Form 8-K MEDGENICS, INC. For: Aug 04

 

 

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

 

August 4, 2016
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, Suite 715

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 August 4, 2016, Medgenics, Inc., a Delaware corporation (the “Company”), issued a press release regarding its financial results for the three months ended June 30, 2016. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 7.01.

Regulation FD Disclosure.

 

As previously announced, the Company will host a conference call and live audio webcast on Thursday, August 4, 2016 at 8:30 a.m. EDT to discuss second quarter 2016 financial results and to provide a business update. 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.

 

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, 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 August 4, 2016 (furnished pursuant to Item 2.02).
99.2	Slide Presentation dated August 4, 2016 (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/ Brian D. Piper
		Name:  Brian D. Piper
		Title: Chief Financial Officer

 

Date: August 4, 2016

 

Exhibit 99.1

 

 

 

 

News Release

  

Medgenics Reports Second Quarter 2016 Financial Results

 

 

PHILADELPHIA, PA – (Marketwired) – August 4, 2016 -- Medgenics, Inc. (NYSE MKT: MDGN)

 

·

Initiated Phase 2/3 study of lead program in mGluR+ ADHD

·

Entered into collaboration for second pediatric product in Inflammatory Bowel Disease

·

Strengthened balance sheet with successful financing

 

Medgenics, Inc. (NYSE MKT: MDGN) (the Company) today announced second quarter 2016 financial results and provided a business update.

 

“We are very pleased with the Company’s accomplishments during the first half of 2016,” stated Mike Cola, CEO of Medgenics. “We have advanced NFC-1 (MDGN-001) into the clinic in mGluR+ ADHD with data expected in 2016, and we will soon initiate a trial in patients with 22q11.2 Deletion Syndrome. The announcement of our collaboration with Kyowa Hakko Kirin demonstrated the Company’s ability to advance our growing pipeline of opportunities, and the successful fundraising we recently completed will further enable us to accelerate the development of these programs. We remain steadfast in our focus on developing innovative, genomically-based, best-in-class therapies focused on improving the lives of children and adults with rare and difficult-to-treat diseases.”

 

Recent Milestones and Upcoming Events

 

·

Initiated Phase 2/3 study of NFC-1 (MDGN-001) in mGluR+ ADHD: In June, the Company initiated enrollment in the SAGA (Study of Adolescent Glutamate Receptor Network Copy Number Variant ADHD) trial, a Phase 2/3 clinical trial to evaluate adolescent patients with mGluR mutation positive (mGluR+) attention deficit hyperactivity disorder (ADHD) to confirm the results from the previously completed Phase 1b GREAT study. Initial top-line data from the study are expected in the second half of this year.

 

·

Announced the Second Clinical Development Program from our Collaboration with CHOP: In June, the Company entered into a collaboration with Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) for the development and commercialization of Kyowa Hakko Kirin's first-in-class anti-LIGHT monoclonal antibody (MDGN-002). The Company plans to initiate a signal finding study this year, testing the drug in Severe Pediatric Onset Inflammatory Bowel Disease (IBD) in collaboration with Dr. Robert Baldassano, Director of the Center for Pediatric IBD at The Children's Hospital of Philadelphia (CHOP).

 

·

Strengthened Balance Sheet: In June, Medgenics successfully completed a registered public offering, raising approximately $20 million in net proceeds. The proceeds will be used to fund development activities, including development of companion diagnostics for existing programs, license and research collaborations and for general corporate purposes which could include maintenance of intellectual property, and other business development activities including acquisitions or licensing of complementary products or businesses. The financing extends the Company’s cash runway through at least Q1 2018.

 

 

·

Anticipate initiation of Phase 1/2 study of NFC-1 (MDGN-001) in 22q11.2 Deletion Syndrome during Q3 2016: The Company will conduct a Phase 1/2 study of psychiatric symptoms in children with 22q11.2 Deletion Syndrome to explore symptoms from three major neuropsychiatric disorders: ADHD, Anxiety and Autism Spectrum Disorders (ASD). Enrollment is expected to begin shortly, pending final CHOP approval.

