Stemrim Inc. · TSE:4599
Stemrim — FY2024 Earnings Presentation
40 slides from Stemrim's earnings presentation, Sep 13, 2024
Slide 1: Presentation Material: Financial Results for the Fiscal Year Ended July 31, 2024
（TSE Growth︓4599） Presentation Material Financial Results for the the Fiscal Year Ended July 31, 2024 September 13, 2024
Slide 2: Overcoming Refractory Diseases by Regeneration-Inducing Medicine
Stem cell Regeneration-Inducing Medicine Overcoming Refractory Diseases by TM “Regeneration-Inducing Medicine ” StemRIM is a biotech company aiming to develop TM “Regeneration-Inducing Medicine ” a next generation of regenerative medicine. TM “Regeneration-Inducing Medicine " is new class of medicin
Slide 3: Mode of Action of Regeneration-Inducing Medicine
TM Mode of Action of “Regeneration-Inducing Medicine ” Bone marrow mesenchymal stem cells mobilized into the peripheral blood stream induce the tissue regeneration. Administration of “Regeneration- : Damaged site TM Inducing Medicine ” Chemokines produced in necrotic tissue (e.g. SDF-1α) Mobilizing
Slide 4: Agenda
Agenda 1. Summary of Financial Results for FY 2024 2. Summary of Business Activities for FY 2024 3. Business Development Activities of TRIM3 and TRIM4 Projects 4. Activities of “StemRIM Institute of Regeneration-Inducing Medicine, Osaka University” 5. Activities for Sustainability Goals Appendix 4
Slide 5: 1. Summary of Financial Results for FY 2024
１. Summary of Financial Results for FY 2024 5
Slide 6: Summary of Financial Results
Summary of Financial Results ・For FY 2024, there were no recognition of milestone revenues related to research progress or upfront payments from contracts. As a result, operating revenue was none . Since we are a drug discovery bio- venture, we have an unstable revenue structure considering our busi
Slide 7: 2. Summary of Business Activities for FY 2024
２. Summary of Business Activities for FY 2024 7
Slide 8: Summary of Business Activities for FY2024
Summary of Business Activities for FY2024 Phase 2 clinical trial targeting Ischemic Cardiomyopathy for Redasemtide has begun in June 2024. Additionally, multiple patents have been granted in various countries. Month/Year History Patent Registration (China) for the Use of the HMGB1 Fragment Peptide,
Slide 9: Overview of Development Pipeline
Overview of Development Pipeline Development Stage Project Investi- Out-license Development candidate Indication Status Pre- Phase 1 Phase 2 Phase 3 code gator Research clinical study study study partner Epidermolysis Shionogi & Additional P2 Study -01 bullosa Co., Ltd. Ongoing * Acute Ischemic Shio
Slide 10: PJ1-03: Phase 2 Clinical Trial in Ischemic Cardiomyopathy
PJ1-03:Phase 2 Clinical Trial in Ischemic Cardiomyopathy Ischemic Cardiomyopathy Phase 2 Protocol Study Evaluation of the efficacy and safety of Redasemtide in objectives patients with ischemic cardiomyopathy Study design Multicenter, Randomized, Double-blind, Placebo-controlled Infarct site Ectoder
Slide 11: 3. Business Development Activities of TRIM3 and TRIM4 Projects
3. Business Development Activities of TRIM3 and TRIM4 Projects 11
Slide 12: Next-generation Regeneration-Inducing Medicine TRIM3, TRIM4
TM Next-generation “Regeneration-Inducing Medicine ” TRIM3, TRIM4 We have identified several peptides that mobilize mesenchymal stem cells from the bone marrow into the bloodstream, accumulate in damaged tissues, and induce functional regeneration. Among them, two peptides with particularly prominen
Slide 13: Out-licensing activities for new Regeneration-Inducing Medicine
TM Out-licensing activities for new “Regeneration-Inducing Medicine ” FY 2024.7 Conference Participation BioJapan 2023 2023.10.11～13 ＠Yokohama 42nd Annual J.P. Morgan Healthcare Conference 2024.1.8～11 ＠San Francisco, CA BIO International Convention 2024 2024.6.3～6 @San Diego, CA FY 2023.7 Conference
Slide 14: IP Strategy
IP Strategy TM Patents related to “Regeneration-Inducing Medicine ” have been granted in various countries. We are steadily promoting the intellectual property protection of our research outcomes, paving the way for global expansion. Patent Grant Status Number of IP （Case） Total Patents 125（+12） +12
