Alzecure Pharma Ab · OMXSTO:ALZCUR
Alzecure Pharma Ab — Redeye Investor Forum 2025
33 slides from Alzecure Pharma Ab's conference presentation, Jun 11, 2025
Slide 1: Developing therapies for Alzheimer's & Pain
June 11, 2025 Developing therapies for Alzheimer’s & Pain Martin Jonsson, CEO
Slide 2: Forward-looking statements
This presentation contains forward-looking statements regarding the Company’s intentions, assessments, or expectations in respect of the Company’s future results, financial position, liquidity, development, prospects, expected growth, strategies and possibilities as well as the market within which t
Slide 3: Company overview: Alzheimer's disease and pain
➢ Working in Alzheimer’s Disease (AD) and Pain – Hugh unmet medical need & multi-billion sales potential ➢ Spin-out from AstraZeneca – as a result of their exit from the CNS area ➢ Founded in 2016, out of a research foundation sponsored by Alzheimerfonden ➢ Based at Novum Science Park, Karolinska In
Slide 4: R&D company with out-license and partner model
• We are a Research & Development company • Research & develop through early clinical phase and then to out-license or partner on our projects • Gain incomes through: − Upfront payments − Milestone payments − Royalties on sold products 4
Slide 5: NeuroRestore: multiple candidates increase chance of success
– Multiple candidates increase chance of success Platform Candidate Target Indication Research phase Preclinical phase Phase I Phase II Phase III NeuroRestore® Alzheimer’s Disease, TBI - Traumatic brain Positive allosteric injuries Positive read-out Phase I trial ACD856 modulator (PAM) of Parkinson’
Slide 6: Scientific advisors
Professor Bengt Winblad Professor Maria Eriksdotter Professor Henrik Zetterberg Karolinska Institute Karolinska Institute Sahlgrenska and UCL 6
Slide 7: Professor Jan Lundberg
Professor Jan Lundberg has more than 25 years of experience from leading positions in global pharmaceutical companies, including as global head of research at Astra and then AstraZeneca (1996 – 2009) and global head of research & development at Eli Lilly (2010 – 2018). He has led the development of
Slide 8: Meeting needs of AD patients: Alzstatin and NeuroRestore
MEETING NEEDS OF AD PATIENTS – ADRESSING SHORT TERM NEEDS WITH LONG-TERM BENEFITS Preventive Disease-modifying therapy Symptomatic & pot. Disease-modifying therapy Alzstatin® NeuroRestore® Gamma-secretase modulator Trk-PAM Targeting Amyloid Production Improving Neuronal & Cognitive Function - Novel
Slide 9: Alzstatin
Alzstatin® MoA: Gamma-Secretes-Modulator Targeting Toxic Amyloid Production - Novel Oral Small Molecule
Slide 10: Alzstatin: gamma-secretase modulator
Alzstatin® – gamma-secretase modulator Toxic protein formations – Aβ42 amyloid pathology & plaque – are harming and destroying the brain. The formation process is called the Amyloid Cascade Toxic protein formations, built up of Aβ-42, are harming and destroying the brain structures.
Slide 11: Alzstatin: toxic protein formations
Alzstatin® – gamma-secretase modulator Aβ Toxic protein formations, built up of Aβ-42, are harming and destroying the brain structures. 11 *) GSM = Gamma Secretes Modulator
Slide 12: Alzstatin reduces toxic A42 in mice
Alzstatin® – gamma-secretase modulator 0 30 100 200 µmol/kg Alzstatin potently reduces the Alzstatin reduces toxic A42 and A40, while amount of toxic brain A42 in mice increasing protective A38 and A37 peptides 12
Slide 13: Two-photon preclinical study in APP/PS1 mice
Alzstatin® – gamma-secretase modulator Two-photon-study preclinical study in APP/PS1 mice Vehicle AZ4126 Day 0 Day 28 Day 0 Day28 28-day GSM treatment: • Reduces amyloid plaque growth • Decreases new plaque appearance Birth Growth Unchanged Regression • Induces plaque regression* *Plaque regression
Slide 14: Maintenance, combination and preventive therapy
Alzstatin® – gamma-secretase modulator Maintenance therapy - in patients with established Alzheimer’s • Treatment after initial plaque clearance by monoclonal antibody treatment (as initially proposed by Lilly) e.g., with: Lecanemab (Eisai/Biogen/Bioarctic) & Donanemab (Lilly) Combination therapy -
Slide 15: Phase I will demonstrate PoM and target engagement
Alzstatin® – gamma-secretase modulator • Phase I will demonstrate PoM and central target engagement − SAD/MAD studies conducted in healthy volunteers + AD patients − Evaluation of safety and tolerability after single and repeated administration − Possibility to explore biomarker effects showing cent
Slide 16: Patent and market exclusivity for ACD680
Alzstatin® – gamma-secretase modulator • Recently submitted composition of matter patent application for ACD680 • Patent life expected until 2045 • Additional 5-year market exclusivity in the USA → 2050
Slide 17: NeuroRestore: Trk-PAM
NeuroRestore® Trk-PAM Improving Neuronal Function & Cognition - Novel Oral Small Molecule Shown safety, tolerability & target engagement in clinical trial phase 1 => In preparation for ph 2
Slide 18: Reduced BDNF/NGF levels and brain health
