Niki BioSolutions, Inc. · NASDAQ:NIKI
Niki BioSolutions — Aptorum Group — Technical Presentation (June 2022)
18 slides from Niki BioSolutions's technical presentation, Jun 9, 2022
Slide 1: Facilitating Life Science Innovations to Serve Unmet Medical Needs
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Facilitating Life Science Innovations to Serve Unmet Medical Needs SMART - ACT Ρ - ORPHAN DRUG DEPURPOSING PLATFORM SACT - 1 Nonconfidential Overv
Slide 2: Forward-looking statements
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited This document includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward - loo
Slide 3: Executive summary
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • SACT - 1 is a repurposed oral suspension in development a s an adjunctive therapy to standard of care in relapsed or refractory high - risk neur
Slide 4: Executive summary (cont'd)
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Our completed Phase 1 trial showed the safe use of SACT - 1. The distinctive PK between SACT - 1 and Edurant ® further strengthen the advantage
Slide 5: MEK5 and ERK5 as potential therapeutic targets for cancers
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited So far no approved products are available MEK5 and ERK5 as potential therapeutic targets for cancers in recent years
Slide 6: Proposed mode of action
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • MEK5 - ERK5 pathway is reported to regulate MYCN oncogene expression (Kang et al., 2006; Umapathy et al., 2014; van Hoang et al., 2017) which is
Slide 7: Targeted product profile
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 7 Targeted product profile Preclinical Toxicology Not relevant as this is a repurposed drug PK/PD Model To be determined in Phase 1b/2a trial CM&C
Slide 8: Neuroblastoma - market overview
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • ~ 700 cases of high - risk neuroblastoma patients each year in the US 3 and we estimated EU has 1.5x this number of cases, c. 1050 high risk neu
Slide 9: Standard of care for high-risk neuroblastoma
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Standard of care for high - risk neuroblastoma • Surgery • Chemotherapy • Radiotherapy • Immunotherapy (anti - GD2 monoclonal antibodies) o Dinutu
Slide 10: In vitro and in vivo efficacy
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 10 In vitro and in vivo efficacy In vitro • SACT - 1 demonstrated inhibition of all tested neuroblastoma cell lines (IMR - 32, SK - N - BE(2), SK
Slide 11: In vivo efficacy - neuroblastoma xenograft studies in mice
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 11 In vivo efficacy - neuroblastoma xenograft studies in mice Cont’d SACT - 1 (RPV) dosed at 60 and 160 mg/kg (PO; daily x 21) potentiates the ant
Slide 12: Mechanistic studies - decrease of MYCN expression
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • MYCN is involved in regulating various biological activities, such as apoptosis, proliferation, and angiogenesis in neuroblastoma (Huang and Wei
Slide 13: Mechanistic studies - ERK5 phosphorylation
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • SACT - 1 was found to have a binding constant (K D ) of 150 nM against MEK 5 in a previous study by employing KdELECT Kinase Assay Panel • Expec
Slide 14: Phase I study on bioavailability/food effect
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 14 Phase I study on bioavailability/ food effect Relative Bioavailability • Comparative bioavailability analysis between administration of SACT -
Slide 15: Clinical Development Plan
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Phase 1: Open - label, Randomized, 3 period, 3 - sequence, Single - dose Crossover Bioavailability and Food Effect Study of SACT - 1 and Edurant
Slide 16: Phase 1b/2a trial: Proposed Primary and Secondary Objectives
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Phase 1b/2a trial: Proposed Primary and Secondary Objectives Phase 1b Primary Objective • Evaluate the safety and tolerability of SACT - 1 in comb
Slide 17: Intellectual property
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 17 Intellectual property Exclusive IP Title Country Application Date Expiration date Status Composition Including SACT - 1 and Method for Tr
Slide 18: of any 2022 Aptorum Group Limited
For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 18