Lux Biosciences-New Jersey Center for Biomaterials/Rutgers University Collaboration. Eddy Anglade, MD Chief Medical Officer
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1 Lux Biosciences-New Jersey Center for Biomaterials/Rutgers University Collaboration Eddy Anglade, MD Chief Medical fficer
2 Company verview Development and commercialization of unique and targeted products for ophthalmic disease phthalmic Diseases a high growth area De-risked molecules in development/marketed re-purposed for ophthalmic indications Common biological mechanisms immune mediated diseases Strong product portfolio with 2 late clinical stage opportunities LX201 (undisclosed) Isotechnika flagship Phase 3 calcineurin inhibitor with superior therapeutic window (simultaneously in Phase 3 in psoriasis and Phase 2b in solid organ transplantation) LX211 (Uveitis) LX212 (Dry Eye Syndrome) LX213 (AMD) Proprietary enabling polyarylate technology for ocular delivery with regulatory validation Strategy to leverage seasoned team Emphasis on execution and discipline Semi-virtual; broad network Well-capitalized: $49 million Series A completed in summer 2006 Marquee Investors 2
3 Lux Biosciences Milestones To-Date June 2005 February 06 May 25, 06 July 11, 06 July 19, 06 September 7, 06 September 13, 06 Lux established as Delaware C company Initial Funding from Novo A/S, SVLS, HBM Partners Closing of series A of $36M shared equally among SVLS, Novo A/S and HBM Partners; exclusive License Agreement with Isotechnika on ISA247 (LX211) for ophthalmic use; Lutz Giebel, Thomas Dyrberg and Axel Bolte join Board David Guyer joins Board Second closing of series A for total of $49M; Prospect Venture Partners joins as equal partner with $12M; IBT adds $1M; David Schnell joins Board Lux Biosciences GmbH (Frankfurt, Germany) founded; Manfred Zoltobrocki appointed Managing Director License and Research Agreements with Rutgers for polyarylate technology in ophthalmic indications (inventor Prof J. Kohn) 3
4 The Lux Story da capo of Recent RA Market Dynamics? Patient population (US) Medical need Standard of care Common treatments Market Rheumatology (pre-1995) RA (0.2M), Psoriasis (4M) High, yet little innovation None; few drugs approved NSAID s; steroids; DMARD s (antimetabolites); obscure medications RA: generic, ~$110M (DMARD s) Psoriasis: generic, ~$800M (world) phthalmic Indications (pre-2005) Uveitis (0.2M), Dry Eye (3.2M), AMD (1.6M) High, yet little innovation None; few drugs approved topical steroids; (some antimetabolites); obscure medications Uveitis: generic; ~$40M (US only) Dry Eye: generic; ~$200M (world) Transformational events 1997: Biologics RA Market (2005): ~$5B 2005: Anti-VEGF; (topical CsA) phthalmic Market (2015): tbd 4
5 Lux Pipeline LX201 (Undisclosed) LX211 (Uveitis) LX212 (Dry Eye Syndrome) LX213 (AMD) Research Pre- Clinical Early Clinical Late Clinical Marketed 5
6 Polyarylates: Enabling cular Delivery Technology Rutgers Univ. invention (Prof. Joachim Kohn) Combinatorial library of ~110 polymers with tailored physicochemical features Suitable for peptides; high loading possible Bio-erodible: breakdown into tyrosine and diacids (resorbed) CH 2 C NH n=1,2 CH CH 2 C R C Y C FDA-approved product (hernia mesh) 6
7 Polyarylates: Differentiating Features Relative to Silicone: Bioerodible Wider range of applicability Relative to PLGA: Improved local tolerance (minimal ph drop) Absence of burst effect General: Strong patent estate with FT CH 2 C NH n=1,2 CH CH 2 C R C Y C High entry barrier; extended exclusivity Lux has worldwide exclusive license for ophthalmic use 7
8 Polyarylate Technology: Advantages Sustained local drug delivery Avoidance of systemic toxicity permits pharmacological dosing of agents Treatment of conditions affecting anterior- and posterior segment diseases Pharmacokinetics tunable 8
9 Collaboration: Lux Biosciences- NJ Center for Biomaterials Elements of partnership poised for success NJ Center for Biomaterials Polymer chemistry Rapid prototyping Experience with a variety of compounds Lux Biosciences Development and commercialization across several therapeutic areas Exclusive focus on ophthalmic diseases Team background diverse encompassing all areas of product development from research through approval 9
10 Lux Funding Syndicate SV Life Sciences - $12M Lutz Giebel, Ph.D. (SF office) Among the top 10% performers with ILSF II Highly successful investment in ophthalmic space (Eyetech) HBM Partners - $12M Axel Bolte (Zürich office) Very successful European based VC with strong pharma network Novo A/S - $12M Thomas Dyrberg, M.D., Ph.D. (Copenhagen office) Selective and highly skilled investor with strong roots in diabetes/ immunology and biologics; strong network among pharma companies Prospect Venture Partners - $12M David Schnell, MD (Palo Alto ffice) Strong track record in health care Strong industry expert advisors International Biotechnology Trust plc - $1M Publicly traded on LSE 10
11 Lux Management Team Ulrich Grau, Ph.D., President & CE : CS, Enzon Pharmaceuticals, Inc : President, R&D, BASF Pharma/Knoll : SVP, Product Realization, R&D Integration fficer, Aventis : CE, HMR BV, The Netherlands A. Clarke Atwell, C : VP, Marketing & Sales, Enzon Pharmaceuticals, Inc : Product Director Transplant Director, Hoffmann-La Roche : Marketing Manager, New Product Planning, Merck Eddy Anglade, M.D., CM : VP, Clinical Development, Enzon Pharmaceuticals, Inc : Medical Team Leader, Transplantation Marketing, Hoffmann-La Roche : Senior Assistant Surgeon, National Eye Institute, National Institutes of Health Manfred Zoltobrocki, Ph.D., Man. Director Lux Biosciences GmbH, Frankfurt : CE, Epidauros Biotechnologie AG : VP, Development, HMR and Aventis Pharma, Frankfurt : Director, VP Clinical Research, Hoechst AG 11
12 Lux rganization Semi- virtual rganization: Highly networked (expert consultants) Non- strategic activities outsourced Strategic expertise in- house Internal staffing of ~ 25 Jersey City (headquarter) and Frankfurt (subsidiary) Nearly all internal resources directly devoted to development Senior management hands- on involved in projects Plans to build S&M infrastructure as projects progress Advantages/ Disadvantages: Low fixed costs shifts in schedule inconsequential Direct senior management involvement; quick decisions Give up some control, but gain depth and flexibility, if well aligned 12
13 verview Pure ophthalmic play Proprietary products with unique mechanistic focus Common biological mechanisms immune mediated diseases Strong IP position Strong product portfolio with 2 late clinical stage opportunities LX201 (undisclosed) Next Generation Calcineurin Inhibitor with superior therapeutic window LX211 (Uveitis) LX212 (Dry Eye Syndrome) LX213 (AMD) Creating high entry barrier: Proprietary enabling polyarylate technology for ocular delivery with regulatory validation Addressing high medical needs; very attractive markets Strategy to leverage seasoned team Semi-virtual; broad network Well-capitalized: $49 million Series A from marquee investors Exit window in H2, 2008 with staged portfolio 13
14 Harborside Financial Center Plaza 10, 14 th Floor Jersey City, N.J
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