UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

________________________

FORM 8-K

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

October 15, 2014 (October 15, 2014)
Date of Report (Date of earliest event reported)

MEDGENICS, INC.
(Exact name of registrant as specified in its charter)

435 Devon Park Drive, Building 700

Wayne, Pennsylvania 19087

(Address of principal executive offices, zip code)

(610) 254-4201
(Registrant’s telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Item 2.02 Results of Operations and Financial Condition.

On October 15, 2014, Medgenics, Inc. (the “Company”) issued a press release regarding its financial results for the third quarter of 2014 and initial clinical data from the clinical study of MDGN-201. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information furnished in this report under this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933.

Item 7.01. Regulation FD Disclosure.

As previously announced, the Company will host a conference call and live audio webcast on Wednesday, October 15, 2014 at 9 a.m. EDT to discuss third quarter financial and operational results, as well as the initial clinical data from the MDGN-201 clinical trial. The Company intends to refer to the slide presentation, attached as Exhibit 99.2 and incorporated by reference herein, on the conference call.

The slide presentation, together with an archive of the webcast, will also be available for 30 days after the date of the conference call in the Investor section of the Company’s website at www.medgenics.com.

The information furnished in this report under this Item 7.01, including Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing.

This Current Report on Form 8-K, including the exhibits attached hereto, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. These risks and uncertainties include, but are not limited to, those discussed in the section titled “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, and any updates to those risk factors included in the Company’s Quarterly Reports on Form 10-Q. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this Current Report on Form 8-K, including the exhibits attached hereto, may not occur.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits. The following exhibits are furnished herewith:

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 15, 2014

Exhibit 99.1

News Release 

Medgenics Reports Positive Initial Clinical Data and Third Quarter Financial Results

Wayne, PA and MISGAV, Israel (October 15, 2014) – Medgenics, Inc. (NYSE: MDGN) (the Company), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of orphan diseases, today released initial positive clinical data from the clinical study of MDGN-201, as well as third quarter financial results.

Management Commentary

“We are excited to provide the initial positive results from the first three patients enrolled in our open-label study of MDGN-201,” stated Mike Cola, Chief Executive Officer of Medgenics.

“The modifications we have undertaken to optimize the platform are translating into clinical results that validate our ex vivo gene therapy approach,” stated Garry Neil, M.D., Chief Scientific Officer of Medgenics. “The platform is delivering sustained, physiologically relevant levels of endogenous erythropoietin (eEPO), which in turn is maintaining hemoglobin within the desired range. Based on these results, we plan on initiating programs in identified orphan populations of unmet need, including end stage renal disease (ESRD) patients who are poorly responsive to recombinant humanized erythropoietin (rHuEPO), and Beta Thalassemia Intermedia patients. We intend to initiate Phase 2 proof of concept clinical trials in both of these indications in 2015. Initial results are expected in the second half of 2015. We are also exploring additional orphan indications for MDGN-201.”

“Additionally, we have developed a novel system for the expression and secretion of small, endogenous peptides,” continued Dr. Neil. “This will enable us to address many orphan disease targets, the first of which is GLP-2 (glucagon-like peptide-2) for short bowel syndrome. We look forward to discussing all of these results during our third quarter conference call and webcast.”

MDGN-201 Interim Results

Three patients have been enrolled and implanted to date (3.5, 2.5, and 1.0 months post-implantation).

An abstract detailing these results has been accepted for presentation at the European Society for Gene and Cell Therapy meeting (ESGCT), October 23^rd-26^th in The Hague, Netherlands.

Conference Call and Webcast

Medgenics will host a conference call and live audio webcast on Wednesday, October 15, 2014 at 9 a.m. EDT to discuss initial clinical data from the ongoing MDGN-201 clinical trial and third quarter 2014 financial results. In order to participate in the conference call, please dial (844) 466-4113 (domestic) or (765) 507-2652 (international). The conference ID number is 16997491.

The live webcast can be accessed under “Events” in the Investors section of the Company’s website at www.medgenics.com or you may use the link: http://edge.media-server.com/m/p/want6q8o/lan/en.

A replay of the call will be available two hours after the end of the conference on October 15, 2014 through October 22, 2014. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference the conference ID number.

