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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
1Confidential
Jade’s Proprietary, Modified Hyaluronic Acid (HA)
Fulfills Two Broad Ophthalmology Needs
1. CMHA-S without added drug
 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
 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 2
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)
3Confidential
A Spectrum of Products
Approved New Chemical Entity
Biological rHGH
Small Molecule Antibiotics Anti-Angiogenic
Confidential 4Intravitreal
Mild/Moderate
Dry Eye (0.4 %)
Non-Drug Loaded
Drug Loaded
Eye Drop Lubricant
Moderate Ocular
Surface Injuries (0.75%)
Liquid/Gel
Severe Ocular
Surface Injuries
Film/Sponge
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 5
CMHA-S Eye Drops
• 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 6
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
Confidential 7
Williams DL, Mann BK. PLoS ONE. 2014; 9(6): e99766
Williams DL, Mann BK. Intl J Biomat. Vol. 2013, Article
ID 460437
SentrX Products Now in Widespread Use
In over 1,000 clinics worldwide
Confidential 8
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.
Testimonial from BayerDVM Regarding
the Lubricating Eye Drops
9Confidential
“Feedback from the vets regarding the lubricant for
the animals dry eye syndrome is very good…”
Dr. Birgit Pfost
CAP Marketing
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
* * * * * * * * * * *
 H-1 ‘16 – CE Mark in Europe (assuming necessary funding)
Confidential 10
Experienced Management Team
 Chief Executive Officer: Arthur Klausner, M.B.A.
o Former Partner at the life sciences-focused venture capital firms Domain Associates and
Pappas Ventures
o Significant and varied experience with start-up biopharmaceutical companies
 Chief Operating Officer and Co-Founder: MaryJane Rafii, Ph.D., M.B.A.
o Medical lead on Sustained Release Xalatan at Pfizer
o Medical Director - Ophthalmology Business Unit at Pfizer
o Formerly Chief Medical Officer for Fovea Pharmaceuticals (France)
o Part of the development group for Vitrasert®: an intraocular sustained delivery of Ganciclovir
 Chief Scientific Officer and Co-Founder: Barbara M. Wirostko, M.D.
o Prior Chief Medical Officer of Altheos Inc.
o Former Development Team Lead with Pfizer - originator of the Sustained Delivery Xalatan
o Clinical Adjunct Associate Professor, Moran Eye Center (U. of Utah)
o Recognized Ophthalmic drug development and delivery expert
o Fellow of the American Academy of Ophthalmology
11
Confidential
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 12
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
 Achieves Phase 2a and 2b data with lubricant; IND with rHGH
Confidential 13

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Jade Therapeutics

  • 1. 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 1Confidential
  • 2. Jade’s Proprietary, Modified Hyaluronic Acid (HA) Fulfills Two Broad Ophthalmology Needs 1. CMHA-S without added drug  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  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 2
  • 3. 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) 3Confidential
  • 4. A Spectrum of Products Approved New Chemical Entity Biological rHGH Small Molecule Antibiotics Anti-Angiogenic Confidential 4Intravitreal Mild/Moderate Dry Eye (0.4 %) Non-Drug Loaded Drug Loaded Eye Drop Lubricant Moderate Ocular Surface Injuries (0.75%) Liquid/Gel Severe Ocular Surface Injuries Film/Sponge
  • 5. 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 5
  • 6. CMHA-S Eye Drops • 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 6
  • 7. 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 Confidential 7 Williams DL, Mann BK. PLoS ONE. 2014; 9(6): e99766 Williams DL, Mann BK. Intl J Biomat. Vol. 2013, Article ID 460437
  • 8. SentrX Products Now in Widespread Use In over 1,000 clinics worldwide Confidential 8 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.
  • 9. Testimonial from BayerDVM Regarding the Lubricating Eye Drops 9Confidential “Feedback from the vets regarding the lubricant for the animals dry eye syndrome is very good…” Dr. Birgit Pfost CAP Marketing
  • 10. 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 * * * * * * * * * * *  H-1 ‘16 – CE Mark in Europe (assuming necessary funding) Confidential 10
  • 11. Experienced Management Team  Chief Executive Officer: Arthur Klausner, M.B.A. o Former Partner at the life sciences-focused venture capital firms Domain Associates and Pappas Ventures o Significant and varied experience with start-up biopharmaceutical companies  Chief Operating Officer and Co-Founder: MaryJane Rafii, Ph.D., M.B.A. o Medical lead on Sustained Release Xalatan at Pfizer o Medical Director - Ophthalmology Business Unit at Pfizer o Formerly Chief Medical Officer for Fovea Pharmaceuticals (France) o Part of the development group for Vitrasert®: an intraocular sustained delivery of Ganciclovir  Chief Scientific Officer and Co-Founder: Barbara M. Wirostko, M.D. o Prior Chief Medical Officer of Altheos Inc. o Former Development Team Lead with Pfizer - originator of the Sustained Delivery Xalatan o Clinical Adjunct Associate Professor, Moran Eye Center (U. of Utah) o Recognized Ophthalmic drug development and delivery expert o Fellow of the American Academy of Ophthalmology 11 Confidential
  • 12. 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 12
  • 13. 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  Achieves Phase 2a and 2b data with lubricant; IND with rHGH Confidential 13