 

 

Conference Call and Webcast

 

Medgenics will host a conference call and live audio webcast on Thursday, August 4, 2016 at 8:30 a.m. EDT to report financial results for the second quarter ended June 30, 2016 and discuss recent business updates.

 

In order to participate in the conference call, please dial (877) 718-5098 (domestic) or (719) 325-4917 (international). The conference passcode is 4998119.

 

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: https://www.webcaster4.com/Webcast/Page/1395/16484

 

A replay of the call will be available after the end of the conference on August 4, 2016 through November 11, 2016. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and reference the reply passcode 4998119.

 

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

 

 

Second Quarter Financial Results

 

The Company reported financial results for the three and six months ended June 30, 2016 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.

 

Research and development expenses, both gross and net, for the three months ended June 30, 2016 were $8.74 million, increasing from $4.46 million gross and $3.03 million net for the same period in 2015 mainly due to increased sub-contractor costs to advance our clinical activities related to the NFC-1 (MDGN-001) program and the CHOP collaboration.

 

General and administrative expenses for the three months ended June 30, 2016 were $2.95 million, decreasing from $3.89 million for the same period in 2015 primarily due to a decrease in stock-based compensation expenses related to options granted to directors.

 

Financial expenses for the three months ended June 30, 2016 and 2015 were de minimis.

 

Financial income for the three months ended June 30, 2016 was nil, decreasing from $0.84 million in 2015.  The $0.84 million financial income in 2015 was mainly due to a change in valuation of a warrant liability.  All such warrants were exercised in 2015, thus eliminating the need for such valuation in 2016.

 

 

The Company reported cash and cash equivalents of $53.69 million as of June 30, 2016.

 

For the quarter ended June 30, 2016 the Company reported a loss of $11.7 million or $0.35 per share, compared with a loss of $6.09 million or $0.24 per share for the comparative quarter in 2015.

 

Six Months Financial Results

 

Research and development expenses, both gross and net, for the six months ended June 30, 2016 were $15.69 million, increasing from $8.36 million gross and $6.93 million net for the same period in 2015 mainly due to increased sub-contractor costs to advance our clinical activities related to the NFC-1 (MDGN-001) program and the CHOP collaboration.

 

General and administrative expenses for the six months ended June 30, 2016 were $7.14 million, decreasing from $7.84 million for the same period in 2015 primarily due to a decrease in stock-based compensation expenses related to options granted to directors offset in part by severance benefits recorded upon the termination of an officer of the Company.

 

Financial expenses for the six months ended June 30, 2016 were $0.02 million, decreasing from $0.26 million for the same period in 2015.  The $0.26 million financial expense in 2015 was mainly due to the change in valuation of the warrant liability.  All such warrants were exercised in 2015, thus eliminating the need for such valuation in 2016.

 

Financial income for the six months ended June 30, 2016 and 2015 was de minimis.

 

For the six months ended June 30, 2016 the Company reported a net loss of $22.85 million or $0.69 per share, compared with a net loss of $15.01 million or $0.60 per share for the six months ended June 30, 2015.

 

 

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

 

		June 30, 2016				December 31, 2015
		Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	53,686			$	53,064
Prepaid expenses and other current assets			1,095				747
Total current assets			54,781				53,811
LONG-TERM ASSETS:
Restricted lease deposits			34				23
Property and equipment, net			489				424
Total long-term assets			523				447
Total assets		$	55,304			$	54,258
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables		$	503			$	1,322
Other accounts payable and accrued  expenses			3,424				2,586
Total current liabilities			3,927				3,908
Total liabilities			3,927				3,908
STOCKHOLDERS' EQUITY:
Common stock-$0.0001 par value; 100,000,000 shares authorized; 37,086,843   shares issued and 37,078,343 shares outstanding at June 30, 2016; 32,869,217   shares issued and 32,860,717 shares outstanding at December 31, 2015			4				4
Additional paid-in capital			212,354				188,476
Accumulated deficit			(160,981	)			(138,130	)
Total stockholders' equity			51,377				50,350
Total liabilities and stockholders' equity		$	55,304			$	54,258

