On August 9, 2018 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, 2018 and provided a corporate update (Press release, Protalix, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363036 [SID1234528668]).

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"This has been a fantastic quarter for the company highlighted by the expansion of our partnership with Chiesi that resulted from the strong relationship developed over the past months," commented Moshe Manor, Protalix’s President and Chief Executive Officer. "Additionally, we believe that the recent draft guidelines from the U.S. Food and Drug Administration, or the FDA, released in July regarding enzyme replacement therapies could significantly benefit the regulatory path forward for PRX-102."

2018 Second Quarter and Recent Clinical Highlights

Expanded partnership with Chiesi Farmaceutici S.p.A., or Chiesi, to include exclusive U.S. rights for the development and commercialization of PRX-102. Terms of the agreement include an up-front payment of $25 million, up to $20 million in development costs, up to $760 million, in the aggregate, in regulatory and commercial milestone payments and tiered royalties ranging from 15 to 40%.
In July, the FDA issued a draft guideline "Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies". The draft guideline recognizes the challenges in achieving clinical evidence in rare, slow progressing diseases and provides additional preclinical and clinical results that may be acceptable to the FDA in its consideration for accelerated approval. The Company is reviewing the draft guidelines to determine how they might apply to the Company’s Fabry clinical development program.
With the additional cash from Chiesi, the Company is funded through read-outs of all clinical trials of PRX-102.
Presented data at the Digestive Disease Week (DDW) 2018 Annual Meeting on OPRX-106, which showed mucosal improvement in 61% of patients, mucosal healing in 33% of patients and clinical responses in 67% of patients.
Exchanged 4.50% convertible notes for a combination of shares and cash, and effectively discharged the remainder of the 4.50% notes.
Financial Results for the Six Months ended June 30, 2018

The Company reported a net loss of $20.7 million, or $0.14 per share, basic and diluted for the six-month period ended June 30, 2018 compared to a net loss of $20.6 million, or $0.16 per share, basic and diluted, excluding a one-time, non-cash net charge of $38.1 million in connection with the remeasurement of a derivative, for the same period of 2017.
The Company recorded total revenues of $6.6 million for the six-month period ended June 30, 2018, compared to $9.2 million for the same period of 2017. The decrease is attributed mainly to lower sales of drug substance to Pfizer Inc. and of alfataliglicerase in Brazil.
Research and development expenses were $14.8 million for the six-month period ended June 30, 2018, compared to $15.3 million for the same period of 2017. Chiesi’s participation in the clinical trials of PRX-102 for the treatment of Fabry disease in the amount of $5.0 million was recorded as deferred revenues and not as a deduction from the research and development expenses.
Selling, general and administrative expenses were $4.7 million for the six-month period ended June 30, 2018 compared to $5.4 million for the same period of 2017.
As of June 30, 2018, the Company had $28.3 million of cash and cash equivalents.
Pro forma cash balance for June 30, 2018 to include the upfront from the exclusive license signed with Chiesi for the rights to PRX-102 in the United States is $53.3 million.
Conference Call and Webcast Information

The Company will host a conference call on Thursday, August 9, 2018, 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 9488046.

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.