On November 7, 2019 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 its third quarter 2019 financial results and provided a corporate update (Press release, Protalix, NOV 7, 2019, View Source [SID1234550700]).
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"This has been a consequential quarter for Protalix during which we continued to make solid progress on our goals to move our Fabry program toward commercialization and to pursue strategic partnerships and alliances, and we commenced efforts to improve our capital structure," said Dror Bashan, Protalix’s President and Chief Executive Officer. "During the third quarter, we completed enrollment in our pivotal, head-to-head BALANCE study evaluating PRX‑102 compared to Fabrazyme. We also recently reported positive 12-month interim data from our switch-over Phase III BRIDGE study comparing PRX‑102 to another standard-of-care treatment, Replagal."
"With three, now fully enrolled Phase III clinical trials of PRX‑102, we have a robust and thorough clinical program for the treatment of Fabry disease," concluded Mr. Bashan. "Our management, scientific and clinical teams are all fully committed to bringing this important treatment to the Fabry patient community."
Third Quarter 2019 and Recent Clinical and Corporate Highlights
The Company, together with its development and collaboration partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced the completion of enrollment in the Phase III BALANCE clinical trial of PRX‑102 for the treatment of Fabry disease. The head-to-head Phase III BALANCE clinical study is designed to evaluate the safety and efficacy of PRX‑102 compared to agalsidase beta (Fabrazyme) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta. To date, more than 66 patients are being treated in the Company’s various extension studies after opting to continue treatment with PRX‑102 after completion of an original study.
The Company announced positive 12-month interim on-treatment data from the first 16 out of the 22 adult patients (9 males and 7 females) enrolled in the BRIDGE Phase III open label switch-over study of PRX‑102 for the treatment of Fabry disease. The interim data demonstrate a mean improvement in kidney function, in both male and female patients, when switched from agalsidase alfa (Replagal) to PRX‑102, and will help to support the expected U.S. Food and Drug Administration ("FDA") BLA filing under Accelerated Approval.
The Company and Chiesi plan the submission of a BLA for PRX‑102 via the FDA’s Accelerated Approval pathway based on data from the completed Phase I/II clinical trials of PRX‑102 and the ongoing Phase III BRIDGE clinical trial by April 2020.
Financial Results for the Nine Months Ended September 30, 2019
The Company recorded revenues from selling goods of $12.1 million during the nine-month period ended September 30, 2019, an increase of $4.9 million, or 67%, compared to revenues of $7.2 million for the same period of 2018. The increase is primarily due to higher sales of Elelyso in Brazil.
Research and development expenses, net, were $35.0 million for the nine months ended September 30, 2019, an increase of $11.3 million, or 47%, compared to $23.8 million for the same period of 2018. The increase resulted primarily from an increase of $8.5 million in clinical trial related costs as well as a decrease of $1.8 million in grants received from the Israeli Innovation Authority.
Selling, general and administrative expenses for the nine months ended September 30, 2019 were $6.9 million, a decrease of $1.9 million, or 21%, compared to $8.7 million for the same period in 2018. The decrease is primarily due to costs related to the Chiesi US Agreement we entered into in the third quarter of 2018, which were not incurred in the third quarter of 2019.
Net loss for the nine months ended September 30, 2019 was $18.6 million, or $0.13 per share, basic and diluted, compared to a net loss of $21.0 million, or $0.14 per share, basic and diluted, for the nine months ended September 30, 2018.
At September 30, 2019, the Company had $21.4 million in cash and cash equivalents.
The Company received a communication from NYSE American LLC stating that the Company is not in compliance with the continued listing standards as set forth in the NYSE American Company Guide as it has reported a stockholders’ equity deficiency as of June 30, 2019 and net losses in its five most recent fiscal years ended December 31, 2018. Subsequently, in accordance with the NYSE American Company Guide, the Company submitted to the NYSE American a plan to regain compliance with the continued listing standards.
The Company has engaged a first-tier financial advisory firm to assist in evaluating and pursuing strategic alternatives to maximize stakeholder value and address the foregoing.
As part of the Company’s efforts to advance its clinical development program and to realize future benefits of commercial success, the Company’s Board of Directors, along with the management team, has determined that it is in the Company’s best interest to seek to address to its capital structure.
Accordingly, the Company convened a Special Meeting of Stockholders to seek approval for the following:
– A reverse stock split at a ratio of not less than 1-for-10 and not greater than 1-for-20, with the exact ratio to be set within that range at the discretion of the Board of Directors before the day prior to the Special Meeting of Stockholders without further approval or authorization of the stockholders; and to reduce the total number of shares of the Company’s common stock that the Company is authorized to issue from 350 million to 120 million shares.
The Special Meeting of Stockholders of Protalix BioTherapeutics, Inc. to vote on the proposal will be held at 1:00 p.m., Israel time, on December 9, 2019 at the offices of the Company’s Israeli counsel, Horn & Co., Law Offices, Amot Investments Tower, 2 Weizmann Street, 24th Floor, Tel Aviv 6423902, Israel.
Conference Call and Webcast Information
The Company will host a conference call on Thursday, November 7, 2019, at 8:30 am, Eastern Standard Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:
Domestic (USA): 888-224-1005
International: 323-994-2093
Conference ID: 1931108
Webcast: http://bit.ly/2BSCaiY
The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.