 

 

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

 

		Six months ended June 30,								Three months ended June 30,
		2016				2015				2016				2015
		Unaudited
Research and development expenses		$	15,692			$	8,359			$	8,741			$	4,458
Less:
Participation by the Office of the Chief Scientist			-				(1,430	)			-				(1,430	)
Research and development expenses, net			15,692				6,929				8,741				3,028
General and administrative expenses			7,136				7,836				2,945				3,889
Operating loss			(22,828	)			(14,765	)			(11,686	)			(6,917	)
Financial expenses			(21	)			(262	)			(18	)			(8	)
Financial income			1				24				-				843
Loss before taxes on income			(22,848	)			(15,003	)			(11,704	)			(6,082	)
Taxes on income			3				5				3				4
Loss		$	(22,851	)		$	(15,008	)		$	(11,707	)		$	(6,086	)
Basic loss per share		$	(0.69	)		$	(0.60	)		$	(0.35	)		$	(0.24	)
Diluted loss per share		$	(0.69	)		$	(0.63	)		$	(0.35	)		$	(0.28	)
Weighted average number of Common stock used in computing    basic loss per share			33,211,665				24,875,344				33,469,789				24,906,823
Weighted average number of Common stock used in computing    diluted loss per share			33,211,665				24,969,314				33,469,789				25,094,763

 

 

 

About Medgenics

 

Medgenics is dedicated to unlocking the potential of genomic medicine to identify and treat patients with life-altering conditions. Its efforts, including its internal research and development and ongoing sponsored research and licensing agreements with a well-respected pediatric academic medical center, give Medgenics the ability to focus on the underlying genetic pathway of pediatric diseases with the goal of finding therapeutic solutions for subpopulations of both children and adults living with rare and other difficult-to-treat diseases. Medgenics is also the developer of TARGT™ (Transduced Autologous Restorative Gene Therapy), a proprietary gene therapy platform.

 

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

Brian Piper

240-899-5554

[email protected]

 

Westwicke Partners

Chris Brinzey

339-970-2843

[email protected]

 

 

 

Exhibit 99.2

 

Mid - Year Review and Business Update August 4, 2016

Forward Looking Statement This presentation includes certain estimates and other forward - looking statements within the meaning of Section 21E 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 • Mid - Year Summary • Genomic Medicine Approach • Anti - LIGHT Program Overview • Financials & Milestones

Mid Year - Summary 4 ; NFC – 1 Programs Advancing Rapidly – mGlurR + ADHD • Record response and recruitment to phenotype/genotype study (1,000 Patients) • Confirmation of mGluR + prevalence rate of 25% • Enrolment initiating in June with data expected in 2H2016 • US market opportunity of $2 – 3B – 22q Deletion Syndrome • Orphan program in collaboration with CHOP • Enrolment initiating in August with initial Open - Label data expected 2H2016 ; New Biologics Development Program with KHK in Severe Pediatric IBD – 1st in class P2 ready biologic with minimal investment to POC – Strong genetic thesis and significant unmet medical need – High value commercial opportunity with first US launch anticipated in 2020 ; Strengthened Balance Sheet – Completed registered public offering, raising ~$20M in net proceeds – Extends the cash runway through Q1 2018 ; Genomic Approach – MDGN/CAG translational research continues to prod uce potential development targets

Development Pipeline 5 Preclinical Phase 1 Phase 2 Phase 3 NFC - 1 mGluR+ ADHD (adolescent, age 12 - 17 ) mGluR+ ADHD (pediatric, age 6 - 12 ) * 22q Deletion Syndrome ** Anti - LIGHT Severe Pediatric Onset IBD TARGT CNS Preclinical POC * Initiate Phase 3, H1 2017 ** Phase 1/2 expected to initiate in Q3 2016 pending CHOP approval

Genomic Medicine Approach

Genetic Influence in Pediatric Disorders E arly Onset Disease: ; Distinct genetically driven ; Severe burden of illness ; Aggressive progression ; Less responsive to standard of care 7

