Caixa Empreender Award | Sea 4 Us (Cotec)

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Transcript of Caixa Empreender Award | Sea 4 Us (Cotec)

Discovering new marine leads for unmet clinical needs www.sea4us.pt

info@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 Limapedro.lima@sea4us.pt+351 963807571