NeuroRestore® – positive allosteric modulator of Trk-receptors • The neurotrophins Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF) are key for brain health and cognition • BDNF& NGF bind to their respective receptors, TrkB and TrkA • BDNF& NGF signaling are implicated in sever
Slide 19: ACD856: positive modulator of Trk-receptors
NeuroRestore® – positive allosteric modulator of Trk-receptors TrkA/B • ACD856 is a novel small molecule positive modulator of Trk- NGF/ receptors enhancing the BDNF signaling of neurotrophins such as NGF & BDNF • The enhanced signaling leads to immediate symptomatic effects & with potential long-te
Slide 20: Learn, store, remember
NeuroRestore® – positive allosteric modulator of Trk-receptors Stages of memory formation LEARN STORE REMEMBER Transforming Maintaining the Re-accessing the information into a form encoded information from that can be stored in information in the past which has memory memory been encoded and stored
Slide 21: ACD856 phase 1 results
NeuroRestore® – positive allosteric modulator of Trk-receptors • ACD856 is safe & well tolerated − Single and repeated dosing with ACD856 did not result in any serious adverse events in healthy volunteers at the tested dose levels • ACD856 has an excellent PK profile suitable for once daily oral dos
Slide 22: EU grant for phase 2 trial of ACD856
NeuroRestore® – positive allosteric modulator of Trk-receptors https://www.alzecurepharma.se/en/alzecure-receives-eu-grant-for-phase-2-clinical-trial-of-neurorestore-acd856-for-alzheimers-disease/
Slide 23: Patents and market exclusivity for ACD856
NeuroRestore® – positive allosteric modulator of Trk-receptors => In addition, being a NCE, there is 5 years of expected market exclusivity in the US => 2039 + 5 years = 2044 23 https://www.alzecurepharma.se/en/alzecure-receives-us-patent-for-neurorestore-acd856/ https://www.alzecurepharma.se/en/alz
Slide 24: Osteoarthritis and neuropathic pain projects
Osteoarthritis & severe pain conditions Neuropathic pain > 300 million patients > 600 million patients Project: TrkA-NAM Project: ACD440 Negative allosteric modulator of Topical TRPV1 antagonist in clinical Phase II TrkA-receptors in research phase 24
Slide 25: TrkA-NAM differentiation factors
TrkA-NAM – a negative allosteric modulator Attractive E.g. osteoarthritis in patients who have experienced insufficient pain relief Target population from 1st line standard of care or unacceptable side effects Clinical Mechanism with strong validation – step-changing clinical efficacy with validatio
Slide 26: TrkA-NAM compared with competitor compounds
TrkA-NAM – a negative allosteric modulator Compound Company TrkA TrkB TrkA vs Status Indication (nM) (nM) TrkB ACD137 AlzeCure 0.087 26 400 30,300 Preclin OA* & other pain conditions Cmpd #10 Array Bio. 0.038 210 5,500 Phase OA AK1830 Ashai Kasei 2b LBP^ Cmpd #23 Pfizer 0.64 145 230 inactive OA Cmpd
Slide 27: ACD137 in rat MIA model
TrkA-NAM – a negative allosteric modulator • We have used the rat MIA model to assess the cartilage degeneration, localized inflammation, and pain behaviors after administration of TrkA-NAM compounds, including ACD137, as well as Tanezumab. • RESULTS SHOW: ➢ Potent pain relief in both movement-induc
Slide 28: Patent and exclusivity for ACD137
TrkA-NAM – a negative allosteric modulator • Recently submitted composition of matter patent application for ACD137 • Patent life expected until 2045 • Additional 5-year market exclusivity in the USA → 2050
Slide 29: ACD440: TRPV1 antagonist project overview
ACD440 – a TRPV1 antagonist PROJECT OVERVIEW › Approximately 20M USD already invested in project development Emanates from › Mode of action confirmed in several Phase 1 clinical trials Big Pharma › Synthesized compound and formulation developed TRPV1 – › The vanilloid receptor subtype 1 (TRPV1) is e
Slide 30: Huge potential for ACD440 Gel
ACD440 – a TRPV1 antagonist • Oral treatments used for neuropathic pain have limited efficacy – Up to 80% aren’t experiencing sufficient pain relief • Topical treatment, including lidocaine patches and capsaicin patches are used but with limited level of efficacy • More than 50% of patients received
Slide 31: ACD440 phase 2a results
ACD440 – a TRPV1 antagonist • Demonstrate Positive Proof-of-Mechanism (PoM) results in patients with chronic peripheral neuropathic pain in a placebo cross-over trial • The patients have had chronic pain for many years & were on concomitant medication − A significant analgesic effect on pain induced
Slide 32: Targeting significant unmet medical needs
Targeting areas of significant unmet medical needs m Strong team with extensive experience and track record – from idea to clinic Platforms with first-in-class properties and potential game-changers Parallel investments in several candidates and potent follow-up programs Multi-billion dollar market
Slide 33: Contact details
Karolinska Institutet Novum Science Park Hälsovägen 7, 141 57 Stockholm SWEDEN Martin.jonsson@alzecurepharma.com www.alzecurepharma.com