The archived webcast will be available for 30 days in the Investor section of Medgenics’ website at www.medgenics.com.

Third Quarter Financial Results

The Company also reported financial results for the three and nine months ended September 30, 2014 and the filing with the U.S. Securities and Exchange Commission (SEC) of the Company’s Quarterly Report on Form 10-Q. The Form 10-Q includes unaudited interim consolidated financial statements containing the information presented below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov and at www.medgenics.com.

Gross research and development (R&D) expenses for the three months ended September 30, 2014 decreased to $2.28 million from $2.45 million for same period in 2013. This decrease was due mainly to a decrease in subcontractor costs. Net R&D expenses for the three months ended September 30, 2014 decreased to $1.57 million from $2.34 million for the same period in 2013. The decrease in net R&D expenses was due to an increase of $0.61 million in the participation by the Israeli Office of the Chief Scientist (OCS) in addition to the decrease in gross R&D expenses.

General and administrative expenses for the three months ended September 30, 2014 were $2.31 million, decreasing from $2.56 million for the same period in 2013 primarily due to a decrease in professional fees.

Financial expenses for the quarter ended September 30, 2014 decreased to $0.06 million from $1.26 million for the same period in 2013, mainly due to the change in valuation of the warrant liability.

Financial income for the three months ended September 30, 2014 was $0.90 million, increasing from $0.02 million for the same period in 2013. The increase was primarily due to the change in valuation of the warrant liability.

The Company reported cash and cash equivalents of $14.71 million at September 30, 2014.

For the third quarter of 2014 the Company reported a net loss of $3.04 million or $0.16 per share, compared with a net loss of $6.14 million or $0.33 per share for the third quarter of 2013.

Nine Months Financial Results

Gross R&D expenses for the nine months ended September 30, 2014 were $6.38 million, decreasing from $6.56 million for the same period in 2013 mainly due to a decrease in subcontractor costs. Net R&D expenses for the nine months ended September 30, 2014 decreased to $4.48 million from $5.23 million for the same period in 2013 due to an increase of $0.57 million in the participation by the OCS in addition to the decrease in gross R&D expenses.

General and administrative expenses for the nine months ended September 30, 2014 were $8.26 million, up from $6.70 million for the same period in 2013 primarily due to an increase in personnel and increased stock-based compensation expenses related to options granted to general and administrative personnel.

Financial expenses for the nine months ended September 30, 2014 increased to $0.09 million from $0.02 million for the same period in 2013, mainly due to foreign currency exchange differences.

Financial income for the nine months ended September 30, 2014 was $0.61, increasing from $0.03 million for the same period in 2013. The increase was primarily due to the change in valuation of the warrant liability.

For the first nine months of 2014 the Company reported a net loss of $12.24 million or $0.65 per share, compared with a net loss of $11.92 million or $0.68 per share for the same period in 2013.

About the Clinical Trial

The open-label trial is evaluating the safety and efficacy of sustained _eEPO therapy for anemia in end-stage renal disease (ESRD) patients. The trial will enroll up to 18 patients that require treatment for anemia.   The trial endpoints include plasma eEPO levels, hemoglobin, hematocrit and reticulocytes levels and safety assessment. Each patient will be followed for at least one year.  Additional details may be found on www.clinicaltrials.gov using identifier NCT02117427.

About Chronic Kidney Disease (CKD) and ESRD

CKD is a progressive loss of kidney function over months to years. The three most common causes of CKD are diabetes mellitus, hypertension and glomerulonephritis.  ESRD is also known as Stage 5 CKD. ESRD requires kidney replacement therapy, either dialysis or kidney transplantation.

About Beta Thalassemia Intermedia

Beta thalassemia is a blood disorder that reduces the production of hemoglobin. Hemoglobin is the iron-containing protein in red blood cells that carries oxygen to cells throughout the body. Beta thalassemia is classified into two types depending on the severity of symptoms: thalassemia major (also known as Cooley's anemia) and thalassemia intermedia. The signs and symptoms of thalassemia intermedia appear in early childhood or later in life. Affected individuals have mild to moderate anemia and may also have slow growth and bone abnormalities.

About Medgenics

Medgenics is the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of orphan diseases. For more information, visit the Company’s website at www.medgenics.com.