CAG / CHOP Capabilities CAG’s pediatric biobank contains a high percentage of rare genetic variants Datasets (Genomics EMR) ; Over 75K pediatric and 150K related adult patients GWAS genotyped with associated longitudinal EMR since 2006 Data Analytics ; End to end internal Next - Gen sequencing capabilities ; Integrated bioinformatics ; Rapid identification of novel genetic biomarkers Biobank (BB) ; Fully automated robotic biorepository Consented Patients ; 85% of the BB patients are consented for longitudinal follow up and are eligible for call back for future studies ; ~1.2M patient visits / year ; 10% of all R/O disease patients in N. America are treated at CHOP ; Population is unique in that it represents the most severe forms of common diseases ; Global reach in many therapy areas In the last 9 years CAG has had over 450 peer reviewed publications focused on novel genetic discoveries Highly scalable infrastructure to support translational research 8

• Genetic Discovery and Research • BioBank • Computational Biology CHOP/CAG • In - silico search • Animal Models • Genetically predisposed patient populations Translational Medicine • Development • Regulatory • Manufacturing • BD&L • Commercialization Medgenics Collaboration Capabilities 9

Benefits of Genomic Guided Drug Development Higher Value Medicines Improved response rates Smaller, faster, clinical trials Increased probability of regulatory success Targeted launch Potential label expansion in adjacent genetic diseases G enomic biomarkers improve overall program outcomes 10

Anti - LIGHT mAb Program

Anti - LIGHT mAb Overview ; First - in - Class Biologic from Kyowa Hakko Kirin – Initial Development in Severe Pediatric Onset IBD – Phase 2 Ready Antibody – Strong Regulatory Exclusivity and Robust Intellectual Property Portfolio – High Value Commercial Opportunity with Potential for Indication Expansion ; World Class Partners – Kyowa Hakko Kirin – The Children’s Hospital of Philadelphia ; Rapid and Capital Efficient Global Development Pathway – Minimal investment to POC – Single Pivotal Trial for registration 12

Deal Terms ; MDGN to: – Requalify KHK clinical supplies – Conduct signal finding study (~$2M) – Exercise option to license on positive data (low single - digit millions USD) ; Following option exercise, KHK elects either: – Partnership • “Co - Development/Co - Commercialization ” – Parties share sales and costs equally in US and Canada; MDGN receives double - digit royalty on ex - North Americ a net sales – License • MDGN funds development and commercializes in North America and EU, and retains approximately 75% of profits, MDGN receives double - digit royalty on ROW sales ; Success - based development milestones payable in both scenarios 13

CAG / CHOP Discovery: Genetic Link to Pediatric Onset IBD 14 Key Points ; Established importance of the DcR3 gene in pediatric IBD ; Loss of function of DcR3 correlates with severity ; Prevalence between 10 - 15% Nature Genetics VOLUME 40 | NUMBER 10 | OCTOBER 2008

Rationale for Anti - LIGHT Approach ; DcR3 is strongly linked to Severe Pediatric Onset IBD 1 ; Initial strategy to augment DcR3 – Very short half life – Toxicity reported with previous DcR3 analog ; “Rational Search” based on biological pathway – LIGHT overexpressed in IBD – DcR3 LOF increases LIGHT 2 15 Decoy Receptor 3 DcR3 LIGHT Immune Cell HVEM LT b R 1 Hakonarson, et al 2008. Loci on 20q13 and 21q22 are associated with pediatric - onset inflammatory bowel disease. Nature Genet ics 40 (10): 1211 - 1215 2 Mauri DN, et al 1998. LIGHT, a new member of the TNF superf amily, and lymphotoxin alpha are ligands for herpesvirus entry med iator.Immunity 8 (1): 21 – 30 Our Approach: Therapeutic antibody which mimics DcR3 regulation by binding LIGHT

Human Biomarker Study Supports Role of LIGHT in IBD 16 Single center non - interventional biomarker study* 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Normal (n=26) Ulcerative Colitis (n=27) Crohn's Disease (n=28) LIGHT mRNA Fold Increase vs Normal *Data on file

