GNMX Aevi Genomic Medicine Inc

 

 

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

 

April 17, 2015 (April 16, 2015)
Date of Report (Date of earliest event reported)

 

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

 

Delaware	1-35112	98-0217544
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

 

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):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Item 2.02.

Results of Operations and Financial Condition.

 

On April 17, 2015, Medgenics, Inc., a Delaware corporation (the “Company”), issued a press release regarding its financial results for the three months ended March 31, 2015. 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 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Effective April 16, 2015 (the date of the Annual Meeting of Stockholders), Joel S. Kanter and Stephen D. McMurray retired from the Board of Directors of the Company.

 

Item 5.07.

Submission of Matters to a Vote of Security Holders.

 

On April 16, 2015, the Company held its Annual Meeting of Stockholders. At the meeting, all seven directors of the Company nominated for re-election were elected to serve until the next annual meeting of stockholders and until their respective successors are duly elected and qualified. Tabulated with the name of each of the nominees elected is the number of votes cast for each nominee, the number of votes withheld with respect to each nominee and the number of broker non-votes with respect to each nominee.

 

Nominee	Votes For	Votes Withheld	Broker Non-Votes
Sol J. Barer	8,264,032	428,274	8,468,896
Eugene A. Bauer	7,805,329	866,977	8,468,896
Isaac Blech	8,461,650	230,656	8,468,896
Alastair Clemow	8,682,027	10,279	8,468,896
Michael F. Cola	8,682,107	10,199	8,468,896
Wilbur H. (Bill) Gantz	7,826,168	866,138	8,468,896
Joseph J. Grano, Jr.	7,832,107	860,199	8,468,896

 

 

In addition, the appointment of Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2015 was ratified at the meeting with 17,044,228 votes in favor, 69,003 votes against, 47,971 abstentions and no broker non-votes.

 

Item 7.01.

Regulation FD Disclosure.

 

As previously announced, the Company will host a conference call and live audio webcast on Friday, April 17, 2015 at 8:30 a.m. ET to discuss first quarter 2015 financial results. 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, 2014, and any updates to those risk factors included in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2015. 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:

 

Exhibit No.	Description
99.1	Medgenics, Inc. Press Release dated April 17, 2015 (furnished pursuant to Item 2.02).
99.2	Slide Presentation dated April 17, 2015 (furnished pursuant to Item 7.01).

 

 

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.

 

	MEDGENICS, INC.
	By:	/s/ John Leaman
		Name: John Leaman
		Title: Chief Financial Officer

  

Date: April 17, 2015

 

 

 

Exhibit 99.1

 

 

 

News Release  

 

Medgenics Reports First Quarter 2015 Financial Results

 

·

Commenced enrollment in mid-dose arm of MDGN-201 study

·

Initiated peritoneal dialysis study in Israel

·

Filed U.S. IND for TARGTEPO renal anemia programs

·

Advanced collaboration activities with CHOP

·

Progressed TARGTCNS program with Harvard University

 

Philadelphia, PA (April 17, 2015) – 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 announced first quarter 2015 financial results.

 

Management Commentary

 

“We are very pleased with the considerable progress we have made with our development pipeline for the TARGT (Transduced Autologous Restorative Gene Therapy) platform this quarter,” stated Mike Cola, Chief Executive Officer of Medgenics. “We have initiated enrollment in the mid-dose cohort of our MDGN-201 study, and we continue to see promising results validating the TARGT platform in the low-dose cohort, with one patient currently at 10 months post-implantation. We look forward to presenting data from this study at the upcoming American Society of Gene and Cell Therapy (ASGCT) annual meeting in New Orleans in May.

 

Moving forward, we will focus on initiating small proof-of-concept studies in additional renal indications through the remainder of 2015, beginning with the study of end-stage renal disease (ESRD) patients undergoing peritoneal dialysis now underway in Israel. We filed an investigational new drug (IND) application for MDGN-201 with the FDA this quarter, and expect to initiate our U.S.-based peritoneal dialysis study in the near-term.

 

Furthermore, the Company is actively advancing our collaboration efforts. We are pleased to announce the hiring of Robert Zivin, Ph.D. to head our translational research activities in connection with our collaboration with Children’s Hospital of Philadelphia (CHOP). We are actively working with CHOP to assess and prioritize programs in the collaboration, from which we anticipate announcing a lead program later this year.

