Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to Protallix Biotherapeutics Fiscal Year 2020 Earnings Conference Call. As a reminder, this conference call is being recorded. I will now turn the conference over to our host, Mr. David Holmes of Lifesize Advisor Investor Relations. You may begin your conference, sir. Please proceed.

Thank you, operator. Welcome to Protallix Biotherapeutics Fiscal Year 2020 Financial Results and Business Update Conference Call. With me today are Dora Bichon, President and Chief Executive Officer of Portales, and E.L. Rubin, Chief Financial Officer. A press release announcing the results and the update was issued this morning and is available now on the Portales website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings released 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 statements made. Factors that could cause actual results to differ are described in the disclaimer and in Cortellix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Basham. Dror?

Thank you, David. and welcome everyone to the company's year end of 2020 financial results and business updates. During today's call, I will review the progress of our key clinical programs and lay out the roadmap of our upcoming strategic milestones. Following my remarks, our CFO, Jan Rubin, will review our financial results, and we will then open the line for questions. This year brought many challenges, including, of course, the unexpected global pandemic. However, we have achieved many significant accomplishments throughout all of these, and we have continued that positive momentum in the first part of 2021. Together with our development and commercialization part of PSE, we submitted to the U.S. FDA a BLA for PRX102 for the treatment of adult patients with fibroid disease, and we look forward for the FDA's response. We continue to build of the clinical profile for PRX102 with the release of key data from the Bridge and the Bright Phase III study. And we look forward to seeing the interim data from the balance study during the second quarter of this year. We further advanced our earlier stage pipeline of candidates produced for our Procellex, our property plant cell-based protein expression system. And earlier this year, we strengthened our balances through a public offering and through the sale of shares under our ATM program. Overall, I am very proud of our employees and our external partners for their unwavering commitment to advance our mission to bring differentiated therapeutics to the market to help address unmet medical needs. Please let me now provide some more details regarding our key achievements and upcoming anticipated milestones. Our lead pipeline candidate is Peggy Humigals, who does Alpha. or PRX102, which is a therapeutic protein candidate for the treatment of Fabry disease. Fabry is a rare genetic disease that occurs in one of every 40,000 people. And most experts agree that there are many undiagnosed patients suffering from this disease. The current therapeutic market for Fabry disease consists mainly of enzyme replacement therapies and is forecasted to be around $1.9 billion in 2021 and continue to grow at the cage of approximately 9.5%. As I mentioned earlier, the FDA accepted the BLA filing for PRX102 for the treatment of Fabry disease and granted the BLA priority review. The original PDUFA action date of January 27th of 2021 was subsequently adjusted by the FDA to April 27th, 2021. We and Chiesi have remained in active dialogue with the FDA And as indicated in the BLA filing communication letter last fall, the FDA does not plan to hold an advisory committee meeting to discuss the application. If indeed we receive an approval letter, Protalix and Casey will be ready for a commercial launch of PRX-102 later this year. We continue to build our clinical profile for 102. As a result, a release from our comprehensive phase three clinical program, which is composed of three studies. the BRIDGE, the BRIDE, and the BANAN studies. Last December, we released final results from the 12-month BRIDGE-FRED3 open-label single-arm switch-over trial of up to 22 Fabry patients who were previously treated with Agalcidas-alpha or Eclogal. The data shows substantial improvement in renal function as measured by mean annualized EGFR in both male and female patients who were switched from Agalcidas alfa to PEG-Unigalcidas alfa. The final results from the BRIDGE trial were presented in greater detail in the annual World Symposium this past February. Last month, we have announced positive top-line results from the BRIDE Phase III 12-month open-label switchover study designed to evaluate the safety, efficacy, and pharmacokinetics of PEG-Unigalcidas alfa, two milligram per kilogram administered every four weeks. for the treatment of Fabry disease in Fabry patients, previously treated with commercially available enzyme replacement therapy for at least three years, and on a stable dose administered every two weeks. Topline results indicate the two milligram per kilogram of PRX-102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients following the 12-month protocol period. This presents potential for an additional treatment regimen, one that is considerably more convenient for patients without compromising safety and efficacy. The lead study in our phase three program is a balanced trial, which is a 24-month trial evaluating the safety and efficacy of PEG-1-alpha, one milligram per kilogram dose, every two weeks, and assessing its effects in Fabry patients with declining renal function versus the current used enzyme replacement therapy, Fabrazyme. We expect to receive interim results from the trial in the next quarter, which would then serve as a basis for the European EMA filing. If these trial results are positive, there is a potential for a commercial launch in Europe in the late of 2022 or the first half of 2023. Turning to our early pipeline programs, we continue to work with CellComEd USA to develop Alidromis Alpha or PRX110, which is produced via our Procelec system 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 deliveries. We recently announced an exclusive partnership with Sarkomed USA to evaluate therapeutic candidates for these disease areas via in-health delivery. We look forward to continuing to develop this partnership, and we'll update you on our clinical plans. We are performing preclinical testing of PRX115, our plant cell express recombinant pegylated uricase, a chemically modified enzyme under development for the potential treatment of refractory gout. Gout is the most common inflammatory arthritis in the United States, affecting an estimated 9.2 million adults. An estimated approximately 2% of the gout population is thought to have chronic refractory disease. The uricase enzyme converts uric acids to elimination, which is easily eliminated through urine. However, the uricase enzyme does not exist naturally in the urine. We use prosthetics to express and optimize recombinant uricase enzyme under development for the potential treatment of refractory gout, which we are designing to have an improved half-life, reduce immunogenicity, and potentially longer-term efficacy. We have also began developing or developed of PRX119, or plant cell express pegylated recombinant human DNA1 product candidate, which we are designing to have an elongated half-life in the circulation for the potential treatment of NET-related diseases, NET, or neutrophil extracellular traps, a web-like structure released by activated neutrophils that trap and kill a variety of microorganisms. According to scientific literature, animal studies have demonstrated that DNAS1 treatment reduces net toxicity. Our property modified DNAS1 may potentially enable effective treatment of acute and chronic conditions. We are planning to commence Phase I clinical trials of both PRX115 and PRX119 throughout 2022. Turning to our balance sheet, we ended the year with $38.5 million in cash, cash equivalents, and short-term bank deposits, and we raised an additional approximately $40 million gross proceeds in public equity offering in the first quarter of 2021. We also raised $8.8 million through the sale of common stock under our ATM program during the first quarter of 2021. Eyal will provide more commentary regarding our cash flow plans, but I would like to add that we feel confident about our balance sheet and are appreciative of the support we have received from our existing and new added institutional stockholders. Before I turn it to Eyal, I just wish to recognize what a challenging time this was for all of us and restate how proud I am of our team for their focus and commitment We did not allow this global pandemic to have a material adverse effect on our operations. We are looking forward to an exciting year ahead of Portalix and all of our teammates and partners. Let me turn it to Eyal for a review of our financials. Thank you.