Forward-looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

  MEDGENICS, INC. AND ITS SUBSIDIARY

  MEDGENICS, INC. AND ITS SUBSIDIARY    

Contacts:

Medgenics, Inc.
John Leaman
john.leaman@medgenics.com

Medgenics, Inc.
Brian Piper

brian.piper@medgenics.com

Stern Investor Relations

Beth DelGiacco

212-362-1200

beth@sternir.com

Exhibit 99.2

Corporate Update October 15, 2014

Forward Looking Statement This presentation includes certain estimates and other forward - looking statements within the meaning of Section 21 E of the Securities Exchange Act of 1934 , as amended, including statements with respect to anticipated operating and financial performance, clinical results, potential partnerships, licensing opportunities and other statements of expectation . Words such as “ expects, ” “ anticipates, ” “ intends, ” “ plans, ” “ believes, ” “ assumes, ” “ seeks, ” “ estimates, ” “ should ” and variations of these words and similar expressions, are intended to identify these forward - looking statements . While we believe these statements are accurate, forward - looking statements are inherently uncertain and we cannot assure you that these expectations will occur and our actual results may be significantly different . These statements by the Company and its management are based on estimates, projections, beliefs and assumptions of management and are not guarantees of future performance . Important factors that could cause actual results to differ from those in the forward - looking statements include the factors described in the Company ’ s filings with the U . S . Securities and Exchange Commission . The Company disclaims any obligation to update or revise any forward - looking statement based on the occurrence of future events, the receipt of new information, or otherwise . 2

Agenda 3 • Q3 Financial Update • Operational Update – Phase 1/2 Trial in End Stage Renal Disease (ESRD) patients with Renal Anemia – Update on rare and orphan disease programs

Company Overview Corporate • NYSE - MKT: MDGN • 52 - week range: $4.75 - 9.00 • Approximate Market Cap: $ 9 0 Million (October 2014) • Headquarters: Wayne, PA • R&D: Misgav , Israel Technology • >$100 million invested since 2000 in an autologous protein production platform focused on ex vivo gene therapy • 107 patents filed (49 issued) around platform Leadership • Chairman Sol Barer, Founder and former Chairman and CEO of Celgene • New management team joined September 2013 4

Management Team - Proven Track Record • President, Shire Specialty Pharmaceuticals - Responsible for all aspects of the $2.5 billion business e.g., commercial, R&D, manufacturing, etc. • President, Life Sciences, Safeguard Scientifics – Lead Life Sciences PE team, responsible for both investment and management of portfolio companies • Multiple senior operational leadership positions at Astra Merck/AstraZeneca Mike Cola CEO Garry A Neil, MD Global Head of R&D John H. Leaman, MD CFO • Group President, J&J Pharmaceutical R&D; Corporate VP, Science and Technology, J&J • Multiple senior R&D leadership positions at Astra Merck , Astra , Astra Zeneca and Merck KGaA • Industry R&D Thought Leader : Founder of Transcelerate ; Former Chair of PhRMA Science & Regulatory Committee; BOD of Reagan - Udall Foundation for FDA; BOD of Foundation for NIH • Directly contributed to >20 FDA approvals in mulltiple therapy areas • Vice - President Commercial Assessment for Shire Specialty Pharmaceuticals - Responsible for both corporate and business unit M&A and white space strategies • Principal, Devon Park Bioventures - Responsible for all aspects of venture investing e.g., negotiation, board governance, financing for $125M Life Sciences VC fund • Associate Principal, McKinsey & Company – Worked on strategic issues for multiple Top 25 pharmaceutical companies; specialized in BD/M&A, and payer/reimbursement issues 5

Financial Update 6

Q3 2014 - Results of Operations 7 • Net R&D expenses for the 3 rd Quarter was $2.28 million decreased from $2.45 million for the same period in 2013 due to decrease in sub - contractor costs • G&A expenses for the 3 rd Quarter was $2.31 million decreasing from $2.56 million for the same period in 2013 due to a decrease in professional fees • Net R&D expenses for the nine months ended September 30, 2014 were $4.48M – Decrease from $5.23M for the same period in 2013 – Primarily due to decrease in subcontractor costs and increase in participation by the Office of the Chief Scientist • G&A expenses for the nine months ended September 30, 2014 were $8.26M – Increase from $6.70M for the same period in 2013 – Primarily due to increase in personnel and stock - based compensation expenses • Cash balance as of September 30, 2014 was $14.7 million

