On May 16, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the first quarter ended March 31, 2022 and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAY 16, 2022, View Source [SID1234614708]).

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"We are proud of the great progress Protalix has made throughout the first quarter in advancing our Fabry disease candidate PRX-102," said Dror Bashan, Protalix’s President and Chief Executive Officer. "The announcement of compelling results from both the BRIGHT and BALANCE phase III trials marks a significant milestone, as we have now completed three phase III studies supporting the planned BLA resubmission to the U.S. Food and Drug Administration later this year. As we work toward potential approval and commercialization, we remain focused on our mission of bringing this important treatment option to patients with Fabry disease, while continuing to advance our early stage pipeline. We are grateful for the unwavering dedication of Chiesi Farmaceutici S.p.A, or Chiesi, our development and commercialization partner, and our other external partners and team members and look forward to building on our momentum throughout the rest of 2022."

2022 First Quarter and Recent Business Highlights

Regulatory Advancements

●As previously announced, on February 24, 2022, the Company, together with Chiesi, announced the submission and subsequent validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for PRX-102 for the treatment of adults with Fabry disease. The MAA included final data from the Company’s phase III BRIDGE clinical trial (1 mg/kg every other week) and the phase III BRIGHT clinical trial (2 mg/kg every four weeks); 12-month interim data from the Company’s phase III BALANCE clinical trial (1 mg/kg every other week); and final data from the Company’s phase I/II clinical trial data from naïve/untreated patients, including the extension study related thereto (1 mg/kg every other week).
Clinical Advancements

●On April 4, 2022, the Company, together with Chiesi, announced positive top-line results from its phase III BALANCE clinical trial, a 24-month, randomized, double-blind, active control study designed to evaluate the efficacy and safety of 1 mg/kg of PRX-102 administered every other week compared to agalsidase beta in patients previously treated with agalsidase beta for at least one year. The study met its primary endpoint and demonstrated that PRX-102 was statistically non-inferior to agalsidase beta, as measured by estimated glomerular filtration rate (eGFR) slope. In addition,
results showed a favorable tolerability profile for PRX-102, consistent with results from the Company’s prior trials.
●On March 18, 2022, the Company, together with Chiesi, announced positive final results from its phase III BRIGHT clinical trial, a multicenter, multinational open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of treatment with 2 mg/kg of PRX-102 administered every four weeks for 52 weeks (a total of 14 infusions) in adult patients previously treated with a commercially available enzyme replacement therapy (ERT) (Fabrazyme or Replagal). Results of the BRIGHT study indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was well tolerated, and Fabry disease assessed by eGFR slope and plasma lyso-Gb3 was stable throughout PRX-102 treatment in adult Fabry patients.
First Quarter 2022 Financial Highlights

●The Company recorded revenues from selling goods of $9.0 million for the three months ended March 31, 2022, an increase of $4.5 million, or 100%, compared to revenues of $4.5 million for the same period of 2021. The increase of $5.4 million in sales to Brazil, resulting from timing differences, was partially offset by a decrease of $1.1 million in sales to Pfizer Inc.
●Revenue from licenses and R&D services for the three months ended March 31, 2022 were $7.1 million, compared to $6.8 million for the same period in 2021. Revenue from license and R&D services are recognized, mainly, in connection with the Company’s license and supply agreements with Chiesi.
●Cost of goods sold for the three months ended March 31, 2022 was $6.0 million, an increase of $1.2 million, or 25%, compared to cost of goods sold of $4.8 million for the same period in 2021. The increase in cost of goods sold was primarily the result of higher sales.
●Research and development expenses, for the three months ended March 31, 2022 were $8.8 million, an increase of $1.7 million, or 24%, compared to $7.1 million for the same period in 2021. The increase is primarily the result of subcontractors costs related to the completion of our phase III clinical trials of PRX-102 and maintaining our related extension studies.
●Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2022, an increase of $0.1 million, or 3% from $3.1 million for the same period in 2021.
●Financial expenses, net were $0.4 million for the three months ended March 31, 2022, a decrease of $1.4 million, or 78%, compared to $1.8 million for the same period in 2021. The decrease resulted primarily from lower interest and debt amortization costs due to a decrease in our outstanding notes from an aggregate principal amount of $57.92 million 2021 Notes to an aggregate principal amount of $28.75 million 2024 Notes.
●Cash, cash equivalents and short-term bank deposits were approximately $32.9 million at March 31, 2022.
●Net loss for the three months ended March 31, 2022 was approximately $2.3 million, or $0.05 per share, basic and diluted, compared to a net loss of approximately $5.5 million, or $0.14 per share, basic and diluted, for the same period in 2021.
Conference Call and Webcast Information

The Company will host a conference call today, May 16, 2022, at 8:30 a.m. Eastern Daylight Time, to review the corporate and clinical developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.