 

Additionally, we are advancing our collaboration with Harvard University that will assess the viability and durability of our TARGT platform for potential applications involving the central nervous system (CNS). We look forward to providing preclinical data from this program in the second half of the year.

 

And finally, we continue to be opportunistic in considering collaboration and partnership opportunities, and remain diligent in our assessment of potential novel licensing opportunities. We look forward to discussing these results during our first quarter conference call and webcast.”

 

 

The Company also announced today that all resolutions proposed at the Company's Annual Meeting of Stockholders held yesterday were duly passed.

 

Dr. Sol J. Barer, Dr. Eugene A. Bauer, Mr. Isaac Blech, Dr. Alastair Clemow, Mr. Michael F. Cola, Mr. Wilbur H. Gantz and Mr. Joseph J. Grano, Jr., were reelected to the Board of Directors. 

 

Mr. Joel S. Kanter and Dr. Stephen D. McMurray retired from the Board of Directors at the meeting following the expiration of their terms. "On behalf of the Board of Directors and the entire staff at Medgenics, I extend our deepest gratitude to Mr. Kanter and Dr. McMurray for their service to the company," said Sol J. Barer, Non-Executive Chairman of the Board of Medgenics.

 

Stockholders also ratified the appointment of Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global, to serve as the Company's independent registered public accounting firm for the year ended December 31, 2015.

 

In connection with the appointment of Robert Zivin, the Compensation Committee of the Medgenics Board of Directors has granted Dr. Zivin inducement awards consisting of stock options covering up to 100,000 shares of the Company’s common stock, $0.0001 par value per share (Common Stock), at a per share exercise price of $9.00, representing the closing price of the Common Stock on the grant date. These options have a 10-year term, with one-third of the options vesting on the first anniversary of grant, one-third vesting on the second anniversary, and the final third vesting on the third anniversary of the grant date, subject to Dr. Zivin’s continuous service through each vesting date. The Compensation Committee of the Medgenics Board of Directors, which is comprised solely of independent directors, granted this award on April 16, 2015 pursuant to a stand-alone award agreement outside of Medgenics’ Stock Incentive Plan as an inducement material to Dr. Zivin’s acceptance of his appointment to the company in accordance with Section 711 of the NYSE MKT Company Guide.

 

 

Conference Call and Webcast

 

Medgenics will host a conference call and live audio webcast on Friday, April 17, 2015 at 8:30 a.m. ET to discuss first quarter 2015 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 18428859.

 

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/9erkq6a8/lan/en.

 

A replay of the call will be available two hours after the end of the conference on April 17, 2015 through April 24, 2015. 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.

 

First Quarter Financial Results

 

The Company reported financial results for the three months ended March 31, 2015 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 March 31, 2015 increased to $3.90 million from $2.14 million for the same period in 2014. This increase was due mainly to increased materials and sub-contractor costs and increased stock-based compensation expenses related to options granted to research and development personnel.

 

General and administrative expenses for the three months ended March 31, 2015 were $3.95 million, increasing from $3.09 million for the same period in 2014 primarily due to increased stock-based compensation expenses related to options granted to directors and general and administrative personnel, offset in part by a decrease in professional fees.

 

Financial expenses for the quarters ended March 31, 2015 were $1.08 million, increasing from $0.12 million for the same period in 2014. This increase was mainly due to the change in valuation of the warrant liability.

 

Financial income for the quarters ended March 31, 2015 and 2014 was de minimis.

 

The Company reported cash and cash equivalents of $25.16 million as of March 31, 2015.

 

For the quarter ended March 31, 2015 the Company reported a loss of $8.92 million or $0.36 per share, compared with a loss of $5.36 million or $0.28 per share for the comparative quarter in 2014.

 

 

	MEDGENICS, INC. AND ITS SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except share and per share data)

 

		March 31,				December 31,
		2015				2014
		Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	25,159			$	33,288
Accounts receivable and prepaid expenses			1,603				315
Total current assets			26,762				33,603
LONG-TERM ASSETS:
Restricted lease deposits			83				83
Severance pay fund			97				99
Property and equipment, net			470				495
Total long-term assets			650				677
Total assets		$	27,412			$	34,280
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables		$	487			$	1,076
Other accounts payable and accrued expenses			993				2,562
Total current liabilities			1,480				3,638
LONG-TERM LIABILITIES:
Accrued severance pay			347				368
Liability in respect of warrants			1,686				612
Total long-term liabilities			2,033				980
Total liabilities			3,513				4,618
STOCKHOLDERS' EQUITY:
Common stock-$0.0001 par value; 100,000,000 shares authorized; 24,861,130 shares issued and 24,852,630 shares outstanding at March 31, 2015; 24,851,075 shares issued and 24,818,075 shares outstanding at December 31, 2014			3				3
Additional paid-in capital			132,956				129,797
Accumulated deficit			(109,060	)			(100,138	)
Total stockholders' equity			23,899				29,662
Total liabilities and stockholders' equity		$	27,412			$	34,280

