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Discovering new marine leads for unmet clinical needs www.sea4us.pt
Chronic painunmet clinical need
1.5 billion people (21% of world population)
APED
Diabetes
Arthritis
Limb trauma
Fibromyalgia
Cancer
Shingles
Low-back pain
Low quality of life
No adequate treatmentReduced efficacy
Adverse side effectsAddiction Moderate to Severe Pain Market Sales
2010 2015 2020
2% CAGR
€ 19B € 21B€ 17B
Social & Economic Costs in USA (2008)Salary losses, low productivity and healthcare
€ 406-460 billion
Problem&
Market
Defenses against predators:Marine toxins thatact on ion channels
Ion channels
Marine biology
Involved in pain:Molecular targets for pain therapy
Cor
e Ex
pert
ises
Pre-clinical validation
Lead optimization
Chemical ID and synthesis
Ion channel screening
Library of marine extracts
Clinical trials
Marine toxinsas
novel pharmaceutical drugs
Technology
Pain-sensing neurons
“Pain switch”Block of signal propagation
away from the brain
Brain perception of pain
Spinal cord
Ion channelsin pain-sensing neurons
Pain
High efficacyReduced side-effectsNo addictionEasy administration
Signal propagationin pain-sensing neurons
Marine-derived compound
Target Product Profile
Drug Discovery Pre-Clinical
PhaseI
FDA/EMA Approval
Extract Collection Sales
PhaseIII
Licensing options
Drug Development Phase
IIaPhase
IIb
€ 1 M
Year 1 Year 6 Year 7 Year 12Year 2 Year 4 Year 5Year 3 Year 8 Year 9 Year 10 Year 11
€ 2 M € 16 M
€ 182-273M + double-digit royalties
€ 4M + € 4M/year milestones
Comparable licensing deals:
Total investment for Option II: € 19M(less if orphan disease designation, ex.: trigeminal neuralgia)
(EUA or Europe)
Option I Option II
Option I
Option II
Roadmap
Q1 Q2 Q3 Q4
Year 1 Year 2 Year 3 Year 4
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Bioactive compound
identification
Pre-clinical validationCompound synthesis
€ 539k € 121k € 253k
IND application
€ 913k
Licensing option I
Molecular target #1: Kv1.4
Marine library
Intellectual Property
Required investment
Source
Development Plan
15% approved (€ 83K)85% required (€ 456K)
Filipe Vilas-Boas, PhDMolecular Biology, Genetics,
Microbiology, Neural Development
9 years of experience
Marisa Sousa, PhDBiochemistry, Genetics,
Physiology, Pathology
9 years of experience
Hugo Pacheco, MScEconomics & Finance
Sales & MarketingProcess Expert Sr.
10 years of experience
Pedro A. Lima, PhDNeurophysiology,
Marine Biology
18 years of experience
Team
Chronic pain Sea4Us has core expertise
in marine biology and ion channel modulators.
We are developing a first-in-class analgesic from marine origin that modulates a key ion channel away from the brain, stopping pain perception.
1.5 billion people worldwide
Marine library generation Bioactive compound characterization – Patent
I Synthesis of 1st lead molecule – Patent II Pre-clinical studies Investigational New Drug Application
NEXT STEP DELIVERABLES€ 539K (1.5 years) for bioactive compound intellectual property
€ 913K (3 years) to finish pre-clinical studiesEXIT OPTION
TOTAL INVESTMENT
Summary
www.sea4us.ptPedro [email protected]+351 963807571