INNOVATIVE DRUGS IN STIMULATING LOCAL BLOOD …€¦ · Focus on Topadur priority projects Develop to clinical phase 2 2019-22 Grow and become a global player for rare wound healing

INNOVATIVE DRUGS IN STIMULATING LOCAL BLOOD PERFUSION

TO

ENABLE WOUND HEALING,TREATMENT OF MAJOR EYE AND AGING DISEASES

Reto Naef, PhD, MBACEO and FounderTopadur Pharma AG

Grabenstrasse 11A8952 Schlieren / ZurichSwitzerlandTel. +41 44 755 44 66

[email protected]

© Topadur Pharma AG | November 2019

mailto:[email protected]

The Company

Founded2009 GmbH, 2015 AGLocation: Schlieren/ZurichEmployees: 17 (12 FTEs)

FINANCIALS (past)14.0 M US$ equity3.5 M US$ non-dilutive1.6 M US$ pending

CURRENT EQUITY ROUND14 M US$ Ser-C1 6.5 Mio (2019), Ser-C2 7.5 Mio (2020) Expected exit: 2022

NEXT MILESTONESFIH (TOP-N53) Q4/2019

Problem Indications & MarketsChronic non-healing wounds, excessive scar formationOcular blood flow, medical cosmetics

PDE5enzyme

inhibitioncGMP

sGCenzyme

stimulation

Topadur Drug Platform

Topadur invented LMW drugs based on two key enzymes incGMP metabolism, leading to increased blood perfusion,

stimulating angiogenesis and tissue regeneration to enable new therapies for several indications with high medical needs.

Local application of the angiogenetic drug candidates is expected to result in sustainable disease modification.

Invention & Solution


ManagementLeadership and Board Members

150 years in total - within Pharma

LEADERSHIP TEAM BOARD MEMBERS

Dr. Guido Koch

COO

Dr. Reto Naef

CEO & President of Board

Dr. Hermann Tenor

CSO

Christina Attaalla

CFODr. Christian Ludin

Head Development,

Legal & Secretary o. B.

Pascal Brenneisen

Investor, Legal, Marketing

Prof. Dr. Günther Wess

R&D, Diabetes

Dr. Dominik Escher

Serial Founder,

Ophthalmology


Endothelial Dysfunction -The Solution

Topadur’s unique Drug Platform - based on sGC Stimulation and PED5 Inhibition


Key target cells

Cellular targets and funcional effects increasing cGMP signaling; Topadur’s dual MoA drugs


Cell type Functional effect of cGMP

stimulation

Vascular smooth muscle Blood perfusion

Endothelial cells Angiogenesis

Retinal ganglion cells Neuroprotection

Hair cells (sclap and inner ear) Preservation

Fibroblasts Anti-fibrotic

Intestinal epithelial cells Prevention of colorectal tumors

Head and neck SCC Growth retardation. aptoptosis

Wound healingAngiogenesis

TOP-N53 1st priority

• Diabetic foot ulcers• Orphan ulcera• Decubitus• Major surgery

Scar preventionAnti-fibrotic

TOP-N443rd priority

• Burn wounds• Skin fibrosis• Fibrotic lung/eye

diseases

Opportunistic R&D

TOP-M119TOP-N53; TOP-V122

• Pulmonary ArterialHypertension

• Medical CosmeticsAlopecia, Skin aging

• Hearing loss • HNSCC & colon cancer

Ocular blood flowNeuroprotection

TOP-V1222nd priority

• Glaucoma• dry AMD• Diabetic

Retinopathy

Portfolio andPrioritiesR & D Portfolio


lead finding profiling in vitro POC in vivo POC toxicology FIH Phase 1 Phase 2a/b Phase 3

preclinical clinical

Priority Projects

Opportunistic Projects

Developmental Overview

DFU & wound healing

scar formation, burn wounds

glaucoma, ophta

PAH, hair growth, skin aging

opportunistic R&D, colorectal cancer

Projects forearly Partnering

Drug Candidate - Development

R&D projects


Topadur strategy and development

Max. value generation

Develop to preclinical

POC 2019-21

Focus on Topadur priority projects

Develop to clinical phase 2 2019-22

Grow and become a global player for rare wound healing indications

Go to market >2022

2019 2021 2023 2025Exit/IPO

2022

Maximize value from Topadur’s unique IP platform through early

partnering (after preclinical in vivo proof of concept)and Out-licensing

Alopecia/hair loss, skin aging/dermatology, PAH, colorectal cancer,

HNSCC, hearing loss

Bring Topadur’s priority projects to clinical proof of

concept before out-licensing to global partners

Wound healing, normal tension glaucoma

Become a global

player in a niche

market after IPO

Digital ulcer in

scleroderma


Opportunities

Priorities

Sustainable development

OverviewFinancials

Financial Forecast

Based on the rich and innovative Topadur portfolio, we expect significant future income from Out-licensing transactions. Leading up to Exit in 2022 - anticipated are the current Series C financing

at ca. 14 M US$, plus a further equity round of similar size in 2020/2021.