 

 

	MEDGENICS, INC. AND ITS SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
US Dollars in thousands (except share and per share data)

 

		Three months ended March 31,
		2015				2014
		Unaudited
Research and development expenses		$	3,901			$	2,142
General and administrative expenses			3,947				3,093
Operating loss			(7,888	)			(5,235	)
Financial expenses			(1,078	)			(120	)
Financial income			5				3
Loss before taxes on income			(8,921	)			(5,352	)
Taxes on income			1				5
Loss		$	(8,922	)		$	(5,357	)
Basic and diluted loss per share		$	(0.36	)		$	(0.28	)
Weighted average number of common stock used in computing basic and diluted loss per share			24,843,516				18,872,001

  

About Medgenics

 

Medgenics is developing the TARGT^™ (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient's own tissue for the treatment of orphan and rare 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.

 

 

Contacts:

 

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

 

Medgenics, Inc.
Brian Piper

240-899-5554

brian.piper@medgenics.com

Stern Investor Relations

Beth DelGiacco

212-362-1200

Beth@sternir.com

 

 

 

Exhibit 99.2

 

Q1 2015 Results April 17, 2015

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 • Q1 Operational Update • Q1 Financial Update • CHOP Collaboration • 2015 Milestones

Q1 2015 Operational Update • Low - dose cohort fully enrolled – Positive response to therapy at ~100x lower c max and 10x lower overall exposure vs rHuEPO – Low - dose well tolerated; no treatment related SAE’s • Demonstrated ability to maintain Hb in target range for up to 10 months to date • Initiated enrollment in mid - dose cohort • Initiated TARGT EPO Study in Peritoneal Dialysis – Enrolled first patient in Israel – Filed IND with FDA for TARGT EPO renal failure indications – Anticipate initiating US Peritoneal Dialysis trial by mid year • Advanced CHOP and Harvard Collaborations – Anticipate initial program from CHOP to be announced mid - year – Preclinical data expected from Harvard CNS program H2 2015 4

MDGN - 201 (TARGT EPO ) – Open Label Ascending Dose 5 Clinical endpoints: (1) Serum eEPO levels (2) Hb levels (3) Duration (4) Safety 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 * MDGN - 201 Phase 1/2 Trial Design Enrollment and dose selection Screening 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 Objective : determine dose of TARGT EPO sufficient to maintain hemoglobin in target range [9 - 11,<12 g/ dL ] for > 6 months in ESRD patients

Summary Patient Status – Low Dose Cohort 6 Subject # Age Gender Dialysis (years) Medical History rHuEPO Run - in Dose (IU/ wk ) # of TARGT s Months Post Implant Status E101 70 M 4 hypertension, diabetes 12K 3 10 Ongoing ; s table Hb E102 26 M 0.8 hypertension, IgA nephropathy 12K 2 5 Returned to baseline; received rHuEPO . Exited study. E201 74 F 1.4 hypertension, diabetes, stroke 20K 1 2 Required rHuEPO following surgery unrelated to therapy. Exited study. E202 76 M 9 hypertension, stroke, MI 20K 2 6 Ongoing; stable Hb E203 67 M 1 diabetes 20K 3 5 Ongoing; under evaluation* E204 64 F 0.75 hypertension 8K 3 4 Ongoing; stable Hb * Patient refused 3 out of 4 Depo - Medrol injections

