GRA Ventures:GRA Ventures:A university technology A university technology commercialization programcommercialization program

March 20, 2014

What is GRA Ventures?

• Program for commercializaton of science and technology inventons from the labs of Georgia’s research universites

• Milestone-based, providing funding and advice to facilitate commercializaton

• Focused on creatng sustainable, Georgia-based companies

• Covers the innovaton contnuum from idea generaton to seed investment

• Partcipants: University of Georgia, Georgia Regents University, Georgia Tech, Emory University, Morehouse School of Medicine, Georgia State University

How does GRA Ventures work?• University Representatves at each insttuton

identfy opportunites and help faculty design and implement a development plan.

• Assessment includes:– Intellectual property– Technical feasibility– Market dimensions and dynamics– Funding feasibility– Regulatory and reimbursement issues as appropriate– Management requirements

GRA Ventures process– Development and inital commercializaton proceeds in milestone-

gated phases:– Relevant and measurable milestones identfied for each project– Funding

• Phases I and II are grants to the insttuton• Phase III – loan to the company • All funds awarded in at least two tranches per phase depending on

milestones• GRA Venture Fund, LLC – dedicated to companies emerging from

VentureLab

Results to date

• More than 1,000 university technologies/inventons reviewed since 2002

• 370 awards administered to 265 companies/projects– Awards and loans total over $25 Million

• More than 100 companies formed– Over 650 employees– Greater than $550 million in equity investment– Revenue: $110 million in 2012, $315 million since

2002

GRA Ventures: Part of a dynamic, interrelated ecosystem

UniversityResearch

and Inventon

UniversityResearch

and Inventon

Angels, F&F, SBIR/STTR

GRA Venture Fund

Venture CapitalStrategic Partners

GRA VenturesSustainable

BusinessSustainable

Business

• Water Damage is the number 1 insurance claim

• Costs insurance $9.8 billion annually• Undetected leaks make up over $3B of total

• U.S. - 22 Million Unmetered Apartments

• Utlites are the greatest operatng expense

• Sub-metering benefits all partes – owner, operator and leaser

Current solutions are expensive and difficult to install

The Soneter Solution• Innovatve ultrasonic meters (SMARTFlow™)• Integrated alerts and dashboards• Lower expenses, improved values, save resources

Proprietary Technology

Underlying Principle•Using Soneter’s Patented algorithms

• Water fow can be calculated

•Measure “upstream”•Measure “downstream”

Ultrasonic transducer

Primary Target Markets

Smart Home Monitoring•Leak detecton, water

conservaton•$1.8 B Market

Mult-Family• Increased return on

investment, sustainability, conservaton, legislated

• $1.45 B Market

• Disruptve technology with multple applicatons – consumer, industrial and multfamily housing.

• Existng agreements for supply of manufactured product

• Strong, adaptable management team

Accuitis, Inc.

Accuits, Inc. is a pharmaceutcal company that is engaged in the development of

dermatological and ophthalmic pharmaceuticals.

Clinical Need: RosaceaRosacea is a dermato-ophthalmic condition that affects approximately 43 million in the US & EU:

•Primarily affects the face and eyes

•Most therapeutc development focused on repurposing existng compounds

•Excellent opportunity for a new first in class novel therapy for rosacea

•Potental to transform the value of the rosacea market to one of the largest segments in the dermatology and ophthalmic markets

Platform TechnologyCompound/solution:PTTC (Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenylpropionate)

•First in class topical proteasome inhibitor

•Potentally inhibits the transcripton factor nuclear factor kappa beta (NFkB), a potent mediator of infammaton and a major mediator of skin diseases

•Potental utlity in the treatment of rosacea by addressing the infammatory and collagen-degrading components of the conditon

•Well known and studied safety profile, 30+ years of human exposure through use in food packaging applicatons

•Pending and issued patent applicatons claim formulatons and use

•Stand alone mono-therapy, or can potentally complement current therapies for rosacea, acne, blepharits, dry eye, and skin aging.

ACU-D1 for Dermatological Rosacea Rosacea therapeutc options are limited currently for physicians. Though there's no way to eliminate rosacea, effectve treatment can only relieve signs and symptoms:

• Creams, lotons and gels recommended for the treatment of rosacea but not all of them have been studied sufficiently in trials.

• Major topical ant-infammatory drugs are cortcosteroids, have multple side effects, such as skin atrophy & rosacea.

• Medicatons such as retnoids are irritatng, limitng compliance.

• Treatments with the most evidence so far contain azelaic acid or metronidazole. They have been shown to help relieve the symptoms of rosacea.

•Market opportunity in excess of:

-$500 million+ in annually in the US.

-$250 million+ in the EU

ACU-04 for Ocular Rosacea Rosacea is a leading contributing factor in an ocular conditons posterior blepharitis and dry eye:

• Over 4 million are treated for blepharits in the US annually. Symptoms may include a watery/bloodshot appearance, dryness, grity feeling with burning, itching and/or stnging. Individuals with rosacea may be prone to styes, light sensitvity & blurred vision.

• Posterior blepharits is one of the leading cause of acute of dry eye. Ocular involvement may appear before as well as afer any skin signs or symptoms. • Significant opportunity with

a lack of current therapeutc optons.

• Market opportunity in excess of $200 million+ in annually in the US.

