envisia therapeutics

Envisia Therapeutics

Precisely Engineering the

Future of Ophthalmology™

April 2015

2© ENVISIA Therapeutics– All Rights Reserved

Corporate Milestones

• Company formed in Nov 2013 as a spin out of Liquidia Technologies--$25m in funding

• IND filed for ENV515, a 6 month biodegradable formulation for glaucoma – Ph 2a underway

• Initiated development of ENV905, a biodegradable formulation for post cataract inflammation (IND expected 2H’15)

• Developed XR formulations of biologics – assessing several partnership opportunities

• Appointed Dr. Adrienne Graves and Dr. Gary Phillips to Board of Directors


Envisia Therapeutics Pipeline

Ph 2a

2014 2015 2016 2017 2018

Pre-clinical Ph 2b Ph 3

Research Pre-clinical Ph 2 Ph 3

ENV515 (glaucoma)

ENV905 (post cataract inflammation)

Research Research Collaborations Product Development

Partnership (back of the eye)NDA


PRINT® Technology Platform• Engineering and production of <100 nm particles to

>1000 micron implants

• cGMP manufacturing with high batch-to-batch reproducibility and dose uniformity

• Manufacturing scale capable of supporting commercial demand

cGMP Manufacturing

Best in class control over particle size, shape and formulation


5 µm

0.5 mm

Precisely Engineered Ophthalmic Drug Delivery Systems

Versatile technology, compatible with a wide range of polymers, small molecules and biologics

High Concentration Bevacizumab Particles

Travoprost

PEG Hydrogel/RNA Nanoparticles

Difluprednate

Bevacizumab Microparticles in a Polymer Hydrogel

1 µm

0.5 mm

5 µm

Dexamethasone

0.5 mm

Intracameral Biodegradable FormulationsGlaucoma—ENV515


ENV515 Intracameral Extended-Release

Large

Small

Target Product Profile• 24/7 control of IOP (25-30% decrease)• 6 month duration of action• Less hyperemia than drops• Easy administration• Fully biodegradable• Excellent safety

Extended-release biodegradable travoprost formulation puts the treatment of the disease in the hands of the doctor, not the patient

Travoprost


8 Months of IOP Reduction in Hypertensive Beagle Dogs

Baseline

30% change from baseline

ENV515

Placebo

ENV515

32% reduction in baseline IOP over 8 months from single dose of ENV515


Phase 2a safety, efficacy, and ocular PK in glaucoma patients about to undergo cataract surgery:20 patients, 4 weeks , 4 dose groups, TRAVATAN Z in non-study eye, IOP at several time points, ocular PK in aqueous humor and travoprost content in ENV515 retrieved during cataract surgery

Phase 2a

1. PGA Washout Period

(4 weeks)

• 20 patients enrolled

• All PGA therapy discontinued

2. Masked ENV515 DosingPeriod

(4 weeks)

3. Safety Follow-up Period

(2 weeks)

• All patients • 4 ENV515 dose groups

(5 patients per dose group, 20 patients total)

Dose ENV515Recover ENV515 during cataract surgery

(PK in aqueous humor and travoprost content in recovered ENV515)

IOP IOP IOP IOP IOP

Initiate PGA washout

Phase 2a Study Underway

Subconjunctival Biodegradable FormulationsOcular Inflammation—ENV905


ENV905: Post Cataract Difluprednate XR

Difluprednate

0.5 mm

Target Product Profile• 3-4 week control of inflammation• Lower drug exposure• Easy administration• Fully biodegradable• Excellent safety

Current Situation• Topical steroids are QID dosing• Generics dominate, but branded products are competitive• Need for improvement in overall efficiency of managing cataract

patients from beginning to end

XR steroid formulation puts control of inflammation in the hands of the doctor


ENV905 is Efficacious for More than 3 Weeks in Rabbit Model of Inflammation

ENV905 in subconjunctival space immediately post-dose.

ENV905 dosed at day 1, with sustained efficacy over 3 weeks Placebo

Durezol

ENV905

Single dose ENV905 is equivalent or superior to daily topical QID Durezol® in vivo

Intravitreal Biodegradable Drug DeliveryBack of Eye Diseases


Extended Release Formulation Strategies

Solid-state antibodyor small molecule

(0.1-5 mm)

Extended release depot

(10’smm-mm)

Material design Biodegradable Thermoplastics

Degradable Hydrogels

PRINT creates multiple kinds of patentable size/shape/polymer combinations designed for multi-month delivery of biologics and small molecules

RodsMicroparticles

High conc. mAb Micronized API


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In-vivo Efficacy & Safety Proof-of-Concept Achieved

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Herlihy et al. 2014: ARVO Poster

Retinal Leakage Scores (rabbits at 2 months)

6 Months in-vitro release

Formulation G

Signed collaboration with market validating partnerOther discussions ongoing

Pilot safety and tolerability in nonhuman primate of vehicle and bevacizumab formulation shows good tolerability at 2 months

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New Technology Development


Combination Products

Demonstrated extended release from two different drugs in one release depot formulation

Extended Release Combination Formulations

Polymer

Drug A

Drug B

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M a rk e te d P ro d u c t

P 1 - a n io n ic

P 2 - c a t io n ic

P 3 - c a t io n ic

P 4 - c a t io n ic

Particles can be used to study the effects of size, shape,

chemistry and modulus for improving PK/PD properties

Engineered Nanoparticles for Drug Delivery

THANK YOU

[email protected]

envisia therapeutics

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