Protalix BioTherapeutics Studies Second Quarter 2022 Monetary and Enterprise Outcomes

Firm to host convention name and webcast immediately at 8:30 a.m. EDT

CARMIEL, Israel, Aug. 15, 2022 /PRNewswire/ — Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical firm targeted on the event, manufacturing and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx^® plant cell-based protein expression system, immediately reported monetary outcomes for the second quarter ended June 30, 2022 and offered a enterprise replace on current company and regulatory developments.

“Optimistic topline outcomes from our section III BALANCE medical trial of PRX-102 for the remedy of grownup sufferers with Fabry illness had been introduced final April. The medical research report (CSR) for the trial is now full,” mentioned Dror Bashan, Protalix’s President and Chief Govt Officer. “The ultimate evaluation of the BALANCE research, which was designed to judge the efficacy and security of 1 mg/kg of PRX–102 administered each different week in comparison with agalsidase beta in sufferers beforehand handled with agalsidase beta, confirms the constructive topline outcomes and favorable tolerability profile. The outcomes from the BALANCE research spotlight our confidence that PRX–102 has the potential to change into an necessary remedy choice for sufferers with Fabry illness. We’re excited to maneuver nearer to potential approval of PRX–102 and business launch, and thank our group members and exterior companions for his or her continued assist.”

2022 Second Quarter and Current Enterprise Highlights

Company Developments

• On June 30, 2022, the Firm introduced the appointment of Shmuel “Muli” Ben Zvi, Ph.D. to the Board of Administrators. Dr. Ben Zvi is serving as the brand new Chairman of the Audit Committee and as a member of the Compensation Committee.

Second Quarter 2022 Monetary Highlights

• The Firm recorded revenues from promoting items of $3.Four million for the three months ended June 30, 2022, a rise of $0.2 million, or 6%, in comparison with revenues of $3.2 million for a similar interval of 2021.
• Income from licenses and R&D companies for the three months ended June 30, 2022 had been $5.Four million, a rise of $2.2 million, or 69%, in comparison with $3.2 million for a similar interval in 2021. Revenues from license and R&D companies are comprised primarily of revenues acknowledged in reference to the Chiesi Agreements.
• Price of products bought for the three months ended June 30, 2022 was $4.1 million, a lower of $0.6 million, or 13%, in comparison with value of products bought of $4.7 million for a similar interval in 2021. The lower in value of products bought was primarily the results of decreased manufacturing prices resulting from increased yields and decrease wastage.
• Analysis and growth bills for the three months ended June 30, 2022 had been $7.6 million, a lower of $0.1 million, or 1%, in comparison with $7.7 million for a similar interval in 2021.
• Promoting, common and administrative bills had been $2.6 million for the three months ended June 30, 2022, a lower of $0.6 million, or 19%, in comparison with $3.2 million for a similar interval in 2021. The lower resulted primarily from a lower in wage associated and promoting prices.
• Monetary earnings, web had been $0.2 million for the three months ended June 30, 2022, in comparison with monetary bills, web of $2.1 million for a similar interval in 2021. The lower resulted primarily from decrease curiosity and debt amortization prices resulting from a lower within the Firm’s excellent notes from an mixture principal quantity of $57.92 million of 2021 Notes to an mixture principal quantity of $28.75 million of 2024 Notes, and a rise within the change fee of New Israeli Shekels for U.S. {Dollars} over the interval.
• Money, money equivalents and short-term financial institution deposits had been roughly $28.6 million at June 30, 2022.
• Internet loss for the three months ended June 30, 2022 was roughly $5.Three million, or $0.11 per share, fundamental and diluted, in comparison with a web lack of $11.2 million, or $0.25 per share, fundamental and diluted, for a similar interval in 2021.

Convention Name and Webcast Info

The Firm will host a convention name immediately, August 15, 2022, at 8:30 a.m. Japanese Daylight Time, to evaluate the company and medical developments, which can even be out there by webcast. To take part within the convention name, please dial the next numbers previous to the beginning of the decision:

Convention Name Particulars:

Monday, August 15, 2022, 8:30 a.m. Japanese Daylight Financial savings Time (EDT)

Home:              877-423-9813
Worldwide:         201-689-8573
Convention ID:     13732027

Webcast Particulars:

The convention can be webcast reside from the Firm’s web site and can be out there by way of the next hyperlinks:

Firm Hyperlink:     https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Hyperlink:       Registration – https://tinyurl.com/44z7w7ex 
Convention ID:     13732027

Please entry the web sites at the very least 15 minutes forward of the convention to register, obtain and set up any mandatory audio software program.

The convention name can be out there for replay for 2 weeks on the Occasions Calendar of the Traders part of the Firm’s web site, on the above hyperlink.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical firm targeted on the event and commercialization of recombinant therapeutic proteins expressed by means of its proprietary plant cell-based expression system, ProCellEx. Protalix was the primary firm to realize U.S. Meals and Drug Administration (FDA) approval of a protein produced by means of plant cell-based in suspension expression system. Protalix’s distinctive expression system represents a brand new methodology for creating recombinant proteins in an industrial-scale method.

Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was permitted by the FDA in Might 2012 and, subsequently, by the regulatory authorities of different international locations. Protalix has licensed to Pfizer Inc. the worldwide growth and commercialization rights for taliglucerase alfa, excluding Brazil, the place Protalix retains full rights.

Protalix’s growth pipeline consists of proprietary variations of recombinant therapeutic proteins that focus on established pharmaceutical markets, together with the next product candidates: pegunigalsidase alfa, a modified stabilized model of the recombinant human α–Galactosidase–A protein for the remedy of Fabry illness; alidornase alfa or PRX–110, for the remedy of varied human respiratory illnesses or circumstances; PRX–115, a plant cell-expressed recombinant PEGylated uricase for the remedy of extreme gout; PRX–119, a plant cell-expressed lengthy motion DNase I for the remedy of NETs-related illnesses; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., each in the US and out of doors the US, for the event and commercialization of pegunigalsidase alfa.

Ahead-Wanting Statements

To the extent that statements on this press launch aren’t strictly historic, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Personal Securities Litigation Reform Act of 1995. The phrases “count on,” “anticipate,” “consider,” “estimate,” “undertaking,” “might,” “plan,” “will,” “would,” “ought to” and “intend,” and different phrases or phrases of comparable import are meant to establish forward-looking statements. These forward-looking statements are topic to identified and unknown dangers and uncertainties that will trigger precise future expertise and outcomes to vary materially from the statements made. These statements are primarily based on our present beliefs and expectations as to such future outcomes. Drug discovery and growth contain a excessive diploma of threat and the ultimate outcomes of a medical trial could also be completely different than the preliminary findings for the medical trial. Components which may trigger materials variations embody, amongst others: dangers associated to the timing and progress of the preparation of a Biologics License Software (BLA) resubmission addressing the whole response letter; dangers associated to the timing, progress and chance of ultimate approval by the FDA and European Medicines Company (EMA) of a resubmitted BLA and of a Advertising and marketing Authorization Software, respectively, for PRX–102 and, if permitted, whether or not using PRX–102 can be commercially profitable; chance that the FDA, EMA or different relevant well being regulatory authorities will approve another dosing routine;  failure or delay within the graduation or completion of our preclinical research and medical trials, which can be attributable to a number of components, together with: slower than anticipated charges of affected person recruitment; unexpected questions of safety; willpower of dosing points; lack of effectiveness throughout medical trials; incapacity to satisfactorily display non-inferiority to permitted therapies; incapacity or unwillingness of medical investigators and institutional evaluate boards to comply with our medical protocols; and incapacity to observe sufferers adequately throughout or after remedy; the chance that the FDA, EMA, or different international regulatory authorities might not settle for or approve a advertising software we file for any of our product candidates, and different dangers regarding the evaluate course of; dangers related to the novel coronavirus illness, or COVID–19, outbreak and variants, which can adversely affect our enterprise, preclinical research and medical trials; dangers associated to any transactions we might impact within the public or personal fairness markets to lift capital to finance future analysis and growth actions, common and administrative bills and dealing capital; the chance that the outcomes of the medical trials of our product candidates won’t assist the relevant claims of security or efficacy, or that our product candidates won’t have the specified results or can be related to undesirable unwanted effects or different sudden traits; dangers associated to our capability to take care of and handle our relationship with our collaborators, distributors or companions; dangers associated to the quantity and sufficiency of our money and money equivalents; dangers regarding our capability to make scheduled funds of the principal of, to pay curiosity on or to refinance our excellent notes or every other indebtedness; dangers regarding modifications to interim, topline or preliminary knowledge from medical trials that we announce or publish; threat of serious lawsuits, together with stockholder litigation, which is widespread within the life sciences sector; our dependence on efficiency by third get together suppliers of companies and provides, together with with out limitation, medical trial companies; delays in our preparation and submitting of purposes for regulatory approval; the inherent dangers and uncertainties in creating drug platforms and merchandise of the sort we’re creating; the affect of growth of competing therapies and/or applied sciences by different firms and establishments; potential product legal responsibility dangers, and dangers of securing enough ranges of product legal responsibility and different mandatory insurance coverage protection; dangers associated to our expectations with respect to the potential business worth of our product and product candidates; and different components described in our filings with the U.S. Securities and Change Fee. The statements on this press launch are legitimate solely as of the date hereof and we disclaim any obligation to replace this data, besides as could also be required by legislation. The statements on this press launch are legitimate solely as of the date hereof and we disclaim any obligation to replace this data, besides as could also be required by legislation.

Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
[email protected]

SOURCE Protalix BioTherapeutics, Inc.