Protalix BioTherapeutics Inc. (NYSEAMERICAN: PLX) has announced Q3 2021 financial results and offered an update on the latest clinical, regulatory and corporate developments.
Updates on Fabry Disease treatment
The company and its marketing partner Chiesi Farmaceutici S.p.A. offered a regulatory update in PRX-102, including FDA minutes in Type A meeting and CRL for the BLA for PRX-102 in Fabry disease treatment. The company will resubmit the BLA in 2H 2022.
CEO Dror Bashan said, “We are pleased with the progress we have made over the past few weeks with respect to the regulatory path forward with PRX-102 for the treatment of Fabry disease with both the U.S. Food and Drug Administration and the European Medicines Agency. Following our Type A meeting with the FDA, we believe there is now an established pathway to resubmit the PRX-102 BLA. We remain focused on our mission to bring to the market another important potential alternative treatment for all adult Fabry patients.”
Protalix reported revenue of $4.5 million
The company reported revenue of $4.5 million from selling goods during the quarter representing a 36% YoY increase. License and R&D services revenues were $7.5 million, mainly from license and supply agreements revenue with Chiesi. The company reported a net loss of $4.2 million or $0.09 per diluted and basic share. Protalix ended the quarter with $48.7 million in cash, equivalents, and near-term bank deposits.
On August 25, 2021, Portalix completed exchanges of a significant majority of its 7.50% Senior Secured Convertible Notes due 2021. The company exchanged an aggregate of $54.65 million pf the 2021 Notes for the principal amount of $28.75 million in newly issued 7.5% Notes due 2024, cash of $25.9 million, and $1.1 million in cash for unpaid and accrued interest.
Bashan commented, “Following the note exchange agreement we completed in August, we now have additional financial flexibility and sufficient capital to fund our operations through important milestones in 2022. We are committed to executing our strategy and are looking forward to converting the momentum of the last quarter into a successful 2022.”