Slide 1: Neuro-regenerative therapeutics for Parkinson's disease
Neuro-regenerative therapeutics for Parkinson’s disease Antti Vuolanto, D.Sc. 1
Slide 2: Forward-looking statements
Forward-looking statements 2
Slide 3: Executive Summary
Executive Summary Clinical-stage public company developing therapeutics for Parkinson’s disease (PD) and other CNS disorders HER-096: a disease-modifying peptide mimic of CDNF protein, shown to reverse damage and break the cycle of PD pathogenesis Phase 1a with subcutaneous administration: • Efficie
Slide 4: Innovation is urgently needed for PD treatment
Innovation is urgently needed for PD treatment % of patients not responding to current therapeutics Current therapies only treat symptoms and have significant side effects 43% 39% Many patients have no symptomatic benefit, LEVODOPA/CARBIDOPA ROPINIROLE and none improve 34% 27% No disease-modifying o
Slide 5: HER-096 is an enhanced Phase 1–stage therapeutic based on clinically validated protein CDNF
Herantis’ HER-096 is an enhanced Phase 1–stage therapeutic based on clinically validated protein CDNF CDNF HER-096 CDNF active site Phase 1 clinical trials of CDNF show unprecedented signs of HER-096 mimics the CDNF active site and is neuroprotection and neuro-regeneration in the most optimized to c
Slide 6: HER-096 has a neuro-restorative, disease-modifying mechanism of action
HER-096 has a neuro-restorative, disease-modifying mechanism of action DEGENERATING DOPAMINERGIC NEURON (pre-synaptic / transmittor) ACTIVATED MICROGLIAL CELLS RESTING MICROGLIAL CELLS 2. Accumulation of 2. Decreased ⍺-synuclein toxic ⍺-synuclein aggregates aggregates 1. Normalized 1. Endoplastic HE
Slide 7: Key Advantages of HER-096
Key Advantages of HER-096 Neuro-restorative Subcutaneous Safe 7
Slide 8: HER-096 has potential utility in several neurodegenerative and ischemic diseases
BEYOND PD: HER-096 has potential utility in several neurodegenerative and ischemic diseases ALS Alzheimer’s disease HER-096 Stroke Neuro-regeneration 8
Slide 9: Data & Clinical Trial Design
Data & Clinical Trial Design Preclinical, Phase 1a and Phase 1b 9
Slide 10: In vivo preclinical studies show the unique disease-modifying mechanism-of-action of HER-096
MECHANISM OF ACTION In vivo preclinical studies show the unique disease-modifying mechanism-of-action of HER-096 Reduced α-Syn aggregates Reduced neuroinflammation Increased dopaminergic neurons and dopamine +58% +182% +182% Mice were administered IP a human-equivalent dose of 200 mg HER-096 3 times
Slide 11: Preclinical studies of HER-096 demonstrate potent neuroprotection
Beam-walking test PRECLINICAL EFFICACY Preclinical studies of HER-096 demonstrate potent Normal aged mouse with no treatment neuroprotection Aged PD model mouse with no treatment PD mouse model administered HER-096 has superior beam walking speed to both untreated PD mouse and normal aged mouse Aged
Slide 12: Neurorestoration by intraputamenal CDNF protein in a Rhesus model of PD
PRECLINICAL PROOF-OF-CONCEPT Neurorestoration by intraputamenal CDNF protein in a Rhesus model of PD 6% Three monthly doses of intraputamenal CDNF* were administered in an aged Rhesus monkey MPTP model starting six weeks after MPTP lesion. Clinical improvement was measured by PDRS and histological i
Slide 13: Phase 1 proof-of-concept study of intraputamenal CDNF shows signs of biological response
PHASE 1 CLINICAL SAFETY & PROOF-OF-CONCEPT Phase 1 proof-of-concept study of intraputamenal CDNF shows signs of biological response in advanced PD patients 6% Safe and well-tolerated An intraputamenal device was implanted for administration of CDNF. Patients were at least 10 years post-diagnosis and
