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Patented Timed Drug Delivery to the Eye via Contact Lens/Clear BANDAGE Lens with Extended Wear- REPLACES EYE DROPS CURRENT EYE DROP MARKET $16B (CAGR ~8%)

the Eye via Contact Lens/Clear BANDAGE Lens with Extended … · 2019-12-20 · In Vitro In Vivo Pre-IND Phase I Phase II OM002 - NSAID - eluding anti-inflammatory extended wear lens

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Patented Timed

Drug Delivery to

the Eye via Contact

Lens/Clear BANDAGE

Lens with Extended

Wear-

REPLACES EYE DROPS

CURRENT EYE DROP

MARKET $16B

(CAGR ~8%)

Problem & Solution

PROBLEM• < 5% of drops get to the targeted tissue in the eye• Treatment requires multiple drops/day >300 Drops

for post cataract treatment• Missed dosing costs $70B/complications

OCUMEDIC SOLUTION

✓Drug continuously delivered to targeted tissue✓Enhanced efficacy and convenience ✓Eye Care Professionals are trained to deliver

OcuMedic Therapy at the point of care – no patient compliance issues

✓Reduced Complications & Healthcare cost

OcuMedic Lens Extended Delivery vs. Drop

OcuMedic’s lenses have the potential to deliver 16x more drug per day with 1.3x higherbioavailability. Drops have short residence time caused by quick tear turnover.

201510Time (hours)

50

0

0.005

0.01

0.015

Bioavailability Lens/Eye drop* = 1.31

Mass Drug (µg) Delivered per Day Lens/Eye drop = 160.02

0.025

LensDrop

0.03

Efficacy, Controlled Release, & Safety Data

0

50

100

150

200

250

300

0 2 4 6 8 10 12 14 16 18 20 22 24 26

Drug

Con

cetr

atio

n in

Eye

Tea

r Flu

id (m

g/m

L)

Time (hrs)

Engineered Lens With Memory

Eye Drop (0.035% solution Zaditor®)

TiepApo, C.J. White, A.C. Paine, M.L. Voyles, M.K. McBride, M.E. Byrne. J. Control. Release. 157, 391-397, 2012

OcuMedic Lenses are ~100x more efficient drug delivery devices than topical eye drops–the current standard of care - No drug releasing lenses are in the market today

Controlled Duration of Drug Release

0

0.2

0.4

0.6

0.8

1

0 5 10 15 20 25 30 35

Frac

tio

nal

Bro

mfe

nac

Re

leas

e

Time (days)

3:1 M/T 25:1 M/T

15 days vs 30 day release

Higher M/T Ratio (Monomer/Template Ratio) of lens Polymer Structure Leads to more "Memory" & Longer Release Period

A. Tieppo, K. M. Pate, M. E. Byrne. European Journal of Pharmaceutics and Biopharmaceutics. 81, 170 -177, 2012.

Anti-Inflammatory Drug Eluding LensBromfenac “First Line” eluding anti-inflammatory lens made with silicone Hydrogel (80% of used lenses) for treatment of postoperative inflammation and reduction of pain after cataract and Lasik surgeries

Wear Time 7 Days

Indications• Cataract • LASIK • Corneal Abrasions

First Product in Development

Drug Eluding Lens to treat Dry Eye Syndrome (DES)

Hyaluronic acid/HPMC and cyclosporine - eluding lenses are in development*

Today DES is considered the leading cause of US patient visits to Eye Care providers: 20-30M people have early signs & symptoms of DES

Global revenues in the dry eye treatments market is expected to climb from $4.6 billion in 2018 to $6.2 billion in 2023**

* M. Ali, M.E. Byrne. Controlled Release of High Molecular Weight Hyaluronic Acid from Molecularly Imprinted Hydrogel Contact Lenses. Pharmaceutical Research 26(3), 714-726, 2009

** C. White C, M. McBride, K. Pate, A. Tieppo, M.E. Byrne. Extended Release of High Molecular Weight Hydroxypropyl Methylcellulose from Molecularly Imprinted, Extended Wear, siliconee Hydrogel Contact Lenses. Biomaterials (32):5698-5705, 2011.

Following Products in Development

Milestones

Product Candidate Indication Stage of Development

In Vitro In Vivo Pre-IND Phase I Phase II

OM002 - NSAID - eluding anti-inflammatory extended wear lens

Cataract/LASIK/Corneal Abrasion

OM004 - Cyclosporin and Hyaluronic Acid/Comfort Agent - eluding extended wear lens

Dry Eye Syndrome

OM006 - Prostaglandin Analog, Latanoprost -eluding extended wear lens

Glaucoma

OcuMedic Commercialization Strategy: Exit at Phase II - In Dialogue with Several Potential Acquirers

OcuMedic Platform Technology

OcuMedic's novel technology produces lens polymers, in association with drugs of choice, creating polymeric networks with small pores “macromolecular memory”, unique for each drug, enabling:

• Enhanced affinity of the drug and polymer (high payload)• Continued and controlled diffusion of the drug