Operational Update 8

Medgenics Vision 9 • Driven by our commitment to patients we strive to create the premier rare and orphan disease company by: – Having unparalleled understanding of the underlying science of rare diseases from pheno type to gen otype – Developing first - to - market or best - in - class therapies that are transformative to patients suffering from life altering rare genetic diseases – Pushing the boundaries of medicine and technology to develop new and better therapies – Working with patient s, families and advocacy groups to increase awareness and commitment to research and improve access to therapies

Management Hypothesis • T echnology would be best suited for the treatment of rare and orphan diseases • Potentially highly disruptive to existing therapies • Platform could be substantially improved to increase production, durability , and secretion profile • Platform could be expanded beyond proteins to include peptides and antibodies , opening up vast target space • Platform would allow for rapid and low - cost prototyping from target to predictive pre - clinical proof of concept, reducing development risk 10

R&D Strategy • Validated targets with clear proof of biological activity • Naturally occurring, autologous proteins and peptides • Well characterized safety and high specificity • Where continuous delivery is an advantage • Rare disease focused with high benefit/risk amenable to ex vivo gene therapy • Expedited regulatory pathway via Orphan Drug Act • High barriers to entry via regulatory exclusivity (ODA) • Reduced clinical trial size and expense (ODA) • Potential to independently develop and commercialize 11

2014 Strategic Objectives 12 • Achieve clinical proof of concept using 2 nd Generation Platform producing autologous erythropoietin in ESRD patients – Improve secretion profile, durability >6 months – Phase 1/2 POC trial re - initiated in Israel, June 2014 • Initiate m ultiple protein/peptide programs focused on rare and orphan diseases and progress to in vivo testing by the end of year. • Opportunistically look for M&A opportunities to broaden our R&D capabilities and portfolio in rare and orphan diseases.

Phase 1/2 trial in ESRD Patients with Renal Anemia 13

TARGT TM (Transduced Autologous Restorative Gene Therapy) 1. H arvest Micro - Organs from abdominal dermis using the proprietary DermaVac device. 2. Transduce fibroblasts in Micro - Organs via ex vivo gene therapy to create TARGT EPO 3. Wash out HDAd vector, measure production and choose TARGT EPO for re - implantation. 4. Implant TARGT EPO into patient where it produces endogenous EPO ( eEPO ). Micro - Organ (TARGT EPO ) Cryo - Bank Ex vivo gene therapy via HDAd vector #1 #2 #4 DermaVac # 3 Cassette Bioreactor HDAd vector washed away 14 Transduced Micro - Organ

0 5 10 15 20 25 30 -10 0 10 20 30 40 50 60 70 Serum e EPO , mU /ml Days from implantation Gen 1 System: eEPO Production Drops O ff Rapidly • Excellent safety and tolerability profile • One month of erythropoietin production translates into 4 - 5 months of anemia treatment given lifespan of red blood cells (90 - 110 days ) Average Serum eEPO in 20 Chronic Kidney Disease (CKD) Patients 15

Significant Improvements to Technology Platform (Gen 2) • Vector optimization • Linkers, promoters • Stabilizers • Codon optimization • Culture conditions • Defined media • Re - implantation technique • Device improvements – reduce shearing forces on the micro - organ • Engraftment • Use of Depo - Medrol to reduce inflammation and stabilize episomes 16 The entire system was re - engineered to increase and stabilize secretion levels in vivo

MDGN - 201 Trial Design 17 Prospective, Open - label , Dose Escalation study, to evaluate Safety and Efficacy (control of Hb 9 - 11 and < 12 g/ d L ) of TARGT EPO in ESRD patients . Study Summary Group Treatment N A Low dose eEPO 18 - 25 IU/kg/day 3 + 3 * B Mid dose eEPO 35 - 45 IU/kg/day 3 + 3 * C High dose eEPO 55 - 65 IU/kg/day 3 + 3 * Enrollment and dose selection Screening MDGN - 201 Phase 1 / 2 Trial Design Harvest procedure Ex vivo viral transduction 9 days Treatment and follow - up 12 months Safety follow - up 6 months Implantation procedure 4 weeks run - in * Initial cohort of 3 , expandable to 6 based on response