Slide 14: Completed Phase 1a clinical trial of subcutaneous HER-096: design and objectives
PHASE 1A DESIGN Completed Phase 1a clinical trial of subcutaneous HER-096: design and objectives Study design: Part 1: Part 2: Male, age 20-45 years Male & female, age >50 years • CDNF Protein Single escalating dose Single dose • Sing le d ose , 300 mg 2 placebo + 6 HER-096 • Sing le d ose , 200 mg
Slide 15: HER-096 effectively penetrates blood-brain-barrier and shows expected pharmacokinetics
PHASE 1A PHARMACOKINETICS/PHARMACODYNAMICS HER-096 effectively penetrates blood-brain-barrier and shows expected pharmacokinetics in healthy elderly individuals Levels of HER-096 in CSF after subcutaneous administration Plasma HER-096 in elderly individuals (single s.q. 200 mg dose) Normalization by
Slide 16: Phase 1b Clinical Trial Design
Phase 1b Clinical Trial Design Study started Sep 2024 / expected topline data Q3/2025 Objectives Endpoints 1. 2. 3. Primary Secondary Exploratory Study subjects Dosing 16
Slide 17: Business & Funding
Business & Funding HERANTIS PHARMA 17
Slide 18: The unmet medical need in PD is matched by a large global market for PD therapeutics
MARKET SIZE The unmet medical need in PD is matched by a large global market for PD therapeutics 20% Conservative estimate for market capture based on competitive landscape $9B $2B Conservative Yearly 1.1M Revenue Estimate for HER-096 $10B Projected market in 3.2% target geographies (number of patie
Slide 19: €3.6M cash
HIGHLIGHTED PRESS RELEASE Secured research funding for Phase 1b clinical trial of HER-096 for PD Projects supported €3.6M cash Herantis has secured €6.1M non-dilutive research funding since April 2023 Herantis has secured €15M investment commitment from EIB 19
Slide 20: Strong clinical progress matched by consistent investor interest
MILESTONES & FUNDRAISING Strong clinical progress matched by consistent investor interest 2014 2017– 2023 2023 1H 2024 2H 2024 2026 IPO €46.5M €2.5 M cash + €15M €3.6 M cash Current Launch Phase 2 Nasdaq First North Aggregate sum equity investment Phase 1b funding from Preparing for Phase Trial of H
Slide 21: Executive Team
Executive Team Antti Vuolanto, DSc Tone Kvåle Henri Huttunen, PhD CEO CFO CSO, Co-Founder 20+ years experience in financing, partnering, 25+ years experience in biotech, medtech, and 25+ years experience in neuroscience and R&D, and biologics manufacturing; D.Sc. in life science, including multiple
Slide 22: Board of Directors and Scientific Advisors
BO AR D O F D IREC TO RS SCIENTIFIC ADVISORS Tim o V erom aa, M D , P hD , EM BA Anders Gersel Pedersen, MD Chairman of the Board Chairman of the Scientific Advisory Board Current: Professor of Practice of Drug Development, University of Turku, Finland; C hairman of Current: Board Member and Scienti
Slide 23: Preparing for Phase 2 trial of HER-096 for PD
THE OPPORTUNITY Preparing for Phase 2 trial of HER-096 for PD Milestone Led by Program 2H 2024 1H 2025 2H 2025 1H 2026 2H 2026+ Phase 1b Trial Herantis HER-096 for PD Phase 2 Trial Potential Partner HER-096 for PD Seek Out-lic./Collab. - HER-096 for PD 23
Slide 24: Highlights
Highlights First-in-class disease-modifying, neuro-regenerative therapeutic for Parkinson’s Disease Phase 1 trial of key compound CDNF demonstrated clinical response in several patients, even with advanced-stage disease Successfully completed Phase 1a clinical trial of lead candidate HER-096 Phase 1