Executive Summary


Topical ocular drug delivery for glaucoma, myopia and other eye diseases. Can be worn without replacement for months providing constant 24/7, controlled drug delivery. Solves eye drop failings including dosing variability, avoidable side-effects, instillation difficulties and high rates of non-compliance particularly for the most vulnerable patients.

Amorphex 2 Executive Summary 2016 PDF/Printable Version of Executive Summary

Overview

Amorphex Therapeutics has developed a novel, patented Topical Ophthalmic Drug Delivery Device -TODDD™, a soft, flexible device that floats on the tear film completely concealed under the eyelid. It is easily and quickly replaced by practice staff or even the patient themselves. Animal testing and preliminary human trials have confirmed its safety and efficacy.

Technology

TODDD™ is a non-invasive biocompatible elastomeric device that is placed on the scleral surface and concealed completely under the eyelid.

  • Continuously delivers micro-doses of therapeutic 24/7
  • Exceptionally large capacity for delivery of medication over several months
  • Design optimized for comfort, ease of insertion, long term retention and ease of removal
  • Drug is polymerized into a customized material matrix or loaded into one or multiple polymerized drug depots
  • Capable of delivering several drugs simultaneously and at different rates
  • Patents issued in US, Canada, Europe & Japan

todd_dd

Market and Benefits

  • Ophthalmic topical drug delivery for glaucoma, dry eye, allergies,
    infection & inflammation – $5+ Billion annually.
  • Numerous comparative advantages over eye drops and competitive alternatives
  • The TODDD platform technology provides much more reliable drug delivery for multiple drugs over longer periods of time resulting in:
    • Easier and more effective therapy for patients
    • Easy to adopt, improved disease management for physicians
    • Reduced total patient care costs for providers and insurers
    • Distinct competitive advantages for pharma companies including
      extending the effective patent life of their proprietary drugs

Development Milestones

  • Completed 3rd NIH SBIR grant (Phase II-a), $2.5 million total
  • Demonstrated uninterrupted therapeutic efficacy in human for 180 days
  • Demonstrated efficacy in 90 day timolol rabbit study
  • Reduced IOP more than 35% in a prostaglandin beagle study
  • Confirmed myopia control drug delivery in vivo for 60+ days
  • Demonstrated safety, comfort and retention in human clinical trials
  • Developed low cost pilot cast molding manufacturing process
  • Confirmed regulatory path with FDA

Next Steps – Clinical and Pre-clinical Development

Amorphex will conduct human therapeutic clinical trials of TODDD™ (30+/- subjects) delivering timolol, prostaglandin and both drugs simultaneously, (but independently) from the same device. This funding will also support pre-clinical and clinical development of TODDD™ for myopia progression and pre-clinical work for other applications such as ocular allergy and inflammation as outlined in the chart below.

Future Business Development

There are more than 10 unique drugs and drug combinations with  annual revenues of $250 million to more than $1 billion that could be delivered using TODDD™ technology. With the clinical data from the trials described above, TODDD™ technology will be sufficiently developed and its safety and efficacy demonstrated such that ophthalmic drug companies will be prime potential partners. After conducting the trials, the company will have a number of options for its further development and will pursue one or more of the following – seek to license or sell individual TODDD applications, further develop its most promising prostaglandin product, take more pre-clinical products into Phase 1, or prepare itself for a potential IPO or acquisition.

Funding Sought

Amorphex Therapeutics has received $4.0 million of funding to date including the $2.5 million from NIH grants. We are seeking an additional $7.6 million of funding and there will be several major milestones that can be achieved with a portion of that amount. The $7.6 million will be deployed over 3 years and follow a clear path to potential liquidity events and several substantial increases in valuation.

Dr. Charles Leahy, co-founder of Amorphex Therapeutics, demonstrates how the TODDD drug delivery device is placed under his eye lid.

Management Team

CEO
Robert Thompson
· Extensive start-up and development experience
· Former president of 2 Bausch & Lomb divisions

VP of Technology
Edward Ellis, PhD
· 30+ patents with more than $2 billion in sales

VP of Clinical Affairs
Charles Leahy, OD, MS
· Practicing clinician – Massachusetts Eye & Ear Infirmary/Harvard Medical School

Legal Counsel
Morse, Barnes-Brown & Pendleton
Leason-Ellis

Accounting Firm
Brady and Company P.C.

Advisory Board

L. Jay Katz, MD
– Director of Glaucoma Service, Wills Eye Hosp.

Martin Wax, MD
– CMO, Pan Optica, Inc.

Thomas Brunner, MBA
– President of Glaucoma Research Foundation

Thomas Capetan, MBA
– Former VP of Licensing, Alcon Labs

David Marsh, PhD
– Former Research Investigator, Drug Delivery, Allergan


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