psivida Corp PSDV June 2016

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1 psivida Corp PSDV June 2016

2 Safe Harbor Statement Safe Harbor Statement SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: actual final IOP safety results for Medidur Phase III trials; ability to achieve profitable operations and access to capital; fluctuations in operating results; further impairment of intangible assets; decline in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; number and cost of clinical trials and data necessary to support an NDA for, approval by Indian regulators of the trial design for, timing of filing the NDA for, and regulatory approval and successful commercialization of, Medidur; delays in completion of clinical trials; increases in costs of clinical trials; changes in, or misunderstandings with respect to, FDA guidance on required clinical trials; development of the Latanoprost product and any exercise by Pfizer of its option; ability of Tethadur to successfully deliver large biologic molecules and to develop products using it; ability to successfully develop product candidates, complete clinical trials and receive regulatory approvals; ability to market and sell products; success of current and future license agreements; termination of license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements together with these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forwardlooking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized. Page 2

3 psivida: Ophthalmic Drug Delivery Ophthalmic drug market over $20B growing to $36B CAGR 5.7% Retina biggest segment, 33% growing to over 44% CAGR 8.1% Growth drivers New products for un/poorly treated diseases Novel delivery systems Page 3

4 psivida: Unmet Medical Needs in Retina Eye drops Don t penetrate to retina Systemic Many side effects Intraocular Poor duration Ideal Simple injection (office visit) Maintain constant effective drug levels Long term (minimum 6 months) Page 4

5 psivida: Ophthalmic Drug Delivery We develop drug delivery systems Primary focus is Diseases of the Retina Developed 3 of 4 FDA approved SR retina products A leading developer of drug delivery systems for retina Page 5

6 Technology Evolution of psivida Drug Delivery Systems 1 st Generation Vitrasert CMV retinitis Approved nd Generation Retisert Uveitis Approved ,000x less drug 3 rd Generation Iluvien DME Approved ,000x less drug 4 th Generation BioSilicon Multiple Bioerodible Indications Multiple Preclinical Indications Preclinical psivida TBD 20,000x less drug Page 6

7 Durasert: Approved Technology For Ocular Delivery Long Duration Up to 3 years from single injection Durasert Approved Product Bioerosion Tailored to be bioerodible or not Broadly Applicable Can deliver many small molecule drugs Patented Issued patents covering technology and inserter extend beyond 2027 Page 7

8 psivida: Ophthalmic Pipeline Own Products Medidur Phase III in posterior uveitis Durasert pre-clin in wet AMD and dry AMD Durasert IND filed in osteoarthritis Approved Partnered Products Iluvien in DME (marketed, Alimera Sci) Retisert in Uveitis (marketed, B&L) Page 8

9 Medidur Phase III Product for Posterior Uveitis 3 rd - 4 th largest cause of blindness in US US prevalence 175k Same micro-insert as FDA approved ILUVIEN Delivers FA same drug as Retisert Page 9

10 Medidur Phase III Product for Posterior Uveitis 2 Phase III clinical trials Primary end-point: recurrence of 6 months Trial 1: Fully enrolled Last patient last visit end Q Highly stat. sig. Trial 2: Enrolling Top-line data anticipated Q Page 10

11 Phase III Medidur for Posterior Uveitis Fewer patients had a recurrence 18.4% vs 78.6% p < More patients gained vision (15 letters) (stat sig) Fewer patients lost vision (15 letters) (stat sig) Page 11

12 Phase III Medidur for Posterior Uveitis Small increase IOP above 21mmHg cf controls 10.9% 6 months (27.6% vs 16.7%) 6.6% last follow-up (29.9% vs 23.3%) Average increase in IOP of less than 2mmHg 19% of patients on IOP lowering meds vs 18% controls Page 12

13 Medidur for Posterior Uveitis Next Steps Obtain 12 month follow-up of first Phase III study, expect to confirm extended duration Complete enrollment of second Phase III study Page 13

14 Comparison Medidur vs other SR products Medidur Smaller inserter (27 gauge vs 25 gauge) Causes less elevation of IOP (approx. 50% reduction*) Fewer patients on IOP lowering meds Lower dose * Based on data from Phase III studies. Page 14

15 ILUVIEN DME: Partnered with ALIM ILUVIEN Licensed Product Approvals Approved for DME in US, 17 EUs Payments PSDV received over $55m to date Revenues to PSDV 20% of any product profit Page 15

16 Potential Indications for Medidur-like Products Multi-Billion-Dollar Markets Wet-AMD & Dry-AMD Re-purposed drugs highly effective in pre-clinical models Osteoarthritis Sustained release steroids effective Multi-Million-Dollar Markets Glaucoma Many drugs effective Page 16

17 Osteoarthritis Test Case: Severe OA of Knee Durasert technology being applied to develop sustained release implant for long term therapy for Osteoarthritis Collaboration with Hospital for Special Surgery Targeting severe OA of knee Over 700,000 total knee replacements in US annually Anticipate opening IND shortly Page 17

18 Relationships >$80m partner capital since 2008 Developmental Success & Cash Infusions Page 18

19 Pipeline Product/ Indication Medidur AMD Partner Preclinical Phase I Phase II Phase III Commercial Medidur Osteoarthritis Tethadur Durasert Glaucoma Medidur Uveitis ILUVIEN Alimera Retisert Uveitis B&L

20 Tethadur Tethadur Huge Potential 1cm 3 of porous silicon i.e. sugar cube Page 20

21 Tethadur Tethadur Huge Potential Page 21

22 Tethadur: Proteins, Anti-Bodies and BioSimilars Tool for life cycle management Tool for product differentiation Potential short route to improved biologic products Page 22

23 Tethadur: Proteins, Anti-Bodies and BioSimilars Found to be well-tolerated in pre-clinical models after both subcutaneous and intra-ocular administration Anti-body/Tethadur formulations stable under accelerated conditions In-vitro release profile indicates sustained release of anti-bodies for up to 6 months Next Steps: Pre-clinical PK studies, additional IND enabling safety studies Page 23

24 Current Position Approved partnered products (over $80m received to date) Rich pipeline, approved technologies for developing our own products Proven ability to strategically out-license Cash: $33m at March No Debt 34M shares, 0.6M warrants, 5.1M options Page 24

25 Upcoming Milestones (12 months) 12 month safety/efficacy data from Medidur 1st Phase III Completion of enrollment of second Medidur Phase III Opening of IND filing for Osteoarthritis product Pre-clinical data on wet-amd & dry-amd US sales of ILUVIEN in DME (on-going) Additional License deals Page 25

26 psivida Corp Contact: Paul Ashton CEO c/o Ann Fandel