Epodure (recombinant human erythropoietin) / Avalo Therap - LARVOL DELTA

Medgenics looks to accelerate gene therapy platform after transition year (Proactive Investors) - “…the company had two aims for 2014 - firstly to begin the Phase 1/2 EPODURE trial for human proof-of-concept of the Biopump platform with the second-generation viral vector and protocol, and to replicate the mouse results in humans.”

Anticipated new P1/2 trial • Biosimilar

Medgenics announces beta thalassemia research program (Medgenics Press Release) - "Medgenics...today announced the initiation of a research program to evaluate the use of ^TARGTEPO^TM alone or in combination with iron restriction to ameliorate erythropoiesis in Beta Thalassemia Intermedia (non-transfusion dependent thalassemia or NTDT) and Beta Thalassemia Major (transfusion dependent thalassemia or TDT)...^TARGTEPO will be utilized, in combination with an iron reducing approach, in a preclinical mouse model of beta-thalassemia to assess (1) improvement in anemia in NTDT, (2) reduction in the need for blood transfusions in TDT, and (3) the ability to reduce or potentially prevent or reverse iron overload in both NTDT and TDT."

Preclinical • Biosimilar

TARGTEPO Treatment for Anemia in CKD and ESRD (clinicaltrials.gov) - P1/2; N=10; Completed; Sponsor: Aevi Genomic Medicine; Active, not recruiting ➔ Completed; Trial primary completion date: Mar 2017 ➔ Jun 2016

Trial completion • Trial primary completion date • Biosimilar • Chronic Kidney Disease • Hematological Malignancies • Renal Disease

Medgenics: ASGCT 2015 (Medgenics) - “TARGT procedures are well tolerated and good safety has been observed thus far with TARGT_EPO”; “Average duration of eEPO secretion at the low dose cohort is current at 4.75 months (patients are still in an ongoing follow-up with functioning TARGTs hence duration of effect continue to increase) from a single implantation with 3 out of 6 patient at or above 5 months”

P1/2 data • Biosimilar

Medgenics: EHA 2015 (Medgenics) - “A total of 9 patients have been implanted. 7 out 8 evaluable patients demonstrated a good initial response with reticulocytosis and adequate Hb”; “Thus far, 5/6 patients in the low dose cohort had 5 or more months of TARGT_EPO secretion with stable Hb response”

P1/2 data • Biosimilar

Medgenics: ESGCT Presentation (Medgenics) - "MG-EP-RF-02 Key data"; "10 patients implanted (6 low dose, 4 mid dose)- data available for 9"; "Age range: 26yr-76yr average: 59yr"; "7 male, 3 Female"; "Low dose: 5/6 at or above 5 months"; "One patient at 14 months post implantation"; "As of Aug 31: Average duration in low dose: 6.8 months"; "As of Aug 31: 5/10 overall patients in the study are still ongoing"; "One patient in the mid dose cohort had to undergo phlebotomy 3 times d/t Hb exceeding 13"

P1/2 data • Biosimilar

Medgenics: ESGCT Presentation (Medgenics) - "MG-EP-RF-03/04 summary patients results: Low Dose"

P2 data • Biosimilar

Medgenics: Q4 2014 Results (Medgenics) - Anticipated IND filing for renal failure in Q1 2015; Anticipated initiation of P2 study in renal anemia transplant patients undergoing peritoneal dialysis in Q1 2015; Anticipated pre-IMPD meeting for beta thalassemia intermedia in H2 2015  

Anticipated FDA event • Anticipated IND • Anticipated trial initiation date • Biosimilar

Medgenics: Biotech Showcase Conference (Medgenics) - Anticipated initiation of P2 trial in peritoneal dialysis in Q1 2015; Anticipated initiation of P2 trial in myelodysplastic syndrome in H1 2015; Anticipated initiation of P2 trial in beta thalassemia intermedia in H2 2015; Anticipated initiation of P2 trial in hypo-responders to ESA in H1 2015

Anticipated new P2 trial • Biosimilar

Medgenics: ASN 2015 (Medgenics) - “All patients had good initial response in both EPO and reticulocytes/Hb”; “Thus far, 9/13 patients had 5 or more months of TARGT_EPO secretion with stable Hb response. One patient is over 16 months with stable EPO secretion and Hb response and several patients are still in active follow up. PD and HD patients shows comparable results”; “TARGT platform proved its advantage of dose control in patients and recapitulated the findings in animal models, one TARGT excision in patient 401 d/t Hb above 13 g/dL resulted in reduction in both EPO and Hb levels”

P1/2 data • Biosimilar

Medgenics: Q3 2014 FY Results (Medgenics) - Anticipated interim results from P1/2 trial for ESRD or CKD at European Society of Gene and Cell Therapy (Oct 23 - Oct 26, 2014); Anticipated completion of enrollment in MDGN-201 study in patients with anemia due to end-stage renal disease in Q4 2014; Anticipated initiation of P2 trial for beta thalassemia in H1 2015; Anticipated initiation of P2 trial in patients with anemia who are hyporespondent to EPO in Q1 2015

Anticipated enrollment status • Anticipated P1/2 data • Anticipated trial initiation date • Biosimilar

Medgenics: Corporate Presentation (Medgenics) - Anticipated launch in chronic renal diseases and hematological disorders in 2018

Anticipated launch • Biosimilar

Medgenics: Q1 2015 Results (Medgenics) - Anticipated presentation of P1/2 data (NCT02117427) from mid-dose cohort of  MDGN-201 study in end-stage renal disease (ESRD) patients undergoing peritoneal dialysis at American Society of Gene and Cell Therapy annual meeting (ASGCT) (May 13-16, 2015)

Anticipated P1/2 data • Biosimilar

Medgenics: Q1 2015 Results (Medgenics) - Anticipated initiation of mid-year trial for renal failure at San Antonio in mid-2015; Anticipated completion of enrollment in P1/2 trial (NCT02117427) for renal failure by end of Q3 2015

Anticipated enrollment status • Anticipated trial initiation date • Biosimilar

Medgenics: Corporate Presentation (Medgenics) - Anticipated initiation of P2 trial in anemic CKD transplant in H1 2015; Anticipated initiation of P2 trial in peritoneal dialysis in H1 2015; Anticipated initiation of P2 trial in MDS in H2 2015; Anticipated interim data from small signal finding studies in renal anemia - ESRD in H2 2015; Anticipated submission of IND for hematological disorders in H1 2015; Anticipated interim data from small signal finding studies in hematological disorders in H2 2015/H1 2016; Anticipated interim data from small signal finding studies in beta thalassemia in H2 2015

Anticipated clinical data • Anticipated IND • Anticipated new P2 trial • Biosimilar

Medgenics: JMP Securities Life Sciences Conference (Medgenics) - Anticipated initiation of P2 trial in myelodysplastic syndrome in H2 2015

Anticipated new P2 trial • Biosimilar

Medgenics: Annual Report 2014 (Medgenics) - Anticipated IND for P2 trial in treating peritoneal dialysis patients with ESRD in US in Q1 2015

Anticipated IND • Biosimilar

New positive clinical data supports quest towards orphan designations (SeekingAlpha) - P1/2, N=3; “In all three patients results showed hemoglobin levels were maintained in the 9g/dl - 12g/dl range and that serum EPO levels were much more well-controlled during the TARGTEPO therapy as compared to the run-in period when the patients were given ESA's (again, ESAs are associated with spikes and troughs of serum EPO which has been associated with potentially compromised therapeutic effect and health risks).”

P1/2 data • Biosimilar