TARGT EPO Product Profile EFFICACY • Long acting duration of effect – Physiologic levels of eEPO for >6 months and preferably 1 year • Autologous – Production of a ll 14 isoforms of eEPO vs one for rHuEPO , mimicking the natural system. This may improve receptor binding and enhance cardio - renal protective effects* • Continuous Physiologic Dosing – Leading to more optimal marrow function • Maintain Hb in the targeted range of 9 - 11 and < 12 g/ dL • Reduction of Transfusion – 20 - 25% of ESRD patients treated with rHuEPO require transfusions 18 * Joyeux - Faure, M. JPET 323:759 - 762, 2007

TARGT EPO Product Profile SAFETY • Elimination of s upratherapeutic p eaks – High C max has been associated with hypertension and serious thromboembolic events * • Reduction in blood pressure vs. injectable rHuEPO ADMINISTRATION • Simple outpatient procedure • Increase compliance due to implantation should improve outcomes vs. injectable rHuEPO 19 *Berglund B, et al J Intern Med. 1991 Feb; 229 ( 2 ): 125 - 30 .

Initial Clinical Data & Observations Three patients treated to date are (3.5), (2.5), and (1) month(s) post - implantation of TARGT EPO • Pharmacokinetics – Duration: P atients are meeting target secretion profile of continuously producing physiologic levels of endogenous EPO sufficient to maintain target Hb (Patient 1 at 3.5 months). • Pharmacodynamics – Hemoglobin: All patients are meeting endpoint of hemoglobin (9 - 11 and <12 g / dL ) due to RBC production stimulated by eEPO . – No patient has required rHuEPO or transfusion post implantation • Safety – Consistent with the 23 patients treated with first generation expression cassette there have been no treatment related safety issues. 20 These data presented herein are initial observations from an ongoing, non - randomized open - label trial. As such, no conclusions can be made about the safety and efficacy of TARGT EPO from these observations or the proposed hypotheses in this presentation.

21 Patient One Run - in Period Supratherapeutic doses of rHuEPO required to maintain hemoglobin levels Patient Description: Age: 70 Sex: Male Dialysis: 4 years Underlying disease: HTN & T2DM Days Pre-implantation -25 -20 -15 -10 -5 0 Serum Hb, g/dL 8 9 10 11 12 13 Days Pre-implantation -25 -20 -15 -10 -5 0 Serum rHuEPO, mIU/ml 0 200 400 600 800 1000 1200 Target Hb 9 - 11, <12g/ dL

22 Patient One Interim Results Patient Description: Age: 70 Sex: Male Dialysis: 4 years Underlying disease: HTN & T 2 DM • 3 Transduced Micro - Organs (TARG T EPO ) implanted • Patient stabilizes after approximately 30 days • Target Hb is reached with approx 100x lower C MAX than rHuEPO • Patient appears to have the ability to auto regulate Hb levels • *Possible hemoconcentration Four months post implantation renal anemia is well controlled Target Hb 9 - 11, <12g/ dL Days from implantation 0 10 20 30 40 50 60 70 80 90 100 110 120 Serum eEPO, mIU/ml 0 5 10 15 20 Predicted eEPO baseline 4mU/ml Days from implantation 0 10 20 30 40 50 60 70 80 90 100 110 120 Serum Hb, g/dL 8 9 10 11 12 13 *

23 Patient One – Actively Regulated Reticulocytosis Days from implantation 0 20 40 60 80 100 120 Reticulocytes (10 9 /L) 30 40 50 60 70 80 90 100 ( 3 ) TARGT EPO implanted • O ngoing reticulocytosis is evidence of response to eEPO • Repeated peaks and troughs may be indicative of autoregulation • *Possible hemoconcentration *

24 Patient Two Interim Results Patient Description: Age: 26 Sex: Male Dialysis: 10 months Underlying disease: IgA Neph . • 2 Transduced Micro Organs (TARGT EPO ) implanted • Patient displays higher peak eEPO but stabilizes after 45 days • Target Hb is reached with approx 100 x lower C MAX than rHuEPO . Two months post implantation renal anemia is well controlled • Patient appears to have the ability to auto regulate Hb levels Target Hb 9 - 11, <12g/ dL Days from implantation 0 10 20 30 40 50 60 70 Serum eEPO, mIU/ml 0 2 4 6 8 10 20 40 Predicted eEPO baseline 2.8mU/ml Days from implantation 0 10 20 30 40 50 60 70 Serum Hb, g/dL 8 9 10 11 12 13 //

