Caixa Empreender Award | Sea 4 Us (Cotec)

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Discovering new marine leads for unmet clinical needs www.sea4us.pt [email protected]

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

Page 1: Caixa Empreender Award | Sea 4 Us (Cotec)

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

[email protected]

Page 2: Caixa Empreender Award | Sea 4 Us (Cotec)

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

Page 3: Caixa Empreender Award | Sea 4 Us (Cotec)

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

Page 4: Caixa Empreender Award | Sea 4 Us (Cotec)

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

Page 5: Caixa Empreender Award | Sea 4 Us (Cotec)

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

Page 6: Caixa Empreender Award | Sea 4 Us (Cotec)

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)

Page 7: Caixa Empreender Award | Sea 4 Us (Cotec)

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

Page 8: Caixa Empreender Award | Sea 4 Us (Cotec)

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

Page 9: Caixa Empreender Award | Sea 4 Us (Cotec)

www.sea4us.ptPedro [email protected]+351 963807571