2020 Developments
●On December 30, 2020, we, together with Chiesi, announced final study results from the BRIDGE study.
●On October 2, 2020, we, together with Chiesi, announced the launch of an Expanded Access Program (EAP) in the United States for pegunigalsidase alfa for the proposed treatment of Fabry disease.
●On October 1, 2020, we entered into an ATM Equity OfferingSM Sales Agreement, or the Sales Agreement, with BofA Securities, Inc., or the Agent. Pursuant to the terms of the Sales Agreement, we may sell from time to time through the Agent shares of our common stock having an aggregate offering price of up to $30 million, or the ATM program. We intend to use the net proceeds from the offering, after deducting the Agent’s commissions and our offering expenses, for general corporate purposes.
●On September 3, 2020, we received notification from the NYSE American LLC, or the NYSE American, that we had regained compliance with all of the continued listing standards set forth in Part 10 of the NYSE American Company Guide.
●On August 24, 2020, we, together with Chiesi, announced completion of the treatment period of our BRIGHT study for the proposed treatment of Fabry disease.
●On August 11, 2020, we, together with Chiesi, announced that the FDA had accepted the BLA for PRX-102, and granted Priority Review designation for PRX-102, for the proposed treatment of adult patients with Fabry disease. The FDA indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDA set a PDUFA action date of January 27, 2021. However, as we previously announced in November 2020, the FDA subsequently extended the PDUFA action date to April 27, 2021. As we disclosed last year, the FDA advised us that it will have to inspect our manufacturing facility and the facility of a third party in Europe that performs fill and finish processes for PRX-102 as part of its review of the BLA to ensure cGMP compliance. Due to COVID-19-related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA action date. We, together with Chiesi, are addressing this issue.
●On June 8, 2020, we announced the promotion of Einat Brill Almon, Ph.D. to Sr. Vice President and Chief Development Officer. Dr. Almon first joined Protalix Ltd. in December 2004, originally as a Senior Director and later as Vice President, and became our Senior Vice President, Product Development in 2006.
●On June 8, 2020, we announced the appointment of Yael Hayon, Ph.D. to serve as our new Vice President, Research and Development, effective July 5, 2020. Yoseph Shaaltiel, Ph.D. retired from his position as our Executive Vice President, Research and Development, effective June 15, 2020.
●On May 28, 2020, we, together with Chiesi, announced the submission on May 27, 2020 of a BLA to the FDA for pegunigalsidase alfa for the treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway.
●On May 11, 2020, we announced positive topline results from our BRIDGE study.
●On March 18, 2020, we completed a private placement to certain existing and new institutional and other accredited investors, or the Purchasers, in reliance on the exemption from registration set forth in Section 4(a)(2) of the Securities Act. We sold approximately 17.6 million shares of our common stock to the Purchasers at a price per share of $2.485, or aggregate net committed proceeds equal to approximately $41.3 million. Each share of our common stock issuable in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.
●On March 16, 2020, we announced that we have agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx®. Kirin