Patient Three Interim Results Patient Description: Age: 74 Sex: Female Dialysis: 1.4 years Underlying disease: HTN & T2DM One months post implantation renal anemia is well controlled Target Hb 9 - 11, <12g/ dL Days from implantation 0 10 20 30 40 Serum Hb, g/dL 8 9 10 11 12 13 Days from implantation 0 10 20 30 40 Serum eEPO, mIU/ml 0 5 10 15 20 Predicted eEPO baseline 2.4mU/ml • 1 Transduced Micro - Organ (TARGT EPO ) implanted • O nly patient to receive 1 TMO • Patient has higher Hb levels but within safety margin 25

Initial Observations and Next steps • It has been well tolerated and very effective in controlling renal anemia in ESRD patients thus far. • TARGT EPO , in conjunction with the patient’s residual capacity to produce eEPO and regulate Hb , appears to mimic the restoration of the natural erythropoietic function of the kidneys that has been lost to CKD. • Next Steps: – Report interim results at ESGCT* (October 23 - 26 ) – Complete enrollment in the low dose arm of the trial ( 3 additional patients) – Enroll 6 patient cohort comparing single dose Depo - Medrol to multi - dose Depo - Medrol 26 TARGT EPO has the potential to create a paradigm shift in the treatment of anemia *European Society for Gene and Cell Therapy

TARGT EPO in ESRD Patients Hypo - Responsive to rHuEPO 27

US Market for rHuEPO 28 Source: Evaluate Pharma ®; • Steady decline in rHuEPO usage due to significant safety concerns related to: – Increased risk of thromboembolic events (CHOIR, TREAT) – Increased cancer risk – Supratherapeutic doses have been implicated in these safety issues • Inclusion of injectable drugs in the CMS ESRD bundle has further decreased rHuEPO usage 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 (US $ (mln)) Total US rHuEPO Market Value Procrit (JNJ) Aranesp (AMGN) Epogen (AMGN) Source: Evaluate Ltd

Bulk of Diagnosed CKD Patients in Stage III - V (ESRD) - 2.0 4.0 6.0 8.0 10.0 12.0 14.0 I II III IV V- ESRD Patients MM Stage US CKD Population 29 - 400 800 1,200 1,600 I II III IV V - ESRD Patients 000’s Stage Diagnosed Population • The US CKD patient population is approximately 26 million • The majority of the Stage I - II population ( 96.5 %) is undiagnosed • 90 % of Stage V patients ( 540 , 000 ) have renal anemia Source: National Kidney Disease Outcomes Quality Initiative

Hypo - Responsive Patient Flow 30 600K ESRD Patients ~ 40 - 70 K Hypo - Responsive ESRD patients ~ 366K ESRD patients on ESA • Estimated cost of at least $30K/year for anemia management • > $20K/year rHuEPO • $5 - 10K/year in transfusion costs Source: USRDS database and primary company research Potential US market size: $1B+

TARGT EPO in Hypo - Responsive ESRD Patients 31 Rationale: • Continuous physiologic levels of eEPO will stimulate bone marrow more effectively and safely than intermittent IV dosing • Potential orphan designation • Reduction of overall patient costs ( rHuEPO , iron management and transfusion) • Rapid route to market • Ability to do a small signal finding study (10 - 15 patients ), significantly de - risking the program; interim results H2 2015 • Relatively small, single pivotal trial similar to other orphan development programs for registration Source: USRDS data analysis and primary company research

TARGT EPO in Beta Thalassemia 32

Beta Thalassemia 33 • Beta Thalassemia is the most common genetic disease in the world whose characteristics in symptomatic patients include 1 : • Orphan population with significant unmet need • Severe anemia, iron overload, and splenomegaly • Patients generally require transfusions and/or bone marrow transplant to alleviate anemia ( Hb < 7 gms/dl) 1 Weatherall, D.J. and Clegg, J.B. Bulletin of the World Health Organization , 2001 , 79 : 704 – 712 .