Wound Healing (6-8 M US$):• Clinical development of TOP-N53: FIH, PH1 completed• Development of topical formulation for TOP-N53 and topical toxicology completed • Rare disease designation of TOP-N53 in digital ulcer, clinical POC started

Ophthalmic (normal tense glaucoma) (2-3 M US$):• Complete preclinical ophthalmic profiling of TOP-V122, including in vivo POC ocular perfusion,

in vitro neuroprotection (partially financed by available grant)

Alopecia (2-3 M US$): • Pre-clinical alopecia pharmacology with TOP-M119 completed

(mainly financed by pending grant)• GMP batch production of TOP-M119 • Out-licensing / Partnering Agreement Alopecia (TOP-M119) in place by 2H 2020

Further development of pipeline products (1-2 M US$) (including TOP-N44 and back up products,

OverviewUse of funds

Use of Funds - through mid-2021


Current - Series C Financing (up to 14 M US$)

• Diabetic Foot Ulcer - TOP-N53 wound healing IB, FIH submission• Complete TOP-N53 topical formulation• TOP-N53 POC in digital ulcera rare disease model

• Ophthalmalic - Pre-clinical POC, ocular PK (Out-licensing 2020-21; Top-V122)

• Hair Growth - Complete pre-clinical POC (Out-licensing 2020; Top-M119)

• PAH - define collaboration strategy clarification (Out-licensing 2020; Top-N53)

• Hearing Loss - Evaluate potential for TOP-M119 to stop/slow hearing loss• Skin Aging - Evaluate potential for TOP-M119 skin perfusion• Oncology - Evaluate potential of Topadur’s Dual MoA drugs for Wnt induced cancer

- Evaluate early partnering for prevention of Colorectal Cancer

Next Round - Series D Financing (ca. 13.5 M US$) end-2020 to mid-2021- plus grants in total 3.5 M US$.

Outlook Priorities - 2019 / 2020

OverviewPriorities


Management

Expertise - Topadur Leadership

RETO NAEF, CEO

PhD Chemistry - ETH-Z MBA Executive Mgt. - UZH

33 years Pharma Research14 patents, key contributionsat Novartis: Onbrez®, Foradil ®, Xolair ®

CHRISTIAN LUDIN Head Development & Legal

PhD Chemistry - Univ FreiburgMSc OperationsMgt CEIBSLLM in Law UZH

23 years Pharma R&D25 patents, key contributions:Murepavadin , Balixafortide

CHRISTINA ATTAALLA Finance, HR, LegalB.A. - AKAD Zürich

26 years heading finance and executive board member in SMU

HERMANN TENOR Head Research

MD - Charité Berlin

26 years Pharma Research9 patents, key contributions:Daxas ®, Pantoprazol ®, Ciclesonide ®

GUIDO KOCH, COO

PhD Chemistry - Univ Basel

22 years Pharma R&D8 patents, key contributions:Patupilon, Discodermolide


Board

Expertise - Topadur Board

Dr. DOMINIK ESCHER Founder of several biotech companies;ESBATech, Delenex, CDR life.Successful exits >600 M CHF,President Swiss Biotech Association

Inventor of Beovu®, FDA app. Oct. 19

Dr. CHRISTIAN LUDINSecretary

Dr. RETO NAEFPresident

Prof. Dr. GUENTHER WESS More than 15 years R&D managementin PharmaR&D Europe Head of Aventis15 years Head at Helmholz Munich

PASCAL BRENNEISEN More than 15 years executive positions in Big Pharma (Sandoz, Novartis, HPE, Shire)Experienced board member in Pharma


• Drug R&D Platform (at FIH), based on unique patented Dual MoA with low systemic exposure and excellent tolerability

• TOP-N53: enables Healing of Chronic Wounds, DFU start FIH clinical trial end-2019

• Strong IP, several Patents filed (3+1 ready), first granted in several countries

• Full Pipeline with Own plus Out-licensing Development Products

• Rapid Cash Inflow / Exit Potential via Out-licensing + Trade Sale or IPO (2022)

• Experienced Leadership - Team and Board

• Enormous Market Potential across several indications

• Promising Ophthalmic and Alopecia Program (in-vivo POC)

• Solid potential for several additional high medical need indications

OverviewTopadur

Summary


1. TOP-N53 2. TOP-V122, TOP-T5DIABETES FOOT GLAUCOMA, OPHTHAPAH PAH (back-up)

3. TOP-M119 4. TOP-N44ALOPECIA BURN WOUNDSHEARING LOSS

“HEALTH IS THE MOST IMPORTANT THING“

- Winner - IMD Startup 2016

- Top 100 - Swiss Startups 2017

- Winner - Swiss Innovation Challenge 2017

- Winner - Venture Leaders China 2018

- Winner - SEF High-Tech Award 2018


- Winners - Pitching Battle CEO day 2015

- Finalist - Swiss Innovation Challenge 2015

- Winner - Venture Leaders Life Science 2016


- CTI - Label Company 2016


AWARDS:

Documents

INNOVATIVE DRUGS IN STIMULATING LOCAL BLOOD …€¦ · Focus on Topadur priority projects Develop to clinical phase 2 2019-22 Grow and become a global player for rare wound healing