On August 8, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the six-month period ended June 30, 2019 and provided a corporate update (Press release, Protalix, AUG 8, 2019, View Source;p=RssLanding&cat=news&id=2406197 [SID1234538438]).
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"We are very optimistic about our interactions with the U.S. Food and Drug Administration over the second quarter of 2019, which resulted in our decision to, together with our partner Chiesi Farmaceutici, begin preparing a biologics license application for pegunigalsidase alfa for the treatment of Fabry disease, which we expect to submit in the first quarter of 2020 through the FDA’s Accelerated Approval pathway," said Mr. Dror Bashan, Protalix’s President and Chief Executive Officer. "We are now focused on completing the anticipated filing."
Second Quarter 2019 and Recent Clinical and Corporate Highlights
The Company, together with its collaboration partner, Chiesi Farmaceutici S.p.A, or Chiesi, announced that, following a series of meetings and correspondence with the U.S. Food and Drug Administration (FDA), they plan to file a biologics license application (BLA) for pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease via the FDA’s Accelerated Approval pathway.
The Company and Chiesi have initiated preparations for the BLA submission based on data from the completed Phase I/II clinical trials of pegunigalsidase alfa and the ongoing Phase III BRIDGE clinical trial, and expect to hold a pre-BLA meeting with the FDA in the fourth quarter of 2019.
Enrollment completed in the Phase III BRIGHT clinical trial of pegunigalsidase alfa for the treatment of Fabry disease, via intravenous (IV) infusions of 2 mg/kg administered every 4 weeks.
To date, substantially all patients enrolled in the BRIGHT clinical trial remain on the 4‑week dosing regimen, and all of the patients that completed the study opted, with the advice of the treating physician, to continue treatment under the 4‑week dosing regimen in a long-term extension study.
The Company’s Phase III BALANCE clinical trial of pegunigalsidase alfa for the treatment of Fabry disease is currently 95% enrolled.
To date, more than 55 patients are being treated in the Company’s various extension studies after opting to continue treatment with pegunigalsidase alfa after completion of an initial study.
Results from the Company’s Phase I/II clinical trial of pegunigalsidase alfa were published in an article in the May 2019 edition of the Journal of Inherited Metabolic Disease.
Financial Results for the Six Months Ended June 30, 2019
The Company recorded total revenues of $22.7 million for the six-month period ended June 30, 2019, compared to $11.6 million for the same period of 2018. The increase is primary attributable to the recognition of $15.7 million of license revenues for the six-month period ended June 30, 2019 compared to the recognition of $5.0 million in the same period of 2018.
Research and development expenses, net were $25.0 million for the six months ended June 30, 2019, compared to $13.7 million for the same period in 2018. The increase is mainly due to advancement of the Phase III studies in PRX-102.
Selling, general and administrative expenses for the six months ended June 30, 2019 were $4.3 million, compared to $4.7 million for the same period in 2018.
Net loss for the six months ended June 30, 2019 was $15.0 million, or $0.10 per share, basic and diluted, compared to a net loss of $15.7 million, or $0.11 per share, basic and diluted, for the six months ended June 30, 2018.
On June 30, 2019, the Company had $25.1 million of cash and cash equivalents.
If the BLA submitted for pegunigalsidase alfa is approved by the FDA, the Company will be entitled to a milestone payment, which is currently expected to be payable around the fourth quarter of 2020 or first quarter of 2021.
Based on the Company’s current cash resources and commitments, the Company believes it may not be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months from the date of approval of the financial statements as of June 30, 2019 in the absence of a refinancing or restructuring of its existing obligations. These factors raise substantial doubt as to the Company’s ability to continue as a going concern. Additional information will be included in Note 1(a) and other parts of the Company’s Quarterly Report on Form 10-Q which will be filed the day of the earnings call. The Company is evaluating various financing alternatives and related transactions.
The Company’s management is in the process of evaluating refinancing and restructuring alternatives, including a restructuring of its outstanding convertible notes, and related transactions. However, there is no certainty about the Company’s ability to obtain such funding.
Conference Call and Webcast Information
The Company will host a conference call on Thursday, August 8, 2019, at 8:30 am ET 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: United States: +1 (844) 358-6760; International: +1 (478) 219-0004. Conference ID number 1497319.
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.