Beta Thalassemia Patient Flow 34 ~100,000 Symptomatic Beta Thalassemia patients W.W. ~ 50 , 000 Beta Thalassemia Intermedia patients W.W. ~ 15 , 500 Beta Thalassemia Intermedia Patients US/EU • Avg. cost of ~$100K/year* • ~$60K/year in transfusion costs • (>12 units of blood per year) • ~$40K/year in iron chelation costs *Primary research Potential US/EU market size: $1.5B+

TARGT EPO in Beta Thalassemia 35 • Rationale: • eEPO levels are lower than expected in Beta Thalassemia patients • rHuEPO has shown the ability to reduce transfusions and increase hemoglobin levels in Beta Thalassemia patients 1 • Safety concerns have limited usage of rHuEPO • Continuous physiologic levels of eEPO should stimulate bone marrow more effectively and safely than intermittent IV dosing • May increase fetal hemoglobin levels • Rapid route to market • Ability to do a small signal finding study (5 - 10 patients ), significantly de - risking the program; interim results H2 2015 • Relatively small, single pivotal trial similar to other orphan development programs for registration • Potential to expand into other hemoglobinopathies 1 . Oliveri NF et al. Blood 1992 , 80 : 3258 - 60 .

TARGT EPO - Additional Indications of Interest P latform has the potential to be applied across numerous indications • Anemic CKD transplant candidates – Reducing transfusions would prevent increased immunogenicity, shortening “wait - times” and improving transplant outcomes • Peritoneal Dialysis (PD ) – 20% cost reduction over patients with hemodialysis 1 – Potential for TARGT EPO to improve compliance, outcomes, and cost for patients on PD • Myelodysplastic Syndrome (MDS) – 20 - 55% of MDS patients respond to rHuEPO but use is limited due to safety concerns 2 – Reducing transfusions would limit iron overload – Target population: mild to intermediate patients, EPO levels < 150 36 1 Primary Research 2 Giraldo , P. et al Cancer : 107 - 2807 - 14

TARGT GLP - 2 ™ in Short Bowel Syndrome 37

Glucagon - like peptide 2 (GLP - 2) • 33 amino acid naturally occurring peptide, t 1 / 2 = 6 - 7 min. • Produced by L cells of small intestine • Several important functions: – Increases intestinal absorption – Stimulates intestinal growth – Reduces bone breakdown • Improves intestinal absorption in humans with short bowel syndrome and reduce need for total parenteral nutrition (TPN) – Gattex ® ( teduglutide ) approved in 2012 for this indication • Impacts gastric and intestinal motility and causes dose - related nausea and vomiting in some patients 1 38 1 O’Keefe, S.J.D. et al. Clin . Gastroenterol . Hepatol . 11:815 - 23 2013

MDGN GLP - 2 Program • We adapted the TARGT platform for expression of peptides < 40 amino acids including GLP - 2 • Program has advanced to in vivo stage in SCID mice (n= 5 ) 39 0 5 10 15 20 25 30 7 18 27 39 49 60 Serum GLP - 2 ng/ml Days from Implantation

• TARGT GLP - 2 should provide a more favorable PK profile – physiologic levels of continuous GLP - 2 – lower peak dose and continuous coverage • Indications include short bowel syndrome and IBD • We plan to approach regulatory authorities in H 1 2015 MDGN TARGT GLP - 2 vs teduglutide 40 Source NPS briefing book, Gattex Advisory Committee meeting, 2012

Conclusions • The second generation platform is working well, as evidenced by the positive initial data we are seeing in our ongoing clinical trial • We have identified multiple commercially attractive orphan indications for TARGT EPO where rapid proof - of - concept can be achieved • We have expanded the capabilities of the platform to include peptides, as demonstrated by our preclinical proof - of - concept with GLP - 2 41

Upcoming Activities Include… 42 TIMING Present at European Society of Gene and Cell Therapy (ESGCT) Oct 14 Complete enrollment in MDGN - 201 study Q4 14 Initiate Phase 2 study in Hypo - Responsive Patients Q1 15 Initiate Phase 2 study in Beta Thalassemia Patients H1 15 Approach regulatory authorities for GLP - 2 H1 15