XII Encuentro de Cooperación Farma-Biotech
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1 de Cooperación Santiago de Compostela, 26 de septiembre de 2014 Neuroprotective BN201 for multiple sclerosis and orphan CNS indications
2 de Cooperación Content 1. The Company and the current pipeline 2. The Product - Target Indications - Innovative aspects - Current status of development: proof of concept and trials already performed - Differential features facing the market and business opportunities - IPR protection - Pitfalls & Risks to be considered
3 1.Earlystagedrugdevelopmentco. 2009
4 1.Earlystagedrugdevelopmentco. 2009
5 1.Earlystagedrugdevelopmentco
6 1.Earlystagedrugdevelopmentco Small molecule NCE + First-in-Class Orphan Neuro-ophthalmology
7 2.1OpticNeuritis Inflammatory disease of the optic nerve 5/100,000
8 2.1OpticNeuritis Inflammatory disease of the optic nerve 5/100,000 40,000 patients/yr
9 2.1OpticNeuritis Inflammatory disease of the optic nerve 5/100,000 IV corticos 40,000 patients/yr
10 2.1OpticNeuritis Inflammatory disease of the optic nerve 5/100,000 IV corticos 40,000 patients/yr No improvement visual outcome
11 2.1OpticNeuritis Inflammatory disease of the optic nerve 5/100,000 IV corticos Axon/Myelin 40,000 patients/yr No improvement visual outcome
12 2.1OpticNeuritis Inflammatory disease of the optic nerve 5/100,000 IV corticos Axon/Myelin 40,000 patients/yr No improvement visual outcome Pain Vision loss
13 2.1OpticNeuritis
14 2.1OpticNeuritis Also focused in Neuromyelitis Optica
15 2.2BN201:smallmolecule,NCE,FiC Axon Myelin
16 2.2BN201:smallmolecule,NCE,FiC Neuroprotection Remyelination
17 2.2BN201:smallmolecule,NCE,FiC Neuroprotection Remyelination Novel MOA: SGK agonist (FOXO3) -> cell survival
18 2.3BN201:novelMOA SGK agonist -> FOXO3 translocation No treatment 40X BN201 2µM (15 ) 40X FOXO-3 staining by immunofluorescence in SH-SY5Y after BN201 stimulation
19 2.4WhyOpticNeuritis? Acute
20 2.4WhyOpticNeuritis? Acute
21 2.4WhyOpticNeuritis? Acute Eye
22 2.4WhyOpticNeuritis? Acute Eye Rare
23 2.4WhyOpticNeuritis? Acute + Eye + Rare Demonstrate neuroprotection in humans
24 2.5Milestones POC
25 2.5Milestones Optic Neuritis (x2) (demyelination) POC
26 2.5Milestones Optic Neuritis (x2) (demyelination) POC Multiple Sclerosis (x2) (inflammation)
27 2.5Milestones Optic Neuritis (x2) (demyelination) POC Multiple Sclerosis (x2) (inflammation) Glaucoma (hypertension)
28 2.5Milestones Optic Neuritis (x2) (demyelination) Patent POC Multiple Sclerosis (x2) (inflammation) Glaucoma (hypertension)
29 2.5Milestones Optic Neuritis (x2) (demyelination) POC Multiple Sclerosis (x2) (inflammation) Glaucoma (hypertension) Patent Orphan
30 2.5Milestones Optic Neuritis (x2) (demyelination) POC Multiple Sclerosis (x2) (inflammation) Glaucoma (hypertension) Patent Orphan Pre-IND
31 2.5Milestones Optic Neuritis (x2) (demyelination) POC Multiple Sclerosis (x2) (inflammation) Glaucoma (hypertension) Patent Orphan Pre-IND Regulatory Preclinical Toxicology for IND
32 2.6Developmentstrategy
33 2.6Developmentstrategy Phase 1 (Standard) 2016
34 2.6Developmentstrategy 2016 Phase 1 (Standard) Phase 2a ON 2017
35 2.6Developmentstrategy 2016 Phase 1 (Standard) Phase 2a ON 2017 Phase 2/3 NMO 2018
36 2.6Developmentstrategy 2016 Phase 1 (Standard) Phase 2a ON 2017 Phase 2/3 NMO 2018
37 2.6Developmentstrategy 2016 Phase 1 (Standard) Phase 2a ON 2017 Phase 2/3 NMO 2018 Biz potential after probing neuroprotection
38 2.6Pitfalls&Risks Management Albert G. Zamora, MBA Co-founder, CEO
39 2.6Pitfalls&Risks Management Albert G. Zamora, MBA Co-founder, CEO Pablo Villoslada, MD, PhD Co-founder, CSO
40 2.6Pitfalls&Risks Technical/Strategic risk Been There, Done That
41 2.6Pitfalls&Risks Technical/Strategic risk Been There, Done That Joaquim Trias
42 2.6Pitfalls&Risks Technical/Strategic risk Been There, Done That Joaquim Trias Larry Steinman
43 2.6Pitfalls&Risks Technical/Strategic risk Been There, Done That Joaquim Trias Larry Steinman Steve Hauser
44 2.6Pitfalls&Risks Technical/Strategic risk Been There, Done That Joaquim Trias Larry Steinman Steve Hauser Craig Smith
45 2.6Pitfalls&Risks Technical/Strategic risk Been There, Done That Joaquim Trias Larry Steinman Steve Hauser Craig Smith Ari Green
46 2.6Pitfalls&Risks Regulatory risk
47 2.6Pitfalls&Risks Financial risk 1. Equity round of funding completed 2. International validation by a third party
48 2.6Pitfalls&Risks Patients
49 2.6Pitfalls&Risks Patients Academia
50 2.6Pitfalls&Risks Patients Academia R&D
51 2.6Pitfalls&Risks Patients Industry Academia R&D
52 de Cooperación Santiago de Compostela, 26 de septiembre de 2014 THANK YOU!
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