Potential Orphan Indications for TARGT EPO 7 INDICATION PATIENT / PAYOR NEED CLINICAL RATIONALE ESTIMATED PREVALENCE PERITONEAL DIALYSIS (PD) PD provides 20% cost reduction vs hemodialysis Improved compliance will boost outcomes and reduce costs for PD patients 20,000 (US) 6 ANEMIC CKD TRANSPLANT CANDIDATES Heightened immunogenic profile due to repeat transfusions Reduced transfusions will prevent increased immunogenicity, shorten wait times and improve transplant outcomes 10,000 (US) 6 HYPO - RESPONDERS TO rHuEPO Unable to manage anemia on high doses of rHuEPO ; often leading to hypertension Continuous, physiologic levels of eEPO will stimulate bone marrow more effectively and safely than intermittent IV dosing 5 40,000 – 70,000 (US) 6 MYELODYSPLATIC SYNDROMES (MDS) 20 - 55% of MDS patients respond to rHuEPO but use limited due to safety concerns 3 Reduced need for transfusions would limit iron overload 60,000 (US) 4 BETA THALASSEMIA INTERMEDIA Requires frequent transfusions (up to 12 per annum) rHuEPO shown ability to raise Hb in beta thalassemia 1 ; safety concerns limit use 15,000 (US/EU) 2 1. Oliveri NF et al. Blood 1992 , 80:3258 - 60 2. Weatherall , D.J. and Clegg, J.B. Bulletin of the World Health Organization , 2001 , 79 : 704 – 712 . 3. Giraldo , P. et al Cancer : 107 - 2807 - 14 4. Am Journal Med. 2012 , Jul: 125 ( 7 Suppl ):S 2 - 5 5 . Source : Besarab , A. Semin Nephrol . 2000 ; 20 ( 4 ): 364 6 . U.S . Renal Data System, USRDS 2013 Annual Data Report and primary company research

CHOP Collaboration 8

“Conventional” Drug Development Process 9 10 – 15 Years Timeline with Massive Attrition! New Targets from Literature Animal Models

Genomic Guided Precision Medicine Precision medicine is an emerging approach to disease treatment and prevention based on individual genetic and lifestyle/environmental variation Why now?  Cheap and fast genome sequencing  Availability of new tools for bioanalytics and large clinical datasets  Government/payer support 10

Precision Development A pproach 11 Phenotype (Inherited/Extreme) Tissue Banking Screening/Genomics Hypothesis/Mechanism New “Validated” Target(s)

Precision Drug D evelopment A pproach Phenotype Validated Target & Mechanism Native Peptide/Protein Preclinical POC Enabling Tox Exploratory IND PD Markers Dosing POC Phase IB/II Dose Confirmation Pivotal Trials Submission & Approval 12 12 mos 12 mos 12 mos 12 - 24 mos 12 mos 5 - 6 Yrs

CHOP Medgenics Collaboration Prioritization Criteria • Well characterized and genetically defined rare/orphan disease with clear diagnostic and phenotypic criteria • Serious disease with significant impact on health and/or lifespan of affected individuals • Sufficient characterization of natural history of the disease to allow design of clinical intervention trials • Potential to substantially improve health outcomes for patients by intervention in the identified pathway(s) beyond outcomes achievable by existing therapies • At least 1,000 affected individuals in developed markets – or potential to expand intervention to related populations of at least 1,000 individuals 13

Collaboration Update 14 PARTNER SCOPE KEY DELIVERABLES Harvard University / Massachusetts General Hospital Funding of research program to a ssess the viability of TARGT micro - organs in the CNS Initiated collaboration and anticipate results from initial preclinical experiments mid - year. Stanford University License to novel AAV vector, pLK19, for ex vivo use in the TARGT platform Provide vector flexibility for TARGT platform . GMP manufacturing in H2 2015.

Financial Update 15

Q1 2015 Financial Update • Net R&D expenses for the 1 st Quarter were $3.9MM increasing from $2.1MM for the same period in 2014 due mainly to increased materials and sub - contractor costs and increased stock - based compensation expenses related to options granted to R&D personnel . • G&A expenses for the 1 st Quarter were $3.9MM increasing from $3.1MM for the same period in 2014 primarily due to increased stock - based compensation expenses related to options granted to directors and general and administrative personnel, offset in part by a decrease in professional fees . • Cash balance as of March 31 , 2015 was $25.2MM 16

2015 Milestones 17 PROGRAM TIMING RENAL ANEMIA Complete enrollment in low dose MDGN - 201 cohort ✓ Initiate enrollment in mid dose MDGN - 201 cohort ✓ Initiate Phase 2 study in Peritoneal Dialysis (PD), including: ✓ - Renal Anemia Transplant patients - ESA Hypo - responsive patients HEMATOLOGICAL DISORDERS Initiate Phase 2 study in Myelodysplastic Syndrome (MDS) H2 15 Pre - IMPD meeting for Beta Thalassemia Intermedia H2 15 PRECLINICAL Pre - IMPD meeting for GLP - 2 H1 15 Lead program from CHOP collaboration H2 15