tulinercept (OPRX-106) / Protalix - LARVOL DELTA

Novel Orally Administered Recombinant Anti-TNF Alpha Fusion Protein for the Treatment of Ulcerative Colitis: Results From a Phase 2a Clinical Trial. (PubMed, J Clin Gastroenterol) - "Oral administration of the nonabsorbable OPRX-106 is safe and effective in mild-to-moderate UC, and not associated with immune suppression, while inducing favorable anti-inflammatory immune modulation."

Clinical • Journal • P2a data • Gastroenterology • Immune Modulation • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • FOXP3 • IFNG • IL2RA • IL6

Oral administration of a recombinant anti-TNF fusion protein is biologically active in the gut promoting regulatory T-cells and Is a novel anti-TNF alpha-based therapy for inflammatory bowel diseases: results of a phase I clinical trial (DDW 2016) - P1, N=14; "Oral administration of the non-absorbable PRX-106 is safe, not associated with immune suppression, while inducing a favorable anti-inflammatory immune modulation. PRX-106 may provide an oral, safer, and effective anti-TNF alpha-based immune therapy for inflammatory bowel diseases and non-alcoholic steatohepatitis."

P1 data • Biosimilar • Inflammatory Bowel Disease

Protalix announces data on oral antiTNF to be presented at Digestive Disease Week 2014 meeting (GlobeNewswire) - "Protalix BioTherapeutics...announced today that preclinical data on oral antiTNF (PRX-106) was accepted for presentation at the Digestive Disease Week (DDW) Annual Meeting...In preclinical studies, oral PRX-106 alleviated immune-mediated hepatic symptoms and reduced interferon gamma levels in a concanavalin A (ConA) inflammatory mouse model....The Company expects to initiate clinical trials as part of the oral PRX-106 development program during the next few months."

Anticipated conference • Anticipated new trial • Anticipated preclinical • Biosimilar • Inflammatory Bowel Disease

Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Protalix; Not yet recruiting ➔ Recruiting; Initiation date: Jun 2016 ➔ Sep 2016

Enrollment open • Trial initiation date • Biosimilar • Inflammatory Bowel Disease

Protalix: Rodman & Renshaw Global Investment Conference (Rodman and Renshaw 18th Annual Global Investment Conference 2016, Protalix) - Anticipated initiation of P2 trial (NCT02768974) in mild to moderate ulcerative colitis by Q3 2017; Anticipated results from P2 trial in ulcerative colitis by Q3 2017

Anticipated P2 data • Anticipated trial initiation date • Biosimilar

Protalix: Rodman & Renshaw Global Investment Conference (Rodman and Renshaw 18th Annual Global Investment Conference 2016, Protalix) - Anticipated initiation of P2 trial (NCT02768974) in mild to moderate ulcerative colitis by Q3 2017; Anticipated results from P2 trial in ulcerative colitis by Q3 2017

Anticipated P2 data • Anticipated trial initiation date • Biosimilar

OPRX-106:“Oral administration using OPRX-106 was effective, safe and well tolerated” (Protalix) - DDW 2018: "OPRX-106 was effective as demonstrated by clinical response and improvement in various disease parameters and not associated with immune suppression"

P2a data • Biosimilar

Protalix: Corporate Presentation (Protalix) - Anticipated initiation of P1 trial for treatment of autoimmune diseases in 2014

Anticipated new P1 trial • Anticipated trial initiation date • Biosimilar

Protalix: Q3 FY 2015 Results (Protalix) - Anticipated initiation of proof-of-concept study in inflammatory bowel disease in Q1 2016

Anticipated new trial • Biosimilar

Protalix: Corporate Presentation (Protalix) - "OPRX 106 Phase I – Results"; "Safety: OPRX-106 was safe and well tolerated"; “Immunomodulation: Regulatory T cell activation showed biological activity in the gut CD4/CD25, CD4/Foxp3/CD25, CD8/CD25, CD8/Foxp3/CD25), Alteration of systemic immune system without significant systemic absorption"; "Serum cytokine levels remained stable"

P1 data • Biosimilar

OPRX-106: Expiry of patents related to TNF alpha inhibitor polypeptides and use of plant cells expressing a TNF alpha polypeptide inhibitor in China, Brazil, Canada, US, Australia, Japan, Europe and Israel in 2034 (Protalix) - Annual Report 2019

Patent

OPRX-106: Expiry of patent related to composition-of-matter and method of use in 2034 (Protalix) - Corporate Presentation

Patent

OPRX-106: Expiry of patents related to plant recombinant TNF alpha inhibitor polypeptides in Japan, Australia and US in 2034/2035 (Protalix) - Annual Report 2018: Expiry of patents related to use of plant cells expressing a TNF alpha polypeptide inhibitor in Europe, US and Australia in 2034; Expiry of patent in US covering oral composition comprising a TNF antagonist in 2034

Patent

Protalix Biotherapeutics (PLX) given a $4.00 price target at HC Wainwright (Dispatch Tribunal) - "Our model yields an rNPV of $280M for PRX-102 using a 15% discount rate and 75% probability of approval, accounting for the receipt of royalties on PRX-102 sales globally. We also ascribe an rNPV of $230M to alidornase alfa, a $100M rNPV for $50M rNPV for OPRX-106, translating into a price per share of $4.00. This assumes 149M shares outstanding as of end-2019."

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