged that the FDA did not report any concerns relating to the safety and efficacy of PRX-102. We are working closely with the agency and anticipate the required inspection and subsequent assessment will be completed once the agency's travel restrictions are lifted. I will provide more detailed comments on the CRL shortly. We are continuing to advance our earlier stage pipeline. Additionally, we strengthened our balance sheet during the quarter with a public offering generating $40 million in gross proceeds and feel confident about our ability to continue to fund our clinical programs as we prepare for a potential commercial launch of PRX-102. Now, let me provide more details about our quarter. In late April, we and our development and commercialization partner, Kiesi, received a CRL from the U.S. FDA for PRX-102 for the treatment for adult patients with Fabry disease. In the CRL, the FDA noted the requirement to inspect totalics manufacturing facility in Israel, and that due to travel restrictions as a result of the COVID-19 pandemic, it was unable to conduct the inspection during the review cycle. The FDA explained that it will continue to monitor the public health situation as well as travel restrictions and is actively working to schedule outstanding inspections. For our third-party fit and finish facility for PRX102 in Europe, due to the COVID-19, the FDA reviewed records under Section 704A4 of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection. The FDA stated that that it will communicate any remaining issues related to the facility in order to seek prompt resolution for any pending items. Our third-party fill-in-finish facility received the FDA comments just a few days ago and shared them with us. Together, we are reviewing these comments closely with quality and regulatory consultants. The last significant point was highlighted by FDA in the letter is that Fabrazyme was recently converted to a full approval. This new development will need to be addressed in the context of any potential resubmission seeking accelerated approval of PRX-102. Once again, while we are disappointing to receive the CRL, we intend to work collaboratively with the FDA on resolving issues. These issues are moving forward on the next steps. We are working on scheduling a Type A end-of-review meeting with the FDA, which we plan to request from the FDA by the end of July and should take place approximately 30 days after from our request. Our objective for the meeting is to better understand the issues raised in the CRL and work with the FDA on a plan to resolve these issues. We are confident in the overall clinical profile we have assembled through our development program, and we believe PRS-102 will bring important value to the Fabry patients with unmet clinical needs. We intend to update you on new developments as soon as feasible. During the quarter, we continued to build our clinical profile for PRX102. We released positive top-line results from the Phase 3 BRITE study, which was designed to evaluate the safety and efficacy and pharmacokinetics of PRX102 treatment, two milligrams per kilogram every four weeks in up to 30 patients with Fabry disease, previously treated with commercially available enzyme replacement therapy. Top-line results indicate that two milligrams per kid of PRX102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients and stable clinical presentation was maintained in adult patients. Our results demonstrate the potential for a more convenient therapy option for patients without compromising safety and efficacy. We expect to receive full interim results from our phase three balance trial in the coming weeks. The balance trial is a double blind head-to-head 24-month trial evaluating the safety and efficacy of PEG-unigalcidase-alpha, one milligram per kilogram, dosed every two weeks in Fabry patients with declining renal functions versus Fabrazine. The interim results are anticipated to serve as our basis for the European EMA filing, together with additional data from various clinical trials. Subject to the results, the balanced trial, we could potentially have a commercial launch in Europe in the first half of 2023. We announced in February an exclusive partnership with Sarcomate USA for the worldwide development and commercialization of Alibornis Alpha or PRX-110 for the use in the treatment of any human respiratory disease or condition including but not limited to sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery. Turning to our balance sheet, we ended the quarter with $70.4 million in cash, which includes the proceeds from a public offering of our common stock in February, and Eyal will provide more details around our financial in a moment. We feel confident about our financial position and our ability to fund our development plans for the year. Before we turn to Eyal, I would like to recognize again what a challenging time has been for all of us, and emphasize to our team how proud I am of their focus and readiness. This has been a challenging week for us, for our local employees in Israel, and we wish for imminent peace and stability for all. I will now turn to Eyal for a review of our financials. Eyal, please.