Severe Pediatric Onset IBD: “Top Down” Treatment Paradigm 17 1 Altwegg & Vincent (2014) TNF Blocking Therapies and Immunomonitoring in Patients with Inflammatory Bowel Disease. Mediators of Inflammation. doi:10.1155/2014/172821 Treatment Objectives : ; Induce remission with anti - TNFα immediately so patients can develop normally ; Avoid steroids and IMs ; Manage utilization of anti - TNF alphas to extend time before resistance develops Opportunity: ; 30% of patients do not respond to anti - TNFα ; Up to 50% of patients who initially respond, resistance will develop within 3 years 1 ; Creates significant opportunity for new Therapies / MOAs, that can treat anti - TNF alpha failures Step - up approach “Top - down” approach to more aggressive disease

Rapid Development Pathway to Approval 18 Severe Pediatric Onset IBD POC Trial Anticipated Phase 1b design: ; Single center (CHOP) ; N = up to 12 patients ; Duration 8 – 12 weeks ; Ascending dose Endpoints: ; Endoscopic Evaluation, Pediatric Crohn’s Disease Activity Index (PCDAI), Safety Estimated Cost: ~$2M Single Phase 3 Pivotal Registration Trial Long Term Safety Trial

Severe Pediatric Onset IBD: Anti - LIGHT Opportunity (US Pop.) 19 1 Kappleman et al. (2007) Clin Gastro Hepat 2 Oliva - Hemker (2015) J Pedtr 3 Remicade Monograph 4 Altwegg - Vincent (2014) Mediators of Inflamm Initial Target: ; anti - TNFα failure with DcR3 Loss of Function ; 2,000 – 3,000 IBD patients in US ; $300 - $400M opportunity (based conservative pricing) Potential Upside ; Pediatric anti - TNFα failures: – 15,000 – 16,000 IBD Patients in US ; Pediatric indications with DcR3 LOF (juvenile idiopathic arthritis, psoriasis, etc.) Pediatric IBD Prevalence: 71/100,000 1 (52,000) Anti - TNF Usage 35 - 55% 2 (24,500) Responders (70%) 3 (17,000) Resistance to anti - TNF’s (50%) 4 (8,500) DcR3 LOF (15%) (1,275) Non - responders (30%) 3 (7,350) DcR3 LOF (15%) (1,100)

Financials & Milestones

Q2 2016 Financial Update ; Gross and net R&D expenses for the 2 nd Quarter were $8.7M increasing from $4.5M and $3.0M for the same period in 2015 – Primarily due to increased spend on NFC - 1 program and CHOP collaboration ; G&A expenses for the 2 nd Quarter were $2.9M decreasing from $3.9M for the same period in 2015 ; $53.7M cash balance (cash and cash equivalents) at 6/30/16 – Completed financing for ~$20M net proceeds in June – Current resources estimated to fund operations through Q1 2018 ; ~37.1M shares outstanding at 8/1/16 ; ~11.4M options and ~4.9M warrants outstanding with a weighted average exercise price of $5.84 and $7.27, respectively, at June 30, 2016 21

Upcoming Milestones *Pending final CHOP approval 22 R&D Programs Timing NFC - 1 Complete enrollment in phenotype / genotype study ✓ Initiate enrollment in Phase 2/3 mGluR+ ADHD Adolescent Trial ✓ Top line data H2 16 Initiate enrollment in Phase 1/2 22q Deletion Syndrome Trial* Q3 16 Initial open - label responder data H2 16 Anti - LIGHT mAb Initiate Signal Finding Study Q4 16 Initial open - label responder data H1 17 TARGT CNS Preclinical POC H2 16

Thank You

 

 

 

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• Law Offices of Steven J. Glaros Details Legal Services for Brandon Clients
• Investcorp Credit Management BDC, Inc. Announces Financial Results for the Quarter Ended June 30, 2026
• Andrew Glen Brown Brings Entrepreneurship and Ownership Message to Madison Park Students in Boston