Attractive Target MarketsDermatologic Pharmaceutcals*

• Rosacea is very underserved with a large skin & ocular components • Very few compounds are currently in development for treatng rosacea

*Scrip Business Insights-The Dermatology Outlook to 2016

$17.9B$17.9B2011 Sales

$22.7B$22.7B2017 Sales Projected

Accuitis Summary

• First in class novel new compound targetng one of the largest unmet needs in dermatology and ophthalmology-Rosacea

• Pending and issued patents claiming chemical structures and uses

• Strong POC evidence of efficacy

• Experienced management team

• Follow-on indicatons and additonal pipeline opportunites

• High potental enterprise value

Real-Time Chemical and Biological Sensor Platform

• Founded in June 2011 by startup execs and inventors• Exclusive license from Georgia Tech, March 2012

– Three patents and 22 trade secrets– Inventons based on $20 million in funded research over 20 years

• Funding from private investors, Fortune 100 beverage company, State of Georgia– Closed $2.65 M Series B round in November 2013

• Successful completon of field trials• First product launched January 2014

Lumense Overview

…just a few of which can be met with real-time chemical/bio sensors.

Big challenges…

Technology: Interferometric Sensing

• Multple channel pairs• Chemical and

biological targets• Gaseous and

liquid applicatons• Standard

semiconductor techniques

Input gratngsOptcal waveguide

Output gratngsChannels

Initial Markets • Food and Beverage Safety and Quality

•Development funding from Fortune 100 company•Three monitors under development •Botling plant trials underway

• Agricultural Monitoring•NH3 Monitor Field Trial in poultry house completed•Inital product launched•Five percent productvity gain in $25 billion broiler industry

• Water Safety, Monitoring, and Remediaton•Complete roadmap of increasingly sophistcated sensors•Inital units identfy/quantfy BTEX, chlorinated hydrocarbons

Common Sensor Platform

Replacement/upgradedwaveguides

Replacement/alternatve filters

Lumenseserver

Alerts and FiltersSecurity

DashboardsSofware upgrades and support

Facility controlcenter

target

history

touchscreen

last measurement

thresholds

filter door

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$100,000’s $10,000’s $1,000’s

Value Propositon

Triple negative breast cancer (TNBC) does not express the molecular targets that allow treatment with hormone therapy or Herceptin.

TNBC accounts for 10,000 deaths per year in the US.

Recurrence after primary treatment is a major driver of mortality.

TRIPLE NEGATIVE BREAST CANCERTRIPLE NEGATIVE BREAST CANCERThe most lethal form of breast cancer today.

THE MUC1 TUMOR ANTIGEN IS A THE MUC1 TUMOR ANTIGEN IS A DRUGGABLE TARGET FOR TNBCDRUGGABLE TARGET FOR TNBC

Drug target % expressors in TNBC cohort

Estrogen receptor 0

Her2 0

MAGE-A3 10%

NY-ESO-1 17%

GPMNB 29%

Tumor MUC1 90%

The muc1 tumor antigenThe muc1 tumor antigen

Tumor MUC1 is a glycoprotein structure that is overexpressed in many cancers.

Cancer patients capable of mounting a natural immune response to MUC1 gain a significant survival advantage.

The major efforts to date to develop a MUC1 based therapeutic do not depict the accurate structure of the MUC1 tumor antigen.

Our focus is targeting of the glycosylated protein structure found on tumor cells.

KLH

Theratope® Stimuvax ®

Lacks the peptide component of MUC1

Phase III breast cancer trial did not meet endpoints

Lacks the glycan component of MUC1

Phase III NSCLC trial failed to meet interim analysis endpoints, trial ongoing.

Other investigational compounds that include the MUC1 glycopeptide fail to elicit robust immune responses due to inability to break tolerance.

PRIOR EFFORTS TO DEVELOP A MUC1-PRIOR EFFORTS TO DEVELOP A MUC1-BASED THERAPYBASED THERAPY

Tumor MUC1 glycopeptide

Helper epitope

Covalently linked adjuvant (Pam3CysSK4)

Conceived through a paradigm called Tripartite Immunotherapy.

Defined as a single entity compound that breaks tolerance to glycosylated antigens that are seen as self, inducing innate, humoral and cellular immune responses.

An iterative drug design process guided by the paradigm gave rise to our lead compound: MUC1 Tripartite Immunotherapy (MTI).

MTI

THE lead compoundTHE lead compound

Tested in mice that are transgenic for human MUC1.

MTI is given prior to tumor challenge.

Tumor cells are derived from mammary gland tumors that express human MUC1.

Preclinical testing of MTIPreclinical testing of MTIImmunological efficacy signals and tumor reduction

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• Goal: prevent recurrence in TNBC patients that have undergone chemo/surgery and have evidence of residual disease.

• >80% of TNBC patients exhibit residual disease after chemo/surgery.

• 40% mortality due to recurrence within 4 years of treatment.

• Risk of disease progression peaks 1 year post-treatment.

• Implement MTI 4 to 8 weeks after primary treatment when immune system has recovered.

• Potential endpoint is disease-free survival which would expedite proof of concept trials.

Clinical strategy overviewClinical strategy overview

Intellectual propertyIntellectual propertyI

P portfolio managed by the University of Georgia Research Foundation with the Mayo Clinic as a co-developer.

Portfolio includes:

Composition of matter for a fully synthetic carbohydrate-based vaccine Immunotherapy directed at glycopeptide structures including MUC1 Generation of glycopeptide-specific antibodies Methods of synthesis (trade secret)

Published applications : WO2007079448, WO2010002478 and WO2011156751

Applications are in various stages of US prosecution and nationalization

ViaMune has an exclusive option to license IP relevant to immunotherapeutic applications and manufacturing.

Immunotherapy based on a synthetic compound with a well defined mechanism of action.

Compound/platform developed at the Complex Carbohydrate Research Center, University of Georgia.

Lead compound validated in a stringent animal model at the Mayo Clinic.

Lead compound ready for IND development.

An opportunity to be the first to address a therapeutic void that exists for triple negative breast cancer patients: prevention of recurrence.

SummarySummary