Slide 15: 4. Activities of StemRIM Institute, Osaka University
4. Activities of “StemRIM Institute of Regeneration- Inducing Medicine, Osaka University” 15
Slide 16: R&D Structure and Facilities
R&D Structure and Facilities StemRIM Institute of Regeneration-Inducing Medicine, Osaka University will be established in June 2020 on the Suita Campus of Osaka University as a world-leading research and development center for “Regeneration- TM Inducing Medicine ” research. TM Other domestic and ・Ba
Slide 17: Activities of StemRIM Institute of Regeneration-Inducing Medicine, Osaka University
Activities of “StemRIM Institute of Regeneration-Inducing Medicine, Osaka University” In June 2020, StemRIM Institute of Regeneration-Inducing Medicine, Osaka University (covering an area of 1,540 square meters) was established on the 6th and 7th floors of the Techno Alliance Building at Osaka Unive
Slide 18: 5. Activities for Sustainability Goals
5. Activities for Sustainability Goals 18
Slide 19: Approach to Sustainability
Approach to Sustainability TM Under the corporate philosophy of ‘Overcoming Refractory Diseases by “Regeneration-Inducing Medicine ” TM ,’ we are actively engaged in the development of next-generation pharmaceuticals, “Regeneration-Inducing Medicine ” , which overcome the challenges of conventional
Slide 20: Sustainability Initiatives
Sustainability Initiatives 1 Fostering a workplace culture where diverse talent can thrive We recognize that securing and continuously developing diverse talent with advanced expertise, skills, and experience, as well as fostering a workplace culture where employees can thrive, are critical to achie
Slide 21: Sustainability Initiatives
Sustainability Initiatives ２ Creating a Safe and Comfortable Working Environment We believe that supporting our employees' growth to help them thrive leads to sustainable and stable organizational development. With the aim of creating a more comfortable working environment, we regularly review and u
Slide 22: Sustainability Initiatives: Intellectual Property
Sustainability Initiatives 3 Initiatives related to intellectual property Our company operates a business model in which we license out the development and sales rights of the pharmaceuticals we develop to pharmaceutical companies, generating revenue through upfront payments, milestone payments, and
Slide 23: Appendix
€2 stemrim Appendix
Slide 24: PJ1-01: Redasemtide (Dystrophic Epidermolysis Bullosa)
PJ1-01:Redasemtide(Dystrophic Epidermolysis Bullosa) Additional Phase 2 Protocol Evaluation of efficacy and safety of Redasemtide in patients with dystrophic epidermolysis Study objectives bullosa having intractable ulcers Study design Single arm, multicenter, open label, uncontrolled Intervention R
Slide 25: PJ1-02: Redasemtide (Acute Ischemic Stroke)
PJ1-02：Redasemtide（Acute Ischemic Stroke) Global Phase 2b Protocol Study objectives Verification of efficacy of Redasemtide in patients with acute ischemic stroke • Can be administered within 25 hours from the onset of symptoms to the patients at age 18 or Subject older population • Baseline NIHSS s
Slide 26: PJ1-04: Redasemtide (Knee Osteoarthritis)
PJ1-04：Redasemtide(Knee Osteoarthritis) Phase 2 Protocol Study objectives Evaluation of efficacy and safety of Redasemtide in patients with Osteoarthritis (OA) of the knee Subject Patients with knee OA who have undergone high tibial osteotomy (HTO) and arthroscopic population microfracture Study des
Slide 27: PJ1-05: Redasemtide (Chronic Liver Disease)
PJ1-05：Redasemtide(Chronic Liver Disease) Phase 2 Protocol Main purpose Evaluate the safety and exploratory efficacy in patients with chronic liver disease Clinical trial design Single arm study, Open label, Uncontrolled Patients with chronic liver disease with liver hardness test results of 4 kPa o
Slide 28: Discovery of in-vivo mechanism inducing tissue regeneration
Discovery of in-vivo mechanism inducing tissue regeneration ・Differences between normal skin and epidermolysis bullosa skin In normal skin (Figure A), type 7 collagen functions like an adhesive, bonding the epidermis and dermis, the superficial layers of skin. In epidermolysis bullosa congenita (Fig
Slide 29: Discovery of in-vivo mechanism inducing tissue regeneration
