Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protalyx Biotherapeutics Second Quarter 2021 Financial Results and Business Update conference call. As a reminder, this conference is being recorded. I will now turn the conference over to your host, Mr. David Holmes of LifeSci Advisors, Investor Relations, or Protalyx. You may begin your conference.

Thank you, Joe. Welcome to the Protalyx Second Quarter 2021 Financial Results and Business Update conference call. With me today are Dror Bishan, President and CEO of ProTalex, and Eyal Rubin, Chief Financial Officer. A press release announcing the results and the update was issued this morning and is now available on the ProTalex 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 those statements made. Factors that could cause actual results to differ are described in the disclaimer and in the ProTalex filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

Thank you, David, and welcome everyone to the company's second quarter 2021 financial results, and financial and business update. 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. I would like first to discuss our balance sheet. We ended the quarter with approximately $77 million in cash. As we announced on Friday, on August 12, 2021, we entered into a definitive exchange agreement relating to the exchange of $54.65 million, principal amount of our outstanding 7.5% senior secure convertible notes due 2021. for $28.75 million principal amount of newly issued 7.5% senior secure convertible notes due 2024, $25.9 million in cash and accrued and unpaid interest through the closing date. We plan to close these exchanges as soon as practicable, subject to satisfaction of certain closing conditions. At closing, we will have reduced our debt by $25.8 million and effectively extended the maturity for substantially all of the remaining debt from 2021 until 2024. This extension of the maturity date of the notes allows us to use our cash resources to continue and realize the PRX-102 potential and advance our early stage pipeline. We feel confident about our ability to continue to fund our clinical programs as well as to prepare for potential commercial launch of PRX102. We recently announced that we have submitted a Type A meeting request to the FDA to discuss the complete response letter dated April 27, 2021, regarding the BLA for PRX102 for the proposed treatment of adult patients with Fabry disease. The FDA has scheduled a Type A meeting for September 9, 2021. Our objective for the meeting will be to address the issues raised in the CRL and work with the FDA on a plan for resubmission. We are confident in the overall clinical profile of PRX102 that we have assembled through our extensive development program and believe PRX102 has the potential to provide important value to the Fabry patient community. We plan to update you regarding the new development as soon as feasible. During the quarter, we continued to build our clinical profile for PRX102 with the release of the top-line interim results of our Phase III balanced clinical trial of PRX102 for the proposed treatment for Fabry disease. Based on the interim analysis of the 12-month data generated from the balanced study and in combination with previously reported positive data from the Phase III bright and rich clinical trials of PRX102, Portalix and Chiesi intend, subject to positive meeting with the EMEA Rapporteur, a representative of the EU regulatory authorities, to submit a marketing authorization application to the European Medicine Agency by the first quarter of 2022, and this would position us to potentially have a commercial launch in Europe in the first half of 2023. Two first-stage, early-stage pipeline programs are PRX-115, a planned cell-expressed recombinant pegylated vaccine uricase chemically modified enzyme to treat refractory gout, and PRX119, which is a long-acting DNA for NETS-related diseases. We plan to initiate toxicity studies for PRX115 in the first quarter of 2022, and we are looking forward to updating you on these programs as they progress. Before we turn to Eyal, I would like to recognize what a challenging time has been for all of us. and emphasize how much I appreciate our team and their focus and dedication to our mission of bringing important new medicines to the market for patients with high unmet clinical needs. I will now turn to Eyal for a review of our financials. Eyal, please go ahead.