Locally administered polymer technologies
Either on a standalone basis or to deliver drugs and
biologics in a sustained-release manner – for the
treatment and/or prevention of ophthalmic diseases,
conditions, and injuries
Confidential
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Jade’s Proprietary, Modified Hyaluronic Acid (HA)
Fulfills Two Broad Ophthalmology Needs
1. CMHA-S without added drug
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HA solutions are the standard of care for dry eye and tear film stability
outside the U.S.
Major need for an efficacious dry eye therapy (especially in the U.S.)
CMHA-S already meeting that need globally for veterinary markets
Potential additional use as a corneal repair gel and ocular surface bandage
2. CMHA-S as a sustained drug-release vehicle
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Chronic eye therapy requires frequent and life-long drug administration
For AMD – monthly injections of protein-based drugs needs improvement
CMHA-S can be use to deliver drugs anywhere in the eye
Preclinical data show weeks-to-months delivery for large/small molecules
Confidential
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Thiolated HA (CMHA-S) Technology
 Proprietary, crosslinked, thiolated hyaluronic acid
(HA) hydrogel
 Exclusively licensed from BioTime, Inc., for
human ophthalmic use (either by itself or to
deliver any and all drugs to the eye)
 Currently marketed for dry eye and corneal
wound repair in animals by BayerDVM
 Proven sustained-release of small and larger
molecules in animals
 Formulation “tuned” to match desired drug
release profiles (proteins, oligonucleotides, and
small molecules)
 pH neutral upon degradation (protein-friendly)
Confidential
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A Spectrum of Products
Non-Drug Loaded
Mild/Moderate
Dry Eye (0.4 %)
Eye Drop Lubricant
Drug Loaded
Biological
Small Molecule
Moderate Ocular
Surface Injuries (0.75%)
Liquid/Gel
Approved
Severe Ocular
Surface Injuries
Film/Sponge
New Chemical Entity
rHGH
Antibiotics
Confidential
Anti-Angiogenic
Intravitreal
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Opportunity as a Dry Eye Therapy
 HA is standard-of-care in Asian and European countries
 Topically administered CMHA-S drops
 Better retention due to crosslinking
 Improved compliance (fewer doses/day)
 Increased tear film stability and decreased hyperemia
in animals
Veterinary dry eye product already on the market
 <1 year/$1MM to CE Mark in EU (assuming funding)
Confidential
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CMHA-S Eye Drops
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KCS Gel – 0.4% crosslinked CMHA-S, for veterinary use, SentrX Animal Care
Hylovis – 0.18% HA solution, for human use, TRB Chemedica
Celluvisc – 1% carboxymethyl cellulose, for human use, Allergan
Clinadry – 0.2% HA solution, for veterinary use, IDPHAR Belgian Pharma
HA 0.4% – standard solution of HA in PBS
Confidential
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Successful Masked Dog Study of
CMHA-S Drops in KCS
 Masked study in 20 dogs failing SOC cyclosporine
 Statistically significantly better therapeutic efficacy with
CMHA-S gel than with a solution of non-cross-linked HA
 Owners were happier with the outcome of using the
CMHA-S product than the HA solution
Williams DL, Mann BK. PLoS ONE. 2014; 9(6): e99766
Williams DL, Mann BK. Intl J Biomat. Vol. 2013, Article
ID 460437
Confidential
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SentrX Products Now in Widespread Use
In over 1,000 clinics worldwide
Remend® Eye Lubricating Drops help
support moisture and lubrication of the eye
surface in dogs and cats.
Composed of cross-linked, modified
hyaluronic acid in a preservative-free gel,
Remend® Eye Lubricating Drops help
maintain a normal, healthy environment of
the eye surface to support lubrication and
moisturization of the eye and to help
minimize potential dryness and irritation.
Confidential
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Testimonial from BayerDVM Regarding
the Lubricating Eye Drops
“Feedback from the vets regarding the lubricant for
the animals dry eye syndrome is very good…”
Dr. Birgit Pfost
CAP Marketing
Confidential
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Near-Term Ocular Lubricant Timelines
 Early March 2015 – Submitted pre-IND package to the FDA
 April 14, 2015 – Pre-IND meeting with FDA
 May 2015 – File IND with the FDA
 July/Aug ‘15 – Commence 40-patient crossover study in dry eye patients
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 H-1 ‘16 – CE Mark in Europe (assuming necessary funding)
Confidential
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Experienced Management Team
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Chief Executive Officer: Arthur Klausner, M.B.A.
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Former Partner at the life sciences-focused venture capital firms Domain Associates and
Pappas Ventures
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Significant and varied experience with start-up biopharmaceutical companies
Chief Operating Officer and Co-Founder: MaryJane Rafii, Ph.D., M.B.A.
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Medical lead on Sustained Release Xalatan at Pfizer
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Medical Director - Ophthalmology Business Unit at Pfizer
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Formerly Chief Medical Officer for Fovea Pharmaceuticals (France)
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Part of the development group for Vitrasert®: an intraocular sustained delivery of Ganciclovir
 Chief Scientific Officer and Co-Founder: Barbara M. Wirostko, M.D.
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Prior Chief Medical Officer of Altheos Inc.
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Former Development Team Lead with Pfizer - originator of the Sustained Delivery Xalatan
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Clinical Adjunct Associate Professor, Moran Eye Center (U. of Utah)
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Recognized Ophthalmic drug development and delivery expert
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Fellow of the American Academy of Ophthalmology
Confidential
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Jade’s Pillars of Success
 Unique, versatile platform technology for
use in the ocular space
 Full-spectrum development capabilities
 GLP/GMP manufacturing (SentrX/BioTime)
 Preclinical alliance
 Clinical/regulatory alliance
 Non-dilutive grant support for R&D
 National Science Foundation (Phase II SBIR)
 Department of Defense (Phase II SBIR likely)
 U.S. Army (CRADA)
 Near-to-market product (ocular lubricant)
 CE mark in EU projected for early 2016
 Solid internal/external team
 Management
 Board of directors
 Scientific advisors
Confidential
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Partnering and Financing Objectives
Partnering Objectives:
 CMHA-S lubricant (especially in E.U. as a device )
 CMHA-S as a drug delivery platform (esp. proteins)
 Anterior segment
 Posterior segment
 Initial ophthalmic drug delivery project (rHGH)
 Persistent corneal epithelial defects – orphan designation
 Additional potential corneal repair indications
Financing Objective:
 $6-10MM Series A venture capital round
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Achieves Phase 2a and 2b data with lubricant; IND with rHGH
Confidential
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