Discovery of in-vivo mechanism inducing tissue regeneration TM The beginning of the research and development on “Regeneration-Inducing Medicine ” : Hypothesis of stem cell recruitment mechanism from bone marrow to damaged skin. Necrotic epidermis with Despite loss of epidermal stem blood flow disrup
Slide 30: Discovery of in-vivo mechanism inducing tissue regeneration
Discovery of in-vivo mechanism inducing tissue regeneration Discovery of crosstalk mechanism between damaged skin and bone marrow mesenchymal stem cells via necrotic tissue-derived factor Necrosis of epidermal cells Peeled epidermis HMGB1 released Damaged skin Cytoplasm Epidermal cells Nucleus HMGB1
Slide 31: HMGB1 peptide drugs with improved safety
HMGB1 peptide drugs with improved safety Designing highly safe, chemically synthesized peptide drug from A-Box domain of HMGB1 protein C23 C45 C106 N C HMGB1 protein A box B box Tail An Important in vivo molecule that activate tissue regeneration Prof. Katsuto Tamai Osaka University Identifying the
Slide 32: Advantages of Regeneration-Inducing Medicine
TM Advantages of “Regeneration-Inducing Medicine ” Epidermis formation during human development Carnegie developmental stage (developmental stage of vertebrate embryos) CS1 10 20 30 40 50 60 fertilized eggs CS9*：Embryo section (ectoderm) epidermis 2-cell blastodermic vesicle (inner cell mass ⇒ ES ce
Slide 33: Advantages of Regeneration-Inducing Medicine
TM Advantages of “Regeneration-Inducing Medicine ” Ectodermal mesenchymal stem cells have high pluripotency and differentiation ability to various tissues. Tissues into which differentiation has been confirmed in our collaborative research with Osaka University Tissues into which differentiation is
Slide 34: Expanding Indications and Markets (Number of patients)
Expanding Indications and Markets(Number of patients) Targeting all areas where mesenchymal stem cell therapy can be effective Other countries and regions ：Clinical trial on going Traumatic brain Cardiomyopathy injury 121K in US 13.5M in US In Japan Cerebral infarction Traumatic brain (acute phase)
Slide 35: Functions of mesenchymal stem cells
Functions of mesenchymal stem cells In-vivo mesenchymal stem cells have 5 distinctive capabilities 1. Cell migration ability 3. Trophic factor secretion ability Mesenchymal stem cells migrate to damaged tissue via the Promotes cell proliferation and tissue repair by secreting growth bloodstream fact
Slide 36: In vitro culture reduces the functions of MSCs
In vitro culture reduces the functions of MSCs TM “Regeneration-Inducing Medicine ” can avoid functional degradation of mesenchymal stem cells due to in vitro culture TM Manufacturing process of conventional cellular medicine Induction of MSC in “Regeneration-Inducing Medicine ” Mesenchymal stem cel
Slide 37: Summary of advantages of Regeneration-Inducing Medicine
TM Summary of advantages of “Regeneration-Inducing Medicine ” TM “Regeneration-Inducing Medicine ” includes advantages in both cell therapy and chemicals “Regeneration-Inducing TM Medicine ” Cell therapy Chemicals Applicable for large Tissue Applicable for large- tissue damage with large No regenera
Slide 38: Summary of advantages of Regeneration-Inducing Medicine
Summary of advantages of “Regeneration-Inducing MedicineTM” TM “Regeneration-Inducing Medicine ” can solve the four major problems of conventional cell therapy Cancerization risk Risk of cancer depending on the site of gene insertion iPS cell Somatic ES cell “Regeneration- stem cells Inducing Medici
Slide 39: Corporate information
Corporate information Month/ Company History StemRIM Inc. Year name Established a company aiming to develop new drugs based on the Oct. 2006 discovery of bone marrow multi-potent stem cell mobilization factors Chief Masatsune Okajima (Representative identified by Professor Katsuto Tamai of the Gradu
Slide 40: StemRIM Management
StemRIM Management Director Noriko Sawai, External director Head of healthcare team, Social Innovation and Investment Masatsune Okajima, President and CEO Foundation (Aug. 2022 – present) President and CEO, StemRIM Inc. (Oct. 2023 – Present) Impact Officer, Social Innovation and Investment Foundatio