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OVERVIEW: Drusolv Therapeutics Is a Clinical-Stage Drug Company Based in Philadelphia

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OVERVIEW: Drusolv Therapeutics Is a Clinical-Stage Drug Company Based in Philadelphia OCUSTATIN™ FOR EARLY TREATMENT OF AMD OVERVIEW: Drusolv Therapeutics is a clinical-stage drug company based in Philadelphia. We are developing a high- dose oral statin for early intervention in a blinding eye disease called age-related macular degeneration (AMD). LARGE UNMET NEED: AMD is the leading cause of blindness in developed countries. It affects 150M people worldwide, including 1 in 7 over age 60. That is more that glaucoma and diabetic retinopathy combined. Our product, Ocustatin, is aimed at patients who are still in the intermediate stages of the disease and currently have very limited options to prevent progression to late-stage vision loss. This is a $4B per year, completely unmet need. BREAKTHROUGH PRODUCT: Ocustatin was developed at Harvard University and has been validated in a highly successful proof-of-concept clinical trial. It is based on the strong parallels between atherosclerosis and AMD. Atherosclerosis (or “hardening of the arteries”) is characterized by buildup of cholesterol deposits inside artery walls to form plaque. AMD is characterized by accumulation of cholesterol deposits in the retina to form drusen. Drusen has the same composition as plaque. Just as intensive statin therapy dissolves plaque in atherosclerosis, we have demonstrated that it dissolves drusen in AMD. Our proof-of-concept trial showed dramatic efficacy for intermediate AMD patients treated with high-dose oral atorvastatin (generic Lipitor®). Over 40% of the participants had a marked clearance of drusen, with most experiencing essentially complete disappearance. Furthermore, in a five-year follow- up those who continued treatment had a 75% reduction in progression to late AMD and associated blindness. EXPERIENCED MANAGEMENT TEAM: The Drusolv team has extensive experience with AMD, drug development and startup companies. John Edwards is founder and CEO. Mr. Edwards is a serial entrepreneur with several successes. In particular, he was previously co-founder and CEO of MacuLogix, a venture-backed company successfully commercializing the first practical diagnostic for early detection of AMD. Mr. Edwards has BS and MS degrees in physics from MIT and an MBA from University of Chicago. Tom Hohman, PhD is providing strategic direction. Dr. Hohman is a 35-year veteran of the ophthalmic industry with senior positions at Novartis, Alcon and Allergan. He managed the development of several major retina drugs, including Lucentis®, the most successful of the drugs used to treat late AMD. Joan Miller, MD and Demetrios Vavvas, MD/PhD of Harvard University are providing clinical guidance. Dr. Miller is Chair & Chief of Ophthalmology and a leading authority on AMD. Dr. Vavvas discovered our method for treating intermediate AMD with high-dose statins. PROVEN BUSINESS MODEL: We are following a well-established roadmap for commercializing a repurposed drug. First, Drusolv has exclusive rights to a pending patent (PCT/US2016/056987) for the use of statins to treat AMD. This blocks everyone else from promoting or selling a competing statin for this indication. Second, while Ocustatin uses the same chemical structure as atorvastatin, it has a unique high dose with no branded or generic equivalent. This blocks competition from off-label prescriptions because they will not be exactly equivalent to the unique dose we are establishing as safe and effective. Viagra® is a high-profile example of successful repurposing based on dose. It was originally developed as Revatio® for treatment of pulmonary hypertension. Protected by a subsequent patent for use in treating erectile disfunction and formulated at unique higher doses, Viagra sustained a reimbursement of $35 per pill despite the availability of generic Revatio that costs less than $1 per pill. There are numerous other examples, such as Duexis®, Omidria®, Korlym®, Propecia® and Silenor®. COMPETITION & DIFFERENTIATION: Competition for treatment of intermediate AMD is very limited. The current standard of care is over-the-counter AREDS eye health vitamins that offer modest benefit. There are presently no prescription drugs for this stage of the disease, and there are only two other candidate drugs targeting intermediate AMD that have ongoing clinical trials. Both are in early development. And unlike our oral Ocustatin, both require injections. INVESTMENT OPPORTUNITY: Our objective is to exit via acquisition after completion of a compelling Phase 2 clinical trial, and we have developed a four-year, $20M plan to that end. There is an immediate need for $2M of seed financing to prepare an Investigational New Drug (IND) application and to complete basic formulation and bioavailability studies. There is a follow-on need for an additional $18M, with the major cost being the compelling Phase 2 trial. Drusolv is actively engaged in raising this funding. It will be our first outside capital. 1425 Locust Street, Unit 7C, Philadelphia, PA 19102 ▪ (404) 536-4012 ▪ [email protected] .
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