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Protalix BioTherapeutics Issues 2021 Letter to Stockholders
Dear Protalix Stockholders,
As we look back and reflect on this past year, I am proud of our team and of the progress we have made in a time of continued Covid-19-related uncertainty across all corners of the globe. While the pandemic has added, and continues to add, many challenges that are out of our control, we remain resolute and focused on that which was within our control, including our operational, clinical and regulatory work. We continue to make progress on all fronts and firmly believe that we are on the right path forward towards meaningful, value-adding milestones and transformational catalysts.
I am pleased to briefly highlight some of our more notable milestones achieved in 2021.
Together with our development and commercialization partner,
In addition, we have made important progress in our pre-submission activities toward an anticipated Marketing Authorization Application (MAA) with the
The last patient in our Phase III BALANCE clinical trial, a 24-month, randomized, double blind, active control study of PRX-102 in Fabry patients with impaired renal function, received the final dose in
Earlier in the year, we announced positive topline results from our Phase III BRIGHT clinical trial, a 12-month, open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of PRX–102 via intravenous (IV) infusions of 2 mg/kg administered every 4 weeks in Fabry patients previously treated with a commercially available enzyme replacement therapy (ERT). Topline results of the BRIGHT study indicate that 2 mg/kg of PRX-102 administered by IV infusion every 4 weeks are well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients.
Corporate & Financial Developments
Earlier this fall, we strengthened our balance sheet through exchanges of a substantial majority of our outstanding 7.50% Senior Secured Convertible Notes due 2021 for a combination of cash and new notes. In brief, we issued new 7.50% Senior Secured Convertible Notes due 2024 with an aggregate of
We have much to be thankful for this year, including our progress towards our BLA resubmission in
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the timing and progress of the preparation of an updated BLA addressing the CRL for PRX–102; risks related to the timing, progress and likelihood of final approval by the FDA of a resubmitted BLA for PRX–102 and, if approved, whether PRX-102 will be commercially successful; the risk that the FDA, the EMA or other foreign regulatory authorities may not accept or approve a marketing application filed for PRX–102 or any of our other product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and or lack of sufficient funding to finance our clinical trials; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will have undesirable side effects or other unexpected characteristics; risks relating to our ability to make required payments under our outstanding convertible notes or any other indebtedness as they come due and our ability to obtain additional financing and raise capital as necessary should the regulatory approval process become more extended; risks associated with the COVID-19 outbreak and variants, which may adversely impact our business, preclinical studies and clinical trials; risks relating to our evaluation and pursuit of strategic alternatives; risks relating to our ability to manage our relationship with our collaborators, distributors or partners; risks relating to changes to interim, topline or preliminary data from clinical trials that we announce or publish; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug product to Pfizer; risks related to our expectations with respect to the potential commercial value of our product and product candidates; risks relating to the compliance by Fundação