innovative drugs in stimulating local blood …€¦ · focus on topadur priority projects develop...
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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
Reto.naef@topadur.com
© Topadur Pharma AG | November 2019
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
© Topadur Pharma AG | November 2019
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
© Topadur Pharma AG | November 2019
Endothelial Dysfunction -The Solution
Topadur’s unique Drug Platform - based on sGC Stimulation and PED5 Inhibition
© Topadur Pharma AG | November 2019
Key target cells
Cellular targets and funcional effects increasing cGMP signaling; Topadur’s dual MoA drugs
© Topadur Pharma AG | November 2019
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
© Topadur Pharma AG | November 2019
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 Pharma AG | November 2019
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
© Topadur Pharma AG | November 2019
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$, plus a further equity round of similar size in 2020/2021.
© Topadur Pharma AG | November 2019
Wound Healing (6-8 M US$):• 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$) (including TOP-N44 and back up products,
OverviewUse of funds
Use of Funds - through mid-2021
© Topadur Pharma AG | November 2019
Current - Series C Financing (up to 14 M US$)
• 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
© Topadur Pharma AG | November 2019
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
© Topadur Pharma AG | November 2019
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
© Topadur Pharma AG | November 2019
• 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
© Topadur Pharma AG | November 2019
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
- Top 100 - Swiss Startups 2018
- Winners - Pitching Battle CEO day 2015
- Finalist - Swiss Innovation Challenge 2015
- Winner - Venture Leaders Life Science 2016
- Top 100 - Swiss Startups 2016
- CTI - Label Company 2016
- Top 100 - Swiss Startups 2019
AWARDS:
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