Controlled delivery of drugs from contact lenses has been the subject of investigation for over 50 years

Value Proposition

List of The US/EU Issued Patents (Valid through 2026-30)Patent # US 8,404,271 B2 Contact Drug Delivery System (broad)Patent # EP 1848749 Contact Drug Delivery System (broad)

Patent # US 9,238,003 B2 Extended or Continuous wear silicone Hydrogel Contact Lenses for the Extended Release of Comfort Molecules

Patent # US 8,388,995 B1 Controlled and Extended Delivery of Hyaluronic Acid and Comfort Molecules via a Contact Lens Platform

Patent # US 8,349,351 B2 Contact Drug Delivery System

Patent # US 8,349,352 B2 Therapeutic Contact Lenses with Anti-Fungal Delivery

OcuMedic has 10 issued Patents and "Freedom to Operate" legal opinion, enabling controlled release of drugs to the eye: 5 US, 2 Canada, 1 Mexico, 1 India, 1 EU (broad)

Recent Development Updates

In Q3-2019, OcuMedic achieved 2 Financial and Strategic Partnership Milestones, propelling it to the next phase of regulatory approval and commercialization:

In July 2019 OcuMedic expanded its global presence. The company was awarded Chinese Municipal Government financial support to establish a subsidiary/Joint venture in the province of Shandong, China. OcuMedic will work with an affiliate private company, INNO LINK, to establish the entity, identify collaborative partners for manufacturing, regulatory and marketing and sales in the greater China

In August 2019, OcuMedic finalized an exclusive vertical integration agreement with Gelest Inc., a major global supplier of materials to the contact lens industry. The arrangement included a “Design-in Supply Agreement” using Gelest custom chemistry formulated for specific drug delivery under OcuMedic IP for a contact lens/corneal bandage. Gelest Inc. also participated in the Series A round of financing.

Series A Financing:• Lead investment by Rowan Innovation

Venture Fund • Pre Money valuation $7M• Price/Share $1.00• Participating Preferred Offering $5-7M

(Minimum$25K) With (50% warrant coverage on investment @exercise price of $0.01)

Use of Proceeds:• In vitro Dry Eye Study • FDA In vivo Navigation Study – Q 4 2019• Phase 1-2 Human Studies - 28 mo• Exit/Partner Identification

Investment Highlights

LeadershipKeith Ignotz, MBA - President & CEO

Co-founded & Sold Freedom Meditech as President & COO,

Onset President & CEO of DiaKine Therapeutics,

Co-founded SpectRx as President & COO

Senior VP Allergan Humphrey , division of Allergan

Paul Byrne, MBA - Co-Founder, CBO & CFO

20+yrs McKinsey, PNC Bank Executive, experience on corporate

strategy, ops, distribution, sales

Mark Byrne, Ph.D. - Founder, CTO

16+yrs Distinguished Chemical & Biomedical Engineering Professor & Founding Dean/Dept

Head, Internationally recognized expert biomaterials/drug delivery, manage College faculty/staff

of 100+ people, 90+ peer-reviewed publications, NIH & NSF panel reviewer, 350+

invited/conference talks, 12 patents, 17 mentored PhD and 100+ Engineering research students

Fredrick Cahn, Ph.D. - Acting CRO30 years of experience in biomedical engineering/product development, consulting for Regulatory & Reimbursement with an ophthalmic focus

Scientific and Advisory Board

Mr. Steve Martin Advisory BoardPrior Founder of CIBA Vision Optics (now part of Alcon) and CIBA Vision Ophthalmics (now part of Novartis) At CIBA, he and his team grew sales to over

$1.2 Billion and led >6,000 employees.

Lynn Winterton, Ph.D. Scientific Advisory BoardPrior Global Head of R&D CIBA Vision, 30+yrs developing & commercializing multiple

contact lenses on market today

Paul Karpecki, O.D. Scientific Advisory BoardChief Clinical Editor of Review of Optometry, 20+yrs Director of Corneal Surgery

Steve Hamilton, M.D. Clinical AdvisorBoard Certified Ophthalmologist, 18+yrs specializing in corneal disease and surgery

Mr. Ron Dadino Regulatory AffairsPrior J&J VP leading regulatory strategy for all combination products , 33+yrs

in pharma & medical device sector, led global approval for first drug/stent

combination device >$1B in sales

Gary Novack, Ph.D. Regulatory AffairsPresident of PharmaLogic, 30+yrs in pharma R&D, consultant 400+ pharma

and medical device firms on regulatory strategy

Company Highlights

Experienced Management Team

Strong Worldwide Patent Portfolio - valid until 2030

Strategic Partners Gelest / INNO LINK China for…Growing Markets

Reimbursement at FDA approval with CPT code 92071

Staged to advance to Phase 1-2 Clinical Trials

STRATEGIC TAKE OUT EXIT BENCHMARKS at Phase II

several potential acquirers :

Ophthalmic asset exit Examples:

Eye Gate licensed to B&L Valeant at $135M

Forsight Vision5 licensed to Allergan at $95M